In January 2014, the European Medicines Agency granted marketing authorization to the first nucleotide polymerase inhibitor, sofosbuvir (Gilead’s Sovaldi), for the treatment of hepatitis C virus (HCV) genotypes 1-6. Sofosbuvir’s approval heralds the all-oral, interferon (IFN)-free era of HCV treatment in Europe, an era that has been boosted by the approval of additional direct-acting antiviral (DAA) combination regimens—Janssen/Medivir’s Olysio (simeprevir), an improved protease inhibitor, and Bristol-Myers Squibb’s Daklinza (daclatasvir), the first NS5A inhibitor. Although all-oral, IFN-free regimens will dramatically improve treatment outcomes for HCV patients, they are expected to carry substantial price premiums over the current standards of care. With additional IFN-free agents set to reach the market in the near term—Gilead’s Harvoni, a fixed-dose combination of sofosbuvir and the NS5A inhibitor ledipasvir, and AbbVie’s IFN-free combination of paritaprevir (ritonavir-boosted ABT-450), ombitasvir (ABT-267), and dasabuvir (ABT-333)—the HCV field is once again poised to undergo a radical shift in treatment practice. This report examines levers to optimize market access in the EU5 (France, Germany, Italy, Spain, and the United Kingdom).

Questions Answered in This Report:

  • Explore current and evolving prescribing trends in HCV: What does an analysis of surveyed specialists’ prescribing patterns in the EU5 reveal about the impact of payer policies on the uptake of recently approved agents such as sofosbuvir, simeprevir, and daclatasvir? How do prescribing patterns vary between and within EU5 countries? What percentages of specialists in each country face budgetary and reimbursement restrictions that limit their prescribing of HCV antivirals to eligible patients? How do physicians expect to prescribe emerging DAAs and IFN-free combinations to their HCV patient populations (treatment-naive versus treatment-experienced, cirrhotic versus noncirrhotic)?

  • Assess payer attitudes toward currently marketed and emerging HCV therapies: What access controls have payers across the EU5 placed on available HCV therapies, and what restrictions will they place on emerging therapies? What factors will be important in differentiating emerging IFN-free combinations during health technology assessments and pricing and reimbursement negotiations? What reimbursement challenges and limitations do payers see for key emerging agents and regimens? How and to what extent do healthcare authorities actually monitor prescribing? How might this monitoring evolve given the expected surge in DAA approvals? 


Decision Resources Group’s European Physician & Payer Forum report “Hepatitis C Virus: How Will All-Oral, Interferon-Free Antiviral Regimens Influence Physician and Payer Attitudes Toward Treatment and Reimbursement in the Cost-Constrained EU5?” explores how these stakeholders expect to balance the growing influx of HCV patients seeking treatment and the rising costs associated with emerging treatment regimens against a backdrop of tightening healthcare budgets and increasingly aggressive cost-containment measures in each country. It draws on insights from 251 surveyed hepatologists and gastroenterologists 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: National adviser for Haute Autorité de Santé (HAS), hospital formulary committee president, and hospital pharmacy director.

- 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) and head of drug reimbursement, a hospital pharmacy director, and medical director and national formulary committee member.

- Italy: A member of a regional hospital formulary (PTOR-PTO), a former Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) member, and an adviser to AIFA.

- Spain: A pharmacy director and regional hospital formulary management member, a head of pharmacy and pharmaceutical commission member, and a regional formulary committee member.

- United Kingdom: A regional Clinical Commissioning Group (CCG) formulary committee member and member of CCG Medicines Management committee, a chief pharmacist and hospital formulary committee member, and a hospital pharmacy director.

Author(s): David Holman, Ph.D.