After legal battles and lobbying efforts, tens of thousands of people with hepatitis C virus (HCV) infection are gaining earlier access to expensive drugs that can cure the disease. States that limited access to the medications out of concern over their sky-high prices have begun to lift those restrictions—many under the threat of legal action, according to a report from Kaiser Health News. And commercial insurers, such as Anthem Inc. and United HealthCare, are doing the same.
Massachusetts is the latest state to decide that anyone with HCV infection covered by its Medicaid program will qualify for the newest generation of antiviral drugs. Previously, managed care plans serving Medicaid members often limited use of the drugs, which have list prices of up to $1,000 a pill or more, to people with advanced liver disease.
During the past few months, Florida, New York, and Delaware have also expanded access to costly hepatitis C drugs in their Medicaid programs. And in April, a federal judge rules that Washington state couldn’t withhold treatments from Medicaid members with HCV infection who hadn’t yet developed serious medical complications.
The problem for states that are lifting restrictions: how to offset the expense of covering thousands of patients who may now come forward for HCV treatment. “We want to give these medications to everybody who needs them, but with the prices they’re commanding, something has to give,” said Matt Salo, executive director of the National Association of Medicaid Directors.
The drugs in question—Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) from Gilead Sciences, Viekira Pak (ombitasvir/paritaprevir/ritonavir) from AbbVie Inc.; and Zepatier (elbasvir/grazoprevir) from Merck & Co., among others—eliminate HCV more than 90% of the time––a cure rate almost double that of earlier therapies. The latest entrant in this market, Gilead’s Epclusa (sofosbuvir/velpatasvir), received approval from the FDA last week.
But with sticker prices of $54,600 to $94,500 for an average 12-week course of treatment, dozens of states balked at the budgetary implications and provided the medications for only the sickest patients.
Private insurers followed suit in their group and individual plans, but many have been reversing those policies recently. Anthem Blue Cross and Blue Shield plans in 14 states quietly began authorizing treatment to people “in all stages of fibrosis” in December, the company confirmed in an email to Kaiser Health News. Previously, medication had been limited to HCV patients with severe fibrosis or cirrhosis.
UnitedHealthcare enacted the same policy nationwide on January 1, according to an email from the firm. After a March legal settlement with New York’s attorney general in New York, seven commercial insurers there are extending hepatitis C treatments to people who haven’t yet developed serious liver disease.
Nationally, at least 3.5 million people are believed to be infected with HCV, although half of them don’t know it. Three-quarters are baby boomers who likely became infected from contaminated blood (the blood supply wasn’t tested for HCV until 1992), injection drug use, or sex. Approximately one million patients are thought to be covered by Medicaid.
By law, Medicaid and Medicare are required to cover medically necessary treatments; they can’t exclude an entire class of effective medications for cost considerations alone. Commercial insurers also typically agree to provide all medically necessary care.
There is widespread agreement in the medical community that the expensive new HCV therapies meet this standard. The drugs’ benefits apply even to people who haven’t yet developed serious liver disease, according to guidelines from the American Association for the Study of Liver Disease and the Infectious Diseases Society of America.
The high prices of the HCV medications should fall as new therapies come on the market, increasing competition, the Centers for Medicare and Medicaid Services (CMS) noted. Gilead Sciences has said that average discounts are about 46% off the sticker price––but future discounts may be even greater, bringing the cost of the drugs down to $30,000 or even lower, according to Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law and Policy Innovation.
Source: Kaiser Health News; July 5, 2016.