SHEKOUFEH NIKFAR, Iran Food and Drug Organization

Lead Author: Shekoufeh Nikfar
Organization: Iran Food and Drug Organization
Country: Iran

Abstract

The Islamic Republic of Iran’s Food and Drug Administration (IFDA) as the executive authority has a mission to regulate the registration process of the new medicines. According to the Law on the Organization and Duties of the Ministry of Health and Medical Education (MOHME), Iran Drug Selection Committee (IDSC), as a key component of IFDA, has the responsibility of investigation and approval of new medicines for registration in the Iran Drug List (IDL). The Iran Drug Selection Committee has adapted a generic-based list of medicines The mission of this decision-making committee is to evaluate the new medicines based on their efficacy, safety and cost-effectiveness.

All members of the committee, medical forums, research centers and pharmaceutical companies can make suggestions for new molecules to enter the IDL. Based on the indication and administration, the new medicines are proposed in one or more clinical subcommittees and expert opinions will be drawn. Upon completion of the process, the new medicine is presented in the IDSC and in case of approval; it will be registered in the IDL. 

Currently, there are more than 2900 numbers of drugs in the IDL, including a variety of molecules with different dosage forms and strength. The investigations show that more than 90% of the population of Iran have access to the affordable essential medicines during the last decades. Day by day application of new medicines for non curable diseases and high-tech medicines are invented with support of costly R&D expenditure that is necessary to payback by providing high prices for such medicine. Policy makers should hardly work to find a way to make new medicines accessible despite of their lack of affordability.

Submission

The Islamic Republic of Iran’s Food and Drug Administration (IFDA) as the executive authority has a mission to regulate the registration process of the new medicines. According to the Law on the Organization and Duties of the Ministry of Health and Medical Education (MOHME), Iran Drug Selection Committee (IDSC), as a key component of IFDA, has the responsibility of investigation and approval of new medicines for registration in the Iran Drug List (IDL). The Iran Drug Selection Committee has adapted a generic-based list of medicines The mission of this decision-making committee is to evaluate the new medicines based on their efficacy, safety and cost-effectiveness. 

All members of the committee, medical forums, research centers and pharmaceutical companies can make suggestions for new molecules to enter the IDL. Based on the indication and administration, the new medicines are proposed in one or more clinical subcommittees and expert opinions will be drawn. Upon completion of the process, the new medicine is presented in the IDSC and in case of approval; it will be registered in the IDL.

Currently, there are more than 2900 numbers of drugs in the IDL, including a variety of molecules with different dosage forms and strength. The investigations show that more than 90% of the population of Iran have access to the affordable essential medicines during the last decades. Day by day application of new medicines for non curable diseases and high-tech medicines are invented with support of costly R&D expenditure that is necessary to payback by providing high prices for such medicine. Policy makers should hardly work to find a way to make new medicines accessible despite of their lack of affordability.

Unlimited and mostly competing demands in health care systems, even in rich societies always force decision makers to choose among the priorities for the allocation of resources. Therefore recent developments in Health Technology Assessment (HTA) created a fuller opportunity for allocation of limited resources available in rural areas, health care systems. Although this tool has been used more frequently by developed countries which have substantially more resources available in their health sector, there are increasing efforts in developing countries for using this tool in order to prioritize demands in their national health sector. The fact that HTA evaluate both short and long term impacts of medical interventions for their health outcomes and resource use could provide a clear picture for the real value of the health technologies. This obviously could help for better availability and distribution of resources and improve health care system performance and equity in the society. Therefore this function provides the opportunity to compare the value of different interventions from the society or health care payers’ perspective.
Iran is a Middle Eastern country with more than 78 million mostly young population. Iran GDP per capita which mainly depends on the oil revenue in 2014 reported to be about 4200 USD. In Iran Ministry of Health and Medical Education (MOH) is the main stewardship of the health care system. According to the Iran constitutional law, Iran government has the mandate to provide the highest attainable level of the health care for all Iranian. Therefore, Iran government in past decades has invested heavily in national health care system and created an opportunity for all Iranian to have fairly equitable access to the health care system. The government believes that this investment will bring a valuable return to the society in the long term.

