On the Strength of a Discount and Biosimilar Trastuzumab Savings, NICE Recommends Pertuzumab

The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node—positive disease and if drug maker Roche adheres to its promised discount for the drug.

NICE’s final appraisal indicates that Roche has offered the National Health Service (NHS) a discount on the drug, which carries a UK list price of £2395 (approximately $3068) per 420-mg vial. That discount, taken together with the cost savings made possible by biosimilar trastuzumab agents that have recently entered the UK market, brings the cost-effectiveness estimate for the therapy per quality-adjusted life-year (QALY) gained to “comfortably below £20,000,” or below approximately $25,627, which is NICE’s typical cost-effectiveness threshold.

The decision is a turn-around from previous appraisals of pertuzumab in early breast cancer; in an appraisal consultation document issued in August 2018, NICE noted that biosimilar trastuzumab would lower the cost of treatment, but said it was concerned that the treatment still might not be cost effective.

The 2018 appraisal said that, while the APHINITY trial showed that pertuzumab improved invasive disease-free survival, improvement was marginal, and there was uncertainty about the estimates of the drug’s effect; NICE also said that Roche’s incremental cost-effectiveness ratios included “optimistic” assumptions about the duration of the treatment’s benefit, and it concluded that pertuzumab could not be recommended for routine use.

In its updated and final appraisal, NICE notes it “considered the current commercial-in-confidence price and biosimilar trastuzumab market share to be most appropriate for decision making,” and used a weighted-average biosimilar trastuzumab discount in its estimates. NICE noted that the biosimilar discounts and the new commercial offer are now sufficient to offset the uncertainty about the estimated QALYs gained, at least for patients with lymph node—positive disease.

Clinical commissioning groups and the NHS are required to comply with the NICE recommendation within 3 months of its publication, and the NICE guidance will be considered for review in another 3 years.