Abstract 1602P
Background
Brazil has a well-established public health system (SUS), but the approval process and incorporation of new drugs can be complex and bureaucratic. More than 75% of the Brazilian population depends on SUS for oncology treatment. Considering that Lung Cancer (LC) is the major cause of cancer mortality in the country, and its huge impact on social burden an estimation of Years of Potential Life Lost (YPLL) due to the lack of Crizotinib, an anaplastic lymphoma kinase (ALK) inhibitor, in SUS was made necessary. For this study was considered the time frame from the approval by the National Health Surveillance Agency (ANVISA) in 2016 to 2019.
Methods
The Number of Eligible Patients (NEP) with NSCLC ALK+ was taken from our National Cancer Institute (INCA). Pts with life insurance and other histologies, not NSCLC, were disregarded. For the YPLL calculation purpose the NEP between the years 2016 & 2019 was multiply by the difference of the documented improvement in the overall survival of the therapeutic regimen, according PROFILE 1014; 59,8 months and 19,2 months for crizotinib and chemotherapy regime respectively. For a conservative calculation, we assume that all eligible pts would have had access at the time of first approval in the country.
Results
INCA estimates 28220 (years: 2016 & 2017); 31270 (years: 2018 & 2019) new cases of LC/year in Brazil. Of these, 76.3% are considered to be treated by SUS, upon which 89% are NSCLC and 71.7% have adenocarcinoma histology. Of these 44% have metastasis at diagnosis, and 43%, 7%, 6% are diagnosed in stages III, II and I, respectively. It was used a recurrences rate of 53.79% in stage III, 46.49% in II and 26% in I in 5 years from diagnosis, totalizing 395 (per years 2016 & 2017) & 438 (per year 2018 & 2019): 1466 NEP with ALK+ from 2016 until 2019, resulting in a loss of approximately 5000 YPLL due to the lack of Crizotinib.
Conclusions
The number of potential years of life lost during the interval between the approval process and the lack of availability of this drug in Brazil is substantial. Demonstrating the impact that these legal and bureaucratic difficulties in accessing Crizotinib have caused. Collaborative national initiatives are needed to address this major barrier to access to treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.