Narcolepsy UK Charter adds our collective voice to enable new nationally recommended treatment for excessive daytime sleepiness in adults with narcolepsy with or without cataplexy in England and Wales.

Narcolepsy UK Charter adds our collective voice to enable new nationally recommended treatment for excessive daytime sleepiness in adults with narcolepsy with or without cataplexy in England and Wales.

National Institute for Health and Care Excellence (NICE) has recommended solriamfetol as an option for treating excessive daytime sleepiness in adults with narcolepsy if modafinil and either dexamfetamine or methylphenidate have not worked well enough or are not suitable.

This decision increases treatment options for people with narcolepsy, creating more opportunity for them to access effective treatment sooner. This is a key aim of Narcolepsy UK’s Charter as access to effective treatment can dramatically improve multiple aspects of people's lives including their education, working, family and social life

We welcome NICE’s decision and the committee’s recognition of the need for pragmatism when comparing treatments for rare diseases such as narcolepsy.

However, the guidance still leaves people with narcolepsy to be treated with drugs that have not been assessed in randomised clinical trials (dexamfetamine) or in RCTs in people with narcolepsy (methylphenidate) before newer drugs that have specifically been developed and tested for this disabling condition. Neither is there real-world evidence concerning long term safety issues that may be associated with dexamfetamine or methylphenidate for people with narcolepsy.

We believe that this scenario should be reviewed to guide future appraisals for narcolepsy treatments and for other medical conditions that might face similar issues.

Anticipated Next Steps

England & Wales

Here are the timelines that we anticipate will run from now until the end of the mandated 90 day implementation period for adopting the NICE determination, which starts from 18/11/21. We add the caveat that these are based on our perspective and the way each commissioning area adopts the guidance may vary.

18/11/21 Final Appraisal Determination (FAD) will be published on the NICE website for public consultation

02/12/21 End of the public consultation period

05/01/22 Technology Appraisal Guidance (TAG) will be published on the NICE website – this is the final recommendation document from NICE

17/01/22 The NHS in Wales must provide funding and resources for NICE recommended treatments within 60 days of the first publication of the FAD. This implementation date will be 17th January 2022

16/02/22 The NHS in England must comply with the recommendations of NICE within 90 days following the publication of the Technology Appraisal Guidance (TAG). This implementation date will be 5th April 2022

Scotland

The Scottish Medicines Consortium, which is a different health technology appraisal process for reimbursement in Scotland is currently considering solriamfetol for the treatment of excessive daytime sleepiness caused by narcolepsy.

Northern Ireland

In Northern Ireland, the Department of Health, Social Services and Public Safety review NICE technology appraisals for any financial, policy or equity implications and make a decision on endorsement within four weeks of the final TAG publication by NICE. Any endorsement is then subject to further steps for implementation at Health and Social Care Board and Trust level.

External Links

Jazz Pharmaceuticals plc https://www.prnewswire.co.uk/news-releases/national-institute-for-health-and-care-excellence-nice-issues-positive-guidance-for-jazz-pharmaceuticals-sunosi-r-v-solriamfetol-for-the-treatment-of-adults-with-excessive-daytime-sleepiness-eds-caused-by-narcolepsy-812836580.html

National Institute for Health and Care Excellence https://www.nice.org.uk/guidance/gid-ta10524/documents/final-appraisal-determination-document

Narcolepsy UK Press Enquiries matt.oneill@narcolepsy.org.uk