September 2016 decisions news release
The Scottish Medicines Consortium (SMC) has today published advice accepting three new medicines for routine use in NHSScotland.
Trametinib (Mekinist) was accepted for the treatment of advanced melanoma (a skin cancer) following consideration through the Patient and Clinician Engagement process (PACE). Trametinib is used in combination with another cancer medicine, dabrafenib, in patients whose melanoma cells have a specific genetic mutation called BRAF V600. In the PACE meeting, patient groups and clinicians highlighted that melanoma commonly affects a relatively young population who may have significant work and family commitments. Trametinib can offer patients increased survival time and an improved quality of life.
Idarucizumab (Praxbind) was accepted for use to neutralise the effects of another medicine, dabigatran, which is used to treat and prevent blood clots. Idarucizumab is used to reverse the anticlotting effects of dabigatran rapidly in patients who need emergency surgery or experience life-threatening bleeding. No other current treatment is licensed to reverse the effects of dabigatran.
Dasatinib (Sprycel) was accepted for the first line treatment of chronic myeloid leukaemia (CML), a rare type of blood cancer. In the majority of patients, the diagnosis of CML is made in the initial chronic phase of the disease. Dasatinib offers another treatment option for patients at this stage of the disease and, as a once daily oral medication, offers benefits over other currently available treatment options. SMC also accepted dasatinib for the second line treatment of CML, i.e. for use in those patients who have already received another treatment.
Following consideration through the PACE process, the committee was unable to accept carfilzomib (Kyprolis) for the treatment of multiple myeloma, a rare cancer of the white blood cells. The committee was not satisfied that the company’s evidence on the overall survival benefits was strong enough to justify the medicine’s cost to the NHS. The company has indicated its intention to resubmit.
The committee was also unable to recommend iron (III) isomaltoside 1000 5% (Diafer) for the treatment of iron deficiency in patients with chronic kidney disease. The Committee was not satisfied about its cost-effectiveness relative to other similar iron preparations. The company has indicated their intention to resubmit.
Professor Jonathan Fox, chairman of the SMC Committee, said:
“I am pleased we have been able to accept these new medicines for routine use. We know from the evidence given at PACE that trametinib will be welcomed by patient groups, particularly as it can help improve quality of life."
“Idarucizumab, as the first medicine to reverse the effects of the blood clotting medicine dabigatran, will be a help in emergency situations."
“For CML patients, the availability of dasatinib as both a first and second line oral treatment will offer patients and clinicians a wider range of treatment options.”
“The committee was unable to accept carfilzomib for multiple myeloma as the lack of evidence around its overall survival benefits meant it was not considered to be a good use of NHS resources.”