FDA Approves Harvoni for the Treatment of Hep C
On October 10, 2014 the U.S. Food and Drug Administration (FDA) approved Harvoni (sofosbuvir and ledipasvir) as the first once-a-day complete therapy for Hepatitis C. Harvoni, manufactured by Gilead Sciences, is a once-a-day pill which combines two treatments, sofosbuvir, the key active ingredient in Solvaldi as well as a new medication ledipasvir that is not available as a stand-alone product. Harvoni is expected to provide a shorter course of treatment and enhanced outcomes.
The retail cost for Harvoni is estimated to be $94,500 for a 12-week supply ($1,125 per pill). Through Benecard Central Fill, our clients can expect to see savings over the retail cost. Our Wholesale Acquisition Cost price is expected to be $29,949.75 per 28 days of treatment. Compared to the retail cost above, this is $89,822.25 for 12-weeks. Ultimately this course of treatment is expected to be less expensive than the recently released Sovaldi which requires that additional therapies to be prescribed. Harvoni provides a complete dual combination Hepatitis C treatment attaching the disease two ways at once.
In order to manage the cost as well as provide patients with oversight and clinical support to maintain compliance BeneCard PBF suggests that clients limit Harvoni to distribution through mail order only.
If you have any questions you can contact our Client Services Call Center at 1-877-723-6005.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.