NICE, the healthcare guidance body, has issued final guidance that does not recommend aflibercept (Zaltrap, Sanofi) for treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin containing regimen.

Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of NHS resources even when the patient access scheme submitted by the manufacturer was taken into account.

The Institute received an appeal on its final draft guidance for this appraisal from the manufacturer of aflibercept, Sanofi. The appeal was heard on 23 January 2014 and was dismissed on all points.

Commenting on the final guidance, Sir Andrew Dillon, Chief Executive of NICE, said: “We have already recommended 6 treatments for various stages of colorectal cancer and are disappointed not to be able to add aflibercept as another treatment option for this stage of the disease. However, 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.”

Ends

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Notes to Editors

About the guidance

1. The guidance will be available at http://guidance.nice.org.uk/TA/Wave0/617 from 25 March 2014.

2. Metastatic colorectal cancer is when the primary cancer has spread from the colon or rectum to other parts of the body, such as the liver.

3. Aflibercept is used in combination with irinotecan and fluorouracil based therapy (FOLFIRI).

1. A study submitted by the manufacturer (VELOUR trial) showed that aflibercept extended overall survival by a median of 1.44 months when compared to a placebo.
2. The list price of a vial of 100 mg aflibercept is £295.65, and the list price of a vial of 200 mg aflibercept is £591.30. The cost per patient will vary with dose adjustment and treatment duration. For this appraisal, the manufacturer of aflibercept (Sanofi) had agreed a patient access scheme with the Department of Health that would make aflibercept available with a discount. The size of the discount is commercial in confidence.
3. The Committee therefore concluded that aflibercept did not meet the criteria for an end-of-life therapy as defined by NICE.
4. The manufacturer estimated 4,000 patients in England and Wales would receive second line treatment for metastatic colorectal cancer.
5. When an appeal has been held, regardless of the outcome, NICE always publishes guidance as soon as possible. This means that publication doesn't necessarily take place on the regular NICE publication day, which is the fourth Wednesday of the month.
6. NICE has previously recommended irinotecan, oxaliplatin, capecitabine, tegafur with uracil and cetuximab for the treatment of various stages of colorectal cancer.
7. The Committee therefore concluded that the most plausible ICER was higher than the normally acceptable maximum ICER range of £20,000-30,000 per QALY gained.

The Committee noted that the manufacturer's ICER closest to its preferred assumptions was £44,000 per QALY gained (for age 60), but would increase for the higher age bracket, if the mean value was used from the manufacturer' survey of clinical oncologists after removing the outlier and if an extrapolation function with a less heavy tail had been used. Because the manufacturer's ICERs incorporated a utility value for progressed disease deemed by the Committee to be high, the Committee considered the ICER produced by the ERG using the Committee's preferred assumptions, but which used a utility value for progressed disease of 0.6. The Committee noted that this was approximately £51,000 per QALY gained and would be higher if an extrapolation function with a less heavy tail had been used.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

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