SMC ‘U-turn’ offers lifeline to Scottish skin cancer patients

Opdivo (nivolumab) now recommended to treat Scottish NHS patients with advanced skin cancer.

“Today’s decision will be welcomed by clinicians in Scotland; it means that we can now offer our patients this exciting new medicine. Our understanding of the science of tumour cells continues to advance and has resulted in immunotherapy medicines, such as nivolumab, that are changing the way that we treat advanced skin cancer. Nivolumab has demonstrated its potential to increase survival rates in this devastating disease, which is the ultimate goal of treatment for clinicians, patients and their families,” said Professor Jeff Evans, Director of Institute of Cancer Sciences and Professor of Translational Cancer Research at the University of Glasgow.

Nivolumab has an innovative mode of action that works by harnessing the ability of the immune system to fight advanced (metastatic or unresectable) skin cancer. It has been shown to significantly improve survival in this disease compared to chemotherapy, regardless of whether a patient has received prior treatment or not.

“Until today, we have seen an untenable situation where patients in England and Wales had access to this medicine, while those in Scotland did not,” said Gillian Nuttall, Founder, Melanoma UK. “I am delighted that today’s decision will bring new hope for patients who have been waiting for access to this medicine. I’m pleased that all parties have worked together to come to a solution for patients on this occasion, but to prevent this type of disparity continuing to affect patients in future, it is important that we work towards implementation of a more equitable medicines review process across the UK.”

The decision from the SMC is based on two pivotal Phase III trials (Checkmate -066 and -067). Data from Checkmate -066 have shown significantly more previously-untreated BRAF wild-type patients who received nivolumab were still alive at one year (72.9%), compared with those treated with the chemotherapy dacarbazine (42.1%). Furthermore, in study Checkmate -067 patients with previously untreated advanced melanoma, median progression-free survival was 6.9 months for those treated with nivolumab compared with 2.9 months in those receiving ipilimumab.

Data have also demonstrated that previously-untreated patients who received nivolumab experienced fewer serious (grade 3-4) treatment-related adverse events compared with chemotherapy (13% of patients treated with nivolumab vs. 17% of those treated with chemotherapy.

“Nivolumab is a game-changing medicine and we are delighted that NHS patients in Scotland will now have it available as a treatment option for advanced skin cancer.” said Benjamin Hickey, General Manager, UK and Ireland, BMS. “Today’s decision follows the recent SMC decision to recommend nivolumab for advanced squamous lung cancer, making the SMC the first UK reimbursement authority to recognise the value of nivolumab to patients in different cancer types. We remain committed to bringing Scottish patients rapid access to nivolumab in its additional licensed indications.”