State Review Board Delays Decision on Hep C Coverage Until August

The American Association for the Study of Liver Diseases recommends that Sovaldi be used with patients with late-stage liver disease, but state bureaucrats were ready to block coverage for all patients because of the high price tag of the drug and a report from OHSU’s Center for Evidence-Based Policy that raised red flags about the drug’s studies, helping the state in its attempt to get out of paying for treatment.

A governmental body that meets in Tualatin to determine coverage for Medicaid has deferred a decision on whether the state will require coordinated care organizations to cover pricey drugs that have the promise of curing Hepatitis C.

The move last week by the Value-Based Benefits Subcommittee of the Health Evidence Review Commission comes after the Center for Evidence-Based Policy at the Oregon Health & Science University took the unusual step of releasing to the public a report on the new oral medications, including Sovaldi, which appeared to discredit the efficacy of the drugs, helping the state build its case to deny low-income Hepatitis sufferers treatment of these drugs.

“The current status is that based on poor evidence of clinical effectiveness and extraordinary cost, and given the slow progression of hepatitis C, the staff of Oregon's Health Evidence Review Commission has made a recommendation to the commission's Value-based Benefits Subcommittee that Oregon approve treatment with the new group of drugs for patients who meet certain criteria,” said Oregon Health Authority spokeswoman Karynn Fish. “And that the treatment be placed on line 644 of Oregon's prioritized list of health services. This would place the treatment below the line of services currently funded by the Oregon Legislature.”

The Oregon Health Plan will only fund items above Line 498 on the list, although since CCOs pay for care using a global budget, they can choose to cover this, especially if they think Sovaldi treatment will indeed help them avoid paying for a liver transplant, which is many times more expensive.

The spokeswoman for Willamette Valley Community Health, the Salem CCO, Krista Lovaas, said it would continue to pay for Sovaldi in discrete cases based on its own evidence-based policy if the Health Evidence Review Commission rules against the drug.

“Even if the HERC makes a ruling, we would still go with the policy we developed because that’s the policy we developed with our providers,” Lovaas said.

Sovaldi has become a lightning rod for insurance companies and Medicaid managed plans both in Oregon and nationally because of it’s questionably high price tag -- $85,000 for a 12-week treatment -- compared to $65,000 for the previous treatment, which combined with injections of Interferon, has been used to cure Hepatitis C in 24 weeks.

“As of March 2014, there were 2,466 Health Share members with a diagnosis of Hepatitis C. Treating 30 percent of this population (814 members) at the minimum single drug cost would cost $68.4 million. In 2013, Health Share spent $72.3 million on all pharmaceuticals,” wrote Dr. David Labby of Health Share of Oregon -- the largest CCO in the Portland area -- in his testimony to the evidence review board.

But so far there appears to be no rush to the gate among Hep C sufferers to get treated. Dean Andretta, the interim director of Willamette Valley Community Health, told The Lund Report last month that only one of its patients was currently on the Sovaldi treatment regimen.

The high price tag appears to be an attempt by drug manufacturer Gilead Sciences to cash in on its patent before several competing drugs hit the market in the fall. These new drugs, pending approval of the U.S. Food & Drug Administration, may also be superior to Sovaldi and be used entirely without the hazardous injections of Interferon now paired with Sovaldi and sufferers of Hep C genotype I, by far the most common genotype.

If the state chooses not to fund Sovaldi for any Oregon Health Plan members, it would run counter to the treatment regimen adopted by the Veterans Affairs health system, which has approved Sovaldi for use on the most severe patients, those with Stage IV liver fibrosis or cirrhosis.

It also overrides the guidelines set by the American Association for the Study of Liver Diseases as well as recommendations of OHSU’s own doctors, including its chief of clinical hepatology, Dr. Atif Zaman.

Zaman recommended its use on late stage Hepatitis patients who may not be able to wait for the new drugs, while delaying treatment for all others, acknowledging the outrageous price and the slow progression of the disease, while also recognizing Sovaldi as the standard of care with evidence showing it can provide a cure and prevent recurrence of the Hepatitis C virus.

A chief reason the Center for Evidence-Based Policy used to pooh-pooh the use of Sovaldi was that the drugs are so new there have been no long-term trials, a kind of Catch-22 with any new drug. It also noted that many of the studies praising Sovaldi had conflicts of interest. It calls for more comparative studies and a strict curtailing of its use until these studies can be completed.

But if the state fiddles while waiting for long-term trials -- or drug competition for Sovaldi -- people with cirrhosis of the liver could develop liver cancer, need liver transplants or simply die from the disease. Physicians could still appeal for specific patients to be covered, but this requires going through a potentially burdensome pre-authorization process.

The policy recommendation to the Health Evidence Review Commission did note that there are existing treatments which the state should continue paying for.

The commission’s medical director and staff have recommended that treatment for hepatitis C be included on Lines 205 and 360 of the prioritized list only when using drugs receiving FDA approval prior to 2012 -- before Sovaldi hit the market. These lines are well above the cutoff line.

The problem with these drugs is that they require a course of treatment that is twice as long as Sovaldi, with twice as many injections of hazardous Interferon, which has side effects making patients so ill that many drop out of treatment before ridding their system of Hep C, according to Zaman.

Additionally, for Hep C genotypes II and III, Sovaldi can be taken orally without the painful shots of Interferon.

Interferon is still needed with genotype I, the most common form of Hepatitis C, which infects 70 to 75 percent, but patients only need to take the injections 12 weeks versus 24 weeks with the old treatment.

The decision to delay may have come after one of the CCOs tasked with implementing the Health Evidence Review Commission’s policy recommendation -- Health Share of Oregon -- called for a more comprehensive debate that invited hepatology experts and health economists to the table to more carefully decide and debate if and when the drug was most effective, which patients most need the drug and which patients can wait.

Given its glacial pace, by the time the bureaucracy that sets the state’s prioritized list comes around for ruling, the FDA may be ready to approve those other drugs to compete with Sovaldi.

Chris can be reached at [email protected].
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