In 2014 Iran pharmaceutical market valued about 4.2 billion USD. Despite the fact that promoting of national pharmaceutical industry is one of the main objectives of the Iran national medicine policy, share of national pharmaceutical industry in Iran pharmaceutical market is about 60%. All aspects of medicines regulation, including production, importation, distributions, and sale of medicines in Iran are fully regulated by Iran Food and Drug Administration (IFDA). All medicines should receive registration and marketing authorization before entering the Iranian market. Traditionally Iran Drug Selection Committee, responsible body for developing and revising the Iran Medicine List, used to request acceptable safety, quality and efficacy data for including new medicines to the List. Recently, in the shadow of pressures from limited available resources in a national health care system, Iran policy makers use pharmacoeconomics considerations to evaluate the benefits of medicines in comparison with the extra costs they impose to the health care system. Therefore, the committee now requires pharmacoeconomics evaluation of any submission for new medicine application (4). 

In order to evaluate the budget impact of the use of new medications on the country's national health budget, the applicant should also provide data about the impact of using the new medicine. A budget impact which deals with the ability to pay for the new intervention and its sustainability will help decision makers in regards to the overall impact of the intended intervention on the national health care budget. The model designed for the budget impact analysis must be transparent, and be investigated based on local population data or the scenario which can be generalized to Iran. In these studies, attention must be paid to the population, market share, growth rate, and costs in two scenarios with new drugs and current situation. 
Iran national health system is facing with growing demand for new and mostly expensive medicines. However, due to limited resources available to this sector, Iran health system decision makers decided to implement cost effectiveness analysis for all candidate medicines to be included in Iran Medicine list. Therefore since 2014 all pharmaceutical companies requested to submit pharmacoeconomics analysis for their proposed medicines.

Iran national pharmacoeconomics evaluation committee is part of IFDA and director of the committee is appointed by the minister of Health. Following approval of the committee for cost effectiveness of the candidate medicine the application will be forwarded to the Iran Drug Selection Committee for final decision. In fact the pharmacoeconomics evaluation committee provide positive list for the drug selection committee. In 2014 pharmacoeconomics evaluation committee has published its guideline for submission of files and its criteria for decision making. Although Iran pharmacoeconomics evaluation committee accepts transfer of certain HTA elements from other countries, local data especially in cost section is absolutely necessary.

Iran decision makers believe local production of pharmaceuticals will improve their accessibility and affordability. Therefore, supporting the national pharmaceutical industry is one of the fundamental objectives of Iran national health policy. IFDA considers all locally manufactured medicines as "cost effective". However, local pharmaceutical companies should submit pharmacoeconomics evaluation dossier for their candidate medicine in order to set a baseline price for the medicine. The base price will be set based on ICER and cost/QALY whenever feasible. It should be emphasized that pharmacoeconomics evaluation of medicines in Iran is still in early stage and lack of high quality data both in economic and clinical outcome parts could be considered as a major hurdle to this new field. However, decision makers of Iran health system at its topest level determined to implement HTA in the country health sector and hope in near future the quality of pharmacoeconomics evaluation of medicines will be improved.

In measuring health, economic evaluations, the threshold is an important concept. It signifies the value of health gain and a new intervention is considered satisfactory if its price falls below a certain threshold. Results are usually reported in an incremental costeffectiveness ratio (ICER). The ICER stands for the additional costs per additional health unit produced by one intervention in comparison to another. A common tool for measurement is the quality-adjusted life-year (QALY). QALY encompasses both length and quality of life, which is based on utility. Likewise, various organizations and governmental bodies such as the National Institute for Health and Clinical Excellence (NICE) in the UK, Swedish Pricing and Reimbursement Board, the Pharmaceutical Benefits Advisory Committee in Australia, Dutch Health Care Insurance Board (CVZ) in The Netherlands have adopted certain threshold values. This adoption of threshold optimizes the process of allocation of health care resources. Reimbursement decisions and allocation of health care resources is evolving in developing nations. Though cost-effectiveness analysis is increasingly being used for reimbursement mechanisms in developing countries, however, there is no consistent defined threshold. Most developing countries have adopted one to three times of their local gross domestic product (GDP) per capita as a threshold. This is also recommended by the World Health Organization (WHO). However, it is argued that the range of 1 to 3 folds is a wide range and hence it is imperative to evaluate the exact QALY threshold especially with regards to public preferences. Another tool for estimating threshold is to conduct willingness to pay (WTP) studies. However, WTP for a QALY is inconsistent and dependent on the size, duration, and type of the health gain. Therefore, it is considered that WTP is directly correlated with the nature and burden of disease. For example, WTP would increase if the patient suffers more of a certain disease. Nowadays, most of the new medicines to treat cancer, asthma, arthritis rheumatoid, central nervous system diseases and inflammatory bowel disease are more expensive. Economic burden of these diseases is very high because of direct medical costs as well as disabilities resulting in indirect cost. Cost of illness increases especially when patients have to make out of pocket payment for medicines. 

