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Table 1 Draft list of criteria and performance categories

From: Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals – an application on improving tender decision making in Indonesia

Criteria Intended definition Performance categories Test case 1 Test case 2 Test case 3 Test case 4 Pilot workshop outcome of criteria
Equivalence with the reference (original) product to capture evidence on health outcomes from pharmaceutical-, bioequivalence- and clinical trials (efficacy data from controlled clinical settings) - No data on pharmaceutical equivalence      Included
 - Pharmaceutical equivalence     
 - Interchangeability defined based on local criteria x    
 - Bioequivalence proven based on local criteria   x x  
 - Bioequivalence proven based on European EMA or US FDA criteria     x
 - Therapeutic equivalence proven in clinical trial     
 - Improvement in efficacy and/or safety based on clinical trial data     
Real world clinical or economic outcomes such as adherence or non-drug costs to capture evidence on health outcomes (effectiveness) and costs from real-world data - No real world data on equal a) tolerability, b) adherence and persistence, c) non-drug cost x     Included
 - International real world data on either equal a) tolerability, b) adherence and persistence, c) non-drug cost   x   
 - Local real world data on either equal a) tolerability, b) adherence and persistence, c) non-drug cost    x x
 - International real world data on improvement in a) tolerability, b) adherence and persistence, c) non-drug cost     
 - Local real world data on improvement in a) tolerability, b) adherence and persistence, c) non-drug cost     
Product stability and drug formulation to capture evidence on stability and drug formulation - No data on product expiry or stability      Included
 - Data on non-inferior product expiry or stability in local environment x    
 - Data on improved product expiry    x x
 - Data on improved product stability in local environment   x   
 - Data on improved product expiry and stability in local environment     
Quality assurance to capture evidence on manufacturing- and product quality-, and standardisation - Limited information on quality assurance      Included
 - Local/non GMP quality assurance only for active product ingredient x    
 - Local/non GMP quality assurance for the entire manufacturing process   x x  
- WHO GMP certification     x
- EU or PIC/s GMP     
Macroeconomic benefit to capture wider economic benefits of selecting the medicine (e.g. tax, investment, employment etc.) - The manufacturer has no local investment in the country      Excluded by majority voting
 - The manufacturer has minor local investment in the country x x   
 - The manufacturer has moderate local investment in the country    x  
 - The manufacturer has significant local investment in the country     x
Reliability of drug supply to capture the stability and reliability of drug supply (history and future gurantee) - Major and multiple problems in the last 5 yrs      Included
 - Minor and fairly frequent problems in the last 5 yrs x    
 - Single precedence of supply problems in the last 5 yrs   x   
 - No precedence of supply problems in the last 5 yrs    x x
 - Manufacturer is financially capable and willing to guarantee supply     
Pharmacovigilance to capture data collection and assessment on adverse events of pharmaceuticals - No pharmacovigilance system x     Included
 - Qualified person for pharmacovigilance   x   
 - Qualified person and sophisticated system to collect pharmacovigilance data    x x
Added value service related to the product to capture extra services provided alongside the drug with quantifiable and demonstrated outcomes/benefits - No program or service x     Excluded by majority voting
 - Availability of value added service   x   
 - Major value added service with demonstrated outcomes    x x
Price Acquisition cost of the pharmaceutical product compared to the lowest price available N/A 2200 IDR 2900 IDR 3000 IDR 3800 IDR Included
  1. IDR - Indonesian Rupiah