Table 2 Final list of criteria with scoring functions
From: A multi-criteria decision analysis (MCDA) tool for purchasing off-patent oncology medicines in Egypt
Criterion name | Possible scoring elements | Score (%) |
|---|---|---|
Use in reference countries | Pharmaceutical has an FDA or EMA certificate | 100% |
Pharmaceutical is used in any of the reference countries | 70% | |
Pharmaceutical is not used in any reference country and doesn't have FDA or EMA certificate | 20% | |
Pharmaceutical is not marketed in its country of origin | EXCLUSION | |
Equivalence with the reference product | Bioequivalence is proven through clinical trials or real-world evidence OR reference product | 100% |
Intravenous dosage form OR bioequivalence proven through FDA or EMA | 80% | |
Local bioequivalence certificate (Only for non-intravenous dosage forms) | 50% | |
Pharmaceutical equivalence certificate only | 20% | |
Manufacturing quality | WHO or PIC/s GMP certificate for both API and finished product | 100% |
WHO or PIC/s GMP certificate for API or finished product and the other certificate from another source | 70% | |
GMP certificate for both API and final product from another source than WHO or PIC/s | 40% | |
No GMP certificates | EXCLUSION | |
Pharmacovigilance | A percent of pharmacovigilance measures fulfillment to be provided for each product based on the pharmacovigilance unit report | (0%–100%) |
Supply reliability | No supply reliability issues during the previous 2 years | 100% |
Supplier has 75% or more reliable supplies during the previous 2 years | 80% | |
Supplier has 50%—< 75% reliable supplies during the previous 2 years | 60% | |
Supplier has 25%—< 50% reliable supplies during the previous 2 years | 30% | |
No previous supply | 20% | |
Less than 25% supply reliability during the previous 2 years | EXCLUSION | |
Previous use in local settings | Pharmaceutical is in the local market for 5 or more years, and has won 4 or more governmental tenders during the last 3 years | 100% |
Pharmaceutical is in the local market for less than 5 years, and has won 4 or more governmental tenders during the last 3 years | 80% | |
Pharmaceutical is in the local market for 5 or more years, and has won less than 4 governmental tenders during the last 3 years | 60% | |
Pharmaceutical is in the local market for less than 5 years, and has won less than 4 governmental tenders during the last 3 years | 20% | |
Pharmaceutical is in the local market for less than 3 years, and has not won any governmental tender during the last 3 years | 0% | |
Macroeconomic benefit | The company has full manufacturing in Egypt | 100% |
The company has only a packaging factory in Egypt | 70% | |
The company has no factory in Egypt | 30% |