Cost variation analysis of commonly prescribed anti-diabetic drugs available in Indian market: a pharmaco-economic study

Background: Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary lifestyle, the incidence of DM is increasing. The chronic nature of DM causes significant personal suffering and economic difficulty to families. The was aimed at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various pharmaceutical companies were obtained from current index of medical specialties (CIMS) website, Indian drug review (IDR) 2021 issue and National pharmaceutical pricing authority-pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, metformin 500 mg sustained release showed highest price variation (3668%). Minimum cost variation was found with glipizide 2.5 mg (65%). Amongst the fixed dose combinations, highest cost variation was seen with glimepiride 2 mg+metformin 1000 mg (2703%) while minimum cost variation was found with repaglinide 1 mg+voglibose 0.3 mg (29%).Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all.Background: Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands Background: Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands Background: Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands

Excessive Pharmaceutical Pricing as an Abuse of Dominant Position – The Case of CD Pharma (Denmark)

On 31 January 2018, the Danish Competition and Consumer Authority adopted a decision1 finding the Swedish company generic distributor CD Pharma in breach of Art. 102(a) Treaty on the Functioning of the European Union (TFEU) by abusing its dominant position and having imposed excessive and unfair prices for the drug Syntocinon. The company increased the price of the drug by 2000% in the period April-October 2014 in the Danish pharmaceutical market. CD Pharma appealed to the Danish Competition Appeals Board,2 which on 29 November 2018 upheld the decision by the Authority. On subsequent appeal to the Danish Maritime and Commercial Court,3 the judgment by the previous court was upheld in a 3-2 decision on 2 March 2020, thus finding CD Pharma liable for infringement of Danish competition law as well as Art. 102(a) TFEU. The decision is final and not subject to further appeal. The case raises outstanding legal-economic issues regarding excessive pricing such as relevant market definition in pharmaceutical cases, the length of abuse, competitive price benchmarks, definition of economic value and the matter of dominance in public procurement and tenders. The case is rather unusual in that the alleged abusive period amounted to a six-month period, CD Pharma was the ‘losing’ party in the bidding process for the supply of the medicine in question, and CD Pharma subsequently had reduced prices through negotiations with the Danish central medicine procurer, Amgros. Similar to the Aspen Pharma decision4 by the Italian Competition Authority, where the Italian Medicine Agency (AIFA) reported the case to the Competition Authority, it was the Danish medicine procurer Amgros who had notified the Danish Competition and Consumer Authority about allegedly abusive practices. This subsequently led to an investigation and the adoption of the Decision. Following an introduction describing the Danish pharmaceutical market and specifics of the case, section two of this contribution details the proceedings at Danish Competition Authority. Section three depicts the proceedings at Competition Appeals Tribunal, and section four deals with the proceedings at the Maritime and Commercial Court. Section five concludes.

Drug price control in Malaysia: a stakeholder analysis

PurposePharmaceutical pricing has always been a contentious issue around the world. Recently, the Government of Malaysia has proposed for drug price control. This proposal has received backlash from pharmaceutical industry. Therefore in this study, the authors would like to examine the position of various stakeholders on this issue.Design/methodology/approachThe authors used Policy Maker software to identify and evaluate the position of the stakeholders, their interest and their power. Next, the authors contextualize the factors that might contribute to the success or failure of the policy using Kingdon's multiple stream analysis.FindingsThe authors found that the drug price control regulation received mixed reactions from the stakeholders, with the public sector mainly supporting the proposal whereas the private sectors opposing it. The findings indicate that the drug price control proposal have a high chance of success due to strong political will from both the government and the opposition and also strong support from the public and the consumer groups.Practical implications1. The drug price control proposal received strong political will and strong public support. Thus, it has a high chance of success. 2. The government should be careful in managing concentrated powerful groups. The government should strategically engage with the stakeholders to move them to more positive attitude. 3. The government should avoid backtracking on policies as this will portray critical weakness to other stakeholders.Social implicationsThe public sector provides strong support for the regulation. However, this support must be maintained and remain as their top priority. Their opinions are important in shaping health policies. The public's feedback will provide transparency and accountability in the policy-making process.Originality/valueThe findings indicate that the drug price control proposal have a high chance of success due to strong political will from both the government and the opposition and also strong support from the public and the consumer groups.

Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure

Introduction: Biosimilar medicines are considered promising alternatives to new biologicals with high price tags. The extent of savings resulting from biosimilar use depends on their price and uptake, which are largely shaped by pricing, reimbursement, and demand-side policies. This article informs about different policy measures employed by European countries to design the biologicals market and explores potential savings from the increased use of biosimilar medicines in Germany.Methods: Policy measures that target the price and uptake of biosimilar medicines were identified based on a prefilled questionnaire survey with public authorities in 16 European countries, who were the members of the Pharmaceutical Pricing and Reimbursement Information network (July 2020). Potential savings that could have been generated in Germany if different measures identified in the surveyed countries had been implemented were calculated for six publicly funded biological molecules. Price data of the Pharma Price Information service and German consumption data for 2018 were used for the calculation of five scenarios.Results: Several countries use a price link policy, setting the biosimilar price as a percentage of the price of the reference biological. Also lowering the price of the reference biological upon market entry of a biosimilar is less frequently used. While tendering of biosimilar medicines in the inpatient setting is the norm, it is rarely employed for biosimilars in outpatient use. Reference price systems and INN prescribing of medicines are the commonly used policy measures in the off-patent market, but some countries define exemptions for biologicals. Substituting biosimilars at the pharmacy level is rather an exception. Potential savings in Germany ranged from 5% (simple price link) to 55% (prices at the level of other countries) for the six studied molecules.Conclusion: Despite some differences, there are discernible tendencies across European countries with regard to their applications of certain policy measures targeting the price and uptake of biosimilar medicines. The potential for savings of some of these policies was clearly demonstrated. Monitoring and evaluation of these rather recent measures is key for obtaining a more comprehensive picture of their impact.

Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims

Medicaid formulary committees and other gatekeepers face a difficult task. On the one hand they can utilize technical expertise in evaluating the real world evidence for clinical, quality of life and resource utilization claims for competing products while on the other hand they may be asked to assess claims built by simulation models for pricing and product access. A common option has been to take modeled claims from third parties such as the Institute for Clinical and Economic Review (ICER) at face value without challenging the model structure, its assumptions and its incremental cost-per-QALY claims set against competing products or the existing standard of care. Unfortunately, from the available evidence, it seems clear that many formulary assessment groups, last but not least those for whom the ICER modeling claims are targeted, have little if any appreciation of the limitations of ICER modeling. There are two substantive issues: (i) a failure to appreciate the limitations imposed by the standards of normal science for credible, empirically evaluable and replicable product claims and (ii) an understanding of limitations imposed by the axioms of fundamental measurement. In the latter case, a failure to recognize that the quality adjusted life year (QALY) is an impossible mathematical construct (hence the I-QALY). To these limitations should be added the potential for constructing competing imaginary claims. Surprisingly, ICER has provided the ideal opportunity to construct competing claims with the launch in late 2020 of the ICER Analytics cloud platform. Formulary committees and other health decision makers should be aware that claims based on the ICER Analytics platform together with competing lifetime modelled claims all fail the standards of normal science. Factoring these into formulary decisions is not only misguided but may have unintended consequences for pricing and access that may disadvantage significantly patients and caregivers. We have spent too much time debating the merits or otherwise of the I-QALY for targeted patient groups with the parties failing to recognize that the focus on simulated cost-per-I-QALY value assessments is a mathematical folly; I-QALY claims are a chimera. The I-QALY, at long last, should be abandoned together with modelled lifetime simulations. Medicaid formulary decision makes should rethink the required evidence base for formulary decisions and negotiations. Care should be taken to revisit previous negotiations where ICER recommendations have been utilized to support pricing and access.

Cost Excursion Study of Various Insulin Preparations Available in India

Introduction: Poor drug compliance affects clinical outcome and increases healthcare costs in various disease setting. Several type II diabetes mellitus patients, not controlled on oral hypoglycaemics eventually require insulin therapy. Antidiabetic treatment is to be taken lifelong and in such a setting insulin price variation imposes a huge economic burden on poor diabetic patients. Moderating drug cost is associated with improved adherence to the medication regimen. Aim: To study the variation in cost amongst various brands of insulin analogues. Materials and Methods: This was an observational, cross-sectional study. Data regarding the 116 formulations and cost of 18 types of insulin preparations was collected from sources like Current Index of Medical Specialties (CIMS), National Pharmaceutical Pricing Authority (NPPA), Government of India official website (https://nppaimis.nic.in/nppaprice/pharmasahidaamweb.aspx) and compared with its lowest counterpart. The cost ratio and percentage cost variation was analysed and expressed as percentages. Results: This study showed a noticeable variation in the prices of insulin analogues. The highest percentage of cost variation was found for Insulin (Highly Purified) Zinc-40 IU (135.17%), followed by Insulin (Analogue) Glargine-100 IU (109.31%). The lowest percentage were for: Insulin (Human-Isophane Recombinant)-40 IU (1.40%), and Insulin (Analogue) Aspart- 100 IU (6.26%). Conclusion: A noticeable variation in cost prices was observed especially in commonly used intermediate acting insulin that help basal glycaemic control. Similarly, the lowest variation was observed with recombinant counterparts as an effect of pre-existing high prices of each. Need for vital medication like insulin at affordable costs has incited national and global efforts to make it cheaper and accessible to maximum beneficiaries.

