Paying Physicians to Prescribe Generic Drugs and Follow-On Biologics in the United States

1. Centers for Medicare and Medicaid (2014). NHE Factsheet. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/%20NationalHealthExpendData/NHE-Fact-Sheet.html. Accessed 27 January 2015.

2. Silverman E (2015). Prices for prescription medicines rose how much last year? http://blogs.wsj.com/pharmalot/2015/01/26/prices-for-prescription-medicines-rose-how-much-last-year/. Accessed 11 February 2015.

3. Generic Pharmaceutical Association & IMS Institute for Healthcare Informatics (2013). Generic drug savings in the U.S. http://www.gphaonline.org/media/cms/%20GPhA_Generic_Cost_Savings_2014_IMS_presentation.pdf. Accessed 27 January 2015.

4. Silverman E (2014). “Unsustainable for our country”: Express Scripts calls out pricey meds. http://blogs.wsj.com/corporate-intelligence/2014/04/08/unsustainable-for-our-country-express-scripts-calls-out-pricey-meds/. Accessed 27 January 2015.

5. European Medicines Agency (2015). European public assessment reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit. Accessed 27 January 2015.

6. Grabowski H, Guha R, Salgado M (2014). Biosimilar competition: lessons from Europe. Nat Rev Drug Discov 13: 99–100. doi: 10.1038/nrd4210 24445562

7. (2014) Celltrion files for US FDA approval of Remsima biosimilar. http://www.thepharmaletter.com/article/celltrion-files-for-us-fda-approval-of-remsima-biosimilar. Accessed 27 January 2015.

8. Tavernise S (2015). For first time, F.D.A. panel approves generic copy of costs biologic drug. http://www.nytimes.com/2015/01/08/science/fda-panel-vote-biologics.html. Accessed 27 January 2015.

9. Buehler G (2010). History of bioquivalence for critical dose drugs. http://www.fda.gov/downloads/%20AdvisoryCommittees/…/UCM209319.pdf. Accessed 27 January 2015.

10. Levy G (1998). What are narrow therapeutic index drugs? Clin Pharmacol Ther 63: 501–505. 9630822

11. Dong BJ, Brown CH (1991). Hypothyroidism resulting from generic levothyroxine failure. J Am Board Fam Pract 4: 167–170. 2053456

12. Hope KA, Havrda DE (2001). Subtherapeutic INR values associated with a switch to generic warfarin. Ann Pharmacother 35: 183–187. 11215837

13. Fitzgerald CL, Jacobson MP (2011). Generic substitution of levetiracetam resulting in increased incidence of breakthrough seizures. Ann Pharmacother 45: e27. doi: 10.1345/aph.1P765 21521860

14. Dong BJ, Hauck WW, Gambertoglio JG, Gee L, White JR et al (1997). Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 277: 1205–1213. 9103344

15. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, et al (2008). Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 300: 2514–2526. doi: 10.1001/jama.2008.758 19050195

16. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, et al (2010). Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis. Drugs 70:605–621. doi: 10.2165/10898530-000000000-00000 20329806

17. American Medical Association Council on Science and Public Health (2007). Generic substitution of narrow therapeutic index drugs. http://www.ama-assn.org/resources/doc/csaph/x-pub/csaph2a07-fulltext.pdf. Accessed 27 January 2015.

18. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH (2009). Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 43: 1583–1597. doi: 10.1345/aph.1M141 19776300

19. Woodcock J, Khan M, Yu LX (2012). Withdrawal of generic budeprion for nonbioequivalence. New Engl J Med 367: 2463–2465. doi: 10.1056/NEJMp1212969 23216549

20. Eban K (2013). Dirty medicine. http://fortune.com/2013/05/15/dirty-medicine/. Accessed 27 January 2015.

21. Wang B, Gagne JJ, Choudhry NK (2012). The epidemiology of drug recalls in the United States. Arch Intern Med 172: 1109–1110. doi: 10.1001/archinternmed.2012.2013 22664942

22. Shrank WH, Liberman JN, Fischer MA, Avorn J, Kilabuk E, et al (2011). The consequences of requesting "dispense as written." Am J Med 124: 309–317. doi: 10.1016/j.amjmed.2010.11.020 21435421

23. IMS Institute for Healthcare Informatics (2013). Avoidable costs in U.S. health care. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Institute/RUOM-2013/IHII_Responsible_Use_Medicines_2013.pdf. Accessed 27 January 2015.

