Scotland rejects cancer drugs Opdivo and Perjeta


The Scottish Medicines Consortium (SMC) has rejected Opdivo as a monotherapy for the treatment of advanced melanoma, and Perjeta for treatment of early stage breast cancer.

Three other drugs were given the green light for routine NHS use in Scotland, however. Eisai's Halaven (eribulin) for advanced breast cancer, Novartis' Entresto (sacubitril/valsartan) for chronic heart failure and Astella's Xtandi (enzalutamide) for prostate cancer were all accepted.

Scotland's NHS healthcare cost and clinical effectiveness watchdog says its 'no' decisions on the Bristol-Myers Squibb's Opdivo (nivolumab) and Roche's Perjeta (pertuzumab) is because of uncertainty about their long-term benefits. However it is clear that their high cost is also an issue.

The decision on Bristol-Myers Squibb's Opdivo (nivolumab) is in contrast to the positive ruling from NICE, the equivalent decision-making body for England and Wales.

The ruling is good news for Merck Sharp & Dohme (Merck's European name), which saw its rival PD-1 inhibitor Keytruda (pembrolizumab) approved by the SMC in November. However this approval is only in patients who have not received BMS' Yervoy (ipilimumab), an older immunotherapy which is currently first line standard treatment.

The rejection of Opdivo has been attacked by BMS, which says the decision highlights the inconsistency in medicines assessments across the UK.

Johanna Mercier, General Manager of Bristol-Myers Squibb (BMS) UK & Ireland, said: "Hundreds of advanced melanoma patients in England and Wales will soon be able to receive treatment with nivolumab through the NHS, while the same group of patients in Scotland has now been denied access."

Merck Sharp & Dohme wants to displace BMS' Yervoy as the frontline treatment for advanced melanoma, but BMS believes a Yervoy + Opdivo combination can extend patient lives further. This two drug combination (for use in BRAF V600 wild-type unresectable or metastatic melanoma) was approved in the US in October, but is currently awaiting EU approval.

Such combination treatments will become increasingly common – but will also drive up costs.

This is the case with Roche's Perjeta, also rejected today by the SMC. It is used in combination with Herceptin (trastuzumab) and chemotherapy for the neoadjuvant treatment of patients with HER2+ locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

The SMC says Roche did not did not present a sufficiently robust economic analysis to gain acceptance. The committee said adding Perjeta to existing Herceptin and chemotherapy treatment would add nearly £10,000 per course of treatment.

Roche has also said it was 'extremely disappointed' that the SMC has decided not to fund Perjeta for patients with early-stage breast cancer.

Professor Jonathan Fox, chairman of SMC said:

"I am pleased we were able to accept these new medicines for routine use in NHS Scotland. We know from the powerful inputs we received from patient groups that our advice on medicines for advanced breast cancer, chronic heart failure and prostate cancer will be welcomed.

"Unfortunately, the Committee was not able to recommend pertuzumab for early stage breast cancer in the pre-surgery setting or nivolumab for advanced melanoma.

"Uncertainties in the evidence for both these medicines meant the Committee was concerned they may not represent a good use of NHS resources. We appreciate these decisions will be disappointing for patients and would welcome resubmissions addressing the points raised."

Richard Erwin, General Manager of Roche UK said it would work with the SMC and Scottish government to find a way to allow eligible patients in Scotland access Perjeta and its other innovative medicines.

Both drugs were rejected despite the SMC employing its new Patient and Clinician Engagement (PACE) process, which is designed to give patient groups and clinicians a stronger voice in decision making. These groups were very positive about the clinical benefits of the drugs, but the committee nevertheless rejected the treatments.

Andrew McConaghie

7 March, 2016