The authorities have announced that a revolutionary breast cancer drug will be rejected for use on the NHS.
Experts have been hugely critical of the decision regarding palbociclib, suggesting that it is indicative of serious problems at the heart of the drug appraisal system.
Following the announcement, there have been calls for the NHS drugs watchdog to be urgently overhauled in order to prevent a repeat of this unenviable decision.
Palbociclib halts the most common form of breast cancer, preventing malignant tumours from expanding.
This prevents women from having to undergo a draining program of chemotherapy.
Some experts have described the drug as the biggest advancement in the treatment of breast cancer in over two decades.
Yet as it stands, NHS patients will never benefit from the medicine.
Rationing watchdog NICE published a draft decision rejecting the drug due to its £38,350-a-year cost.
NICE documents that the drug will only be considered cost-effective if the price is reduced by 80%.
But Dr David Montgomery, medical director of Pfizer UK’s oncology division, has indicated that this is simply not financially viable.
“We will offer a discount but only to a reasonable price and only if we think it will get us past the NICE threshold. We would like them to take a more pragmatic view,” Montgomery commented.
Trials have demonstrated that taking palbociclib with an aromatase inhibitor prevents the progress of aggressive cancer for over two years; 10 month longer than a standard treatment.
And some patients respond even better to the treatment than this.
Dr Nicholas Turner, of London’s Institute of Cancer Research, who led the clinical trials, believes that the importance of this medicine cannot be overstated.
“Palbociclib is one of the most important advances in treating the most common type of breast cancer in 20 years. It is very disappointing that palbociclib is not being made available to patients, but cost is the limiting factor. If the manufacturer, NICE and NHS England can find a way of making this treatment available for patients, they will substantially improve the lives of patients with breast cancer.”
Organisations with a particular interest in breast cancer have been strongly critical of the decision.
Baroness Delyth Morgan, chief executive of the Breast Cancer Now charity, called for the way that drugs are assessed within the NHS system to be fundamentally changed.
“This is the clearest illustration to date that the drug appraisal system is totally unfit-for-purpose in assessing first-in-class breast cancer medicines. For women with incurable breast cancer in England to potentially be made to wait years for such a promising drug – while NHS bodies and pharmaceutical companies haggle over pricing – would be totally unacceptable. Palbociclib could benefit a large proportion of metastatic breast cancer patients and may even be the closest thing these women would have to a cure in their lifetime.”
Morgan also called on the manufacturer to work with the NHS to broker a solution.
“Pfizer must urgently reconsider their decision not to offer the NHS any form of discount on the list price. But the decision also makes plain the systemic flaws of the NICE appraisal process.”
However, Professor Carole Longson, director of the centre for health technology assessment at NICE, defended the decision to reject palbociclib, while acknowledging that the medicine can have benefits.
“Even when allowing for these potential benefits, it was still not enough to make palbociclib cost effective at its current price. The committee heard from the patient expert that delaying the progression of their cancer for as long as possible and being able to continue with normal activities, including working, is valued very highly by patients and their families. But taking the costs into account, the committee concluded that it could not recommend palbociclib for NHS use at present.”