Switching from Originator Brand Medicines to Generic Equivalents in Selected Developing Countries: How Much Could Be Saved?

Cameron, Alexandra; Mantel‐Teeuwisse, Aukje K.; Leufkens, Hubert G.M.; Laing, Richard

doi:10.1016/j.jval.2012.04.004

Cited by 151 publications

(144 citation statements)

References 18 publications

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“…Multifaceted demandside measures enacted to achieve these savings include high International non-proprietary name (INN) prescribing, formularies, prescribing guidance, continuous medical education, quality circles, strengthening of drug and therapeutic committees (DTCs), prescribing targets, financial incentives and prescribing restrictions (2,12,13,18,19,21,(24)(25)(26). Considerable savings can also be achieved in low-and middle-income countries from switching from use of originators to use of the lowest-priced equivalent generic drugs (27)(28)(29).…”

Section: Introductionmentioning

confidence: 99%

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Zhang

Godman

et al. 2014

GaBI J

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Introduction: Pharmaceutical expenditure rose by 16% per annum in China during the past decade, and now represents 46% of total health care expenditure. Initiatives to moderate growth include pricing regulations for pharmaceuticals and encouraging INN prescribing. However, there is limited monitoring of physician prescribing and current incentives encourage hospitals and physicians to profit from drug procurement. Objective: Assess changes in statin utilisation and expenditure as additional generics are launched. Subsequently, compare results in China with findings among European countries to provide future guidance. Methods: Observational retrospective study of statin utilisation and procurement expenditure from 2004 to 2013 in two large teaching hospital groups. Results: Statin utilisation rose 32 fold in one hospital group and 54 fold in the other. Expenditure also increased but to a lesser extent, i.e. from just over CNY 0.65 million in 2004 to 15.3 million in 2013 in one hospital group and from CNY 0.49 to 19.3 million in the other. Atorvastatin (originator) was the most utilised statin. Utilisation of each generic statin was typically low, e.g. 10% in 2013 in one hospital group. Procurement prices fell over time, greatest for generic simvastatin (-74 to -91%) mirroring data from European countries. However, no increase in their prescribing was observed. In fact, a significant decrease in generic prescribing was seen in one hospital group between 2004 and 2013. Conclusion: There are considerable opportunities to improve prescribing efficiency in China based on European experience. However, current incentives encouraging hospitals and physicians to profit from drug procurement need to be addressed.

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Section: Introductionmentioning

confidence: 99%

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Zhang

Godman

et al. 2014

GaBI J

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“…There is a large body of literature, including on European countries, that confirmed the savings' potential through lower prices by implementing generics policies [101,[107][108][109].…”

Section: Generic Policiesmentioning

confidence: 99%

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Vogler

Paris

Ferrario

et al. 2017

Appl Health Econ Health Policy

151

118

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Key points for Decision Makers: European countries apply different pharmaceutical pricing and reimbursement policies. These policies are frequently assessed against their financial consequences and their ability to contain costs but less so in terms of access to medicines. Policies should be accompanied by regular evaluations, facilitated by the use of the appropriate methodology and access to the relevant data. There appears to be a need for additional changes beyond traditional pharmaceutical pricing and reimbursement policies. Collaborative approaches (e.g. between countries or between regulatory authorities, pricing and reimbursement agencies) and more transparency in terms of real medicine prices, R+D costs and medicines in the pipeline are considered as possible pathways for the future. AbstractThe paper discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation, however implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the 2 hospital and offpatent outpatient sectors has proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing, and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.3

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“…Therefore, bioequivalence does not always correspond to therapeutic equivalence. Even though BE studies can be considered as a test for pharmacokinetics, pharmacodynamics, or comparative clinical trials depending on whether the drugs work systemically or locally [22] Even the active ingredient does not differ between brand name drug and generic drug, other excipients, may be different and they may have contradicted effect [22] since a wide variety of excipients can be used in drug formulation [23][24][25][26]. Therefore, differences in excipients between brand-name drugs and their generic counterparts can cause problems [27] even with rational drug use [28].…”

Section: Introductionmentioning

confidence: 99%

Comparison Between Generic Drugs and Brand Name Drugs From Bioequivalence and Thermoequivalence Prospective

Arafat

Ahmed

Arafat

2017

Int J Pharm Pharm Sci

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ABSTACTThe belief that generic drugs are inferior to brand name drugs has been always under debate. Especially since the price of generic drugs is generally far cheaper than brand-name drugs. Although, this is because of waiving the preclinical studies and clinical trials for the generic drug, the quality, and purity of materials used for generic drug preparation is still arguable. Thus, the objective of this overview was to find out the tolerable deviations between generic and brand name drugs which should not alter the pharmacology. Using inactive additives in the generic drug different than in the brand name drug, such as binders, glidants, diluents, anti-adherents, disintegrants or polymer carrier material and filler should not change the drug bioavailability and pharmacokinetic parameters as long as both products using the identical active ingredient(s) in equivalent amounts. Even if both drug products are bioequivalent to each other in terms of active ingredient, they are not in terms of inactive ingredients. Hence, the probability of unexpected adverse drug reaction and allergies from the generic formulation are possible, especially, when people react sensitive toward specific component. Therefore, the occasional negative response occurring upon the switch from brand-name drug to the generic drug can be attributed to intra-and inter-patient variations toward inactive ingredients. Variations toward inactive ingredients can be obtained experimentally by utilizing a proper thermoanalytical technique. As a result, thermoequivalence of generic drugs to brand name drugs can be determined based on thermal information obtained from both products. In conclusion, thermoequivalence study can be a useful tool to demonstrate any possible variation between the inactive ingredients of both products.

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Switching from Originator Brand Medicines to Generic Equivalents in Selected Developing Countries: How Much Could Be Saved?

Cited by 151 publications

References 18 publications

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries

Comparison Between Generic Drugs and Brand Name Drugs From Bioequivalence and Thermoequivalence Prospective

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