FDA approves a Gilead pill that is first to treat all forms of hepatitis C

Gilead Sciences won regulatory approval on Tuesday to sell a new hepatitis C combination drug, which can combat all six strains of the disease, and priced it below its older treatments.

The new drug, which is called Epclusa, combines the older Sovaldi medication with the newer velpatasvir, and costs $74,760 for a 12-week course of treatment, although that’s before any rebates are offered to payers. This is less than the list prices for both Sovaldi and Harvoni, another Gilead hepatitis C treatment.

Gilead has been widely criticized for its pricing policies ever since Sovaldi was launched in early 2014. At the time, the medication sported a list price of $84,000, before rebates, for a 12-week course of treatment, or about $1,000 a day. This caused public and private payers to worry the drug would become a budget buster.

That’s because the medicine can cure more than 90 percent of patients, which prompted an upsurge in prescriptions, and also because Gilead initially lacked competition. Pricing concerns were magnified when Gilead later released Harvoni at a list price of $94,600 for 12 weeks, and some payers responded by restricting coverage to patients whose disease was at a more advanced stage. Late last year, a US Senate investigation concluded the company placed profits over patients, and the Massachusetts Attorney General threatened Gilead with a lawsuit over its pricing.

Gilead has argued its treatments are more affordable than paying for liver transplants, cancer, and hospitalizations. To what extent the newest drug will cause payers concern is unclear. Epclusa will cost roughly half of the most commonly used treatment regimen for patients with Genotype 3 of the disease.

This genotype is “the most difficult to treat and one of the reasons Epclusa was granted priority review by the FDA,” wrote Leerink analyst Geoffrey Porges in an investor note. He forecasts global Epclusa sales of $1.8 billion this year and $10.3 billion in 2017, before eroding to $2.2 billion in 2021, as more competition kicks.

Meanwhile, the older standard of care is a combination treatment that includes Sovaldi and Bristol-Myers Squibb’s Daklinza. The Bristol component has a $63,000 list price, suggesting the combined cost of this older treatment may place Bristol at a competitive disadvantage.

An executive at one large health plan welcomed the additional treatment option.

“Keep in mind that most hepatitis C cases, about 70 percent, occur among people with the genotype (or strain) that is most prevalent,” genotype 1, said Michael Sherman, chief medical officer at Harvard Pilgrim Health Care, the second-largest health plan in New England. “Having more options is a good thing and I don’t think this will lead to increased costs, although we will have to see what the rebates look like.”

Meanwhile, a spokesman for Express Scripts, which is the nation’s largest pharmacy benefits manager and has tussled with Gilead over its pricing, wrote us that “we are pleased that they have been responsive to the discussions we have been having over the past few years, and complement them on their restraint around the list price of this new drug. We will continue to negotiate with Gilead in regards to net pricing for our clients.”

The safety and efficacy was evaluated over a 12-week period in three Phase 3 studies of 1,558 people with or without cirrhosis, according to the US Food and Drug Administration.

The approval is expected to give Gilead a boost. Although Sovaldi and Harvoni generated combined sales of more than $19 billion last year, a 54 percent increase from 2014, sales fell more than 5 percent in the first quarter of 2016. This was explained, in part, by added competition. AbbVie began selling a pill in late 2014 and, earlier this year, Merck launched a pill at a much lower list price.

One consumer advocate charged the pricing for the new drug was out of line. “Gilead still doesn’t get it — their pricing is outrageous. Once again, Gilead has shown that it is more concerned with protecting its profits rather than making its drugs available to all Americans,” said Tahir Amin, a cofounder of the Initiatives for Medicines, Access & Knowledge, which has challenged Gilead patents in other countries.