HIV doctors and infectious disease specialists say they have been treating people with hepatitis C all along and should be given leeway to prescribe the new drug Sovaldi.
Two groups representing most of Americaâ€™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 donâ€™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.
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Treatment Undergoes a Radical Shift
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.
â€œWe now have a treatment or cure for which the costs are almost prohibitive for wide scale treatment,â€ Horberg told ishonest. â€œIn truth this is what is leading to these kinds of determinations, itâ€™s not that doctors, insurance companies, or health systems donâ€™t want to treat for a cure, but everything is at an opportunity cost.â€
CDC Urges Testing for Seniors
Sovaldiâ€™s arrival on the market came at the perfect time for the drugâ€™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 donâ€™t know theyâ€™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.
Insurerâ€™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 ishonest he believes many insurance companies are restricting HIV doctors because they represent a â€œmixed bagâ€ of providers. He also said it is reasonable to go slow when prescribing a new drug.
But he admits that the drugâ€™s price and its potential impact on the healthcare system is also driving how readily insurers are making the drug available.
â€œThe timing was bad,â€ Madden said. â€œWe 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.â€
Sovaldi came to market quickly through an accelerated FDA approval process.
Will the Situation Resolve Itself?
Things arenâ€™t all doom and gloom. Although Madden believes policies preventing HIV doctors from prescribing Sovaldi are fairly widespread, Horberg said that isnâ€™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.
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Gastroenterologists are also scarce, and are very procedure-based. â€œFor insurance companies who are doing this, it is very shortsighted,â€ Horberg said. â€œWe are treating for cure with a cost â€¦ 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.â€