How Will Healthcare Reform and Payer-Led Cost-Containment Strategies Impact U.S. Prescribing?

The market opportunity for hepatitis C virus (HCV) features a large prevalent population, a significant proportion of which is at risk of advancing liver disease. The primary goal of HCV treatment is to completely eliminate the virus from the patient’s body and thereby reduce or halt the progression of liver fibrosis, preventing further complications, such as cirrhosis and hepatocellular carcinoma. Previous treatment strategies for HCV included the prescribing of suboptimal interferon (IFN)-based therapies (Roche’s Pegasys or Merck’s PegIntron), which were associated with significant tolerability issues, efficacy limitations, and long treatment durations. The HCV treatment landscape in the United States has been dramatically altered by the approval of novel antiviral therapies, including Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir), Janssen’s Olysio (simeprevir), and AbbVie’s Viekira Pak (paritaprevir/ombitasvir/ritonavir plus dasabuvir), ushering in the era of IFN-free therapy for HCV. These therapies are typically highly efficacious and well tolerated, making it difficult for pharmaceutical companies to differentiate their products from competitors. An important battleground in the future will be duration of treatment, where genotype-1 market leader Harvoni holds the potential to reduce treatment duration to 8 weeks from the current standard of 12-24 weeks for genotype-1 patients. In addition, pan-genotypic activity and elimination of ribavirin (Roche’s Copegus; Merck’s Rebetol; generics) from treatment regimens represent key unmet needs in the HCV space. Marketers of HCV therapies also face an increasingly competitive landscape and maneuver to secure formulary inclusion and preferred status through exclusive deals, rebates, and discounts. U.S. payers and prescribers are challenged with incorporating these highly desirable but costly new therapies into medical practice.

Questions Answered in This Report:

  • Gilead’s therapies Harvoni and Sovaldi continue to dominate the HCV market across genotypes. What are physician and payer perceptions of the future of these agents regarding expected patient shares, reimbursement environment, payer-imposed restrictions on patient access, and the likely impact of emerging therapies on Gilead’s continuing market dominance?

  • Payers employ utilization management controls such as prior authorization and treatment eligibility requirements, as a means of restricting patient access to HCV therapies in order to defer the high cost of treatment. What restrictions do physicians and payers most frequently encounter/employ for specific HCV regimens, and how do these restrictions affect physician prescribing practices? What has been the impact of high drug pricing on managed care organization (MCO) formulary decision making? Has aggressive discounting of HCV therapies translated to increased patient share among competitors with similar efficacy?

  • Daclatasvir (Bristol-Myers Squibb’s Daklinza) was recently approved for the treatment of genotype-3 patients in combination with Gilead’s Sovaldi. Merck’s fixed-dose combination (FDC) of grazoprevir/elbasvir is expected to be approved for the treatment of genotype-1 patients and has shown efficacy in “difficult-to-treat” patients such as those with severe renal impairment. What impact do physicians believe daclatasvir will have on the current standard of care regimen, Sovaldi + ribavirin, in genotype-3 HCV patients? Are physicians willing to prescribe grazoprevir/elbasvir and for which populations? What type of cost-containment measures and formulary-level restrictions do payers plan to impose on daclatasvir and grazoprevir/elbasvir? What do physicians and payers believe are the most important qualities in emerging therapies that will influence their prescribing practices and formulary decisions?


Markets covered: United States.

Primary research: Physicians’ responses were collected in two separate surveys. Physician survey 1 recruited 90 gastroenterologists and 10 hepatologists, for a total of 100 respondents who completed the survey. Physician survey 2 recruited 86 gastroenterologists and 14 hepatologists, for a total of 100 respondents who completed the survey. MCO pharmacy director (PD) responses were collected in one survey; 14 MCO PDs and 17 medical directors (MDs) completed the survey for a total of 31 respondents.

Emerging therapies: Phase III: 1 drug; registered: 1 drug.

Author(s): James T. Heeres, Ph.D.
Brenda Perez-Cheeks, Ph.D.