June 2021 decisions news release
Advice on five new medicines for use in conditions including advanced gastric cancer and chronic lymphocytic leukaemia has today (Monday 7 June) been published by the Scottish Medicines Consortium.
Trifluridine/tipiracil (Lonsurf) was accepted for the treatment of advanced gastric cancer following consideration through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. In the PACE meeting, patient groups and clinicians highlighted that patients with gastric cancer have a poor prognosis as they are usually diagnosed at a late stage. Limited treatment options are available for the small number of patients that are suitable for treatment, trifluridine/tipiracil may offer a modest survival benefit in the context of a very poor prognosis. As an oral treatment, it provides patients with an option to receive treatment at home which can be valuable near the end of life.
Mogamulizumab (Poteligeo) was accepted for the treatment of advanced mycosis fungoides (MF) and Sezary Syndrome (SS) – two rare cancers of the blood cells that affect mainly the skin. It can be used in patients who have received previous treatment for their condition. PACE participants spoke of how advanced MF and SS can significantly impact on patients’ lives. The conditions cause skin tumours that can ulcerate and weep, leading to severe discomfort and distress, making it difficult to carry out daily tasks. There is also a risk of infection when the skin is broken and irritated, and some patients may suffer from life-threatening sepsis. Treatment options for MF and SS are limited. Mogamulizumab slows the progression of MF and SS and may offer patients better tolerability and symptom control than other treatment options such as chemotherapy.
Also accepted through the PACE process was nintedanib (Ofev) for the treatment of chronic fibrosing interstitial lung diseases (ILDs), a group of conditions of various causes in which fibrous tissue forms in the lungs that worsens over time. Through PACE, patient groups and clinicians highlighted that ILD is characterised by scarring and hardening of the lung tissue which leads to breathing difficulties. Patients are often reliant on family and carers for support with daily tasks. There is currently no licensed treatment option for this condition. Nintedanib can slow the rate of decline in lung function and may reduce exacerbations of ILD, giving patients extended time when they may be able to work and carry out daily tasks.
Acalabrutinib (Calquence) was accepted for the treatment of certain patients with previously untreated chronic lymphocytic leukaemia (CLL). CLL is an incurable, relapsing blood cancer that tends to affect older adults. Treatment needs to be tailored to individual patients with consideration of any co-morbidities. CLL can lead to substantial fatigue and difficulties carrying out activities of daily living and patients have increased risks of infection as their immune system is compromised. The incurable nature of the condition can be associated with anxiety and the overall reduction in quality of life may lead to mental health issues. Acalabrutinib offers an additional treatment option for this condition. As an oral treatment which can be administered at home it may allow patients to engage more fully in family life.
The committee also accepted baricitinib (Olumiant) for the treatment of moderate to severe atopic dermatitis in patients who have been previously treated. Atopic dermatitis is a chronic inflammatory dry skin condition which causes itchiness, which can be intense, relentless and unbearable. Constant scratching causes the skin to split and bleed, leaving it open to infection. There are limited effective treatment options available for this condition and self-care can be time consuming. Baricitinib can improve the symptoms of atopic dermatitis and allow patients a better quality of life. As an oral treatment it may help patients better manage their care.
SMC Chairman Mark MacGregor said:
“We are pleased to be able to accept these five new medicines for use by NHSScotland.”
“From the evidence given by patients and clinicians in the PACE meeting, we know that trifluridine/tipiracil may allow patients with gastric cancer, their families and carers to have additional time together. We hope our decision on will be welcomed.”
“For patients with MF and SS, our decision on mogamulizumab offers the chance to slow progression of these distressing and uncomfortable conditions with better symptom control.”
“As the first licensed treatment option for non-IPF progressive fibrosing ILDs, nintedanib provides patients with a treatment that can slow the decline in their lung function, allowing them to continue leading their daily lives for longer.”
“For those patients previously untreated for CLL, acalabrutinib offers another treatment option which may enable them to continue to fully take part in family life and routine daily activities.”
“Our decision on baricitinib provides another treatment option for atopic dermatitis which may improve symptoms and provide patients with a better quality of life.”