SCENESSE® update

SCENESSE® Update from CLINUVEL  for EPP patients in England 30 June 2023

At the BPA, we’re immensely disappointed that SCENESSE® is still not available to EPP patients in England. This means that patients have been denied access to what is presently considered as the only effective treatment that is avaiable for their condition.

Please see a statement from CLINUVEL relating to the outcome of the most recent NICE appeal hearing:

We’ll keep you updated of further developments as soon as we know more.


SCENESSE® update 8 February 2021

SCENESSE® to become available to Scottish EPP patients while more data is gathered

The Scottish Medicines Consortium (the body that assesses clinical and cost-effectiveness for all new medicines for NHS Scotland) has today released exciting information about SCENESSE® for patients with erythropoietic protoporphyria (EPP).

Despite being designated as ‘not recommended’, the new Ultra-Orphan Medicines Pathway allows this medication to be made available to patients through the NHS in Scotland for up to three years while further data is collected on the medication. It will then be reassessed and a further decision will be made on whether it can be recommended as a routine treatment in Scotland.

NHS Scotland, the Scottish porphyria doctors and Clinuvel (the manufacturer of SCENESSE) are currently agreeing what data needs to be collected and how. They are also finalising how and where it will become available, as well as the logistics of getting the medication to patients – a process likely to be hindered by Covid-19 restrictions. Despite this, the hope is that within a few months, EPP patients in Scotland will be able to benefit from access to SCENESSE.

This is a really exciting development for patients which we are following closely. The availability of SCENESSE in Scotland could have an immensely positive impact for EPP patients. We are very keen to see how this develops in the future.


What is EPP?

Erythropoietic protoporphyria (EPP) is a rare genetic condition that causes patients to have high levels of a substance called protoporphyrin IX (PPIX) in the blood and tissues. PPIX is phototoxic and when exposed to light causes damage to the blood vessels and surrounding tissues. This causes excruciating pain and swelling of the skin upon exposure to visible light. This prevents patients from being able to spend time outdoors or in places with bright light. Read more about the porphyrias.



SCENESSE (afamelanotide) is an implant that is inserted under the skin for patients over 18 years of age. The active ingredient is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH). Primarily, the medication works by stimulating the production of a pigment known as eumelanin in the skin, this provides photoprotection by reducing the level of light that can penetrate through the skin and cause damage to cells. It also has an antioxidant effect. More information is available from


SCENESSE® update April 2020

The NICE process for Scenesse has stagnated with no significant developments since our last publication, but we have been working hard behind the scenes to try to get things moving again. We have no news to announce at the moment, but will keep our communications going with NICE and with Clinuvel to make sure that EPP patients have a voice going forwards.


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


SCENESSE® update: 24 Dec 2017

NICE have published a provisional evaluation for making Scenesse available on the NHS. The evaluation follows the appraisal meeting held on 23rd Nov and is now available on the NICE website. This takes the form of an Evaluation Consultation Document (ECD).

NICE are proposing that Afamelanotide (Scenesse) is not recommended for use in England. The BPA is incredibly disappointed at this news. This recommendation is made despite acknowledgement of the enormous impact and severity of EPP.  The reasons for the decision are based largely on health economics grounds.

Please take time to read the documentation which is available at NICE – Afamelanotide Appraisal ID927. This decision is not yet final and the BPA is currently formulating an appropriate response to the document.

NICE is seeking further evidence and clarification by 24th January 2018. The evaluation committee is interested in receiving comments on the following:

  • Has all of the relevant evidence been taken into account?
  • Are the summaries of clinical effectiveness and value for money reasonable interpretations of the evidence?
  • Are the provisional recommendations sound and a suitable basis for guidance to NHS England?

In order to make sure your voice is heard please contact the BPA with any comments on the documentation in relation to the above points.

Amongst other things, we are currently seeking advice from Genetic Alliance ( an umbrella charity for many rare disease charities. They have experience in actively campaigning on issues of policy and practice to influence governments, policy makers, industry and care providers such as the NHS.

For further information on the recommendation, please also see Clinuvel’s latest press release at

In the meantime, we will continue to support EPP patients and keep members informed.