options for formulary development in middle-income countries

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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

HTAi 2016Tokyo, Japan 2016

OPTIONS FOR FORMULARY DEVELOPMENT IN MICs13/05/2016 2

Agenda

• Background• Objective• Framework• Mexico case study


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


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


Framework

Methodology• Literature review (Rapid evidence assessment)• 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


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


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


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


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• CSG has representatives from the six institutions• Coverage and provision of health is fragmented

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


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


Case Study Mexico:Assessment of the interventionIn 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


Case Study Mexico:Appraisal of the intervention1. CSG • Cost-effectiveness (public sector) • Budget impact (not for all treatment) • 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


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

– Differences in the epidemiologic profiles of states should be considered when identifying the “priority” interventions


Mexico Case Study: Conclusions (2)• Macro-level factors are not considered in any

stage of decision making process• Equity is rarely considered • Reduce inconsistent decisions among institutions

• Even when supported by the CSG, products are not taken up in the various insurance formularies across the system

• Health gain measurement• Adjustment to health-related quality of life


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]

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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


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

options for formulary development in middle-income countries

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