High cost of cure sparks ethical dilemma

Family nurse practitioner Laura Bush helped Richard Davis, who had hepatitis C, get a new two-drug, 12-week treatment that cured him of the disease, but also cost $180,000. (Greg Sorber/Albuquerque Journal)

ALBUQUERQUE, N.M. — Richard Davis hit a low point early this year after his insurance company denied him coverage for an effective new therapy for hepatitis C, a viral illness that damaged his liver and caused him constant pain.

“I have known people who died of (hepatitis C) and it’s not a pleasant death,” Davis, 57, told the Journal, saying his diagnosis with the disease in 2013 left him stunned. “I knew what was coming.”

Davis also knew that he couldn’t pay the huge cost of the two-drug treatment he needed.

“Not if my life depended on it, and that’s what it came down to – my life depending on it,” he said.

The approval in December of Sovaldi, a $1,000-a-pill medication that doctors describe as a “near-perfect” treatment for hepatitis C, offered new hope for severely ill patients like Davis – but it also sparked a global debate about the cost and availability of lifesaving drugs.

In New Mexico, Medicaid will pay for Sovaldi only when a patient is diagnosed with advanced liver disease, under new guidelines issued this month by the Human Services Division.

The one-pill-a-day treatment has proven effective in curing 90 percent or more of patients with hepatitis C, a potentially deadly viral illness that infects some 4.4 million Americans, including an estimated 32,000 to 35,000 New Mexicans, according to Dr. Sanjeev Arora, a hepatitis C specialist at the University of New Mexico Health Sciences Center.

But state and insurance company officials fear Sovaldi’s cost of $84,000 for a 12-week treatment – if given to all those with hepatitis C – would exhaust their financial resources. And the drug is usually given in conjunction with other drugs.

“At the Medicaid program, we have to balance the wise and efficient and effective use of taxpayer funds” with patient needs, said Julie Weinberg, director of the medical assistance division of the state Human Services Division.

“That’s why we came up with these guidelines, to assure that people who were suffering liver damage would be treated and cured before they got sicker.”

By Aug. 1, about 200 New Mexico patients had qualified for Sovaldi treatment through the state’s four Medicaid-managed care organizations, Weinberg estimated.

“What we want to do is avoid the need for liver transplants,” she said.

Hepatitis C is the nation’s leading cause of liver transplants, which cost about $250,000 per surgery, according to the U.S. Centers for Disease Control and Prevention.

New Mexico clinicians who specialize in the treatment of hepatitis C say they are frustrated that more patients can’t obtain coverage for Sovaldi.

“I want all my patients to receive treatment,” said Laura Bush, a family nurse practitioner at First Choice Community Healthcare in Los Lunas, who treated Davis for hepatitis C this year.

“It’s imperative that we treat it and not wait until they’re cirrhotic,” requiring costly hospitalization, she said. “Being a provider, my main priority is getting medication for my patients and curing them of a disease that I know is curable.”

After Davis was rejected by his insurance company for coverage of Sovaldi and a second drug, Bush appealed directly to two pharmaceutical companies, including the California-based Gilead Sciences Inc., which manufactures Sovaldi.

In some cases, the firms provide indigent patients with free medications under what are called patient-assistance programs. Davis was able to obtain both drugs at no cost and was cured in August after a 12-week treatment.

“It’s lovely, but difficult to get,” Bush said of the free-drug programs. “You have to fill out the paperwork – dot the i’s, cross the t’s. It’s intense.”

Clinicians describe hepatitis C as a cruel disease that can lead to many dangerous conditions other than liver disease, including type-2 diabetes, depression, kidney failure and cancers.

Society would reap huge benefits by treating large numbers of patients for hepatitis C, said Arora. Sovaldi “has the potential to actually eradicate the disease. This drug has the potential to save 90 to 95 percent of all (hepatitis C) patients,” Arora said.

“Some of us have spent our lifetimes battling this disease and now all of a sudden we have a magic bullet,” said Arora, who has treated hepatitis C for more than three decades. “The government stands to benefit from treating large numbers of patients so they don’t have to pay for transplants and cancer care in the future.”

But, given Sovaldi’s high cost, a policy of treating only the sickest patients is the state’s best option, officials said.

“We agree. We would love to treat all the patients who have documented chronic hepatitis C,” said Louanne Cunico, director of pharmacy for Presbyterian Health Plan. But, “with the patient population that’s been identified just in our state alone, it would bankrupt the state.”

In addition, many people infected with hepatitis C never develop symptoms or they clear the virus without treatment, Cunico said.

“There are patients who don’t even know they have hepatitis C and live their whole lives without experiencing any symptoms or side effects,” she said.

Presbyterian Health Plan is one of the four managed care organizations that manage Medicaid under contract with the state. The others are Blue Cross Blue Shield of New Mexico, Molina Healthcare and United Health Care.

All four companies agree on the overall approach to the state guidelines, Cunico said.

So far this year, Presbyterian Health Plan has approved Sovaldi treatment for 48 patients, including 25 Medicaid patients, she said.

‘As good as it gets’

Hepatitis C treatment for years relied largely on interferon – a toxic and potentially life-threatening drug. Treatment typically lasted 48 weeks and only about half of those treated were cured. Side effects included anemia and depression, and, in rare cases, death.

“Previously, many people didn’t want treatment because interferon was so toxic,” Arora said. “Lots and lots of side effects.”

Approval of Sovaldi in December 2013 was “a game changer” that made all hepatitis C patients candidates for treatment, Arora said.

“The drug has near-perfect characteristics in that it doesn’t have any side effects,” he said.

Sovaldi is a one-a-day pill with no drug or food interactions. It is a direct-acting anti-viral that kills the virus by blocking replication.

Sovaldi “is as good as it gets,” Arora said.

For now, Sovaldi is still used in combination with interferon, but the 12-week duration makes treatment far easier for patients, he said.

And interferon may soon no longer be used. A new drug expected to reach the market in October, which combines Sovaldi with a second drug in a single pill, is expected to eliminate the need for interferon as a treatment for hepatitis C, Arora said.

“Interferon will become obsolete, basically,” he said.

However, the new two-drug combination does not ease the cost dilemma. It will probably will cost about $95,000 per treatment, but clinicians won’t know until it is released, Arora said.

He and other clinicians said they are no longer prescribing interferon treatment for patients because they expect the new drug to be available soon.

“Treatment has become so simple that anybody who has hepatitis C will want it,” he said. “So it has completely expanded the marketplace.”

Generic version deal

It has also created a new dilemma for states, insurers and nations around the world with large numbers of hepatitis C patients.

“It is unprecedented that there is a medicine that cures a chronic viral infection that affects so many people in the United States,” said Dr. Karla Thornton, a UNM professor of infectious diseases. “But the cost of the medication makes it difficult to imagine treating all infected patients. It’s a huge dilemma.”

Sovaldi’s manufacturer, Gilead Sciences Inc. of Foster City, Calif., has drawn fire from congressional leaders criticizing the drug’s pricing. Some states have limited access to treatment to minimize costs.

Gilead announced last week that it had reached a deal with several generic drugmakers to produce a cheaper version of the drug for use in developing countries.

“The right thing for us to do as a society is to treat every single person,” Arora said. “But as a citizen, I understand that we as a society don’t have enough money to treat everybody.” States and insurance companies “are rightly concerned that this could break the bank, basically,” he said. “It’s a very difficult situation.”

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