What has SMC said?
The Scottish Medicines Consortium (SMC) has accepted zilucoplan used together with other treatments for adults with generalised myasthenia gravis (gMG), which is a rare long-term autoimmune condition that leads to muscle weakness and tiredness. Zilucoplan is used in patients whose immune system produces antibodies against a protein called the acetylcholine receptor (anti-AChR positive gMG).
SMC has accepted zilucoplan for restricted use.
The restriction means it can be used in patients with anti-AChR positive gMG that is refractory (has not responded to treatments) if:
- the disease has not responded well enough to corticosteroids and at least two othertreatments (including rituximab and non-steroidal immunosuppressive therapies), if theseoptions are suitable and
- the disease is not controlled, as measured by a Myasthenia Gravis-Activities of Daily Living(MG-ADL) score of 6 or more, or a Quantitative Myasthenia Gravis (QMG) score of 12 or more, and
- patients are being considered for treatment with maintenance intravenous immunoglobulin(IVIg) or plasma exchange (PLEX).
This document summarises the SMC decision and what it means for patients.
You can find more detailed information about the SMC assessment of zilucoplan by looking at the SMC Detailed Advice Document (SMC2955).
What does SMC’s decision mean for patients?
Zilucoplan for use as described above is available for prescribing on the NHS in Scotland. Your healthcare professional can discuss with you if it is the right treatment for you.
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’s decision takes into account a confidential discount offered by the pharmaceutical company.
SMC was also able to be more flexible in its decision-making because the medicine 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 organisations below can provide more information and support for people living with myasthenia gravis and their families. SMC is not responsible for the content of any information provided by external organisations.
Myaware
https://www.myaware.org 01332 290 219
Muscular Dystrophy UK
https://www.musculardystrophyuk.org 0800 652 6352
You can find out more about zilucoplan (brand name: Zilbrysq®) 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/