Market Access & Health Technology Assesment: Denmark

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Please make a general introduction to the public health sector in your country and its organization

The Danish healthcare system

The Danish public healthcare system is universal – all registered Danish residents are automatically enrolled in the publicly financed system – and it is based on the principles of free and equal access to healthcare. 

The public healthcare system operates across three overall levels: the national level (the state), the regional level (the five Danish regions), and the local level (the 98 municipalities). 

The Danish public healthcare system is decentralized; while the government sets the regulatory framework, is responsible for licensing of healthcare professionals, monitoring and allocates funding, the healthcare services are provided by the regions and the municipalities. 

In 2017, Denmark spent 10.1% of its GDP on health. The largest category of spending is outpatient care (appointments with general practitioners and ambulatory care). Inpatient care (mainly care provided in hospitals) accounted for one fourth of health spending. In 2018, the total expenditures on medicine was DKK 14.523 million. 

In Denmark, the majority of healthcare and social services are financed by general taxes and are supported by a system of central government block grants, reimbursements and equalization schemes. 

Approximately 84% of healthcare expenditure in Denmark is publicly financed, with the remaining spending mostly paid out-of-pocket by households (mainly for medicines and dental care).  

Services covered by the publicly financed healthcare system include:

• Primary care

• Preventive care

• Hospital care

• Medicines prescribed in connection with inpatient hospital care

• Mental health care

• Dental services for children under the age of 18

Certain services (such as maternity care, consultation for preschool children, and home care) are funded by the local municipalities.

Other services and products, such as prescription drugs within the primary healthcare sector and adult dental care, are partially covered through subsidies.

Costs of medicines

There are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals). 

Approximately 60% of the total public expenditure on medicines in Denmark is consumed by hospital medicines. 

Hospital medicine is free-of-charge for patients. Within the primary sector, patients have to pay part of the bill for prescription medicines at local pharmacies. 

The companies placing the medicinal products on the Danish market are in principle free to set the prices for the medicinal products both within the primary sector and the secondary sector. 

However, the unrestricted pricing is to a certain extent influenced by pricecap agreements negotiated every four years by the Ministry of Health, the Danish Regions, and the Danish Association of the Pharmaceutical Industry (Danish: Lægemiddelindustriforeningen or Lif). For more information on the price-cap agreements please see Chapter 3.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities?

As mentioned, the Danish public healthcare system operates across three levels: the national level (the state), the regional level (the five Danish regions), and the local level (the 98 municipalities). 

The Danish public healthcare system is decentralized; while the government sets the regulatory framework, and is responsible for licensing of healthcare professionals, monitoring and allocates funding, the healthcare services are provided by the regions and the municipalities. 

National level

At the national level, the healthcare system is regulated and monitored by the Parliament, the Ministry of Health and a number of governmental agencies, including:

•The Danish Health Authority (which is responsible for advising and support the general population, the Ministry of Health, the regions and the municipalities on health issues, and for ensuring the best possible quality of healthcare and elderly care across the country)

•The Danish Medicines Agency (which is responsible for authorisation and monitoring of pharmaceutical companies, licensing of medicinal products in the Danish market, monitoring adverse reactions from medicinal products, authorisation of clinical trials, deciding on matters concerning reimbursement with respect to medicinal products, monitoring medical devices, and appointing and supervising proprietary pharmacists)

•The Danish Patient Safety Authority (which authorises healthcare professionals and health organisations, and handles the central administration of the reporting system for adverse events in healthcare services)

•The Danish Agency for Patient Complaints (which handles patient complaints and compensation cases)

•The Danish Health Data Authority (which is responsible for developing and running national health registers, digital health solutions and for coordinating efforts to ensure cyber and information security within the Danish healthcare sector)

Regional level

The five regions

Denmark is divided into five regions: the Capital Region of Denmark, the Central Denmark Region, the North Denmark Region, the Region of Zealand, and the Region of Southern Denmark. Each region is governed by democratically elected Regional Councils.

The regions are, i.e., responsible for treatment provided under the Danish healthcare system and operate the Danish public hospitals. The regions are also responsible for the functioning of the medical practice sector, they are funding the majority of the services provided by private general practitioners, and they plan and deliver specialized healthcare services.

The Danish Medicines Council

The treatment of hospital patients is characterized by treatment guidelines made by the Danish Medicines Council (Danish: Medicinrådet). The objective of the Danish Medicines Council is to provide guidance and recommendations on new medicines and standard therapies used in Denmark. The Danish Medicines Council provides information to Amgros who uses the information to negotiate prices with suppliers of medici-nal products. Based on joint evaluations of effectiveness and costs, the Medicines Council issues recommendations to the Danish regions on whether to adopt a medicine as standard treatment.

Amgros

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

The Danish Health Technology Council

The Danish regions have also established the Danish Health Technology Council (Danish: Behandlingsrådet). The objective of the Health Technology Council is to target Danish healthcare resources at the technologies and interventions that provide best value for money, across both physical and mental health services, in order to help raise the quality of health services, ensure more equality in treatments, and reduce cost pressure in the healthcare system. The Health Technology Council conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects. 

Local level

At the local level, Denmark is divided into 98 municipalities. 

The municipalities are, i.e., responsible for financing and delivery of services within nursing home care, certain dental care services, school health services, and rehabilitation.

2. Which are the administrations, bodies and institutions in charge of drug approvals in your country and what are their respective responsibilities?

Development and testing

In order to initiate and conduct a clinical trial with medicinal products, the person or entity in charge of the trial must apply for an authorisation from the Danish Medicines Agency. 

Further, clinical trials with medicinal products involving humans must be approved by a competent state medical committee. 

Manufacturing

The manufacture, import, export, storage, distribution, provision, dispensing, splitting and packaging of medicinal products and intermediate products intended for further processing into medicinal products are subject to authorization from the Danish Medicines Agency. 

Further, in order to manufacture, import and distribute active substances intended for use in the manufacture of medicinal products for human use that are covered by a marketing authorization, a company must register with the Danish Medicines Agency.

Marketing

As a starting point, only medicines that have been authorized by the Danish Medicines Agency or the European Commission may be marketed and dispensed in Denmark. 

In order to obtain a marketing authorization for a medicinal product, the applicant must show that the benefits of the medicinal product outweigh the risks and side effects, that the medicinal product is safe and that it is of a sufficiently high and consistent quality.

When applying for a marketing authorization, the manufacturer may choose between four types of procedures:

i)  The centralized procedure;

ii) The decentralized procedure;

iii) The national procedure; or

iV) The mutual recognition procedure.

While the European Medicines Agency (“EMA”) is responsible for the centralized procedure, the Danish Medicines Agency is responsible for granting of marketing authorizations through the decentralized procedure, the national procedure and the mutual recognition procedure.

3. Which are the administrations, bodies and institutions that qualify as “payers” in your country and what are their respective responsibilities?

Healthcare Services

Approximately 84% of healthcare expenditure in Denmark is publicly financed, with the remaining spending mostly paid out-of-pocket by households (mainly for medicines and dental care).  

Healthcare expenditures at regional level and the municipality level are financed mainly through national income tax, where the government allocates funding to the regions and the municipalities mostly as block grants (allocated based on demographic and social structures). The regions also receive activity-based subsidies from the government and the municipalities 

based on the amount of patient-related activities within the hospitals of the region.

The municipalities have the authority to collect taxes, but they also receive block grants (in proportion to the individual municipalities’ tax bases).

