NICE says Afinitor and Imbruvica “may be removed” from Cancer Drugs Fund

pharmafile | August 18, 2016 | News story | Research and Development, Sales and Marketing Afinitor, Cancer Drugs Fund, Janssen, NICE, Novartis, imbruvica 

NICE has published draft guidance advising the removal of Novartis’s Afinitor (everolimus) and Janssen’s Imbruvica (ibrutinib) from the Cancer Drugs Fund as they are “not cost effective”.

Afinitor was made available on the fund, in combination with exemestane, for the treatment of HER2-negative, hormone-receptor-positive advanced breast cancer. Imbruvica, meanwhile, was indicated for the treatment of mantle cell lymphoma. In their preliminary decision, which they stress is out for consultation, NICE has decided that neither are suitable to be funded on the Cancer Drugs Fund.

In the case of Afinitor, which around 1,500 people would be eligible to receive, NICE decided that the drug is not as efficacious in overall survival as original data suggested and that even with the price discount in the revised patient access scheme, it would not be cost effective.

For Imbruvica, NICE judged that the clinical benefits of the drug compared with current treatment were “unclear”. They also criticised the price put forward by Janssen as “still substantially above the normal range considered cost-effective for NHS use.” Around 360 patients each year would benefit from the aggressive non-Hodgkin’s lymphoma drug.

Sir Andrew Dillon, NICE chief executive, says: “NICE is committed to making sure that the treatments the NHS provides are ones that are both clinically effective and represent good value for money. Although the committee felt that everolimus with exemestane is effective in delaying the growth and spread of breast cancer, they found that the new overall survival data suggested the drug is less clinically effective than it appeared in the data provided for our original guidance.

“In the case of ibrutinib, whilst the committee did recognise the drug’s clinical effectiveness, the price offered by the company was still too high to recommend it as cost-effective for routine use in the NHS or in the CDF.”

Janssen reacted by issuing a statement, saying: “Ibrutinib is the most requested treatment on the Cancer Drugs Fund (CDF) for patients with this hard-to-treat cancer. Janssen remains committed to continuing to work with both NICE and NHS England, to ensure that permanent access to ibrutinib is achieved for patients with relapsed or refractory MCL through a positive NICE recommendation.”

The consultation is open until 9th September. NICE will fully consider all the relevant information at its meeting on 29th November, following which new draft guidance will be issued.

Those currently receiving either of these drugs should continue to receive the drug until they or their NHS clinician consider stopping it.

Sean Murray

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