NICE responds to failure of talks to reach price agreement on Enhertu
Talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged.
We are extremely disappointed that talks to reach a price agreement that would have made advanced breast cancer drug Enhertu available to around 1000 women in England and Wales have not been successful.
Dr Samantha Roberts continues, "As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price. We have done all we can to try and achieve that.
“Once again I would like to thank the breast cancer community for their hard work on this issue and I am sorry the outcome was not what we, nor they and the patients they represent, expected.”
We were set to act swiftly on receipt of an agreed new cost-effective price with updated guidance and patient access to the treatment within days.
In the talks both ourselves and NHS England continued to offer as much flexibility as possible, but despite the intervention of Secretary of State for Health Wes Streeting, the companies did not put forward a cost-effective price that would have enabled us to recommend Enhertu as value for money for the taxpayer.
Enhertu remains the only breast cancer treatment we’ve been unable to recommend for 6 years and breaks a line of 21 positive breast cancer recommendations. This includes the positive recommendation in February for talazoparib (Talzenna) for treating HER2 negative locally advanced or metastatic breast cancer.
Talzenna was approved using the same process as the evaluation of Enhertu for advanced HER2-low breast cancer.
A recent report showed the new severity weighting is working as intended and expected.
It has been applied more widely than the end-of-life modifier it replaced.
It has contributed to an increase in positive decisions for cancer medicines and non-cancer medicines.
The proportion of positive decisions where the new additional severity weighting was used is higher (84.4%) than with end of life (82.7%)
We are saying yes to a greater proportion of new cancer treatments.
The proportion of positive cancer recommendations overall is higher (79% compared to 78%) and
The proportion of positive recommendations for advanced cancer treatments is higher (81% compared to 69%)
Our committees can now give greater weight to severe conditions and conditions characterised by a poor quality of life such as hepatitis D and cystic fibrosis – neither would qualify for additional weighting under the narrower end of life criteria.