MaxIntel Pharmacy Trend Alert
Drug Approval and Market Entry
§ On January 28, 2016, the U.S. Food and Drug Administration (FDA) announced the approval of the 6th novel agent to be added to the medical armament against Hepatitis C viral (HCV) infection.
§ Zepatier™ is a fixed-dose combination product containing elbasvir, a hepatitis C virus NS5A inhibitor, and grazoprevir, a protease inhibitor. Both of these agents work in synergy to inhibit viral replication.
§ Zepatier™ is manufactured by Merck & Co. and is approved for treatment of patients with genotype 1 and 4 HCV infections.
§ The safety and efficacy of Zepatier™ used with or without ribavirin was evaluated in clinical trials totaling 1,373 patients with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The overall cure rates ranged from 94-97% in genotype 1-infected patients and from 97-100% in genotype 4-infected patients across trials for the approved treatment regimens.
§ It is estimated that nearly 3 million people in the US suffer from Hepatitis C. However, many infected individuals are often unaware of their infection for several years until liver damage develops. This blood-borne disease may lead to serious complications including bleeding, yellowing of the skin and eyes, fluid accumulation, liver cancer, and death.
§ Of these 3 million individuals, approximately 70% are infected with genotype 1, and less than 1% are infected with genotype 4.
§ Zepatier™ is a fixed-dose combination product containing 50 mg of elbasvir and 100 mg of grazoprevir in a single tablet. The recommended dosage is one tablet taken orally once daily with or without ribavirin.
§ For patients with Genotype 1a, testing for the presence of HCV with NS5A resistance-associated polymorphisms is recommended. Liver function test should also be assessed before initiation of therapy as the duration and dosing of Zepatier™ is based on these parameters.
§ Based on the genotype, previous treatments that the patient has failed, and presence of the NS5A resistance-associated polymorphisms Zepatier™ therapy may range from 12 – 16 weeks in duration.
§ No dosage adjustment is necessary in renal impaired patients. However, in patient with severe liver impairment Zepatier™ is contra-indicated.
§ Zepatier™ is also subject to drug-drug interactions and the full list is available in the product labeling.
§ The most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache, nausea, and anemia.
Anticipated Market Impact
§ The novel HCV agents offer patients a higher cure rate, in many cases up to 100% opposed to the cure rates between 50-60% with the older regimen, and fewer severe side effects. They also offer patients an all oral therapy opposed to the older treatment regimen which requires an injectable medication.
§ Currently the market consists of five other novel Hepatitis C therapies. The cost of these therapies range from $94,000 to over $160,000 per treatment course.
§ The anticipated cost of Zepatier™ is expected to be approximately $54,000 per course of treatment.
§ In the past two years it was highly anticipated that as more novel agents for the treatment of HCV entered the market competition would drive down the cost. However, up until now, there had been very little difference in cost of the newer agents and plan payers had to rely on manufacturer rebates to lower cost of therapy. The strategic pricing of this product makes it the first product in this class to offer true competition, and hence it is expected to significantly impact utilization within this category.
MaxCare Management Options
§ Once Zepatier™ is available on the market, it will be added to MaxCare Specialty Program. All Hepatitis C treatments are currently included in our Specialty Management Program to ensure appropriate clinical parameters are met and that the most cost-effective product is used.
§ For more clinical solutions pertaining to the management of new Hepatitis C treatments please contact your MaxCare account manager and request a consultation with the MaxCare Clinical Department. Ask your MaxCare account manager about the MaxOutcomes Specialty Care Program, a program designed to maximize return on investment of complex and costly medication treatments for both plan sponsors and patients.
 FDA News Release. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4. Available online: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm Last updated 1/2016. Last accessed 2/2016.
 Zepatier™ Product Information. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164dc02a-9180-426a-b8b5-04ab39d2bbd4#S2.2 Last updated 2/2016.