title: Impact of ibrutinib and idelalisib on the pharmaceutical cost of treating chronic lymphocytic leukemia at the individual and societal levels.
abstract: OBJECTIVE
  To evaluate the impact of approval of ibrutinib and idelalisib on pharmaceutical costs in the treatment of chronic lymphocytic leukemia (CLL) at the societal level and assess individual out-of-pocket costs under Medicare Part D.
  
  
  METHODS
  Average wholesale price of commonly used CLL treatment regimens was ascertained from national registries. Using the population of Olmsted County, Minnesota, we identified the proportion of patients with newly diagnosed CLL who experience progression to the point of requiring treatment. Using these data, total pharmaceutical cost over a 10-year period after diagnosis was estimated for a hypothetic cohort of 100 newly diagnosed patients under three scenarios: before approval of ibrutinib and idelalisib (historical scenario), after approval of ibrutinib and idelalisib as salvage therapy (current scenarios A and B), and assuming use of ibrutinib as first-line treatment (potential future scenario).
  
  
  RESULTS
  Estimated 10-year pharmaceutical costs for 100 newly diagnosed patients were as follows: $4,565,929 (approximately $45,659 per newly diagnosed patient and $157,446 per treated patient) for the historical scenario, $7,794,843 (approximately $77,948 per newly diagnosed patient and $268,788 per treated patient) for current scenario A, $6,309,162 (approximately $63,092 per newly diagnosed patient and $217,557 per treated patient) for current scenario B, and $16,414,055 (approximately $164,141 per newly diagnosed patient and $566,002 per treated patient) for the potential future scenario. Total out-of-pocket cost for 100 patients with newly diagnosed CLL under Medicare Part D increased from $9,426 under the historical scenario (approximately $325 per treated patient) to $363,830 and $255,051 under current scenarios A and B (approximately $8,800 to $12,500 per treated patient) and to $1,031,367 (approximately $35,564 per treated patient) under the future scenario.
  
  
  CONCLUSIONS
  Although ibrutinib and idelalisib are profound treatment advances, they will dramatically increase individual out-of-pocket and societal costs of caring for patients with CLL. These cost considerations may undermine the potential promise of these agents by limiting access and reducing adherence.
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL shanafelt.tait@mayo.edu.
authors: Tait D
authors: TD
authors: Shanafelt
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Bijan J
authors: BJ
authors: Borah
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Heidi D
authors: HD
authors: Finnes
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Kari G
authors: KG
authors: Chaffee
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Wei
authors: W
authors: Ding
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Jose F
authors: JF
authors: Leis
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Asher A
authors: AA
authors: Chanan-Khan
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Sameer A
authors: SA
authors: Parikh
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Susan L
authors: SL
authors: Slager
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Neil E
authors: NE
authors: Kay
authors: Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and Mayo Clinic, Jacksonville, FL.
authors: Tim G
authors: TG
authors: Call
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005102:Health Expenditures; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D054524:Medicare Part D / Q000191:economics; D008910:Minnesota; D018803:Models, Economic; D010880:Piperidines; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011687:Purines / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011720:Pyrazoles / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D052999:Quinazolinones / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011687:Purines; D011720:Pyrazoles; D011743:Pyrimidines; D052999:Quinazolinones; C551803:ibrutinib; D000225:Adenine; C552946:idelalisib