California Poised To Expand Access To Hepatitis C Drugs

Gov. Jerry Brown and state lawmakers have set aside $70 million dollars in next year’s budget – which starts July 1 – so that almost all Medi-Cal recipients with hepatitis C will become eligible for the medications, as long as they are at least 13 years old and have more than one year to live.

Patrick Garcia wasn’t completely surprised when he learned recently he had hepatitis C. Until a few years ago, he had experimented with numerous drugs, injecting heroin, methamphetamine, cocaine — you name it.

“I haven’t lived exactly a perfect life,” said Garcia, 43, whose mouth, hand and back were injured in a motorcycle wreck last year.

Medi-Cal, California’s public health program for the poor, paid for his post-accident care and the bloodwork that led to his hepatitis C diagnosis. But it wouldn’t pay for the pricey new medications that cure the disease.

“I got denied twice,” said the Sacramento-area resident, who was told he didn’t meet the criteria for treatment. “It’s frustrating, to say the least.”

For at least four years, Medi-Cal has limited coverage of medications such as Harvoni and Sovaldi. Under current guidelines, only people with liver scarring or HIV, women of childbearing age, active injection-drug users, and patients who fall into other high-risk categories can get these drugs.

Still, many Medi-Cal patients who need the drugs have been able to get them.

Starting next month, Medi-Cal is expected to loosen its restrictions and begin providing the drugs to hepatitis C patients, like Garcia, who currently don’t have access.

Gov. Jerry Brown and state lawmakers have set aside $70 million in next year’s budget — which starts July 1 — so that almost all Medi-Cal recipients with hepatitis C will become eligible for the medications, as long as they are at least 13 and have more than one year to live.

The agency expects to treat 2,090 Medi-Cal patients with that extra money in the next fiscal year. In 2017, about 7,800 Medi-Cal recipients received the drugs under the current guidelines.

Brown, who proposed this funding, is likely to approve it by the end of the month.

“We are really glad to see California … ensuring that everybody gets hepatitis C treatment, particularly the most vulnerable in the state,” said Anne Donnelly, health care policy director at Project Inform, which advocates for patients with hepatitis C and HIV.

Hepatitis C, the most deadly infectious disease in the United States, was responsible for 18,153 deaths in 2016, according to the Centers for Disease Control and Prevention. The virus is primarily transmitted through intravenous drug use and, less frequently, through sexual contact.

California’s Department of Public Health tallied 33,748 newly reported cases of chronic hepatitis C in 2015, the last year for which data are available.

In 2013, the U.S. Food and Drug Administration approved Sovaldi, one of the first new hepatitis C drugs known as “direct-acting antivirals.” At that time, its list price was $84,000 for a 12-week course of treatment. Public health programs such as Medi-Cal often negotiate prices down.

Sovaldi and similar drugs, including Harvoni and Viekira Pak, have fewer side effects, work faster and are more likely than older medications to cure the disease.

In the past few years, newer direct-acting antivirals have come to market at lower list prices. Merck’s Zepatier lists at $54,600 for a course of treatment, and Mavyret is $26,400.

Compared with other states, California’s current restrictions are moderate, according to stateofhepc.org, a Harvard University-affiliated research project. The website gives California a “B+,” docking its grade for the requirement that a patient have liver damage.

Montana, Arkansas and South Dakota received “F” grades for requiring Medicaid patients to have severe liver damage and six months of sobriety, and to choose from a limited list of providers to obtain a prescription.

Patient advocates and researchers believe the high cost of the newer hep C drugs has led some state Medicaid programs to ration them to the sickest patients. The state of Washington was sued over the matter.

“[Medi-Cal] plans were being very restrictive,” Donnelly said. “It did seem to hinge on money.”

California’s Department of Health Care Services, which manages Medi-Cal, has previously denied that drug costs determine coverage.

Agency spokesman Tony Cava said the impending changes are based on recommendations from the federal government and the American Association for the Study of Liver Diseases.

“Evidence suggests that when people with chronic hepatitis C are treated early in the course of the disease, outcomes improve and the spread of disease decreases significantly,” Cava said in a written statement.

State officials also have allocated $106 million in next year’s budget to treat inmates with hepatitis C in California’s prisons. The officials plan to allocate the same amount in each of the two following years.

About 22,000 prisoners with the disease started benefiting from expanded access to the lifesaving drugs in December. The new guidelines in prisons essentially mirror the new Medi-Cal rules.

The state Department of Corrections and Rehabilitation has treated about 2,300 inmates this fiscal year at a cost of $60 million, according to recent budget documents.

Dr. Aaron Cleveland, medical director at the Sacramento Native American Health Center, which serves mostly Medi-Cal recipients, said his patients experience long delays and bureaucratic hurdles trying to obtain the groundbreaking hepatitis C drugs.

“It has taken us over a year to get approval for some patients,” he said. “But we keep fighting. And we fight, and we fight and we fight” until the patients receive the medication.

Cleveland said the change will streamline the treatment process and make patients happier.

Patrick Garcia said he’ll try again to obtain the medications under the new rules. He doesn’t want his condition to deteriorate into liver cancer or make him unemployable, he said.

Garcia said he just wants to live a “long, fruitful life. Isn’t that what anybody wants?”

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