Media release: SMC decisions October 2026

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The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday, October 12) published advice on eight medicines.

Mirvetuximab soravtansine (Elahere®) was accepted for treating adults with a certain type of advanced ovarian cancer, where the patient has already received previous treatments.

Vutrisiran (Amvuttra®) was accepted for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM). This is a rare condition where abnormal proteins called amyloid build up in tissues around the heart.

Obinutuzumab (Gazyvaro®) was accepted for the treatment of adults with lupus nephritis. In lupus nephritis the immune system attacks the kidneys causing inflammation and damage.

Standardised allergen extract of pollen from white birch (Itulazax®) was accepted to treat adults with moderate to severe allergy symptoms due to pollen from birch trees and related species.

Atogepant (Aquipta®) was accepted to treat migraine symptoms in adults.

Deuruxolitinib (Leqselvi®) was accepted to treat severe alopecia areata in adults.

Palopegteriparatide (Yorvipath®) was not recommended for the treatment of adults with chronic hypoparathyroidism. Hypoparathyroidism is a rare condition where the parathyroid glands in the neck do not work properly, leading to low blood calcium levels and problems with bones, muscles and nerves.

Inavolisib (Itovebi®) was not recommended for the treatment of adults with a certain type of advanced breast cancer.

SMC Chair Dr Rob Peel said: “The committee is pleased to be able to accept these new medicines for use by NHSScotland.

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“Mirvetuximab offers an effective targeted treatment for this group of patients with advanced ovarian cancer who have limited treatment options.

“Vutrisiran offers another treatment option for patients with ATTR-CM, that is administered in a different way from the currently available option and may suit some patients better.

“Obinutuzumab offers an effective treatment option for lupus nephritis which may help more patients achieve remission from their condition.

“Itulazax® is the first targeted treatment specifically for people suffering severe allergy symptoms due to pollen from birch trees and may help patients whose symptoms have not responded to currently available treatments.

“The committee was unable to accept palopegteriparatide for the treatment of hypoparathyroidism. The company’s evidence around the cost effectiveness of the treatment was not sufficient.

“The committee was also unable to accept inavolisib for the treatment of a type of advanced breast cancer. The company’s evidence around the cost effectiveness of the treatment, compared with other options, was not sufficient.

“For the medicines we were unable to accept, we would welcome resubmissions from the companies addressing the issues we have raised.”

Dr Rob Peel
SMC Chair

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/

  1. 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.
  2. 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)
  3. 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/

  1. For medicines that have not been recommended, SMC welcomes a resubmission from the company at any time with new clinical and/or economic evidence.
  2. 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.
  3. For further information and to view the complete advice for the medicines detailed above, visit our website at: www.scottishmedicines.org.uk.
  4. For further information on ILAP, please visit the MHRA website https://www.gov.uk/guidance/innovative-licensing-and-access-pathway