Generic Uptake Research Articles

Does the first generic exclusivity system provide an economic incentive for early generic entrance under the patent linkage system?

A period of exclusivity for the first generics, as part of the patent linkage system, was established in South Korea to provide an economic incentive for early generic entry. This study describes the dynamics of generic penetration and assesses the first mover market share advantages under the patent linkage system. Pairs of originators and their corresponding generics granted the first generic exclusivity from 2015 to 2020 were identified. We categorized generics into first movers and latecomers, described the penetration curves of generics, and estimated the saturated market share of generics, first movers, and latecomers. Volume-based monthly prescriptions were used to describe the generics' penetration curves. A logistic growth model was adopted to estimate the saturated market shares of generics. We identified 28 pairs of originators and generics, presented penetration curves, and estimated generics market shares. The saturated market share of generics was 30%, and the time to saturation was approximately 33 months. The shapes of penetration varied by nationality, route, and number of generics. The existence of latecomers was associated with the decreased penetration speed over time and decreased market share of generics. However, the first mover market share advantages or latecomers' disadvantages were consistently observed. The generic uptake in South Korea is delayed, limited, and context-dependent. However, first generics' market share advantage suggests that a period of exclusivity, as part of the patent linkage system, could provide an economic incentive for early generic entrance.

Challenges and Strategies for Improving Access to Cancer Drugs in Malaysia: Summary of Opinions Expressed at the 2nd MACR International Scientific Conference 2022.

Considerable progress has been made in cancer drug development in recent decades. However, for people in low- and middle-income countries, including Malaysia, many of these drugs are not readily available. During the 2nd Malaysian Association for Cancer Research (MACR) International Scientific Conference, a forum discussion was held to address these challenges and explore strategies to improve access to cancer medicines in the country. This paper presents the results of the said forum discussion. A few challenges to cancer drug access were highlighted, including lengthy approval and regulatory practices, cost of medicines, and manufacturing barriers. Besides, a few strategies for mitigating some of these challenges were proposed, such as mechanisms for cost reduction, uptake of biosimilars and generics, local manufacturing, public-private partnerships, strengthening the role of insurance companies, funding and regulation, and advocacy for fair pricing, by drawing examples from cancer medicines access initiatives in Malaysia and initiatives for different disease groups. Overall, this paper provides a comprehensive overview of the challenges and strategies for improving access to cancer medicines in Malaysia and provides valuable insights for policymakers, healthcare providers, the pharmaceutical industry, cancer patients, cancer support groups, and other stakeholders working on this important issue.

EE251 A Budget Impact Analysis of the Introduction of Generics Ambrisentan and Tadalafil for the Treatment of Pulmonary Arterial Hypertension in Greece

The purpose of this study was to estimate the potential budget impact of the introduction and uptake of generics of Ambrisentan and Tadalafil for the treatment of Pulmonary Arterial Hypertension (PAH) in Greece.

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

For over 15 years, the pharmaceutical industry has been engaged in developing medicines for children to comply with the European Union (EU) and the United States (US) regulatory requirements. We assessed the authorization availability of these medicines in countries without paediatric regulatory obligations. Special attention was given to the authorization availability of paediatric formulations. Medicines for children were sampled from the US Food and Drug Administration and European Medicines Agency websites. We carried out systematic content analysis of product information and compared paediatric labelling in Australia, Brazil, Canada, Russia and South Africa with the EU or the US. The authorization availability of paediatric formulations in originator and generic medicines was reviewed. In Kenya, the authorization availability of sampled medicines and paediatric formulations was investigated. A total of 161 medicines authorized in the EU or the US were sampled. Whilst at least one paediatric indication was found in 70% of the medicines, the EU and US level of authorization was on average 38% in Australia, Brazil, Canada, Russia and South Africa. Paediatric formulations were authorized on average for 40% of originator and 36% of generic medicines. Kenya had the lowest authorization availability of medicines (40%) and formulations (26%). The authorization availability of novel medicines for children is lower in countries without paediatric regulatory obligations. Paediatric formulations often do not reach other countries if left unregulated, and their generic uptake is low. To increase authorization availability, submission of paediatric development results should become obligatory in each jurisdiction. Policy initiatives to stimulate the introduction of developed formulations should be encouraged.

