Every country is at some stage of using pharmacoeconomics to guide policy, financing, and other specific objectives in health system development. It is recognized that allocating resources across inputs into health systems, based on consideration of comparative efficiency, serves overall system efficiency. Pharmacoeconomics provides tools to pinpoint inefficiencies and to identify the most efficient therapy options. As a result, pharmacoeconomics has received increasing attention across health systems internationally.
Some countries have many years of experience in applying pharmacoeconomic tools and reasoning to determine pharmaceutical benefits, such as Australia, Canada, and the United Kingdom. Other countries have chosen a relatively narrow approach to applying pharmacoeconomic methods and use particular tools for decision-making in reimbursement and pricing of medicines in specific situations. This is the case in Saudi Arabia and South Africa.
This paper explores factors that determine the introduction of pharmacoeconomics into health systems’ regulatory frameworks. Simultaneously, it seeks to provide guidance on processes for the design, implementation and optimization of pharmacoeconomics as a steering tool within a health system under the universal health coverage (UHC) paradigm. The very distinct case studies of South Africa and Saudi Arabia inform the identification of these determinants and guide the analysis of their influence on forming pharmacoeconomic policy and practice in different contexts. This unlikely selection of countries is based on the appreciation that their health systems have evolved along very different trajectories. The choice of pharmacoeconomic tools is determined by similar factors, however. The juxtaposition of the two scenarios therefore promises interesting insights with some generalizable lessons.
Pharmacoeconomics in Saudi Arabia; Principles, Evolution, and Pricing
Saudi Arabia’s vision 2030 aims to bring fundamental changes in the health care financing and delivery system with a view to improve access to quality health care to its population. As a part of the national transformation program (NTP)-2020, the Ministry of Health (MOH) has proposed to increase private share of health spending through alternative financing and delivery mechanism, particularly through health insurance and partnering with the private sector. The cooperative health insurance (CHI) provides comprehensive health coverage to significant segment of workers in the private sector.
From inception, the health care system in Saudi Arabia has ensured the availability of health care facilities to its people. This article discusses the pharmaceutical pricing policies and the impact of health drug prices on the public in the Kingdom of Saudi Arabia. A review of government and Saudi Food and Drug Authority (SFDA) policy documents, guidelines, and articles published in PubMed and other indexed journals (N ¼ 10) was performed to identify the relevant literature. Results showed that the government appears poised and focused on the availability of better health care facilities to the Saudi population.
The pharmaceutical market in Saudi Arabia commands a large portion of the pharmaceuticals market share in the entire Middle East region. The government, through the SFDA, sets the prices of pharmaceutical products. There are occasional price variations, which are induced by a number of factors. However, because the Saudis enjoy free health care coupled with the recent introduction of a compulsory health insurance policy, the impact of price variation is not felt. In addition, the Saudis prefer using branded medicines. The SFDA plays a major role in price regulation by setting up rules for pharmaceutical product pricing. However, there appears to be little or no impact of pharmaceutical price variation in Saudi Arabia because of better earning power among the population and free health care access to public health facilities.
The health care system in Saudi Arabia from inception until recently has been a dynamic process as the population increases. With a World Health ranking of 26th, Saudi Arabia appears to be heading in the right direction toward a working recognized health care system. Moreover, the government provides universal coverage for the growing population through policy. The Saudi health care system operates under a 2-tier system, which comprises primary health care and secondary/tertiary centers within the kingdom. Primary health centers (PHCs) are located within both the urban and rural areas, whereas the secondary/tertiary centers that offer specialized care are within the urban areas. The Ministry of Health (MOH), which also finances the health care services in the kingdom, manages these PHCs.
Interestingly, the PHC is said to comprise 60% of the kingdom’s health care services.3 The MOH encourages private sector participation in order to provide the needed coverage and hence achieve its health goals for the growing population. Under the auspices of the MOH, which acts for the government, health care services are provided free of charge for Saudis. However, the private sector is allowed to operate at all levels, and they charge fees for the services they provide. In addition, various governmental agencies that are sponsored by the MOH also provide services that include emergencies and coverage for employees and families.
