EU Physician and Payer Forum

August 2013

Market Access Challenges Facing Newly Launched and Emerging Type 2 Diabetes Agents in the EU5: Physician Prescribing Perspectives and Payer Insights

Introduction:

Europe’s type 2 diabetes therapy market is entering a new era heralded by the convergence of innovative offerings from the pharmaceutical industry and an increasingly cost-conscious reimbursement climate. Recent regulatory approvals by the European Medicines Agency include those for Bristol-Myers Squibb/AstraZeneca’s first-in-class SGLT-2 inhibitor Forxiga (dapagliflozin) and two novel insulins from Novo Nordisk (Tresiba [insulin degludec] and Ryzodeg [insulin degludec + insulin aspart]). Together with other emerging agents, these drugs could more than double the EU5 type 2 diabetes market by 2021. However, the German GBA’s ongoing benefit assessment of the entire DPP-IV inhibitor class, triggered by its initial assessment of Boehringer Ingelheim/Eli Lilly’s Trajenta (linagliptin), will certainly have consequences for novel drugs in Germany and, potentially, throughout Europe given the influence of German pricing on neighboring country-specific reimbursement policies. At a time when nationalized healthcare systems are striving to cut drug costs, particularly for chronic disorders such as type 2 diabetes, this report explores the market access levers and barriers for newly launched and emerging agents for this increasingly prevalent disease.

Questions Answered in This Report:

  *   Physician and payer perspective on current and evolving prescribing trends: How have current therapies within the GLP-1 receptor agonist and DPP-IV inhibitor classes influenced prescribing trends in Europe? How do prescribing patterns vary by country? What have been the main constraints in uptake, and how do surveyed endocrinologists and diabetologists anticipate they might evolve by the end of 2015?How will the launch of the new SGLT-2 inhibitor drug class and the availability of new insulin options affect prescribing trends for other drug classes?

  *   The mechanisms by which type 2 diabetes therapies are reimbursed in the EU5. The GLP-1 receptor agonists are the most expensive diabetes drugs ever marketed, and the DPP-IV inhibitors are the most expensive oral antidiabetic agents available. How and to what extent does price prevent access to these branded agents in the increasingly price-sensitive EU5 markets? How does reimbursement vary between countries? How do healthcare authorities regulate the prescribing of antidiabetic agents to manage costs?

  *   Physician and payer attitudes toward novel type 2 diabetes agents. Which clinical attributes will be the most persuasive in influencing physician prescribing decisions? Will Trajenta’s non-renal route of excretion be sufficient to differentiate the drug from other DPP-IV inhibitors in the eyes of prescribers and payers? How will these parties react to the availability of a once-weekly GLP-1 receptor agonist? How does physicians’ anticipated use of key novel emerging agents vary across the EU5? How do payers view the likely reimbursement environments faced by these agents?

Scope:

Decision Resources’ European Physician & Payer Forum report “Market Access Challenges Facing Newly Launched and Emerging Type 2 Diabetes Agents in the EU5: Physician Prescribing Perspectives and Payer Insights” explores the many clinical and funding/budgetary/reimbursement factors that affect the use and sales of type 2 diabetes agents. It draws on insights diabetologists, endocrinologists, and general practitioners (GPs) in the EU5 and from interviews with 15 European payers,all of whom have influence at a national or regional level. Interviewed payers include the following:

- France: A national payer and past member of the Transparency Commission (CT), a member/advisor of CEPS(France’s economic committee),hospital pharmacy directors.

- Germany: A member of the Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen(GBA; Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds);payer-advising KOL involved in writing diabetes guidelines; hospital pharmacy directors.

- Italy: Regional hospital formulary (PTOR) members with responsibility for assessing new drugs for formulary inclusion, an Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) advisor,regional payers.

- Spain: Consultant for the Ministry of Health and aDirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products)advisor,a hospital pharmacy director,a chief pharmacist, and an assistant university professor.

- United Kingdom:Payer-advising KOL who also acts as gateway lead for diabetes for a regional primary care trust (PCT); Clinical Commissioning Group (CCG) Head of Medicines management, also involved in writing the joint formulary guidelines for diabetes managed entry;chief pharmacist on a health board, also a member of the AWMSG (All Wales Medicines Strategy Group) and a regional prescribing committee.


Search Reports

Mentioned in this report:

  • - AstraZeneca
  • - Boehringer Ingelheim
  • - Bristol-Myers Squibb
  • - Eli Lilly
  • - Furiex
  • - Intarcia Therapeutics
  • - MannKind
  • - Merck
  • - Novartis
  • - Novo Nordisk
  • - Roche
  • - Sanofi
  • - Takeda
  • - Zealand Pharma
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