Advocates for those living with Hepatitis C are urging the state Department of Social Services to ease new criteria patients must meet in order to have an expensive medication covered by Medicaid.
DSS has issued a bulletin to medical care providers, notifying them that patients with Hepatitis C who are enrolled in HUSKY A, HUSKY C or HUSKY D — parts of the state’s Medicaid program — must have “prior authorization” in order for prescriptions for the medication Sovaldi to be covered.
Prior authorization typically is required by insurers when they want to make sure certain prescription drugs are appropriately used. In essence, it requires enrollees to meet a higher threshold of criteria before insurers will agree to cover the medication’s expense.
A dozen groups have collectively sent a letter to Social Services Commissioner Roderick Bremby, urging DSS to reconsider the move. Leaders of AIDS Connecticut, Doctors for America Connecticut, the Mental Health Association of Connecticut and the Connecticut Legal Rights Project are among those who signed the letter.
They say the decision “bars treating providers from even requesting prior authorization for Sovaldi if narrow substantive criteria are not met,” according to the letter.
Sovaldi is made by Gildead Sciences, a Branford-based biopharmaceutical company. The medication sells for about $1,000 a pill, with a typical 12-week regimen costing more than $80,000.
For those suffering from Hepatitis C, the medication can be life-changing, said Shawn Lang, deputy director of programs and policy at AIDS CT.
“It can cure Hepatitis C,” she said. “Not just treat it, not manage it, but cure it.”
Hepatitis C is a contagious liver disease that can range from mild illness lasting a few weeks to a lifelong illness that attacks the liver. It’s the result of the Hepatitis C virus, which is spread mainly through contact with the blood of an infected person, according to the Centers for Disease Control and Prevention.
The CDC estimates there are 3.2 million people nationwide living with chronic Hepatitis C.
There are other medicines that treat the disease but they are not cures, Lang said, and patients prescribed other drugs typically end up needing liver transplants. Those who receive transplants must then take other medications for the rest of their lives, she added.
“Limiting it (access) doesn’t make dollar sense at all, from any perspective,” she said, since the consequences of going without Sovaldi are more costly than the drug.
Other drugmakers are working on similar cures — which would drive down prices if they make it to the market — but for now Sovaldi’s cost puts it out of reach for many patients without insurance coverage, Lang said.
In their letter, the advocacy groups say the new DSS policy will restrict access to “medically necessary treatment through Sovali” in various ways.
In particular, the groups take issues with criteria that will approve coverage of the drug only for those with advanced liver disease, blocking others from getting it; authorize only five kind of specialists to provide written consults as a prerequisite for approval; and bar women who are pregnant or may become pregnant from accessing the drug, among others.
The DSS bulletin says female patients must not be pregnant and must agree to use “adequate” birth control during treatment, and male patients must not have a female partner who is pregnant and must agree to use adequate birth control.
In written patient information accompanying Sovaldi, Gilead Sciences warns that women who are pregnant or could become pregnant should not to take the drug because it may cause birth defects. The drugmaker says women must have a negative pregnancy test before beginning treatment.
The advocacy groups say in the letter, however, that the pregnancy danger is not associated with Sovaldi directly but with “adjunct” medications that are recommended with the drug and can be replaced.
The DSS bulletin was sent to physicians, pharmacy providers, nurse practitioners, physician assistants, long-term care providers, clinics and hospitals in November. The advocacy groups sent their letter to DSS last month.
DSS spokesman David Dearborn said the department is “in a sensitive stage” of evaluating how Medicaid will cover medications for enrollees diagnosed with Hepatitis C.
The state has not yet determined which Hepatitis C drug it will put on its “preferred drug” list as eligible for Medicaid payment, he said. DSS officials expect to make that decision after its Pharmaceuticals and Therapeutics Committee meets in May, he said, noting that committee advises DSS on pharmacy-related matters.
Until a different decision is made, Sovaldi is covered under prior authorization. Meanwhile, Connecticut is part of an eight-state pharmaceutical buying pool that is negotiating with drugmakers, Dearborn said.