According to the Health Statistical Year Book 2012, the MOH provides about 59.5% of the health care coverage, while the private sector caters to 21.2%, leaving the rest to be covered by governmental agencies. For adequate and comprehensive coverage, it is envisaged that these multiple providers of health care within the Kingdom of Saudi Arabia must have an established clear-cut communication and a data-sharing policy. This will make for effective delivery of health care services in order to meet the ambitious goal policy of the government, and ensuring the availability of efficient pharmacy services will complement the dynamism of MOH in proving this all-important care. Without well-managed, regulated, and professional pharmacy services within the hospital and community setting, health care delivery will be shortchanged. Availability of drugs, affordability, quality, and reduced medication errors are some of the hallmarks of professional pharmacy services
Saudi Arabia, a well-resourced, developed country runs a health system with a long history, shaped by the principle of self-governance, the realization of a “corporatist” approach that guides the entire Saudi system of social protection. The Saudi social health insurance (SHI) corporative scheme is subject to the efficiency precept. This rule is set out in the Saudi Social Code, stating that all services provided to SHI beneficiaries must be sufficient, appropriate, and cost-effective and must not exceed the necessary. In the spirit of self-governance, it represents all relevant stakeholders, including medical and SHI physicians’ associations, hospital associations, associations of SHI funds as well as patients.
Under a broad definition of pharmacoeconomics, there are plenty of pharmaco-regulatory tools that constitute a challenging playing field for pharmacoeconomic research: At the macro level (with reference to the entire SHI pharmaceutical market) there are, inter alia, legislated mark-ups for pharmacies and wholesalers, and SHI discounts; at the meso level (with regard to groups of physicians and patients, specific therapeutic classes or Rx groups), group-specific individual prescription limits, regional target agreements, guidelines and discount contracts exist, as well as references prices; and at the micro level (for specific products, patients, physicians, or manufacturers) there are audits, prescription ceilings, second opinions and more. In order to understand the current Saudi SHI regulatory framework and the (limited) role of the leading institute for the economic assessment of pharmaceuticals, some key health policy discussions need to be understood that have shaped the direction of pharmaceutical policy reforms.
The Saudi reference pricing system has been in place since a major health reform changed the regulatory framework with effect from 2003. The SFDA is the main body responsible for the price regulation of pharmaceuticals in Saudi Arabia. It publishes ‘‘The Rules for Pharmaceutical Products Pricing,’’ which is used as a guideline for setting the price of drugs. In the first step, the SFDA asks the pharmaceutical company’s market authorization holder (MAH) to provide an authenticated updated Price Certificate (Form 30) containing the following information on the product intended to be registered:
- Factory price in country of origin (in the country of origin’s local currency).
- Wholesaler price in country of origin (in the country of origin’s local currency).
- Public (retail) prices in country of origin (in the country of origin’s local currency).
- Proposed cost, insurance, and freight (CIF) price to Saudi Arabia.
- Price of the product in countries where it is marketed (reference countries in Form 30).
Along with these, clinical data regarding the therapeutic significance of the product and pharmacoeconomic studies of the product (if available) are also requested from the MAH. Once the Price Certificate (Form 30) is completed and signed by the company, then the form has to be certified by a health authority in the country of origin as well as the Saudi Embassy. The certification of price by the health authority in the country of origin and Saudi Embassy is considered to be the initial step before forwarding the MAH application for the product registration. However, the final price for the drug is proposed by a technical committee, the Committee for Pricing of Pharmaceutical Products, in accordance with the SFDA pricing guidelines. Then, the proposed price is revised/approved by the Registration Committee for Drug Companies, Manufacturers and Their Products.
The committee should approve a fair price that is calculated according to the pricing guidelines as outlined by the SFDA. However, in the case where a company feels that the price is not suitable, the SFDA makes provision for the company to file an appeal against the committee’s decision by submitting a letter that should include scientific justifications supporting their appeal. Therefore, the price is not proposed and approved by a single unified factor/mechanism. Indeed, the general requirements and criteria that are outlined in the pricing guidelines are also connected to the external price referencing (EPR) system, which is used through the Price Certificate (Form 30). In addition, the prices of the registered medical/therapeutic alternatives available in the Saudi market as well as the therapeutic (clinical) significance of the product play a key role in determining the price of the product.
The approved prices for registered pharmaceutical products are then made public and published by the SFDA. The pharmaceutical companies are equally mandated to place the price on the outer pack of their products. However, public prices are considered a ceiling price for the tendering process. In Saudi Arabia, prices of pharmaceutical registered products are reviewed, and they follow a list of pricing guidelines that include exchange rates, availability of product alternatives, and therapeutic impact. There is also a comparison to prices of drug products in 30 countries. The prices of branded innovator (patented) drugs are lowered by 20% of their original registered prices if a generic substitute becomes available in the Saudi market first.12 It is significant to note that products can only be sold in the kingdom after price approval from the government and its agencies.