Factors Associated With Generic Drug Uptake in the United States, 2012 to 2017

ObjectivesIn the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower-cost generics become available. Delayed generic drug uptake may increase spending and worsen medication adherence and patient outcomes. We assessed recent trends and factors associated with generic uptake. MethodsAmong 227 drugs facing new generic competition from 2012 to 2017, we used a national claims database to measure generic uptake in the first and second year after generic entry, defined as the proportion of claims for a generic version of the drug. Using linear regression, we evaluated associations between generic uptake and key drug characteristics. ResultsMean generic uptake was 66.1% (standard deviation 22.1%) in the first year and 82.7% (standard deviation 21.6%) in the second year after generic entry. From 2012 to 2017 generic uptake decreased 4.3% per year in the first year (95% confidence interval, 2.8%-5.8%, P < .001) and 3.2%/year in the second year (95% confidence interval, 1.2%-5.1%). Generic uptake was lower for injected than oral drugs in the first year (38.5% vs 70.0%, P < .001) and second year (50.3% vs 86.9%, P < .001). In the second year, generic uptake was higher among drugs with an authorized generic (86.1 vs 80.1%, P = .045) and those with ≥3 generic competitors (87.7% vs 78.6%, P = .055). ConclusionEarly generic uptake decreased over the past several years. This trend may adversely affect patients and increase prescription drug spending. Policies are needed to encourage generic competition, particularly among injected drugs administered in a hospital or clinic setting.

Does NICE influence the adoption and uptake of generics in the UK?

The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry.

The impact of patent expiry on drug prices: insights from the Dutch market

ABSTRACT Background: Currently literature on the impact of patent expiry on drug prices is lacking. Objective: To determine the impact of patent expiration and generic entry on drug prices in the Netherlands. Methods: Prescription and price data from 1999 up to and including December 2016 were collected from two national databases. The overall price ratio of drugs prices up to 48 months after patent expiration was compared to the price in the month before expiry. Sub-analyses were performed to provide insights in generic uptake, length of market exclusivity and price development for originators and generics separately. Results: In total 250 drugs faced patent expiration during the study period. Forty-eight months after patent expiration the median price ratio decreased to 0.59 (IQR = 0.23–0.86) compared to the month prior patent expiry. Major differences in price developments were observed depending on the level of revenue prior to patent expiration and the time of patent expiration with ratios ranging from 0.08 (IQR = 0.07–0.16) to 0.81 (IQR = 0.62–0.97). Prior to patent expiry, the price decreased by 2.3% annually while having market exclusivity for 11.3 years on average. Conclusion: This study showed that the median drug price after patent expiration decreased by 41% after 4 years. The results of this study can be used to provide more reliable estimates on drug prices over its lifecycle and can be implemented in economic evaluations to inform the cost-effectiveness and long-term budget impact of new drugs.

Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended-Release Case Study.

Real-world spontaneous adverse event reports and administrative health care data were utilized as one part of a multipronged approach to verify surveillance signals related to generic drug formulations. This study used metoprolol succinate extended release as a historic case example from which to develop an analytic framework. The US Food and Drug Administration Adverse Event Reporting System was utilized for disproportionality analyses and to identify outcomes of interest. Claims data were analyzed for generic uptake, proportion of prescriptions with "dispense as written" orders, time to discontinuation or switching, and relative rates of clinical events. Adverse Event Reporting System data showed that the Medical Dictionary for Regulatory Activities terms for product quality were higher for generic metoprolol cases and that a number of clinical events were increased that could be side effects of high or low variability in drug levels. Compared to amlodipine-benazepril, which also had a first-approved generic at the same time, market share data showed that metoprolol succinate had lower utilization and more prescriptions written as dispense as written. Switching and discontinuation were generally higher for metoprolol users compared to amlodipine-benazepril users. Finally, clinical event rates were generally higher for generic versus brand metoprolol but lower for the same comparison for amlodipine-benazepril users. In the claims-based analyses, the 90-day period immediately after generic entry provided stronger signal capture than using the entire study period. This analytic framework can be implemented to actively monitor new generic formulations for potential bioequivalence failures. Signals from these analyses require confirmation (eg, via pharmacometric analyses) to be informative for regulatory action.

