Vast regional differences, discrepancies in pricing and reimbursement processes, and contentious right-to-treatment scenarios are just a few of the unique elements that make up the market access and reimbursement landscape in Brazil.
Given Brazil’s economic growth over the past twenty years leading to the ascent of the middle class—paired with an aging population—the demand for private hospital provision has risen, but private health insurers struggle to grow their market. In addition, a record number of new competitors have recently entered the Brazilian market. If you are not prepared for success in Brazil, all these factors combine to make a cocktail of market access confusion as potent as a caipirinha on Copacabana Beach.
Brazil’s Payer Stakeholders
The Brazilian government, through the National Health System (SUS), is the largest purchaser of medicines in Brazil. The government provides health insurance coverage to all the nation’s citizens as guaranteed in the country’s 1988 Constitution. However, there is great disparity in quality and access to care. Currently, approximately 149 million Brazilians (71.5 percent of the population) rely on the government as their primary health provider. Due to the COVID-19 outbreak, public health officials believe the percentage of citizens who depend on public healthcare services will increase considerably across the next few years.
Private health insurance is gaining momentum and now covers approximately 46 million Brazilians (28.5 percent of the population). Employers comprise the second-largest payer group. However, in some cases citizens invest on their own, thus meaning that the individual payer concept also exists in Brazil.
National Health Surveillance Agency – Approvals and Pricing
The National Health Surveillance Agency (ANVISA) oversees drug approvals. The agency is also responsible for establishing regulations applicable to clinical trials and drug pricing, which is carried out by the Câmara de Regulação do Mercado de Medicamentos (CMED). CMED is the key launch price decision maker and controls the increase in the maximum approved retail price of established drugs. Increases are sanctioned on an annual basis based upon multiple factors:
- Exchange rate movements
- Degree of generic penetration within relevant drug classes
- A contentious “productivity coefficient” that is applied uniformly across the industry, which has attracted widespread complaints from manufacturers
New drugs can be sold to the private sector upon marketing authorization by ANVISA and receiving CMED approval for a maximum retail price. However, products that seek state-funded reimbursement must overcome additional hurdles:
- The Comissão Nacional de Incorporação de Tecnologias (CONITEC) conducts a rigorous pharmaco-economic analysis of the new drug
- Final decision on funding by the Ministry of Health (MOH)
While MOH decisions take CONITEC evaluations into account, political and financial factors can mean a positive CONITEC recommendation does not always lead to a reimbursement listing. The government faces a growing number of legal challenges filed by patients seeking treatment with drugs that have been refused listing on subsidized outpatient formularies.
Benefit Schemes Designed to Protect Patients
Inpatient drugs are reimbursed in full, but patients must typically pay out of pocket for most drugs prescribed to them on an outpatient basis. Several outpatient benefit schemes designed to protect the patients from catastrophic medical expenses, which drive public sector drug spending. The significant schemes include:
- The national AIDS program, under which some 150,000 patients receive free antiretroviral treatment
- The Programa de Medicamentos de Alto Custo ou Excepcionais (PMACE)– program under which the government funds the provision of expensive drugs for the treatment of serious diseases
- The Farmácias Populares initiative, under which patients can access a limited range of heavily subsidized drugs, including asthma, rhinitis, glaucoma, osteoporosis, Parkinson’s disease, anti-hypertensive and diabetes drugs, and simvastatin from state-owned pharmacies and registered private retail outlets
CONITEC uses a cost-effectiveness model for inclusion on Federal reimbursement list. However, the more complex the medicine, the less this model is used. This has created a movement within the Pharmaceutical Industry Research Association (Interfarma) to lobby the government to use simpler models for value assessment that also include patient value.
Important Points to Keep in Mind
Private Plan Nuances
About 46 million Brazilian patients have private health insurance. Private health plans cover hospital-administered prescription medicines only. As a result, one in three beneficiaries of health plans in São Paulo resort to the National Health System (SUS) or to private healthcare professionals due to delays, problems or denial of care through the accredited network.
Lawsuits are a common route for patient access in Brazil. Many new and expensive drugs, including those for rare and chronic diseases, are not included in the SUS list. However, the government is obligated to purchase these medicines when the patient wins the right to treatment in court. In most cases, the Brazilian courts rules in favor of the patient, which has created a veritable litigation industry.
Despite being a problem for the government, medicines purchased by court order have become an important source of revenue for industry. The government has recently tried to decrease the number of court cases by creating a law that exempts from court rulings those drugs not yet approved by ANVISA.
Updated Rare Disease Research Regulations
In 2018, ANVISA established a process for the approval of rare disease clinical trials, reducing the total evaluation time of up to 6 months to an estimated 3 months. This resolution enables access to therapeutic options for the treatment of rare diseases in Brazil, making it an attractive place for rare disease clinical trials to take place.
The government is more willing to include products on its purchasing list when it reaches a technology transfer agreement with the pharmaceutical company. A medicine will be included on government formularies and after 10 or 15 years, the government assumes ownership of the technology and production of the product.
Implications for Industry
With price controls in place in Brazil, new drug launches are now the sole driver of real growth. However, the use of the international referencing mechanism limits initial launch price levels. Growing volume and/or capturing market share from competitors have emerged as dominant sources for companies to increase their market value.
Understanding the rapidly changing economic, regulatory and judicial landscape is critical to market access success in Brazil. The patient-first approach of seeking court action for access has been successful, but also requires deep knowledge of key actors and influencers at the federal and state levels.
Physicians are not pressured to limit prescribing to certain subgroups of patients in Brazil. Consequently, advocacy groups play an enormously important role in patient access to medicines. GLOBALHealthPR has worked with advocacy groups in all major therapeutic areas in Brazil and can help you connect your brand with the right patients.
Most recently, while the Federal Government has already negotiated a supply and licensing deal with AstraZeneca for hundreds of millions of doses of the University of Oxford’s COVID-19 vaccine, other states in Brazil have already signed agreements with China and Russia to produce their own coronavirus vaccines through technology transfer contracts. These large investments in COVID-19 vaccines (as well as potential therapeutics) may at some point impact the future reimbursement of other medicines.
Finally, competition, particularly in the biotech sector, is fierce in Brazil. Several new entrants (both startup and international) arrive in Brazil each year. This, combined with a wide-open generics market (with biosimilars imminent), makes it increasingly difficult for companies to stand out. GLOBALHealthPR has years of experience in developing strategies and campaigns to maximize your chances of value recognition and patient access in Brazil.
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