fter two years of controversy over the cost of hepatitis C treatments, the fast-growing market is poised to undergo a price war.
Late Thursday, Merck received Food and Drug Administration approval for its Zepatier medication and set a list price of just $54,600 for a 12-week course of treatment. This is considerably lower than the cost of rival medicines that have helped spark national outrage over prescription drug pricing.
By comparison, the list price for the Harvoni drug sold by Gilead Sciences is $94,500, while AbbVie charges $83,300 for its Viekira Pak for 12-week regimens. List prices, however, do not reflect any rebates, which can vary. Despite receiving such partial refunds, though, many insurers and government health programs have restricted coverage of these treatments in order to contain costs.
By setting a much lower price, Merck is moving quickly to grab market share. The strategy is helped by the fact that its once-daily, single tablet is equally effective as Harvoni, although doctors should watch for raised liver enzymes and may want to test patients for resistance to the treatment. Merck’s Zepatier is also more convenient to use than the AbbVie treatment, which consists of two pills for most patients.
Analysts appear divided on the extent to which the gambit will work.
RW Baird analyst Brian Skorney, for instance, wrote in an investor note that labeling references to liver enzymes and recommended patient testing places the Merck drug at a disadvantage. He noted that liver monitoring is on the Viekira Pak label, but not on the Harvoni label. And resistance testing is not recommended for either Harvoni or Viekira.
In any event, Credit Suisse analyst Vamil Divan raised similar caveats and estimated Zepatier will generate nearly $1.6 billion in revenue next year. Gilead’s Harvoni notched $10.5 billion in sales in the first nine months of 2015.
For now, though, investor sentiment appears to favor Merck. Its stock rose on Friday, while both Gilead and AbbVie shares fell on a day when the stock market climbed smartly.
“Merck knows its franchise has to be differentiated,” said Steve Brozak, who heads WBB Securities and tracks biopharma stock. “And this is a wake-up call to Gilead and AbbVie, because Merck is going out there and providing a quality product at a reasonable price. This is exactly the way business should be conducted in health care.”
Indeed, Merck’s move may also help blunt the accelerating criticism of the pharmaceutical industry. About three-quarters of the American public believe the prices of brand-name medicines are unreasonable, while 26 percent expressed that view about generics, according to a recent poll by STAT and the Harvard T.H. Chan School of Public Health.
Over the past few months, prescription drug pricing has become fodder in the presidential campaign with Hillary Clinton, Bernie Sanders and, more recently, Donald Trump taking aim at drug makers. Next week, the latest in a series of congressional hearings will be held with a particular focus on companies, such as Valeant Pharmaceuticals, that have bought medicines and then raised prices to sky-high levels.
This is not the first time, however, that a new entrant into the burgeoning market for hepatitis C drugs was expected to lower prices.
When AbbVie introduced Viekira Pak a year ago, the drug maker tried to undercut Gilead by offering deals with pharmacy benefits managers, which represent insurers, government agencies and companies. But some patients with a certain subtype of hepatitis C must add an older drug that not only increases the pill count to six a day from four but can also cause difficult side effects.
By contrast, Gilead’s Harvoni is a once-daily, single tablet regimen. This helps explain why prices for the hepatitis C medicines, by and large, did not fall significantly over the past year, despite rebates offered to some buyers. The marketplace simply lacked added competition to spur Gilead and AbbVie to further lower their prices.
What remains to be seen is how pharmacy benefit managers react.
A spokesman for Express Scripts, which is the nation’s largest benefits manager and used the new AbbVie drug to extract rebates from Gilead, wrote us that “having multiple, clinically effective options allows us to again leverage competition and make medicine more affordable for our clients while ensuring appropriate patient access.”
One industry consultant, Roger Longman of Read Endpoints, a research firm that tracks reimbursement issues, believes that Merck’s pricing may be sufficiently tempting for benefits managers. That’s because its new treatment carries a lower list price than the Harvoni list prices, regardless of whether patients take that treatment for eight or 12 weeks, depending upon their strain of the virus.
“Essentially, what Merck has done is undercut Harvoni” in most patient populations, he explained. “And remember that Merck will also offer rebates. So they’re giving themselves some room to make it still more attractive for pharmacy benefits managers, some of which may have contracts that allow them to switch drugs if there’s a dramatic price difference from a new product.”