Guidance
Evidence-based recommendations on crizanlizumab for preventing sickle cell crises in people aged 16 or over with sickle cell disease.
Commercial arrangement
There is a managed access agreement, which includes a commercial access agreement for crizanlizumab. Contact ukonc.comfin@novartis.com for details.
NICE is aware that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended revoking the conditional marketing authorisation for crizanlizumab after reviewing preliminary results from the ongoing global phase 3 STAND trial. These showed no statistically significant difference between crizanlizumab and placebo in annualised rates of sickle cell crises leading to a healthcare visit over the first year.
The preliminary results do not suggest new safety concerns with crizanlizumab, but showed a higher rate of severe and serious treatment-related side effects for crizanlizumab compared with placebo. So, the CHMP concluded that its benefits do not outweigh the risks.
The Medicines and Healthcare products Regulatory Agency (MHRA), the regulator of medicines in the UK, will make the decision on whether the licence is also revoked within the UK. The managed access agreement for crizanlizumab will continue unless it is withdrawn from the market, loses its regulatory approval from the MHRA or if the company indicates that updating the NICE guidance would be futile.
NHS England will closely monitor all regulatory reviews and decisions, and communicate any changes in its commissioning policy with providers of crizanlizumab.
Guidance development process
How we develop NICE technology appraisal guidance
Your responsibility
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.