Two groups representing most of America’s HIV doctors have challenged moves by insurance companies to keep them from prescribing lifesaving hepatitis C medications.
Insurers are requiring doctors prescribing sofosbuvir (Sovaldi), a once-daily pill for hepatitis C, to either be hepatologists or gastroenterologists. Those doctors specialize in issues related to the liver, which hepatitis C destroys.
But hepatitis C is often transmitted along with HIV, so HIV doctors have long been treating their patients for both conditions.
Insurer restrictions don't stop with HIV doctors. Even infectious disease specialists are in some cases prohibited by insurers from prescribing Sovaldi, said Dr. Michael Saag. Saag is a member of the Infectious Diseases Society of America (IDSA) panel that created new guidelines for treating hepatitis C.
Treatment Undergoes a Radical Shift
The treatment of hepatitis C has undergone a huge change in the past year. Sovaldi can cure around 90 percent of people of the deadly disease in just 12 weeks. Approved at the very end of last year, the pill has minimal side effects and almost always works for people who have hepatitis C genotype 1. There are multiple hepatitis C genotypes that each need to be treated differently.
Sovaldi, which can be effective for four of the genotypes, costs $84,000 for a 12-week course. That does not include the cost of drugs recommended to be used alongside it or for physician care. All told, the price tag runs north of $100,000, said Dr. Michael Horberg of the HIV Medicine Association (HIVMA).
Hundreds of thousands of American seniors and others at risk for hepatitis C, including people serving time behind bars, rely on government-supported health programs. If everyone who needed Sovaldi started taking it today, it would no doubt bankrupt the healthcare system, Saag said.
“We now have a treatment or cure for which the costs are almost prohibitive for wide scale treatment,” Horberg told Healthline. “In truth this is what is leading to these kinds of determinations, it’s not that doctors, insurance companies, or health systems don’t want to treat for a cure, but everything is at an opportunity cost.”
CDC Urges Testing for Seniors
Sovaldi’s arrival on the market came at the perfect time for the drug’s manufacturer, Gilead. The U.S. Centers for Disease Control and Prevention has recommended that every American born between 1945 and 1965 get tested for hepatitis C. The CDC estimates that of 3 million Americans with hepatitis C, most are baby boomers. Three in four don’t know they’re infected.
Prior to Sovaldi, hepatitis C treatment was effective half the time at best, Saag said. It had only recently begun to move away from medications with unpleasant and sometimes agonizing side effects.
Saag wrote about Sovaldi and other emerging hepatitis C medications in this editorial published last month in the Journal of the American Medical Association.
In a joint letter to the federal Centers for Medicare and Medicaid Services, the IDSA and HIVMA affirmed that some state Medicaid programs had locked them out of prescribing Sovaldi.
The majority of the doctors sitting on the FDA's Antiviral Drugs Advisory Committee, the group that recommends whether or not the FDA should approve new hepatitis C drugs, are also infectious disease specialists.
Insurer's Chief Medical Officer Responds
Dr. Michael Madden is the chief medical officer of Gateway Health, a Pittsburgh-based health insurer. Gateway prevents HIV doctors from prescribing Sovaldi. He told Healthline he believes many insurance companies are restricting HIV doctors because they represent a “mixed bag” of providers. He also said it is reasonable to go slow when prescribing a new drug.
But he admits that the drug's price and its potential impact on the healthcare system is also driving how readily insurers are making the drug available.
“The timing was bad,” Madden said. “We knew it was coming, but nobody had time to get ready for this. Nobody expected the recommendations for it would come out in favor of [Sovaldi] so strongly so early.”
Sovaldi came to market quickly through an accelerated FDA approval process.
More hepatitis C medications are expected to arrive on the market next month. Speaking as an individual and not a representative of IDSA or HIVMA, Saag said he hopes competition drastically drives down the drugs' prices. “If they want to be heroes, they should price it one-fifth the cost [of Sovaldi],” he said.
Madden said Gateway Health is going to review its policies once the new hepatitis C medications become available. He said that in the case of Sovaldi, the pricing seems unreasonable. “It is an incredibly expensive medication,” he told Healthline.
Will the Situation Resolve Itself?
Things aren’t all doom and gloom. Although Madden believes policies preventing HIV doctors from prescribing Sovaldi are fairly widespread, Horberg said that isn’t the case at Kaiser Permanente, where he sees patients.
Saag said a situation in which a costly cure comes at the same time that millions of people could use it is unprecedented. The situation is magnified by the number of potential low-income patients whose treatment would need to be paid for by government-subsidized insurance programs.
He believes the situation will eventually work itself out. But for now, most people seeking a Sovaldi prescription will have to get it from a gastroenterologist. Gastroenterologists and hepatologists are specialists widely accepted by insurers, but hepatologists are at a premium and usually manage very sick patients.
Gastroenterologists are also scarce, and are very procedure-based. “For insurance companies who are doing this, it is very shortsighted,” Horberg said. “We are treating for cure with a cost ... that none of us thought would be beyond the realm of limited resources. Decisions are having to be made. But they have to be reasonably made decisions.”