International Reference Prices Research Articles

A conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs)

Building effective medicine pricing policies is a challenging task in all high-, middle- and low-income countries. In high-income countries have stable health systems in place, trained workforce, as well as specialised agencies to evaluate innovative drugs for reimbursement. However, in low- and middle-income countries (LMICs) the challenges are manifold. A large majority of low- and middle-income countries lack technical expertise either to evaluate new medicines or to set efficient medicine prices. The countries also lack comparator reference pricing data to set prices. Also, there are significant out-of-pocket expenditures as people pay for medicines by themselves. An effective medicine pricing policy is vital in the context that it can be used as a tool to improve access and affordability among the masses. This discussion paper presents a conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs). The enablers to build effective medicine pricing policies are also discussed. This includes (a) data and statistics on the pharmaceutical situation of the country (b) Having a national medicine policy in the country (c) The availability of the medicine pricing data and (d) Human resources and technical capacity. WHO has recommended several strategies including External Price Referencing (EPR), Internal Reference pricing, Value-based pricing, Cost-plus pricing, and Generic medicine policies to build a pricing policy. However, this information is generic and it's a complex task for countries to tailor to their needs, hence a critical analysis is provided on these policies. The concepts related to fair medicine pricing, providing information to consumers and price transparency are also discussed.

Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation.

The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal. A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide. The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations. Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.

The impact of changing the reference countries on the list prices for patented medicines in Canada: A policy analysis

Background: Canada's Patented Medicine Prices Review Board (PMPRB) uses external and internal reference pricing (IRP) to regulate patented drug list prices. PMPRB has changed external reference countries from 7 to 11 to include countries with prices closer to the OECD median. We examined the impact on the list prices for patented medicines had the amendment been implemented from 2013.Methods: Using IQVIA MIDAS® quarterly sales data, we selected branded products that were launched in Canada in 2013–2018. The list price for each product in each country was calculated as its average annual price during the 3rd year post Canadian launch. The median international price (MIP) was the median of the list prices of PMPRB7 (MIP7) and PMPRB11 (MIP11). We assumed the same IRP would be (scenario 1) or would not be used (scenario 2).Results: Among the selected 400 products, 80.3 % (321) had MIP7 and MIP11 (launched in at least one reference country); 18.3 % did not have MIP11. The total current expenditures were $7,134.4 M. In scenario 1, MIP11 would not be binding for most products and expenditures would decline only by 0.7 %. If IRP were abolished, expenditures might decline by 14.1 % if the launching sequence would not change.Conclusions: MIP11 might not be binding for most medicines. The impact depends on whether to retain the IRP and approaches taken for medicines without MIP11.

Availability, price, and affordability of anti-hepatitis B virus drugs: a cross-sectional study in China.

The global prevalence of hepatitis B virus (HBV) has presented a persistent challenge for public health prevention and treatment. However, studies that assess the public's access to anti-HBV drugs are absent. To examine the availability, pricing, and affordability of anti-HBV drugs in Jiangsu province, China and provide recommendations for improvement. An enhanced methodology developed by the World Health Organization (WHO) and Health Action International was applied in a cross-sectional study that included 1026 healthcare facilities distributed in 13 prefectural-level cities in Jiangsu province. Since almost all drugs had an availability of less than 30%, the accessibility of anti-HBV drugs was notably low. Primary healthcare facilities had the lowest availability, reporting 1.4% for Original Brands (OBs) and 1.7% for lowest-priced generics (LPGs). Furthermore, the northern Jiangsu region recorded the lowest availability at 0.7%. LPGs demonstrated higher availability than OBs, with median availability probabilities of 2.6% and 1.4%, respectively. The drugs listed on the WHO Essential Medicines List exhibited higher availability than those on other lists. The median price ratios for OBs, LPGs, and volume-based purchasing drugs were 0.83, 0.50, and 0.27, respectively, less than 1.5 times the international reference price. Despite favorable pricing, affordability rate was 23% for urban residents and 0% for rural residents, which was discouraging. Low availability and affordability of anti-HBV drugs were observed. Policy recommendations should emphasize the improvement of LPG availability by incentivizing priority prescribing. Healthcare subsidies should be provided more effectively and equitably.

P7 International Reference Pricing and Joint Clinical Assessments—How Will European-Level HTA Evaluations Impact International Reference Pricing and Launch Sequencing?

P7 International Reference Pricing and Joint Clinical Assessments—How Will European-Level HTA Evaluations Impact International Reference Pricing and Launch Sequencing?

