Pirtobrutinib can be used as an option to treat relapsed or refractory chronic lymphocytic leukaemia (CLL) in adults who have had a Bruton's tyrosine kinase (BTK) inhibitor, only if:
retreatment with a covalent BTK inhibitor (including after fixed-duration regimens) is not clinically appropriate
the company provides it according to the commercial arrangement.
This recommendation is not intended to affect treatment with pirtobrutinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.
Pirtobrutinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Pirtobrutinib must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that pirtobrutinib provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Standard treatment for relapsed or refractory CLL in adults after a BTK inhibitor is venetoclax alone or venetoclax plus rituximab. Some people may have another covalent BTK inhibitor if they stopped using the first covalent BTK inhibitor either because they completed the fixed course of treatment or because of its side effects. Standard treatment for people who have tried a venetoclax regimen and a covalent BTK inhibitor is idelalisib plus rituximab.
Clinical trial evidence shows that people having pirtobrutinib have longer before their condition gets worse than people having either idelalisib plus rituximab or bendamustine plus rituximab (which is no longer widely used in the NHS). The evidence also suggests that people having pirtobrutinib may live longer than people having these treatments, but this is uncertain. Indirect comparisons suggest that people having pirtobrutinib may have a similar amount of time before their condition gets worse as people having venetoclax alone or venetoclax plus rituximab. There is limited evidence comparing pirtobrutinib with covalent BTK inhibitors in people with CLL that has been previously treated.
When comparing pirtobrutinib with idelalisib plus rituximab, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources.
Assumptions of clinical similarity support cost comparisons against venetoclax alone and venetoclax plus rituximab. These suggest that costs for pirtobrutinib are similar to or lower than costs for venetoclax alone or venetoclax plus rituximab. But there is not enough evidence to support a cost-effectiveness comparison against covalent BTK inhibitors.
So, pirtobrutinib can be used only if retreatment with a covalent BTK inhibitor (including after fixed-duration regimens) is not clinically appropriate.