Argentina has no formal pharmaceutical price controls and manufacturers have been free to set list ex-factory prices. In June 2020, the current government administration fixed the maximum retail price of an orphan drug, nusinersen (marketed as Spinraza, a treatment for spinal muscular atrophy). Such price regulation is unprecedented, and raises questions on the future of drug pricing in Argentina.
Nusinersen first received access in Argentina prior to regulatory approval by the ANMAT (National Administration of Drugs, Foods and Medical Devices) via exception through the RAEM (Regime of Exception for Access to Medication). Exceptional access is commonly used for orphan drugs with FDA approval in indications with high unmet need, with payers reimbursing the importation price in $USD (in the case of nusinersen, the full US WAC of $125k/injection). The price of nusinersen faced a lot of scrutiny given the budget impact implications and the mismatch with payers’ ability to pay.
Following ANMAT approval, the government administration decided to negotiate a confidential price with the manufacturer, responding to the increasing pressure from patients demanding access and the impending budget impact. However, the agreement was not well received by payers because the price was still prohibitive and the drug was included in the PMO (Mandatory Medical Program), which does not provide funding and mandates coverage for union HMOs and prepagas (pre-paid healthcare companies).
Facing increasing pressure from payers, the current administration took actions in June to break the previous agreement, remove nusinersen from the PMO, and fixed the maximum retail price. Price control measures included referencing to the Brazil list price set by CMED and an internal calculation to harmonize the price with Argentina’s situation. The new resulting controlled price of $27k/injection is lower than other countries in the region, such as Brazil and Colombia, and represents a price cut of ~80% compared to the initial price matching the US WAC.
The question now is whether the current government could institutionalize drug price control more broadly in Argentina following this precedent. Experts highlight that it could be possible given the pressures facing the current government and the significant impact of the COVID-19 crisis on the overall economy and the healthcare budget. Pharmaceutical manufacturers should consider this as a possibility on the horizon; therefore, it is a good idea to understand potential risks for the pricing strategy of upcoming launches in Argentina, in relation to the rest of Latin America.