The Scottish Medicines Consortium published advice on eight medicines on 7 September 2026. All eight were accepted:1
- Atidarsagene autotemcel (Libmeldy®) — Accepted for metachromatic leukodystrophy (MLD) in children who are pre-symptomatic or have early symptomatic late-infantile or early-juvenile disease. This is a routine use recommendation following ultra-orphan reassessment. List price approximately £2.8 million per patient.
- Nusinersen (Spinraza®) — Accepted for pre-symptomatic spinal muscular atrophy (SMA) in infants and children identified through newborn screening.
- Lorlatinib (Lorviqua®) — Accepted for first-line treatment of adults with ALK-positive advanced non-small cell lung cancer. Routine use recommendation following interim acceptance review.
- Capivasertib (Truqap®) — Accepted in combination with fulvestrant for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after one or more endocrine-based regimens.
- Elacestrant (Korserdu®) — Accepted for adults with ER-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations following one or two lines of endocrine-based therapy.
- Epcoritamab (Tepkinly®) — Accepted for adults with relapsed or refractory follicular lymphoma after two or more prior lines of therapy.
- Pembrolizumab (Keytruda®) — Accepted in combination with platinum-based chemotherapy and fluorouracil for first-line treatment of adults with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1, for patients suitable for surgical resection.
- Seladelpar (Livdelzi®) — Accepted for treatment of primary biliary cholangitis (PBC) in adults who have an inadequate response to, or cannot tolerate, ursodeoxycholic acid.
Eight high-cost specialist medicines accepted in a single month is an unusually high volume for the SMC.
Blueteq comment: All eight medicines accepted in September would typically require prior-approval forms in a digital HCD governance system. Atidarsagene autotemcel at ~£2.8 million per patient is one of the most expensive medicines ever accepted by the SMC. The breadth of this month’s decisions makes the operational case for a Scotland-wide prior-approval platform stronger than ever.
References
1. SMC decisions September 2026 — media release. Healthcare Improvement Scotland. 7 September 2026. https://www.healthcareimprovementscotland.scot/publications/media-release-smc-decisions-september-2026/
