ARTICLE SUMMARY:
After years in development, Brazil launched a public price benchmarking database for implantable devices April 1. Excerpted from Pathways’ Picks, April 7.
The first devices to be put under the limelight in the database are coronary stents, both bare-metal and drug-eluting. The database is intended to help counter a history of corruption linked to overinflated pricing for implantable devices in the country. It lists reference prices, with quartile ranges, for stents with different technical attributes, based on a combination of list price information the manufacturers submit to ANVISA as part of the regulatory registration process and public procurement information. The government is not imposing any price controls on the products—the information is intended to improve transparency so hospitals are at greater advantage in procurement negotiations. (See “Brazil Device Price Database Plan Starts to Take Form,” Market Pathways, August 7, 2020.)
Device companies selling products into Brazil have engaged closely with the regulatory agency ANVISA on the development of the price database policy. The agency has used it as a pilot process for adopting internationally recognized “good regulatory practices,” including a transparent regulatory impact assessment procedure, which will now apply for the development of all new ANVISA regulations. Firms were already required to submit price data before the new rules—now, they need to more directly link list prices with particular product attributes, such as stent coating, drug, thickness, etc. Upon the April 1 launch, 3,957 stent models were listed in the database from 20 different companies. ANVISA has identified 11 additional cardiac device types, including various types of cardiac rhythm management devices, that will ultimately be included in the price database. The agency says it will work with stakeholders to define and update the appropriate technical attributes to monitor for each device.
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