Restricted Access Begins to Lift on High Cost Hepatitis C Drugs

Threat of legal action prompts several states to allow greater access to curative HCV drugs.

Under the threat of legal action, states with limited access to high-priced, disease-curing hepatitis C (HCV) medications have begun to lift the restrictions.

“These aren’t me-too drugs with marginal benefits: they’re actual cures,” Nicholas Bagley, professor of law at the University of Michigan, told Kaiser Health News. “While their cost is a huge fiscal problem, states are permitted under the law to restrict access to medically necessary therapies on the grounds that they cost too much.”

Massachusetts recently allowed HCV patients covered by its Medicaid program to qualify for the newest generation of anti-viral drugs. Prior to the expansion, managed care plans serving Medicaid members often limited drugs that cost up to $1000 per pill or more to be used only for patients with advanced liver disease.

Delaware, Florida, and New York have also expanded access to Medicaid programs over the past few months. However, states that have begun to lift the restrictions must address how to offset the expense of providing coverage for thousands of HCV patients who may now come forward for treatment.

Drugs such as Harvoni, Sovaldi, Viekira Pak, and Zepatier have a cure rates in excess of 90%. But with a price range between $54,600 and $94,500 for these drugs, many states allow only the sickest patients to access to the medication. An ongoing dilemma exists between these short-term costs for curing the disease versus the much greater long-term cost impact from denying access to medication, which can include treating liver cancer and surgical transplantation.

Private insurers have also recently begun to loosen their restrictions under the threat of lawsuits. In December 2015, Blue Cross and Blue Shield plans began authorizing treatment in 14 states to people in all stages of fibrosis, instead of just those with severe fibrosis or cirrhosis.

Medicaid and Medicare are unable to exclude an entire class of medications that have been proven effective for cost considerations alone.

In an attempt to clarify the legal situation, the US Centers for Medicare and Medicaid Services (CMS) issued a bulletin last November stating that a drug used for a specific disease can only be denied if the excluded drug does not have a significant and clinically meaningful therapeutic advantage in terms of clinical outcomes, effectiveness, and safety.

According to CMS, medications costs are expected to drop as new drugs come onto the market, increasing competition. Kaiser reported that discounts could bring some HCV drug costs down to $30,000 or even lower.

Last week, Gilead and Bristol-Myers Squibb responded to the Massachusetts attorney general’s threat of a lawsuit by agreeing to provide greater discounts. Although the extent of the rebates has not been disclosed, the lower prices of these medications could provide more patients with access to these curative medications.