SCENESSE® update (12 Oct 2018)

An appeal hearing was held on 30th July 2018, regarding NICE’s December 2017 recommendation not to fund Scenesse (Afamelanotide) on the NHS in England. The outcome of the appeal hearing has been published and is available from the NICE website:

In summary, the appeal panel upheld some of the stakeholders’ appeal points: (1) that NICE failed to include IPPN in a committee meeting, (2) that NICE used assessment methodologies likely to have discriminated against EPP patients and (3) that it was unreasonable of NICE to state that the trial results showed small benefits with afamelanotide.

So what does this mean to UK patients?

Unfortunately, this is still unclear. Whether or not this decision will lead to a change in the recommendation in the Final Evaluation Determination document remains to be seen. What we can say at the moment, is that it is no longer a definite no. We will provide further details as soon as we know more.

The BPA is grateful to all parties, including the British Association of Dermatologists (BAD), the International Porphyria Patient Network (IPPN) and EPP patients throughout Europe and the rest of the world, who added highly valuable commentary to the debate. In particular, special thanks go to the German and Swiss patient networks for both the strength and quality of responses delivered to NICE’s initial Evaluation Consultation Document.

Further details can be found on the NICE website at: NICE – Afamelanotide Appraisal ID927

A press release from Clinuvel is available at: Clinuvel – Investors