Cladribine repurposed in multiple sclerosis: making a fortune out of a generic drug. Buiter HJC, Derijks L, Mulder CJJ. Eur J Hosp Pharm. 2019 Sep;26(5):246-247
We have discussed this before and it is clear that the cost of MS drugs, bear no real relationship to their manufacturing costs. MS trials are very expensive and these costs need to be re-couped. Now, I am not going to defend the pricing strategy of pharma, but this paper is a call to arms to recommend pharmacists start to prescribe the generic version to save money.
However, what doesn’t seem to filter through in this article is that this approach rather goes against government policy, where the pharmaceutical industry is encouraged to make make money, so that they continue to invest in health. We can develop repurpose generics as long that is does not tread on pharma toes.
In this study they look at the costs of oral cladribine and suggest that the manufacturers are having some form of perverse laugh when they charge over €2,000 for a 10mg dose of drug, when the equivalent parenteral dose is about €9 a 1mg. There could cheap alternatives perhaps like chlorfarabine and fludarabine. This doesn’t work quite the same a cladribine, but chlorfarabine does and it is orally active too. However they say that chlofarabine has a higher bioavailability compared with fludarabine and cladribine. Unfortunately, an oral drug formulation of chlofarabine is not yet available. Surprise, surprise……. when I last looked was own and probably parked on a shelf, so it won’t compete with their lymphocyte depleting monoclonal antibody for MS.
They say subcutaneous cladribine for MS was originally developed for compassionate use. As such, it has only been administered to MS patients in few centres around the world….ProfK and BartsMS doesn’t get a mention:-(
I suspect the revolution will not come until small molecule generics arrive. The first was due to be in 2019 when the fingolimod patents expired. However in the US these have been extended by court action. If Glatiramer acetate can get patent protection for 40 years after it was invented, we may be waiting some time.