This is compounded by the fact that newer biotechnology medicines are very expensive and even their generic versions are not affordable. In this context, consistent threshold would pose a problem, equity will be affected and as for most of expensive drugs they will be rejected from the reimbursable list of medicines. This would defy the access as newer medicines are necessary for patients with more complicated illnesses. The role of government is to implement a policy for equal opportunities that is healthy aligning with the equity in health. Considering this approach, WTP may be a better solution for decision making while calculating a threshold. WTP rationally expresses the health state of patients while taking into consideration patients’ views about the health. Though the calculation of WTP is time consuming and sometime it’s feasibility questioned too. Evaluation of strengths and limitations of differing estimations of thresholds is vital. This helps to find appropriate monetary values for QALY. More pragmatic researches are needed in this area and work toward a higher level of reliability in decision-making is required.

Efficiency and allocations in healthcare are emerging concerns in the field of pharmacoeconomics and pharmaceutical policy. New ideas, methods, and findings of applied pharmacoeconomics in implementation of pharmaceutical policies is needed to be developed by international cooperation to improve equity and access to medicines in order to increase health for all the world.

Bibliography and References

1-Nikfar et al. Monitoring of National Drug Policy (NDP) and its standardized indicators; conformity to decisions of the national drug selecting committee in Iran. BMC Int Health Hum Rights. 2005 May 10;5(1):5. PubMed PMID: 15885139; PubMed Central PMCID: PMC1145184.
2- Nikfar S., Abdollahi M., Cheraghali A. A drug and poison information centre. Essential Drug Monitor 2000 (28&29): 30-31.
3- Cheraghali AM, Nikfar S, Behmanesh Y, Rahimi V, Habibipour F, Tirdad R, Asadi A, Bahrami A. Evaluation of availability, accessibility and prescribing pattern of medicines in the Islamic Republic of Iran. East Mediterr Health J. 2004 May;10(3):406-15.
4- Cheraghali A.M., Solemani F., Behmanesh Y., Habibipour F., Ismaeilzadeh A., Nikfar S., Rahimi W. Physicians attitude toward injectable medicines. Journal of Pharmacology and Toxicology 2006, 1(1): 33-39.
5- Hashemi-Meshkini A, Varmaghani M, Yousefi M, Yaghoubifard S, Zekri HS, Nikfar S, Kebriaeezadeh A. From generic scheme to brand-generic scheme: Have new policy influenced the efficiency of Iranian pharmaceutical companies?
6- Abdollahiasl A, Kebriaeezadeh A, Dinarvand R, Abdollahi M, Cheraghali AM, Jaberidoost M, Nikfar S.A system dynamics model for national drug policy. Daru. 2014 Apr 1;22(1):34.
7- Jaberidoost M, Nikfar S, Abdollahiasl A, Dinarvand R. Pharmaceutical supply chain risks: A systematic review. DARU, Journal of Pharmaceutical Sciences, 2013; 21(1): 69.
8- Salari P, Namazi H, Abdollahi M, KhansariF, Nikfar S, Larijani B, Araminia B. Code of ethics for the national pharmaceutical system: Codifying and compilation. J Res Med Sci. 2013 May;18(5):442-448.
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10- Hashemi Meshkini A., Kebriaeezadeh A., Dinarvand R., Nikfar S., Habibzadeh M., Vazirian I. Assessment of the vaccine industry in Iran in context of accession to WTO: A survey study. DARU, Journal of Pharmaceutical Sciences 2012; 20(1):19.
11- Abdollahiasl A, Nikfar S, Abdollahi M. Pharmaceutical market and health system in the Middle Eastern and Central Asian countries: Time for innovations and changes in policies and actions. Archives of Medical Science 2011; 7(3): 365-367.
12- Abdollahiasl A, Nikfar S, Kebriaeezadeh A, Dinarvand R, Abdollahi M. A model for developing a decision support system to simulate national drug policy indicators. Archives of Medical Science 2011; 7(5):744-746.
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