Bayer Plc v NHS Darlington Clinical Commissioning Groups (CCG) & Ors

A healthcare commissioning policy is lawful if it is realistically capable of implementation without leading to, permitting or encouraging unlawful acts. Where a policy permits several methods of implementation, the possibility that one method might be unlawful does not invalidate the policy if realistic lawful methods exist. Particular decisions may be challenged separately.

National healthcare authorities may assess comparative clinical effectiveness, safety and cost, including for medicines proposed for off-label use. A clinician may take cost into account when selecting between treatments regarded as equivalent in clinical effectiveness and safety.

Bayer and Novartis challenged policies adopted by twelve Clinical Commissioning Groups which identified Avastin as the preferred treatment for wet age-related macular degeneration, while preserving access to NICE-approved Lucentis and Eylea.

The challenges alleged breaches of EU medicines law and the duty of sincere cooperation, interference with access to NICE-recommended treatments, and defects in draft patient and clinician information documents. The central issues included the competence of the EMA, cost-sensitive prescribing, the status and safety of compounded bevacizumab, and whether the proposed supply routes could lawfully implement the policy.

1. Claim dismissed. All four grounds of challenge failed.
2. The EMA’s competence concerns marketing authorisations for therapeutic uses sought by manufacturers. It does not prevent NICE or CCGs from assessing the clinical effectiveness, safety and cost of a medicine proposed for use outside its marketing authorisation. That assessment falls within national competence.
3. Cost may be considered by national healthcare authorities and clinicians. Properly construed, the GMC guidance that licensed medicines should usually be prescribed did not prohibit prescribing an unlicensed medicine where a licensed alternative existed. In the unusual circumstances of equivalent effectiveness and safety, a clinician could select Avastin having regard to cost and resource allocation.
4. The court did not need to resolve the expert safety dispute. The CCGs’ conclusion was not irrational, and NICE Guideline NG 82 concluded that the anti-VEGF treatments had no clinically significant differences in effectiveness and safety.
5. For this case, compounded bevacizumab was treated as an unlicensed medicine on the basis of the MHRA’s 2011 guidance, although the court invited the MHRA to review that position. Original-vial use was off-label and did not require a fresh marketing authorisation. The other proposed supply routes could potentially be lawful, depending on the facts.
6. The correct question was whether the policy was realistically capable of implementation by NHS Trusts without leading to, permitting or encouraging unlawful acts. The policy was advisory, left implementation to providers, and had several realistic potential modes.
7. Lucentis and Eylea remained available within their NICE technology-appraisal parameters. The draft patient leaflet was not a reviewable decision by the CCGs, and the clinician Q&A was not materially unlawful or misleading.