Table 1: Cost Effectiveness Analysis (CEA)

	Cost of therapy (INR)	Effectiveness	CEA(INR)
BDQ-based regimen
Another regimen

Total Cost of a Treatment Option

 = Mean Cost per Defined Daily Dosage (DDD)×Duration of Therapy

Mean cost /DDD of treatment option available at NCH will be use.

The effectiveness measure involved theoretical framework by analysis of positive and negative outcome of each treatment option from review of literature as in Table 2 for effectiveness of Drug Resistant Anti TB regimen options.

Table 2: Effectiveness rating

Criteria	BDQ-based regimen	Value	Another regimen	Value
Efficacy
Adverse Drug Reaction
Frequency of administration
Bioavailability

Efficacy and Bioavailability will be taken by reviewing various scientific literature.

Effectiveness of a treatment option (in natural unit) =Sum of all criterion rating, where Criterion Rating= Criterion Value× Assigned Weight.

Table 3: Decision Analysis of effectiveness of Drug Resistant Anti TB Drug:

	BDQ-based regimen			Another regimen
Criteria	Value	Assigned weight	Criteria rating	Value	Assigned weight	Criteria rating
Efficacy
Tolerability
Frequency of administration
Bioavailability
Sum of criteria rating (effectiveness)

The criteria value and assign weight which determines the criteria rating is somewhat arbitrary hence fairly subjective. However, each option being considered was treated identically with respect to the assigned weight to limit the subjectivity.

2) Cost Minimization Analysis: The costs to be included in the analysis include medicine costs, along with other health service costs (e.g., hospital cost, medical staff cost), equipment costs (e.g., syringes, needles, IV sets, sterile water for dilution).

Table 4: Cost Minimization Analysis

Cost categories	BDQ-based regimen	Another regimen
Acquisition price
Doses per Day
Prices per Day
Health service cost per Day
Supplies (to administer medicine)
Cost of ADR
Cost of laboratory tests
Total cost

Cost will be provided by District Tuberculosis Centre and Central Drug Store.

3) Cost Utility Analysis: It is a special type of cost effectiveness analysis, in which the outcome is expressed as a utility measure (e.g., Quality Adjusted Life Year (QALY)

- If an individual has perfect health for a period of 1 year, they will be said to have 1 QALY

- If an individual lives in perfect health but only for half a year, that individual will have 0.5 QALY

- If an individual lives for 1 year in a situation with 0.5 utility (half of perfect health) that individual will have 0.5 QALY

4) Cost Benefit Analysis: It is an economic evaluation that measures both the costs and benefits of treatment alternatives in monetary amounts. The results of cost benefit analysis can be stated as a ratio of benefits to costs or as a simple difference representing the net benefit or alternative over another. Results of such analysis are expressed as benefit- to – cost ratios.^[12] It is done by calculating Disability Adjusted Life Year (DALY).

DALY=Years of Life Lost (YLL) + Years Lost due to Disability (YLD)

YLL= Number of deaths × Standard life expectancy at age of death in years.

YLD = Number of prevalent cases × Disability weight

Disability weight is a weight factor that reflects the severity of the disease on scale from 0 (perfect health) to 1 (equivalent to death).

Required data will be recorded in case record form (CRF). 

Details regarding the safety of the patient (ADR data) will be recorded in ADR reporting form 1.4 version. 

Details regarding the adherence of the medication will be recorded in prevalidated questionnaire. 

The assessment of causality, preventability and severity of ADRs will be done by using WHO-UMC causality assessment criteria, Modified Schumock and Thornton scale and Modified Hartwig and Seigel scale respectively. 

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