Scottish Medicines Consortium September 2019 decisions news release

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

Tisagenlecleucel (Kymriah) was accepted for the treatment of adult patients with diffuse B cell lymphoma (a type of blood cancer) who have relapsed or not responded after two previous lines of treatment. Tisagenlecleucel is a new type of medicine called CAR-T cell therapy, which offers a one-time treatment. It uses the patient’s own immune cells (T-cells) to destroy the cancer cells. The patient’s T-cells are collected and modified in the laboratory to recognise and attack the cancer cells. They are then reinfused back into the body. The medicine was considered through SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines to treat end of life and very rare conditions. In the PACE meeting, patient groups and clinicians highlighted that patients at this stage of the condition have very poor prognosis and an average survival time of around six months. Current treatment options are limited and the condition therefore has an emotional impact on both patients and their carers in addition to a significant symptom burden for the patient. Tisagenlecleucel may offer a potentially lifesaving option with the possibility of a long-term response.

Pembrolizumab (Keytruda) for metastatic squamous non-small cell lung cancer (NSCLC) was also accepted following consideration through the PACE process. PACE participants emphasised the devastating nature of this incurable illness, which has a life expectancy of under a year for the majority of patients. Pembrolizumab, when added to current treatment with chemotherapy, may enable patients to remain healthier for longer, offering them and their families more valuable time together in the context of limited overall survival.

Dacomitinib (Vizimpro) was accepted for the treatment of another form of NSCLC. It is used specifically for patients with advanced NSCLC whose cancer cells have a defect in the gene that makes a protein called epidermal-growth-factor receptor (EGFR). Dacomitinib offers these patients another treatment option. The committee was unable to accept osimertinib (Tagrisso) for the treatment of the same form of NSCLC. This was due to uncertainties in the company’s evidence about the benefits of the medicine in relation to its cost.

Dapagliflozin (Forxiga) was accepted for the treatment of Type 1 diabetes in combination with insulin). Patient group submissions highlighted that this form of diabetes can have a significant impact on patients’ daily lives and they may struggle to manage their condition without putting on weight. The addition of dapagliflozin to insulin, may allow some patients to better control their diabetes which would be expected to reduce the chance of long-term complications.

Also accepted was ospemifene (Senshio) for the treatment of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and causing painful sexual intercourse) in post-menopausal women. It is an oral tablet and offers a treatment option for women in whom topical therapies are not suitable.

The committee was unable to accept prolonged-release 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 of cost effectiveness compared to existing preparations was not strong enough.

SMC Chairman Dr Alan MacDonald said:

“The committee is pleased to be able to accept these five new medicines.”

“From the testimonies given by patient groups and clinicians through our PACE process, we know that treatment for diffuse B cell lymphoma at this stage of the condition impacts heavily on both patients and their carers. We hope that our decision on tisagenlecleucel, as a potentially curative medicine, will be welcomed.”

“For those with metastatic NSCLC, pembrolizumab in combination with chemotherapy can give patients the chance of some valuable extra time with their families in the context of this incurable illness.”

“Dacomitinib for the treatment of NSCLC in those with a defect in the EGFR gene offers a valuable additional treatment option. Unfortunately we were unable to accept osimertinib for the same condition as the company’s evidence around the medicine’s cost effectiveness was not strong enough.”

“For those with diabetes Type 1, dapagliflozin, used in combination with insulin, may allow better management of their condition.”

“Ospemifene provides a treatment option for those unable to use current therapies for vulvovaginal atrophy.”

“We were unable to accept prolonged-release melatonin as the evidence around its cost effectiveness was not strong enough when compared to other current preparations.”

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