MaxIntel® Pharmacy Trend Alert

 

Epclusa (Sofosbuvir/Velpatasvir)

 

 

 

Drug Approval and Market Entry[i],[ii]  

 

§  On June 28, 2016, the U.S. Food and Drug Administration (FDA) announced the approval of EpclusaTM (sofosbuvir-velpatasvir). Epclusa ™ is manufactured by Gilead, the maker of Harvoni™ and Sovaldi™.

 

§  Epclusa™ is a fixed-dose combination product containing sofosbuvir, previously released as Sovaldi™, and a new chemical entity called velpatasvir. Both of these agents work in synergy to inhibit viral replication. 

 

§  Epclusa™ is the first pan-genotypic, all-oral, single tablet treatment regimen, FDA approved for adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 

 

§  In clinical trials consisting of 1,035 patients treated with Epclusa for 12 weeks, 98% of patients achieved an SVR12 (cure). In patients with decompensated cirrhosis receiving Epclusa + Ribavirin for 12 weeks, 94% of patients achieved an SVR12.

 

 

 

Anticipated Market Impact

 

§  It is estimated that nearly 3 million people in the US have Hepatitis C. Of these 3 million individuals, approximately 70% are infected with genotype 1, and 30% is estimated be infected with genotype 2-6.

 

§  Treatment regimens differ with each genotype and may require one agent or multiple agents, with costs ranging from $54,600 to over $189,000 per treatment course.  Treatment courses vary between 8 to 24 weeks in duration depending on genotype, viral load, presence of resistant HCV polymorphisms, or severity of cirrhosis.  The following table shows an estimated cost comparison for the typical 12 week regimen based on wholesale acquisition cost (WAC).

 

 

 

Cost Comparison of Novel HCV Therapies

 

 

 

 

 

Medication Details

 

  • Although the FDA granted Epclusa™ a priority review and Breakthrough Therapy designation, Gilead announced that Epclusa™ will be priced at $74,760, or roughly $890 per pill,[iii] which is lower than both Sovaldi™ and Harvoni™.

  • The strategic pricing of this product makes it competitive compared with Zepatier™ (Merck).  However, Zepatier™ is only indicated for treatment of HCV genotypes 1 and 4.  Zepatier™ also requires the higher cost 16 week regimen if patient has a certain viral polymorphism.  With Epclusa™, the only variable cost is the addition of ribavirin, estimated to be up to $3,500 per 12 weeks.

  • For all 6 genotypes the recommended dosing and duration is as follows:

     

 

Patient Population

Recommended Treatment Regimen

Patients without cirrhosis or compensated cirrhosis

12 weeks of Epclusa once daily

Patients with decompensated cirrhosis

12 weeks of Epclusa once daily + Ribavirin

 

                     

 

  • The most commonly reported side effects were fatigue, headache, nausea, anemia, insomnia and diarrhea.  Epclusa™ is also subject to drug interactions and the full list is available in the product labeling.

     

    MaxCare Management Options

 

  • Once Epclusa ™ 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 MaxCare 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.

 



[i] FDA News Release. FDA approves Epclusa for treatment of chronic Hepatitis C virus infection. Available online: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm. Last updated June 28, 2016.   Last accessed June 29, 2016.

[ii] Epclusa™ Product Information. Available online at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf Last updated 1/2016.   Last accessed 2/2016.

[iii] Associated Press (CBS News). FDA Approves First Pill to Treat All Forms of Hepatitis C.  Available online at: http://www.cbsnews.com/news/fda-approves-first-drug-epclusa-to-treat-all-forms-of-hepatitis-c/. Last updated June 28, 2016.  Last accessed June 29, 2016.