SMC accepts 14 new medicines for use by NHS Scotland

Fourteen newly licensed medicines have been accepted for use on NHS Scotland by the Scottish Medicines Consortium (SMC), bringing a raft of new treatment options for conditions including epilepsy, depression and cancer.

Among the decisions, the SMC endorsed NHS use of Alimera Science's Iluvien (fluocinolone acetonide) implant as the first treatment to prevent relapse in non-infectious uveitis affecting the posterior segment (NIU-PS), a recurrent form of uveitis that affects the back of the eye.

The move follows data showing that the drug increases the time patients are free from the recurrence of uveitis (median 657 days recurrence-free for eyes treated with Iluvien compared with 70.5 days for eyes given treated control).

Study data also shows that Iluvien prevents recurrence for up to six months in more than two thirds (72.4%) of eyes and for up to three years in a third (34.5%) of eyes, while patients given the drug also required fewer adjunctive treatments (57.5%) compared to (97.6%) those receiving treated control.

“It is good to have a treatment option that can be directly delivered into the eye which helps keep inflammation down to non-sight threatening levels,” commented Dr Mohan Varikkara, consultant ophthalmologist at University Hospital Ayr.

“It is a long acting implant which could potentially work for three years to prevent relapse and protect patients from further vision loss. The Iluvien implant can also reduce the need for systemic medications, minimising their associated side effects and decreasing the need for regular blood monitoring, thus reducing the burden for patients.”

GW Pharma's cannabidiol Epidyolex was accepted for the treatment of Lennox-Gastaut syndrome, a rare type of epilepsy that presents in early childhood, as well as in combination with clobazam for the treatment of Dravet syndrome, another rare type of epilepsy.

Cannabidiol can reduce the frequency and severity of seizures for some patients, enabling them to have a better quality of life, the agency noted.

“We are delighted with this decision by the SMC,” said national charity Epilepsy Scotland. “Participating in the PACE process it is clear that they have listened to patients and clinicians about the profound impact of these severe and difficult to treat epilepsy syndromes and the long-standing need for a specifically approved treatment option. This recommendation is very welcome news for those affected by Dravet and Lennox Gastaut Syndromes, their families and carers. It means eligible children and adults in Scotland will now be able to access this treatment for free on the NHS alongside the rest of the UK.”

In direct contrast to a rejection by NICE just days ago, Janssen Spravato (esketamine) was accepted by the SMC for treatment-resistant major depression in adults.

The drug is given as a nasal spray in combination with other antidepressants when at least two other treatments have failed, following clinical trial evidence that treatment with Spravato plus standard-of-care led to significant decreases on the Montgomery-Åsberg Depression Rating Scale (MADRS) – a commonly-used tool for the assessment of depressive symptom severity.

“We recognise this outcome results in a discrepancy in access between patients in Scotland and those in the rest of the UK and are currently working closely with NICE in the hope that patients will also be able to access esketamine nasal spray routinely in England, Wales and Northern Ireland,” said Amanda Cunnington, director of Health Economics, Market Access, Reimbursement (HEMAR) & Patient Engagement and Government Affairs, Janssen-Cilag.

The SMC also accepted MSD's Keytruda (pembrolizumab) for the treatment of head and neck squamous cell carcinoma (HNSCC) where the cancer has spread or cannot be removed, and together with axitinib for the treatment of advanced renal cell carcinoma, offering patients new treatment options for two notoriously difficult to treat cancers.

“This is very positive news for Scottish patients with head and neck cancer who previously had only been able to access immunotherapy after chemotherapy had failed. By then many are often too weak to consider further treatment. Patients with HNSCC are faced with a difficult quality of life and the side effects from the current standard of care can be challenging. An additional treatment option which could potentially ease a patient’s journey is a substantial advancement for them,” noted Dr Allan James, neuro-oncologist, Beatson West of Scotland Cancer Centre.

“I’m delighted that this new treatment combination will now be available to kidney cancer patients across Scotland,” added Professor Robert Jones, director, Cancer Research UK Clinical Trials Unit, University of Glasgow. “Despite the emergence of many new treatments in recent years, kidney cancer, in its more advanced forms, remains a lethal disease. This news of additional treatment options being made available for patients with renal cell carcinoma is very welcome in Scotland.”

Also accepted was Astellas' Xosapta (gilteritinb) for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients who have a particular change (mutation) in the gene for a protein called FLT3.

The only option currently available is salvage chemotherapy which is associated with considerable toxicity. The drug is an oral tablet shown to increase overall survival and also possibly the chance of a patient being suitable for a subsequent stem cell transplant which may cure their disease.

In addition to these medicines, SMC has also accepted the following medicines through an expedited approach to minimise delay in patient access following the early phase of the COVID-19 pandemic:

• Roche's Perjeta (pertuzumab) for the adjuvant treatment of early stage breast cancer

• Sanofi's Cablivi (caplacizumab) for a blood clotting disorder known as acquired thrombotic thrombocytopenic purpura (aTTP)

• AstraZeneca's Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia

• Novartis' Beovu (brolucizumab) for the treatment of the ‘wet’ form of age-related macular degeneration (AMD)

The following medicines have been accepted for interim use subject to ongoing evaluation and future reassessment by SMC:

• Portola's Ondexxya (andexanet alfa) to stop life-threatening or uncontrolled bleeding in adults taking certain medicines used to thin the blood

• Roche's Polivy (polatuzumab) to treat a type of lymphoma in patients who are unsuitable for a stem cell transplant

• Chiesi's Holoclar, a stem-cell treatment used to replace damaged cells in the eye after chemical or physical burns