November 2023 decisions news release
The Scottish Medicines Consortium (SMC), which advises on newly-licensed medicines for use by NHSScotland, has today (Monday, November 13) published advice on nine medicines.
Selpercatinib (Retsevmo®) was accepted on an interim basis for the treatment of a rare type of non-small cell lung cancer. The medicine will be available while further information is gathered. Following this, SMC will review the evidence and make a decision on routine availability in NHSScotland.
Durvalumab (Imfinzi®) was accepted for the treatment of adults with advanced biliary tract cancer, cancer of the bile ducts which carry bile from the liver and the gallbladder to the intestines, which is newly diagnosed.
Tafamidis (Vyndaqel®) was accepted for the treatment of adults with transthyretin amyloidosis cardiomyopathy. This is a rare condition where abnormal proteins called amyloid build up in tissues around the heart.
Avacopan (Tavneos®) was accepted for the treatment of adults with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). GPA and MPA are rare conditions that cause blood vessels to become inflamed which can restrict blood flow and cause damage to vital organs such as the lungs and kidneys.
Bimekizumab (Bimzelx®) was accepted for the treatment of adults with psoriatic arthritis, an inflammatory arthritis associated with the skin condition psoriasis.
Risankizumab (Skyrizi®) was accepted for treating Crohn’s disease in patients 16 years or older.
The committee was unable to accept efgartigimod alfa (Vygart®) for the treatment of adult patients with generalised Myasthenia Gravis (gMG). It was also unable to accept pegunigalsidase alfa (Elfabrio®) for the treatment of Fabry Disease, a rare inherited condition that can lead to kidney failure and heart problems. Mercaptamine (Procysbi®) was also not accepted for use in patients with nephropathic cystinosis, a rare inherited condition that can affect the kidneys.
SMC Chair, Dr Scott Muir, said: “We are very pleased to be able to accept six new medicines for use by NHSScotland for a range of serious and disabling conditions.
“The early data for selpercatinib in a form of lung cancer is very promising. There will be a further review of updated evidence to ensure that this treatment offers what is expected in terms of clinical outcomes and good value for patients in NHSScotland.
“Tafamadis is the first treatment to be licensed for transthyretin amyloidosis cardiomyopathy. The company presented data that suggested there would be improvements in mortality and fewer hospitalisations for patients with this terrible condition.
“From the evidence given by patients and clinicians, we know that advanced biliary tract cancer has a very poor prognosis. Adding durvalumab to current treatment may increase survival for some patients, so we know this decision will be welcomed.
“The evidence for the medicines we were unable to accept was not strong enough to satisfy the committee. We would welcome resubmissions for them once the companies have had an opportunity to address the key clinical and cost effectiveness uncertainties highlighted.”