The National Institute for Health and Care Excellence (NICE) has today announced that major new breast cancer drugs palbociclib (Ibrance, Pfizer) and ribociclib (Kisqali, Novartis) are to be made routinely available to NHS patients in England, in new draft guidance following their technology appraisals.
Palbociclib and ribociclib are both licensed as first-line treatments for post-menopausal patients with hormone receptor (HR) positive, HER2 negative locally advanced or metastatic breast cancer. They form part of a new class of drugs that work by inhibiting two crucial cell division proteins called CDK4 and CDK6 – known as CDK4/6 inhibitors.
Clinical trials suggest that both palbociclib and ribociclib, given with letrozole (an aromatase inhibitor), could substantially improve upon letrozole alone for treatment of this type of breast cancer, offering around 10 additional months of progression-free survival compared to letrozole alone.
Following NICE’s provisional rejection of palbociclib in initial draft guidance in February 2017, campaigners – alongside Breast Cancer Now – called on Pfizer and NICE to explore every possible solution to ensure the drug is made available to NHS patients, with Pfizer making the treatment available for free in the interim while a final decision was made.
It is estimated that around 8,000 patients each year across England will now be eligible for treatment with either palbociclib or ribociclib.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
“This is a life-changing and long-awaited step forward in treatment for many patients with metastatic breast cancer, potentially offering thousands of women the closest thing they would have to a cure in their lifetime.
“Palbociclib and ribociclib represent an exciting new generation of medicines capable of slowing the spread of incurable breast cancer, and their introduction to NHS care in England is fantastic news for patients and their doctors. Around eight thousand women each year can now be given significant extra time before their condition progresses – time that will be truly invaluable to them and their loved ones.
“That NICE has recognised the importance of this progression-free time to patients in approving these drugs is incredibly encouraging and, we hope, a sign of things to come. But the willingness of Pfizer and Novartis to put patients first and price their products responsibly has been critical, and we hope this will very much lead the way for the rest of the industry to follow suit.
“We’re thrilled that major new breast cancer drugs are now beginning to be made available on the NHS. But these advances are often coming at considerable delay, leaving patients in anxious uncertainty. We urgently need to see a more efficient drug system, with effective negotiation happening much earlier in the process and red-tape being cut to ensure NHS patients can benefit from the advances that repurposed off-patent drugs offer.”
Vikki Orvice (55), a sports writer from St Albans, has been living with incurable secondary breast cancer for over 10 years. She received palbociclib as part of a clinical trial for almost two years, finishing in May 2016. Vikki said:
“It is such amazing news that other women in England can now receive this ground-breaking drug on the NHS. I was fortunate enough to benefit from palbociclib on a clinical trial at the Royal Marsden Cancer Hospital. This fantastic drug gave me two years without my cancer progressing, with minimum side-effects. It allowed me to continue working full-time at a national newspaper, even covering the Olympics in Rio last summer, and to lead a relatively normal life.
“I have since been on two other older drugs, but they caused a number of unpleasant side-effects and have failed to control the disease for as long as palbociclib.
“I am thrilled that so many other women will now be given the same chance at a more normal life. Living with metastatic cancer can be challenging enough, and for some patients time really is of the essence – particularly when drugs like this can make such a difference.”