Our local, not-for-profit, public transportation system here in the Philadelphia region (the Southeastern Pennsylvania Transportation Authority or SEPTA) has filed what appears to be a groundbreaking lawsuit against a pharmaceutical company regarding the pricing of a branded pharmaceutical product. The potential ramifications of this case are considerable.
There is no media information about this lawsuit on the SEPTA web site. However, as reported by Reuters and discussed in an article on the Wall Street Journal web site, on Tuesday this week, SEPTA (a self-insured “payer”) filed a class action lawsuit accusing a pharmaceutical manufacturer (Gilead Sciences) of seeking “exorbitant” reimbursement for a drug used in the treatment of hepatitis C (sofosbuvir or Sovaldi®). Since the approval of sofosbuvir (on December 6, 2013), SEPTA claims to have paid > $2.4 million for treatment with this drug on behalf of its employees, and SEPTA is seeking to represent a class that includes anyone or any organization in the USA that has paid for sofosbuvir or has not been able to afford recommended and approved treatment with this drug.
According to the available information,
- The suit seeks an unspecified amount of monetary damages.
- SEPTA claims, among other things, that Gilead has “limited rights as a patent holder [which] do not translate into a license to price gouge consumers.”
What does not seem to be in dispute is that sofosbuvir is an extremely effective treatment for hepatitis C; that its nominal cost is $1,000 per pill here in the USA (i.e., $84,000 for a typical 12-week course of treatment); that certain purchasers are able to seek and obtain significant discounts on that price; and that, in other countries around the world, sofosbuvir can be purchased at significantly lower prices.
All that we can really tell readers at this time is that there are going to be a lot of people (with very different perspectives) watching this lawsuit to see what happens.
It is worth noting that on October 10, 2014, the U.S. Food and Drug Administration also approved a combination of two drugs (sofosuvir + ledipasvir) known as Harvoni® as an even newer form of treatment for hepatitis C, also manufactured by Gilead. The nominal price for this new combination therapy here in the USA is said to be $94,500 for a 12-week course of therapy (equivalent to $1,125 per pill).