Legal threat to NHS as drug companies challenge proposals to provide patients with cheaper alternatives

Research has led to the discovery that a drug costing £12 is as effective as injections costing £800.

Drug companies who produce the more expensive injections argue that the use of the cheaper drug is a “breach of patient rights to be treated with drugs backed by the watchdogs; the National Institute of Health and Care Excellence (NICE)”.

The medication at the centre of the battle is used to treat age-related macular degeneration (AMD), a leading cause of sight loss. Currently patients are offered either Eylea injections (Bayer -£700 per dose) or Lucentis injections (Novartis – in the region of £1000 per dose) but local health authorities are developing plans to instead offer patients the opportunity to receive an Avastin injection, used to treat cancers but found to be as effective, at a cost of between just £10-30 per dose.

Avastin is not currently licensed for use in treatment of AMD despite its effectiveness at treating the disease. Complications arise as Avastin is part-owned by Novartis (who produce one of the more expensive drugs; Lucentis) following an agreement in its development with Genentech, part of the Roche group. The Lucentis injection generates far greater profits and so there is no financial incentive for the Novartis to invest in the time and research that it takes to license Avastin for use in treating AMD.

The use of unlicensed products is not rare and happens often in the provision of paediatric care. The General Medical Council (GMC) explains that clinicians should usually prescribe licensed medicines in accordance with the terms of their licence, but that in some instances unlicensed medicines are necessary to meet a patient’s need and therefore provide guidance on what to consider before deciding to prescribe an unlicensed medication eg: being satisfied that there is sufficient evidence in the success of the product and making decisions in collaboration with patients.

If the NHS were able to swap to using Avastin injections as a matter of course it would make savings of more than £500million a year.

A spokesperson for Bayer said that using unlicensed products routinely “runs the risk of setting a precedent that undermines the regulatory framework and NHS constitution” but this is exactly the approach that the United States and France have taken; insurance companies in the US will reimburse the cost of Avastin but not Lucentis and the UK and France will allow reimbursement of the use of Avastin as an unlicensed medicine.

A solicitor in the Medical Negligence team says: “There are recurring discussions about drug manufacturers withholding medication from the people who need it most. Whilst we understand that substantial investment goes into the development of these medications it is unacceptable that companies such as Novartis make excuses to avoid licensing cheaper alternatives. In 2014 Novartis and Roche were fined €182.5million by Italy’s anti-trust regulator (AGCM) for colluding to block the use of Avastin for AMD so they are well aware of the impact that they are having on the market and are encouraging trusts to take advantage of loopholes which our NHS will have to continue doing as such drastic savings simply cannot be avoided”.