Lomustine, an off-patent anticancer indicated for Hodgkin's lymphoma and brain tumors, was sold in the US by BMS at 50 dollars a pill. From 2013 to today, the new company that produces it, Next Source, has come to offer it for 768 dollars. With the risk that many patients cannot afford it
Of Maurice DiLucchio – December 28, 2017 – Aboutpharma
There are stories that do not help improve the image of the global pharmaceutical industry in the eyes of the public. One of these concerns lomustine, an anticancer drug launched on the market in 1976 and already without patent protection for some time. According to reports from the Wall Street Journal, this medicine, of which there are no generic versions, was sold in the US until 2013 by Bristol-Myers Squibb (under the trade name CeeNU) for about 50 dollars (42 euros) per pill for the highest dosage.
In 2013, however, the drug, indicated for the treatment of Hodgkin's lymphoma and brain tumors, was purchased by a Miami startup, NextSource Pharmaceuticals. The latter relaunched Lomustine on the market under another name (Gleostine) and significantly increased the selling price. At the moment, according to the WSJ, the cost of a pill is 768 dollars (688 euros). This is a figure that is fifteen times the initial price: the increase is over 1400%.
“The price can be explained by the high development costs”. But there are those who think that for many the drug will be inaccessible
Only in 2017, reports the New York newspaper, NextSource raised the price of 20% in August and 12% in November. The Miami-based company takes a stand, replying to the Journal that the price is due to the high development costs. In addition - he says - it is commensurate with the benefits for patients. In addition, NextSource CEO Robert DiCrisci said, the company is providing discounts and financial assistance to patients who cannot afford the drug. Yes, but to what extent? According to an expert interviewed by the WSJ, many Americans will not be able to buy the drug or will in any case go into debt to access it.
The FDA tries to avoid new cases similar to that of lomustine
However, the case of lomustine risks not being the only one. There are numerous off-patent drugs which have not been generic and which, therefore, do not fear price competition from equivalents. The Wall Street Journal writes that the FDA, also to comply with President Trump's intention to lower the prices of medicines, is speeding up the review process of over 300 drugs with no more patent coverage that could give rise to new cases similar to the one of the anticancer drug marketed by NextSource.
On the other hand, in a period in which some breakthrough therapies cost several hundred thousand dollars (think of gene therapy Novartis tisagenleuclel, That in the USA it costs 475 thousand dollars, or to the new one FDA-approved gene therapy for an eye disease, with potential costs in the $1 million range), it's no wonder regulators will put even more effort into making innovative medicines as accessible as possible.
Related news: LOMUSTINE – lomustine capsules, gelatin coated
FDA. GLEOSTINE safely and effectively. See full prescribing information for GLEOSTINE.
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