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Acalabrutinib and venetoclax with or without obinutuzumab for untreated chronic lymphocytic leukaemia

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1 Recommendations

1.1

Acalabrutinib and venetoclax with or without obinutuzumab should not be used for untreated chronic lymphocytic leukaemia (CLL) in adults.

1.2

This recommendation is not intended to affect treatment with acalabrutinib and venetoclax with or without obinutuzumab 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.

What this means in practice

Acalabrutinib and venetoclax with or without obinutuzumab is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether it is value for money in this population.

Why the committee made these recommendations

This appraisal only reviews the evidence for acalabrutinib and venetoclax without obinutuzumab, because the company did not include evidence for venetoclax with obinutuzumab in its analysis. The company also presented evidence for untreated non-high-risk CLL only.

Standard treatment for untreated CLL is:

  • venetoclax plus ibrutinib

  • venetoclax plus obinutuzumab

  • acalabrutinib monotherapy, or

  • zanubrutinib monotherapy.

Acalabrutinib plus venetoclax has not been directly compared in a clinical trial with standard treatments. Indirect treatment comparisons were done with venetoclax plus ibrutinib and venetoclax plus obinutuzumab. But because not all relevant comparators were included, the clinical effectiveness of acalabrutinib plus venetoclax compared to standard treatment in the NHS is uncertain.

There are also uncertainties in the company's economic model, including how subsequent treatments are modelled.

Because of these uncertainties it is not possible to determine the most likely cost-effectiveness estimates for acalabrutinib plus venetoclax. So, acalabrutinib plus venetoclax with or without obinutuzumab should not be used.