Generic Counterparts Research Articles

How promotion mix helps sustain brand sales during market transitions: insights from the pharmaceutical industry

Purpose Pharmaceutical marketers use detailing, sampling and direct-to-consumer advertising (DTCA) to promote a branded prescription drug (brand drug) to health-care professionals and consumers. These promotion mix elements help raise brand awareness, increase prescription likelihood and guard a product market against competing brand drugs. However, the extent to which these elements remain effective when a brand drug goes off patent and its marketing exclusivity expires, allowing low-price generics to enter the market, remains unclear. This study aims to explore the effectiveness of promotion mix elements before and after the market entry of a generic drug. Design/methodology/approach The authors collected and analyzed a panel data set of 41 brand drugs from 7 therapeutic classes between 2007 and 2014 (3,201 observations) using the two-stage control function approach to address potential endogeneity. Findings The effectiveness of promotion mix elements changes significantly, but not in a universally uniform way, during a market transition. Detailing and DTCA are increasingly effective after a brand drug’s generics enter the market. In contrast, sampling is more effective before the market transition. The positive effects of sampling on brand sales are stronger when the price of a brand drug is higher than the average price of its competing brands. Sampling also helps amplify the positive influences of detailing and DTCA on brand sales. Research limitations/implications This study shows that pharmaceutical promotion is not equally effective in the brand drug market with/without generic competitors. Detailing and DTCA are increasingly effective when generic competition intensifies. In contrast, the distribution of free drug samples is less effective after more generic drugs enter the market. Practical implications Incumbent brands’ promotion expenditures often drop dramatically when the expiration of their patents is near, a practice that likely continues after generics enter the market. Taking into consideration these industry norms and their findings, the authors suggest that promotional decisions during a market transition should not overly focus on cutting promotional expenditures across the board. Since a firm’s promotional expenditure tends to be expensive, factoring in information on the effectiveness of each promotion mix element helps marketers make well-informed strategic decisions on resource allocation during the transition from a market without generics to a market with generics. Originality/value Previous studies do not explicitly account for structural changes in the brand drug market over time. However, the expiration of patent and marketing exclusivity marks a transitional period in which a brand drug eventually competes with its generic counterparts. Given the criticality of such structural change, the authors examine brand drugs’ promotion effectiveness in the presence of their generic counterparts.

Provably Trainable Rotationally Equivariant Quantum Machine Learning

Exploiting the power of quantum computation to realize superior machine learning algorithms has been a major research focus of recent years, but the prospects of quantum machine learning (QML) remain dampened by considerable technical challenges. A particularly significant issue is that generic QML models suffer from so-called barren plateaus in their training landscapes—large regions where cost function gradients vanish exponentially in the number of qubits employed, rendering large models effectively untrainable. A leading strategy for combating this effect is to build problem-specific models that take into account the symmetries of their data in order to focus on a smaller, relevant subset of Hilbert space. In this work, we introduce a family of rotationally equivariant QML models built upon the quantum Fourier transform, and leverage recent insights from the Lie-algebraic study of QML models to prove that (a subset of) our models do not exhibit barren plateaus. In addition to our analytical results we numerically test our rotationally equivariant models on a dataset of simulated scanning tunneling microscope images of phosphorus impurities in silicon, where rotational symmetry naturally arises, and find that they dramatically outperform their generic counterparts in practice. Published by the American Physical Society 2024

HELP PHARMACEUTICAL INDUSTRY TO BUILD MEANINGFUL PERSONALIZED HEALTHCARE PROFESSIONAL EXPERIENCE

Unlike the consumer industry, biopharma, medical technology, and wellness companies have struggled to build meaningful, personalized patient and healthcare professional (HCP) experiences. The increase in drug launches and growing competition across therapy areas has made it challenging for brands and organizations to stand out from the crowd, whether for new molecules vs. legacy brands in an established treatment area and their generic counter-parts or for new molecules in a rare disease where trust is not yet earned. The customers’ needs and preferences are changing at lightning speed. The hierarchy of engagement has transformed, disrupting the dynamic between patients and healthcare professionals. Studies (1, 2) show that drug marketers too often turn various aspects of their product profile into signals – and may inadvertently “reinforce the habitual behavior the marketer is trying to change”. We encourage pharmaceutical companies to use a “data-driven approach to uncover new opportunities for growth” and improvement, and we’re committed to delivering results that make a difference for the patient, HCPs and for the system (value-based healthcare approach). Applying the Brand Leadership Circle, a new strategic tool, will help understand the patients’ journey and other stakeholders’ needs to implement successful approaches in marketing, communications and services using systematic research methods and techniques.

