The Evolution of HTA in Emerging Markets Health-Care ... - TREE

OHE Consulting Report for PhRMA
5 January 2011
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Blood and blood products and immunobiologics.
Component of Specialized Pharmaceutical Assistance
This component is devoted to financing drugs on a list of specialized drugs. These are defined as
drugs with potential of having a high budget impact, either due to treating high prevalent diseases or
because of a high unit cost. The inclusion of new drugs in the list of this component should be
evaluated by the National Commission for Technology Incorporation (CITEC), and all new inclusions
should be accompanied by a clinical protocol and therapeutic guideline. In this list, there are three
categories:
1A – Drugs purchased centralized by the federal government;
1B – Drugs purchased by states with funds from the federal government;
2 – Drugs purchased by states with their own funds;
3 – Drugs purchased by municipalities with their own funds.
The drugs included in the three programs above are offered free of charge to patients. In addition to
this, the Popular Pharmacy Program was created in 2004. This program is implemented in two ways:
Pharmacies are owned by the State and managed by Oswaldo Cruz Foundation (FIOCRUZ).
There are currently 521 pharmacies offering access to 107 drugs at cost. These drugs cover
diseases with high incidence in Brazil –gastric ulcers, depression, asthma, infections,
migraine, burns, alcoholism, among others. FIOCRUZ buys the drugs preferably from official
public pharmaceutical laboratories and, whenever necessary, from private laboratories.
Private pharmacies in a partnership with the public system: 7,292 pharmacies are eligible to
offer drugs included in the program, covering treatments for diabetes, hypertension and
contraceptives. The federal government pays for 80% of the reference list price and the
difference should be paid by patients out-­‐of-­‐pocket. This is part of the initiative to
universalize access to health care.
The legal right to access to drugs for health
Given constitutional right to health, Brazilian citizens sometimes sue the government for access to
specific medicines that are not on the national formulary. The suit applies only to the specific
patient who brings it: it is not a “class action.” Some would argue that this is an untenable approach
in the long run. Effectively, it becomes a route around HTA as well as the negative decisions by
CITEC). Clearly, it is a costly and inefficient method to reach these societal decisions.
Provision and Reimbursement
Services are provided by primary care units and public hospitals in the federal, state, and municipal
level. Services may be also provided by private hospitals and clinics dedicated to the public system.
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