In October 2014, the FDA approved the medication Harvoni to treat adults with chronic hepatitis C genotype 1 infection. This all-oral, single-tablet regimen containing the blockbuster drug Sovaldi offers several advantages for patients. In addition to a lower pill burden (one tablet taken daily compared to upwards of 10 tablets with other medications), Harvoni also has fewer potential interactions with other medications. It is also approved for use in patients who previously failed treatment on either Incivek or Victrelis.
After a review of this medication, Harvard Pilgrim has named Harvoni the preferred drug for treating patients with chronic hepatitis C genotype 1 and is now offering coverage for this medication with prior authorization.
In addition, Harvard Pilgrim recently became the first regional health plan in New England to negotiate a discount with Gilead Sciences Inc., the maker of Harvoni, which will result in millions of dollars in savings for its customers and help to slow the growth of escalating health care costs.
Prior authorization criteria
Harvard Pilgrim requires prior authorization for the use of Harvoni for the Premium and Value formularies to ensure appropriate use for patients. To obtain prior authorization, providers must meet the requirements of the Harvoni Clinical Criteria:
- Is 18 years of age or older
- Has a diagnosis of chronic hepatitis C infection, genotype 1
- Was prescribed this medication by a gastroenterologist, infectious disease specialist, or physician specializing in the treatment of hepatitis (e.g., hepatologist)
- Is not taking medications known to interact with Harvoni
- Is not currently abusing alcohol or illicit substances or is receiving counseling services as an adjunct to HCV treatment
- Has had liver disease staged within the past 3 years with either an invasive or non-invasive test and the resulting fibrosis score is greater than or equivalent to METAVIR F2
- Has had a pre-treatment HCV RNA level taken within the past 3 months
Please refer to the clinical criteria for complete information. To request prior authorization, complete the appropriate Medication Request Form and fax it back to MedImpact Healthcare Systems at 888-807-6643. Harvoni will be available through the specialty pharmacy Accredo.
In addition, Harvard Pilgrim will also be requiring prior authorization for the use of Harvoni for our Medicare Advantage Stride formulary, pending approval by the Centers for Medicare and Medicaid Services (CMS). The criteria for this Medicare Advantage formulary may differ slightly.
Please refer to our Medicare Advantage Stride prior authorization criteria for details.
Coverage for other medications
While Harvoni is the preferred drug for patients with chronic hepatitis C genotype I, Harvard Pilgrim will continue to cover other all-oral treatment regimens, including Viekira Pak or Sovaldi + Olysio, when clinically appropriate. These medications also require prior authorization.
In order for either Viekira Pak or Sovaldi + Olysio to be covered for patients with chronic hepatitis C, genotype 1, the prescriber must also indicate why treatment with Harvoni would be clinically inappropriate or why the patient was, or will be, unable to tolerate Harvoni. Otherwise, criteria for coverage of Viekira Pak or Sovaldi + Olysio are similar to that of Harvoni. For more complete information, please refer to the clinical criteria for these medications.
For more information, please visit Harvard Pilgrim’s pharmacy webpage.