The Scottish Medicines Consortium (SMC) has recommended the use of Novartis’ B cell lymphoma drug, Kymriah (tisagenlecleucel) in its latest round of advice.
The organisation decided on four new medicines to be licensed for use by NHSScotland, including MSD’s Keytruda (pembrolizumab), Pfizer’s Visimpro (dacomitinib), AstraZeneca’s Forxiga (dapagliflozin) and Shionogi’s Senshio (ospemifene).
Kymriah, leading the decisions, was accepted for the treatment of the blood cancer for patients who have relapsed or not responded after two previous lines of treatment. The CAR-T cell therapy offers a one-time treatment, using the patient’s own immune cells (T-cells) to destroy the cancer cells.
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.
The decision is great news for eligible patients, as 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.
Also accepted was Keytruda, MSD’ cancer blockbuster. The recommendation was for metastatic squamous non-small cell lung cancer (NSCLC), also through the PACE process.
The consortium said that participants participants emphasised the devastating nature of this incurable illness, which has a life expectancy of under a year for the majority of patients and that when added to current treatment with chemotherapy, the treatment may enable patients to remain healthier for longer, offering them and their families more valuable time together in the context of limited overall survival.
Another cancer drug was approved in the form of Vizimpro, for a different form of NSCLC. The treatment 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).
The committee announced that it was, however, unable to accept AZ’ Tagrisso (osimertinib) for the treatment of the same form of NSCLC, due to uncertainties in the company’s evidence about the benefits of the medicine in relation to its cost.
Forxiga bagged a recommendation, having also just been granted FDA Fast Track in the US. The type I diabetes drug was accepted in combination with insulin, which “may allow some patients to better control their diabetes” to “reduce the chance of long-term complications.”
Finally, Senshio was accepted by the organisation for the treatment of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and causing painful sexual intercourse) in post-menopausal women.
Despite the positive decisions, the SMC also made some rejections such as Slenyto (prolonged-release melatonin) for the treatment of insomnia in children with autism spectrum disorder and/or Smith-Magenis syndrome, which is a rare neurogenetic disorder. Again, the evidence of cost effectiveness compared to existing preparations was not strong enough.
SMC Chairman Dr Alan MacDonald said that the committee is “pleased” to accept the medicines, and that “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.”
He continued, “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.”
Commenting on Forxiga, he said that "used in combination with insulin, it may allow better management of their condition.”
“Ospemifene provides a treatment option for those unable to use current therapies for vulvovaginal atrophy.”
In addition, following an abbreviated submission Dovato (dolutegravir/lamivudine) was also accepted for for the treatment of HIV-1 in certain adults and adolescents 12 or older.
The decisions were released on September 9th.