January 2022 decisions news release
Advice on four new medicines for use in conditions including advanced breast cancer and non-small cell lung cancer has today (Monday 17 January) been published by the Scottish Medicines Consortium (SMC).
Trastuzumab deruxtecan (Enhertu) was accepted for the treatment of patients with advanced HER2-positive breast cancer, subject to ongoing evaluation and future reassessment once further information is available. Trastuzumab deruxtecan is used to treat patients who have already received two or more HER2-targeted treatments for their advanced cancer. The clinical evidence in the company submission was based on a single-arm clinical trial, which means there is no comparison with placebo or another treatment, leading to uncertainty in the evidence for decision making. The medicine was considered 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, participants highlighted that this aggressive form of breast cancer is life limiting, causing severe symptoms such as fatigue, bone pain and breathlessness. Trastuzumab deruxtecan offers the potential to control the disease and its symptoms, and may slow disease progression which could lead to longer overall survival. The committee accepted trastuzumab deruxtecan on an interim basis subject to ongoing evaluation and will consider further evidence on its effectiveness once this is available. Further information on the interim acceptance process is available on our website.
Tucatinib (Tukysa) was also accepted through PACE for the treatment of adult patients with advanced HER2-positive breast cancer. It is used in combination with other medicines to treat patients who have already received two or more HER2-targeted treatments for their advanced cancer. Tucatinib is expected to allow patients more time before the cancer progresses.
Osimertinib (Tagrisso) was accepted through PACE for the treatment of non-small cell lung cancer (NSCLC) in patients whose cancer cells have changes (mutations) in a gene responsible for making a protein called EGFR. Cancer cells with this kind of mutation are described as EGFR positive and around 10% of patients with NSCLC have these cancer cells. Osimertinib is used for the initial treatment of these patients where the cancer is advanced (has spread to tissues near the lung or to other parts of the body). Through PACE, the committee heard that this form of lung cancer is incurable, debilitating and life limiting, often impacting on a patient’s ability to self-care and live independently. Osimertinib provides a treatment option that could increase survival and may have fewer side effects.
Tralokinumab (Adtralza) was also accepted for the treatment of moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry). It is used in patients for whom treatment applied directly to the skin cannot be used or is not effective enough. Moderate to severe atopic dermatitis causes intense itching and makes the skin dry, sore and painful. There are usually flare-ups where the symptoms get worse, followed by periods of improved symptoms. Tralokinumab provides another treatment option that may be more effective or cause fewer side effects for some patients.
The committee was unable to accept nivolumab (Opdivo), when used with another medicine, ipilimumab, and chemotherapy, for the treatment of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Nivolumab was not recommended as the company’s evidence was not strong enough to satisfy the committee that it offers value for money to NHSScotland when compared to the current treatment option.
SMC chairman Mark MacGregor said:
“The committee is pleased to be able to accept these four medicines for use by NHSScotland.”
“From the PACE meetings, we heard of the heavy symptom burden for patients living with HER2-positive breast cancer. Trastuzumab deruxtecan may be a useful additional treatment but as the evidence considered was limited, the committee decided to accept its use subject to reassessment once further evidence is available. Trastuzumab deruxtecan and tucatinib may provide patients with additional treatment options that have the potential to slow disease progression and control the symptoms of this aggressive form of breast cancer.”
“Participants in our PACE meeting told us of the devastating impact non-small cell lung cancer has on patients and their families. We hope that our decision on osimertinib may help patients live more normal daily lives.”
“Tralokinumab provides another treatment option for atopic dermatitis which may improve symptoms and provide patients with a better quality of life.”
“We were unable to accept nivolumab as the evidence provided by the company was not strong enough to satisfy the committee of its cost effectiveness.”