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    • Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Talazoparib is not recommended, within its marketing authorisation, for treating HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had:

  • an anthracycline or a taxane, or both, unless these treatments are not suitable, and

  • endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable.

1.2 This recommendation is not intended to affect treatment with talazoparib 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 clinician consider it appropriate to stop.

Why the committee made these recommendations

For most people with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA mutations, talazoparib, if recommended, would be used instead of chemotherapy.

Evidence from a clinical trial shows that talazoparib increases how long people live without their cancer getting worse compared with chemotherapy. But, the trial does not show any difference in how long people live.

When considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates for talazoparib are above what NICE considers an acceptable use of NHS resources. So, talazoparib is not recommended. The committee requests further analyses.