A new treatment for hepatitis C developed by AbbVie won approval from the Food and Drug Administration on Friday, setting the stage for a marketing battle with Gilead Sciences, whose two new drugs for the disease have drawn an outcry about the high cost of medicines.
Insurers and state Medicaid programs have been eagerly awaiting the approval of the AbbVie regimen, which is called Viekira Pak, hoping that competition will drive down prices.
AbbVie said the wholesale price of Viekira Pak would be $83,319 for a typical 12-week course of therapy. That is less than the $94,500 for 12 weeks of Gilead's Harvoni, but probably not enough of a discount to allay complaints about high prices.
The price is "higher than we had hoped," said David Lassen, chief clinical officer of Prime Therapeutics, a pharmacy benefit manager owned by Blue Cross and Blue Shield plans.
Morry Smulevitz, a spokesman for AbbVie, said the price for Viekira reflected both market dynamics and the value the drug brings to the health care system.
AbbVie's regimen is a combination of four different drugs that work by three different mechanisms to disable the virus. One of the drugs was jointly developed with Enanta Pharmaceuticals.
In studies, Viekira has been shown to be about as effective as Harvoni, curing 90 percent of patients or more who are infected with the most common subtype of the virus, known as Genotype 1. As with Harvoni, side effects are generally mild or moderate.
"The new generation of therapeutics for hepatic C virus is changing the treatment paradigm for Americans living with the disease," Dr. Edward Cox, who oversees antimicrobial products for the F.D.A., said in a statement.
More complicated regimens could raise the risk that patients will stop taking their drugs, but some pharmacy benefit managers said that since the treatment is typically for only 12 weeks that would not be much of a factor in deciding which drug they prefer.
"We believe that given the similar efficacy, cure rates, safety profile that we would really be looking at cost as the biggest driver for that decision," Mr. Lassen said.
Humira sales of $9.18 billion in the first nine months of the year accounted for nearly two-thirds of AbbVie's total sales. But its main patent in the United States expires in 2016, subjecting Humira to possible competition from copycat versions known as biosimilars.
Previous treatments for hepatitis C involved weekly injections, cured a smaller percentage of patients, took six months to a year to work and had such severe side effects that many patients quit midstream or did not even start.
By being easier to use and more effective, the new drugs, particularly Sovaldi, which was approved last December, have spurred a flood of patients to seek treatment.
Sovaldi had sales of $8.55 billion in the first nine months of this year, with $7.33 billion of that in the United States, by far the largest first-year sales of any drug in history and on pace to be one of the best-selling drugs ever. Gilead priced Sovaldi at $84,000 for the typical 12-week course of treatment, or $1,000 per daily pill. Sovaldi has to be taken with at least one other drug, raising the cost.
Gilead says the price of Sovaldi is comparable to that of previous hepatitis C treatments and that the drug will save the health system money in the long run by preventing liver cirrhosis and cancer and reducing the need for expensive liver transplants.
"There's never been big competition when there are just two products in the marketplace," said Dr. Steve Miller, chief medical officer at Express Scripts, the largest pharmacy benefit manager.
Still, the pharmacy benefit managers have become more effective recently in pitting one company against another to get discounts below the list price. They can offer to make the lower-priced drug the preferred choice, with a lower co-payment. They are also now becoming more willing to completely bar reimbursement for the less preferred drugs.
