IHS Healthcare and Pharma research poster on payer information and patient access for relative effectiveness assessments. ISPOR 2012 poster

1. Payer Information Requirements for Relative
Effectiveness Assessment Vary Across
Markets & Create Discrepencies in Patient
Access to Medicines
Marinoni G, Lockwood C, Honoré A, Rodrigues T, Izmirlieva M, Walker S, and Ando G (IHS, London, United Kingdom)
Objective Case study 1: ticagrelor
(prevention of thrombotic events)
Across markets, rationalisation of healthcare expenditure is at the Australia (PBAC) • ccepted for reimbursement upon a risk-sharing
A
top of the political agenda. Increasingly, payers are evaluating agreement to address uncertainty
pharmaceuticals in relation to existing treatments—in terms of Canada (CADTH) • Rejected for reimbursement
efficacy, safety, and sometimes cost—to make PR decisions. As United Kingdom (NICE) • Recommended for NHS use
such, this study aimed to evaluate how relative effectiveness France (TC) • Accepted for reimbursement
• eemed a minor improvement over existing therapies
D
assessment (REA) is used within the national PR processes.
Germany (G-BA) • Reimbursed
• eemed of significant added benefit in patients
D
Methods
with non-ST-elevation myocardial infarction or
unstable angina; of no proven added benefit in
other patient populations
IHS assessed the impact of REA on patient access to medicines
Case study 2: fingolimod
in Australia, Brazil, Canada, France, Germany, Italy, the United (relapsing remitting multiple sclerosis)
Kingdom, and the United States through primary and secondary Australia (PBAC) • Accepted for reimbursement upon price cut
research. Over 30 key relative effectiveness assessors and PR Canada (CADTH) • Restricted reimbursement
decision makers were interviewed to understand the methodology United Kingdom (NICE) • ecommended for NHS use upon proposal
R
for REA in their respective country, as well as their data of a patient access scheme
requirements and preferences by care segment and therapeutic France (TC) • Accepted for reimbursement
• Deemed a minor improvement over existing therapies
area.
Germany (G-BA) • Reimbursed
• eemed of no proven added benefit except in
D
Results patients with rapidly evolving RRMS where a slight
added benefit was found
Some countries assess new pharmaceuticals in relation to their Case study 3: fampridine
appropriate comparators to make public funding decisions, some (improvement of walking ability in adults with multiple sclerosis)
to inform pricing decisions/negotiations, and others leverage REA United Kingdom • Not recommended for NHS Scotland use1
(SMC; NETAG) • NETAG found no evidence for cost-effectiveness
in both their pricing and reimbursement decision-making
France (TC) • onditional reimbursement (reassessment within
C
processes. In terms of how therapeutic value is factored into the 12 months, 15% reimbursement level)
PR decision-making process, countries can be segmented into • Deemed of no improvement over existing therapies
broad categories based on whether or not costs are considered in Germany (G-BA) • Reimbursed
• Deemed of no proven added benefit
addition to clinical performance.
Italy (AIFA) • Rejected for reimbursement
REA position in REA assessment 1
: Automatic rejection, as manufacturer did not submit a reimbursement dossier
PR process methodology RRMS: relapsing-remitting multiple sclerosis | NETAG: North East Treatment Advisory Group
Source: IHS research, 2012
Australia Informs pricing Economic evaluation
and reimbursement In terms of information needs, payers wish to be in a position to
Brazil Informs pricing Mix of methodologies1 evaluate how new medicines compare with the standard of care in
and reimbursement their specific healthcare setting and in their patient population
Canada Informs pricing Mix of methodologies when making their PR decisions. In addition, they prefer hard
and reimbursement clinical endpoints on which to base their decisions. Surrogate
France Informs pricing Added therapeutic endpoints are not looked upon favourably, and when used, they
and reimbursement value evaluation
must be validated.
Germany Informs pricing Added therapeutic
value evaluation
Italy Informs pricing
and reimbursement
Mix of methodologies
Conclusions
United Kingdom Informs reimbursement Economic evaluation In relation to REA, patient access to medicines is more stringent in
United States Informs reimbursement Mix of methodologies countries that undertake economic evaluation. In the future, REA
will increasingly be used by payers to rationalise finite healthcare
1: Consists of the use of both an economic evaluation and an
evaluation of added therapeutic value
resources and budgets. This will limit patient access to medicines
Source: IHS research, 2012 that are not deemed to bring sufficient benefit in relation to
existing treatment alternatives. Reimbursement delisting and
The evaluation of the therapeutic value of a medicine can result in restricted reimbursement decisions are also likely to become
PR decision discrepancies across markets. These coverage more common.
disparities notably reflect societal and methodological differences
in the way the available evidence is interpreted across markets.
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