One for ProfK, as cladribine manufactureres are accused of making money

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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.

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MouseDoctor

4 comments

  • MD, in 2015, when I first read about Cladribina here on the blog, I sent emails to the 02 largest MS associations here in Brazil. I talked about the possibility of using the generic version of Cladribine in SUS (the public health system here), which would bring huge savings for the country (much cheaper and more effective medicine, which would decrease the number of MSers hospitalizations), with outbreaks, and with much more expensive drugs and with the same activity of effectiveness) and would give us MSers an opportunity for a really effective treatment against the disease. I got the answer, “ah, this drug has not yet been widely accepted by the medical-scientific community, and has not been incorporated into the SUS free drug distribution list.”
    When this year was the oral version marketed by Merck Serono was quickly incorporated into the list of free distribution of high-cost medicines in SUS. I came to comment here that Anvisa (health agency) here in Brazil had approved the free distribution in SUS of a generic version of Fingolimode, manufactured by a pharmaceutical industry here, but was approved without following the necessary criteria to prove the effectiveness of the new version (not even phase 3 testing). The brazilian medical community lobbied, saying generic Fingo was not as efficient as Gylenia, and Novartis on the other hand also pushed. The generic Fingo was discontinued and Gylenia was distributed.

  • Your post remind me those who say “I am not a racist, but…” (and then you say something really racist).
    You are not in favor of this -outraging- pharma cost policies, but…
    With prices skyrocketing the last decade and very modest investments on me-too/old generic drugs and research, there are no excusions. You either take a stance against it, or you don’t.

    There is a Novartis scandal under investigation right now in Greece, involving the price of Gilenya, as Greece prices would push for higher prices in other countries through “external reference pricing”. This is not just about Novartis, nor is it an isolated “Greek case” (the scandal also includes paying doctors and academics to communicate in scientific conferences about their products and promote them, a common practice for all pharma).

    I am afraid there is no “but” here.

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