• Public Health Officials Call for Wider Access to HCV Drugs

Public Health Officials Call for Wider Access to HCV Drugs

Experts from the Public Health Service and President Obama’s Advisory Council on HIV/AIDS are calling on federal and state Medicaid officials to widen access to prescription drugs that could cure tens of thousands of people with hepatitis C virus (HCV) infection.

They say restrictions on the drugs imposed by many states are inconsistent with sound medical practice, per treatment guidelines issued by health care professionals and the Department of Veterans Affairs.

Current restrictions on access to hepatitis treatments are “unreasonable and discriminatory” and are “not supported by medical evidence,” the advisory council said in a letter to President Obama. The federal government should require states to relax or eliminate the restrictions, which delay or deny treatment to low­income people on Medicaid, the panel said.

The panel also recommended increasing funding to the Centers for Disease Control and Prevention (CDC) to increase screening for HCV infection.

The advisory council did not say how to pay for the changes, but it said that Medicaid and other public programs should disclose the prices they paid. It also said manufacturers should be required to disclose the costs of developing and producing such drugs.

The council criticized 3 types of restrictions: some states cover the new drugs only for patients who have advanced liver disease, many states require patients to abstain from the use of alcohol or illicit drugs for up to 1 year before treatment, and then some states do not cover the drugs unless they are prescribed by specialists or experts on infectious diseases.

The New York Times wrote on August 25th that the drugs, including Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) cost $84,000 for the recommended treatment lasting 12 weeks, or 84 days. States can obtain discounts, but prices still generally exceed $600 a pill.

In a survey of state laws, the CDC expressed concern about “limited access to new hepatitis C virus treatments.” “Many state Medicaid programs limit treatment to patients at the most immediate risk for death from liver disease,” said Lauren A. Canary, an epidemiologist at the CDC.

Medicaid programs in most states “ration this lifesaving treatment” in ways that conflict with guidelines published by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, she said.

The New York Times wrote that expensive anti-HCV treatments are eventually cost effective, because it’s cheaper to treat patients immediately than to wait for them to develop cirrhosis and other complications, and then undergo liver transplantation.

In meetings over the last 9 months, advocates for hepatitis patients have urged the Obama administration to issue guidance to state Medicaid directors on appropriate coverage of the new drugs, but federal officials have been noncommittal.

Other administration officials said they wanted to ensure access to the new hepatitis drugs, but also had to consider the financial effect on the federal government, which pays at least half of the cost for Medicaid patients in every state.

Moreover, federal officials said they were being cautious because any directives for Medicaid coverage of hepatitis drugs could set a precedent affecting new drugs for other conditions, and many expensive drugs are in the pipeline.

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