Plenary Session
Conference Co-Chair
Implementing Pharmacoeconomic Guidelines In
EvidenceEvidence-Based Decision Making In Latin America:
Lessons Learned?
First Panel: When To Develop PE Guidelines
Second Panel: Issues In Developing PE Guidelines
Third Panel: Issues In Implementing PE Guidelines
Marcos Bosi Ferraz MD, PhD
Professor and Director
São Paulo Center for Health Economics
Federal University of São Paulo
São Paulo, Brazil
Plenary Session
First Panel: When To Consider PE Guidelines
Lead Panelist
Federico Augustovski MD,
Buenos Aires, Argentina
Plenary Session
First Panel: When To Consider PE Guidelines
Panel Members
Panel Members
Gabriel Carrasquilla G
Bogotá, Colombia
Pamela de la Rosa
Guatemala, Guatemala
Alarico Rodriguez MD
Marino J. Gonzá
González R. PhD, MSc, MD
Motevideo, Uruguay
Caracas, Venezuela
Plenary Session
Plenary Session
Second Panel: Issues In Developing PE Guidelines
Third Panel: Issues In Implementing PE Guidelines
Lead Panelist
Lead Panelist
Panel Member
Guillermo Melendez MD, MSc
Mexico City, Mexico
Emilio Santelices Cuevas MD, MBA
Santiago, Chile
Alexandre Lemgruber MD
Brasilia, Brazil
F ir s t
Plenary Session
Implementing Pharmacoeconomic Guidelines In
EvidenceEvidence-Based Decision Making In Latin America:
Lessons Learned?
Several countries in the region have developed,
or are considering developing PE guidelines.
The use of PE guidelines in decisiondecision-making
raises many methodological and practical issues.
Given the experience already gained with PE
guidelines within the region, it is time to learn
from each other.
In this plenary we explore what can be learned
by considering three clusters of countries at
different stages in their use of guidelines.
Michael Drummond MCom, DPhil
Professor of Health Economics
Centre for Health Economics, University of York
York, UK
Plenary Session
First Panel: When To Consider PE Guidelines
When to Consider PE Guidelines
Lead Panelist
Federico Augustovski MD, MSc
Director, Health Economic Evaluation and
Technology Assessment
IECS (Institute for Clinical Effectiveness
and Health Policy)
Buenos Aires, Argentina
Health Care System Characteristics
y Framework – How is health care financed?
y Approval Policies – How is a technology / drug
/ device approved?
y Pricing Policies – How is price determined?
y Reimbursement Policies – How is it reimbursed
– i.e., who pays?
y Financial Control Policies – Formulary or other
financial control procedures
Argentina – Colombia Framework
y Multitier system divided in three large sectors: public
(35%), social security (55%), and private (10%).
y Compulsory Medical Package (PMO) for social security
y Financing and delivery of healthcare by each of the 24
y Social Security System based on health insurance with two
schemes: Contributive - 40-50% of population; and
Subsidized (for the poor) – 30-35%
y More coverage (procedures, interventions, medicines) for
contributive, but the per capita unit price is smaller for
subsidized. Compulsory Plan of Health (POS)
Guatemala – Uruguay Framework
y Social Insurance provides workers and pensioners healthcare
(workers and employees contributions)
y Free consultations and tests in hospital and primary care
networks mainly for uninsured
y Main out of pocket expenses in drugs (pharmacies through
“Programa de Accesibilidad de Medicamentos”).
y 2008: the National Integrated Health System (SNIS), the
National Health Insurance (FONASA) and the National Board of
Health (JUNASA). 100% coverage (56% public providers)
y The Integrated Plan for Health Care (PIAS) is the health benefits
package mandatory for basic providers (private and public) and
the National Agency for Highly Specialized Medical Procedures
(FNR). The FNR is a marking fund that finances catastrophic
procedures, devices and drugs.
Argentina – Colombia
Approval Policies
y Classic licensing agency (ANMAT ), with no formal fourth
hurdle system currently in place.
y The Superintendence of Health Services of the Ministry of
Health (SSS) is responsible for the PMO
y The Federal Health Council (COFESA) convenes the federal
minister and the provincial ministers of health
y New drugs or medical devices to be included in the benefit
packages must be approved by the CRES (Regulatory
Commission of Health).
y Recommendations should come from the Committee of
Assessment of Medicines and Health Technology.
y Methodological guidelines (PE/BIA) have just been
developed for the Ministry of Social Protection.
