Palbociclib is licensed for treating hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer. Clinical trials suggest that palbociclib with letrozole (an aromatose inhibitor) could substantially improve upon letrozole alone for treatment of this type of breast cancer. Palbociclib with letrozole provides around 10 additional months of progression-free survival compared to letrozole alone.

Palbociclib was not considered under the end of life criteria, despite being an important option for use in treating incurable secondary breast cancer.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“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.

“This must not be the end for this pioneering drug and we now urge Pfizer and NICE to work together to explore every possible solution to ensure it is made available to NHS patients. 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. We now need to see wholescale reform of this system by the Government, including effective renegotiation of the Pharmaceutical Price Regulation Scheme, otherwise major new breast cancer drugs will continue to pass NHS patients by.”