The financing of the Danish public healthcare system is based on annual financial agreements between the government, the regions and the municipalities, which establish a fixed level of public expenditure. The annual financial agreements are part of the national budget law.

Complementary voluntary health insurance is available to cover statutory co-payments (e.g., within primary sector prescription medicines, travel vaccinations, temporary home care and adult dental care) and services that are not covered by the state (e.g. physiotherapy). Further, supplementary private insurances related to private healthcare providers are available.

Hospital products and products within primary care

Within the field of hospital products, there are typically no co-payment by patients. The stakeholders relevant for payments are the regions. 

Within the primary sector, patient co-payment applies, and is supplemented by reimbursement determined by the Danish Medicines Agency (and paid by the relevant Danish region). 

4. Which are the administrations, bodies and institutions in charge of pricing decisions in your country and what are their respective responsibilities?

As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals). 

The companies placing the medicinal products on the Danish market are in principle free to set the prices for the medicinal products both within the primary sector and the secondary sector. However, the unrestricted pricing is to a certain extent influenced by price-cap agreements negotiated every four years by the Ministry of Health, the Danish Regions, and the Danish Association of the Pharmaceutical Industry (Danish: Lægemiddelindustriforeningen; Lif).

Medicine prices are published by the Danish Medicines Agency on the website www.medicinpriser.dk. 

In the primary healthcare sector, pharmacies have the exclusive right to sell prescription medicines (and most over-the-counter medicines) to consumers. 

New medicines (or existing medicines with new indications) that are intended to be placed on the Danish hospital market must be assessed by the Danish Medicines Council (Danish: Medicinrådet). 

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. 

5. Which are the administrations, bodies and institutions in charge of reimbursement decisions in your countries and what are their respective responsibilities?

Medicines used in the secondary sector (public hospitals) are provided free-of-charge in Denmark. Within the primary sector, there is a comprehensive reimbursement system. 

The Danish Medicines Agency decides on the reimbursement status of medicinal products in Denmark based on applications from the company placing the medicinal product on the market. The Danish Medicines Agency bases its decision on recommendations provided by the Danish Reimbursement Committee (Danish: Medicintilskudsnævnet). The Danish Medicines Agency may determine that the reimbursement should be conditional, e.g. on the medicine being prescribed to certain patient groups or specific diseases. 

6. Which are the administrations, bodies and institutions in charge of Health Technology Assessment in your countries and what are their respective responsibilities?

Health technology assessments for medicines in Denmark are carried out by the Danish Medicines Council (Danish: Medicinrådet) and by Amgros  (the public sector wholesale organization established by the five Danish regions that is responsible for medicine procurement services (and small-scale medical device procurement) of the regions). 

The Health Technology Council (Danish: Behandlingsrådet) conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects.

Further, each region has a system of drug and therapeutics committees (DTCs). The main activities of the DTCs are to develop hospital drug formularies. The DTCs are organized differently in the different regions, but their members are typically specialist physicians, pharmacists, general practitioners, nurses and clinical pharmacologists. 

Lastly, in an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy (Danish: Indsatser for Rationel Farmakoterapi) under the Danish Health Authority drafts advice targeted general practitioners based on available evidence to help general practitioners prescribe medicines in accordance with rational pharmacotherapy.

The Danish Medicines Council

The Danish regions have established the Danish Medicines Council (Danish: Medicinrådet). The objective of the Danish Medicines Council is to provide guidance and recommendations on new medicines and standard therapies used in Denmark. The Danish Medicines Council provides information to Amgros who uses the information to negotiate prices with suppliers of medicinal products. Based on joint evaluations of effectiveness and costs, the Medicines Council issues recommendations to the Danish regions on whether to adopt a medicine as standard treatment. 

The Danish Medicines Council consists of three units: the expert committees, the Secretariat and the Council.

Amgros

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

The Danish Health Technology Council

As mentioned above, the Danish regions have established the Danish Health Technology Council (Danish: Behandlingsrådet). The objective of the Health Technology Council is to target Danish healthcare resources at the technologies and interventions that provide best value for money, across both physical and mental health services, in order to help raise the quality of health services, ensure more equality in treatments, and reduce cost pressure in the healthcare system. The Health Technology Council conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects.

7. Which are the administrations, bodies and institutions in charge of public procurement and tendering in your country and what are their respective responsibilities?

The main actors involved in a public tender are the contracting authority, i.e. the authority that needs to procure a product or a service and thus initiates the tender process, and the tenderers, i.e. the suppliers/companies who submit bids to the tender.

Amgros is responsible for securing the supply of drugs and hearing aids to public Danish hospitals and hearing clinics. 

8. What are the other actors of significance with regards to market access in your country and what are their respective responsibilities?

The Danish council for the Use of Expensive Hospital Medicines (Danish: Rådet for Anvendelse af Dyr Medicin; RADS) and the Coordinating Council for First Use of Hospital Medicines (Danish: Koordineringsrådet for ibrugtagning af sygehusmedicin; KRIS) were the two bodies responsible for evaluating the clinical benefits of new medicines entering the hospital market until January 2017. The board of the Danish regions established the Danish Medicines Council on the basis of the experiences of RADS and KRIS.

On the side of the pharmaceutical companies, the Danish Association of the Pharmaceutical Industry (Danish: Lægemiddelindustriforeningen; Lif) is worth mentioning. Lif is a trade association for the researching pharmaceutical industry and works to ensure that the pharmaceutical industry has the best possible conditions to develop, market, distribute and provide information on medicinal products. 

Other pharmaceutical industry associations in Denmark include the Association of Generic and Biosimilar Pharmaceuticals (Danish: Industriforeningen for Generiske og Biosimilære Lægemidler; IGL), and the Association of Parallel Importer of Medicines (Danish: Foreningen for parallelimportører af medicin). 

The Ethical Committee for the Pharmaceutical Industry (Danish: Etisk nævn for lægemiddelindustrien; ENLI) is a self-regulating body established by Lif, IGL and the Association of Parallel Importer of Medicines, which monitors participating pharmaceutical companies’ compliance with Danish law and certain agreedupon ethical standards and guidelines concerning, i.e., promotion of medicines, and collaboration with healthcare professionals, hospitals and patient organizations. 

Naturally, the Danish pharmacies have a significant role in the market for prescription medicines within the primary healthcare sector. In Denmark, the pharmacies are organized in the Association of Danish Pharmacies (Danish: Danmarks apoterforening). 

Lastly, while some pharmaceutical companies have their own distribution systems and channels, other companies rely on established wholesalers. In Denmark, the wholesaler market mainly consists of the companies and authorised wholesalers Tjellesen Max Jenne and Nomeco.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. What are the pricing principles and processes in your country?

As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals). A third market consists with respect to the retail sale of certain over-the-counter medicines.

The companies placing the medicinal products on the Danish market are in principle free to set the prices for the medicinal products both within the primary sector and the secondary sector. 

The company responsible for placing a medicinal product on the market must notify the pharmacy purchase price (Danish: Apoteksindkøbspris) to the Danish Medicines Agency at least 14 days prior to launch of the products, and prices can be changed every 14 days. The prices are published by the Danish Medicines Agency on the website www.medicinpriser.dk. 

However, the principle of free pricing is influenced by a number of factors, e.g. by the assessments made by the Danish Medicines Council, pricecap agreements, and the system of substitution and reimbursement also influences the pricing of medicines (please also see below). 