Venezuela – Framework
y In the last 12 years, there have been no significant
reforms in the financial, regulatory or organizational
sectors. In practice, decentralization has also regressed.
y Health System with two contributive regimes
“Solidario”, compulsory affiliation
Complementary, voluntary affiliation
y Main Health Institutions: Ministerio de Sanidad y
Asistencia Social (MSAS), Instituto Venezolano de los
Seguros Sociales (IVSS), Instituto de Previsión Social del
Ministerio de Educación (IPASME), Instituto de Previsión
Social de las Fuerzas Armadas (IPSFA).
Guatemala – Uruguay
Approval Policies
y New drugs or devices approved by “Dirección General de
Regulación, Vigilancia y Control de la Salud’ (MoH dependency)
y Cordinated with “Dirección del Sistema Integral de Atención en
Salud”, quality control and auditing
y Also regulates acreditation of health services
y Also participates and supports research, training, and diffusion
of information
y There is no regulatory agency. The Division of Technology and
Drugs of the General Health Direction (DIGESA)-Ministry of
Health, acts as such (no fourth hurdle).
y The Ministry of Health includes PIAS and FTM. In the case of
drugs included in the FTM of FNR, review of economic
evaluation, and budget impact performed.
Venezuela – Approval Policies
y New Drugs, and
y New Devices,
y Need approval/authorization by “Ministerio del
Poder Popular para la Salud”.
y No fourth hurdle
Argentina – Colombia
Pricing Policies
y There is no formal drug price regulation, and sale prices are
set according to market demands.
y For the insurance companies as well as hospitals the
pharmaceutical companies make agreements for discounts
depending on the amount of the purchase.
y The Ministry of Commerce (Not the MoH) makes decisions
on policies for drug prices and defines a top price that
should be in the label of the package.
y For the insurance companies as well as clinics and hospitals
the pharmaceutical companies make agreements for
discounts depending on the amount of the purchase.
Guatemala – Uruguay
Pricing Policies
y Multilateral agreement for open contracting in order to obtain
competitive prices
y Bidding related to drugs considered by WHO for poor countries
y Sale prices of drugs distributed by the Program for Drug
Accessibility authorized by a board, with a sustainability margen
of 35%
y No price regulation. The Trade Direction controls prices in
pharmacies and drug stores and allows a 25% discount.
y Private providers perform agreement discounts
y Public providers engage in joint bids for the purchase.
y Medicines under coverage of FNR (monopsony) are marketed
through negotiations of FNR-pharmaceutical industry or tender.
Argentina – Colombia
Reimbursement Policies
y Essential drugs in a positive list delivered to all of the public
primary care centers (Program “Remediar”, or now FEAPS).
y Compulsory package of benefits (PMO) social security.
Venezuela – Pricing Policies
y Mixed price system since 1994
y List of essential drugs, whose prices are published by
the “Ministerio de Comercio” jointly with MoH.
y The rest of drugs, and devices, are not regulated.
y IVSS has a policy for high-costs drugs for chronic
and oncological illnesses that gives any citizen free
acces to it.
Guatemala – Uruguay
Reimbursement Policies
y No reimbursement system in place for the Public Sector
y Only in the private sector through insurance companies
y Ambulatory drugs are subsidized in a variable proportion
y Special fund (APE) to reimburse the funds for most of the high-
cost technologies.
y Insurance companies provide all services included in the benefit
y When the Insurance company denies the provision of heath
care, the patient goes to the Justice.
y In this case the insurance company is reimbursed by FOSYGA
(Solidarity and Warranty Fund)
y Drugs in the FTM of compulsory coverage for basic
providers are bought by the providers (private through
copay or public).
y Those under coverage of FNR funded by that institution
without copayment.
