The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Bayer’s darolutamide (Nubeqa) for adults with metastatic hormone-sensitive prostate cancer (mHSPC). Announced on 24 October 2025, the decision represents a key regulatory milestone in the U.K.’s health technology assessment (HTA) framework, opening NHS access to a life-extending therapy through an accelerated cost-comparison process.
Up to 6,000 patients in England are expected to benefit from the new treatment option. For NICE, the approval demonstrates its commitment to speed, evidence, and affordability in evaluating high-impact cancer therapies.
NICE’s Commitment to Patient Access
Darolutamide, developed by Bayer, will be used alongside androgen deprivation therapy (ADT), the standard hormone treatment for advanced prostate cancer. By blocking testosterone, darolutamide prevents cancer cells from receiving the hormones they need to grow and spread. Clinical evidence shows that combining it with ADT improves survival compared with ADT alone.
NICE used a cost-comparison approach to streamline its appraisal. Bayer had to show that darolutamide plus ADT offers comparable or lower costs than apalutamide plus ADT, an existing NICE-recommended regimen under guidance TA741.
This allowed the review to conclude five weeks faster than standard timelines. The company also entered a confidential commercial arrangement with NHS England, providing a discount that supports long-term affordability across the NHS.
“We are determined to ensure that effective treatments such as darolutamide, which can help extend the length and quality of people’s lives, are made available fast to the people who need them,” said Helen Knight, Director of Medicines Evaluation at NICE.
The streamlined process reflects NICE’s adaptive methods for oncology reviews, using comparative economic evidence to shorten approval cycles while maintaining HTA rigor.
Clinical Strength Reinforces Regulatory Confidence
Darolutamide is an oral androgen receptor inhibitor taken as two tablets twice daily. It has demonstrated significant overall survival benefit and a favourable safety profile compared to similar therapies such as enzalutamide and apalutamide.
NICE’s appraisal committee confirmed that darolutamide provides equivalent clinical benefit with potentially fewer side effects, particularly due to lower central nervous system toxicity. These findings reinforced NICE’s confidence that the therapy delivers high clinical value at a sustainable cost.
The drug has already gained approval in major markets including the U.S., EU, and Japan, and its inclusion in the NHS formulary now positions the U.K. as one of the first European health systems to make the treatment broadly available under public reimbursement.
The decision is expected to have immediate effect, expanding the treatment options available through the NHS. According to Peter Johnson, National Clinical Director for Cancer at NHS England, “This decision provides another welcome treatment option for patients living with an advanced and aggressive form of prostate cancer. It gives clinicians and patients more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
Each year, approximately 55,000 men in England are diagnosed with prostate cancer, with around 10–15% presenting with metastatic disease. Access to an additional therapy like darolutamide is particularly important for those who may not tolerate chemotherapy or other hormone therapies well.
NICE’s guidance also underscores its role in ensuring rapid and equitable patient access to cost-effective innovation. By applying a cost-comparison framework rather than a full technology appraisal, NICE reduced bureaucratic delay and provided faster clarity for both clinicians and payers.
NICE’s Growing Influence in Market Access
The darolutamide recommendation highlights NICE’s expanding influence as a strategic HTA authority guiding market access decisions in Europe. Pharmaceutical companies increasingly engage with NICE early in the development process, aligning evidence packages with HTA criteria to secure faster reimbursement decisions.
The agency’s value-based approach combining economic analysis, clinical evidence, and managed access agreements has become a reference model for balancing innovation and sustainability. Our analysts see this decision as part of NICE’s wider effort to modernize oncology evaluations and optimize NHS resources.