- NICE did not recommend the drug combination of abemaciclib and fulvestrant
- Known commercially as Verzenzio it is made by US firm Eli Lilly
- NICE said it normally costs £2,950 for a packet of 56 150mg tablets
- Despite a discount for the NHS, NICE said this figure is not cost-effectiveA decision by health officials to reject a breast cancer drug which extends the life of women with an incurable form of breast cancer has been called a 'devastating blow' for thousands of women.
The National Institute for Health and Care Excellence (NICE) decided not to recommend the drug combination of abemaciclib and fulvestrant, known as Verzenios, for routine use on the NHS in England.
It cites a lack of cost-effectiveness because the treatment of the almost £3,000 a month per patient price tag.
Use of the drug in people with a rare and incurable form of breast cancer has previously been found to delay the need for chemotherapy and gives an extra nine months of life.
It has been available since 2019 via the Cancer Drugs Fund (CDF) which provides access to experimental treatment and has so far been given to 876 women.
Breast Cancer Now charity believes NICE's non-recommendation will see thousands of women in the future be left without access to the drug.
Breast cancer has become the most commonly diagnosed cancer type in the world, the World Health Organisation revealed earlier this week.
Abemaciclib with fulvestrant (Verzenios) is used to treat patients with hormone receptor positive HER2 negative secondary breast cancer after prior endocrine (hormone) therapy.
Taken as a twice-daily pill, Verzenios is part of a class of drugs called CDK4/6 inhibitors, which block cancer cell proteins.
This prevents the cells from dividing and growing, delaying the progression of the disease.
NICE said if this recommendation stays the same following public consultation, the treatment will be removed from the CDF.
Should this happen, patients already taking the drug will continue to get it but new patients will not be given it.
Charity Breast Cancer Now said it is 'deeply concerning' that patients could be denied the chance of benefiting from the treatment.
Data suggests people taking the combination of abemaciclib and fulvestrant have longer before their disease worsens and live longer than people with the alternative treatment, a combination of exemestane and everolimus.
For patients who have received prior hormone therapy, a major trial (MONARCH 2) found that giving abemaciclib in combination with fulvestrant extends the time before a patient’s condition progresses by 7.6 months on average.
Data also demonstrated that the treatment combination improved overall survival, providing an additional 9.4 months on average.
But NICE criticised the data collection and said there is significant uncertainty around how well the drug will work in clinical practice
They add that it is unclear how long people would have treatment for, and therefore how much the treatments would cost.
Because of these uncertainties the cost-effectiveness estimates vary, and the most likely estimates are higher than NICE considers a cost-effective use of NHS money.
NICE said it normally costs £2,950 for a packet of 56 150mg tablets, but Eli Lilly, the drug manufacturer, has purportedly agreed a confidential NHS discount.
Baroness Delyth Morgan, chief executive at Breast Cancer Now, said: 'Today's news that NICE has been provisionally unable to approve abemaciclib with fulvestrant for routine use on the NHS following its time on the Cancer Drugs Fund is a devastating blow for thousands of women with incurable secondary breast cancer who could benefit from this innovative treatment in future.
'Crucially, the side effects of this combination treatment differ to those of other CDK4/6 inhibitors, and may be more tolerable for some women, so it's vital new patients have this treatment option available to them, to help improve their quality of life during the treasured extra months the treatment can give them.
'The treatment can also help delay patients needing chemotherapy and enduring its associated side effects such as hair loss and cognitive impairment.
'Abemaciclib with fulvestrant is an example of continued advances in treatment and care for secondary breast cancer and it's deeply concerning that new patients could be denied the chance to benefit from this progress.
'Whilst treatment will continue for women currently receiving it, Nice, NHS England and Lilly UK must work swiftly together to explore all possible solutions to see this provisional decision reversed, including considering additional discounts.
'Unless this happens, patients in the future will pay the price of being denied the precious chance this treatment brings to live well for longer.'
Eli Lilly told MailOnline: 'Lilly is disappointed that NICE has not yet recommended the continued use of abemaciclib in combination with fulvestrant for women with metastatic breast cancer, as it moves out of the Cancer Drugs Fund into routine commissioning.
'Lilly believes this is an important treatment option that has helped many patients and we will continue to work closely with NICE during the Appraisal Consultation Document (ACD) consultation period. We hope a positive recommendation can be made at the end of this time.'