The primary healthcare sector

In the primary healthcare sector, pharmacies have the exclusive right to sell prescription medicines (and most over-the-counter medicines) to consumers. 

The medicines reserved for the exclusive sale in pharmacies must be sold at the same price from all pharmacies and the pharmacies must charge the so-called pharmacy retail price (Danish: Forbrugerpris) when selling to consumers. The pharmacy retail price is calculated on the basis of the pharmacy purchase price, a retail margin and potentially different handling fees, in accordance with the defined formulas and margins set out in the Danish Executive Order on Calculation of Consumer Prices on Medicines (Executive Order no. 2500 of 13 December 2021). 

As mentioned above, the prices for medicines are set for 14 days at a time and can be changed every second Monday. The purpose of the frequent price changes is that it may facilitate competition. The prices are available at www.medicinpriser.dk. 

The prices for over-the-counter medicines that are not reserved for the exclusive sale in pharmacies are not specifically regulated, and the pharmacies and other authorised retail sellers are free to determine the consumer prices.

General practitioners are free to determine which medicines to prescribe for their patients. However, in an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy (Danish: Indsatser for Rationel Farmakoterapi) under the Danish Health Authority drafts advice targeted general practitioners based on available evidence to help general practitioners prescribe medicines in accordance with rational pharmacotherapy. 

Further, general practitioners are influenced in several other ways when prescribing medicines, e.g. as part of educational meetings, treatment guidelines, and drug formularies.

The secondary healthcare sector (public hospitals)

New medicines (or existing medicines with new indications) that are intended to be placed on the Danish market within the secondary sector must be assessed by the Danish Medicines Council (Danish: Medicinrådet). Please see more information on the Danish Medicines Council and their assessments below in Chapter 5. 

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

2. What pricing models are currently being utilised in your country?

As mentioned above, medicine pricing is in principle unrestricted as the companies placing the medicinal products on the Danish market are free to set the prices for the medicinal products. 

The main pricing models are: 

i) Cost-plus pricing (i.e., letting the price be determined on the basis of production/distribution costs and a profit margin);

ii) Competition-based pricing (i.e., letting the price be determined on the basis of price levels of competitors’ products);

iii) Willingness-to-pay pricing (i.e., basing the price on the highest price a consumer or buyer is willing to pay for one unit);

iv) Value-based pricing (i.e., letting the price be determined on the basis of perceived value to the costumers as opposed to actual costs, market price, competitors’ prices or historical prices); and 

v) Mixed price models.

The suitable pricing model will often depend on the type of pharmaceutical company/pharmaceutical products in question. 

For example, due to the significant time spent on and costs related to research and development of new innovative medicines, companies with originator medicines will often define their pricing strategies on the value-based model. Conversely, companies with generic/biosimilar medicines will normally not have the same incentives as they do not have the same initial level of investments into research and development that they need to recoup. Therefore, generic/biosimilar companies often rely on cost-plus pricing mod-els, as their costs are primarily of a variable nature. 

Another factor that contributes to selection of a pricing model is the consideration of the applicable customer/payer. For example, within the public hospital sector there are no patient co-payments and costs are handled by the hospitals/the Danish regions. 

3. What are the processes and principles around reimbursement approval?

Substitution system

In an effort to facilitate competition, the Danish pharmacies are as a starting point required to hand out the cheapest medicines within so-called substitution groups established by the Danish Medicines Agency. 

The substitution groups are established based on the following criteria: 

• at the most, there may be 10 pct. (25 pct. for certain medicinal products) divergence in the size of package from the smallest package to the largest package in the group;

• as many packages as possible must be placed in the same substitution group;

• if it is not possible to include all packages within a group, the package that is furthest percentage-wise from the rest of the packages is omitted (defined substitution groups); and

• the percentage calculation is made on the basis of the smallest package size in the group.

The medicines within the substitution groups are said to be synonymous – they include the same active ingredient, the same quantity and are based on the same form of administration.

The substitution system means that once generic medicines enter the market, the generic (and parallel imported) medicines will be placed in the same group as the originator medicines. Thus, essentially, the substitution system intends to give incentive for manufacturers to lower their prices, as the cheapest price given in the abovementioned 14-day periods will “win” the most sales within the substitution group.

However, there are certain exemptions to the pharmacies’ obligations under the substitution system. The pharmacies are not required to hand out the cheapest medicine within a substitution group if i) the prescribing physician has indicated on the prescription that there is to be “no substitution”; ii) the patient wants to purchase the specific medicine that the physician has prescribed even though cheaper alternatives are available; and iii) if the price difference between the cheapest medicine in the substitution group and the prescribed medicine is less than certain specified thresholds.

If the medicines within a substitution group are subject to reimbursement, the substitution groups are often referred to as reimbursement groups (Danish: tilskudsgruppe), and the reimbursement price will be calculated on the basis of the cheapest product within the reimbursement group. 

Reimbursement system

In the Danish public hospital sector, pharmaceutical treatments are administered or dispensed to patients free of charge – the hospitals cover the costs and there are no co-payments from patients. Within the primary sector, the amount of money the patient must pay for medicines depends, i.e., on the reimbursement status of the medicine.

In Denmark, the Danish Medicines Agency decides on the reimbursement status of each medicinal product. The cost of medicines eligible for reimbursement is funded by the state.

The Danish Medicines Agency determines which medicinal products that are eligible for reimbursement based on an application from the company placing a medicinal product on the market. 

There are three types of general reimbursement:  

i) reimbursement for prescription-only medicinal products; 

ii) conditional reimbursement for prescription-only medicinal products (e.g., the condition that reimbursement is only available to a specific patient population – i.e. that reimbursement is only available for a specific indication); and 

iii) conditional reimbursement for over-the-counter medicinal products.

In special cases, the Danish Medicines Agency may also grant individual reimbursement for individual patients. Such reimbursements are granted on the basis of an application from the patient’s physician. 

The criteria for obtaining general reimbursement are set out in the Executive Order on Reimbursement (Executive Order no. 728 of 30 May 2022). The main criteria are:

i) the medicine must be safe and have a valuable therapeutic effect on a well-defined indication; and 

ii) the price of the medicine must be proportionate with the treatmentrelated value. 

General reimbursement will as a starting point not be granted where:

i) initiation of the treatment requires special examination and diagnosis;

ii) there is a high risk that the medicine will be used outside the approved indication; 

iii) the medicine is used exclusively or predominantly for treatments that cannot reasonably be expected to be subsidized by the Regional Councils;

iv) the effect of the medicine is not clinically documented;

v) there is a risk that the medicine will be used as first choice treatment, even if the Danish Medicines Agency finds that it should not; 

vi) it has not been determined whether the medicine should be used as first choice treatment; 

vii) there is a high risk that the medicine will result in substance abuse; 

viii) the medicine will mainly be used for treatment within the hospital sector; or

ix) the formulation of the medicine means that patients are not able to administer the medicine themselves.

The Danish Medicines Agency may base its reimbursement decision on recommendations provided by the Danish Reimbursement Committee (Danish: Medicintilskudsnævnet).

The Danish Medicines Agency determines the annual reimbursement thresholds (i.e., the amount a person must spend on medicinal products within a 12 month period before being eligible for reimbursement), and the reimbursement prices. The reimbursement thresholds and the reimbursement prices are used when calculating the applicable reimbursement rate and the amount of co-payment of the patient. The reimbursement thresholds in 2022 are as follows: 

The one-year reimbursement period commenced when the patient purchases reimbursable medicine for the first time after expiry of the preceding period. 

