SCENESSE® update (April 2019)

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.

In follow up to the appeal, a further committee meeting was held at the NICE offices in Manchester. A collaborative and highly involved team of EPP patients, BPA committee members, representatives from the International Porphyria Patient Network (IPPN), leading photodermatologists from the British Association of Dermatologists, as well as an international EPP specialist from Switzerland all took part in the meeting. We are still awaiting the outcome of this session and will keep members posted as soon as we know more.

So what does this mean to UK patients?

Unfortunately, this is still unclear. Whether or not these developments will lead to a change in the recommendation in the Final Evaluation Determination document remains to be seen.

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