Background
Current policy objectives for OPPs
Limitations of lowest price policy objectives in developing countries
Current procurement framework for off-patent pharmaceuticals in Indonesia
Need for multi-criteria decision making in OPPs
Previous work in this concept
Methods
Pre-workshop preparation
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 |
Methodology of ranking and weighting criteria
Preparation of an MCDA excel framework
Initial validation by key local experts
Outline of the workshop
Weight and scoring function of pharmaceutical price
Creating scoring functions and ranking of non-price criteria
Weighting non-price criteria
Validating the framework on test cases
Results
Institution | Number of experts | % |
---|---|---|
Badan Pengawas Obat dan Makanan (BPOM) - Local drug regulatory agency | 4 | 20% |
Lembaga Kebijakan Pengadaan Barang Jasa Pemerintah (LKPP) - National Public Procurement Agency of the Republic of Indonesia | 1 | 5% |
Kementerian Kesehatan Republik Indonesia - Ministry of Health of the Republic of Indonesia | 7 | 35% |
Dewan Jaminan Sosial Nasional - Jaminan Kesehatan Nasional (DJSN – JKN) - National Social Security Council | 1 | 5% |
Perhimpunan Rumah Sakit Seluruh Indonesia - Hospital association | 1 | 5% |
Komite Nasional Penyusunan Formularium Nasional - National Formulary Committee | 4 | 20% |
Gabungan Perusahaan Farmasi Indonesia - Pharmaceutial manufacturers association | 2 | 10% |
Total | 20 | 100% |
n | + 0% | + 5% | + 10% | + 15% | + 20% | + 25% | + 30% | + 35% | + 40% | + 45% | + 50% | + 55% | + 60% | + 65% | + 70% | + 75% | + 80% | + 85% | + 90% | + 95% | + 100% | Median | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Price weight (initial) | 16 | 1 | 5 | 8 | 1 | 1 | 50% | |||||||||||||||||
Swing weighting | vote 1 | 16 | 4 | 1 | 3 | 1 | 1 | 1 | 3 | 1 | 1 | 15% | ||||||||||||
vote 2 | 15 | 1 | 1 | 2 | 1 | 10 | 100% | |||||||||||||||||
vote 3 | 16 | 4 | 1 | 4 | 2 | 1 | 1 | 3 | 50% | |||||||||||||||
vote 4 | 16 | 16 | 0% | |||||||||||||||||||||
vote 5 | 15 | 2 | 1 | 1 | 1 | 7 | 1 | 2 | 50% | |||||||||||||||
Price weight (adjustment) | 15 | 1 | 7 | 7 | 40% |
Criterion | SMART Ranking | Swing weighting (see Table 3) | Relative scores for swing weighting | Weight of non-price criteria | Draft Weights | Final weights of initial MCDA |
---|---|---|---|---|---|---|
Price advantage | N/A | 50.0% | 40.0% | |||
Quality assurance | 1 | Vote 5: + 50% | 51.75 | 31.4% | 15.7% | 18.8% |
Equivalence with the reference (original) product | 2 | Vote 4: + 0% (=equal importance) | 34.5 | 20.8% | 10.4% | 12.5% |
Product stability and drug formulation | 2 | Vote 3: + 50% | 34.5 | 20.8% | 10.4% | 12.5% |
Reliability of drug supply | 3 | Vote 2: + 100% | 23 | 14.0% | 7.0% | 8.4% |
Real world clinical or economic outcomes such as adherence or non-drug costs | 4 | Vote 1: + 15% | 11.5 | 7.0% | 3.5% | 4.2% |
Pharmacovigilance | 5 | N/A | 10 | 6.0% | 3.0% | 3.6% |
Process | Steps | Deliverable | |
---|---|---|---|
Development | Desk research | Defining the decision problem | MCDA objectives |
Initial selection and structure of criteria | Draft list of criteria | ||
Initial scoring functions for criteria | |||
Policy workshop | Final selection of criteria | Final criteria list | |
Scoring functions for criteria | |||
Weighting the criteria | Criteria weighting | ||
Initial dissemination | Initial MCDA tool is released with submission template | Publication (with or without training) | |
Policy application | Pilot - Repeated use of initial MCDA tool | Manufacturers submit necessary data based on MCDA submission template | Performance matrix |
Secretariat of decision-making body validates information submitted by manufacturers | |||
Calculation of aggregate scores | |||
Final review of alternatives’ performance by members of decision-making committee | |||
Interpretation and reporting | MCDA recommendation | ||
Policy decision | Final decision | ||
Revision of MCDA | Revision of initial MCDA tool based on early experiences | Final MCDA tool | |
Policy workshop to finalize MCDA tool | |||
Final dissemination | Final MCDA tool is released with submission template | Publication (with or without training) |