As a starting point, the reimbursement price used for calculation is the same as the pharmacy retail price. 

However, as described above, the Danish Medicines Agency may establish so-called substitution groups of “synonymous” medicinal products. For medicinal products within a substitution group/reimbursement group, the applicable reimbursement price will as a starting point be based on the cheapest medicinal product(s) in the group.

The agency is responsible for making periodic reassessments of the reimbursement status of primary care medicine.  

The Danish Medicines Agency’s website www.medicinpriser.dk includes information on the price, substitution groups and reimbursement status of all authorised medicinal products. 

Process for reimbursement

The first step in the reimbursement process is for the manufacturer to submit its application. The information required to be submitted as part of an application is detailed in the Danish Medicines Agency’s template application form, which can be found on the agency’s website.  It is optional for manufacturers to submit health economic assessments with respect to new medicines.

The next steps in the process will depend on whether the Danish Medicines Agency finds there is a need to involve the Danish Reimbursement Committee. This will usually be the case when the application concerns a new medicine or a medicine with a new indication. 

The Danish Medicines Agency will compile a medical file with information on the medicine’s effect and safety profile relative to the current standard of care for the specific indication.

The Danish Medicines Agency will present the case to the Danish Reimbursement Committee, who will then issue a recommendation on whether general reimbursement should be granted. 

There are also opportunities for representatives of the manufacturer to participate in meetings with the Danish Reimbursement Committee to present the application.

If the recommendation from the Danish Reimbursement Committee is negative, then there will be a hearing of the manufacturer who will be given the opportunity to comment on the recommendation. Afterwards, the Danish Reimbursement Committee will provide their recommendation to the Danish Medicines Agency who will then issue a decision on the reimbursement status of the medicine.

A negative decision can be appealed by the manufacturer to the Ministry of Health. 

Risk sharing pilot programme

On 1 June 2022 a 4-year pilot programme on risk sharing entered into force. The risk-sharing scheme means that certain medicines are selected, and the manufacturer and the Danish Medicines Agency agrees on a number of patients that should be treated and eligible for reimbursement. The medicine in question is then granted a general reimbursement with a clause concerning the number of patients. If the number of patients is exceeded, then the Danish Medicines Agency will be refunded by the manufacturer for the excessive number of patients. 

Starting on 1 June 2022 (and until 31 May 2024), companies/manufacturers can apply for their medicines to be included under the pilot programme.  

Price-cap agreements

As mentioned above, the starting point in Denmark is that manufacturers are free to set the prices of their medicines. However, the Ministry of Health, the Danish Regions, and the Danish Association of the Pharmaceutical Industry  (Lif) have entered into agreements on price-caps (Danish: prisloftsaftaler) that influence the free pricing with respect to the members of Lif. 

With regard to hospital medicines, the main principles of the agreement provide that the price-caps from the agreement of 4 June 2009 and the price reductions from the agreement of 18 December 2012 are extended. The price-cap is to be reduced by 2.5% on December 1, 2019, 2.5% on October 1, 2020, 2.5% on October 1, 2021, 2.5% on October 1, 2022 and 2.5% on February 2023. In all cases, the price-cap reduction will take effect in the first pricing period after the listed dates. As a starting point, the prices of hospital medicines are not to be increased more than these prices up until March 31, 2023.

With regard to prescription only medicines eligible for reimbursement, the price-cap agreement constitutes an extension of the price-caps in the agreements of December 15, 2006, December 19, 2008, December 20, 2011, December 15, 2014 and July 1, 2016. This means that in general the price-caps for individual medicine between April 1, 2019 and March 31, 2022 are the prices in place on August 30, 2006 with subsequent adjustments in accordance with previously concluded price-cap agreements.

All prices in the price-cap agreements refer to the pharmacy purchase prices as notified to the Danish Medicines Agency. The price-cap agreements can be found (in English as well as in Danish) on the website of Lif. 

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?

The Danish Medicines Council

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

The objective of the Danish Medicines Council is to provide guidance and recommendations on new medicines and standard therapies used in the Danish hospital sector. 

The Danish Medicines Council does this through two separate processes: assessments of new medicine, where a new compound is compared to the standard therapy used in Denmark and guidelines, where several medicines for a specified disease are compared. The guideline process results in a recommendation with a prioritized list of medicines to be used for patients with the specified disease.

The Danish Medicines Council consists of three units: the expert committees, the Secretariat and the Council.

Amgros

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

The Danish Health Technology Council

As mentioned above, the Danish regions have also established the Danish Health Technology Council (Danish: Behandlingsrådet). The objective of the Health Technology Council is to target Danish healthcare resources at the technologies and interventions that provide best value for money, across both physical and mental health services, in order to help raise the quality of health services, ensure more equality in treatments, and reduce cost pressure in the healthcare system. The Health Technology Council conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects. 

The Health Technology Council might accept proposals for evaluations from the Danish regions, hospital management and companies. The assessments of technologies include: 

i) clinical effectiveness and safety;

ii) patient experiences;

iii) organizational impact; and

iv) health economics.

However, new technologies do not have to be approved by the Health Technology Council in order to be used at the Danish hospitals. 

Drug formularies in primary care

In an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy (Danish: Indsatser for Rationel Farmakoterapi) under the Danish Health Authority drafts advice targeted general practitioners based on available evidence to help general practitioners prescribe medicines in accordance with rational pharmacotherapy.

Further, in order to help general practitioners within primary care, the Danish Health Authority has developed a national drug formulary.  Each region has also developed a drug formulary called “basislisten” based on the national drug formulary.

Hospital drug formularies (secondary care) are also widely used in Denmark – these are based on the treatment guidelines from the Danish Medicines Council.

2. Do regulators/payers require HTA studies in your country?

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

3. How are HTA assessments translated into pricing conditions in your country?

On the basis of an assessment report from Danish Medicines Council, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review. When negotiations with the company have been completed, Amgros will send a negotiation note to the Secretariat of the Medicines Council with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.

4. How are HTA assessments translated into reimbursement conditions in your country?

When applying for reimbursement in Denmark, it is optional for companies to include health economic evaluations. If submitted, such evaluations must comply with the guidelines issued by the Danish Medicines Agency. 

5. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?

Assessment criteria

Recommendations by the Danish Medicines Council are based on:

• A medical assessment of the added clinical value to patients

• An economic assessment of the added costs per patient (and impact on the overall budget)

• Price negotiations (between the pharmaceutical company and Amgros) to ensure that there is a reasonable relationship between the added costs and the added clinical value of the medicine as compared to the current standard treatment

The recommendations are also based on the seven overarching principles for prioritization of hospital medicine issued by the Danish Parliament. The seven principles are:

1. Professional competence

2. Independence

3. Geographical equality

4. Transparency

5. Rapid update of new, effective medicines

6. Value for money in health

7. Access to treatment

Process of assessments 

The Danish Medicines Council’s process for assessing new medicines and extensions of indication uses the following steps:

1. Request for assessment 

The assessment process at the Danish Medicines Council is in principle independent of the marketing authorization process, but a company wanting a medicine assessed by the Danish Medicines Council must submit its request for assessment to the council (the Secretariat) no earlier than day 120 in the assessment process at the EMA for new medicines under the normal approval procedure at the EMA and no earlier than day 1 for extensions of indications or new medicines under the accelerated procedure at the EMA. The relevant form must be downloaded from the Danish Medicines Council’s website and sent to the Danish Medicines Council’s e-mail: medicinraadet@medicinraadet.dk.

