VP32 Incorporation Of The Only Drug For Primary Biliary Cholangitis Brazil
Bibliographic record
Abstract
Introduction Primary biliary cholangitis (CBP) is a rare autoimmune cholestatic liver disease, inflammation and progressive destruction of small and medium-sized interlobular ducts, progressing to fibrosis, cirrhosis, and death. Currently, the Brazilian public health system (SUS) offers treatment of the symptoms of cirrhosis, and has no medication with indication for CBP. Methods Scientific technical opinion with systematic review (SR) of available evidence in the databases MEDLINE (Pubmed), LILACS and Cochrane Library (accessed July 2017) on ursodeoxycholic acid (AUDC). Methodological quality was evaluated with AMSTAR and Newcastle Ottawa tools. Meta-analyses were performed in Review Manager® 5.2 in the random effects model. Analysis of the budget impact calculation deterministic model, from the perspective of five years for the SUS. Results Ten SRs and three cohorts were included. There was no statistically significant difference between AUDC and placebo in outcome. Overall survival was significantly (P <0.001) higher in the AUDC group compared to that predicted by the Mayo model or placebo. Treatment with UCD showed an increase in the long-term transplant-free survival time from the fifth year of treatment, with statistically significant results for years five, eight and ten (p <0.01). There were no statistically significant differences for safety outcomes. Based on the assumptions adopted, the incremental budgetary impact with the incorporation of the AUDC into SUS would be BRL 11.77 million (EUR 2.68 million) in the first year and BRL 98.52 million (EUR 22.45 million) in the accumulated five years, considering a market share of 10 percent per year. Conclusions Despite the uncertainties in the evidence of effectiveness of the AUDC and the probably underestimated budgetary impact, AUDC was incorporated into the SUS because it is the only alternative with indication for CBP and in use for more than two decades, allowing everyone access to the medicine
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.018 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.019 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".