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Published in: PharmacoEconomics 10/2016

Open Access 01-10-2016 | Original Research Article

BEACON: A Summary Framework to Overcome Potential Reimbursement Hurdles

Authors: William C. N. Dunlop, C. Daniel Mullins, Olaf Pirk, Ron Goeree, Maarten J. Postma, Ashley Enstone, Louise Heron

Published in: PharmacoEconomics | Issue 10/2016

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Abstract

Objective

To provide a framework for addressing payers’ criteria during the development of pharmaceuticals.

Methods

A conceptual framework was presented to an international health economic expert panel for discussion. A structured literature search (from 2010 to May 2015), using the following databases in Ovid: Medline® and Medline® In-Process (PubMed), Embase (Ovid), EconLit (EBSCOhost) and the National Health Service Economic Evaluation Database (NHS EED), and a ‘grey literature’ search, were conducted to identify existing criteria from the payer perspective. The criteria assessed by existing frameworks and guidelines were collated; the most commonly reported criteria were considered for inclusion in the framework. A mnemonic was conceived as a memory aide to summarise these criteria.

Results

Overall, 41 publications were identified as potentially relevant to the objective. Following further screening, 26 were excluded upon full-text review on the basis of no framework presented (n = 13), redundancy (n = 11) or abstract only (n = 2). Frameworks that captured criteria developed for or utilised by the pharmaceutical industry (n = 5) and reimbursement guidance (n = 10) were reviewed. The most commonly identified criteria—unmet need/patient burden, safety, efficacy, quality-of-life outcomes, environment, evidence quality, budget impact and comparator—were incorporated into the summary framework. For ease of communication, the following mnemonic was developed: BEACON (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence).

