Indication-specific pricing of pharmaceuticals in the US healthcare system
Abstract
Aim: To explore the potential of indication-specific pricing (ISP) of pharmaceuticals and to discuss prospects for implementation in the US healthcare system. Materials & methods: The Institute for Clinical and Economic Review convened a policy forum with 44 healthcare leaders from 22 payer and life sciences companies. Models of ISP were discussed. Results: Payers and drug manufacturers saw the potential benefits of an ISP system that balances affordability for payers, sustainability for manufacturers and access for patients. The US healthcare system presents many challenges to implementation, including potential conflicts with existing pricing policies (Medicaid Best Price, average sales price and 340B) and insufficient data systems and analytic capabilities. Conclusion: Possible solutions and policy recommendations for payers and manufacturers are provided.
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References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Medicaid. Medicaid drug rebate program. www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/medicaid-drug-rebate-program.html
2.
Garrison LP, Carlson JJ, Bajaj PS et al. Private sector risk-sharing agreements in the United States: trends, barriers, and prospects. Am. J. Manag. Care 21(9), 632–640 (2015).
• Describes what does and does not work for payers and manufacturers in risk-sharing agreements.
3.
Bach PB. Indication-specific pricing for cancer drugs. JAMA 312(16), 1629–1630 (2014).
•• Often cited as a paper that introduces the concept of indication-specific pricing and uses specific examples in oncology to illustrate how it could work.
4.
Loftus P. New push ties cost of drugs to how well they work. Wall Street J. 25 (2015). www.wsj.com/articles/newpushtiescostofdrugstohowwelltheywork1432684755
5.
Kelly LF. Express Scripts leads indication-specific pricing with launch of OCV program. Health Business Daily 17(3), (2016).
6.
Kelly C. CVS indication-based pricing for cancer drugs may roll out later in 2016. Pink Sheet Daily. 4 (2016).
7.
Medicare program; Part B Drug Payment Model; Proposed Rule. Federal Register. 81(48), 13229–13261 (2016).
8.
Hebborn A. Value-based pricing across indications: a company perspective. Presented at: International Society for Pharmacoeconomics and Outcomes Research 19th Annual International Meeting. Montreal, Canada, 31 May – 4 June 2014.
9.
Pearson SD, Dreitlein B, Henshall C. Indication-specific pricing of pharmaceuticals in the United States health care system: a report from the 2015 ICER Membership Policy Summit. http://icer-review.org/material/isp-white-paper/
•• Full description of the Institute for Clinical and Economic Review Policy Summit on indication-specific pricing (ISP) with deeper discussions of the types of ISP and the risks, benefits, barriers and recommendations for both payers and pharmaceutical manufacturers.
10.
Chatham House: The Royal Institute of International Affiars. Chatham House Rule. www.chathamhouse.org/about/chatham-house-rule#
11.
REVATIO®, prescribing information. Pfizer, Inc; New York, NY (2005).
12.
VIAGRA®, prescribing information. Pfizer, Inc; New York, NY (1998).
13.
Redbook Online [online database]. Truven Health Analytics. www.micromedexsolutions.com
14.
Mestre-Ferrandiz J, Towse A, Dellamano R, Pistollato M. Multi-indication pricing: pros, cons, and applicability to the UK. www.ohe.org/news/multi-indication-pricing-pros-cons-and-applicability-uk
•• Provides a description of indication-specific pricing and how it is implemented in several European countries.
15.
AMCP guide to pharmaceutical payment methods - 2013 (Version 3.0). www.amcp.org/pharmaceutical-payment-guide/
16.
Polite B, Conti RM, Ward JC. Reform of the buy-and-bill system for outpatient chemotherapy care is inevitable: perspectives from an economist, a realpolitik, and an oncologist. Am. Soc. Clin. Oncol. Educ. Book 2015, E75–E80 (2015).
17.
Medicare Payment Advisory Commission. Report to Congress: Overview of the 340B Drug Pricing Program. (2015). www.medpac.gov/documents/reports/may-2015-report-to-the-congress-overview-of-the-340b-drug-pricing-program.pdf
18.
Congress of the United States Congressional Budget Office. Competition and the cost of Medicare’s prescription drug program. www.cbo.gov/publication/45552
19.
Criminal Penalties for Acts Involving Federal Health Care Programs. 42 U.S.C. Sect. 1320a-7b. (2010).
20.
Food and Drug Administration. National Drug Code Database Background Information. www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM070829
21.
Duke-Margolis Center for Health Policy. Policy options for off-label communication: Supporting better information, better evidence, and better care. www.pharmamedtechbi.com/∼/media/Supporting%20Documents/The%20Gray%20Sheet/42/8/160218_OffLabel.pdf
22.
Eli Lilly and Anthem. Promoting Value-Based Contracting Arrangements. https://lillypad.lilly.com/WP/wp-content/uploads/LillyAnthemWP2.pdf
• Provides a description of the legal considerations faced by payers and manufacturers when attempting to implement value-based contracts for pharmaceuticals.
23.
Promotion of Investigational Drugs. 21 C.F.R. Sect. 312.7. (2016).
24.
Department of Health and Human Services Office of Inspector General. OIG compliance program guidance for pharmaceutical manufacturers. Federal Register. 68(86), 23731–23743 (2003).
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Published online: 12 July 2017
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Indication-specific pricing of pharmaceuticals in the US healthcare system. (2017) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2017-0018
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