24. Ornstein C, Weber T, LaFleur J (2013). Medicare’s failure to track doctors wastes billions on name-brand drugs. http://www.propublica.org/%20article/medicare-wastes-billions-on-name-brand-drugs. Accessed 27 January 2015.

25. U.S.C. § 262(k).

26. FDA (2014). Biosimilar guidances. http://www.fda.gov/Drugs/GuidanceCompliance%20RegulatoryInformation/Guidances/ucm290967.htm. Accessed 27 January 2015.

27. Elsevier (2012). Biosimilars—U.S. and international update. http://www.goldstandard.com/wp-content/uploads/Biosimilars%E2%80%93US-and-International-Update.pdf. Accessed 27 January 2015.

28. Megerlin F, Lopert R, Taymor K, Trouvin JH (2013). Biosimilars and the European experience: implications for the United States. Health Aff 32: 1803–1810. doi: 10.1377/hlthaff.2009.0196 24101072

29. Liang BA, Mackey T (2011). Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity. Ther Clin Risk Manag 7: 489–493. doi: 10.2147/TCRM.S27495 22241945

30. Hunt D, Kavanagh D, Drummond I, Weller B, Bellamy C, et al (2014). Thrombotic microangiopathy associated with interferon beta. N Engl J Med 370: 1270–1271. doi: 10.1056/NEJMc1316118 24670186

31. Pollack A (2012). Biotech firms, billions at risk, lobby states to limit generics. http://www.nytimes.com/2013/01/29/business/battle-in-states-on-generic-copies-of-biotech-drugs.html. Accessed 27 January 2015.

32. Mass Gen Laws ch 112, § 12EE. https://malegislature.gov/Laws/GeneralLaws/PartI/%20TitleXVI/Chapter112/Section12EE. Accessed 11 February 2015.

33. Or Rev Stat § 689.522. https://www.oregonlegislature.gov/bills_laws/ors/ors689.html. Accessed 11 February 2015.

34. Utah Code § 58 17b-605.5. http://le.utah.gov/xcode/Title58/Chapter17B/58-17b-S605.5.html?v=C58-17b-S605.5_1800010118000101. Accessed 11 February 2015.

35. (2014) Health advocacy organizations submit letter to FTC regarding biosimilars naming policy. http://www.prnewswire.com/news-releases/health-advocacy-organizations-submit-letter-to-ftc-regarding-biosimilars-naming-policy-243474711.html. Accessed 27 January 2015.

36. Alliance for Safe Biologics (2012). ASBM advisory board members urge FDA to adopt unique names for biosimilars. http://safebiologics.org/resources/2012/06/asbm%20-advisory-board-members-urge-fda-to-adopt-unique-names-for-biosimilars/. Accessed 27 January 2015.

37. Fischer MA, Vogeli C, Stedman M, Ferris T, Brookhart MA, Weissman JS (2008). Effect of electronic prescribing with formulary decision support on medication use and cost. Arch Intern Med 168: 2433–2439. doi: 10.1001/archinte.168.22.2433 19064827

38. Fischer MA, Avorn J (2012). Academic detailing can play a key role in assessing and implementing comparative effectiveness research findings. Health Aff 3: 2206–2212. doi: 10.1377/hlthaff.2012.0817 23048098

39. O'Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen et al (2007). Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. CD000409. 17943742

40. Fuhrmans V (2008). Doctors paid to prescribe generic pills. http://online.wsj.com/%20news/articles/SB120114138064112219. Accessed 27 January 2015.

