Prescribing unlicensed drugs – the Avastin judgment

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In its recent judgment in Bayer Plc (and others) v NHS Darlington CCG (and others) [2018] EWHC 2465, the High Court has confirmed that the Clinical Commissioning Groups (“CCGs”) have acted lawfully in adopting the policy listing Avastin as the preferred treatment option to patients suffering from neovascular age-related macular degeneration (wet AMD). Avastin’s manufacturer did not hold a marketing authorisation for such use.

The facts

Wet AMD is a medical condition which may result in blurred vision or loss of vision in the centre of the visual field.

There are two licensed drugs for the condition: Lucentis (manufactured by Novartis Pharmaceuticals UK Ltd) and Eylea (manufactured by Bayer Plc), both of which are particularly expensive – the former costs £561 and the latter costs £800.

Avastin is a cheaper alternative to the above drugs, available at a price of £28 per injection. It is not licensed for wet AMD treatment in the UK, however it is widely used abroad, including in the US. The guidance issued in 2011 by the Medicines and Healthcare Products Authority (MHRA) stated that the use of Avastin for treatment of wet AMD was unlicensed. MHRA did not recommend its use for that reason, but it did make a class-level recommendation in relation to prescribing anti–vascular endothelial growth factor treatment (which may be Avastin-based) for wet AMD.

Earlier this year, Avastin was held as safe and effective as the two licensed drugs by the National Institute for Health and Care Excellence (NICE). However, the use of Avastin in wet AMD treatment was off-label since it involved so-called compounding, i.e. splitting the available vial into separate individual doses, which technically made it unlicensed.

Twelve CCGs have adopted the policy recommending Avastin, following which Bayer and Novartis applied for its judicial review.

The decision

The High Court dismissed the claim and held that the CCGs and NICE have exclusive competence to assess Avastin’s clinical effectiveness in treatment of wet AMD.

The court stated that MHRA and the European Medicines Agency (EMA) have exclusive competence to grant a marketing authorisation in relation to the use of a drug for a particular purpose. Such marketing authorisation cannot be issued without the manufacturer of the drug applying for it in the first place. However, this does not prohibit CCGs and NICE from considering efficacy and safety of drugs. Otherwise, pharmaceutical companies would effectively have the power to decide which drugs they choose to make available for certain conditions, which would have a negative impact on the cost-effectiveness of the national health system and, consequently, would be detrimental to the public interest.

In addition, the clinicians are not prohibited from prescribing unlicensed drugs under the guidance issued by the General Medical Council (GMC), which requires them to consider the costs of the treatment as part of their decision-making process.

The court held that the CCG policy is capable of being lawfully implemented and that it does not undermine patient’s access to the treatments recommended by NICE, especially in the light of the fact that the licensed drugs remained available treatment options.

Geldards’ comment

With around 40,000 new wet AMD diagnoses per year, the decision will be welcome by the NHS whose estimated annual saving may reach £500m. On the other hand, the judgment will also have a significant financial and strategic impact on the pharmaceutical companies. Whilst they cannot be legally forced to apply for an authorisation to market a particular drug for a particular purpose, the door is now open for the prescribers to make the appropriate clinical effectiveness assessment and, subject to the results and the applicable guidance, recommend the best treatment which may not necessarily be licensed.

Our dedicated Life Sciences team at Geldards will be pleased to assist you – if you have any queries, please do not hesitate to contact a member of our Life Sciences or Commercial Dispute Resolution Team.

RELATED: DISPUTE RESOLUTION - EXPERTISE

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