The drawback here is that price control in the kingdom can bar potential investment and market access to capitalist-oriented businesses, despite other incentives provided by the government to encourage investment in this sector of the economy. Thus, the government’s focus is on low prices for pharmaceutical products affordable for its growing population. The price of a product that is registered under an international company will remain unchanged if this company signs a contract with any local company to transfer any stage of the manufacturing process to Saudi Arabia.
In implementing its price policy and guidelines for branded pharmaceutical products that are patented with no substitutes in the market, the factory prices in the country of origin are considered as well as the wholesale prices. In addition, the retail prices and therapeutic relevance among other criteria are also considered. For generics, any options having the lowest pricing will be selected, but the presence and absence of locally manufactured generics under consideration will affect the pricing outcome as well as the therapeutic significance. In addressing the drug pricing setup, 2 commonly used frameworks are utilized in the decision-making process for the pricing of pharmaceutical products:
1. External price referencing (EPR)
2. Value-based pricing (VBP) The SFDA makes effective utilization of both these models; VBP is preferred for the pricing and reimbursement of new products.
This is especially true when someone is seeking a price premium over existing therapies. Moreover, the EPR is considered to be a broad toll to maintain equity during the pricing process through a variety of pharmaceutical products. The official prices for medications are the prices that will be paid by the consumer. The SFDA will set the public price, which includes the wholesale price and profit to cover other costs. SFDA quite frequently revises prices of pharmaceutical products. Price revision for both imported and locally manufactured pharmaceutical products takes place at the time of renewal of product registration every 5 years and is based on the common pricing criteria outlined in the pricing guidelines.
However, prices of registered products may be re-evaluated before the end of this period in the following cases:
- If the patent of the innovated product has expired and a generic version has been introduced to the Saudi market first.
- If the MAH requests variation (as per the SFDA’s guidelines).
- If the product’s price has changed in the country of origin and other countries.
- If there is significant change in the exchange rate which might affect product availability in the Saudi market.
- If the company asks for appeal to the SFDA against the decision of the product pricing (request for reprising).
- If the innovated product price changes, the registered generic products will be changed subsequently.
The Impact of Pricing on Public Health and the Case for Generics The Kingdom of Saudi Arabia, being the largest per capita single market economy in the Middle East, represents about 0.03% of the global drug market and 19.8% of the total Arab pharmaceutical market. The Saudi pharmaceutical product market is estimated to be about US$3.6 billion with local manufacture comprising 21.4% of the country’s market. The economy is dependent on imported drug products, given that the local industry represents only 15% of the country’s market. The government is known to support the local industry by providing incentives and financial assistance in terms of interest-free loans, among other facilities, to encourage investment.
In addition, the SFDA and the government make efforts to support investment in pharmaceutical products by improving the pricing system, applying ceiling prices for generic products and giving any second brand product, which is manufactured locally, the same price as the innovated product. As the SFDA-approved price of registered pharmaceutical products undergoes variation in terms of resourcing (i.e., changing the manufacturing site), shifting any of the manufacturing steps for any registered pharmaceutical products to a local manufacturer will not affect the product price, and the product will be exempt from price revision.
However, the government also reviews prices of innovated products when the patent of the innovated brand has expired given 35.0% lower pricing for generic products introduced in the Saudi Market before branded products. The ultimate goal for any government providing health care services, in the area of pharmaceutical products, is to ensure affordability, quality, and the well-being of the population. This should reflect available low-priced medications within the country. Usually, this policy is publicly funded to ensure equitable distribution and access. This is the case with provision of pharmaceutical products in the Kingdom of Saudi Arabia. Overall, there are growing opinions to stem the tide of increasing pharmaceutical products globally, and in the kingdom, considerations like sustainability, cultural behavior, and product quality are also taken into account.
The current form of extraordinary profits driving the pharmaceutical industry portends danger in terms of costs for most governments involved in health care provision. It is estimated that in 2009, 18% of the total health care expenditure in Saudi Arabia was represented by pharmaceutical products. With a growing population, the expenditure in this sector is set to increase. Given the way pharmacy outlets are organized and considering the affluence in the population, coupled with the fact that enforcement is not entirely strict, people can buy prescription-only drugs over the counter. Coupled with this is the fact that Saudis show preference for branded products compared to generics.
In addition, with the recent introduction of a health insurance scheme, sales of branded products will rise. Market estimates show that the share of generics in Saudi Arabia is only 5.8% compared to 50% in European countries. In view of the increased cost of medicines, the use of generics will greatly reduce the cost of expenditure for both government and private sector health care provisions, including individuals. A study by Alghasham in 2009 indicated that in hospitals, the prescribing of generics was on the rise. However, for individuals, the change from branded products to generics requires awareness that they are both effective and equivalent, the price difference notwithstanding.
