Last week, the Brazilian Ministry of Health (MoH) announced plans to spend BRL$ 130 million (~US$ 188 million) per year to make trastuzumab (Roche's Herceptin) available to public healthcare patients, by incorporating this drug into the public healthcare units of the National Health System (SUS). Trastuzumab is considered one of the most effective drugs in the treatment of breast cancer and also one of the most sought after; in a country where approximately 75% of the population relies entirely on government-sponsored healthcare, this initiative is a major advance in the treatment of breast cancer.
Trastuzumab's inclusion in the SUS is part of the National Plan for Prevention, Diagnosis and Treatment of Cervix and Breast Cancer, a strategy to expand cancer care in Brazil. The initiative was approved by the National Commission on Incorporation of Technologies (CONITEC), and covers trastuzumab for the treatment of early and advanced breast cancer in patients with HER2 amplification. Many more Brazilian breast cancer patients will now be able to receive free treatment with this effective drug, previous access to which was restricted almost entirely to women who could prove their entitlement to receive it from the government by resorting lawsuits. The Brazilian Federal Constitution dictates that access to healthcare is a social right and independent of financial capacity, so, as was explained to Decision Resources by a member of the Comissão de Farmácia e Terapêutica (CFT) at SUS for our previous studies, If a patient can't access treatment, it is up to judicial action. That's how it works in Brazil. Indeed, this phenomenon is not limited to trastuzumab; we found, from primary research with oncologists, that in Brazil almost one-third of patients who receive government funding for a targeted cancer drug do so only after a court order has been issued. Nonetheless, trastuzumab is the seventh most requested drug by judicial action to the MoH. In 2011, the MOH spent BRL$ 266 million on the purchase of drugs by court decisions, and BRL$ 4.9 million to meet the 61 purchase orders of trastuzumab specifically. In 2012, at the time of writing, the federal government has already received 98 court orders for the purchase of this medicine and spent BRL$ 12.6 million.
Brazil's Health Minister, Alexandre Padilha, has declared that the decision to incorporate trastuzumab into the public healthcare system was independent of the judicial actions associated with trastuzumab, and that this acquisition was possible only because of cost savings generated by technological innovation, public-private partnerships, international price comparison, and centralized purchasing. The incorporation of the drug into the SUS requires that the price used by industry is consistent with what is applied in the international market. Moreover, because it is a bulk purchase, and to secure steady demand and provision, there will be price negotiations between the government and the manufacturing laboratory, which may have to lower the price of its drug up to 50% in order to settle the public acquisition. Currently, trastuzumab is not manufactured by Roche in Brazil, so the product has to be imported from the Western markets. As it will be acquired by the government, trastuzumab will be exempt from all taxes. However, even with tax exemption, the cost of trastuzumab will weigh heavy on the SUS budget, and we believe that the Brazilian government will strongly encourage the local development of biosimilars once trastuzumab's patent expires in 2014. Therefore, the immediate question in our minds is, how aggressive will Roche's market strategy be for the commercialization of its drug in order to secure provision of it to breast cancer patients in public institutions after the entrance of biosimilar trastuzumab into the Brazilian market. A suboptimal strategy may see this market opportunity slip away, because whichever company matches the demanded units with the lowest price will surely win the public acquisition of trastuzumab by the MoH.