Scottish Medicines Consortium July 2019 decisions

A medicine used to treat advanced breast cancer has today (Monday 8 July) been accepted by the Scottish Medicines Consortium (SMC) for use in NHSScotland.

Palbociclib (Ibrance), used in combination with another medicine, fulvestrant, was accepted following consideration 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 at this stage breast cancer is incurable and treatment options are limited. Palbociclib can increase the time before the condition progresses, allowing patients valuable additional months in the context of limited overall survival time. Palbociclib can delay the need for chemotherapy with its associated side-effects.

Daratumumab (Darzalex) for the treatment of multiple myeloma was also accepted through PACE. This is a rare incurable cancer of the blood with complications that impact significantly on the quality of life for patients and carers. Participants at the PACE meeting highlighted that multiple myeloma is a relapsing-remitting cancer and new treatments are required. Use of daratumumab, as part of a combination treatment regimen, in patients who have received prior treatment for their condition can prolong the time until the disease progresses, reducing the risk of complications such as bone fractures and renal impairment.

Arsenic trioxide (Trisenox) was accepted for use in combination with another medicine, tretinoin, for the treatment of acute promyelocytic leukaemia (APL), a very rare form of cancer of the white blood cells. APL can cause fatigue, chest pain and bleeding from the lining of the gut or in the brain. Patient group submissions highlighted that current treatment with chemotherapy can have significant side effects and may be difficult for some patients to tolerate. Arsenic trioxide offers an effective alternative to chemotherapy and can improve survival rates.

The committee was unable to accept encorafenib (Braftovi) for the treatment of metastatic melanoma (skin cancer) following consideration through PACE. Encorafenib is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in the 'BRAF' gene. Despite the additional flexibility the PACE process allows the committee in the decision making process, encorafenib was not recommended as the evidence of cost effectiveness compared to treatment options already available was not strong enough.

The committee was also unable to accept darvadstrocel (Alofisel) for the treatment of complex perianal fistulas (an abnormal passage that develops between the end of the bowel and the skin near the anus) in adult patients with Crohn’s disease (an inflammatory condition of the gut). Darvadstrocel is a stem-cell therapy developed to promote healing of the fistula. Despite consideration through PACE, the committee was unable to accept the medicine because of uncertainty in the company’s evidence around its long term benefits.

SMC Chairman Dr Alan MacDonald said:

“I’m pleased we were able to accept three new medicines for use by NHSScotland.”

“We know from our PACE meeting that having additional time to spend with family and friends is important to those with advanced breast cancer, and we hope our decision on palbociclib will be of value to them.”
“Patients with multiple myeloma have to deal with a significant symptom burden in addition to coming to terms with reduced life expectancy. Our decision on daratumumab offers additional time before the disease relapses.”

“For those with acute promyelocytic leukaemia (APL), arsenic trioxide offers a treatment that is easier to tolerate and may help improve survival rates.”

“Although the PACE process gives our committee members additional flexibility in their decision making, they were unable to accept encorafenib (Braftovi) for the treatment of metastatic melanoma as the company’s evidence around its cost effectiveness when compared to other treatment options was not strong enough.”

“We were also unable to accept darvadstrocel for the treatment of complex perianal fistulas following consideration through PACE. This was because of uncertainties in the company’s evidence about the medicine’s long term benefits.”

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