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State Medicaid Programs Should Cover Hepatitis C Treatment, Federal Agency Says

The Centers for Medicare & Medicaid Services last week issued a letter to state Medicaid programs stating that they are expected to cover new interferon-free antiviral therapies for hepatitis C without undue restrictions, as well as a letter to the pharmaceutical companies that make these drugs asking about purchasing arrangements to ensure wider access.

The letter to state Medicaid directors "reminds states of their obligation to provide access to these promising therapies…based on the medical evidence, and that they have tools available to manage their costs," CMS acting administrator Andy Slavitt wrote in a blog post. The letter to manufacturers "asks them to provide us with information on pricing arrangements and asks them for ideas to support the provision of these lifesaving medications to Medicaid programs at sustainable prices."

While coverage of prescription drugs is an optional Medicaid benefit, all 50 states and Washington, DC, currently provide drug coverage. According to existing law, states may subject a covered outpatient drug to prior authorization or exclude or restrict coverage if the prescribed use is not for a medically accepted indication.

However, in most cases a drug may only be excluded for an identified population if it does not have a "significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome…over other drugs included in the formulary."

Accordingly, states are legally required to provide coverage for outpatient drugs for medically accepted indications that are produced by manufacturers that have entered into "best price" rebate agreements; drug companies are required to offer Medicaid programs their "best price." This applies to both Medicaid fee-for-service and managed care organizations, the latter of which are generally more restrictive.

The letter acknowledges that due to the high cost of new direct-acting antiviral (DAA) drugs for hepatitis C virus (HCV), states have raised concerns about the budgetary impact on their Medicaid programs. CMS suggests that competition among DAAs "may enhance the ability of states to negotiate supplemental rebates or other pricing arrangements with manufacturers to obtain more competitive prices."

CMS expressed concern that some states are restricting access to DAA drugs by imposing unreasonable restrictions, for example covering only patients with advanced liver fibrosis (Metavir stage F3) or cirrhosis (stage F4), requiring a period of abstinence from drug and alcohol use, and requiring that DAAs be prescribed by specific types of specialist providers.

"[T]he effect of such limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections," the letter concludes. "States should, therefore, examine their drug benefits to ensure that limitations do not unreasonably restrict coverage of effective treatment using the new DAA HCV drugs."

CMS referred to guidelines for testing, managing, and treating hepatitis C issued by the American Association for the Study of Liver Diseases, Infectious Diseases Society of America, and International Antiviral Society-USA, which recommend treatment for all patients with chronic HCV infection, except for those with short life expectancies who are not expected to benefit. CMS also suggests that states consider implementing programs that provide supportive care to enhance their adherence, thereby increasing treatment success rates.

Noting that "manufacturers have a role to play in ensuring access and affordability to these medications," CMS sent a letter to the manufacturers of DAA drugs asking them to provide information about value-based purchasing arrangements they offer so that states could participate.

The letter was sent to AbbVie (maker of Viekira Pak and Technivie), Gilead Sciences (maker of Sovaldi and Harvoni), Johnson & Johnson (maker of Olysio), and Merck (maker of grazoprevir/elbasvir, currently under FDA review)

"[CMS] appreciates the work that manufacturers have done to bring new curative therapies to the market for our consumers, especially when such treatments address a major public health concern such as HCV," the letter reads. "CMS is committed to ensuring that pharmaceutical treatments are available to Medicaid beneficiaries, when medically necessary. As the agency works with states on these matters, now and in the future, we cannot do that without addressing affordability concerns."

Advocates generally applauded the CMS effort to broaden treatment access.

"We are extremely gratified to see this strong guidance to state Medicaid programs regarding what NVHR considers highly discriminatory restrictions on access to hepatitis C curative therapy," said Ryan Clary, executive director of the National Viral Hepatitis Roundtable. "Some of the most egregious restrictions are directly counter to expert medical guidance on treating hepatitis C…Especially as we bear witness to a second wave of this epidemic coming on the heels of the opioid crisis, it is vital that the treatment of people with active substance use disorders be informed by evidence, not stigma or conjecture."

"Calls to our hotline indicate patients are being denied left and right," said Hepatitis Foundation International CEO Ivonne Fuller Cameron. "For the more than 3.5 million people living with HCV, access to curative medicines remain right before them, but yet are so difficult and out of reach for the most vulnerable to access."

A recent analysis, published in the August 4, 2015, Annals of Internal Medicine, found that a majority of state Medicaid systems impose limitations on coverage for Sovaldi (sofosbuvir), including restrictions based on drug or alcohol use (88%), extent of liver damage (74%), or type of provider.

"Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access," said lead author Lynn Taylor from the Miriam Hospital. "The current restrictions do not make clinical, public health, or long-term economic sense, and should be removed. It is critically important that patients have access to highly effective drugs that not only cure them but will also lower the associated costs of long-term management of the disease."

Some critics have suggested that the letters do not go far enough. While CMS "encourages states to exercise sound clinical judgment," it stops short of requiring them to cover DAA drugs for specific groups of people living with HCV.

"We share the concern about the affordability of hepatitis C treatments, and affirm that significant downward pressure must be made on the cost before we can consider broad expansions of coverage," Matt Salo, executive director of the National Association of Medicaid Directors, told HIVandHepatitis.com. "However, while nothing in these letters could be construed as requiring drug prices to come down, the letter itself can potentially be used to force states to expand coverage, thereby absolving the manufacturers of any responsibility to partner in a solution.

11/10/15

Sources

Center for Medicaid and CHIP Services. Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Drugs. Medicaid Drug Rebate Program Notice No. 172. November 5, 2015.

Andy Slavitt, Centers for Medicare and Medicaid Services. Prescription Drugs: Advancing Ideas to Improve Access, Affordability, and Innovation. Blog.CMS.gov. November 5, 2015.

National Viral Hepatitis Roundtable. Centers for Medicare and Medicaid Services Urges States to Ensure Access to Curative Hepatitis C Treatment and Comply with Federal Medicaid Law. Press release. November 5, 2015.

Hepatitis Foundation International. Hepatitis Foundation International Supports Prompting from Obama Administration to the Centers for Medicare and Medicaid on Restrictions to Hepatitis C Treatment. Press release. November 6, 2015.

S Barua, R Greenwald, J Grebely, et al. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Annals of Internal Medicine 163(3):215-223. August 4, 2015.

Lifespan/Miriam Hospital. National Study Finds Life-Threatening Barriers in Access to Breakthrough Drugs. Press release. June 29, 2015