Expenditure Control and Cost-Containment Policies
Trench Rossi e Watanabe / Brazil
Join industry executives in staying informed on the market access and HTA process in Brazil.
1. Please describe the main cost containment policies in place in your country and their fundamental principles
a. Pricing and impact of generic/biosimilar approval
Generic drugs must have their PF 35% cheaper than the corresponding reference drug, as mentioned in Chapter 3, Question 2.
b. Clawback/Payback/Discounts/Rebates
As explained in Chapter 4, Question 1.1., PMVG is a mandatory discount over the PF, and applicable for sales to the public administration when the drug to be purchased is destined to comply with a court order or in cases where the drug is listed in the CMED’s Resolution 03/2020.
c. Existence of Price/Volume agreements in the frame of public tendering
Although there is no legal obligation in this regard, public administration entities are allowed to enter into such agreements if relevant to pursue the best public interest.
d. Existence of price freezes and cuts
Due to the principle of legality foreseen in the Federal Constitution, price freezes and price reductions can only be determined by law and in justified circumstances.
e. Post-launch monitoring of prescriptions/sales
Whenever applicable, sales of drugs must respect the PF established by CMED, as well as the PMC at retail level, as explained in items Chapter 4, Question 1.1. and 1.3.
f. Existence of Generic Substitution Policies
SUS doctors must always prescribe the active ingredient of the drug instead of brand names, which promotes access to generics.
g. At prescriber level
The policy mentioned in Question 1 above.
h. At retail level
At the retail level, drugs must be sold respecting the PMC set by CMED, as detailed in Chapter 4, Question 1.3.
2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc)?
Yes. There are tax incentive programmes aimed at pharmaceutical companies and certain drugs receive tax incentives. There is also the Popular Pharmacy Programme, which offers free medicines or at significant discounts through partnerships with private pharmacies and drugstores. In addition, the SUS provides financial incentive programmes for private health institutions that work in partnership with the public health system, as well as for other health actions, depending on the relevance/necessity.
