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OHE Consulting Ltd: Results reported here are preliminary, and subject to change as a result of journal peer review. The content of these slides is not
to be quoted or used without the consent of the authors.
OPTIONS FOR FORMULARY DEVELOPMENT IN MIDDLE-INCOME
COUNTRIESKarla Hernández-Villafuerte1, Martina Garau1, Adrian
Towse1, Lou Garrison2, Simrun Grewal2, David Grainger3
1Office of Health Economics, 2University of Washington,3Eli Lilly
XXXVI Jornadas de Economía de la SaludAES 2016
Murcia, Spain
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 2
Agenda
• Background• Objective• Framework• Mexico case study
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 3
Background• Middle-income countries (MICs) are undertaking major
reforms in pursuit of Universal Health Coverage (UHC)• WHO identifies HTA as a key tool in support of UHC• However…
• HTA has become synonymous with resource-intensive processes– Cost-effectiveness analyses – MICs have different levels of resources and capability
• Need for policy approaches enabling countries to make available new health interventions
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 4
Objective
To develop recommendations of the types of methods and processes that MICs could
introduce to identify medicines to include in national formularies and benefit plans
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 5
Framework
Methodology• Literature review • Panel of experts consulted (semi-structured interviews,
structured workshop and a survey)
Factors that should be considered1. Macro-level decision-making
• Related to design and organisation of the health system2. Micro-level decision-making
• Related to decisions on individual health technologies
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 6
Macro-level decision making factors
For each intervention considered
Does the new intervention match one or more of the national health
priorities?
To what extent is the current health care system ready for the
introduction of the new intervention?
Disease priorities
Health reforms (UHC)
Selected new treatments that are
feasible and match the national health
priorities
Additional factors to consider:
Are there positive spill-overs related to the new technology?
Health system intervention value (HSIV):Candidate for assessment and appraisal
WHO Building blocks(1) governance, (2) essential medical
products, vaccines and technologies, (3) financing, (4) service delivery, (5) health workforce (6) health information system
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 7
Micro-level decision making factors
Characteristics of the target population
(e.g. equity)
Disease-related factors (e.g. severity of the
condition)
What are the new intervention
effects?
Health effects
Impact on existing process
of careNon-health
benefits
Are population’s values and expectations
reflected in the analysis? Is the new
treatment good value for money?
Budget impact analysis
Cost effectiveness/
cost per clinical outcome
Is it the treatment affordable for the health system?
Financial factors
Affordability measures
Total financial impactAggregate intervention value
For each intervention considered
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 8
Decision making stagesBreadth of factors to consider
Value assessed Decision on:
How stages are allocated and
managed (process) varies from country to
country
Nomination and prioritisation Macro-level factors HSIV
Interventions to be assessed and
appraised
Decision making
approaches (aggregation) varies from country to
country
Assessment of the intervention Micro-level factors
Aggregate intervention value
and value for money
Recommendation for inclusion (or
exclusion)
Appraisal of the intervention
Micro-level factors HSIVDecision of
inclusion (or exclusion)
Macro-level factors Aggregate
intervention value and value for money
Financial assessment Budget Impact analysis
Financial sustainability
Affordability measure/s
Decision making stages
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 9
Responsible Institution Decision
COFEPRIS Market Approval
General Health Council (CSG) Inclusion in the public positive list
Via separated processes: Seguro Popular, IMSS, ISSTE, PEMEX, SEDENA and SEMAR
Inclusion in institutional positive list
Commission of price negotiation CCPNM
Negotiate public procurement prices for patented drugs
Mexico Case Study
Source: Authors’ elaboration with information from Santa-Ana-Tellez et al. (October 19th 2014)and Gómez-Dantés et al. (2012)
Process to make a new health intervention available to patients in the public sector
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 10
In general• There is not prioritisation: Manufacturers initiate the CSG
assessment processValue assessed• No consideration of macro-factorsDecision on• All the interventions are assessed and appraised Recommendations • CSG should be more proactive
• Request the submission of new treatments related to the priority diseases of the country
Mexico Case Study:Nomination and prioritisation
Framework Macro level factors:
Health system intervention value
(HSIV)
Framework Interventions to be assessed and
appraised
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 11
Case Study Mexico:Assessment of the intervention
In general• Each social security institution does an assessment• Assessment from the CENETEC Value assessed• Main analysis is for the cost-effectiveness for the public sectorDecision on• CENETEC opinion is not binding • Institutions prepare a position to be discussed at the CSG committeeRecommendations • Reduce duplication of assessments• More systematic consideration of :
o Equity issueso The impact on existing processes of care or care pathways
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 12
Case Study Mexico:Appraisal of the interventionIn general1. CSG • Cost-effectiveness (public sector) • Other factors not considered very systematically2. Appraisal in each institution• Budget impact and affordability• Other factors not considered very systematicallyRecommendations • Formal consideration of equity and the impact on existing
processes of care or care pathways • Formal consideration of regional differences• Health effects are measured in life year gained
– Adjustment to health-related quality of life
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 13
Mexico Case Study: Conclusions (1)• Achieving UHC:
• New treatment approved by the CSG and the social security institutions should be in line with the governmental reforms
• CSG• More proactive in the selection of the treatments that
are going to be considered for the public positive list• Spillovers
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 14
Mexico Case Study: Conclusions (2)
• Macro-level factors are not considered in any stage of decision making process
• Equity is rarely considered • Health effects measure adjustment to health-related
quality of life• Reduce inconsistent decisions among institutions
• Even when supported by the CSG, products are not taken up in the various insurance formularies across the system
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 15
THANKS FOR YOUR ATTENTION
This research was supported with funding from Pharmaceutical Research and Manufacturers of America (PhRMA)
To enquire about additional information and analyses, please contact Dr. Karla Hernandez-Villafuerte at [email protected]
To keep up with the latest news and research, subscribe to our blog, OHE NewsFollow us on Twitter @OHENews, LinkedIn and SlideShare
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OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 16
Mexico Case Study:Methodology
• Primary source- three interviews:• An industry representative• A representative of The National Center for Health
Technology Excellence (CENETEC)• An academic
• Secondary sources:• Literature review (rapid evidence assessment)• International data bases
OPTIONS FOR FORMULARY DEVELOPMENT IN MICs15/06/2016 17
In general• The six institutions consider this separately• The price of new medicines is negotiate by the CCPNMValue assessed• International Prices• Affordability of the health technologiesDecision on• Price for the patented drugs purchased by the public sector
Mexico Case Study:Financial assessment