Liver Patients Try To Pull Burwell Into Debate Over Sovaldi Coverage Restrictions

Advocates for patients with liver disease are trying to pull HHS Secretary Sylvia Burwell into the debate over coverage of high-cost specialty drugs by asking her to convene a meeting among drug makers, plans, patients and providers to figure out how to make Sovaldi available to everyone infected with hepatitis C. Separately, the Campaign for Sustainable Rx Pricing, which represents plans and other stakeholders such as hospitals, has been trying to convene a meeting to negotiate down the price of Sovaldi, but Ryan Clary, executive director of the National Viral Hepatitis Roundtable, said the patient effort is different because it is not focused on lowering the drug's price.

Clary, who spearheaded the patient groups' letter to Burwell, says he thinks everyone can be treated without forcing Sovaldi-maker Gilead to lower the drug's price and without cutting services to other beneficiaries, but he doesn't say how the problem should be solved. Plans and Medicaid directors say it's unrealistic to think that the health care system can afford Sovaldi without cutting coverage of other health care services or without significantly raising cost sharing or taxes.

Many private plans and some Medicaid programs are restricting the drug to the sickest patients, and they're not giving Sovaldi to those who inject street drugs. Not only does that ration the drug, it requires needless, sometimes invasive tests, such as biopsies, and use of traditional treatments that are hard for some patients to endure, says Natarajan Ravendhran, Chief of Gastroenterology and Liver Disease at St. Agnes Hospital in Baltimore. Ravendhran is not on the letter, but he argued against coverage restrictions at a media event at the Capitol on Sept. 12. Ravendhran runs clinical trials for Gilead.

Clary says Sovaldi rings in a new era in which hepatitis C can be eradicated, but he worries the national drug pricing debate is stifling that possibility. “[T]he growing crisis in treatment access, combined with a highly public media debate about who is worth the expense of a hepatitis cure, has quickly dashed this hope,” the letter states.

The patient advocates hope that stakeholders will figure out how to cover everyone who learns that they're infected. That effort starts by getting plans and others to realistically project the cost, Clary says. That requires the Centers for Disease Control and Prevention to get a handle on the number of infected and the government to convene stakeholders to discuss how the cost will be covered.

“Your leadership is essential to bring together these stakeholders, including the pharmaceutical industry, public and private payers, government health officials, hepatitis C medical experts, and representatives from the hepatitis C patient and advocacy community to begin these badly needed discussions,” the groups write to Burwell.

A spokesperson for Gilead says company executives would participate, were Burwell to convene a meeting. “We have ongoing dialogue with the constituents outlined in the letter and are happy to continue to engage with them on this topic,” the spokesperson states in an email.

Plans and drug makers have been trying to get patients on their respective sides, and many patient groups have sided with the drug makers -- patient groups are often funded by drug makers. Case in point, when the National Coalition on Health Care launched it's Campaign for Affordable Rx Pricing, some patient groups that are part of the National Coalition on Health Care refused to participate, and at least one group left the coalition.

Clary says there are many misconceptions about the cost of Sovaldi. The drug costs about $84,000 per course, and the total treatment cost often runs about $150,000 when patients take it with Olysio. CDC estimates that 3.2 million Americans are infected, but many believe that's a low figure and CDC is updating its estimates, Clary adds. At this point plans are multiplying $150,000 by 3.2 million to come up with projected treatment costs, which doesn't account for the fact that many people don't know that they're infected at this point, which makes the near-term costs lower, he says.

Through the first half of this year, 70,000 were treated with Sovaldi, company executives said, and at this point it is estimated that about 400,000 people know they're infected.

Clary also notes that the far-term costs could be higher once new estimates come in, but adds: “We’re a long way away from that.”

CMS announced in June that Medicare will cover hepatitis C screening for Medicare beneficiaries who are either at risk of being infected or who were born between 1945 and 1965. Many believe that between that and the free annual wellness exams that Obamacare put in place, in the coming years many more people are likely to find out that they're infected. --John Wilkerson (jwilkerson@iwpnews.com)