Calibration of polydimethylsiloxane and polyurethane foam passive air samplers for measuring semi volatile organic compounds using a novel exposure chamber design

Passive air sampling is increasingly used for air quality monitoring and for personal sampling. In a novel experimental exposure chamber study, 3 types of polydimethylsiloxane (PDMS, including sheet and wristband) and 1 type of polyurethane foam (PUF) passive air samplers were tested for gas-phase uptake of 200 semi volatile organic compounds (SVOCs) during six months. For 155 SVOCs including PAH, PCB, phthalates, organophosphate esters, musk compounds, organochlorine- and other pesticides, a normalized generic uptake rate (Rs) of 7.6 ± 1.3 m3 d−1 dm−2 and a generic mass transfer coefficient (MTC) of 0.87 ± 0.15 cm s−1 at a wind speed of 1.3 m s−1 were determined. Variability of sampling rates within and between passive sampling media and analyte groups was not statistically significant, supporting the hypothesis of air-side controlled uptake regardless of sampling material. A statistical relationship was developed between the sampling rate and windspeed which can be used to obtain a sampling rate applicable to specific deployment conditions. For 98 SVOCs, partition coefficients (Ksampler-air) for PUF and PDMS were obtained, which determine the duration of linear uptake and capacity of the sampler for gas-phase uptake. Ksampler-air for PDMS were approximately 10 times higher than for PUF, suggesting that PDMS can be deployed for longer time per volume of sampler, while uptake remains in the linear phase. Statistical relationships were developed to estimate Kpuf-air and Kpdms-air from Koa. These results improve the understanding of the performance of PDMS and PUF passive samplers and contribute to the development of PDMS for the use as a promising personal sampler.

ESTIMATES OF THE PRICE ELASTICITY OF SWITCHING BETWEEN BRANDED AND GENERIC DRUGS

We estimate price elasticities of switching from branded to generic drugs for two widely used drugs: Prozac and Zocor. We find the price elasticity of switching varies by drug and is between 0.01 and 0.10. While elasticity estimates for Zocor are robust to the inclusion of controls for supply‐side factors, those for Prozac are not. Our results indicate consumers in managed care plans are most responsive to differences in out‐of‐pocket (OOP) cost, and we estimate that a 10% increase in the OOP cost difference between Zocor and generic Simvastatin increases an individual's probability of switching to the generic by approximately 0.3%. This would result in a modest total savings of $36,700 among our sample of 114,218 privately insured Zocor users. Our finding that individuals are relatively unresponsive to the lower prices caused by generic introduction implies that policies targeting supply‐side behavior are likely to have a larger effect on generic uptake than price‐based inducements. If generic‐uptake did occur immediately within the first 18 months after generic introduction, the total savings among individuals and insurance companies within our sample would be approximately $7 million for Zocor and $255,000 for Prozac. (JEL I11, I18)

PHP23 - 2018 Japan Drug Pricing System Radical Reform: Toward Enhancement of Drug Price Containment

Japanese drug pricing system is experiencing a radical reform in 2018 to sustain universal healthcare coverage and promote medical innovation in order to improve health care and reduce disease burden. This study aimed to describe the reform, the trend, and the potential impact on the healthcare landscape in Japan. Governmental policy reports related to the reform published by Chuikyo (Japanese Central Social Insurance Medical Council) were reviewed. The review was completed with an analysis of literature review, policy reports, and grey literature. The policy trend and potential impact were analysed. The main elements of the reform consist of: 1) closer drug price survey and price revision, 2) prompt price discount when high sale extension is observed, 3) restriction of price maintenance premium, 4) implementation of cost-effectiveness analysis (CEA), 5) enhanced price reduction of older products and generic uptake incentives, and 6) external reference pricing revision to contain costs. Because CEA was delayed, the reform is strongly focused on cost containment. CEA is high on the policy agenda but was delayed once again. It is unclear if the high cost containment measures are the outcome of a trade-off to delay CEA or if it is a first step towards a broader use of CEA. Unlike generics, which are the focus, not a single statement on biosimilars was identified in the reform. Given that the high price of biologic drugs are the faster growing segment of pharmaceuticals, policy to incentivise the use of biosimilars may reinforce the free important resources to fund the flow of expensive innovations such as cell and gene therapies. The Japanese drug pricing system is experiencing a radical reform in 2018 toward enhancement of cost containment and full implementation of CEA after 2019. Biosimilar use incentive may provide room for more innovation adoption.

