PRICE DIFFERENCES FOR ORPHAN DRUGS ACROSS THE EU-5 COUNTRIES: A COMPARATIVE ASSESSMENT

  • Pricing and reimbursement decisions after the European marketing authorization are the responsibility of each country, which can lead to inequalities and differences in access and prices for drugs1.
  • The aim of this study was to assess market access and price differences in the five European Union countries (EU5) for orphan drugs approved by the European Commission (EC).

PRICE DIFFERENCES FOR ONCOLOGY DRUGS ACROSS THE EU-5 COUNTRIES: A COMPARATIVE ASSESSMENT

  • Pricing and reimbursement decisions after the European marketing authorization are the responsibility of each country, which can lead to inequalities and differences in access and prices for drugs1 .
  • The aim of this study was to assess market access and price differences in the five European Union countries (EU5) for oncology drugs approved by the European Commission (EC).

TIME TO MARKET AND PRICE COMPARISON FOR BIOSIMILAR DRUGS IN EU5

  • After a medicine receives European Medicines Agency (EMA) marketing authorization, each member state then decides how that medicine is implemented at local level. In Germany, after EMA marketing authorization the drug is available by law. The existing differences between European countries in their policies on biosimilars may explain the heterogeneity in the drug uptake of these biosimilars. As a consequence of these differences, variations in savings can also be observed1.
  • The aim of this study was to compare the time elapsed from EMA authorisation to national commercialization. Additionally, price differences of biosimilar drugs in five European countries (EU5) were assessed to evaluate whether the existing biosimilar policies might drive this difference.

Cancer drugs in Germany: HTA decisions of new and innovative oncology drugs in Germany – an analysis using the Prismaccess® database

  • The German Pharmaceutical Market Restructuring Act (AMNOG) enters its eighth effective year.
  • The aim of the law is to disclose the added benefit of a new patented drug over existing therapies by an early assessment, which also serves as the basis for the price negotiation.
  • This study is a descriptive analysis of the early benefit assessments for new oncologics in Germany.

COMPARISON OF EU5 MARKET ACCESS DECISIONS FOR CROHN’S DISEASE BASED ON THE PRISMACCESS® DATABASe

  • Crohn’s disease (CD) is a long term condition in which inflammation of the digestive system leads to diarrhoea, abdominal pain, tiredness and weight loss. There is no cure for CD at the moment [1].
  • When the CD is active, drug treatment is usually used to manage the symptoms quickly and bring on remission.
  • Prevalence of CD for Germany in 2010 was 322 (95% confidence interval [CI]: 302-346) per 100000. In line with worldwide reports, the numbers suggest a considerable increase for CD prevalence in Germany since the 1980s, which need to be adapted by healthcare services and dealt with the burden associated with increasing numbers of patients. [2]
  • New therapies have been launched in Europe over the last few years. One key question remains if these new therapies reach patients in terms of market access in various European countries and how the national HTA agencies have decided on these therapies.
  • This study visualizes the heterogenous multiple decisions by EU-5 HTA agencies using the Prismaccess®/Evalumade® database and their three-colored scale. Hence, this study will shed light on those decisions in a transparent and understandable manner for industry.

THE BUDGET IMPACT OF NICOTINIC SUBSTITUTE REIMBURSEMENT

  • At the end of 2017, the French ministry of health decided to allow the reimbursement of nicotinic substitutes in order to reduce tobacco smoking. Before this decision, patients could only benefit from a fixed e150 per-year reimbursement basis to cover nicotinic substitute expenses (patches and gum).

THE BUDGET IMPACT OF GLOBAL TELEMEDICINE SOLUTION IN FRANCE

  • The global telemedicine solution allows patients to consult a physician from a distance in the same conditions as a visit in a traditional office: the physician talks with the patient and provides clinical health care, such as monitoring medical measurement or delivering prescriptions.

Harmonisation of European HTA - A round table discussion

MEDVANCE, a unique health care consultancy based on five independent local consultancies, also leads local market access system debates and has invited key opinion leaders in the field of a potential European joint HTA for a round table discussion in Barcelona on 11.11.2018.