The manufacturer of Copaxone is the target of a US Justice Department lawsuit and its outcome could affect many of us who receive copay help for our medications.
The legal case involves 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.
Specifically, the Justice Department is eyeing two Teva Pharmaceutical subsidiaries that donate funds to two foundations that provide grants like the one I received. So, you might ask, what’s the problem with that?
Is this a kickback?
It’s complicated. If you have commercial drug insurance, a pharmaceutical company is allowed to help you pay part or all of your insurance copay. But that’s prohibited for people receiving Medicare. For Medicare patients, drug companies must pay for all or nothing at all. In those cases, people may be forced to turn to a foundation for copay help.
In a complaint filed a couple of weeks ago, the Justice Department accuses the two Teva subsidiaries of skirting this direct copay restriction by donating to foundations and using them as “conduits” to pay the partial copay that the pharmaceutical company aren’t allowed to pay directly.
According to the complaint, Teva’s aim was to make sure that Copaxone users never had to pay very much, out-of-pocket, for the medication. That induced patients, including those on Medicare, to use Copaxone. And that, government prosecutors believe, violates a federal anti-kickback statute.
Teva has vowed to fight the lawsuit issuing a statement saying the case brought by the Department of only seeks to further restrict patients’ access to important medicines and health care.
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 the programs that make nurses available 24/7 to answer patients’ questions.
The Journal named Sanofi and Biogen as two of several pharmaceutical manufacturers whose programs were being scrutinized. Sanofi makes Aubagio (teriflunomide) and Lemtrada (alemtuzumab). Biogen makes Tysabri (natalizumab), Avonex (interferon beta-1a), Tecfidera (dimethyl fumarate), and Plegridy (peginterferon beta-1a).
Is this good or bad?
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, in exchange, the actual price of the medications was lowered significantly?”
I couldn’t answer my question then, and I still can’t answer it. Can you? What do you think?
(A version of this post first appeared as my column on the MS News Today website.)
(Featured image by Thomas Breher from Pixabay.)
