Short-term victory for campaigners as Pfizer offers drug free-of-charge to the NHS in the interim, while NICE appraisal process continues.
New breast cancer drug palbociclib is set to be available to NHS patients across the UK in the short term, with manufacturer Pfizer offering the drug free-of-charge to the NHS while NICE’s appraisal of the treatment in England continues.
Palbociclib (Ibrance, Pfizer) is licensed as a first-line treatment for hormone receptor (HR) positive, HER2 negative locally advanced or metastatic breast cancer. It is the first of a new class of drugs that work by inhibiting two crucial cell division proteins called CDK4 and CDK6.
Clinical trials suggest that palbociclib 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Following NICE’s provisional rejection of palbociclib in draft guidance in February 2017, campaigners – alongside leading charity Breast Cancer Now – called on Pfizer and NICE to explore every possible solution to ensure the drug is made available to NHS patients.
With NICE’s appraisal of this drug paused to enable the company to present further clinical data, palbociclib will now – in the interim – be available to eligible patients for the full duration of their treatment, via the ‘Ibrance Patient Programme’.
The programme is expected to be open for a maximum of five months – closing six weeks after NICE issue final guidance on the drug, or on the 30th September 2017, whichever is earlier – with access being dependent on individual NHS Trusts signing up to the scheme.
It is estimated that around 6,000 patients across the UK would be eligible for palbociclib over a 12-month period.
Fiona Hazell, Director of Policy and Engagement at Breast Cancer Now, said:
“This is an unexpected lifeline for thousands of women living with this type of breast cancer. We are delighted that Pfizer have listened to our campaigners and have found a way to enable patients to access this first-in-class drug in the short term.
“While only an interim measure, more than sixteen women every day could have their lives changed by this drug during this window. Palbociclib can offer a large proportion of patients with incurable metastatic breast cancer significant extra time before their disease progresses – time that can be truly invaluable to them and their loved ones.
“We want all women who could benefit from this hugely promising drug to know that it should be available on the NHS – and we’d encourage any patients who think they may be eligible to speak to their doctors. Crucially, we also urge Pfizer and all NHS Trusts and Health Boards to ensure agreements are put in place as soon as possible to deliver this programme and maximise the potential of this opportunity.
“However, D-Day for palbociclib is still to come and this temporary fix cannot hide the desperate need for Pfizer, NICE and the SMC to do everything they can to ensure this drug is made routinely available on the NHS beyond the timeline of this scheme.
“Ultimately, NICE’s provisional rejection of palbociclib two months ago demonstrated once more that the appraisal system is not fit-for-purpose in assessing first-in-class breast cancer drugs. Unless the flaws in the system are fixed, patients in England will struggle to access the best new breast cancer medicines, and both the taxpayer and NHS patients will miss out on the deals making these drugs available in other countries.”
Palbociclib will be offered free (via the programme) to all nations of the UK, with availability being subject to agreements being reached with the relevant local or national health bodies.
While Wales and Northern Ireland usually follow the recommendations made by NICE, it is currently unclear when Pfizer will make an application to the Scottish Medicines Consortium (SMC) for the drug to be considered for NHS use in Scotland.
On the future availability of palbociclib in Scotland, Fiona Hazell added:
“We are now calling on Pfizer to keep palbociclib free for patients in Scotland until the Scottish Medicines Consortium (SMC) has had an opportunity to consider it for routine NHS use.”
Vikki Orvice (54), 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 good news that other women could now receive this ground-breaking drug in the interim.
“I was fortunate enough to benefit from palbociclib on a clinical trial. 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, and to lead a relatively normal life.
“I truly believe that all eligible patients deserve access to it too. 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.”
With the programme having been launched on Tuesday 18 April 2017, the availability of palbociclib is currently being communicated to healthcare professionals and NHS Trusts across the country.
Find out more about in our blog about Pfizer's decision.