The following information must be included in the form: 

• Name of company

• Contact person and possibly power of attorney, if the company uses an external representative.

• Information about the medicine (incl. ATC code, form of administration, dose)

• Expected timeline for issuing marketing authorisation and for the final application to the Danish Medicines Council

• Brief account of the disease and existing treatment in Denmark

• The new medicine

• Any relationship with existing treatment guidelines

• Any further information as needed for dialog with the Secretariat

Based on an assessment request, the council’s Secretariat will enter into a dialogue with the company about the content of its application and plan the assessment process. 

If there is a need to set up a new expert committee to carry out the assessment, the Secretariat will start establishing the expert committee upon receipt of a request for an assessment.

2. Dialogue before application

When a company has submitted a request for assessment, it can request a meeting with the Secretariat’s project group for advice on the application and process. Prior to the meeting, the company should submit any questions and relevant material, e.g., information on clinical studies or expected health economic analysis.

3. Application

When EMA (CHMP) has given a positive opinion, the company can submit a formal application to the Danish Medicines Council. Applications must consist of a completed application form (format can be found on the website of the Danish Medicines Council), a health economic analysis and a budget impact analysis.

The Secretariat will carry out a technical validation of the application by reviewing the application materials to ensure that all the specifications of requirements have been met. The company will be notified on whether the application can be approved and considered as satisfactory as soon as possible, and by no later than within 10 business days.

Day 0 is the day that the Danish Medicines Council receives an application that has been validated by the Secretariat as complete.

4. Assessment report

The Secretariat and the expert committee work together on reviewing and assessing the application material from the company. The assessment report includes a description and assessment of the clinical studies, the effect and safety of the medicine against comparator(s), and a description and assessment of the health economic analysis from the company.

When the expert committee and the Secretariat have completed the assessment report, it will be sent to the company and to Amgros. This will usually be 12 weeks after day 0.

The company will be asked to review the draft assessment report and comment on any errors and redaction of confidential information.

5. Negotiation

On the basis of the assessment report, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review.

When negotiations have been completed, Amgros will send a negotiation note to the Secretariat with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.

6. Decision regarding recommendation

When the Council is to make a decision on recommendation of a medicine, it must determine whether the efficacy and safety of a product is proportionate to the cost of putting the medicine into use. As mentioned above, the assessment will, i.e., be based on the Danish Parliament’s seven overall principles for prioritising hospital medicines, as well as the principles of caution and severity.

The Council will formulate its recommendation, and publish the recommendation immediately thereafter.

Normally, the assessment process takes up to 16 weeks from the date of receipt of a complete application by the Secretariat (i.e., day 0) to a final recommendation by the Danish Medicines Council.

The Danish Medicines Council’s recommendations for standard treatment that are largely followed by the physicians.

Updating treatment guidelines

The Danish Medicines Agency can also assess new medicines (and extensions of indications or new formulas) by updating existing treatment guidelines or drawing up new guidelines. This process can be followed if the effect and safety profile of the medicine is comparable with existing treatment options.

If the expert committee and the Council agree that the Danish Medicines Council should assess the medicine in a treatment guideline, the following standard process will be used: 

1. In the request for assessment, the company must state that the Danish Medicines Council is requested to assess the medicine by preparing or updating a treatment guideline. The request must include appropriate documentation to support that the medicine has the same efficacy and safety in the form of a comparison with the relevant comparator medicine.

2. The expert committee will assess whether they agree with the company’s request, and submit its recommendations to the Council that a treatment guideline should be prepared or updated.

3. The Danish Medicines Council will prepare or update the treatment guideline, after which the Council will approve. 

4. The Danish Medicines Council will prepare or update the relevant cost analysis, and the Council will approve on the basis of comparison.

5. Amgros will inform the Secretariat of the new prices.

6. The Secretariat will update or prepare the medicine recommendation, and this will subsequently be approved by the Council. 

Generic/biosimilar medicines

For generic and biosimilar medicines, it is possible to place these products on the Danish hospital markets without having to go through the Danish Medicines Council, e.g. by simply participating in tenders that are based on active ingredients or therapeutic use (please see more information on Amgros and the tender procedures below).

6. What is the methodology used in your country for HTA assessment?

A recommendation for a medicine by the Danish Medicines Council is based on an assessment of whether the effect (measured as quality-adjusted life-years (QALY)) and safety of a medicine is reasonably proportionate to the cost of bringing the medicine into use. 

7. Which are the other decisions impacted by the assessed outcome in your country?

Please see answers to questions above.

8. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?

The guidance from the Danish Medicines Council provides that documentation of clinical effect and safety should be derived from full-text articles published in scientific, peer-reviewed journals, European Public Assessment Reports (EPAR) prepared by the European Medicines Agency (EMA), reports by the Food and Drug Administration (FDA) or the HTA agencies.

Also from this Market Access & Health Technology Assessment

Taken from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on the HTA decision analysis framework in Denmark. Buy The Pharma Legal Handbook: Market Access & HTA – Denmark here for £359.

1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?

The Danish Medicines Council

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

The objective of the Danish Medicines Council is to provide guidance and recommendations on new medicines and standard therapies used in the Danish hospital sector.

The Danish Medicines Council does this through two separate processes: assessments of new medicine, where a new compound is compared to the standard therapy used in Denmark and guidelines, where several medicines for a specified disease are compared. The guideline process results in a recommendation with a prioritized list of medicines to be used for patients with the specified disease.

The Danish Medicines Council consists of three units: the expert committees, the Secretariat and the Council.

Amgros

Amgros is the Danish wholesale distribution company responsible for the majority of procurement on behalf of the Danish Regions (the Danish hospitals). Price negotiations are done in collaboration with the Danish Medicines Council, the Drug and Therapeutics committees and the pharmacies at the hospitals. After tendering, Amgros enters into contracts with the winning suppliers on behalf of the Danish Regions. Amgros also provides economic evaluations to the Danish Medicines Council.

The Danish Health Technology Council

As mentioned above, the Danish regions have also established the Danish Health Technology Council (Danish: Behandlingsrådet). The objective of the Health Technology Council is to target Danish healthcare resources at the technologies and interventions that provide best value for money, across both physical and mental health services, in order to help raise the quality of health services, ensure more equality in treatments, and reduce cost pressure in the healthcare system. The Health Technology Council conducts evaluations and issues recommendations on use of medical devices and healthcare technologies (primarily those used in hospitals) based on evaluations of whether expenses are proportional with the related effects.

The Health Technology Council might accept proposals for evaluations from the Danish regions, hospital management and companies. The assessments of technologies include:

1. i) clinical effectiveness and safety;
2. ii) patient experiences;

iii) organizational impact; and

1. iv) health economics.

However, new technologies do not have to be approved by the Health Technology Council in order to be used at the Danish hospitals.

Drug formularies in primary care

In an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy (Danish: Indsatser for Rationel Farmakoterapi) under the Danish Health Authority drafts advice targeted general practitioners based on available evidence to help general practitioners prescribe medicines in accordance with rational pharmacotherapy.

Further, in order to help general practitioners within primary care, the Danish Health Authority has developed a national drug formulary.[1] Each region has also developed a drug formulary called “basislisten” based on the national drug formulary.

Hospital drug formularies (secondary care) are also widely used in Denmark – these are based on the treatment guidelines from the Danish Medicines Council.

