1.1 Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if:
they have lymph node-positive disease
the company provides it according to the commercial arrangement.
1.2 This guidance is not intended to affect adjuvant treatment with pertuzumab 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
There is uncertainty about the size of the clinical benefit for pertuzumab in the adjuvant treatment of HER2‑positive early stage breast cancer at high risk of recurrence. Clinical trial evidence measuring invasive disease-free survival suggests that 1.7% fewer people with this type of cancer have invasive disease at 4 years with adjuvant pertuzumab. Evidence from people with lymph node-positive disease (that is, disease that has spread to lymph nodes in the armpit) suggests more benefit in this population, with 3.2% fewer people having invasive disease at 4 years. However, it is not known whether this means that adjuvant pertuzumab increases the overall length of time people live.
Because of the uncertainty in the clinical-effectiveness evidence, the cost-effectiveness estimates are very uncertain. Given this uncertainty, an estimate above £20,000 per quality-adjusted life year (QALY) gained is not considered a cost-effective use of NHS resources. The company's final model includes only people with lymph node-positive disease, and incorporates the committee's preferred conservative estimates of how long treatment benefit with pertuzumab lasts after treatment is stopped. If the commercial discount to the price of pertuzumab, together with a weighted discount for biosimilar intravenous trastuzumab are taken into consideration, the cost-effectiveness estimate is comfortably below £20,000 per QALY gained. Therefore, adjuvant pertuzumab is recommended for HER2-positive early stage breast cancer in people with lymph node-positive disease.