@article{MTMT:3365326,
	title = {An Evidence Framework for Off-Patent Pharmaceutical Review (EFOR) for Health Technology Assessment in Emerging Markets.},
	url = {https://m2.mtmt.hu/api/publication/3365326},
	author = {Brixner, D and Kaló, Zoltán and Maniadakis, N and Kim, K and Wijaya, K},
	doi = {10.1016/j.vhri.2018.01.003},
	journal-iso = {VAL HEALTH REG ISS},
	journal = {VALUE IN HEALTH REGIONAL ISSUES},
	volume = {16},
	unique-id = {3365326},
	issn = {2212-1099},
	abstract = {OBJECTIVE: This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. METHODS: A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). RESULTS: The IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. CONCLUSIONS: Emerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials.},
	year = {2018},
	eissn = {2212-1102},
	pages = {9-13},
	orcid-numbers = {Kaló, Zoltán/0000-0001-7762-2607}
}

@article{MTMT:3406418,
	title = {Guidance toward the implementation of multicriteria decision analysis framework in developing countries},
	url = {https://m2.mtmt.hu/api/publication/3406418},
	author = {Inotai, András and Nguyen, HT and Hidayat, B and Nurgozhin, T and Kiet, PHT and Campbell, JD and Németh, Bertalan and Maniadakis, N and Brixner, D and Wijaya, K and Kaló, Zoltán},
	doi = {10.1080/14737167.2018.1508345},
	journal-iso = {EXPERT REV PHARMACOECON OUTCOMES RES},
	journal = {EXPERT REVIEW OF PHARMACOECONOMICS AND OUTCOMES RESEARCH},
	volume = {18},
	unique-id = {3406418},
	issn = {1473-7167},
	abstract = {INTRODUCTION: Multiple Criteria Decision Analysis (MCDA) is increasingly used in health care mainly because it moves decision-making from ad hoc to an evidence-based and comprehensive process. Developing countries with more restricted financial and human research capacities, however, should consider their own methods of MCDA development and implementation. Areas covered: An MCDA framework to improve procurement decisions of off-patent pharmaceuticals was developed for developing countries and adapted to Indonesia, Kazakhstan and Vietnam during three policy workshops. Based on the experience of these workshops and one joint workshop with international experts and decision makers from multiple developing countries, general recommendations were formulated on how to implement MCDA specifically in developing countries. We provide 17 practical MCDA implementation recommendations in four major areas, including (1) MCDA objectives; (2) technical considerations of MCDA tool; (3) development and customization of MCDA tool and (4) policy implementation of MCDA in decision-making. Expert commentary: These practical MCDA recommendations for developing countries contribute to feasible, transparent, stepwise, iterative and standardized decision-making in health care.},
	year = {2018},
	eissn = {1744-8379},
	pages = {585-592},
	orcid-numbers = {Inotai, András/0000-0002-0663-2733; Kaló, Zoltán/0000-0001-7762-2607}
}

@article{MTMT:30557183,
	title = {Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia},
	url = {https://m2.mtmt.hu/api/publication/30557183},
	author = {Inotai, András and Brixner, Diana and Maniadakis, Nikos and Dwiprahasto, Iwan and Kristin, Erna and Prabowo, Agus and Yasmina, Alfi and Priohutomo, Sigit and Németh, Bertalan and Wijaya, Kalman and Kaló, Zoltán},
	doi = {10.1186/s12913-018-3805-3},
	journal-iso = {BMC HEALTH SERV RES},
	journal = {BMC HEALTH SERVICES RESEARCH},
	volume = {18},
	unique-id = {30557183},
	issn = {1472-6963},
	abstract = {BackgroundOff-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia.MethodsAn initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion.ResultsAn MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6+1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%).ConclusionsAccording to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.},
	keywords = {Developing Countries; bioequivalence; Tender; Multi-criteria decision analysis; Off-patent pharmaceuticals},
	year = {2018},
	eissn = {1472-6963},
	orcid-numbers = {Inotai, András/0000-0002-0663-2733; Kaló, Zoltán/0000-0001-7762-2607}
}

@article{MTMT:1835872,
	title = {A hazai referencia gyógyszerárkeacute;pzés orvosszakmai problémái [Medical problems associated with the national reference pricing system in Hungary].},
	url = {https://m2.mtmt.hu/api/publication/1835872},
	author = {Kerpel-Fronius, Sándor},
	journal-iso = {ORV HETIL},
	journal = {ORVOSI HETILAP},
	volume = {145},
	unique-id = {1835872},
	issn = {0030-6002},
	abstract = {The author analyses the medical problems associated with the proposed reference pricing system prepared for the 2004 pharmaceutical price and reimbursement negotiations by the Hungarian National Health Insurance Fund (HNIF). In case of drugs containing identical active ingredients the author does not consider it acceptable that from the criteria of reference grouping bioequivalence was omitted, since bioequivalence is the basic clinical pharmacologic principle underlying the safe utilization of generic drugs. The proposal introduces in Hungary the therapeutic reference pricing for drugs belonging to the same ATC 5 level group, having different chemical structures but identical mechanisms of action. The products are listed according to their defined daily dose (DDD) and the arithmetic mean of the cheapest products giving together 50% market share is calculated. Each ATC 5 group has a given per cent reimbursement level and the fixed amount paid by the HNIF for all drugs in the group is defined as the given percentage of the mean price. This sum is reimbursed irrespective whether the products are patent protected or not, furthermore those drugs whose price is three times higher than the fixed mean price are excluded from the reimbursement system. As a result the patients' co-payment for the more expensive drugs will be significantly increased in the future. The basis of the therapeutic reference price is the assumption that the outcome of the treatment will be the same using drugs with the same mechanism of action. However, this assumption lacks valid scientific proof. According to the author, the proposed budget centric reference pricing system, which does not take into account the differing clinical pharmacologic profiles of the drugs, will significantly inhibit the use of new, innovative drugs, the establishment and continuous improvement of truly cost-effective patient care. Several alternative approaches are proposed for controlling drug budget. Finally the author recommends that a Committee should be established to develop a comprehensive proposal for the reorganization of the pricing and reimbursement system of the drugs available for general and/or hospital use, and for the follow-up of the health care effects of these measures.},
	keywords = {Humans; Hungary; Cost-Benefit Analysis; Therapeutic Equivalency; Patents as Topic; Fees, Pharmaceutical/*standards; Drugs, Generic/economics; Drug Costs/*standards},
	year = {2004},
	eissn = {1788-6120},
	pages = {913-918},
	orcid-numbers = {Kerpel-Fronius, Sándor/0000-0002-3245-7414}
}