ObjectiveAcross markets, rationalisation of healthcare expenditure is at the top of the political agenda. Increasingly, payers are evaluating pharmaceuticals in relation to existing treatments—in terms of efficacy, safety, and sometimes cost—to make P&R decisions. As such, this study aimed to evaluate how relative effectiveness assessment (REA) is used within the national P&R processes.

Methods IHS assessed the impact of REA on patient access to medicines in Australia, Brazil, Canada, France, Germany, Italy, the United Kingdom, and the United States through primary and secondary research. Over 30 key relative effectiveness assessors and P&R decision makers were interviewed to understand the methodology for REA in their respective country, as well as their data requirements and preferences by care segment and therapeutic area.

ResultsSome countries assess new pharmaceuticals in relation to their appropriate comparators to make public funding decisions, some to inform pricing decisions/negotiations, and others leverage REA in both their pricing and reimbursement decision-making processes. In terms of how therapeutic value is factored into the P&R decision-making process, countries can be segmented into broad categories based on whether or not costs are considered in addition to clinical performance.

1: Consists of the use of both an economic evaluation and an evaluation of added therapeutic valueSource: IHS research, 2012

The evaluation of the therapeutic value of a medicine can result in P&R decision discrepancies across markets. These coverage disparities notably reflect societal and methodological differences in the way the available evidence is interpreted across markets.

1: Automatic rejection, as manufacturer did not submit a reimbursement dossierRRMS: relapsing-remitting multiple sclerosis | NETAG: North East Treatment Advisory GroupSource: IHS research, 2012

In terms of information needs, payers wish to be in a position to evaluate how new medicines compare with the standard of care in their specific healthcare setting and in their patient population when making their P&R decisions. In addition, they prefer hard clinical endpoints on which to base their decisions. Surrogate endpoints are not looked upon favourably, and when used, they must be validated.

ConclusionsIn relation to REA, patient access to medicines is more stringent in countries that undertake economic evaluation. In the future, REA will increasingly be used by payers to rationalise finite healthcare resources and budgets. This will limit patient access to medicines that are not deemed to bring sufficient benefit in relation to existing treatment alternatives. Reimbursement delisting and restricted reimbursement decisions are also likely to become more common.

Case study 1: ticagrelor(prevention of thrombotic events)

Australia (PBAC) • Accepted for reimbursement upon a risk-sharing agreement to address uncertainty

Canada (CADTH) • Rejected for reimbursement

United Kingdom (NICE) • Recommended for NHS use

France (TC) • Accepted for reimbursement• Deemed a minor improvement over existing therapies

Germany (G-BA) • Reimbursed• Deemed of significant added benefit in patients

with non-ST-elevation myocardial infarction or unstable angina; of no proven added benefit in other patient populations

Case study 2: fingolimod(relapsing remitting multiple sclerosis)

Australia (PBAC) • Accepted for reimbursement upon price cut

Canada (CADTH) • Restricted reimbursement

United Kingdom (NICE) • Recommended for NHS use upon proposal of a patient access scheme

France (TC) • Accepted for reimbursement• Deemed a minor improvement over existing therapies

Germany (G-BA) • Reimbursed• Deemed of no proven added benefit except in

patients with rapidly evolving RRMS where a slight added benefit was found

Case study 3: fampridine(improvement of walking ability in adults with multiple sclerosis)

United Kingdom (SMC; NETAG)

• Not recommended for NHS Scotland use1

• NETAG found no evidence for cost-effectiveness

France (TC) • Conditional reimbursement (reassessment within 12 months, 15% reimbursement level)

• Deemed of no improvement over existing therapies

Germany (G-BA) • Reimbursed• Deemed of no proven added benefit

Italy (AIFA) • Rejected for reimbursement

Payer Information Requirements for Relative Effectiveness Assessment Vary Across Markets & Create Discrepencies in Patient Access to MedicinesMarinoni G, Lockwood C, Honoré A, Rodrigues T, Izmirlieva M, Walker S, and Ando G (IHS, London, United Kingdom)

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REA position in P&R process

REA assessment methodology

Australia Informs pricing and reimbursement

Economic evaluation

Brazil Informs pricing and reimbursement

Mix of methodologies1

Canada Informs pricing and reimbursement

Mix of methodologies

France Informs pricing and reimbursement

Added therapeutic value evaluation

Germany Informs pricing Added therapeutic value evaluation

Italy Informs pricing and reimbursement

Mix of methodologies

United Kingdom Informs reimbursement Economic evaluation

United States Informs reimbursement Mix of methodologies