- Express Scripts will exclude 48 drugs from its list of preferred medicines for next year, dropping AbbVie's fast-selling hepatitis C therapy Mavyret, Gilead's HIV treatment Atripla and other brands from its national formulary.
- In a statement, the pharmacy benefit manager said the changes would impact only 0.2%, or about 50,000, of the more than 25 million Americans who are covered by plans managed by Express Scripts.
- Dropping Mavyret deals a blow to AbbVie, which has made large gains in wresting share of the hepatitis C market away from Gilead's rival therapies over the past six months. Express Scripts' formulary lists Gilead's Epclusa, Harvoni, Vosevi, and Merck & Co.'s Zepatier as preferred therapies.
Major PBMs like Express Scripts hold considerable clout. Through drug formularies, the benefits managers can extract concessions on price from manufacturers and push health plan members away from a higher cost treatment toward a lower priced option.
According to Express Scripts, the exclusions from its 2019 formulary will save its clients an estimated $3.2 billion.
For AbbVie, the decision to drop Mavyret (glecaprevir/pibrentasvir) could blunt some of the drug's commercial momentum. Sales of the hepatitis C medicine totaled more than $1.8 billion over the first six months of the year on the back of steady gains in share of new prescriptions.
"We are disappointed by [Express Scripts'] decision to remove Mavyret from their formulary, an AbbVie spokesperson said in an email.
"Mavyret is the most prescribed HCV treatment due to its competitive clinical profile and value as the lowest-priced pangenotypic option. This decision eliminates a low WAC option for patients with genotypes 2,3,5 and 6, which comprises 23% of patients," the spokesperson said, referring to the list price, or wholesale acquisition cost.
AbbVie had priced Mavyret competitively compared to Gilead's therapies, while securing approval in 2017 of a convenient eight-week regimen that could treat all six genotypes of the liver disease.
Gilead's Harvoni (ledipasvir/sofosbuvir), by comparison, is only OK'd to treat genotypes 1, 4, 5 and 6, and is administered over 12 weeks in most cases. Epclusa (sofosbuvir/velpatasvir) can be given to patients with any of the six genotypes.
With Mavyret excluded from Express Scripts' list, Gilead's drugs could gain back some of the ground they lost to AbbVie's drug.
"Gilead is the principal beneficiary of the Mavyret exclusion and stands to see share gains from the ~50% of individuals who would have received Mavyret on Express Scripts plans," wrote Leerink analyst Geoffrey Porges in a Aug. 7 note to clients.
Leerink estimates Express Scripts manages plans representing about a quarter of patients with commercial insurance.
However, the hit to AbbVie's revenues — most of which come from its top-selling Humira (adalimumab) — may be limited to about 1% or less of the company's 2019 revenues, Porges wrote.
Shares in AbbVie fell 3% Tuesday.
In announcing its list, Express Scripts referred to pricing of the hepatitis C medicines, calling Merck's Zepatier (elbasvir/grazoprevir) the "low-price leader." In July, Merck announced it would cut the list price of Zepatier by 60%, seemingly in response to criticisms of high drug prices from the Trump administration.
That announcement was undercut, however, by the negligible sales Merck has earned for Zepatier in 2018. In fact, between April and June, the pharma recorded negative $10 million in revenues for the drug.
In addition to Mavyret, notable brands set to be excluded by Express Scripts are Boeheringer Ingelheim's Pradaxa (dabigatran), Sanofi's Eloctate (antihemophilic factor, recombinant) and Gilead's Atripla (efavirenz/emtricitabine/tenofovir).
One potential winner from the 2019 formulary is Synergy Pharmaceuticals, which saw its constipation drug Trulance go from excluded this year to preferred for next year.