| AbbVie’s Viekira Pak Will be Available If a Patient Receives Medical Exception or Prior Authorization|
AbbVie’s Viekira Pak isn’t included on CVS Health’s drug formulary. Bloomberg News
Updated Jan. 5, 2015 12:27 p.m. ET
The battle for supremacy in one of the fastest-growing pharmaceutical markets intensified on Monday, with CVS Health Corp. saying it will make Gilead Sciences Inc. ’s drugs Sovaldi and Harvoni the exclusive options for patients with hepatitis C.
A competing treatment made by AbbVie Inc., called Viekira Pak, will be excluded from CVS’s drug formulary of approved medications, except in cases when it is medically necessary, CVS said in a letter sent to employment-benefit consultants that was reviewed by The Wall Street Journal.
The letter from CVS, a retail chain and pharmacy-benefits manager, doesn’t indicate whether Gilead gave CVS a discount on the expensive hepatitis C drugs. Sovaldi costs $84,000 per patient and Harvoni $94,500 per patient in the U.S. for 12-week treatments. Gilead and CVS declined to comment on specifics of the deal.
“Our goal was to create the lowest net-cost solution for the entire population of patients with all genotypes of hepatitis C,” Christine K. Cramer, a CVS spokeswoman, said in an email. CVS made its decision based on a clinical review of the different hepatitis C regimens and their costs, she said.
AbbVie’s Viekira Pak costs $83,319 per patient in the U.S. for a 12-week regimen.
World-wide sales of new hepatitis C drugs, which have higher cure rates and fewer side effects than older therapies for the viral liver disease, are estimated to have reached $13 billion in 2014, according to RBC Capital Markets. The hepatitis C drug market is expected to grow 42% to $18.5 billion this year, RBC said.
Doctors and patients have praised the drugs’ cure rates, but insurers and state health officials have criticized their pricing, calling it unsustainable. Many state Medicaid programs have limited access to the drugs because of the cost.
Express Scripts Holding Co. , the largest U.S. pharmacy benefit manager, said in December it had agreed to give preferred formulary status to AbbVie’s Viekira Pak in exchange for a discount from AbbVie. Express Scripts, which has been among the most vocal critics of Gilead’s pricing of hepatitis C drugs, said it would exclude from its formularies Gilead’s drugs for hepatitis C patients with the most common form of the disease, known as genotype 1. Express Scripts also said it would make AbbVie’s drug available to all patients, regardless of their disease severity.
Gilead shares fell 13% through the end of December after the agreement between Express Scripts and AbbVie was announced, with some investors worried AbbVie would use price discounting to gain a larger share of the hepatitis C drug market than anticipated. The Nasdaq Biotechnology Index fell 4.1% over the same period as some analysts worried of increased pressure from pharmacy-benefit managers and health insurers on drug pricing.
On Monday, shares of Gilead were up 2% to $96.79. AbbVie shares fell 1.9% to $64.65.
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CVS’s policy will go into effect Jan. 7 and will apply to all hepatitis C genotypes. The company’s policy will apply to Medicare and Medicaid patients who receive drug benefits through CVS, as well as beneficiaries covered under health plans sold through marketplace exchanges and CVS’s standard commercial formulary. The change won’t necessarily apply to CVS customers who use custom formularies, the CVS letter said.
Sales of Gilead’s Sovaldi, approved in late 2013, were $8.55 billion in the first three quarters of 2014 in what is thought to be the most successful drug launch ever. Harvoni was approved by the Food and Drug Administration this past October as the first treatment for genotype 1 cases of hepatitis C that doesn’t require two older drugs known to cause serious side effects.
AbbVie received approval for its Viekira Pak on Dec. 19.
“Gilead is very pleased to have reached an agreement with CVS that will enable access to Harvoni for people living with HCV,” Amy Flood, a Gilead spokeswoman, said in an email.
Viekira Pak is thought to be as effective as Gilead’s drugs in genotype 1 patients, though not as convenient because it requires patients to take more pills at one time.
“Our multiyear agreement with Express Scripts is an example of how we will ensure all hepatitis C patients beyond just the very sickest…gain access to treatment,” David Freundel, an AbbVie spokesman, said in an email.
“We welcome others to follow our lead,” Brian Henry, an Express Scripts spokesman, said of CVS’s agreement with Gilead.
—Peter Loftus contributed to this article.
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