Cost regulators for the National Health Service in England and Wales are rejecting the use of Roche's Perjeta to treat certain forms of breast cancer.
The National Institute for Health and Care Excellence has published draft guidelines advising that the drug shouldn't be funded for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory or early-stage breast cancer, because of uncertainty over its long-term benefit.
While there was evidence that adding Perjeta (pertuzumab) to trastuzumab and docetaxel was more successful at getting rid of cancer in the breast and lymph nodes before surgery, the Committee said it was very uncertain about the extent to which this would reduce the risk of the disease recurring and result in longer survival.
"Taking all the uncertainties around the clinical effectiveness of pertuzumab into account, as well as uncertainties with the economic data presented by the company, the committee concluded that it could not recommend the drug for the treatment of HER2-positive breast cancer before surgery as a good use of NHS resources," said Sir Andrew Dillon, NICE chief executive.
But Roche has slammed the decision, noting that it means "over 1,800 women per year in the UK with this aggressive type of breast cancer could be denied access to Perjeta through the NHS in England. If the decision is not overturned, no breast cancer medicines will have been judged cost-effective by NICE in the last seven years".
The provisional recommendation "is a tangible example of the fears expressed by 15 leading cancer charities earlier this week that nothing has been done to update NICE's inflexible assessment methods," the Swiss drug giant noted.
In an open letter to the Prime Minister - published in The Daily Telegraph - the heads of cancer charities warned that plans to leave the appraisal methodology employed by NICE unchanged will soon lead to effective new cancer medicines struggling to gain approval, and called for "a sustainable system, flexible enough to ensure that the best cancer drugs can routinely benefit NHS patients".