PT48 International Reference Pricing Analysis of Medicines in Turkiye By 2022

PT48 International Reference Pricing Analysis of Medicines in Turkiye By 2022

Prices, availability and affordability of selected essential medicines for chronic diseases in Türkiye.

Fair access to essential medicines is a significant parameter in fulfilling the right to basic health. We investigated the availability, prices and affordability of essential medicines for chronic diseases in Ankara, Türkiye. We used the procedures outlined in the WHO and Health Action International guidelines for measuring prices, availability, affordability, and price components of medicines. The sample consisted of 334 (14%) of the 2354 pharmacies in Ankara, and 24 essential medicines for cardiovascular diseases, diabetes, chronic respiratory diseases, and palliative care, adopted from the WHO Model List of Essential Medicines (2021). We collected the data in 2021 using a questionnaire administered through face-to-face survey and analysed the data using SPSS version 22. The findings showed that 15 medicines (62.5% of the selected medicines) met the 80% availability target set by WHO, while 9 did not. The original medicines were more readily available than the generic ones. Among the original medicines, furosemide (10.11) and acetylsalicylic acid (9.26) had the highest median price ratios. The generic medicines seemed to be more affordable than original medicines. Glibenclamide, budesonide, gliclazide, and diazepam had low availability and were sold at higher prices than their international reference prices. This research highlights priority areas of action to improve access to affordable medicines for chronic diseases in Ankara, Türkiye.

External reference pricing for medicines in Ukraine: latest trends

Compared to the previous year, the share of healthcare expenditure in the state budget of Ukraine has decreased, which is associated with increased funding for the security and defense sector. In terms of gross domestic product, healthcare spending has reduced to 2.8 %, which corresponds to the figures for 2019. These circumstances indicate the importance of proper budget utilization, including effectively regulating medicine prices. One of the key elements of rational healthcare budget usage is the development and implementation of external reference pricing (ERP). A well-formulated and implemented ERP policy for pharmaceuticals contributes to improving patient access to essential medicines (EMs). The aim of this study is to analyze the current status of ERP implementation in Ukraine and provide recommendations for improving this policy. Materials and methods. During the research process, an analysis of the ERP’s current regulatory framework was conducted, and ERP implementation in Ukraine was assessed according to adherence to the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015. Results. In Ukraine, ERP has been introduced for medicines from the National Essential Medicine Lists (NEML) and the “Affordable Medicines” program. The Ministry of Health (MoH) of Ukraine has approved a Register of marginal wholesale prices for medicines purchased with state budget funds and subject to price regulation. Currently, the register includes 1239 medicinal products, of which 1233 are from NEML and 6 have undergone Health Technology Assessment (HTA). Approximately 58 % of medicines have a set price through ERP, 24 % are regulated by internal reference pricing (IRP), and nearly 18 % have declared prices. This indicates a lack of uniformity in approaches to price regulation for medicines and requires further improvements. According to the latest update of the Register of medicines for reimbursement under the state medical guarantees program, there are 486 medicines, including 72 insulins and 21 immunosuppressive medicines (184 medicines are provided with co-payment). Different approaches, including different reference countries and price calculation algorithms, are applied for the price regulation of medicines in NEML and the “Affordable Medicines” program. An assessment of the implementation of the ERP system in Ukraine based on the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015 showed that the current policy does not adhere to all principles. Conclusions. The analysis revealed different approaches to pricing for medicines NEML and the “Affordable Medicines” program, indicating the need for harmonizing pricing policies for different lists. The adoption of a unified positive list can contribute to improving pricing policies and efficient resource utilization. Collecting, disseminating, and exchanging data on drug prices is crucial to support transparency in pricing and its control. Regular monitoring of prices in the market will help ensure compliance with pricing policies and take appropriate measures in case of violations. The implementation of a unified pricing regulation policy for medicines in Ukraine is an important step towards European integration and compliance with international standards.

Access to Essential Medicines and Diagnostic Tests for Cardiovascular Diseases in Maputo City, Mozambique.

