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SMC Ruxolitinib (Opzelura) appraisal update (May 2024)

 Posted on 28th May 2024  3 minute read

Earlier this year The Scottish Medicines Consortium (SMC) has announced that it was considering Ruxolitinib (Opzelura) or treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

What is Opzelura?

Developed by pharmaceutical company Incyte Biosciences, Opzelura is a medicine developed for treating non-segmental vitiligo. It is a topical selective Janus kinase (JAK) inhibitor cream that affects your immune system, reducing inflammation and encouraging the regeneration of melanocytes to produce pigment over time.

What is the SMC?

The Scottish Medicines Consortium is a committee of clinicians, pharmacists, NHS board representatives, the pharmaceutical industry, and the public. Members of the committee consider a broad range of evidence in order to decide which medicines should be accepted for use by NHS Scotland.

What has happened so far?

The Vitiligo Society participated in this assessment as a patient representative group, providing information on the impact that living with vitiligo has on individuals in our community. We provided an initial patient group submission, and have attended a SMC committee meeting this week where the medicine was discussed.

Unfortunately earlier this month the SMC announced that “after careful consideration of all the evidence, the SMC Committee has been unable to recommend this medicine for use by NHS Scotland.” 

The relevant Detailed Advice Document can be found here and a link to the Decision Explained public information summary can be found here.

What happens next?

There are several options now available to the pharmaceutical company which provided the submission to SMC. 

Following publication of SMC advice companies, in this case Incyte, can request a meeting with the SMC to discuss the assessment and understand why their medicine has not been accepted. Further information on that meeting can be found here.

Submitting companies then have two options they can pursue:

Firstly, they can apply for a fast track re-submission where they have made changes to their Patient Access Scheme (PAS) or there is a reduction in the list price that has been confirmed by the Department of Health. The re-submission must be received within three months of the date the original SMC decision was issued to the company. In this process only economic evidence is reviewed and there is no change to any other aspect of the submission (including the proposed positioning of the medicine).

Participating Patient Group Partners from the original assessment are notified of this fast track re-submission.

Secondly, a company can submit the medicine for another full submission assessment. This will go through the same process as the original assessment where the company can submit improved clinical and cost effective evidence. Participating Patient Groups will be invited to take part and submit evidence to this as a standard submission.

In the meantime all Scottish NHS boards have procedures in place to consider requests for the use of a medicine in an individual patient when a doctor feels this would be appropriate. Patients are recommended to discuss this option with their healthcare professional.

In response to the decision Incyte told us:

On 13th May 2024, the Scottish Medicines Consortium (SMC) published advice regarding Opzelura®(ruxolitinib) cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. This guidance follows an evidence assessment by the SMC’s multidisciplinary team of clinicians, pharmacists, health economists and an evaluation via the SMC’s New Drugs Committee(NDC). The SMC’s guidance does not recommend ruxolitinib cream.

At Incyte Biosciences UK, we are deeply aware that people living with vitiligo have long had limited treatment options and we continue to be fully committed to engaging with the SMC and NHS Scotland and, ultimately work towards making ruxolitinib cream available to eligible patients seeking to treat their vitiligo.

Updates and the outcome of the consultation can be found on the SMC website below:

Incyte can be contacted via telephone for any questions relating to the treatment and its availability:

Funding disclosure:
The Vitiligo Society has project work supported by an educational grant from Incyte Biosciences UK Ltd. The Vitiligo Society maintains full control over the all project management and content, ensuring independence and impartiality in its work.

When it comes to any external funding we follow the current guidance and rules as set out by the Charity Commission and the Fundraising Regulator. We report any research collaborations and/or financial contributions received from industry in our annual reports and accounts as well as being transparent about our partnerships on our website.

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