People living with multiple sclerosis know that the medications used to treat it are expensive. According to the National Multiple Sclerosis Society, the median annual price of brand-name disease-modifying therapies (DMTs) last year was $91,835. Five of them carried a price tag of more than $100,000 a year.
Many pharmaceutical companies help defray the out-of-pocket costs of their DMTs for patients. But U.S. law strictly limits how this can be done for people covered by federal insurance programs, such as Medicare. Officials are concerned that copay assistance and grants to foundations that help patients pay for their treatments may promote the sale of the companies’ products, which is illegal.
Last year, the U.S. Justice Department filed a complaint against two Teva Pharmaceutical subsidiaries, accusing them of skirting copay restrictions by donating to foundations and then using those organizations to funnel copay assistance to patients they were prohibited from directly helping. Officials said Teva wanted to ensure that Copaxone (glatiramer acetate) users, including those on Medicare, wouldn’t ever have to pay much, if anything, for the medication. That induced patients to select that DMT over others.
‘Seed and sweep’
This brings us to a lawsuit filed late last month by the health insurance company Humana against drug manufacturer Biogen. The lawsuit alleges that Biogen attempted to boost sales of its MS medications Tysabri (natalizumab), Avonex (interferon beta-1a), and Tecfidera (dimethyl fumarate) by “seeding” patients with free samples of those drugs. When sample periods ended, the company then allegedly “swept” patients into government programs, such as Medicare, where they had large copays, the lawsuit alleges.
According to the website Fierce Pharma, which covers the pharmaceutical industry, the lawsuit claims Biogen gave money to the “nominally charitable foundations” Chronic Disease Fund and The Assistance Fund “with the intent and understanding that they would use Biogen’s money specifically to cover the copays of patients taking Biogen’s MS Drugs. … In so doing, Biogen intended that the MS drug patients—but not insurers—avoid the steep prices charged for the drug.”
As Fierce Pharma noted, the two foundations mentioned in the lawsuit — the Chronic Disease Fund and The Assistance Fund — had previous settlements with the Justice Department over the same issue, for $2 million and $4 million, respectively.
In an email, I asked Biogen spokeswoman Allison Parks about the recent lawsuit, but she responded by saying, “We do not comment on pending litigation.”
What do you think?
When I first wrote about this issue three years ago, I asked the following questions:
Do the pharma companies use their assistance programs to push their own products? Sure.
Do their patient services drive up the cost of already expensive medications? Probably, at least to some extent.
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 don’t know.
What do you think?
A version of this post first appeared as my column on the MS News Today website.
(Featured image by North Charleston.)