To tackle the increasing burden of non-communicable diseases (NCDs) and reduce premature cardiovascular (CV) mortality by a third by the year 2030, countries must achieve 80% availability of affordable essential medicines (EMs) and technologies in all health facilities. To evaluate access to EMs and diagnostics for CV diseases in Maputo City, Mozambique. Using a modified version of World Health Organization (WHO)/Health Action International (HAI) methodology, we collected data on availability and price of 14 WHO Core EMs and 35 CV EMs in all 6 public-sector hospitals, 6 private-sector hospitals, and 30 private-retail pharmacies. Data on 19 tests and 17 devices were collected from hospitals. Medicine prices were compared with international reference prices (IRPs). Medicines were considered unaffordable if the lowest paid worker had to spend more than one day's wage to purchase a monthly supply. Mean availability of CV EMs was lower than that of WHO Core EMs in both public (hospitals: 20.7% vs. 52.6%) and private sectors (retail pharmacies: 21.5% vs. 59.8%; hospitals: 22.2% vs. 50.0%). Mean availability of CV diagnostic tests and devices was lower in public (55.6% and 58.3%, respectively) compared to private sector (89.5% and 91.7%, respectively). Across WHO Core and CV EMs, the median price of lowest priced generic (LPG) and most sold generic (MSG) versions were 4.43 and 3.20 times the IRP, respectively. Relative to the IRP, median price of CV medicines was higher than that of Core EMs (LPG: 4.51 vs. 2.93). The lowest paid worker would spend 14.0 to 17.8 days' wage monthly to undergo secondary prevention. Access to CV EMs is limited in Maputo City owing to low availability and poor affordability. Public-sector hospitals are not well equipped with essential CV diagnostics. This data could inform evidence-based policies for improving access to CV care in Mozambique.

Study on the accessibility and affordability of 50 drugs in Wuhan based on the WHO/HAI standardization method.

To understand the availability and affordability of essential drugs in Wuhan since the implementation of the national essential medicine system, and to provide a basis for the subsequent formulation and improvement of related policies. Using the standard survey method jointly developed by the WHO and Health Action International (HAI), a sample of 50 essential drugs was selected to investigate and evaluate their availability and affordability in public medical and health institutions and social retail pharmacies in Wuhan, using six diseases with high clinical morbidity as the targets. The availability of the original drug and the lowest-priced generic drug in public hospitals is 26.4 and 42.47% respectively, and that in retail pharmacies is 26.8 and 54.4% respectively. The median price ratio of the original drug and the lowest-priced generic drug is 28.71 and 2.23 respectively in public hospitals, and 29.24 and 3.59 respectively in retail pharmacies; In addition to individual drugs, such as omeprazole, others are affordable. The availability of essential drugs in public hospitals in Wuhan is lower than that in social retail pharmacies, and the availability of the lowest-priced generic drugs is much higher than that of original drugs. The availability of essential drugs in public hospitals in Wuhan is lower than that in social retail pharmacies, and the availability of the lowest-priced generic drugs is much higher than that of original drugs. The price of the original drug is much higher than the international reference price; The price of medicines in public hospitals is lower than that in retail pharmacies;the overall condition of affordability is good, but there is a big gap between the affordability levels of original drugs and generic drugs, and the affordability of original drugs is relatively poor. It is recommended to adjust the relevant policies according to the actual situation of Wuhan city itself, moderately ensure the supply of original drugs, improve the price transparency of retail pharmacies, and ensure that the basic drug needs of the public are met.

PS-P07-6: ACCESS TO ESSENTIAL MEDICINES AND DIAGNOSTIC TESTS FOR HYPERTENSION AND HEART FAILURE IN MAPUTO CITY, MOZAMBIQUE

Objective: To evaluate access (availability, price, affordability) to essential medicines (EMs) and diagnostic tests and technologies for management of hypertension and heart failure (HF) in Maputo City, Mozambique. Design and method: In a cross sectional survey, using a modified version of World Health Organization (WHO)/Health Action International methodology, data from a representative sample comprising 6 public and 6 private sector hospitals and 30 private sector retail pharmacies was collected. Upon reviewing WHO Model EM List (EML), Priority Medicines for Children and Women list, Mozambique National EML and guidelines, 50 EMs, including 14 WHO Core and 36 cardiovascular diseases (CVD) EMs were selected. Of those, data for 19 EMs (including different formulations and dosages) for management of hypertension and HF are presented here. Data on 19 diagnostic tests and 17 devices was collected from hospitals. Availability was calculated as percentage of surveyed facilities where a medicine or diagnostic tool was found on the day of survey. Median price ratio (MPR) refers to median consumer price of a medicine compared to respective international reference price (IRP). Medicines were considered unaffordable if to purchase a monthly supply, the lowest paid government worker had to spend more than one day wage. Results: Mean availability of anti hypertensive and HF medicines combined was far below WHO target (80%), both in private (retail: 35.0%, hospital pharmacies: 30.6%) and public sectors (hospital pharmacies: 27.8%). Only two surveyed medicines were available in over 80% of public-sector hospital pharmacies. Most (11/19) medicines were available in less than 50% of retail pharmacies. Median MPR (range) of medicines was high [Lowest Priced Generic (LPG): 3.2 (0.98;19.84); Most Sold Generic (MSG): 4.8 (1.67;19.98)] compared to WHO recommendation (no one should pay greater than 4 times the IRP). LPG versions above that recommendation included amlodipine, enalapril, spironolactone. The lowest paid worker, on average, would spend more than one day wage to purchase a monthly supply of most EMs. Mean availability of CVD diagnostic tests and devices was lower in public (54.6% and 61.1%, respectively) compared to private (89.5% and 91.7%, respectively) sector. Conclusion: Access to EMs for management of hypertension and HF is very limited in Maputo City, characterized by high prices, low availability and affordability. Access to CVD diagnostic tests and devices is particularly low in public-sector. These data raise important concerns and may guide policies and interventions for improving access to cardiovascular care and serve as benchmark for future comparations.

