Essential medicines in the USA – acquisition of generic marketing licenses causing exponential price rise

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In the USA an alarming trend for pharmaceutical companies to purchase marketing rights for aged off-patent drugs and then immediately raising the cost of the generic medication extortionately by as much as 5433% has been highlighted in an editorial in the New England Journal of Medicine (Alpern, Son & Stauffer, 2016).

A much publicised case is pyrimethamine (bought by Turing Pharma in 2015), a first line treatment for toxoplasmosis, and its huge price rise on acquisition. The consequence of this very high price means that it is prohibitively expensive for most people (many of whom are in low socio-economic disadvantaged groups) and many are forced to receive only second-line treatment instead.

Pile of gold coinsThis is not unique and sadly prices have dramatically risen for many older off-patent drugs most of which are on the WHO Essential Medicines List (EML). These medicines are in niche markets where often no other therapies exist. Such actions are resulting in making potentially life-saving therapies unavailable to disadvantaged groups of patients.

Most of the targeted medicines are anti-infectives for tropical or opportunistic infections. The majority of patients have no insurance and may only have access through a public programme.

Flucytosine is an example of an important generic antifungal which has been monopolised in the USA. A daily dose now costs $2000, but only $22 in the UK (Merry et al). As a first line treatment for cryptococcal meningitis (~20% of AIDS mortality is due to cryptotoccosis) flucytosine is back on the WHO EML, as a result of representation by groups including GAFFI.

One of GAFFI’s targets is to campaign for antifungal treatments to be made available to all people who need them at an affordable cost. The new “business model” of acquiring drugs in niche markets where there are no or few alternative medicines – in order to maximise profits but without any intention to develop new medicines or to carry out research and development – must be challenged. A solution to promoting competition in niche drug markets must be found.

Flucytosine price map and availability

Alpern, Son & Stauffer, 2016

Merry et al. 2016