Table 1 Draft list of criteria and performance categories

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