2. Do regulators/payers require HTA studies in your country?

New medicines (or product with new indications) that are intended for the Danish hospital market, must first be assessed by the Danish Medicines Council.

3. How are HTA assessments translated into pricing conditions in your country?

On the basis of an assessment report from Danish Medicines Council, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review. When negotiations with the company have been completed, Amgros will send a negotiation note to the Secretariat of the Medicines Council with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.[2]

4. How are HTA assessments translated into reimbursement conditions in your country?

When applying for reimbursement in Denmark, it is optional for companies to include health economic evaluations. If submitted, such evaluations must comply with the guidelines issued by the Danish Medicines Agency.[3]

5. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?

Assessment criteria

Recommendations by the Danish Medicines Council are based on:

• A medical assessment of the added clinical value to patients
• An economic assessment of the added costs per patient (and impact on the overall budget)
• Price negotiations (between the pharmaceutical company and Amgros) to ensure that there is a reasonable relationship between the added costs and the added clinical value of the medicine as compared to the current standard treatment

The recommendations are also based on the seven overarching principles for prioritization of hospital medicine issued by the Danish Parliament. The seven principles are:

1. Professional competence
2. Independence
3. Geographical equality
4. Transparency
5. Rapid update of new, effective medicines
6. Value for money in health
7. Access to treatment

Process of assessments

The Danish Medicines Council’s process for assessing new medicines and extensions of indication uses the following steps:[4]

1. Request for assessment.

The assessment process at the Danish Medicines Council is in principle independent of the marketing authorization process, but a company wanting a medicine assessed by the Danish Medicines Council must submit its request for assessment to the council (the Secretariat) no earlier than day 120 in the assessment process at the EMA for new medicines under the normal approval procedure at the EMA and no earlier than day 1 for extensions of indications or new medicines under the accelerated procedure at the EMA. The relevant form must be downloaded from the Danish Medicines Council’s website and sent to the Danish Medicines Council’s e-mail: medicinraadet@medicinraadet.dk.

The following information must be included in the form:

• Name of company
• Contact person and possibly power of attorney, if the company uses an external representative.
• Information about the medicine (incl. ATC code, form of administration, dose)
• Expected timeline for issuing marketing authorisation and for the final application to the Danish Medicines Council
• Brief account of the disease and existing treatment in Denmark
• The new medicine
• Any relationship with existing treatment guidelines
• Any further information as needed for dialog with the Secretariat

Based on an assessment request, the council’s Secretariat will enter into a dialogue with the company about the content of its application and plan the assessment process.

If there is a need to set up a new expert committee to carry out the assessment, the

Secretariat will start establishing the expert committee upon receipt of a request for an assessment.

2. Dialogue before application. When a company has submitted a request for assessment, it can request a meeting with the Secretariat’s project group for advice on the application and process. Prior to the meeting, the company should submit any questions and relevant material, e.g., information on clinical studies or expected health economic analysis.

3. Application. When EMA (CHMP) has given a positive opinion, the company can submit a formal application to the Danish Medicines Council. Applications must consist of a completed application form (format can be found on the website of the Danish Medicines Council), a health economic analysis and a budget impact analysis.

The Secretariat will carry out a technical validation of the application by reviewing the application materials to ensure that all the specifications of requirements have been met. The company will be notified on whether the application can be approved and considered as satisfactory as soon as possible, and by no later than within 10 business days.

Day 0 is the day that the Danish Medicines Council receives an application that has been validated by the Secretariat as complete.

4. Assessment report. The Secretariat and the expert committee work together on reviewing and assessing the application material from the company. The assessment report includes a description and assessment of the clinical studies, the effect and safety of the medicine against comparator(s), and a description and assessment of the health economic analysis from the company.

When the expert committee and the Secretariat have completed the assessment report, it will be sent to the company and to Amgros. This will usually be 12 weeks after day 0.

The company will be asked to review the draft assessment report and comment on any errors and redaction of confidential information.

5. Negotiation. On the basis of the assessment report, Amgros will negotiate the price of the medicine with the company. Negotiations with Amgros take place at the same time as the company has the draft assessment report for review.

When negotiations have been completed, Amgros will send a negotiation note to the Secretariat with the negotiated prices. The Secretariat updates the assessment report on the basis of the agreed prices from Amgros.

6. Decision regarding recommendation. When the Council is to make a decision on recommendation of a medicine, it must determine whether the efficacy and safety of a product is proportionate to the cost of putting the medicine into use. As mentioned above, the assessment will, i.e., be based on the Danish Parliament’s seven overall principles for prioritising hospital medicines, as well as the principles of caution and severity.

The Council will formulate its recommendation, and publish the recommendation immediately thereafter.

Normally, the assessment process takes up to 16 weeks from the date of receipt of a complete application by the Secretariat (i.e., day 0) to a final recommendation by the Danish Medicines Council.

The Danish Medicines Council’s recommendations for standard treatment that are largely followed by the physicians.

Updating treatment guidelines

The Danish Medicines Agency can also assess new medicines (and extensions of indications or new formulas) by updating existing treatment guidelines or drawing up new guidelines. This process can be followed if the effect and safety profile of the medicine is comparable with existing treatment options.

If the expert committee and the Council agree that the Danish Medicines Council should assess the medicine in a treatment guideline, the following standard process will be used:[5]

1. In the request for assessment, the company must state that the Danish Medicines Council is requested to assess the medicine by preparing or updating a treatment guideline. The request must include appropriate documentation to support that the medicine has the same efficacy and safety in the form of a comparison with the relevant comparator medicine.
2. The expert committee will assess whether they agree with the company’s request, and submit its recommendations to the Council that a treatment guideline should be prepared or updated.
3. The Danish Medicines Council will prepare or update the treatment guideline, after which the Council will approve.
4. The Danish Medicines Council will prepare or update the relevant cost analysis, and the Council will approve on the basis of comparison.
5. Amgros will inform the Secretariat of the new prices.
6. The Secretariat will update or prepare the medicine recommendation, and this will subsequently be approved by the Council.

Generic/biosimilar medicines

For generic and biosimilar medicines, it is possible to place these products on the Danish hospital markets without having to go through the Danish Medicines Council, e.g. by simply participating in tenders that are based on active ingredients or therapeutic use (please see more information on Amgros and the tender procedures below).

6. What is the methodology used in your country for HTA assessment?

A recommendation for a medicine by the Danish Medicines Council is based on an assessment of whether the effect (measured as quality-adjusted life-years (QALY)) and safety of a medicine is reasonably proportionate to the cost of bringing the medicine into use.[6]

7. Which are the other decisions impacted by the assessed outcome in your country?

Please see answers to questions above.

8. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?

The guidance from the Danish Medicines Council provides that documentation of clinical effect and safety should be derived from full-text articles published in scientific, peer-reviewed journals, European Public Assessment Reports (EPAR) prepared by the European Medicines Agency (EMA), reports by the Food and Drug Administration (FDA) or the HTA agencies.

References

[1] https://www.sst.dk/da/viden/laegemidler/rationel-farmakoterapi/den-nationale-rekommandationsliste-_nrl_

[2] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 107707), page 13. Available at: https://medicinraadet.dk/om-os/in-english

[3] https://laegemiddelstyrelsen.dk/en/reimbursement/general-reimbursement/application/health-economic-analyses-in-reimbursement-applications/

[4] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 136636), pages 8-14. Available at: https://medicinraadet.dk/om-os/in-english

[5] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 136636), pages 17-8. Available at: https://medicinraadet.dk/om-os/in-english

[6] The Danish Medicines Council methods guide for assessing new pharmaceuticals (Version 1.2, Document.no: 107707), page 5. Available at: https://medicinraadet.dk/om-os/in-english

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Please describe the main cost containment policies in place in your country and their fundamental principles 

On an overall level, control of healthcare expenditures is based on budget laws and annual agreements between the Danish state, the regions and the municipalities. 