Fourth Pharmacoeconomics International Masterclass: Vital Initiative

The annual Pharmacoeconomics International Masterclass has been organized by Global Healthcare Activities Academy (GHAA) every year since 2017, to enrich the knowledge of healthcare professionals and provide them with the necessary tools to maximize the quality of the healthcare services provided around the world. ​ The topics discussed in the Masterclass were choosen to cover as many aspects as possible from different stakeholders whether they were healthcare practitioners, academics, pharmaceutical companies or policy makers. The masterclass is divided into four main session topics, each including more specific sub-topics. The main session topics are the novel values in health economics, the alternative access models for innovative treatment, the pharmaceutical pricing techniques and lastly, the role of academia in PE development. As the principles of pharmacoeconomics gain more appreciation and acceptance around the world, the Arabic world is starting to take steps towards the implementation of these principles, with countries starting to establish official HTA organization and publishing official guidelines. Taken these changes into account, defining “value” in an accurate, inclusive manner is vital to assure maximum benefit and cost-containment. More concepts regarding quality adjusted life years, novel values, gene replacement therapy values, managing entry agreements, reference and value based pricing were discussed. The Pharmacoeconomics International Masterclass is a vital and important element for the introduction and development of pharmacoeconomics principles in the Middle East. The benefit of the masterclass comes from the fact that year after year, more in-depth issues are discussed, and bigger challenges are tackled. From the introduction to pharmacoeconomics principles in the 1st masterclass to the discussion of novel values and optimizing the healthcare services provided, each year the topic is more relevant and more crucial for the application of health economics principles in the area. With two paper already published based on discussions and recommendations in the previous masterclasses, the 4th Pharmacoeconomics International Masterclass is expected to produce many fruitful insights and helpful recommendations.

Managing Pharmaceutical Expenditures: Estimating the Effect of Internal Reference Pricing for Three Pharmacological Categories

Background: Internal reference pricing (IRP) is one of the pharmaceutical pricing approaches, which is widely favored by health policymakers in different countries as a cost-containment tool for managing medicine expenditure. Evidence related to the implementation of this method confirms its usefulness in reducing pharmaceutical costs. Accordingly, the purpose of this study was to calculate potential changes in pharmaceutical expenditure using the IRP method for products belonging to three pharmaceutical categories in the pharmaceutical system of Iran. Methods: This routine data study assessed the potential effect of IRP in three pharmaceutical categories including statins, non-steroidal anti-inflammatory drugs, and proton pump inhibitors (PPIs). Two scenarios for reference groups (levels 4 and 5 of the ATC code) and four scenarios for the reference price (i.e., the minimum, median, mean, and the mean of three minimum prices in the reference group) were considered in this regard, and the price and sales data source was the report published by the Iranian Food and Drug Administration. Then, cost changes were calculated with each hypothetical scenario. It was assumed that other intervening factors remain unchanged, including consumers and prescribers’ behavior. Results: Based on the results, the two largest potential saving effects belonged to the minimum price scenario and the mean of the scenario of the three minimum prices, respectively. However, the results showed that the consequence of using a price scenario other than the minimum price as the reference price is highly related to the details of the distribution of prices in the related reference group. In addition, appropriate decisions regarding outlier products (e.g., imported products) might have extremely important effects on the result, especially for the mean price scenario. The minimum price scenario concomitant with a premium for superior products can also be considered, but part of it is outside the scope of this study and requires independent research. Conclusion: Thus if an appropriate scenario is selected for the reference price and group, the IRP method has the potential to reduce the costs of medicines. Therefore, pharmaceutical policymakers must pay enough attention to the details of planning this system and the needed procedure for updating the details of this system.