A State of Healthcare in Brazil
Brazil is projected to become the world’s sixth largest pharmaceutical market by 2014 which should, in theory, provide an excellent market for new and innovative therapies for patients with lymphoma and leukaemia. Adding to the potential attractiveness of the Brazilian market is that universal access to healthcare is guaranteed for all citizens, regardless of income and whether or not the person is Brazilian.
In essence, if a doctor prescribes a treatment, the constitution says it has to be paid for by the government. To facilitate access to treatment, funding reviews are undertaken within nine months.
To help ensure Brazilians receive treatment in a prompt fashion, the government is taking steps to speed up the regulatory review process for technological innovations and priority medications for hypertension, diabetes and cancer with the aim of having approvals made within six months rather than the average nine months.1 In addition, as of April 15, 2013, all drug applications need to be made electronically with the goal of having all drug evaluations done electronically by the end of 2013.1
Changes have also been made to the funding review process carried out by CONITEC (National Commission of Incorporation of Technologies). Since its establishment in 2012, it has issued 32 appraisals that have assessed 48 health technologies (85 per cent for drugs) for 26 therapeutic indications, almost twice the number of the former health technology assessment commission CITEC (Commission for Incorporation of Technologies) evaluated in an average year.
So, this sounds good but all is not quite what it seems.
While the 1998 Brazilian constitution guarantees universal access to healthcare, not all medicines are included in the formulary. This results in patients taking legal action to force the government to provide the medication. If the court decides in favour of the patient, the treatment must be made available within 72 hours or authorities are fined.2 Lawsuits — most frequently filed by patients with cancer or a rare disease — have increased from 3,200 in 2009 to 19,500 in 2011.2 While it would seem that patients at least have the means of taking action, not all of them are likely to be aware of their constitutional rights and doctors are under tremendous pressure not to prescribe medications that are not available.
While there is a priority review system, it is targeted towards approving generics rather than innovative treatments and technologies. In addition, there is a lack of transparency and it is not clear what drugs receive a priority review. The regular review process undertaken by ANVISA (National Health Surveillance Agency) takes an average 18 months; however, the length of time depends on the quality of the information provided by the manufacturer and whether any information is missing. Even if the submission is made correctly, there is a lack of transparency as to what is actually happening during the review process.
Lenalidomide provides an excellent example of how long the review process can take. Originally submitted in 2007, it was not approved because there was confusion among advocacy groups as well as other bodies as to whether or not it was similar to thalidomide and would result in the same negative effects seen with thalidomide in the 1960s. The second time lenalidomide was submitted for review, it was turned down because no trials had been done that compared it with bortezomib. Efforts then had to be made to find studies that had compared lenalidomide with other drugs for the treatment of multiple myeloma. This information has now been gathered and a decision has to be made whether to submit to ANVISA for a third time.
When it comes to funding reviews, the work undertaken by CONITEC is not as wonderful as it would seem. When first formed, CONITEC required all drugs already submitted for a funding review to be resubmitted. CONITEC also appears to take into account decisions made by other funding bodies. For example, if the National Institute for Health and Clinical Excellence (NICE) in the UK has issued a negative appraisal, CONITEC will not evaluate the drug submission. However, a positive appraisal by NICE does not necessarily mean a positive appraisal by CONITEC. Reasons for denying funding have included insufficient evidence to support efficacy and safety claims (73 per cent); studies not undertaken for a long enough period of time (36 per cent); and insufficient sample size and no phase III/IV studies included (20 per cent). Of the innovative treatments receiving a positive appraisal, most were for relatively small patient populations and it would seem that all appraisals requested by the Ministry of Health received a positive recommendation; nearly all submitted by pharmaceutical companies were rejected.3
Reimbursement by the government is also tied to the type of cancer a patient has. However, with the new treatments available reimbursement is inadequate as they are too expensive. Rituximab provides a good illustration of this problem. In 2009, the Minister of Mines and Energy Resources, Dima Rouseff who is now the current president, was diagnosed with non-Hodgkin’s lymphoma. She was surprised to learn that her treatment was not covered by the Cancer Treatment formulary. It wasn’t until August 2010, that rituximab was included in the formulary. What is unclear if its inclusion was the result of political pressure or efforts on the part of other organisations.2
And even if a treatment is included in the formulary, as public healthcare funding is collected and distributed at the state and municipal levels, treatment may not be widely available in every state or municipality for a number of reasons; namely, only a few patients have been diagnosed with the illness, there is a lack of awareness that the drug is on the formulary, and a lack of knowledge or commitment on the part of doctors to ensure patients have access to treatment.2
What can we do given that our aim is to make every effort to ensure patients with lymphoma and leukaemia receive the best possible care, in spite of the lack of transparency and other road blocks encountered in getting new and better treatments available in Brazil? We can try and make the approval and funding process smoother and more transparent. If you would like to help with this initiative please contact us through our website at http://www.abrale.org.br/.
Merula Steagall and Dr. Dirceu Raposo de Melo. ABRALE, Brazilian Association of Leukaemia and Lymphoma
1. Brazil to expedite review and approval process. regLink News. March 25, 2013. http://www.reglinkassociates.com/reglink_breaking_news_archive.html. Accessed July 25, 2013.
2. Yates M. Brazil’s healthcare conundrum. PMLiVE. June 25, 2013. http://www.pmlive.com/pharma_news/brazils_healthcare_conundrum_484408. Accessed July 25, 2013.
3. Unlocking the key to public funding in Brazil. Pharma Exec. June 1, 2013. http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=816162&pageID=1&sk=&date=. Accessed July 25, 2013.