August 2021 decisions news release

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has today (Monday 9 August) published advice accepting six new medicines.

Avelumab (Bavencio) was accepted for the maintenance treatment of advanced urothelial carcinoma (bladder cancer). The medicine was accepted following consideration through SMC’s Patient and Clinician Engagement (PACE) process. PACE participants highlighted that this is an aggressive form of cancer with very poor overall prognosis. Patients experience considerable pain and discomfort which can be challenging to treat. Avelumab may increase overall survival, delay cancer growth and prevent symptoms for longer. Having an effective treatment with the potential for prolonged survival may help relieve the emotional and psychological burden for patients and their families.

Autologous anti-CD19-transduced CD3+ cells (KTE-X19) (Tecartus) was accepted for interim use subject to ongoing evaluation and future reassessment. It can be used to treat advanced mantle cell lymphoma (a cancer of B cells, a type of white blood cell) when the cancer has come back after two or more previous treatments. This is a type of medicine called CAR-T cell therapy that uses the patient’s own immune cells (T-cells) to destroy the cancer cells. The patient’s T-cells are removed and modified in the laboratory, then injected back into the patient. The CAR-T cells bind to and kill the cancer cells. In the PACE meeting, patient groups and clinicians explained that mantle cell lymphoma is usually an incurable condition that causes disabling symptoms, with recurrent relapses that become increasingly difficult to treat. This treatment may provide the opportunity for a prolonged remission where the patient is able to participate in family and social activities. Further information on interim acceptance can be found on the SMC website.

Also accepted through PACE was nivolumab (Opdivo) for the treatment of advanced oesophageal squamous cell carcinoma (a cancer of the gullet or food pipe) after treatment with chemotherapy. In the PACE meeting, participants spoke of how this is a severe and debilitating condition with short life expectancy. Patients experience difficulty swallowing, vomiting, pain and general deterioration in health, which often progresses very rapidly over just a few months. Symptoms have a major negative impact on the quality of life of patients, their carers and families. Current treatment options are very limited. Nivolumab is the first targeted immunotherapy treatment for these patients and it may provide an overall survival benefit, giving patients valuable additional time with family and friends. Nivolumab causes fewer side effects than chemotherapy.

Avatrombopag (Doptelet) was accepted for the treatment of chronic immune thrombocytopenia in those who have not responded to previous treatment. This is 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. Avatrombopag offers a new oral treatment option that may raise platelet levels for some patients who cannot use or who have not responded to current treatment options.

Guselkumab (Tremfya) was accepted for the treatment of psoriatic arthritis, an inflammatory arthritis associated with the skin condition psoriasis. Psoriatic arthritis usually affects the hands and feet, but other joints and connective tissue can be involved. Symptoms include pain, swollen joints, itchy skin and fatigue and the condition can also cause dexterity and mobility issues. Guselkumab offers another treatment option for patients who have not responded to previous therapies.

The committee also accepted inclisiran (Leqvio) to lower cholesterol levels in patients at high cardiovascular risk in whom standard drug therapy has not lowered cholesterol levels adequately. Inclisiran is administered by six monthly injections and may provide a convenient option for some patients to manage their condition.

SMC chairman Mark MacGregor said:

“The committee is pleased to be able to accept these six new medicines for use by NHSScotland.”

“Through our PACE meeting for avelumab (Bavencio), we heard about the devastating impact that advanced urothelial carcinoma can have on patients, their families and carers. We hope this new therapy may allow patients to enjoy additional quality time with friends and family.”

“Our decision to accept autologous anti-CD19-transduced CD3+ cells (Tecartus) on an interim basis means that those with mantle cell lymphoma will be able to access treatment while further data are gathered on the benefits of this medicine.”

“As the first targeted immunotherapy for advanced oesophageal squamous cell carcinoma, nivolumab offers patients the potential for improved overall survival, which will be valuable to both them and their families.”

“For those with chronic immune thrombocytopenia, our decision on avatrombopag provides another treatment option if they have not responded to current treatments.”

“For patients with psoriatic arthritis, guselkumab offers another treatment option to help control this long term condition.”

“The committee’s decision on inclisiran provides another treatment option for some patients with high cholesterol, which may allow them to better manage their condition.”

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