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?) | Physician & Payer Forum | EU5 | 2014
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).
