NICE Initiates Appraisals for Two Cancer Immunotherapies: Sasanlimab-BCG Combination and Cemiplimab Adjuvant Treatment
Key Insights
NICE has selected sasanlimab with BCG for appraisal in high-risk non-muscle-invasive bladder cancer (search) patients with papillary tumours (search) or carcinoma in situ (search) who are untreated with BCG.
Cemiplimab has been chosen for evaluation as adjuvant therapy for high-risk cutaneous squamous cell carcinoma (search) following surgery and radiotherapy.
Both appraisals are anticipated to be of significant importance to patients, healthcare professionals, and commissioners to ensure clinical benefits are realized and NHS resources are optimally utilized.
The National Institute for Health and Care Excellence (NICE) has initiated appraisals for two cancer immunotherapies, marking significant developments in the evaluation of novel treatment options for bladder cancer and cutaneous squamous cell carcinoma patients.
Sasanlimab-BCG Combination for Bladder Cancer
NICE has selected sasanlimab in combination with BCG for appraisal in treating high-risk non-muscle-invasive bladder cancer (search) with papillary tumours (search) or carcinoma in situ (search) in patients untreated with BCG. The appraisal will evaluate the clinical and cost effectiveness of this combination therapy within its marketing authorization.
The decision to proceed with this appraisal reflects NICE's anticipation that the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realized, inequalities in use addressed, and help them make the best use of NHS resources.
The scoping process commenced on November 17, 2025, with consultation on the suggested remit, draft scope and provisional stakeholder list scheduled from November 17 to December 8, 2025. The project is being led by Emily Richards, with the evaluation following NICE's Standard Technology Appraisal (STA) process.
Cemiplimab Adjuvant Therapy for Skin Cancer
NICE has also selected cemiplimab for appraisal as an adjuvant therapy for treating high-risk cutaneous squamous cell carcinoma (search) after surgery and radiotherapy. The evaluation will assess the clinical and cost effectiveness of cemiplimab within its marketing authorization for this indication.
Similar to the sasanlimab appraisal, NICE anticipates this topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realized, inequalities in use addressed, and help them make the best use of NHS resources.
The cemiplimab appraisal is scheduled to begin scoping in January 2026, with consultation on the suggested remit, draft scope and provisional stakeholder list planned for January 22 to February 19, 2026. This evaluation will also follow the STA Standard process under Emily Richards' project leadership.
Regulatory Timeline and Process
Both appraisals represent NICE's commitment to evaluating innovative cancer treatments that could provide significant clinical benefits to patients with limited treatment options. The sasanlimab-BCG combination received its topic selection decision on July 15, 2024, and transitioned to active development status, while cemiplimab's selection was confirmed on October 9, 2025.
The parallel evaluation of these two immunotherapy approaches underscores the growing importance of immune checkpoint inhibitors and combination therapies in cancer treatment, particularly for patients with high-risk disease who may have limited therapeutic alternatives.