Impact of federal regulation on access to Oral Chemotherapy (OC) and Hormonal Therapy (HT) in the Brazilian Private Health System (PHS)

Abstract

were extracted alongside whether the priority status, pre-or post-NOC pCODR submission, and if the drug was a first submission or line extension. Statistical comparisons were made using Student's t-test. RESULTS: 32 pCODR reports were extracted with an average of 203 days between pCODR submission to recommendation, with a wide variation between different drugs (range: 119-329 days, median: 198). There was no significant variation in the average time required for pCODR decision-making based on priority status (prioritisation granted: 232 days, [n= 3]; prioritisation not granted: 202 days, [n= 29]; p= 0.17). There was also no significant variation in time required for line extensions versus first submissions (line extension: 197 days, [n= 9]; first submissions: 205 days, [n= 23]; p= 0.34). pCODR decision-making time did also not significantly vary between those submitted prior-versus post-regulatory approval (pre-NOC: 213 days, [n= 18]; post-NOC: 191 days, [n= 14]; p= 0.26). CONCLUSIONS: Although there are some wide variations in the time required for pCODR to issue recommendations between different drugs, this did not correlate with prioritisation status, whether the drug was a first submission or line extension, or if a submission was made pre-or post-NOC in a statistically significant manner. However, the small sample sizes may have precluded finding statistical significances. Further research is needed to define the key factors underlying this variation. PCN157 ImPaCt of federal regulatIoN oN aCCess to oral ChemotheraPy (oC) aNd hormoNal theraPy (ht) IN

Increasing Access to Oral Anticancer Medicines in Middle-Income Countries: A Case Study of Private Health Insurance Coverage in Brazil

“…Between January 2013 and December 2014, the number of requests for oral antineoplastic treatment increased by almost 90% in the private health insurance sector. 7 …”

“…Few studies have detailed the consequences of this change in regulatory policy on the private health insurance sector and on the treatment of people living with cancer; however, the available data suggest an important increase in the percentage of requests for oral chemotherapy in private health insurance between 2013 and 2014 (approximately 90%), 7 and the authors are currently working with data from Intercontinental Marketing Services Health to quantify the increase to access that has occurred since January 2014 when the coverage became official. In the current context of political and economic crisis, it is unlikely that such innovations could be incorporated into Brazil’s public health system, already affected by dramatic cuts of 70 billion reais (nearly 20 billion dollars) in 2015.…”