January 2021 decisions news release

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday 18 January) published advice accepting five new medicines.

Daratumumab (Darzalex) was accepted for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. It is used in combination with other medicines. Daratumumab was considered through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. PACE participants spoke of how multiple myeloma is a rare cancer of the white blood cells that may result in complications including severe bone pain, kidney damage and a depleted immune system with a consequent risk of serious infection. There is currently no cure. Daratumumab may improve disease control, reduce disease-related symptoms and allow patients to feel well for longer. This is important at this early stage of the disease when patients are younger and fitter. For some patients treatment and prolonged periods of remission may mean they are able to progress to a stem cell transplant.

Also accepted through PACE was entrectinib (Rozlytrek), for treating adults with a rare advanced non-small-cell lung cancer (NSCLC) that has a genetic abnormality called ROS1 gene fusion. In the PACE meeting, patient groups and clinicians highlighted that patients are often diagnosed at an advanced stage of the disease and have short life expectancy. There are limited treatment options available. As this form of NSCLC tends to affect a younger age group than more common lung cancers, this diagnosis can have a devastating impact on both the patient and their family. Patients who respond to entrectinib may have reduced symptoms with increased quality and duration of life, enabling patients to remain independent for longer. Delaying the time till the condition progresses may delay the need for chemotherapy which is also beneficial.

Fostamatinib (Tavlesse) was accepted for chronic immune thrombocytopenia, a long-term blood disorder in which the immune system destroys healthy platelets in the blood. Platelets are needed to form clots and stop bleeding. Through PACE, patient groups and clinicians emphasised how patients with the condition live with the constant worry of spontaneous or excessive bleeding, and are more hesitant to participate in social and sporting activities or work. Patients also often experience severe fatigue. Fostamatinib offers a new treatment option for some patients who cannot use or who have not responded to current treatment options.

Brentuximab vedotin (Adcetris) was accepted for the treatment of systemic anaplastic large cell lymphoma (sALCL, a cancer of lymphocytes called T-cells), a rare condition with debilitating symptoms including fatigue, weight loss, fever and night sweats. It is used in combination with other cancer medicines in people who have not received previous treatment and can help significantly increase the time until the disease progresses.

The committee also accepted secukinumab (Cosentyx) for the treatment of non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that mainly affects the spine. It is a painful and progressive long-term condition for which there is no cure. Secukinumab may be used in adult patients who have not responded to treatment with non steroidal anti inflammatory drugs (NSAIDs), helping them to continue to working and lead an independent life.

The committee was unable to accept melatonin (Slenyto) for the treatment of insomnia in children with autism spectrum disorder and/or Smith-Magenis syndrome (a rare neurogenetic disorder). Melatonin was not recommended as the evidence provided by the company was not strong enough to satisfy the committee that it offers value for money to NHSScotland.

SMC chairman Mark MacGregor said:

“I am pleased the committee has been able to accept these five medicines for use by NHSScotland.”

“For those with newly diagnosed multiple myeloma, daratumumab offers the opportunity to better control their condition and its symptoms, and for some patients may eventually lead to stem cell transplant.”

“Participants in our PACE meeting for entrecitinib told us of the devastating impact a diagnosis of advanced NSCLC with ROS1 gene fusion can have on patients and their family alike. We know our decision on this medicine will be welcomed by them.”

“Our decision on fostamatinib provides those with chronic immune thrombocytopenia with another treatment option if they have not responded to current treatments.”
“For patients with sALCL, brentuximab vedotin offers the chance of improved progression free survival.”

“Secukinumab gives patients with non-radiographic axial spondyloarthritis an alternative treatment where NSAIDs have not worked.”

“We were unable to accept melatonin as the evidence provided by the company was not strong enough.”

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