Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU

Annals of Hematology

Volumn 94, Issue 2, 2015, Pages 249-257

  Conti, Rena M ^a   Padula, William V ^a   Larson, Richard A ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

Cancer; Chronic myeloid leukemia; Cost effectiveness; Generic entry; Health economics; Imatinib; Patent expiration; Tyrosine kinase inhibitors

Indexed keywords

GENERIC DRUG; IMATINIB; ANTINEOPLASTIC AGENT; BCR ABL PROTEIN; BCR-ABL1 FUSION PROTEIN, HUMAN; BENZAMIDE DERIVATIVE; PIPERAZINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE;

CHRONIC MYELOID LEUKEMIA; COST EFFECTIVENESS ANALYSIS; EUROPEAN UNION; HEALTH CARE COST; HEALTH CARE QUALITY; HEALTH ECONOMICS; HUMAN; PATENT; PRIORITY JOURNAL; REVIEW; UNITED STATES; ADVERSE EFFECTS; ANIMAL; ANTAGONISTS AND INHIBITORS; CLINICAL PRACTICE; COST CONTROL; DRUG COST; ECONOMICS; ENZYMOLOGY; HEALTH IMPACT ASSESSMENT; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MOLECULARLY TARGETED THERAPY; PROCEDURES; STATISTICAL MODEL;

ANIMALS; ANTINEOPLASTIC AGENTS; BENZAMIDES; COST SAVINGS; DRUG COSTS; DRUGS, GENERIC; EUROPEAN UNION; FUSION PROTEINS, BCR-ABL; HEALTH IMPACT ASSESSMENT; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MODELS, ECONOMIC; MOLECULAR TARGETED THERAPY; PATENTS AS TOPIC; PHYSICIAN'S PRACTICE PATTERNS; PIPERAZINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; UNITED STATES;

EID: 84925940374     PISSN: 09395555     EISSN: 14320584     Source Type: Journal    
DOI: 10.1007/s00277-015-2319-x     Document Type: Review

References (53)

