Tagged with CCE

Pharma Legal Handbook 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…

Pharma Legal Handbook 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).…

Pharma Legal Handbook 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,…

Denmark 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.   Which are the health technology assessment (HTA) evaluation…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…