Prescriber Restrictions Hurt Hepatitis C Patients, AAFP Argues

April 20, 2016 01:56 pm Jill Sederstrom

In an effort to ensure that all patients with hepatitis C virus (HCV) have access to the best treatment, the AAFP is pressing CMS to help end restrictions that prevent primary care physicians from exercising their clinical expertise with the disease.

[Hepatitis C Virus. Medical Concept with Blurred Text, Stethoscope, Pills and Syringe on Grey Background]

The latest oral HCV drugs have significantly higher cure rates with fewer side effects than older treatments did, but they also carry much higher price tags. Limiting patients' access even more, some states have implemented prescriber restrictions that make it more difficult for patients to receive the drugs without involving a subspecialist.

To help solve this problem, the AAFP and seven other organizations sent a joint letter(2 page PDF) to CMS Acting Administrator Andy Slavitt on April 8 that urged his agency to revise its policies so patients who need HCV drugs have access to physicians who can prescribe them.

"We believe that treatment for chronic HCV should be based on the prescribing physician's expertise rather than a requirement of medical specialist consultation," the letter said.

Previously, patients with HCV typically were treated with self-injections of interferon, which the letter pointed out "had terrible side effects and only a 50 percent cure rate." The cost of this treatment ranged from $15,000 to $20,000.

In contrast, ledipasvir-sofosbuvir (Harvoni), a daily oral pill, has a cure rate of 90 percent and few side effects. But each pill costs $1,125, which translates to $94,500 for three months of treatment or $189,000 for six months, according to an article the letter cited.(

"When hepatitis C treatments were very complicated and toxic, there were no restrictions on who could prescribe those extremely complex drugs," the letter said. "Prescriber restrictions are only now being added as newer and more effective medications with fewer side effects that are easily administered in oral form have come to the market."

The letter cited one study of reimbursement criteria( across the United States for sofosbuvir (Sovaldi) published in the Annals of Internal Medicine that found 29 states have implemented restrictions based on prescriber type. Fourteen of these states require the prescriber to be a specialist in gastroenterology, hepatology, infectious diseases or liver transplantation. The remaining 15 states allow treatment decisions only after consultations with a specialist.

The letter pointed out that these restrictions are especially troubling in light of recent specialty shortages and because of the greater problems they present in rural areas.

According to the 2010 U.S. census, only 9 percent of physicians practice in rural areas, where about 20 percent of the population resides. In addition, the letter noted the CDC has said that acute HCV infections increased by 150 percent from 2010 to 2013, with the largest increase occurring in rural areas.

Family physician Beth Oller, M.D., told AAFP News her Stockton, Kan., practice is fortunate because a specialist in gastroenterology regularly comes to her rural community, but she knows that is not the case for many rural areas. She said prescriber restrictions that require patients to travel great distances for treatment could harm many people who cannot make such trips regularly.

"You are going to be keeping these rural patients from being able to seek treatment options that should be available to them," Oller said.

The letter to CMS pointed out that many primary care physicians have the education and experience necessary to treat HCV patients and have been doing so -- with older, more complicated regimens -- for years.

"Only recently, when costly new drugs became available, did new restrictions occur," the letter said.

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