Contextualization, Authenticity, and the Problem Description Effect

In recent years, computing education researchers have investigated the impact of problem context on students’ learning and programming performance. This work continues the investigation motivated, in part, by cognitive load theory and educational research in computer science and other disciplines. The results of this study could help inform computing assessment design. If the context and authenticity of a programming problem aid student performance then, instructors’ time in creating appropriately contextualized programming problem descriptions is time well-spent. On the other hand, if the context of a programming problem hinders performance, then instructors should leave it out of programming problems. Recent studies investigating the impact of programming problem context on student success have arrived at different conclusions. Presented here is a series of experiments, conducted over 3 years, investigating the impact of context on novice programmers’ success in algorithmic programming assignments using three contextualized tasks and their generic counterparts. This experiment series also looked into the possibility of “authenticity” as a factor affecting performance. Common sense would suggest that a student would perform better on a problem if they understood or cared about it. Contextualization could provide authenticity and authenticity could provide interest. Research suggests that perceiving a problem as authentic has a positive effect on engagement and learning. Alternatively, if a problem is “just an abstract set of numbers”, it may be harder to make sense of the details and the lack of context could consequently contribute additional cognitive load to an already challenging assignment. The results of this study show that assignment context and problem context authenticity have no effect on the performance of novice programmers. We think, however, that contextualization could be worth investing in to support students’ interest in computing. Additional implications of the results suggest that instructors can assign equivalent versions of the same problem in varied contexts to suit their students’ interests without worrying if the context will hinder performance.

A practical guide to machine-learning scoring for structure-based virtual screening.

Structure-based virtual screening (SBVS) via docking has been used to discover active molecules for a range of therapeutic targets. Chemical and protein data sets that contain integrated bioactivity information have increased both in number and in size. Artificial intelligence and, more concretely, its machine-learning (ML) branch, including deep learning, have effectively exploited these data sets to build scoring functions (SFs) for SBVS against targets with an atomic-resolution 3D model (e.g., generated by X-ray crystallography or predicted by AlphaFold2). Often outperforming their generic and non-ML counterparts, target-specific ML-based SFs represent the state of the art for SBVS. Here, we present a comprehensive and user-friendly protocol to build and rigorously evaluate these new SFs for SBVS. This protocol is organized into four sections: (i) using a public benchmark of a given target to evaluate an existing generic SF; (ii) preparing experimental data for a target from public repositories; (iii) partitioning data into a training set and a test set for subsequent target-specific ML modeling; and (iv) generating and evaluating target-specific ML SFs by using the prepared training-test partitions. All necessary code and input/output data related to three example targets (acetylcholinesterase, HMG-CoA reductase, and peroxisome proliferator-activated receptor-α) are available at https://github.com/vktrannguyen/MLSF-protocol , can be run by using a single computer within 1 week and make use of easily accessible software/programs (e.g., Smina, CNN-Score, RF-Score-VS and DeepCoy) and web resources. Our aim is to provide practical guidance on how to augment training data to enhance SBVS performance, how to identify the most suitable supervised learning algorithm for a data set, and how to build an SF with the highest likelihood of discovering target-active molecules within a given compound library.

Manufacturing dexamethasone intravitreal implants: Process control and critical quality attributes

Over 20 long-acting injectable formulations based on poly(lactide-co-glycolide) (PLGA) have been approved by the FDA to date. PLGA is a biodegradable polymer that can extend drug release from these dosage forms for up to six months after administration. Despite the commercial success of several of these formulations, there are still a limited number of products that utilize PLGA, and there are currently no generic counterparts of these products on the market. Significant technical challenges are associated with preparation of chemically and structurally equivalent formulations that yield an equivalent drug release profile to the reference listed drug (RLD) both in vitro and in vivo. In this work, Ozurdex (dexamethasone intravitreal implant) was used as a model system to explore how the manufacturing process of PLGA–based solid implants impacts the quality and performance of the dosage form. Control of implant structural characteristics, including diameter, internal porosity, and surface roughness, was required to maintain accurate unit dose potency. Implants were prepared by a continuous hot-melt extrusion process that was thoroughly characterized to show the importance of precise feeding control to meet dimensional specifications. Five extruder die designs were evaluated using the same hot-melt extrusion process to produce five structurally-distinct implants. The structural differences did not alter the in vitro drug release profile when tested in both normal saline and phosphate-buffered saline (pH 7.4); however, implant porosity was shown to impact the mechanical strength of the implants. This work seeks to provide insight into the manufacturing process of PLGA–based solid implants to support development of future novel and generic drug products.