Argentina – Colombia
Financial Control Policies
Venezuela – Reimbursement Policies
y IVSS has a policy of reimbursement for high cost
drugs for chronic and end of life illnesses which gives
free access to all citizens.
y National reference pricing for +/-200 essential drugs
y Generic prescribing has been strongly enforced.
y Agreements between the government and pharma
y PMO is irregularly updated.
y CRES has the mandate to define the UPC each year as
well as the content of benefit packages.
y Guidelines will be developed in the coming year that
should have an economic evaluation and budget impact
y Based on this evaluation, CRES will define what should
be included in the POS given budget constraints
Guatemala – Uruguay
Financial Control Policies
y Open Bidding for listed drugs
y Drug list based on consensus
y Process of elaboration of national guidelines that include
health economic information and efficiency principles
y Basic service providers must report monthly to the General
Secretariat Director (DIGESE) of the MoH in the National
Information System (SINADI): total expenditure on
medicines, dispensed drugs, number of prescriptions, etc.
y The FNR does not report to the SINADI. Nonetheless, it
has external and internal financial control that is publicly
y Group of countries with a rather fragmented
healthcare systems
y Most have a compulsory benefit package for the
social security system
y No formal pharmacoeconomic / 4th hurdle system
currently in place
y Methodological guidelines are being
considered/developed that include PE guidelines
mainly for inclusion of services in the benefit
packages (Uruguay, Colombia)
Venezuela – Financial Control Policies
y There are no financial control policies in place.
y At the ambulatory and hospital level, only drugs that
are listed in the current essential drug list are
y Strong preference for generics in case there is a
y No formal drug price regulation, except for reference
prices for essential drugs in some countries
y Reimbursement policies for some high costs/impact
technologies (Argentina, Uruguay, Venezuela)
y Most have a list of essential drugs provided or
subsidized by the government or social insurance
y Finnacial control policies include range from
reference pricing, mandatory positive lists, open
bidding processes, and incorporating a 4th hurdle
Plenary Session
Thank You!
y [email protected]
Second Panel: Issues In Developing PE Guidelines
Lead Panelist
y [email protected]
y [email protected]
y [email protected]
Guillermo Melendez MD, MSc
Mexican Health Foundation
Mexico City, Mexico
y [email protected]
Issues in Developing PE Guidelines
Health Care System Characteristics –
Discussion Points
y Framework – How is health care financed?
Health Reform in Chile
y Approval Policies – How is a technology / drug
/ device approved?
y Issues to consider on implementing PE guidelines in
a country
Health Reform Principles
y Right to health
{ Inequity
to access, opportunity and financial
{ Epidemiologic transition
{ People’s demand increasing
All Chileans must count on a mechanism of social protection,
universal access to suitable and timely health care, and
healthy conditions in their communities and workplaces.
To safeguard the right to health, explicit guarantees in access,
opportunity, quality, and financial protection are established,
as well as the instruments to effectively exercise them.
y Equity in Health
The health reform seeks to reduce all unjust and avoidable
inequalities by increasing the levels of social protection and
universal access to health care.
Health Reform Principles
y Solidarity in Health
The deliberate effort Chilean society makes so that the most vulnerable
have same guarantees as the most privileged individuals
y Efficiency
In order to realize the preceding principles, a prerequisite is reaching a
high level of efficiency in the use of resources inverted in the sector.
This improved efficiency must be attained through better resource
management, and better focalization and the use of health subsidies.
y Social participation in health
It implies recognizing individuals as users and citizens to whom the
health system is accountable. It allows citizens to express their
preferences and expectations with respect to the health system and its
corresponding public policies
Health Guarantees Law
y Access : Care associated with the list of priority illnesses and
appropriate level of complexity
Systems with
Explicit Guarantees
y Opportunity: Health care protocols and maximum time of
delivery services
y Quality : Services delivered by accredited providers
y Financial Protection :
56 Priority pathologies
Maximum Times - Protocols - Financial Protection
Access not limited by payment capacity
Free access for beneficiaries lacking ability to pay
For those who can pay, a maximum co payment
Studies to determine priority
1. Pathology value study: It analyzes the problem magnitude
between the pathologies (included in this priority scale)
and the effectiveness of the related interventions/
operations proposed to resolve each of them.
2. Social value assigned to the health care system: This study
is included to consider citizens’ opinion/assent regarding
each pathology importance.
3. Expected Cost confirmation: This procedure includes cost-
studies to determine individual expenses related to each
pathology standard of care.
Health Reform in Mexico –
y Two main access to health care populations are
represented in Mexico
Insured (51%)
Uninsured (49%)
y Insured population is covered by
{ IMSS, ISSSTE, PEMEX, Military, Navy and private insurance
y Uninsured population is covered by Federal
Popular Insurance
Ministry of Health facilities for the worst off.