Conclusions

The BEACON framework aims to capture the ‘essence’ of payer requirements by addressing the most commonly described criteria requested by payers regarding the introduction of a new pharmaceutical.
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Literature
1.
go back to reference Grignolo A. Collaboration and convergence: bringing new medicines to global markets in the 21st century. Ther Innov Regul Sci. 2013;47(1):8–15.CrossRef Grignolo A. Collaboration and convergence: bringing new medicines to global markets in the 21st century. Ther Innov Regul Sci. 2013;47(1):8–15.CrossRef
2.
3.
go back to reference Epstein RS, Sidorov J, Lehner JP, Salimi T. Integrating scientific and real-world evidence within and beyond the drug development process. J Comp Eff Res. 2012;1(1 Suppl. 1):9–13.CrossRefPubMed Epstein RS, Sidorov J, Lehner JP, Salimi T. Integrating scientific and real-world evidence within and beyond the drug development process. J Comp Eff Res. 2012;1(1 Suppl. 1):9–13.CrossRefPubMed
4.
go back to reference Schnipper LE, Davidson NE, Wollins DS, Tyne C, Blayney DW, Blum D, Dicker AP, Ganz PA, Hoverman JR, Langdon R, Lyman GH, Meropol NJ, Mulvey T, Newcomer L, Peppercorn J, Polite B, Raghavan D, Rossi G, Saltz L, Schrag D, Smith TJ, Yu PP, Hudis CA, Schilsky RL, American Society of Clinical Oncology. American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33(23):2563–77. doi:10.1200/JCO.2015.61.6706.CrossRefPubMed Schnipper LE, Davidson NE, Wollins DS, Tyne C, Blayney DW, Blum D, Dicker AP, Ganz PA, Hoverman JR, Langdon R, Lyman GH, Meropol NJ, Mulvey T, Newcomer L, Peppercorn J, Polite B, Raghavan D, Rossi G, Saltz L, Schrag D, Smith TJ, Yu PP, Hudis CA, Schilsky RL, American Society of Clinical Oncology. American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33(23):2563–77. doi:10.​1200/​JCO.​2015.​61.​6706.CrossRefPubMed
5.
go back to reference Stafinski T, Menon D, Philippon DJ, McCabe C. Health technology funding decision-making processes around the world: the same, yet different. Pharmacoeconomics. 2011;29(6):475–95.CrossRefPubMed Stafinski T, Menon D, Philippon DJ, McCabe C. Health technology funding decision-making processes around the world: the same, yet different. Pharmacoeconomics. 2011;29(6):475–95.CrossRefPubMed
7.
go back to reference Hao Y, Thomas A. Health technology assessment and comparative effectiveness research: a pharmaceutical industry perspective. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):447–54.CrossRefPubMed Hao Y, Thomas A. Health technology assessment and comparative effectiveness research: a pharmaceutical industry perspective. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):447–54.CrossRefPubMed
10.
go back to reference Pinto MB, Pinto JK. Project team communication and cross-functional cooperation in new program development. J Prod Innov Manage. 1990;7(3):200–12.CrossRef Pinto MB, Pinto JK. Project team communication and cross-functional cooperation in new program development. J Prod Innov Manage. 1990;7(3):200–12.CrossRef
13.
go back to reference Gispen-De Wied CC, Leufkens HGM. From molecule to market access: drug regulatory science as an upcoming discipline. Eur J Pharmacol. 2013;719(1–3):9–15.CrossRefPubMed Gispen-De Wied CC, Leufkens HGM. From molecule to market access: drug regulatory science as an upcoming discipline. Eur J Pharmacol. 2013;719(1–3):9–15.CrossRefPubMed
14.
go back to reference Methley AM, Campbell S, Chew-Graham C, McNally R, Cheraghi-Sohi S. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Serv Res. 2014;14:579.CrossRefPubMedPubMedCentral Methley AM, Campbell S, Chew-Graham C, McNally R, Cheraghi-Sohi S. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Serv Res. 2014;14:579.CrossRefPubMedPubMedCentral
21.
go back to reference Ouellet D. Benefit-risk assessment: the use of clinical utility index. Expert Opin Drug Saf. 2010;9(2):289–300.CrossRefPubMed Ouellet D. Benefit-risk assessment: the use of clinical utility index. Expert Opin Drug Saf. 2010;9(2):289–300.CrossRefPubMed
23.
go back to reference Püntmann I, Schmacke N, Melander A, Lindberg G, Mühlbauer B. EVITA: a tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage. BMC Pharmacol Toxicol. 2010;10(1):5.CrossRef Püntmann I, Schmacke N, Melander A, Lindberg G, Mühlbauer B. EVITA: a tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage. BMC Pharmacol Toxicol. 2010;10(1):5.CrossRef
24.
go back to reference Berger M, Martin B, Husereau D, et al. A questionnaire to assess the relevance and credibility of observational studies to inform healthcare decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health. 2014;17:143–56.CrossRefPubMedPubMedCentral Berger M, Martin B, Husereau D, et al. A questionnaire to assess the relevance and credibility of observational studies to inform healthcare decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health. 2014;17:143–56.CrossRefPubMedPubMedCentral
25.
go back to reference Carrothers TJ, Hodge FL, Korsan RJ, Poland WB, Dykstra KH. Decision-making in drug development: application of a clinical utility index. Clinical trial simulations—applications and trends. Heidelberg: Springer Verlag; 2011. p. 85–107. Carrothers TJ, Hodge FL, Korsan RJ, Poland WB, Dykstra KH. Decision-making in drug development: application of a clinical utility index. Clinical trial simulations—applications and trends. Heidelberg: Springer Verlag; 2011. p. 85–107.
26.
go back to reference Pearson SA, Institute for Clinical and Economic Review (ICER). (2015) Framework for payer assessment of the value of new technologies: a US approach. Seminar briefing 16. Office of Health Economics Research (OHE). Published Feb 2015. Pearson SA, Institute for Clinical and Economic Review (ICER). (2015) Framework for payer assessment of the value of new technologies: a US approach. Seminar briefing 16. Office of Health Economics Research (OHE). Published Feb 2015.
27.
go back to reference Cartwright ME, Cohen S, Fleishaker JC, Madani S, McLeod JF, Musser B, et al. Proof of concept: a PhRMA position paper with recommendations for best practice. Clin Pharmacol Ther. 2010;87(3):278–85.CrossRefPubMed Cartwright ME, Cohen S, Fleishaker JC, Madani S, McLeod JF, Musser B, et al. Proof of concept: a PhRMA position paper with recommendations for best practice. Clin Pharmacol Ther. 2010;87(3):278–85.CrossRefPubMed
28.
go back to reference Marsh K, Lanitis T, Neasham D, Orfanos P, Caro J. Assessing the value of healthcare interventions using multi-criteria decision analysis: a review of the literature. Pharmacoeconomics. 2014;32(4):345–65.CrossRefPubMed Marsh K, Lanitis T, Neasham D, Orfanos P, Caro J. Assessing the value of healthcare interventions using multi-criteria decision analysis: a review of the literature. Pharmacoeconomics. 2014;32(4):345–65.CrossRefPubMed
29.
go back to reference Sussex J, Rollet P, Garau M, Schmitt C, Kent A, Hutchings A. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health. 2013;16(8):1163–9.CrossRefPubMed Sussex J, Rollet P, Garau M, Schmitt C, Kent A, Hutchings A. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health. 2013;16(8):1163–9.CrossRefPubMed
30.
go back to reference Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value Health. 2012;15(8):1172–81.CrossRefPubMed Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value Health. 2012;15(8):1172–81.CrossRefPubMed
31.
go back to reference Thokala P, Marsh K. Choosing appropriate multi-criteria decision analysis technique(s) to support health care decisions: issues and considerations. 37th Annual Meeting of the Society for Medical Decision Making, Missouri, USA; 2015. Thokala P, Marsh K. Choosing appropriate multi-criteria decision analysis technique(s) to support health care decisions: issues and considerations. 37th Annual Meeting of the Society for Medical Decision Making, Missouri, USA; 2015.
36.
go back to reference Ghabri S, Hamers FF, Josselin JM. Exploring uncertainty in economic evaluations of drugs and medical devices: lessons from the first review of manufacturers’ submissions to the french national authority for health. PharmacoEconomics. 2016;34(6):617–24.CrossRefPubMed Ghabri S, Hamers FF, Josselin JM. Exploring uncertainty in economic evaluations of drugs and medical devices: lessons from the first review of manufacturers’ submissions to the french national authority for health. PharmacoEconomics. 2016;34(6):617–24.CrossRefPubMed
39.
go back to reference Neumann PJ, Cohen JT. Measuring the value of prescription drugs. N Engl J Med. 2015;373(27):2595–7.CrossRefPubMed Neumann PJ, Cohen JT. Measuring the value of prescription drugs. N Engl J Med. 2015;373(27):2595–7.CrossRefPubMed
Metadata
Title
BEACON: A Summary Framework to Overcome Potential Reimbursement Hurdles
Authors
William C. N. Dunlop
C. Daniel Mullins
Olaf Pirk
Ron Goeree
Maarten J. Postma
Ashley Enstone
Louise Heron
Publication date
01-10-2016
Publisher
Springer International Publishing
Published in
PharmacoEconomics / Issue 10/2016
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI
https://doi.org/10.1007/s40273-016-0427-7

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