1. Health

A push for wider access to costly hepatitis C drugs

WASHINGTON — Federal and state Medicaid officials should widen access to prescription drugs that could cure tens of thousands of people with hepatitis C, including medications that can cost up to $1,000 a pill, health care experts have told the White House.

The experts, from the Public Health Service and President Barack Obama's Advisory Council on HIV/AIDS, said restrictions on the drugs imposed by many states were inconsistent with sound medical practice, as reflected in treatment guidelines issued by health care professionals and the Department of Veterans Affairs.

The drugs, including Sovaldi and Harvoni, 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.

Hepatitis C, which federal officials refer to as a silent epidemic, kills more people than AIDS in the United States — nearly 20,000 people a year.

The advisory council did not say how to pay for increased use of the new hepatitis drugs, but it did say Medicaid and other public programs should disclose the prices they paid. And, it said, manufacturers should be required to disclose the costs of developing and producing such drugs.

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 Obama. The federal government should require states to relax or eliminate the restrictions, which delay or deny treatment to low-income people on Medicaid, the panel said.

The council criticized three 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 a year before treatment. And some states will not cover the drugs unless they are prescribed by specialists like gastroenterologists or experts on infectious diseases.

In a survey of state laws, the Centers for Disease Control and Prevention 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 disease control agency.

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 guidelines recommend treatment "for all patients with chronic hepatitis C virus infection," except those who have a life expectancy of less than a year because of some other disease.

Dr. David L. Thomas, a professor at the Johns Hopkins University School of Medicine and co-chairman of the panel that wrote the guidelines, said the new drugs worked far better, and were much less toxic, than older treatments.

"It's astonishing," said Thomas, one of the world's leading experts on hepatitis. "We can cure most patients with as few as 84 pills.

"The treatments are eventually cost-effective," he said. "It's cheaper to treat patients than to wait for them to develop cirrhosis and complications and then get a liver transplant."

If left untreated, infections can lead to liver cancer and liver failure. The new drugs block the replication of the hepatitis C virus. About one-fourth of people with HIV are also infected with the hepatitis C virus.

Sovaldi and Harvoni are made by Gilead Sciences. Other new hepatitis drugs include Viekira Pak, made by AbbVie, and Daklinza, which is made by Bristol-Myers Squibb and was approved by the Food and Drug Administration on July 24.

In meetings over the past nine 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.

"States have flexibility to determine the best way to manage their Medicaid benefits, including drug benefits," said J. Timothy Gronniger, a senior official at the federal Centers for Medicare and Medicaid Services who worked at the White House until recently.

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.

The administration of President Bill Clinton took a more aggressive stance in 1996, when states were limiting access to a new generation of potent but costly drugs for HIV and AIDS.

The Clinton administration told state Medicaid directors that they had to cover the new AIDS drugs, known as protease inhibitors. States could impose certain limits on use of the drugs, but the limits must not "excessively or unreasonably restrict coverage of effective treatments" for people with HIV and AIDS, the Clinton administration said.

Cindy Mann, the top federal Medicaid official from 2009 to January of this year, said there was "an increasing consensus among health care professionals" about the circumstances in which the new hepatitis drugs should be provided. But this consensus is not reflected in state policies, she said, so the federal government "needs to provide some guidance and clarification" to states.

Ryan D. Clary, executive director of the National Viral Hepatitis Roundtable, a coalition of 250 organizations working to end the epidemic, said: "The promise of the Affordable Care Act was to provide access to quality, affordable care regardless of a person's pre-existing conditions. People are now mandated to have insurance. But many people with hepatitis C are finding themselves unable to obtain curative treatment for the condition that kept them from getting insurance before the health care law."

One reason, Clary said, is the stigma attached to hepatitis C. Many people are infected through blood on needles or other equipment used to inject unlawful drugs.

"If there were a cure for Alzheimer's or breast cancer that cost $40,000 or $50,000, we would not be having this conversation," Clary said.

Price negotiations are secret. But Matt D. Salo, the executive director of the National Association of Medicaid Directors, which represents state officials, said he understood that the new hepatitis drugs could sometimes be obtained for $50,000 a person, down from $84,000 last year.

"Prices have come down," Salo said. "Competition is working, but not enough to make a significant difference. Prices are nowhere near where they need to be to make hepatitis C treatment available to all who need it."

The "criteria for prior approval" of the new hepatitis drugs in Illinois illustrate the policies that have been adopted, in some form, by many state Medicaid programs. In Illinois, a patient must have advanced liver disease, as indicated by a biopsy or other test showing extensive damage to the liver.

In addition, the rules say that a patient must not have received a diagnosis or treatment for alcohol or drug abuse in the last 12 months, and that the patient must have a urine test to check for recent drug use.

John K. Hoffman, a spokesman for the Illinois Department of Health Care and Family Services, said the criteria were "based on commonly accepted medical practices."

But Robert L. Greenwald, an expert on health law and policy at Harvard Law School, said: "These criteria defy clinical guidelines and best practices. Rather than recommending the exclusion of people who inject drugs, we should encourage earlier treatment as a way to prevent transmission of the virus."