NICE Draft Guidance Recommends Pirtobrutinib as At-Home Oral Option for CLL Patients After BTK Inhibitor Failure

The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending pirtobrutinib (Jaypirca; Eli Lilly) as a take-at-home oral treatment option for adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have previously received a Bruton’s tyrosine kinase (BTK) inhibitor and for whom further BTK inhibitor therapy is not suitable.

This recommendation applies to patients whose disease has returned after prior treatment and who may benefit from a therapy that can be administered outside the hospital setting. Pirtobrutinib is a non-covalent BTK inhibitor designed to offer a further treatment option at a potentially challenging point in the patient’s care pathway.

The draft guidance, published on 17 April 2026, states that pirtobrutinib can be used as an option to treat relapsed or refractory CLL in adults who have had a BTK inhibitor, only if further BTK inhibitor treatment is not suitable. The recommendation is based on the potential of pirtobrutinib to delay disease progression while allowing patients to take the medication at home, reducing the need for frequent hospital visits.

Patient and clinical experts involved in the NICE assessment highlighted that the oral, at-home administration of pirtobrutinib could support greater independence in daily life, particularly for older patients or those with comorbidities such as impaired kidney function who may not tolerate more intensive therapies.

CLL is the most common type of leukaemia in England and typically follows a course marked by cycles of treatment, remission, and relapse. For patients whose cancer has stopped responding to existing BTK inhibitors or who cannot tolerate them, pirtobrutinib represents a potential alternative that may help manage disease progression.

The draft guidance is currently open for consultation, with the consultation period running from 17 April 2026 to 11 May 2026. During this time, stakeholders including patient groups, clinical professionals, and healthcare commissioners are invited to provide feedback on the recommendation.

Eli Lilly, the manufacturer of pirtobrutinib, is listed as the sponsor of the technology appraisal. Several comparator companies, including AbbVie (venetoclax), AstraZeneca (acalabrutinib), BeOne Medicines UK (zanubrutinib), and Janssen-Cilag (ibrutinib), have signed confidentiality agreements and are participating in the appraisal process.

NICE emphasizes that the recommendation aims to ensure clinical benefit is realized, address potential inequalities in access, and support the best use of NHS resources. The final guidance will be published following the conclusion of the consultation period and review of stakeholder input.