Availability, affordability and access to essential medications for asthma and chronic obstructive pulmonary disease in three low- and middle-income country settings.

Despite the rising burden of chronic respiratory disease globally, and although many respiratory medications are included in the World Health Organization Essential Medications List (WHO-EML), there is limited information concerning the availability and affordability of treatment drugs for respiratory conditions in low- and middle-income countries (LMICs). All public and private pharmacies in catchment areas of the Global Excellence in COPD outcomes (GECo) study sites in Bhaktapur, Nepal, Lima, Peru, and Nakaseke, Uganda, were approached in 2017-2019 to assess pricing and availability of medications for the management of asthma and COPD. We surveyed all 63 pharmacies in respective study areas in Nepal (95.2% private), 104 pharmacies in Peru (94.2% private) and 53 pharmacies in Uganda (98.1% private). The availability of any medication for respiratory disease was higher in private (93.3%) compared to public (73.3%) pharmacies. Salbutamol (WHO-EML) monotherapy in any formulation was the most commonly available respiratory medication among the three sites (93.7% Nepal, 86.5% Peru and 79.2% Uganda) while beclomethasone (WHO-EML) was only available in Peru (33.7%) and Nepal (22%). LABA-LAMA combination therapy was only available in Nepal (14.3% of pharmacies surveyed). The monthly treatment cost of respiratory medications was lowest in Nepal according to several cost metrics: the overall monthly cost, the median price ratio comparing medication costs to international reference prices at time of survey in dollars, and in terms of days' wages of the lowest-paid government worker. For the treatment of intermittent asthma, defined as 100 mcg Salbutamol/Albuterol inhaler, days' wages ranged from 0.47 days in Nepal and Peru to 3.33 days in Uganda. The availability and pricing of respiratory medications varied across LMIC settings, with medications for acute care of respiratory diseases being more widely available than those for long-term management.

HPR109 Medicines Pricing in Bosnia and Herzegovina – What Could Be the Solution to Reduce Prices

Bosnia and Herzegovina (B&H) introduced medicines price regulation based on international reference pricing (IRP) setting maximal allowed wholesaler prices (MWP). Referent countries are Slovenia, Croatia and Serbia. Even this resulted in price decrease, still there are discussions that medicines prices are higher than in neighboring countries. Due to country organization there are differences in retail or reimbursed prices across the country. Prices of medicines are formed by adding distribution and retail margin, and value added tax (VAT). We have conducted analysis on factors affecting prices and suggested possible action to reduce prices.

HPR82 Price Leakage Due to International Reference Pricing: Impact of Pfizer's Not-for-Profit Pricing Initiative on Price Levels in Additional Countries

In May 2022, Pfizer announced it will make its 23 patent protected medicines and vaccines available on a not-for-profit basis to 45 low- and lower-middle-income countries. The initiative will benefit around 1.2 billion people, but tiered pricing, especially if the at-cost price is publicly disclosed, carries risks. If other countries use any of the 45 countries as part of their reference basket for International Reference Pricing (IRP) purposes, price cuts could be imposed on Pfizer products elsewhere. We assess the risk to Pfizer, given its current selection of 45 countries, and explore how much greater the risk would have been if it had extended not-for-profit price levels to all low- and middle-income countries (LMICs).

