Colorado is latest state to be sued for restricting access to hepatitis C drugs

You can add Colorado to the list of states be sued for refusing to extend access to medicines for hepatitis C in your state Medicaid program.

The demand who is seeking a class-action lawsuit was filed on behalf of two Coloradans on Monday in response to a longstanding policy by the state Medicaid program to restrict coverage only to people with more advanced stages of the liver disease such as cirrhosis.

State “unlawfully restricted” access to medically necessary treatment “can be provided by drugs” Hepatitis C available, depending on demand. The state also “violates” standard medical care and “flaunts clear instructions and warnings” of federal authorities. The lawsuit was filed by the American Civil Liberties Union US and the Center for Health Law and Policy Innovation at Harvard Law School.

The article continues after the announcement

The demand comes amid increasing pressure on public and private payers to loosen restrictions on coverage on medicines for hepatitis C. These new types of treatments began arriving in early 2014 and they have very high cure rates, but they are also expensive, ranging in price from $ 54,600 to $ 94,500, depending on the dose and guidelines, although this is before applying rebates or discounts.

high cure rates led many doctors to prescribe medicines – in particular for Sovaldi and Harvoni drugs sold by Gilead Sciences. Drug manufacturers and their advocates have argued that short-term spending saves money long term in the treatment of liver failure or liver cancer, and liver transplants. However, taxpayers have complained of drug budgets are wound, and instituted some restrictions on coverage.

Since 2013, the Colorado Medicaid program spent $ 26.6 million on treatment of 326 patients with hepatitis C, or about $ 82,000 per person, according to the Department of Health Care Policy and funding, which oversees the program. Last month, a department spokesman said that if the State had to cover all Medicaid eligible patients with hepatitis C, it would cost $ 237 million.

State restrictions are under fire, however. Last November, the Obama administration wrote the state Medicaid programs that may be violating federal law restricting access to medicines for hepatitis C. And last May, a federal judge ordered Medicaid program to lift the restrictions on coverage of Washington state.

After the Civil Liberties Union last month threatened to sue officials of Colorado, Department of Policy health care and government funding restrictions loosened so that more people would be eligible for coverage under the Medicaid program.

The State found that more patients would be covered for drugs depending on the severity of their illness. Now, up to 70 percent of the approximately 14,450 people who are diagnosed with chronic hepatitis C are eligible, a department spokesman said.

However, the lawsuit claims that the change does not go far enough and argued that there should be restrictions. The lawsuit claims the drugs do not reverse the disease, so treatment should be provided as soon as possible; The disease can progress rapidly in some patients, suggesting treatment should not be delayed; Common test methods and do not always produce accurate results.

A spokesman for the Department of Policy and state health care funding specifically refused to comment on the lawsuit

should be noted that the Center for Health Law and Policy Innovation of Harvard University is funded in part by three drugmakers – Gilead, Bristol-Myers Squibb and Johnson & Johnson. These companies account for between 20 and 25 percent of the center’s budget, according to Kevin Costello, litigation director of the plant, although he did not know the size of the annual budget.

However, he said that industry support is only used for education and policy advocacy and litigation efforts are funded separately by the Harvard Law School and private philanthropists. “We have a firewall here,” he said. industry funding of the center was first reported by Bloomberg News.

As Bloomberg, the center’s director, Dr. Robert Greenwald, last year helped persuade other members of the Presidential Advisory Council on HIV / AIDS urge federal regulators noted for call the restrictions on drugs “unreasonable and discriminatory” hepatitis C. also urged the Council, however, to seek transparency in drug prices and negotiations.

However, Matt Salo, executive director of the National Association of Medicaid Directors, questioned the industry funding.

“Access to medicines is inextricably linked to the costs and would not be having these conversations if manufacturers had not drug prices out of reach,” he said. “Clearly, prices are falling, largely because there is no competition and access is increasing, partly due to the demands.

“But the (funds) is unseemly,” he continued. The company is “bending tools to keep their prices and profit margins and different financing ways to do that, when it really should be doing is to make affordable drugs in the first place.”

A lawyer for the ACLU in Colorado told us that the organization did not accept industry funding. A lawyer for the law firm representing two applicants are also two also said the industry was not funding the work of the company.

A spokeswoman for Gilead says the company “has not provided funds to support litigation related to hepatitis current C against the state of Washington, or any other similar lawsuits have been filed across the country. However it is not a surprise, that some of the same organizations that have funded in relation to disclosure and education, on behalf of patients with HCV who also advocate reducing any barrier of a patient may face access to attention.

added that Gilead has not played “a role” in the dispute, but believes that restrictions on “how sick a Medicaid recipient has to be treated are bad for patients, bad policy and illegal with respect Medicaid. ”

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