Primary sector

Within the primary sector, cost containment measures include the Danish substitution system, price-cap agreements, and limitations on permitted discounts/rebates that may be offered to pharmacies. Further, as mentioned above, in an effort to promote rational and appropriate use of medicines within primary healthcare, the Institute for Rational Pharmacotherapy provides advice targeting general practitioners. 

As described above, generic substitution is endorsed through the mandatory Danish reimbursement/substitution system. Essentially, the Danish substitution system seeks to give incentive for manufacturers to lower their prices, as the cheapest price within an established group will “win” the most sales within the substitution group.

With respect to discounts/rebates, it follows from Section 71a-c of the Danish Medicines Act (Act no. 99 of 16 January 2018) that bonuses or other economic advantages may not be paid or offered to users of medicinal products in connection with the sale of a pharmacy-only medicinal product. This means that as a starting point (within the primary sector), pharmacies must not be offered rebates/discounts on medicines below the determined pharmacy purchase price. However, the act modifies this starting point, as it provides that the supplier may grant discounts provided they only reflect cost savings for the supplier/discount provider. Such discounts shall be commensurate with the cost savings and must be in the form of a price reduction.

At retail level, medicines reserved for the exclusive sale in pharmacies must be sold at the same price from all pharmacies and the pharmacies must charge the so-called pharmacy retail price (Danish: Forbrugerpris) when selling to consumers. The pharmacy retail price is calculated on the basis of the pharmacy purchase price, a retail margin and potentially different handling fees, in accordance with formulas and margins defined by law. 

The prices for over-the-counter medicines that are not reserved for the exclusive sale in pharmacies are not specifically regulated, and the pharmacies and other authorised retail sellers are free to determine the consumer prices.

Secondary sector

Within the secondary sector (e.g., hospital area), cost control measures include national treatment guidelines, health technology assessments for new medicines or medicines with new indications, price-cap agreements and tender procedures. 

Further, as mentioned above, the Danish government announced in 2018 that they intended to introduce a system of external price referencing for medicines that are not subject to the price-cap agreements. 

2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc.)?

Please see answer to question above. 

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Have local authorities published recommendations/guidelines surrounding value assessment dossiers? (If yes please add link)

The Danish Medicines Agency has published two main guidelines:

i) The Danish Medicines Council’s process guide for assessing new pharmaceuticals; and

ii) The Danish Medicines Council methods guide for assessing new pharmaceuticals, which clarify the requirements for companies wanting to have a new medicine or extension of indication for an existing pharmaceutical assessed by the Danish Medicines Council. The method guide includes detailed information, i.e. on the specific requirements for analysis to be conducted by the company, on literature searches, presentation of study date, statistical comparisons, estimation of health effects and costs, how to approach uncertainties in health economic analysis, and how to conduct budget impact analysis. 

(Both guides are available at: https://medicinraadet.dk/om-os/in-english) 

2. Describe the overall process of preparing and submitting a HTA dossier in your country.

For information on the process for submitting applications with the Danish Medicines Council please see answers to the questions above. 

3. Describe the overall content of the HTA dossier in your country.

A submission to the Danish Medicines Council should include, i.e.: 

i) A summary of the application (with descriptions of the indications covered, the relevant patient population, the new pharmaceutical, the comparator pharmaceuticals, and most important outcomes in clinical studies); 

ii) Description of the pharmaceutical and therapeutic area; 

a. The disease and current standard treatment in Denmark

b. The new pharmaceutical

c. The patient population

d. The choice of comparator

iii) The results of the company’s literature search in accordance with international principles and with a systematic and transparent approach to formulating focused questions defined by PICO;

a. Documentation of clinical effect and safety for the intervention and comparator(s)

b. Other sources of data for the health economic analysis

iv) Presentation of effect and safety studies;

v) Documentation on effect differences between the intervention and the comparator(s);

a. Direct comparisons and meta-analyses

b. Indirect comparisons

c. Other statistical methods

d. Use of real-world data

e. Presentation of results for the comparative analysis

f. Assessment of evidence quality

vi) Health economic analysis;

vii) Measuring and weighting health effects (summary of health effects using the QALY in the health economic analysis);

viii) Identification, quantification and value direct and derived resource consumption for each pharmaceutical included in the analysis;

ix) Identification and description of uncertainties in the health economic analysis; and

x) A budget impact analysis.

The detailed requirements as to methodologies and evaluations are set out in the Danish Medicines Council’s methods guide for assessing new pharmaceuticals (available at: https://medicinraadet.dk/om-os/in-english).

4. Describe the overall process of preparing and submitting a HTA dossier in your country.

Please see answer above and the detailed guidance issued by the Danish Medicines Council.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Are there any Managed entry agreements in place in your country? (If so, please list them)

There have been examples of use of managed entry agreements in Denmark. For example, Amgros may enter into agreements with pharmaceutical companies with terms concerning payment upon documentation of results (efficacy and safety), terms related to discounts, a cap on annual expenditures.

Further, there has in the past been examples of agreements between the Danish Medicines Agency and pharmaceutical companies concerning risk-sharing (i.e., where certain medicines are selected, and the manufacturer and the Danish Medicines Agency agrees on a number of patients that should be treated and eligible for reimbursement. The medicine in question is then granted a general reimbursement with a clause concerning the number of patients permitted for reimbursement. If the number of patients is exceeded, then the Danish Medicines Agency will be refunded by the manufacturer for the excessive number of patients). 

1.1. For each Individual Managed entry Agreement, describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it.

The specific terms of the Managed Entry Agreements are not necessarily publicly available. However, Amgros has published guidance on negotiation processes and a list of different models for alternative agreements at: https://amgros.dk/en/pharmaceuticals/price-negotiations-and-tendering/new-pharmaceuticals-and-negotiations/alternative-agreements/

2. What are the pricing models, processes and principles for generics and biosimilars drugs?

This depends on the type of Managed Entry Agreement in question.

3. What are the reimbursement approval processes and principles for originator drugs?

There are no specific requirements, and it depends on the type of agreement in question. With respect to the general reimbursement system in Denmark, please see Chapter 3.

4. What are the reimbursement approval processes and principles for generics and biosimilar drugs?

With respect to the general reimbursement system in Denmark, please see Chapter 3.

5. What are the potential challenges associated with this Managed Entry Agreement?

N/A

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Which are the main actors involved in public procurement and tendering?

During the tender:

The main actors involved in a public tender are the contracting authority, i.e., the authority that needs to procure a product or a service and thus initiates the tender process, and the tenderers, i.e. the suppliers/companies who submit bids to the tender.

In Denmark, public tenders are conducted primarily at the local level, whereas the central government and the regions have a lower share of tenders. The company, Amgros, is responsible for securing the supply of drugs and hearing aids to public Danish hospitals and hearing clinics. Thus, if a company wants to supply a product to the public Danish hospitals, the tendering procedures will be conducted by Amgros on behalf of Danish Regions.

After the tender:

If a person finds that a contracting authority did not comply with the rules of public procurement, a complaint may be filed with the Complaints Board for Public Procurement.