41. Solomont EB (2008). Insurers pay doctors to push generic drugs. http://www.nysun.com/business/insurers-pay-doctors-to-push-generic-drugs/81992/. Accessed 27 January 2015.

42. Med-Vantage (2011). 2010 national p4p survey. http://www.imshealth.com/%20deployedfiles/ims/Global/Content/Solutions/Healthcare%20Analytics%20and%20Services/Payer%20Solutions/Survey_Exec_Sum.pdf. Accessed 27 January 2015.

43. Yegian J, Yanagihara D (2013). Value based pay for performance in California. http://www.iha.org/pdfs_documents/p4p_california/Value-Based-Pay-for-Performance-Issue-Brief-September-2013.pdf. Accessed 27 January 2015.

44. American Medical Association (2014). Frequently asked questions from physicians. http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/frequently-asked-questions.page. Accessed 27 January 2015.

45. U.S.C. § 1320a-7b(b).

46. Radick R (2013). The anti-kickback statute and the Affordable Care Act: a law enforcement tool suddenly goes missing. http://www.forbes.com/sites/insider/2013/11/13/the-anti-kickback-statute-and-the-affordable-care-act-a-law-enforcement-tool-suddenly-goes-missing/. Accessed 27 January 2015.

47. Blumenthal D (2004). Doctors and drug companies. N Engl J Med 351: 1885–1890. 15509823

48. Downing NS, Aminawung JA, Shah ND, Krumholz H, Ross JS (2014). Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA 311: 368–377. doi: 10.1001/jama.2013.282034 24449315

49. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, et al. (2002). Timing of new black box warnings and withdrawals for prescription medications. JAMA 287: 2215–2220. 11980521

50. Fischer MA, Choudhry NK, Brill G, Avorn J, Schneeweiss S, et al (2011). Trouble getting started: predictors of primary medication nonadherence. Am J Med 124: e9–22. doi: 10.1016/j.amjmed.2011.06.005 22114839

51. Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K, et al (2006). The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med 166: 332–337. 16476874

52. Edney A (2014). Generic-drug testing goes widespread in U.S. FDA effort. http://www.bloomberg.com/news/2014-02-21/first-u-s-testing-of-generic-drugs-is-unveiled-by-fda.html. Accessed 27 January 2015.

53. The Henry J. Kaiser Family Foundation (2015). Health insurance coverage of the total population. http://kff.org/other/state-indicator/total-population/. Accessed 27 January 2015.

54. U.S. Department of Health and Human Services (2014). Open enrollment week 5: December 13-December 19, 2014. http://www.hhs.gov/healthcare/facts/blog/2014/12/open-enrollment-week-five.html. Accessed 27 January 2015.

55. Shrank WH, Liberman JN, Fischer MA, Girdish C, Brennan TA, et al (2011). Physician perceptions about generic drugs. Ann Pharmacother 45: 31–38. doi: 10.1345/aph.1P389 21205953

56. Hsiao CJ, Decker SL, Hing E, Sisk JE (2012). Most physicians were eligible for federal incentives in 2011, but few had EHR systems that met meaningful-use criteria. Health Aff 31: 1–8. doi: 10.1377/hlthaff.2011.1315 22535501

57. ALOSA Foundation (2014). Where is academic detailing used? http://www.alosafoundation.org/academic-detailing/where-academic-detailing-used/. Accessed 27 January 2015.

58. Thaler RH, Sunstein CR (2009). Nudge: improving decisions about health, wealth, and happiness. New York, NY: Penguin Books.

59. Stenner SP, Chen Q, Johnson KB (2010). Impact of generic substitution decision support on electronic prescribing behavior. J Am Med Inform Assoc 17: 681–688. doi: 10.1136/jamia.2009.002568 20962131

60. Redelmeier DA, Shafir E (1995). Medical decision making in situations that offer multiple alternatives. JAMA 273: 302–305 7815657