Cost-utility analysis of interferon-free treatments for patients with early-stage genotype 1 hepatitis C virus in Brazil

Abstract INTRODUCTION We conducted a cost-utility analysis of available interferon-free treatments for patients with early-stage genotype 1 chronic hepatitis C based on a Brazilian public health system perspective. METHODS A Markov model was derived using a cohort of stage F0-F2 patients treated as recommended by the Brazilian national guidelines. RESULTS: Glecaprevir plus pibrentasvir was superior to all other treatments, followed by sofosbuvir plus velpatasvir. Sofosbuvir plus daclatasvir was identified as the least cost-effective option. CONCLUSIONS: The above findings were confirmed via probabilistic sensitivity analysis and the tested scenarios.


Background and objectives 3
Provide an explicit statement of the broader context for the study.
Present the study question and its relevance for health policy or practice decisions. Page 3, lines 3 to 5

Methods
Target population and subgroups 4 Describe characteristics of the base case population and subgroups analysed, including why they were chosen.
Setting and location 5 State relevant aspects of the system(s) in which the decision(s) need(s) to be made. 13b Model-based economic evaluation: Describe approaches and data sources used to estimate resource use associated with model health states. Describe primary or secondary research methods for valuing each resource item in terms of its unit cost. Describe any adjustments made to approximate to opportunity costs.

Not applicable
Currency, price date, and conversion 14 Report the dates of the estimated resource quantities and unit costs. Describe methods for adjusting estimated unit costs to the year of reported costs if necessary. Describe methods for converting costs into a common currency base and the exchange rate.
Page 4 line 13 Choice of model 15 Describe and give reasons for the specific type of decision-analytical model used. Providing a figure to show model structure is strongly recommended.
Page 3 line 18 Assumptions 16 Describe all structural or other assumptions underpinning the decision-analytical model.

Page 5 lines 11 and 22
Analytical methods 17 Describe all analytical methods supporting the evaluation. This could include methods for dealing with skewed, missing, or censored data; extrapolation methods; methods for pooling data; approaches to validate or make adjustments (such as half cycle corrections) to a model; and methods for handling population heterogeneity and uncertainty.

Study parameters 18
Report the values, ranges, references, and, if used, probability distributions for all parameters. Report reasons or sources for distributions used to represent uncertainty where appropriate. Providing a table to show the input values is strongly recommended.

Incremental costs and outcomes 19
For each intervention, report mean values for the main categories of estimated costs and outcomes of interest, as well as mean differences between the comparator groups. If applicable, report incremental cost-effectiveness ratios. Table 1 Characterising uncertainty 20a Single study-based economic evaluation: Describe the effects of sampling uncertainty for the estimated incremental cost and incremental effectiveness parameters, together with the impact of methodological assumptions (such as discount rate, study perspective).

Not applicable 20b
Model-based economic evaluation: Describe the effects on the results of uncertainty for all input parameters, and uncertainty related to the structure of the model and assumptions.
Page 6, lines 1 to 21 Characterising heterogeneity 21 If applicable, report differences in costs, outcomes, or costeffectiveness that can be explained by variations between subgroups of patients with different baseline characteristics or other observed variability in effects that are not reducible by more information.

Discussion
Study findings, limitations, generalizability, and current knowledge 22 Summarise key study findings and describe how they support the conclusions reached. Discuss limitations and the generalizability of the findings and how the findings fit with current knowledge.
Respond to each item with "Yes", "No" or "Not clear", except for items 11 to 14, 21, 23, and 24, which should be answered with "Yes", "No", "Not clear" or "Not applicable" Items Critical evaluation a) Study design

Were the main alternatives included in the study, and was a comprehensive description of the analyzed alternatives provided?
Yes

Was the model time horizon long enough to reflect the main differences -in cost and health outcome -between the strategies?
Yes

Was the study approved by any institution qualified in ethics research?
No