The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D.

The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic immunosuppressants using US Medicare Part D Prescription Drug Event (PDE) and Colorado pharmacy claims (including both Part D and non-Part D) data from 2008 to 2013. Data from 26070 kidney, 15548 liver, and 6685 heart recipients from Part D, and 1138 kidney and 389 liver recipients from Colorado were analyzed. The proportions of patients with PDEs or claims for generic and brand-name tacrolimus or mycophenolate mofetil were calculated over time by transplanted organ and drug. Among Part D kidney, liver, and heart beneficiaries, the proportion dispensed generic tacrolimus reached 50%-56% at 1year after first generic approval and 78%-81% by December 2013. The proportion dispensed generic mycophenolate mofetil reached 70%-73% at 1year after generic market entry and 88%-90% by December 2013. There was wide interstate variability in generic uptake, with faster uptake in Colorado compared with most other states. Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand-name products within a year of market entry.

Tendering for off-patent outpatient medicines: lessons learned from experiences in Belgium, Denmark and the Netherlands

Objectives To study the impact of tendering for off-patent outpatient medicines in terms of savings for payers and availability of medicines, to explore stakeholder perceptions and to elaborate prerequisites for a successful implementation of the policy. Methods We selected three case studies (Belgium, Denmark and the Netherlands). Information was collected through literature review and stakeholder interviews. Key findings The three case study countries used tendering in different designs. While Dutch health insurers have been tendering for off-patent medicines for more than a decade, Belgium applied this policy for only two substances in 2007/2008 and then stopped. Denmark has a kind of tendering practice: pharmaceutical companies have been submitting biweekly price bids for reimbursable outpatient medicines to the Medicines Agency since the mid-1990s. Stakeholder perception varies between the countries: generic industry, pharmacists and partially patients tend to oppose the tendering practice; in Denmark, however, the system is highly appreciated by all stakeholders. All three countries reported savings for public payers. Experiences related to availability limitations were mixed (Belgium – the winner of the second tender had no capacity to procure; Denmark – no indication of availability limitations; and the Netherlands – frequent medicine shortages, both for tendered and nontendered medicines). Conclusions The findings suggest that tendering for off-patent medicines is able to contribute to cost-containment. However, as the policy possibly risks leading to availability limitations, it has to be strategically designed to avoid or at least deal with shortages through backup mechanisms. Further prerequisites for a successful introduction of tendering include a robust legal and organisational framework, an appropriate stakeholder management and demand-side policies to promote generic uptake.

Provider and Patient Determinants of Generic Levothyroxine Prescribing: An Electronic Health Records-Based Study.

Despite the availability of generic levothyroxine products for more than a decade, uptake of these products is poor. We sought to evaluate determinants of generic prescribing of levothyroxine. In a cross-sectional analysis of electronic health records data between 2010 and 2013, we identified adult patients with a levothyroxine prescription from a primary-care physician (PCP) or endocrinologist. We used mixed-effect logistic regression models with random intercepts for prescribing provider to examine predictors of generic levothyroxine prescribing. Models include patient, prescription, and provider fixed-effect covariates. Odds ratios (ORs) and 95% CIs were generated. Between-provider random variation was quantified by the intraclass correlation coefficient (ICC). Study patients (n = 63 838) were clustered among 941 prescribing providers within 25 ambulatory care clinics. The overall prevalence of generic prescribing of levothyroxine was 73%. In the multivariable mixed-effect model, patients were significantly less likely to receive generic levothyroxine from an endocrinologist than a PCP (OR = 0.43; 95% CI = 0.33-0.55; P < 0.001). Women were less likely to receive generic levothyroxine than men from endocrinologists (OR = 0.68; 95% CI = 0.59-0.78; P < 0.001) but not from PCPs. Between-provider variation in generic prescribing was 18.3% in the absence of fixed-effect covariates and could be explained marginally by patient, prescription, and provider factors (ICC = 15.9%). Generic levothyroxine prescribing differed by PCPs and endocrinologists. Residual variation in generic prescribing, after accounting for measurable factors, indicates the need for provider interventions or patient education aimed at improving levothyroxine generic uptake.