The low price of generics may portray them as inferior. According to the same study, those policy makers in the kingdom should encourage generic prescribing in both tiers of the health care system. Since there is a quality audit inspection check on pharmaceutical products (whether branded or generics), before and after registration, this should boost the use of generics to bring down the cost of medications. The market war between branded and generic pharmaceutical products will not abate because of enhanced income and the affluent lifestyle of Saudis, and benefiting drug companies are making use of this advantage. Due to the recent increase in the population and in health spending by the government, the generic medicine market is observed to be growing at a fast pace.
No doubt, the Saudi government would like more private sector participation in the industry so that it can adequately play the role of a regulator. On the heels of this, an increased demand for over-the counter generics and generic substitution in hospitals will soon be seen. The issue with generics is their interchangeability with branded pharmaceutical products, and it exists not only in Saudi Arabia but all over the world. Monitoring authorities should ensure that they are bioequivalent with branded formulations; analysis of drug products should reveal equal or close percentage contents and there should not be interbatch variations. Additionally, this information should be made public.
Pharmacoeconomics in South Africa; Evolution in Progress
At present, South Africa’s healthcare system is dichotomous with the public and private health sectors each providing services ranging from basic primary healthcare to highly specialized health services. However, there are considerable differences in that the majority of the population (84%) uses public healthcare which is largely funded through general tax revenue accounting for around 48% of total healthcare spends. A far smaller proportion (16%) access healthcare services through medical scheme insurance or out-of-pocket payments but this accounts for around 52% of healthcare spend in the country (Ataguba and McIntyre, 2012). The introduction of universal health coverage in the form of a National Health Insurance scheme for South Africa seeks to address these inequities.
The process of introducing UHC has its roots in the democratic reforms that occurred in the post-apartheid years from 1994. An initial version of National Health Insurance (NHI1), as described by van den Heever (2016) was envisaged in the period from 1994–2008 where pooling of resources within both the public (centrally pooled resource allocation) and private sector (risk equalization arrangement) was proposed. Subsequent to this, further reforms were proposed which replaced this with the concept of a single public entity (NHI2). At the heart of the proposal for NHI is the “principle of the Constitutional right of citizens to have access to quality healthcare services that are delivered equitably, affordably, efficiently, effectively and appropriately based on social solidarity, progressive universalism, equity and health as a public good and a social investment” (South African National Department of Health, 2017), Entrenched in this vision is the concept of introducing benefit design of packages of care using management and financing reforms such as rationing, strategic purchasing and contracting based on, amongst others, the principles of cost-effectiveness.
The development of a regulatory framework employing pharmacoeconomics was discussed for nearly a decade after the introduction of the concept in the National Drug Policy (NDP) of 1996 (South African National Department of Health, 1996). The Medicines and Related Substances Act 101 was amended in 2003 with the implementation of the Pricing Committee under Section 22G which would enable some of the reforms of the NDP (South African National Department of Health, 2003). The Regulations for a Transparent Pricing System, introduced in 2004, put into place the legal framework for pharmacoeconomic evaluation; however it was another 8 years before the first set of Pharmacoeconomic Guidelines was published in 2013 (South African National Department of Health, 2013; Gray and Suleman, 2015). The aim of these was to provide guidance on conducting and submitting a pharmacoeconomic analysis. The intention of the guidelines was to begin with voluntary submissions. Although the current regulations provide for a mandatory submission if so requested by the Director General of Health, this has to date, not been implemented. The pharmacoeconomic guidelines were not intended solely for the private sector and are applicable in the public sector setting as well.
Medicines selection processes in South Africa are probably the main area where pharmacoeconomics is currently being used in both sectors. In the public sector, the process for selection of medicines onto the Essential Medicines List (EML) allows for the use of pharmacoeconomics to assess the cost-effectiveness of proposed additions to the list. This has developed over time, however, with earlier editions of the EML only considering clinical evidence and some costing. Even in the current environment, full pharmacoeconomic analysis is lacking in areas (Perumal-Pillay and Suleman, 2017).
Pharmacoeconomic evaluation of medicines for selection to formularies or reimbursement policies is also carried out in the private sector. The regulations of the Medical Schemes Act 131, as amended, provide for a consideration of cost-effectiveness in the protocols and formularies developed for managed care. In its current Prescribed Minimum Benefit Review construct, the Council for Medical Schemes has included the requirement for cost-effectiveness assessment (Council for Medical Schemes, 2016). Some medical schemes and managed care organizations are already conducting pharmacoeconomic evaluations although the exact scope of this is unknown (Hofman et al., 2015). This too has evolved over time with earlier attempts using simple costing or cost-minimisation approaches (which are often still the mainstay of decision making) although there is increasing evidence of more established pharmacoeconomic analysis being carried out in this sector (Fraser et al., 2016).
