What has SMC said?
The Scottish Medicines Consortium (SMC) has not recommended omaveloxolone for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and over. Friedreich’s ataxia is a rare inherited condition that causes progressive damage to the nervous system and movement problems.
This document summarises the SMC decision and what it means for patients.
You can find more detailed information about the SMC assessment of omaveloxolone by looking at the SMC Detailed Advice Document (SMC2845).
What does SMC’s decision mean for patients?
Omaveloxolone for use as described above should not normally be prescribed on the NHS in Scotland. Your healthcare professional should talk with you about other treatment options.
If your healthcare professional thinks you would benefit from it, they can make a request to prescribe omaveloxolone. All health boards have procedures in place to consider these requests.
You can find more information about making decisions about your treatment here: Medicines in Scotland: What’s the right treatment for me?
More about SMC’s decision
SMC was unable to accept omoveloxolone as described above for routine use. The evidence from the company about the benefits the medicine offers when compared to current treatments was not strong enough to justify the additional cost of the medicine. In addition, the company's evidence of the medicine’s value for money was not strong enough. This was despite using a more flexible approach* in the assessment as it is for a rare condition.
How does SMC make its decision?
SMC carefully considers every new medicine to make sure it benefits patients and is likely to be a good use of NHS resources.
To do this SMC studies the following:
- Evidence from the company about how well the medicine works compared with current treatments available in Scotland, in relation to how much they will cost to buy and use to treat patients.
- Information from patient groups about the potential impact of the medicine on patients and carers.
- Advice from healthcare professionals about any benefits of the new medicine compared to current treatment, along with how the new medicine is likely to be used.
When SMC assesses a medicine it takes account of the needs of all patients in NHSScotland, not only those who may be treated with the medicine.
You can find out more about how SMC decides here: https://www.scottishmedicines.org.uk/how-we-decide/
More information and support
The organisation below can provide more information and support for people living with Friedreich’s ataxia and their families. SMC is not responsible for the content of any information provided by external organisations.
Ataxia UK
https://www.ataxia.org.uk
0800 995 6037
You can find out more about omaveloxolone (brand name: Skyclarys®) in the Patient Information Leaflet (PIL) by searching for the medicine name on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
https://products.mhra.gov.uk/