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Same-Day Analysis

Brazilian National Healthcare System Fails to Update List of High-Cost Reimbursed Drugs in Four Years

Published: 09 August 2006
The Brazilian Ministry of Health has not updated the list of reimbursed exceptional medicines, which are used for the treatment of chronic ailments, and high-cost drugs, in the last four years.

Global Insight Perspective

Significance

Despite pressure from patient groups, pharmaceutical companies, state authorities and the country’s courts, the list of high-cost reimbursed treatments in Brazil has not been updated since 2002.

Implications

The failure to update this list of exceptional medicines is clearly affecting patients across the country, who have been unable to access to more innovative and effective treatments free of charge.

Outlook

It remains to be seen whether the Ministry of Health will eventually admit that the list of exceptional medicines needs to be revised, and whether it will finally agree to expand it to include newer and more innovative drugs.

List of Reimbursed Exceptional Drugs Not Updated Since 2002…

The Ministry of Health in Brazil has failed to update the list of reimbursed exceptional medicines that are provided free to eligible patients within the public healthcare system, SUS, since 2002, according to local media. The list includes around 100 treatments indicated for several chronic ailments, such as cancer, hepatitis and diabetes. It is understood that approximately 390,000 people are registered in the Ministry of Health’s official programme for exceptional medicines, and are therefore entitled to receive these drugs free of charge within the public healthcare system. As the list has not been updated for the last four years, many patients have been forced to pay out when doctors have recommended a more innovative drug that is not included in the list. In other cases, patients have filed lawsuits against the public healthcare system to force it to provide the therapy free of charge. The number of lawsuits filed against the Ministry of Health has been increasing significantly in recent years. For instance, the state of Sao Paulo was obliged to reimburse drugs worth 200 million reais (US$92 million) last year following lawsuits.

Representatives of local doctors’ associations have stated that the list does not include essential treatments such as the anticoagulant clopidogrel and recombinant tissue plasminogen activators (rtPA), which are indicated for preventing cerebral vascular accidents (CVA). Other absentees from the list are the anti-hypertension drug losartan, which is recommended to 15% of patients suffering from hypertension, and psoriasis treatments containing infliximab, etanercept and efalizumab.

... As State Authorities Claim Funding is Insufficient

In addition, state authorities have claimed that the funds transferred by the central government to purchase these essential drugs are insufficient to meet current patient demands. The Ministry of Health transferred one billion reais to the different states for purchasing high-cost treatments for the SUS this year. However, a survey conducted by local daily OEstado de Sao Paulo shows that 15 of the 26 states and the federal district of Brasilia have been forced to increase their budgets for buying high-cost medicines. On average, the federal government should cover around 80% of the cost of exceptional medicines, although this percentage varies in many cases. For instance, the secretary of health in the state of Ceará claims that the state is responsible for 44% of high-cost drug funding.

Outlook and Implications

Brazil does not have a comprehensive public sector reimbursement scheme for out-patients. However, over the past few years, the government has implemented several schemes where reimbursement is available for specific ailments, or where low-income patients can access essential treatments either free of charge or at subsidised prices. For instance, the Ministry of Health ensures free access to HIV/AIDS treatment to any patient requiring it. The country’s AIDS programme is internationally lauded for distributing anti-retroviral (ARV) drugs free of charge, and is estimated to currently include around 170,000 patients. Another initiative is the state-owned pharmacy chain, Farmácias Populares, which was rolled out in 2004. Some 100 basic drugs are dispensed to poor patients at subsidised prices through this network. About 175 Farmácias Populares are currently operating in 135 municipalities across the country.

The failure to include new innovative drugs in the list of exceptional treatments is affecting patients more than anyone, as they cannot access newer and more effective therapies. Meanwhile, pharmaceutical companies are also being affected by the exclusion of their products in the list of drugs reimbursed by the SUS. It remains to be seen whether the Ministry of Health will agree to revise the list. It is understood that it has pledged to establish working groups for discussing the inclusion of new treatments. Global Insight believes that the eventual inclusion of therapies in the list will greatly depend on their price and cost-effectiveness, and the level of demand within the SUS.

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