Abemaciclib (Vernezios) was accepted for the treatment of advanced or metastatic breast cancer in two different settings. It was accepted for use in combination with a class of medicines known as aromatase inhibitors as an initial therapy in patients who have not had previous endocrine (hormone) based therapy. It was also accepted for restricted use in combination with fulvestrant for patients whose condition has progressed on or after endocrine therapy or during first-line endocrine-based therapy. The use of abemaciclib at this stage of treatment was considered through the 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 advanced breast cancer is incurable. When the condition progresses after initial treatment, this can cause a significant symptom burden on the patient, both physical (pain and fatigue) and psychological (anxiety and distress), as well as impacting on the lives of their family and carers. Abemaciclib may prolong the time to disease progression and delay the need for chemotherapy, allowing patients more good quality time with their family.
Pembrolizumab (Keytruda) for advanced melanoma (a form of skin cancer) was also accepted following consideration through PACE, for use after surgery. Patients and clinicians explained that this skin cancer often affects young patients who may have significant family and work commitments. As there is no other active treatment available at this stage of the disease, current management is surveillance through routine monitoring and scans. Pembrolizumab can delay further disease progression and reduce the risk of recurrence.
Also accepted was cariprazine (Reagila) for the second line treatment of schizophrenia in adult patients where the symptoms are diagnosed as being 'predominantly negative.' These include emotional withdrawal and inability to feel pleasure. Existing anti-psychotic medicines can be limited in their effectiveness; cariprazine provides another treatment option for patients with these symptoms.
Doxylamine succinate/pyridoxine hydrochloride (Xonvea) for the treatment of nausea and vomiting of pregnancy was not recommended. The committee was unable to accept doxylamine succinate/pyridoxine hydrochloride because of uncertainties in the company's evidence around the clinical benefits and cost effectiveness of the medicine.
SMC Chairman Dr Alan MacDonald said:
"I am pleased we have been able to accept these new medicines for use by NHSScotland."
"Through the evidence given by patients and clinicians, we know that our decisions on abemaciclib will be welcomed, as this may allow patients to maintain a good quality of life for longer.''
"Our decision on pembrolizumab means there is a treatment for patients currently relying on a 'watch and wait' approach to monitor their melanoma. Having the reassurance of a treatment that may give them more time will support those at this stage of the condition."
"Cariprizine provides a helpful treatment option for those with schizophrenia whose main symptoms include lack of motivation and social withdrawal."
"We were unable accept doxylamine succinate/pyridoxine hydrochloride as there was too much uncertainty in the company's evidence about both its clinical benefits and its cost effectiveness."