Gilead pushes some patients out of assistance program as it fights restrictive insurers

Gilead Sciences ($GILD) has gotten a lot of pushback from payers over the high prices of its hepatitis C drugs Sovaldi and Harvoni. Now, Gilead is doing some pushing of its own. The only problem is that some patients are caught in the middle.

The drugmaker is unhappy that some insurers continue to refuse to cover or put limits on the coverage of the drugs even after being offered discounts from Gilead. So the drugmaker is changing is patient assistance program criteria to exclude patients whose insurers have set limits, or are only willing to cover AbbVie's ($ABBV) competing product Viekira Pak, according to a recent letter to patients that has circulated on the Internet.

A spokesperson for the company could not be reached but in the letter, Gilead said that the assistance program was set up to help "uninsured patients with the most need." But because it was providing the drug at little or no cost to "virtually all patients who met financial and other program requirements," some payers figured they didn't have to cover them.

"While many payers responded to these discounts by opening access broadly, some payers have continued to restrict access despite the discounts," the letter from Coy Stout, vice president for managed markets reads. "As a result, our PAP criteria enabled continued restrictions by some payers by providing a generous route for them to deny access and refer patients they have chosen not to cover."

That will now stop, the drugmaker said. Insisting the changes will affect only "a very small number of patients," the drugmaker said it will no longer cover patients who have insurance but have been denied coverage of Sovaldi or Harvoni, for any of 5 reasons, including fibrosis score restrictions, step-therapy requirements, or because their insurer prefer or only will only cover AbbVie's treatment, which came on the market at a lower price but is not as convenient to take. "We believe these changes also will help increase access among those payers who continue to restrict access," Stout said.

Some patients are fighting battles of their own. One recently sued Anthem Blue Cross, saying her plan blocked her from treatment because she's not sick enough to qualify under its rules. Still, some patients will no longer be able to get the drugs, and for them it is a daunting idea. One patient on a forum named Else said that she would no longer be eligible for the drugs. "Now I'm feeling very unlucky that I have insurance. If I was uninsured, I would still qualify and get medication. This roller coaster really has me tapped out. I'm starting to think I should work on not caring anymore."

The cost of Gilead's combo drug Harvoni, which runs $95,000 per 12-week treatment course, and Sovaldi, which lists at $84,000 per 12 weeks, sparked reactions from payers and patient groups even before they were approved. Express Scripts ($ESRX) CMO Steve Miller ignited a pricing war by selecting AbbVie's Viekira Pak as the company's preferred hep C treatment in return for a hefty discount. Gilead was then forced to offer discounts that it has suggested will run to about 45% this year. With more competing treatments expected soon from Merck & Co. ($MRK) and Bristol-Myers Squibb ($BMY), the market will get even more difficult for Gilead.

Still, the treatments are raking in the money for the Foster City, CA-based drugmaker. Sovaldi and Harvoni combined had sales of $4.55 billion in the first quarter, $1 billion more than analyst consensus. The drugmaker has insisted all along that insurers will save money in the long run by covering the drugs, which can cure more than 90% of patients. A recent study provided some new support for its argument, saying that investing in new hep C therapies could save the U.S. and Europe billions of dollars in lost productivity.

- read the letter (PDF)

Suggested Articles

The CD19 antibody, used in tandem with Celgene's Revlimid, represents the first FDA approval in second-line diffuse large B-cell lymphoma.

Sanofi has faced a probe into birth defects tied to seizure med Depakine for years. Now, the investigation is moving forward on manslaughter charges.

Pfizer launched a multichannel awareness campaign centered on a first-ever radio station dedicated solely to metastatic breast cancer.