ver the past two years, state Medicaid programs have done a better job of disclosing information about access to hepatitis C medicines and are also making progress in reducing or eliminating restrictions that pose a barrier to treatment, according to a new preliminary analysis.
In 2014, 17 states did not make public their criteria for treatment, compared with just seven state programs this year. And in the past two years, 16 state programs cut or dropped restrictions to access based on a patients’ stage of liver disease, which has been a key test for determining treatment. The preliminary analysis was released Monday; a final version will be published next year. (Here is the previous analysis looking at 2014).
Despite such improvements, there are signs that other restrictions continue to impede access to treatment, according to the authors of the analysis, who maintain this violates federal law and runs counter to treatment guidelines and a notice from the Centers for Medicare & Medicaid Services.
“We’re making progress, but many state Medicaid programs still limit access due to cost concerns and are dragging their feet,” said Robert Greenwald, who heads the Center for Health Law and Policy Innovation of Harvard Law School, which conducted the analysis and has filed lawsuits against two state programs over restrictions.
Last year, CMS officials warned state Medicaid programs against “imposing conditions for coverage that may unreasonably restrict access” to hepatitis C drugs. Placing restrictions may be “contrary to the statutory requirements” of a federal law that requires state Medicaid programs to pay for all medically necessary treatments, they wrote.
Also last year, the American Association for the Study for Liver Diseases and the Infectious Diseases Society of America issued guidelines that counseled physicians to “treat all patients as promptly as feasible.” However, the groups acknowledged that physicians may have to take into account the cost of the hepatitis C medicines when deciding who to treat first.
Indeed, the findings reflect ongoing tumult over the cost of prescription medicines, but hepatitis C treatments, in particular. After Gilead Sciences began marketing Sovaldi nearly three years ago, many public and private payers responded by restricting access to the medicine and subsequent drugs.
Gilead priced Sovaldi at $84,000, or $1,000 a pill, for a 12-week course of treatment. At the time, there were no competitive treatments, the company and its supporters argued that a cure rate approaching 90 percent would eventually lower over health care costs.
Since then, Gilead began marketing yet another pricey treatment called Harvoni, and Merck and AbbVie began selling rival drugs. In all, prices for hepatitis C medicines currently range from $54,600 to $94,500, depending upon doses and regimen, although this is before rebates or discounts are applied.
Nonetheless, payers have remained anxious over their budgets, even though costs have come down and prescribing rates have fallen as more people are treated. A key restriction adopted by state Medicaid programs has been to limit treatment to patients with the most serious stages of liver disease.
Other tactics have included requiring individuals to demonstrate they have not abused drugs or alcohol for a period of time before starting treatment or limiting which providers are eligible to prescribe hepatitis C medicines to specialists, such as hepatologists or gastroenterologists.
The preliminary analysis noted that only seven states have eased limitations on physician prescribing and just seven states decreased their sobriety restrictions.
Meanwhile, the analysis also noted that, of 42 states with private Medicaid managed care plans with available information, eight states have liver disease stage requirements for accessing HCV treatment that are more restrictive than their corresponding fee-for-service program.
Jeff Myers, who heads the Medicaid Health Plans of America, a trade group for Medicaid managed care plans, criticized the findings. “It’s based on an assumption that plans or states, by not providing unfettered access, are putting patients at risk. And it’s simply not true,” he said.
“Given the decisions by drug makers to price their medications as they did and the tremendous costs, it makes absolute sense that decisions would made to slow down access… Now that prices have started to come down and experience of drugs is better known, states are expanding access.”
He added that CMS last year also asked Gilead, AbbVie, Merck and Johnson & Johnson for their pricing arrangements with payers, which could affect what state Medicaid programs pay for the drugs. Under federal law, Medicaid is entitled to receive rebates of at least 23 percent of the so-called best price — or lowest price — for which a drug maker sells its products.
As we noted, the restrictions have prompted lawsuits.
Last May, the Washington state Medicaid program was ordered to lift restrictions on coverage in response to a lawsuit filed by state residents who claim the drugs are “medically necessary.” Two months ago, a suit was filed against the Colorado state program.
The Center for Health Law and Policy Innovation, in fact, has been instrumental in pursuing litigation against the state Medicaid programs. In Colorado, the center is working with the American Civil Liberties Union, which has also filed a similar lawsuit in Indiana.
We should point out, by the way, that the center is funded, in part, by three drug makers — Gilead, Bristol-Myers Squibb, and Johnson & Johnson, all of which have been active in developing hepatitis C treatments.
These companies account for between 20 percent and 25 percent of the center’s budget, said Greenwald. However, he maintained that industry support is only used for education and policy advocacy, and litigation efforts are funded separately by Harvard Law School and private philanthropy.
The ties to industry prompted a strong reply from Matt Salo, who heads the National Association of Medicaid Directors. “It’s the cost of these treatments that make them inaccessible to Americans, and real bravery would be demonstrated by standing up to the industry, or in making a persuasive case to Congress for relief,” he said. “But since they’re heavily funded by the industry, I guess that’s not how they define bravery.”
The National Viral Hepatitis Roundtable, which also backed the study, says it receives funding from Gilead, Merck, AbbVie, Johnson & Johnson, Bristol-Myers Squibb, OraSure, Quest, Walgreens and the US Centers for Disease Control and Prevention.
This post was update to include comment from the National Association of Medicaid Directors and to note industry support for the National Viral Hepatitis Roundtable.