title: Budget Impact of Enzalutamide for Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.
abstract: BACKGROUND
  Prostate cancer is expected to account for approximately one quarter of all new diagnoses of cancer in American men in 2015. The cost of prostate cancer care is expected to reach $15.1 billion by the year 2020, up from $11.9 billion in 2010. Given the high burden of prostate cancer, health care payers are interested in quantifying the potential budget impact of new therapies.
  
  
  OBJECTIVE
  To estimate the budget impact of enzalutamide for the treatment of chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) from a U.S. payer perspective.
  
  
  METHODS
  A model was developed to assess the budget impact of enzalutamide for treatment of chemotherapy-naïve mCRPC patients in a hypothetical 1-million-member U.S. health plan over a 1-year time horizon. Comparators included abiraterone acetate, sipuleucel-T, radium Ra 223 dichloride, and docetaxel. Epidemiologic data, including National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) incidence rates, were used to estimate the number of chemotherapy-naïve mCRPC patients. Dosing, administration, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. Drug costs were obtained from RED BOOK and Centers for Medicare & Medicaid Services (CMS) average sales price pricing files, costs of administration and monitoring from the CMS physician fee schedule, and adverse events from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project and published literature. Market shares were estimated for each comparator before and after adoption of enzalutamide. The incremental aggregate budget impact, per patient per year (PPPY), per patient per month (PPPM), and per member per month (PMPM), was calculated. One-way sensitivity analyses were performed.
  
  
  RESULTS
  In a population of 115 chemotherapy-naïve mCRPC patients, adopting enzalutamide had an annual incremental budget impact of $510,641 ($4,426 PPPY, $369 PPPM, and $0.04 PMPM). Results were most sensitive to enzalutamide drug cost, size of the chemotherapy-naïve mCRPC patient population, and enzalutamide adoption rate.
  
  
  CONCLUSIONS
  Results indicate a modest 1-year budget impact of adopting enzalutamide for chemotherapy-naïve mCRPC patients, partly because of the cost offset of a moderate incidence of adverse events and lack of additional required monitoring.
authors.affiliation: 1 Director, Global Health Economics and Outcomes Research, Oncology, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: Cat N
authors.initials: CN
authors.lastname: Bui
authors.affiliation: 2 Director, Global Health Economics, Xcenda, Palm Harbor, Florida.
authors.forename: Ken
authors.initials: K
authors.lastname: O'Day
authors.affiliation: 3 Director, Health Economics and Outcomes Research, Oncology, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: Scott
authors.initials: S
authors.lastname: Flanders
authors.affiliation: 4 Assistant Clinical Professor, Department of Clinical Pharmacy, University of California, San Francisco.
authors.forename: Nina
authors.initials: N
authors.lastname: Oestreicher
authors.affiliation: 5 Medical Director, Medical Affairs, Medical Science Liaisons, Medivation, San Francisco, California.
authors.forename: Peter
authors.initials: P
authors.lastname: Francis
authors.affiliation: 6 Scientific Account Associate Director, Managed Markets and Health Economics and Outcomes Research, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: Linda
authors.initials: L
authors.lastname: Posta
authors.affiliation: 7 Manager, Global Health Economics, Xcenda, Palm Harbor, Florida.
authors.forename: Breanna
authors.initials: B
authors.lastname: Popelar
authors.affiliation: 8 Senior Medical Director, Oncology, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: Hong
authors.initials: H
authors.lastname: Tang
authors.affiliation: 9 Regional Director, Medical Affairs, Medical Science Liaisons, Medivation, San Francisco, California.
authors.forename: Mark
authors.initials: M
authors.lastname: Balk
mesh_terms: D000069501:Abiraterone Acetate / Q000191:economics / Q000627:therapeutic use; D000368:Aged; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D002017:Budgets; D000077143:Docetaxel; D016527:Drug Costs; D006801:Humans; D008297:Male; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000191:economics*; D011868:Radioisotopes / Q000191:economics / Q000627:therapeutic use; D011883:Radium / Q000191:economics / Q000627:therapeutic use; D043823:Taxoids / Q000191:economics / Q000627:therapeutic use; D014020:Tissue Extracts / Q000191:economics / Q000627:therapeutic use; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D011868:Radioisotopes; D043823:Taxoids; D014020:Tissue Extracts; D000077143:Docetaxel; C511774:sipuleucel-T; D000069501:Abiraterone Acetate; C581106:radium Ra 223 dichloride; D011883:Radium