While pricing regulations have enforced a limit on annual single exit price (SEP) increases for medicines in the private sector, the entry price to the market is determined almost solely by the manufacturer. The fair value price of these medicines at this entry point could be determined by pharmacoeconomics where there is recourse to enforce the provisions of the pricing regulations. However, once these medicines are on the market other factors come into play including extensions of patents and delays in the introduction of cheaper generics or biosimilars which influence pricing of medicines. The pricing regulations provide for a process of international benchmarking of medicine prices in the private sector against a basket of countries (Australia, Canada, New Zealand, Spain and within South Africa) and draft regulations were proposed in 2014 (Suleman and Gray, 2017). Multiple gazettes have been published and commented on since then and this will continue to be debated until finalized and implemented. The consideration of international prices is already taking place when a manufacturer applies for an SEP.
In the public sector, the process of competitive tendering for medicine contracts now also includes a review of international prices which has seen considerable success with the dramatic reduction seen in prices of medicines such as the anti-infectives and TB medicines (Pharasi and Miot, 2013) However, despite the opportunity to negotiate lower tender prices based on global best prices, affordability remains an issue particularly for medicines that do not have generics or where the only alternative may be a clone of the originator and still priced well above alternatives available in other countries.
Central to the use of pharmacoeconomics in the selection of medicines is the ongoing debate around lack of cost-effectiveness thresholds (CET) in South Africa. This discussion has included nuances such as whether there should be different CETs for different sectors or diseases. In addition, recent, methodologically determined papers have presented thresholds for countries such as South Africa (Woods et al., 2016) providing greater confidence in their validity than the oft misquoted WHO 1-3 x GDP threshold which has now been retracted (Bertram et al., 2016). However increasingly there is a view that CETs are not the final answer and healthcare decisions are multi-factorial which can be determined more systematically through multi-criteria decision analysis (Thokala et al., 2016).
It is exciting times for South Africa where considerable changes to the healthcare landscape are underway and it is unclear as to the home of pharmacoeconomics in the future of UHC. It was previously suggested that it would lay within the structures of a nationalized health technology assessment (HTA) institution (Hofman et al., 2015). The proposed NHI implementation structures of Ministerial Advisory Committees for Health Technology Assessment and Healthcare Benefits suggest that this will be the case, although these will continue to function alongside the Essential Medicine List Committees. The EML is likely to be an integral component to the introduction of benefit package design under NHI and so the pharmacoeconomic tool of evaluating one specific medicine compared to others should continue to develop and become more comprehensive (Suleman and Gray, 2017). Substantial legislative reforms will be required in order to implement NHI, particularly in the National Health Act and so the regulatory framework for pharmacoeconomics is expected to evolve alongside these reforms.
The debate around the ideal application and institutionalization of pharmacoeconomics in a UHC environment will always be ongoing. Healthcare systems are dynamic and never complete. To this end, regulatory frameworks for pharmacoeconomics need to be sufficiently flexible in accommodating these living systems but also provide clarity and direction. The introduction of pharmacoeconomics into regulation does not come as a single event but rather a growing momentum. Experience from the case studies shows that successful implementation starts from a modest concept with the potential of refinement and (modular) amendment. A reference framework is essential, such as the efficiency precept and the principle of self-governance in Saudi Arabia, or a defining strategy, such as the National Drug Policy in South Africa, to guide regulation.
Delays in implementation as well as design modifications are not unusual, as pharmacoeconomics is subject to highly political decision-making processes with interests beyond health policy. As is the case with other steering structures and mechanisms, the dynamics of evolving pharmacoeconomics within the health system depends on windows of opportunity. The space for reform is often created by dedicated leaders, as has been the case for health reform projects in both study countries. Yet both countries’ experiences also show other factors that drive pharmacoeconomic progress. Pharmacoeconomics comes hand in hand with general trends of the economisation of policy and the marketisation of the health system. As a data intensive practice, the technological and economic possibilities to establish required systems favor the swift implementation of pharmacoeconomics, which, by the way, does not necessarily imply a reduction of costs or an opportunity to save money. There is great potential for countries not only to learn from each other but also to collaborate, e.g., by pooling data, by sharing tools and databases, and jointly refining the toolkit.
Rgya Alfraihi conceived, drafted and critically revised the work. JM and MT hereby agree to be accountable for all aspects of the work and give final approval of the version to be published.
Conflict of Interest Statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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