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NICE U-turn sees Opdivo backed as adjuvant therapy for skin cancer

But it is only available via the CDF for now


England's cost effectiveness watchdog NICE has recommended BMS' Opdivo  as an adjuvant treatment for skin cancer, reversing its initial decision to reject earlier use of the immunotherapy.

That's great news for BMS, which has fallen far behind its main rival, MSD's Keytruda in the biggest cancer market, non-small cell lung cancer.

The U-turn means Opdivo is now approved as an adjuvant treatment for those with completely resected melanoma with lymph node involvement or metastatic disease. However, this availability will only be available via the Cancer Drugs Fund (CDF), as NICE says the company hasn't supplied any data showing Opdivo can extend overall survival compared to standard of care, which is routine surveillance.

This means the drug will only be available for patients in England for the next two years, after which NICE has to make a final decision as to whether it should be approved for routine use.

While the UK’s cost effectiveness watchdog has highlighted the benefits of Opdivo during the common comparator study in CheckMate238, it said “there is currently no reliable clinical evidence to show that it improves overall survival. This means that the clinical and cost effectiveness of adjuvant nivolumab is uncertain”.

In the meantime, BMS will collect further data from CheckMate238, which has already shown that Opdivo improves recurrence-free survival compared to Yervoy (ipilimumab), as it aims for a routine licence.

NICE has said the drugmaker needs to compare Opdivo with routine surveillance and collect mature overall survival data for this, but the drug has “the potential to be cost effective”.

The appraisal document said: “The committee accepted that the early trial results are promising. Despite the current uncertainty about the clinical and cost effectiveness of nivolumab there is plausible potential for nivolumab to be cost-effective if further data confirms the current efficacy predictions for recurrence-free and overall survival”.

The drug was first given NICE approval for patients with advanced melanoma in 2016, but a shift to earlier treatment should help extend lives, and provide BMS with access to a larger group of patients. BMS estimates that around 1,480 people will be eligible for the treatment in the new setting.

It’s priced at £439 per 4ml vial, or £1,097 per 10ml vial, however BMS has agreed a discount for use on the NHS, but as always this figure remains confidential.

Veronique Walsh, general manager, Bristol-Myers Squibb UK & Ireland, said: “Today’s recommendation represents an important step forward in improving outcomes for melanoma patients by treating them with immunotherapy earlier as the first I-O treatment available in the UK.

“Since approval in the summer, we have provided nivolumab as adjuvant treatment to surgery for any patient whose physician requested it through a controlled programme to ensure patients had access before reimbursement. So we are delighted that more people will have the opportunity to receive treatment on the NHS, via the CDF.”

Article by
Gemma Jones

30th November 2018

From: Regulatory



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