May 2021 decisions news release

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHSScotland, has announced today (Monday 10 May) that it has accepted four new medicines for routine use.

Encorafenib (Braftovi) was accepted for use in combination with the medicine cetuximab for the treatment of colorectal cancer (cancer of the large bowel or rectum) in patients with a gene mutation called 'BRAF V600'. It can be used when the cancer has spread elsewhere in the body and has previously been treated with other medicines. Encorafenib was accepted following consideration through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. Colorectal cancer is a life-limiting disease which can affect multiple organs of the body. PACE participants spoke of the significant impact the condition can have on patients, their families and carers, with patients often requiring multiple hospital admissions during the course of their illness. Encorafenib taken with cetuximab may improve overall survival, delaying disease progression and allowing patients to maintain quality of life. As an oral treatment, it has benefits over some chemotherapy options.

Ravulizumab (Ultomiris) was accepted for the treatment of atypical haemolytic uremic syndrome (aHUS), a rare, life threatening disease that causes abnormal blood clotting in small blood vessels and the breakdown of red blood cells resulting in kidney failure. The condition can also affect the heart, lungs, brain and digestive system. In the PACE meeting, patient groups and clinicians highlighted that aHUS can have a substantial impact on patients’ day-to-day activities, often requiring them to severely restrict their diet and fluid intake. Current treatment options are administered by intravenous infusion every two weeks, placing a burden on the patient and their family or carers and limiting options for work and travel. Ravulizumab is given every eight weeks, reducing the frequency of healthcare visits and relieving some of the psychological burden of living with the condition for patients and their families.

Also accepted through the PACE process was chlormethine hydrochloride (Ledaga), a medicine used to treat mycosis fungoides-type cutaneous T-cell lymphoma. This is a rare type of lymphoma (cancer of the white blood cells) that mainly affects the skin. In the PACE meeting, patient groups and clinicians emphasised how diagnosis of this cancer, which is often delayed, can have a substantial physical, functional, psychological and social impact on patients and carers. They have to cope with the diagnosis of a chronic and relapsing cancer that in most cases is incurable, with very few available treatment options. Patients may experience symptoms including itching, pain and fever. The visible aspect of the condition (eruptions of the skin) can result in embarrassment and social withdrawal. Chlormethine gel is an alternative to phototherapy which requires frequent hospital attendance.

The committee was also able to accept niraparib (Zejula) for the treatment of advanced ovarian cancer. Patient group submissions highlighted that ovarian cancer has a significant impact on quality of life, with the majority of women being diagnosed at a late stage. This means treatment is aimed at minimising the burden of the disease and maximising periods of wellness between treatments. Chemotherapy options for ovarian cancer have a significant impact on both health and daily living, requiring regular hospital attendance and leaving patients with potentially long-term side-effects. As an oral medication, niraparib offers patients greater flexibility in their treatment with potentially fewer side effects and may extend progression free survival, allowing more quality time with family and friends.

SMC Chairman Mark MacGregor said:

“We are pleased to be able to accept these medicines for use by NHSScotland.”

“For patients with colorectal cancer with the 'BRAF V600' cell mutation, our decision on encorafenib will delay disease progression in some patients, enabling them to enjoy valuable time with family and friends.”

“From the evidence given by patients and clinicians in the PACE meeting, we know that our decision on ravulizumab will help reduce the treatment burden for those with aHUS, which may in turn improve quality of life for both patients and their families.”

“Our decision on chlormethine hydrochloride offers an effective alternative to other current treatments for patients with mycosis fungoides-type cutaneous T-cell lymphoma.”

“For patients with advanced ovarian cancer, niraparib may allow a longer time without disease progression, and potentially with good quality of life.”

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