Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the (a) efficacy of and (b) adequacy of the provision of Clozapine.

Clozapine is licenced by the Medicines and Healthcare products Regulatory Agency (MHRA). Products are licenced by the MHRA where the benefit-risk assessment has been found to be positive in relation to quality, safety, and efficacy. Clozapine is marketed in different strengths and formulations, for the following indications.

Firstly, Clozapine is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for an adequate duration. Secondly, Clozapine is indicated in psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed. Further information is available on the MHRA’s website, which is available at the following link:

https://products.mhra.gov.uk/

The Department is not aware of any supply issues regarding the provision of this medicine. Furthermore, decisions about what medicines to prescribe are made by the doctor or healthcare professional responsible for that part of the patient’s care. Prescribers are accountable for their prescribing decisions.

It is for the responsible clinician to work with their patient and decide on the best course of treatment, with the provision of the most clinically appropriate care for the patient always being the primary consideration. Prescribers must always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed and that they take account of appropriate national guidance on clinical effectiveness, as well as the local commissioning decisions of their respective integrated care boards (ICBs). The National Institute for Health and Care Excellence (NICE) has developed a Quality Standard on psychosis and schizophrenia in adults. NICE quality standards are concise sets of statements designed to drive quality improvements within a particular area of care and cover the NHS, public health, and social care. The Quality Standard recommends that adults with schizophrenia that have not responded adequately to treatment with at least two antipsychotic drugs are offered Clozapine, and provides quality measures to be used by service providers, commissioners, and healthcare professionals to assess the quality of care or service provision.