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.
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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.