NICE approves Novartis and Pfizer’s rival breast cancer drugs

NICE has announced that it has given the nod to two new treatments for breast cancer with the approval of Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib).

The news marks a rapid turnaround for Novartis drug, with a NICE approval coming only months after its August European Commission Approval, and means that it enters the UK market at the same time as Pfizer’s rival CDK4/6 inhibitor.

The speed of the approval marks the introduction of NICE’s new approval process, which has seen the cancer treatment receive recommendation within 90 days of marketing authorisation.

The approval alongside Pfizer’s treatment could be seen as showing the benefit of speeding up approval of a rival drug, as it forced Pfizer’s hand to reach a deal with the UK body. However, there will not always be a case where there is a competitor waiting in the wings – leaving question marks remaining over the current evaluation process.

Both treatments have the same list price for one cycle of treatment, at £2,950, but Pfizer had previously had Ibrance rejected by NICE on cost-effectiveness grounds back in February of this year.

Pfizer’s treatment still holds an advantage over Kisqali, given that it is eligible for all women with oestrogen receptor positive breast cancer, after it has metastasised – whereas Kisqali will be made available only for women who have gone through menopause.

Both treatments have been found to halt the spread of breast cancer for 10 months; however, as yet there is no long term data on how this improves overall survival, though NICE ruled that it is likely that there would be improvement.

Professor Paul Workman, Chief Executive of the ICR, said:

"It’s great news that this innovative new type of cancer treatment has been approved for use on the NHS. These two new drugs target weaknesses in cancer cells specifically, and so have far fewer side-effects than conventional chemotherapy.

"Using them alongside an aromatase inhibitor gives us just the sort of innovative combination treatment that we need more of, and I’m pleased that the ICR played a part in the development of one of the new drugs, palbociclib.

"It’s frustrating that the approval of palbociclib on the NHS was such a long, drawn-out process, even if on this occasion the manufacturer made the drug available for free in the meantime."

Though the delay that Pfizer faced for approval is of concern, it’s of note that Novartis’ treatment managed to be approved within 90 days – showing that the system does work when companies are willing to negotiate efficiently on price. Both treatments agreed a negotiated reduction on the list price to gain NICE’s approval.

When approached to discover Novartis' perspective on the access for medicines in the UK, Barak Palatchi, General Manager of Novartis Oncology UK & Ireland, was still relatively critical of the current landscape, despite the approval:

"UK patients, particularly those in England, face increasing barriers in accessing the medicines they need. The UK continually lags behind other European countries, with just 17 UK patients receiving a medicine within the first year of availability compared with 100 patients in countries such as France and Germany. The recent changes within NICE, to accelerate funding approval for oncology medicines, are positive steps for patients to access innovative cancer treatments they urgently need. This is an opportunity for the UK to become a country that makes new treatments available to those in need at the time of receiving European license.​"