Cost-effectiveness, drug utilization study and safety of bedaquiline and delamanid based regimen in pediatric and adolescent MDR-TB patients in a tertiary care hospital.

An observational study has been designed as per STROBE guidelines. Institutional Ethics Committee (IEC) approval has been obtained, and the data collection will be started after the approval of the CTRI. Data will be collected according to the inclusion and exclusion criteria and recorded in the case record form.

The data will be analyzed for

1. Pharmacoeconomics study
2. Drug utilization study (DUS)
3. The assessment of causality, preventability and severity of ADRs

Pharmacoeconomics study will be assessed by

1.      Cost effectiveness analysis (CEA): In CEA drug acquisition cost (DTC and Central Drug Store) will be considered.

 Table 1: CEA

Cost of
therapy

(INR)

Effectiveness

(%)

CEA

|Regimen A

    |Regimen B

     |Regimen C

Total cost of a treatment option = mean cost per defined daily dosage (DDD) × duration of therapy

Effectiveness of a treatment option (in natural unit) = sum of all criterion rating

(where criterion rating = criterion value × assigned  weight)

                                                                                                                 Table 2: Decision analysis of effectiveness of multi drug resistant antitubercular drug:

 

Regimen A

Regimen B

Regimen C

|Criteria

Value(%)

Assigned weight

Criteria rating

Value(%)

Assigned weight

Criteria rating

Value (%)

Assigned weight

Criteria rating

|Efficacy

          |Tolerability

          |Frequency of administration

          |Bioavailability

          |Sum of criteria rating

(effectiveness)

                2.      Cost minimization analysis:  Cost minimization analysis measure the

Monetary value.

 3.      Cost utility analysis: Cost utility analysis measure the QALY (Quality Adjusted Life Year).

 4.      Cost benefit analysis: Cost benefit analysis measure the Disability-adjusted life years (DALYs).

Drug utilization study (DUS) will be carried out by using WHO prescribing core indicators and facility indicators.

·        WHO prescribing core indicators:

Ø  Average number of medicines prescribed per encounter

Ø  Percentage of medicines prescribed by generic name

Ø  Percentage of encounters with an antibiotic prescribed

Ø  Percentage of encounters with an injection prescribed

Ø  Percentage of medicine prescribed from an essential medicine list or formulary.

Ø  Average drug cost per encounter.

 Â·        Facility indicators:

Ø  Availability of copy of essential drug list or formulary

Ø  Availability of key drugs

The assessment of causality, preventability and severity of ADRs will be done by using

• WHO-UMC causality assessment criteria
• Modified Schumock & Thornton scale
• Modified Hartwig & Seigel scale

Data will be analyzed by descriptive statistics and appropriate tests with SPSS software’s 20th version (which is freely available).