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

This article 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 been 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 hospital and offpatent outpatient sectors has been 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.

Key drivers for market penetration of biosimilars in Europe

ABSTRACTBackground & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU).Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition.Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake.Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.

Effect of Generic Competition on Atorvastatin Prescribing and Patients' Out-of-Pocket Spending.

In November 2011, the cholesterol level-lowering medication atorvastatin calcium became available in the United States as a generic drug. However, only a single generic form (from a manufacturer that qualified for market exclusivity by challenging several of Pfizer's patents) and an authorized generic form (a brand-name drug sold as a generic) were available for the first 180 days. To describe trends in the prescribing of generic atorvastatin after expiration of market exclusivity for the brand-name medication and the effect on patients' out-of-pocket spending. A US population-based study used commercial claims data from the Optum Clinformatics research database (UnitedHealth Group) from December 1, 2010, to May 31, 2013. Participants were 1 968 709 adults with commercial insurance who had been prescribed 1 or more statins (13 285 223 statin prescriptions). An interrupted times series model was used to examine the effect of limited and full generic competition on brand-name and generic atorvastatin prescriptions. Data were analyzed from December 1, 2010, to May 31, 2013. Prescription of brand-name atorvastatin, generic atorvastatin, and authorized generic atorvastatin were distinguished using National Drug Codes. Total number of prescriptions dispensed per month and out-of-pocket expenditures for a typical 30-day supply of 20-mg atorvastatin during the periods of brand-name availability only, limited generic competition (lasting 180 days after market exclusivity ended), and full generic competition. Of the 1 968 709 beneficiaries, 1 483 066 (58.8% male and 41.2% female; mean [SD] age, 55.6 [10.2] years) received a prescription for a single statin and were included in the analysis. The introduction of the first generic competitor was associated with a reduction in monthly brand-name atorvastatin fills by 20 896 prescriptions (level change, P = .001), an 18.1% change compared with the month preceding loss of exclusivity. Full generic competition reduced brand-name fills by 54 944 prescriptions (level change, P < .001), a 47.6% change relative to the month preceding loss of exclusivity. During the first 180 days of generic competition, no meaningful difference in monthly out-of-pocket spending was found between brand-name (median, $16.98; interquartile range [IQR], $8.76-$48.66) and generic (median, $19.98; IQR, $7.50-$54.90) atorvastatin. After full generic competition, estimated monthly out-of-pocket spending for generic atorvastatin (median $5.10; IQR, $3.36-$19.98) or authorized generic atorvastatin (median, $5.52; IQR, $3.48-$19.98) was substantially lower than that for brand-name atorvastatin (median, $30.00; IQR, $15.00-$91.38). Among patients with commercial health insurance, delays in generic uptake and high levels of out-of-pocket spending during the first 180 days after atorvastatin lost market exclusivity slowed changes in drug prescribing and decreases in patients' out-of-pocket costs.

Exploring factors underlying the attitude of community pharmacists to generic substitution: a nationwide study from Poland.

