Could a Justice Department Lawsuit Threaten Copay Assistance Programs?

The U.S. Justice Department has the manufacturer of Copaxone (glatiramer acetate injection) in its crosshairs, and the outcome could have a much greater reach. It appears the case could directly affect the copay help many of us receive for our medications and the patient services some drug companies provide.

The legal case targets the interaction between pharmaceutical companies and nonprofit organizations that provide grants to people who need help paying for their treatments. For example, when I couldn’t afford the monthly copay for Aubagio (teriflunomide) several years ago, I qualified for a $6,000 foundation grant that covered my copay for a year.

Now, the Justice Department is eyeing two Teva Pharmaceutical subsidiaries that donate funds to two foundations that in turn provide grants like the one I received. So, you might ask, what’s the problem?

Is this a kickback?

It’s complicated. If you have commercial drug insurance, a pharmaceutical company is allowed to help you pay either part or all of your insurance copay. But that’s prohibited for people receiving Medicare. For Medicare patients, drug companies must provide their medication free of charge or they can’t provide any financial help. In those cases, people may be forced to turn to a foundation for copay help.

In a complaint filed a few days ago, the Justice Department accused two Teva subsidiaries of skirting this copay restriction by donating to foundations and using them as “conduits.” The foundations allegedly paid the part of the copay that the pharmaceutical company couldn’t directly pay.

According to the complaint, Teva’s intent allegedly was to ensure that Copaxone users never had to pay very much, if anything, for the medication. That induced patients, including those on Medicare, to use Copaxone. And that, government prosecutors allege, violates a federal anti-kickback statute that bars nonprofits that assist with drug copayments from helping Medicare patients this way.

In a statement to news organizations including The Wall Street Journal, Teva vowed to fight the lawsuit. “This case brought by the Department of Justice regarding these charitable contributions only seeks to further restrict patients’ access to important medicines and health care,” the statement said.

Are patient assistance programs in danger?

The federal government has been probing the legality of the patient assistance programs of several pharmaceutical companies since at least 2018. The Wall Street Journal has reported that this includes direct copay assistance, donations to foundations, and even programs that make nurses available around the clock to answer patients’ questions by phone.

The Journal named Sanofi and Biogen as two of several pharmaceutical manufacturers whose programs were being looked at. Sanofi makes Aubagio (teriflunomide) and Lemtrada (alemtuzumab). Biogen makes Tysabri (natalizumab), Avonex (interferon beta-1a), Tecfidera (dimethyl fumarate), and Plegridy (peginterferon beta-1a).

Sanofi also reportedly was asked for information about its patient assistance program for users of its diabetes medication. That program is similar to Sanofi’s “MS One to One,” Biogen’s “Above MS,” and other MS patient help lines. One has to wonder if these programs also are in the crosshairs of federal prosecutors.

Is this a good or bad thing?

There are two sides to this coin. When I wrote about this issue nearly two years ago, I asked: “Do the pharma companies use their programs to push their own products? Sure. … Do their patient services push up the cost of already expensive medications? Probably, at least to some extent. But would more patients be able to afford these treatments if the assistance programs were eliminated and the actual price of the medications was lowered significantly?”

I couldn’t answer my question then, and I still can’t answer it now. What do you think?

You’re invited to visit my personal blog at www.themswire.com.

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 Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.