title: Budget impact model of adding erlotinib to a regimen of gemcitabine for the treatment of locally advanced, nonresectable or metastatic pancreatic cancer.
abstract: OBJECTIVE
  The aim of this study was to determine the budget impact of adding erlotinib to a US health plan insurer's formulary as a combination therapy with gemcitabine for the treatment of nonresectable pancreatic cancer.
  
  
  METHODS
  An Excel-based budget impact model was developed to evaluate the costs for National Comprehensive Cancer Network guideline-recommended treatment options for patients with locally advanced, nonresectable or metastatic pancreatic cancer from the perspective of a US managed care plan. The model compared treatment with gemcitabine alone and in combination with erlotinib, including the costs of treatment, adverse events (AEs), and administration. Inputs for the model were derived from the Surveillance, Epidemiology and End Results Cancer Registry, clinical trials, and publicly available sources and were varied in sensitivity analyses to identify influential inputs. The model addressed first-line use in a single indication and assumed that the proportion of patients aged >or=65 years in a managed care organization was the same as in the general population. The model did not account for patient copayments for oral medications, a factor that could lower a plan's overall cost further than estimated herein.
  
  
  RESULTS
  For a hypothetical managed care plan with 500,000 members, the model estimated 43 newly diagnosed pancreatic cancer cases each year, of which 56% (n=24) would be treated with gemcitabine as first-line therapy. Assuming that erlotinib were added to the treatment regimen in 40% (n=10) of gemcitabine-treated patients for 15.7 weeks of therapy per patient, the expected 1-year cost in 2006 dollars would be US $466,700 compared with $346,700 had all patients been treated with gemcitabine alone. Administration costs accounted for 10% to 12% of total costs, while AE management costs made up 14% to 16% of total costs. These estimates corresponded to an incremental cost of $120,000, or $0.020 per member per month (PMPM). The results were relatively insensitive to drug costs, drug administration costs, and costs of treatment of AEs based on sensitivity analyses.
  
  
  CONCLUSIONS
  In this analysis of the budget impact of adding to the health plan formulary erlotinib to a regimen of gemcitabine as first-line treatment of locally advanced, nonresectable or metastatic pancreatic cancer in the United States, the budget impact was $0.020 PMPM. The relatively low incidence of pancreatic cancer and the assumption of treating only 23% of these patients with erlotinib were likely the principal reasons for the low budgetary impact of erlotinib. In this model and using these reasonable assumptions, the results suggested that the incremental cost impact on a PMPM basis may be small.
authors.affiliation: Outcomes Insights, Inc., Newbury Park, California 91320, USA. mark@outins.com
authors.forename: Mark D
authors.initials: MD
authors.lastname: Danese
authors.forename: Carolina
authors.initials: C
authors.lastname: Reyes
authors.forename: Kelly
authors.initials: K
authors.lastname: Northridge
authors.forename: Deborah
authors.initials: D
authors.lastname: Lubeck
authors.forename: Chin-Yu
authors.initials: CY
authors.lastname: Lin
authors.forename: Paula
authors.initials: P
authors.lastname: O'Connor
mesh_terms: D000368:Aged; D002017:Budgets / Q000706:statistics & numerical data*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D016527:Drug Costs; D004359:Drug Therapy, Combination; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D009367:Neoplasm Staging; D017063:Outcome Assessment, Health Care / Q000191:economics*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary; D047428:Protein Kinase Inhibitors / Q000191:economics / Q000627:therapeutic use; D011799:Quinazolines / Q000191:economics / Q000627:therapeutic use*; D012264:Ribonucleotide Reductases; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology; D000093542:Gemcitabine
chemical_list: D007166:Immunosuppressive Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D012264:Ribonucleotide Reductases; D066246:ErbB Receptors; D000093542:Gemcitabine