Why did Genzyme/Sanofi remove CAMPATH from the market before the development of Lemtrada?
They are both Alemtuzumab, one was used for Cancer at a cost, for MS use of about £1000, and the other the MS drug at a cost of about £28,000. So this is a big jump in cost because of a bit of packaging and dilution of the amount of antibody in the packaging.
Whilst the company will argue they are recovering costs etc o the trials, they have removed the anti-cancer version from the market and would provide this for free for people with cancer, Why?
Maybe they could see the problem brewing that is now an issue for Roche/Novartis.
There is an antibody that is used to treat cancer, which stimulates growth of blood vessels to help them grow. To do this there is a production of vascular endothelium growth factor. This is targeted by a drug called Avastin . It was also found that injecting a small amount of this ($50 worth) into the eye also stopped a degenerative condition in the eye (macular degeneration). So the company did studies and licenced another version of the antibody, which was diluted compared to Avastin and marketed this as Leucentis at a vastly inflated price ($2,000). However, you can take Avastin and use it regularly in the eye disease and the cost is vastly reduced, saving the NHS vast sums of money. So Novartis threatened to sue (but didn’t press the court case) the NHS.
Apparently this summer, the Italian Medicines Agency decided to reimburse patients who are given Avastin to treat age-related macular degeneration. And France’s National Assembly passed a law allowing for reimbursement of off-label medicines, and specifically mentioned Avastin.
The moves reflect efforts to cuts costs on medicines by cash-strapped European governments. Interestingly, anti-trust authorities in both Italy and France are eyeing Roche and Novartis on suspicion of anti-competitive practices.
The Royal College of opthalmologists says switching to the drug could save the NHS £100m and whilst eye docs in the UK can prescribe it “off-label”, but they are only supposed to do that if there is no suitable licensed drug and are personally liable if they do.
The Royal College say regulators should find a way of getting round what they call the “bureaucratic hurdles” that prevent its use, and called for the General Medical Council and National Institute for Health and Care Excellence to provide guidance. It is suggested that either the regulators find a way to license a drug without the sponsorship of the company that owns it or NICE must find a way to consider an off-label drug that is not being submitted for appraisal by the companies.
Genzyme have thus avoided a headache by removing CAMPATH from the shelf.
The news that azathioprine can be at least as effective as beta interferons brings this issue into focus of MS and will have importance for the studies aiming to use/repurpose existing drugs for the treatment of progressive MS, because once a licenced pharma drug arrives for progressive MS then this problem will apply.
Should the NHS and UK Docs be taking on big Pharma for the sake of the coffers of UK PLC?
Maybe ProfG can do a poll