Express Scripts to cover AbbVie's Viekira Pak, exclude Gilead's Harvoni

Express Scripts said Monday that it will make AbbVie's newly-approved hepatitis C combination therapy Viekira Pak available to all patients with genotype 1 infection after agreeing a "significant discount" with the company. Meanwhile, Gilead Sciences' Harvoni (ledipasvir/sofosbuvir) will be excluded for most patients by the US pharmacy benefit manager from January 1.

Viekira Pak, which was cleared by the FDA on December 19, combines Viekira (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir), with or without ribavirin, and is authorised for patients with genotype 1 chronic hepatitis C, including those with cirrhosis. AbbVie has announced that Viekira Pak will cost $83 319 for a 12-week treatment course before any negotiated discount, around 12-percent below the price of Harvoni, which costs $94 500 for a 12-week course.

Steve Miller, Express Scripts' chief medical officer, declined to reveal the size of the discount on Viekira Pak, but noted "it's sufficient enough that we can guarantee to our plans that treating everyone is the right thing to do." He added that the price agreed with AbbVie was narrowing the gap towards the lower cost that some European countries have negotiated for Gilead's Sovaldi (sofosbuvir), which ranges from $51 373 in France to $66 000 in Germany.

Miller remarked "we have asked pharma companies to work with us closer and demonstrate good judgment," adding "AbbVie heard our concerns and they came to the table in a very creative way." The pharmacy benefit manager indicated that the pricing deal with AbbVie, which was signed on December 19 after its independent Pharmacy & Therapeutics Committee determined Viekira Pak to be "at least clinically equivalent" to Harvoni, covers its National Preferred Formulary. Miller noted that the agreement is for multiple years and stems from two months of negotiations between the parties.

Miller said that the pact represents the first time a specialty drugmaker agreed to a major discount off of its published price in exchange for fewer restrictions on access to the medication. Miller added that Gilead had been privately offering a discount of around 8 percent for Harvoni to prescription benefit managers. "Gilead has been negotiating in good faith with Express Scripts and other payers to ensure patients and health-care providers have access to our medications and can make informed treatment decisions," Gilead commented.

The majority of patients receiving treatment with Viekira Pak must take four to six tablets a day for 12 weeks, compared with one tablet a day for Harvoni. However, Miller said "the difference in the pill burden is trivial," adding AbbVie's drug "comes in a really elegant blister pack" that makes it easy to use. Analysts estimate that Viekira Pak will generate sales of $2.9 billion next year.

Commenting on the move, Miller said "this is exactly what our plan sponsors hire us to do is to negotiate and try to make drugs more affordable." He added "we look at this as being the first of what will happen the field of cancer, rheumatoid arthritis and many other of the expensive specialty fields."

Express Scripts also excluded Sovaldi from the national formulary, although the drug will remain on the list for patients with other types of HCV who have advanced liver disease, and Johnson & Johnson's Olysio (simeprevir).

For related analysis, see ViewPoints: This means war! Impact of AbbVie's HCV deal with Express Scripts goes well beyond Gilead and Spotlight On: Harvoni’s exclusion by Express Scripts may be good news for biosimilars manufacturers.

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