Mexico – Framework
y A fragmented Health system split into multiple
institutions such as IMSS and ISSSTE (50%),
PEMEX (6%), Popular Insurance Coverage (30%),
Military (2%) Navy (2%), and the private sector
(10%) makes it inefficient.
y Important inequalities in health care per capita
y Total health expenditure around 6.3% of GDP, one of
the lowest within the OECD
Mexico – Approval Policies
y COFEPRIS is the Regulatory Agency approving a drug to be
able to get into the private market.
y Health General Council (HGC) is the Regulatory Directorate
approving a drug to be included into the National Formulary
y By law a pharmacoeconomic analysis is required in the
submission dossier
y After the HGC has granted inclusion into the National
formulary, each institution is entitled to decide whether or not
the drug is purchased according to:
y Budget availability
y Previous experience with the drug at the institution
y Priority of disease
y Drug costs.
Issues in Developing PE Guidelines
y After the MoH realized that the purchasing by
different institutions representing the insured
population was inefficient, as prices varied
importantly among institutions, the government
created the “Coordinating Commission for Prices
negotiation” on February 26th, 2008.
y This commission is composed by representatives of
Ministries of Economics, Tax Collection, IMSS and
y This is a commission to contain institutional costs
Lessons Learned
y To establish a Health System with an explicit guarantee
has been a great challenge in Chile
y To identify an algorithm of prioritization is key in the
design of Program.
y Is necessary to implement guidelines for each different
pathology selected.
y We recommend that the design of protocols are built with
the participation of specialists and developed across the
best evidence
Lessons Learned
y To create a guaranteed mode of health services
involves :
To prepare the providers for new demand
To increase resources in all levels:
Infrastructure, Human Resources, Technologies and Budget.
To create mechanisms to avoid discrimination between
patients with Financial Guarantees over patients without
them (Pathologies non included).
{ To install monitoring procedures with Technological
Issues in Developing PE Guidelines
Issues in Developing PE Guidelines
y What benefits does a country obtain by
y What benefits does a country obtain by
implementing PE guidelines-1?
implementing PE guidelines-2?
Cost containment
Evidence based medicine for a new drug
Evidence for improved standard of care
Setup clear rules for all parties on what to consider when including a new drug in the medications budget of any particular institution
Technically, new evidence is being produced for the comparators
Issues in Developing PE Guidelines
Cons • Not all playing parties might agree on setting up the guidelines
• Lack of qualified personnel to submit and to review the new health technology assessment?
• Guidelines might be ahead of the right time and interest for implementing it may be lost. • Guidelines may be a point of controversy between government and the productive sector. {
More objective evidence is produced for supporting the purchasing decision making.
Everybody understands the PE guidelines are supporting tools only.
Decision­makers can estimate the impact on budget.
Are part of a more efficient decision process in the budget expenditure. Issues in Developing PE Guidelines
ƒ Who wants the guidelines to be implemented?
ƒ Is it the government who wants the guidelines?
ƒ Is it the Pharmaceutical Industry who wants the
ƒ Do all sectors involved agree on the guidelines
setting up?
Plenary Session
y Implementing pharmacoeconomic guidelines in a
country should represent a real benefit.
y All involved parties must agree on the
implementation and be aware of acquired
responsibilities with the guidelines
y Guidelines have limitations, they just make the rules
y Circumstances evolve and so the guidelines require
periodical review to keep updated. They are not once
in a life work
Third Panel: Issues In Implementing PE Guidelines
Lead Panelist
Alexandre Lemgruber MD
Head, Office of Economic Evaluation of New Technologies
Brazilian National Health Surveillance Agency (ANVISA)
Brasilia, Brazil
Issues in Implementing PE Guidelines
(The Brazilian Experience)
Pricing decisions
Price regulation policies are defined by a body formed by
5 Ministries
{ The implementation is responsibility of the Office of
Economic Regulation, at the Brazilian Health
Surveillance Agency (ANVISA)
{ Pharmacoeconomics is applied to the decisions on the
prices of new drugs
{ If a new drug is no better than the best treatment
available, its ceiling price is defined based on a costminimization analysis; if it is better, the ceiling price will
be the lowest among 9 reference countries
{ A mandatory discount of 24,92%, based on Human
Development Index, is applied for a list of drugs
Pharmacoeconomic studies area complex task:
Reimbursement decisions
There is a Committee responsible for giving
recommendation to the Minister of Health regarding
the incorporation of new technologies (CITEC)
{ The Minister has the final call
{ This Committee decides based on HTA reports
{ Economic Evaluation is one of the requirements set by
the legislation
“to identify, to measure, to value and to compare the costs
and consequences of alternatives being considered”
Ù That includes:
| To choose variables: efficacy/effectiveness/QALY,
| To choose modeling: analytical models, perspective,
time horizon, type of evaluation, sensitivity analysis.
