Patients with breast cancer and mantle cell lymphoma living in England and Wales have been dealt a blow after cost regulators rejected two drugs currently available through the Cancer Drugs Fund for routine NHS use.
The National Institute for Health and Care Excellence has now published draft guidelines advising that certain indications for Novartis' Afinitor (everolimus) and Janssen's Imbruvica (ibrutinib) are not cost effective, meaning that they could be pulled from the CDF.
In the case of Afinitor, the Institute ruled that the drug is effective in delaying growth and spread of breast cancer when used in combination with exemestane, new overall survival data suggest it is less clinically effective previously thought.
"The committee considered that even with the price discount in the revised patient access scheme, everolimus plus exemestane would not be cost effective," noted NICE's chief executive Sir Andrew Dillon.
When looking at Imbruvica for MCL, the independent appraisal committee also recognised that the drug is clinically effective but when compared with current treatment the benefits are unclear.
The price put forward by the company, incorporating a patient access scheme offered a discount, but was still "substantially above the normal range considered cost-effective for use in the NHS," it said, noting that, for all but one of the scenarios presented by Janssen, the incremental cost-effective ratio was above £70,000 per QALY gained.
Janssen said it is disappointed with the decision. Jennifer Lee, Director of Health Economics, Market Access & Reimbursement at Janssen UK, said: "Ibrutinib is the most requested treatment on the CDF for patients with this hard-to-treat cancer," and that the firm "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."
Ibrutinib was recently recommended by the Scottish Medicines Consortium (SMC) in Scotland for relapsed or refractory MCL, and Janssen is aiming to achieve the same outcome in England and Wales.
Consultees, including the company, healthcare professionals and members of the public have until 9 September to comment on the preliminary guidance.