1. Saglio G, Kim DW, Issaragrisil S, le Coutre P, for the ENESTnd Investigators et al (2010) Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 362:2251–2259
2. Larson RA, Kim DW, Jootar SS, Pasquini R et al (2014) ENESTnd 5-year (y) update: long-term outcomes of patients with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib vs imatinib. J Clin Oncol 32:5s, suppl; abstr 7073
3. Jabbour E, Kantarjian HM, Saglio G, Steegmann JL et al (2014) Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood 123(4):494–500
4. Kantarjian HM, Shah NP, Hochhaus A et al (2010) Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 362(24):2260–2270
5. Radich JP, Kopecky KJ, Appelbaum FR, Kamel-Reid S et al (2012) A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood 120(19):3898–3905
6. Cortes JE, Kim DW, Kantarjian HM, Brummendorf TH et al (2012) Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol 30:3486–3492
7. Hehlmann R, Lauseker M, Jung-Munkwitz S, Leitner A et al (2011) Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-alfa in newly diagnosed chronic myeloid leukemia. J Clin Oncol 29:1634–1642
8. Deininger MW, Kopecky KJ, Radich JP, Kamel-Reid S et al (2014) Imatinib 800 mg daily induces deeper molecular responses than imatinib 400 mg daily: results of SWOG S0325, an intergroup randomized phase II trial in newly diagnosed chronic phase chronic myeloid leukaemia. Br J Haematol 164:223–232
9. Authors’ calculations from Novartis worldwide sales data 2014. Available at: http://www.novartis.com/investors/financial-results/product-sales.shtml. Last accessed: July 2014
10. Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Müller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saußele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R (2013) European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 122(6):872–884
11. Conti RM (2013) Why are cancer drugs commonly the target of numerous schemes to extend patent exclusivity? Health Affairs webblog. December 4. Available at: http://healthaffairs.org/blog/2013/12/04/why-are-cancer-drugs-commonly-the-target-of-schemes-to-extend-patent-exclusivity/. Last accessed: July 2014
12. Scherer FM (1993) Pricing, profits, and technological progress in the pharmaceutical industry. J Econ Perspect 7(3):97–115
13. European Medicines Agency. Generic medicines. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/11/WC500012382.pdf. Last accessed: July 2014
14. Conti RM, Berndt ER (2014) Specialty Drug Prices and Utilization After Loss of U.S. Patent Exclusivity, 2001–2007. NBER Working paper 20016. Available at: http://www.nber.org/papers/w20016
15. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/11/WC500012382.pdf. Last accessed: July 2014
16. Berndt ER, Newhouse JP (2013) Pricing and reimbursement in U.S. pharmaceutical markets. In: Danzon PM, Nicholson S (eds) The Oxford handbook of the economics of the biopharmaceutical industry. Oxford University Press, New York, pp 201–265
17. IMS Institute for Healthcare Informatics (2014) Medicine use and shifting costs of healthcare: a review of the use of medicines in the United States in 2013. Available at: http://www.imshealth.com/cds/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Secure/IIHI_US_Use_of_Meds_for_2013.pdf. Last accessed: July 2014
18. Congressional Budgetary Office (1998) How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry. July. Available at: http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/6xx/doc655/pharm.pdf. Last accessed: July 2014
19. Simoens S (2008) Trends in generic prescribing and dispensing in Europe. Expert Rev Clin Pharmacol 1(4):497–503
20. Harris G (2013) Top Court in India Rejects Novartis Drug Patent. The New York Times. April 2. Available at: http://www.nytimes.com/2013/04/02/business/global/top-court-in-india-rejects-novartis-drug-patent.html?pagewanted=all&_r=0. Last accessed October 2014.
21. Kishore SP, Aisola M, Lopert R, Koney N. Proposal for the inclusion of imatinib mesylate for the treatment of chronic myelogenous leukemia in the WHO model list of essential medicines for adults. January. Available at: http://www.who.int/selection_medicines/committees/expert/19/applications/Imatinib2__8_2_A_Ad.pdf. Last accessed October 2014
22. Panattoni L (2011) The effect of paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms. J Health Econ 30(1):126–145
23. Scott-Morton FM (1999) Entry decisions in the generic pharmaceutical industry. RAND J Econ 30(3):412–440
24. Grabowski H, Kyle M (2007) Generic competition and market exclusivity periods in pharmaceuticals. Manag Decis Econ 28:491–502
25. Hemphill CS, Sampat B (2013) Drug Patents at the Supreme Court. Science. Available at: http://www.sciencemag.org/content/339/6126/1386.short. Last accessed: July 2014
26. Puig-Junoy J (2010) Impact of European pharmaceutical price regulation on generic price competition: a review. PharmacoEconomics 28(8):649–663
27. Grabowski H, Vernon J (1992) Brand loyalty, entry and price competition in pharmaceuticals after the 1984 Drug Act. J Law Econ 35:331–350
28. Reiffen D, Ward MR (2005) Generic drug industry dynamics. Rev Econ Stat 87(1):37–49
29. Grabowski H, Vernon J (1996) Longer patents for increased generic competition in the U.S.: the Waxman-Hatch Act after one decade. PharmacoEconomics 10(Suppl2):110–123
30. Wiggins SN, Maness R (2004) Price competition in pharmaceuticals: the case of anti-infectives. Econ Inq 42(2):247–263
31. Frank RG, Salkever DS (1992) Pricing, patent loss and the market for pharmaceuticals. South Econ J 59:165–179
32. Frank RG, Salkever DS (1997) Generic entry and the pricing of pharmaceuticals. J Econ Manag Strateg 6(1):75–90
33. Ellison SF, Cockburn IM, Griliches Z, Hausman JA (1997) Characteristics of demand for pharmaceutical products: an examination of four cephalosporins. RAND J Econ 28(3):1–36
34. Griliches Z, Cockburn IM (1994) Generics and new goods in pharmaceutical price indexes. Am Econ Rev 84(5):1213–1232
35. Aitken ML, Berndt ER, Bosworth B, Cockburn IM, Frank RG, Kleinrock M, Shapiro BT (2013) The regulation of prescription drug competition and market responses: patterns in prices and sales following loss of exclusivity. National Bureau of Economic Research, Cambridge, MA, Working Paper No. 19487, October
36. Allan GM, Lexchin J, Wiebe N (2007) Physician awareness of drug cost: a systematic review. PLoS Med 4(9):1486–1496
37. Vivian J (2008) Generic substitution laws. US Pharm 33(6):30–34
38. Bennett S, Quick JD, Velásquez G (1997) Public-Private Roles in the Pharmaceutical Sector - Implications for Equitable Access and Rational Drug Use. World Health Organization, Health Economics and Drugs Series, No. 005. Available at: http://apps.who.int/medicinedocs/en/d/Jwhozip27e/10.3.html#Jwhozip27e.10.3. Last accessed: July 2014
39. Simoens S, De Coster S (2006) Sustaining generic medicines markets in Europe. K U Leuven, Leuven, Belgium. Available at: www.egagenerics.com. Last accessed: July 2014
40. Dunne S, Shannon B, Dunne C, Cullen W (2013) A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol 14:1
41. US Food and Drug Administration (2009) What are generic drugs? May 12. Available at http://www.fda.gov/Drugs/ResourcesforYou/Consumers/BuyingUsingMedicineSafely/UnderstaingingGenericdrugs/ucm144456.htm. Last accessed: July 2014
42. The National Institute for Health Care Management (2002) A primer: generic drugs, patents and the pharmaceutical marketplace. Washington, DC, pp 1–28
43. Dusetzina SB, Winn AN, Abel GA, Huskamp HA, Keating NL (2014) Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol 32(4):306–311. doi:10.1200/JCO.2013.52.9123
44. Paradis PE, Latrémouille-Viau D, Moore Y, Mishagina N, Lafeuille MH, Lefebvre P, Gaudig M, Duh MS (2009) Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries. Curr Med Res Opin 25(7):1793–1805
45. Padula WV, Breteler MJM (2013) Sharing perspectives on HTA from both sides of the pond. ISPOR Connect 19(1):15
46. Dylst P, Vulto A, Simoens S (2012) How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing? Pharm Pract (Granada) 10(1):3–8, Review
47. Stephens JM, Handke B, Doshi JA (2012) International survey of methods used in health technology assessment (HTA): does practice meet the principles proposed for good research? Comp Eff Res 2:29–44
48. Shih YC, Bekele NB, Xu Y (2007) Use of Bayesian net benefit regression model to examine the impact of generic drug entry on the cost effectiveness of selectiveserotonin reuptake inhibitors in elderly depressed patients. PharmacoEconomics 25(10):843–862
49. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB (1996) Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA 276(15):1253–1258
50. Meltzer D, Johannesson M (1999) Inconsistencies in the “societal perspective” on costs of the Panel on Cost-Effectiveness in Health and Medicine. Med Decis Mak 19(4):371–377
51. Sullivan PW, Lawrence WF, Ghushchyan V (2005) A national catalog of preference-based scores for chronic conditions in the United States. Med Care 43(7):736–749
52. Brazier J, Roberts J, Deverill M (2002) The estimation of a preference-based measure of health from the SF-36. J Med Microbiol 51(3):269–272
53. Feeny D, Furlong W, Torrance GW, Goldsmith CH, Zhu Z, DePauw S, Denton M, Boyle M (2002) Multiattribute and single-attribute utility functions for the health utilities index mark 3 system. Med Care 40(2):113–128