| To choose parameters: discounting rate, transition
Thus, many countries have been developing
pharmacoeconomic guidelines to ensure robustness of the
study and applicability of the results on decision making
The process of elaborating the Brazilian
Pharmacoeconomic Guidelines
Pharmacoeconomic Guidelines around the world
y Working Group on HTA (GT-ATS) (2006):
Definition of the general issues: objectives, target audience,
First version (2007):
{ Cid Manso Vianna (IMS/UERJ)
{ Rosângela Caetano (IMS/UERJ)
First revision (2007): Maria Alícia Ugá (Fiocruz)
Two workshops for evaluating the guidelines (2007),
{ Representative from the Ministries of Health and of Economy,
Regulatory Agencies and Universities
{ Experts in economic evaluation
Discussions in broader audience (2008)
{ 2nd ISPOR Brazilian Chapter Congress
{ Public consulting
Final revision (2009): Everton Nunes da Silva (Decit/MS)
Publication (2009)
To consider methodological issues turned to economic
evaluation of health technologies
Few publications in Portuguese language
To standardize the economic evaluation in the Ministry
of Health:
Internal technicians
External researchers
Ù Industry
Level of agreement with the Guideline
y All 23 major topics had agreement of 50% or more of the
participants in the public consulting (Government: 37%;
Universities: 37%; Industry: 19%; Others: 7%)
y Only 3 topics had agreement of less than 60%: study
perspective, intervention description and discount rate.
The focus was not to produce didactic material,
but to make recommendations to be used in
Using the Pharmacoeconomic
Guideline - today
Using the Guideline – near future
y At the Ministry of Health:
Internal reports
Public calls
It guides the internal literature evaluation
The Ministry of Health, through the Department of Science and
Technology, demands economic evaluation studies which must use
the guidelines as their north. Around 40 studies are following the
y MERCOSUL: The Brazilian Guideline has been adapted
and is under review by the MERCOSUL members
y Industry: to follow the guideline when to submit studies
to the Government
y ANVISA and ANS: to use the guideline in all economic
In the context of its process, they can demand economic evaluation
studies and they also evaluate the same kind of studies coming
from the industry in order to subsidize the decision making
CONCLUSIONS: What have we learned?
y The elaborating process must aggregate a broad
{ Experts in the field
{ Researchers that carry out economic evaluation
{ Stakeholders
Plenary Session
Implementing Pharmacoeconomic Guidelines In
EvidenceEvidence-Based Decision Making In Latin America:
Lessons Learned?
y The process is as important as the final product
y It might have periodical revisions of the
{ The guideline will be revised in two years, based on
the feedback given by the users.
Michael Drummond MCom, DPhil
Professor of Health Economics
Centre for Health Economics, University of York
York, UK
Plenary Session
Respondent Discussion
David Bruhn
PharmD, MBA
Outcomes Research Scientist
San Diego, CA, USA
Wilson Follador PhD,
PharmD, MSc
Joaquin Federico Mould
Quevedo PhD, MBA, MSc
Outcomes Research Manager
Market Access and Health
Pfizer SA de CV
Economics Manager
Mexico City, Mexico
SanofiSanofi-Aventis Farmaceutica Brazil
São Paulo, Brazil
Plenary Session
Implementing Pharmacoeconomic Guidelines In
EvidenceEvidence-Based Decision Making In Latin America:
Lessons Learned?
Michael Drummond MCom, DPhil
Professor of Health Economics
Centre for Health Economics, University of York
York, UK
Plenary Session
Implementing Pharmacoeconomic Guidelines In
EvidenceEvidence-Based Decision Making In Latin America:
Lessons Learned?
Questions & Answers

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