HPR133 Impact of International Reference Pricing (IRP) on Medicines Reimbursement Prices in Bosnia and Herzegovina

HPR133 Impact of International Reference Pricing (IRP) on Medicines Reimbursement Prices in Bosnia and Herzegovina

HPR5 Reimbursement of Pharmaceuticals in Turkey: Comparison With Approvals of the FDA Between 2010-2021

Turkey has a highly regulated pharmaceutical market with profound challenges for market approval, pricing and reimbursement decisions. The external and internal reference pricing procedures, low value of exchange rate used in pricing, high statutory discounts required from companies during reimbursement applications, the complex system with imported drugs and alternative reimbursement mechanisms have contributed to the decreased willingness of companies to launch new molecules or new indications for already available ones. This study’s main aim is to have a picture of the new molecule and indication reimbursement trends of Turkey in comparison to FDA approvals between 2010-2021.

HPR175 Is International Reference Pricing Applied Consistently at Pharmaceutical Price Re-Evaluation for Retail and Specialty Products?

HPR175 Is International Reference Pricing Applied Consistently at Pharmaceutical Price Re-Evaluation for Retail and Specialty Products?

HPR74 International Reference Pricing Analysis of Medicines in Turkiye By 2021

HPR74 International Reference Pricing Analysis of Medicines in Turkiye By 2021

Affordability of anti-hypertensive and anti-hypertensive co-morbid with diabetes in Jos and environs, Central Nigeria

Background: Although research has been undertaken on medicine prices, there has so far been insufficient progress in improving medicine affordability and availability for individual patients in many countries. Hypertension is a major risk factor for cardiovascular disease (CVD) such as acute myocardial infarction (AMI), stroke, heart failure and death. WHO has estimated that hypertension alone accounts for 4.4% of all disability adjusted life years that are ranged from NGN1200 to NGN4250. The aim of this study is to do a pharmacoeconomic evaluation of hypertension and hypertension comorbid with diabetes medications in selected health facilities in Jos and environs, Central Nigeria. Patients’ income per month was assessed ranging from <20,000.00 to ≥ NGN181, 000.00. The medications presented to the patients first were rotated for different patients to eliminate bias. There was a relatively higher cost of treatment in Nasarawa compared to Plateau state. The cost of treatment was highest in private facilities, higher in Faith-based institutions than the public facilities. It cost an unskilled labourer between 27 to 45 days wages to treat hypertension (catastrophic). The monthly cost of medication ranges from NGN1000 to NGN3725 cost. Results show that the monthly cost of treating hypertension ranged from NGN1000 to NGN3000 and NGN1200 to NGN4250 for comorbid cases. Prices of essential medicines used in the management of hypertension and hypertension comorbid with diabetes is quite high compared with the international reference prices. The treatment in both cases were mostly unaffordable for the threshold of an unskilled labourer and majority of the patients. Policy options towards ameliorating these catastrophic effects as the main focus of government and relevant stakeholders is hereby recommended.

Accessibility of essential anticancer medicines for children in the Sichuan Province of China.

Compared with high-income countries, the survival rate of childhood cancer is lower in low- and middle-income countries. Access to essential anticancer medicines is an indispensable component of pediatric cancer treatment, which is still a big challenge in low- and middle-income countries. To assess the accessibility of essential anticancer medicines for children in public hospitals in the Sichuan Province of China. Based on the data of the Sichuan Province Drug Use Monitoring Platform in 2020, a retrospective study was conducted to investigate the original brands and generics of 34 anticancer and three supportive essential medicines for children (a total of 97 specific strengths) in Sichuan Province. The availability, price, and affordability of surveyed medicines were evaluated in all 152 tertiary public hospitals (120 general hospitals, 31 children's hospitals, and one cancer hospital) that could diagnose and treat cancer for children. The average availability of generics and original brands was 18.5% and 2.6%, respectively. In regions with different gross domestic product (GDP) per capita levels, the average availability was similar, but the city with lower GDP per capita levels had fewer tertiary public hospitals. The prices of most original brands were higher than the lowest-priced generics, and the median price ratios of 31 lowest-priced generics and 16 original brands were 0.744 (P25~P75, 0.446~2.791) and 2.908 (1.719~6.465). After paying medical insurance for medicines, the affordability of essential anticancer medicines was improved. The monthly medicine cost did not exceed 10% of the monthly household income for 78.9% (30/38) of the lowest-priced generics and 50.0% (8/16) of the original brands. The availability of lowest-priced generics was higher than original brands in public hospitals, but the availability of both was low, which was similar to previous studies in low- and middle-income countries. About half of the lowest-priced generics and 87.5% of the original brands cost more than 1.5 times the International Reference Price. Although the National Basic Medical Insurance greatly improved the affordability of essential anticancer medicines for children, higher subsidies for essential medicines for cancer treatment to limit catastrophic health expenditures are still recommended.