Media release: SMC decisions September 2026

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The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday, September 07) published advice on eight medicines.

Atidarsagene autotemcel (Libmeldy®) was accepted for the treatment of metachromatic leukodystrophy (MLD), a rare genetic condition that causes damage to the nervous system. Atidarsagene autotemcel has been available for use as part of the ultra-orphan pathway, while further evidence on its effectiveness was collected. Following reassessment, it has now been accepted by SMC for routine use.

Nusinersen (Spinraza®) was accepted for the treatment of pre-symptomatic 5q spinal muscular atrophy, a very rare genetic condition that causes muscle wasting.

Lorlatinib (Lorviqua®) was accepted to treat adults with advanced ALK-positive non-small cell lung cancer (NSCLC), a rare type of lung cancer.

Capivasertib (Truqap®) was accepted, used together with fulvestrant, for the treatment of adults with a certain type of advanced breast cancer.

Elacestrant (Korserdu®) was accepted for the treatment of post-menopausal women, and men, with a certain type of advanced breast cancer.

Epcoritamab (Tepkinly®) was accepted for the treatment of patients with follicular lymphoma, who have already received two lines of treatment. Follicular lymphoma is a type of blood cancer.

Pembrolizumab (Keytruda®) was accepted to treat patients with locally advanced head and neck squamous cell carcinoma (HNSCC), that can be removed by surgery.

Seladelpar (Livdelzi®) was accepted for the treatment of adults with primary biliary cholangitis, a rare liver disease.

SMC Chair Dr Rob Peel said:

Ends

Notes to editor

1. The Scottish Medicines Consortium (SMC) is the national source of advice on the clinical and cost-effectiveness of all new medicines for NHSScotland. Our aim is to ensure that people in Scotland have timely access to beneficial new medicines. 

2. We are part of Healthcare Improvement Scotland. Our committee is made up of clinicians, pharmacists, NHS board representatives, the pharmaceutical industry and the public. Most of the clinicians have a direct role in patient care, while our three volunteer public partners ensure the views of the Scottish public are taken into account during decision making. This wide mixture of backgrounds ensures decisions are made from a broad perspective. 

3. Members of the SMC Committee make their decisions based on a broad range of evidence in order to help health professionals deliver the best possible care within the finite resources available. They consider detailed evidence presented by pharmaceutical companies, patient groups and clinicians in order to decide which medicines provide value for money for NHSScotland. 

4. When we talk about value for money or cost effectiveness, this does not just mean how much a medicine costs to buy, but the wider costs and benefits associated with it being regularly used to treat those with a particular condition. The NHS does not have unlimited resources and if we accept a medicine where the benefits are not clear it may mean other patients lose out. 

5. When considering a new medicine we look at: 

• how well the medicine works 

• which patients with the particular condition would benefit from it 

• whether it is as good as or better than the medicines already used to treat the particular condition, and 

• whether it is good value for money. 

For more information on how we make our decisions, go to the SMC website, https://www.scottishmedicines.org.uk/how-we-decide/ 

6. Changes to the way we assess medicines for end of life and rare conditions (https://www.scottishmedicines.org.uk/how-we-decide/pace/) have allowed our committee additional flexibility in decision making. These changes include the option of a Patient and Clinician Engagement (PACE) meeting which gives patient groups and clinicians the opportunity to provide additional evidence to the committee. 

7. A new approach to the assessment of medicines which treat extremely rare conditions has been introduced (https://www.scottishmedicines.org.uk/how-we-decide/ultra-orphan-medicines-for-extremely-rare-conditions/) in line with the Scottish Government announcement in June 2018 on a new pathway (https://news.gov.scot/news/treatments-for-rare-conditions) 

8. SMC can make the following decisions on a medicine: 

• accepted 

• accepted with a restriction(s) (for example, the medicine can only be accepted in a particular group of patients with the condition. This typically occurs because the company has requested this explicitly in the submission) 

• accepted on an interim basis, or 

• not recommended 

SMC can accept some medicines on an interim basis subject to ongoing evaluation and reassessment. You can find out more about this on our website https://www.scottishmedicines.org.uk/how-we-decide/interim-acceptance-decision-option/ 

SMC may be unable to accept a medicine for use in Scotland if the committee is not satisfied that the benefits of the medicine offer value for money for patients and the NHS or where there is a high degree of uncertainty about the clinical benefits of the medicine. You can find out more about the reasons we may not recommend medicines on our website: https://www.scottishmedicines.org.uk/how-we-decide/ 

9. For medicines that have not been recommended, SMC welcomes a resubmission from the company at any time with new clinical and/or economic evidence. 

10. When a medicine has not been recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient. 

11. For further information and to view the complete advice for the medicines detailed above, visit our website at: www.scottishmedicines.org.uk. 

12. For further information on ILAP, please visit the MHRA website https://www.gov.uk/guidance/innovative-licensing-and-access-pathway