Darzalex, Ibrance among latest SMC decisions

by | 9th Jul 2019 | News

The Scottish Medicines Consortium (SMC) has announced its latest round of decisions for NHS Scotland, publishing advice accepting three new medicines.

The Scottish Medicines Consortium (SMC) has announced its latest round of decisions for NHS Scotland, publishing advice accepting three new medicines.

Leading the pack is Janssen’s Darzalex (daratumumab), which was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process for the treatment of multiple myeloma. The drug is a monoclonal antibody and was approved by the US Food and Drug Administration (FDA) just last month.

Participants at the PACE meeting highlighted that multiple myeloma is a relapsing-remitting cancer and that new treatments are required. Use of Darzalex, 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.

Pfizer’s Ibrance (palbociclib), a medicine for end of life and very rare conditions, was also accepted by PACE when in combination with Faslodex (fulvestrant). The combination can increase the time before the condition progresses, allowing patients valuable additional months in the context of limited overall survival time and can delay the need for chemotherapy with its associated side-effects.

The third medicine accepted was Trisenox (arsenic trioxide), when used in combination with Retin-A (tretinoin) for the treatment of acute promyelocytic leukaemia (APL), a very rare form of cancer of the white blood cells.

Patient group submissions highlighted that current treatment with chemotherapy can have significant side effects and may be difficult for some patients to tolerate, so Trisenox offers an effective alternative to chemotherapy and can improve survival rates.

The committee was, however, unable to accept two more medicines; Pierre Fabre’s Braftovi (encorafenib) and Takeda drug Alofisel (darvadstrocel), for the treatment of metastatic melanoma and complex perianal fistulas respectively.

SMC chairman Dr Alan MacDonald said that he was “Pleased we were able to accept three new medicines for use by NHSScotland.”

He continued, “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.”

The decisions were published on Monday 8th July.

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