The Complaints Board can pass legally binding decisions, e.g., annul an awarded contract, and award damages for losses suffered by person in question.

Other:

The Danish Competition and Consumer Authority acts as supervisory authority in the area of public procurement. The authority makes preparatory legislative work and provides guides for public procurement.

2. What are the main characteristics of the public procurement and tendering system?

Purpose and source of law

The purpose of the public procurement and tendering system in Denmark is to ensure open and transparent public procurement, which enables optimal use of public funds via effective competition.

The main source of law for tenders is the Public Procurement Act (Act no. 1564 of 15 December 2015), which is an implementation of the European Public Procurement Directive (2014).

For the Danish Public Procurement Act to apply, the public contract must as a main rule have an estimated value above DKK 1,043,126 (2022 value) in relation to contract by the central government (state) and DKK 1,601,944 (2022 value) in relation to contracts by sub-central authorities (regional and municipal). Other thresholds may apply in relation to specific types of contracts, e.g., construction work, utility contracts, etc.

Procedure

The contracting authority has to prepare procurement documents, which contain the technical specifications of the product or service that the authority intends to procure. For the tenderer’s submission to be eligible of being awarded the contract in question, it must be drafted in accordance with the requirements stipulated in the procurement documents.

Different procurement procedures may be used, depending on which type of contract is being procured. The ordinary procedures are the “restricted procedure” and the “open procedure”, with the latter being the most common.

The open procedure commences with the contracting authority sending a procurement notice to the Official Journal of the EU. Following this, the time limit for submission of tenders is minimum 30-35 days. Within this period, the contracting authority hosts a Q&A session as well as a potential information meeting.

The tenderers have easy access to procurement notices and public authority procurement plans on the website www.udbud.dk.

After the submission deadline, the contracting authority evaluates the submissions and awards the contract to the tenderer who offers the best combination of price and quality (if that is the selected award criterion). At this point, there is a stand-still period of 10 days before the contracting authority and the winning tenderer may conclude a contract.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. Has an essential or priority drug list been published in your country? (If so provide the link)

The guideline process of the Danish Medicines Council results in recommendations with prioritized list of medicines to be used for patients with specific diseases. The guidelines and recommendations are available on the Danish Medicines Council’s website: https://medicinraadet.dk/anbefalinger-og-vejledninger?page=&order=&take=&currentpageid=1095&database=1095&secondary=&q=&period=0 

Hospital drug formularies (secondary care) are also widely used in Denmark – these are based on the treatment guidelines from the Danish Medicines Council.

Further, as mentioned above, in order to help general practitioners within primary care, the Danish Health Authority has developed a national drug formulary.  Each region has also developed a drug formulary called “basislisten” based on the national drug formulary. The lists of the individual regions can be accessed on this website: https://www.sundhed.dk/sundhedsfaglig/opslag-og-vaerktoejer/administrative-vaerktoejer/medicin/laegemiddellister/basislisten/ 

2. If so what is the impact/consequences of a drug being published on the EDL/PDL:

a. In terms of market approval

b. In terms of reimbursement

c. In terms of pricing

d. In terms of value assessment and pharmacoeconomic requirements

The lists are generally based on the guidelines and recommendations made by the Danish Medicines Council (secondary sector) and the Institute for Rational Pharmacotherapy. Please see input above on the interplay between such guidelines, recommendations and market approvals, reimbursement decisions, pricing and value assessments.

3. Do value assessment and pharmacoeconomic data play a role in terms of access to the list?

The lists are generally based on the guidelines and recommendations made by the Danish Medicines Council (secondary sector) and the Institute for Rational Pharmacotherapy. Please see input above on the interplay between such guidelines, recommendations and market approvals, reimbursement decisions, pricing and value assessments.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. What is the definition of an orphan drug in your country?

The term “orphan drug” usually refers to medicins used for rare diseases – i.e. diseases where the prevalence of the condition in the EU is not more than 5 in 10,000.

Applications for orphan designation are examined by the European Medicines Agency’s Committee for Orphan Medicinal Products.

According to the Regulation (EC) no. 141/2000 on orphan medicinal products, a medicine must meet the following criteria in order to qualify for an orphan designation:

i) the drug must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;

ii) the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the drug will generate sufficient returns to justidy the investment needed for its development; and

iii) no satisfactory method of diagnossis, prevention or treatment of the condition can be authorised.

2. Describe the pricing process of orphan drugs in your country.

In principle, the pricing process is no different from other medicines, however, in practice, pricing often reflects that the medicines have a limited business potential.

3. Describe the reimbursement process of orphan drugs in your country.

Denmark does not have special reimbursement or recommendation criteria for orphan drugs.

4. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of orphan drugs differ from that of other drugs?

No

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. What is the definition of a vaccine in your country?

Danish legislation refers to the definition found in the European Pharmacopoeia. 

2. What are the classifications of vaccines in your country?

Vaccines are classified as medicines. The Danish legislation refers to the definition found in the European Pharmacopoeia. 

3. Describe the pricing process for vaccines in your country (based on their classifications).

As a starting point, the pricing process for vaccine follows the same process as other medicines.

The vaccines available under the national vaccination program are provided free of charge.

4.  Describe the reimbursement approval process for vaccines in your country (based on their classifications).

The Danish Medicines Agency cannot grant general reimbursement for vaccines. Applications for reimbursement for vaccines must be submitted to the Danish Health Authority.

The Danish Health Authority will determine whether the regional councils should grant reimbursement to specific patient groups. In its assessment, the Danish Health Authority will consider whether:

i) the vaccine has been approved for marketing in Denmark; 

ii) the vaccine has a valuable preventive effect; 

iii) the vaccine prevents a disease that would otherwise be of significant burden to the individual and/or the society as a whole; and 

iv) whether the price of the vaccine is reasonable considering the effect of the vaccine.

An application for reimbursement status must include:

i) information on the name, active ingredients, formulation, strength, approved indications, proposed patient population, therapeutic group, dosage, dispensing group, size of packaging, and consumer price;

ii) expected date for marketing of the vaccine; 

iii) information on any synonymous vaccines marketed in Denmark; and 

iv) name and address of the entity bringing the vaccine on the market in Denmark.

The application should include the marketing authorisation, the product of summary characteristics, pharmacological and clinical documentation and information on the expected use/consumption of the vaccine within the initial 5 years following marketing. It is optional whether to include a health economic analysis. 

5. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of vaccines differ from that of other drugs?in your country (based on their classifications).

As a starting point (except as described above) vaccines follow the same procedures as other medicines.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Denmark. 

1. In addition to the clinical data obtained through clinical studies please list the data required for:  a. Market approval / b. Pricing Decisions / c. Reimbursement Decisions

a. Market approval

Please see the detailed guidance on the Danish Medicines Agency’s website on applications for marketing authorisations: https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/marketing-authorisation/application-for-marketing-authorisation/guidelines-for-new-applicants/ (in English).

b. Pricing Decisions

As mentioned above, the companies placing the medicinal products on the Danish market are in principle free to set the prices for the medicinal products both within the primary sector and the secondary sector. 

c. Reimbursement Decisions

The information required to be submitted as part of an application is detailed in the Danish Medicines Agency’s template application form, which can be found on the agency’s website:  

• Marketing authorisation;

• Summary of product characteristics;

• Pharmacological and clinical documentation;

• Information on the expected use/consumption of the medicine within the initial 5 years following marketing of the medicine (based on gender and age); and 

• (optional) a health economic analysis.