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The Brazilian Drug Funding Process: Is there Order and Progress?
As I sip coffee from the mug with the "Order and Progress (Ordem e Progresso, in Portuguese)" motto national flag of Brazil, which I got in Rio de Janeiro on route to the 4th Latin America ISPOR Conference in Buenos Aires, Argentina, I think about the progress that has been made in the realms of the country's health technology assessment (HTA) process.
This takes me back to the jam-packed session at ISPOR that I managed to squeeze myself into so I could listen to the head of CONITEC, Clarice Petramale. This relatively recently created HTA agency is the Brazilian equivalent of the UK's NICE, but Brazil's public SUS has a considerably smaller medicine budget to play with.
This session started with a third-party analysis of CONITEC's appraisals so far, looking if timelines have been met as well as at statistics about positive and particularly negative recommendations. This largely fell in line with the secondary research I undertook for the IHS poster presented at ISPOR, albeit I just focused on biologic medicine appraisals since the agency was created in December 2011 until March 2013.
My analysis mainly found there was an apparent mismatch between CONITEC expectations and the manufacturers' ability to adjust to evidence requirements needed in supporting funding applications of biologics. Notably, I ascertained manufacturers were struggling to adapt to the new requirements of showing superior efficacy and safety of their medicines, particularly in comparison to the outdated gold standard treatments used in the SUS.
Following the overview of CONITEC's appraisals, it was Petramale's turn to speak. She was not surprised that the "cold examination" of CONITEC deliberation reports found that funding request submissions by manufacturers had been rejected far more than those by the Ministry of Health (MoH). My own research reached to same conclusion despite the vast improvements with regards to transparency and timelines of decision-making compared to the previous public funding process.
Read entire submission dossier
The problem with manufacturers is that the MoH has not asked for the technology at the centre of the funding request, so it constitutes an offer, according to Petramale. She called for submission dossiers to have greater clarity and cohesiveness. Often sponsors ask a third-party firm to conduct the evidence part whilst another firm undertakes the economic evaluation. However, "somebody in the sponsor firm should read the whole submission" and ask if it makes sense, she added.
Lack of data not an excuse
Petramale realises that it is difficult to find epidemiological data for Brazil, a problem that also extends to other Latin America countries. The data currently used by most sponsors is from the Information Technology Department of SUS (DATASUS), which was designed to determine reimbursement of treatment costs. According to Petramale, DATASUS is "a payment system and not an epidemiological system", besides having many biases towards less complex clinical cases.
Although this scenario has to change, the head said this should not be used as an excuse. Manufacturers can help by conducting more local Phase IV studies as well as undertaking studies in the target population for which reimbursement is sought after. Without the appropriate evidence, there is no way to justify a governmental expenditure, Petramale added. This is why CONITEC "denied a treatment for severe asthma as they did not have a study for that indication" and only had it for the moderate form, Petramale said. Although not named, this drug is most likely to be Xolair (omalizumab) that was rejected funding in April 2013.
Petramale also highlighted the agency's quest to improve the terminology used in their published reports. The agency often says a "treatment is not effective or it did not demonstrate effectiveness", but intends to say that submitted clinical studies do not support funding for that indication. The use of more precise technical jargon is expected to be seen in the newer reports to avoid misinterpretations or negative connotations, particularly by more lay stakeholders like patient associations.
Having just looked through 47 pages of CONITEC report on the human papillomavirus (HPV) vaccine for the prevention of cervical cancer following the MoH's November 2013 to fund Gardasil, I did notice some terminology changes. This is mainly related to the language used to refer to the similar efficacy and safety of HPV quadrivalent type 6, 11, 16 and 18 vaccine Gardasil and HPV bivalent type 16 and 18 vaccine Cervarix.
At the end of the session, Petramale highlighted how both CONITEC and the pharmaceutical industry should "continue being open". It is clear that the interaction between both parties is evolving and there are many signs of progress. However, this does not seem to be the case for manufacturers of the latest generation biologics that continue to be denied funding. From April 2013 until now, in addition to Xolair, CONITEC issued negative funding recommendations to MabThera/Rituxan (rituximab) for non-Hodgkin lymphoma, Tysabri (natalizumab) for multiple sclerosis and orphan drug Ilaris (canakinumab) for cryopyrin-associated periodic syndromes.
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