Background Generic uptake will increasingly be promoted by governments in the face of increasing healthcare costs and global economic uncertainties. Objective The purpose of this study was to investigate attitudes towards generic substitution among community pharmacists, with a focus on the perception of the efficacy, knowledge of the generics characteristics, as well as the willingness to recommend generic substitution. Setting Community pharmacies in Poland. Method The survey was conducted in 2013 by telephone interviews with 802 holders of an MSc degree in pharmacy working as community pharmacists. Stratified sampling was implemented to make the study representative in geographic terms. Main outcome measure Pharmacists’ attitudes towards generics drugs. Results The study showed that only 40 % of pharmacists always inform patients about their right to choose a generic substitute. It was also shown that the less time a pharmacist has been practising, the less likely they are to invite consumers to choose between generic and innovator products. The likelihood of informing was not affected by pharmacist’s sex or age, or by pharmacy location or status (chain vs. independent pharmacy) (p > 0.05). Pharmacists varied in their approach to their statutory obligation to inform about a generic; a more or less equal share of respondents were either in favour or against it. Approximately 60 % pharmacists were shown to be familiar with the definition of a generic medicine. Pharmacists with shorter time of practice proved to know more about generics. However, more than 30 % respondents failed to choose the correct statement on generic versus reference medicine dosage. The majority of respondents (67 %) believed there are no differences in efficacy between generics and innovator drugs, whereas 31 % claimed that original brands could be more effective. A significant correlation was demonstrated between the views of pharmacists on the therapeutic efficacy and their willingness to substitute for generics whenever permitted by a physician. Conclusion It is important to address all concerns pharmacists may have over generics, for example by implementing comprehensive awareness-raising campaigns. Also, pharmacotherapy monitoring systems (i.e. provided in a framework of pharmaceutical care) could be considered to identify any safety or quality concerns that may arise.Electronic supplementary materialThe online version of this article (doi:10.1007/s11096-015-0227-8) contains supplementary material, which is available to authorized users.

The diffusion of generics after patent expiry in Germany

To identify the influences on the diffusion of generics after patent expiry, we analyzed 65 generic entries using prescription data of a large German sickness fund between 2007 and 2012 in a sales model. According to theory, several elements are responsible for technology diffusion: (1) time reflecting the rate of adaption within the social system, (2) communication channels, and (3) the degree of incremental innovation, e.g., the modifications of existing active ingredient's strength. We investigated diffusion in two ways: (1) generic market share (percentage of generic prescriptions of all prescriptions of a substance) and, (2) generic sales quantity (number of units sold) over time. We specified mixed regression models. Generic diffusion takes considerable time. An average generic market share of about 75% was achieved not until 48months. There was a positive effect of time since generic entry on generic market share (p<0.001) and sales (p<0.001). Variables describing the communication channels and the degree of innovation influenced generic market share (mostly p<0.001), but not generic sales quantity. Market structure, e.g., the number of generic manufacturers (p<0.001) and prices influenced both generic market share and sales. Imperfections in generic uptake through informational cascades seem to be largely present. Third-party payers could enhance means to promote generic diffusion to amplify savings through generic entry.

Solution-driven approaches to generic substitution challenges - a survey among international experts.

The main objective of this study was to explore the perception and understanding of economic, legal, and social barriers that may restrain generic uptake among recognized international experts in health care, and to identify and verify recommendations on how to streamline generic substitution (GS) at no expense of therapeutic safety. A questionnaire survey was devised, and experts with world-renowned expertise in the field of generic medicinal products were selected. Almost 3/4 of respondents claimed that all drugs that satisfy bioequivalence criteria represent similar efficacy and adverse effects, and 1/4 of respondents believed that some differences could be reported. The majority of experts supported (i) the right of patients to refuse GS, (ii) the right of physicians to veto GS, and (iii) the introduction of a statutory obligation to provide patients with access to the cheapest generics available on the market. The main obstacles to more general uptake of generics were as follows: (i) perception of generics as lower quality products, (ii) absence of a transparent policy governing GS, and (iii) disincentives to pharmacists and physicians. Among the most popular recommendations were as follows: (i) introduction of various measures to aid physicians in generic prescribing, (ii) setting clear guidelines specifying when GS is not advisable, (iii) supporting competition on the generic market. The views of experts and the resulting recommendations were strongly affected by their opinion on the bioequivalence of generics. From this analysis, we have selected several principal recommendations which could help shape successful healthcare policies regarding GS.