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29-Aug-2019

Health Service Executive (HSE) ‘yes’ grants efficacious and cost effective combination therapy

BRAFTOVI® (encorafenib) plus MEKTOVI® (binimetinib) to adult patients in Ireland with unresectable or metastatic melanoma with a BRAF V600 mutation 

Reading, United Kingdom – Pierre Fabre has today announced that the HSE has reimbursed the efficacious and cost effective targeted oral combination BRAFTOVI® (encorafenib) plus MEKTOVI® (binimetinib) for use on the Irish health service to treat adult patients with unresectable or metastatic melanoma with a mutation in the BRAF V600 gene. This reimbursement means that eligible patients in the Republic of Ireland can potentially benefit from encorafenib plus binimetinib with immediate effect.

Metastatic melanoma is one of the most serious and life-threatening types of skin cancer, and is responsible for the majority of skin cancer deaths in Ireland. There are over 1,000 cases of melanoma diagnosed on average per year in Ireland, making it one of the most common cancers. Melanoma diagnosed as metastatic disease (stage IV) has a much lower five-year survival (<20%) than earlier, stage III disease (>50%). Between 2011 and 2014, there were on average 159 deaths from melanoma per year in Ireland, giving Ireland the highest mortality rate in Europe. BRAF mutations occur in approximately half of melanoma patients.

BRAFV600-mutant metastatic melanoma patients still face significant challenges managing their disease, and there remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival.

The HSE’s reimbursement is based on data from the pivotal Phase 3 COLUMBUS trial. Results demonstrated that the combination of encorafenib 450 mg daily plus binimetinib 45 mg twice daily improved median progression-free survival (primary endpoint) compared with vemurafenib alone 960mg twice daily (14.9 months versus 7.3 months, respectively: hazard ratio [HR] 0.54, 95% confidence interval [CI], 0.41–0.71; p<0.001). Additionally, treatment with encorafenib in combination with binimetinib achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as monotherapy (HR 0.61, 95% CI, 0.47–0.79; nominal p<0.0001) in the planned OS analysis. All secondary efficacy analyses, including OS, are descriptive in nature.

The discontinuation rate due to suspected treatment-related adverse events (AEs) was shown to be lower with this targeted therapy (6%) compared to vemurafenib (14%). Only 13% of the patients receiving encorafenib in combination with binimetinib stopped treatment as a result of AEs, compared to 17% of the patients treated with vemurafenib.

“This reimbursement is great news for Irish melanoma patients. We are pleased that the HSE has been able to recognise encorafenib in combination with binimetinib as an efficacious and cost-effective therapy so quickly. We are committed to providing patient access in difficult-to-treat cancers,” said Laura McMullin, General Manager UK & Ireland.  

Editor Details

  • Company:
    • Health Service Executive (HSE)
  • Name:
    • Health Service Executive (HSE)
Last Updated: 29-Aug-2019