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NICE refuses to back Zaltrap as Sanofi exhausts its options

Patient access scheme and appeal fail to overcome cost concerns

Sanofi Zaltrap aflibercept

Sanofi's new colorectal cancer drug Zaltrap (aflibercept) has failed to win NICE's backing, despite the Institute considering it a clinically effective treatment.

In its final guidance NICE does not recommend Zaltrap as a treatment for metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin containing regimen.

It's the last stage in a process that saw Sanofi first offer to reduce the price of its drug through a patient access scheme and then unsuccessfully appeal NICE's final draft guidance.

Nevertheless, the drug's cost remained a sticking point for NICE, which said it did not represent an effective use of NHS resources.

Sir Andrew Dillon, NICE's chief executive, said: “We have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them. Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of NHS funds.”

Although the cost of using Zaltrap to treat patients with colorectal cancer varies due to dose adjustment and treatment duration, NICE's advisory committee concluded the most plausible ICER was higher than the normally acceptable maximum range of £20,000–30,000 per QALY gained.

The advisors also took into consideration Sanofi's VELOUR trial, which showed Zaltrap extended overall survival by a median of 1.44 months compared to a placebo.

NICE's decision comes just two weeks after its Scottish counterpart the SMC reversed its original decision and backed Zaltrap's use in the same indication on the back of the same evidence.

Steve Oldfield, Sanofi's managing director for the UK and Ireland, said:

We are extremely disappointed NICE has not approved aflibercept, particularly given that based on the same basic evidence, the Scottish Medicines Consortium accepted aflibercept. Sanofi wanted NICE to be able to approve aflibercept for patients in England and Wales and offered a patient access scheme as part of the appraisal. ”

Zaltrap was approved in Europe in February last year and included in the Cancer Drugs Fund in May.

Since then Sanofi said there has been “significant clinical demand” for its drug, pointing to 321 requests for its use through the Fund, an access mechanism that is due to end in 2016.

Oldfield added: “The lack of a long-term solution for access to innovative cancer medicines is seriously undermining the UK's ability to maintain its status as a world leader in innovative medical technology.

“More importantly, it risks cancer patients in England and Wales being unable to access effective new medicines. NICE issued no positive final guidance for cancer medicines in 2013 - it's clear that something needs to change.”

Article by
Dominic Tyer

25th March 2014

From: Sales



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