NHS Scotland's May 2019 Funding Decisions

Theresa Bebbington

May 15, 2019

The Scottish Medicines Consortium (SMC) has this month approved drugs for advanced or metastatic breast cancer, advanced melanoma, and schizophrenia in adults.

Breast Cancer Treatment

Abemaciclib (Vernezios, Eli Lilly) was accepted for the treatment of advanced or metastatic breast cancer in two different settings.

The SMC said it was accepted for use in combination with aromatase inhibitors as an initial therapy in patients who have not had previous endocrine-based therapy.

This medicine was also accepted for restricted use in combination with fulvestrant (Faslodex, Astra Zenica) 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 impact 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.

SMC Chairman Dr Alan MacDonald said: "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."

Advanced Melanoma

Following consideration through PACE, pembrolizumab (Keytruda, Merck Sharpe & Dohme) for advanced melanoma was accepted 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.

Dr MacDonald said: "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."

Schizophrenia

Cariprazine (Reagila, Recordati Pharmaceuticals) was accepted 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.

Commenting on cariprazine, Dr MacDonald said it "provides a helpful treatment option for those with schizophrenia whose main symptoms include lack of motivation and social withdrawal".

Not Approved

The SMC was not able to recommend doxylamine succinate/pyridoxine hydrochloride (Xonvea, Alliance Pharmaceuticals) for the treatment of nausea and vomiting of pregnancy.

There were too many uncertainties in the company's evidence around the clinical benefits and cost effectiveness of the medicine, it said.

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