An insertability constraint for shape optimization

Patient-specific implants offer a host of benefits over their generic counterparts. Nonetheless, the design and optimization of these components present several technical challenges, among them being the need to ensure their insertability into the host bone tissue. This presents a significant challenge due to the tight-fitting nature of the bone-implant interface. This paper presents a novel insertability metric designed to efficiently assess whether a rigid body can be inserted into a tight-fitting cavity, without interference. In contrast to existing solutions, the metric is fully differentiable and can be incorporated as a design constraint into shape optimization routines. By exploiting the tight-fitting condition, the problem of planning an interference-free insertion path is reformulated as the search for a single interference-free movement, starting from the inserted configuration. We prove that if there exists any outward movement for which no interference is indicated, then the body can be fully extracted from or, equivalently, inserted into the cavity. This formulation is extremely efficient and highly robust with respect to the complexity of the geometry. We demonstrate the effectiveness and efficiency of our method by applying it to the optimization of two-dimensional (2D) and three-dimensional (3D) designs for insertability, subject to various design requirements. We then incorporate the proposed metric into the optimization of an acetabular cup used in total hip replacement (THR) surgery where geometric and structural requirements are considered.

A Cost Variation Analysis of Oral Contraceptive Pills Available in the Indian Market

Background: Oral Contraceptive Pills (OCPs) are highly effective contraceptives if used regularly and adequately, and they also have added non-contraceptive benefits. This gives way to their increasing use in recent years, which has led to the introduction of numerous brands of drugs with different costs in the Indian market. Hence the current study was conducted to analyze the cost ratio and cost variation of different brands of OCPs available in the Indian market and to compare the cost of branded and generic drugs.
 Materials and Methods: The cost of the drugs was obtained from the Current Index of Medical Specialties (CIMS) - 44th Year April – July 2022 and from the website https://www.mims.com/india/. The Cost Ratio (CR) and Percentage Cost Variation (CV) was calculated. The cost of generic drugs was obtained from the website http://janaushadhi.gov.in/SortingView.aspx.
 Results: 124 brands of various OCPs were available in the Indian market. Among all the regular OCPs available, the CR and CV were highest for Ormeloxifene 30mg at 10.19 and 919.4%, respectively, and they were lowest for Dienogest +Ethinylestradiol which comes under combined OCPs with the results of 1.007 and 0.73% respectively. The cost of all generic OCPs was lesser when compared with brand OCPs, and the difference in cost was maximum for Ulipristal.
 Conclusion: There is wide variation in the cost of Oral Contraceptive Pills available in the Indian market, and the cost of brand drugs is higher than their generic counterparts. Physicians have to be made aware of this price difference so that they can prescribe drugs that are more affordable to the patients to improve their adherence to the regimen.

Availability, and price of anti-hypertensives and antidiabetics in public and private health facilities in Jos, Plateau State and environs North Central Nigeria

Background: One of the elements restricting access to medicines is high medicine prices. This can have a detrimental effect on patients' health as well as the healthcare system in terms of lack of patient  compliance with treatment and subsequent hospitalisation for serious complications. The aim of the study is to evaluate the availability and price of antidiabetics and antihypertensives in private and public health centres in Jos and environs. Method: This study is based on a methodology developed by the World Health Organization (WHO) and HealthAction International (HAI), 2004. It uses a short list of medicines to determine the prices of medicines in different health sectors. Data Analysis was done using the SPSS software. The median price ratio for each drug was calculated as well as the percentage availability. Results: Most antihypertensives and antidiabetics were sold above the international reference price, median price ratio was above 2.5 for all the drugs surveyed. The mean availability of antihypertensives was 85.43% for generic and 1.59% for branded. In public pharmacies, the mean availability of antihypertensives was 79.45% for generic antihypertensives, and 2.37% for branded antihypertensives. Conclusion: In both public and private pharmacies availability of Branded antihypertensives and antidiabetics were very low compared to their generic counterparts. The poor availability of essential medicines is likely to be multifactorial, further facilitated by cash-flow constraints, inadequate local manufacturing capacities and resulting import dependencies.

Cost Variation Study of Various Brands of Oral Fluoroquinolones Available in India: An Economic Perspective

Fluoroquinolones are broad-spectrum antibacterial for treating respiratory tract, intra-abdominal, urinary tract, pelvic, joint, bone, soft tissue, and skin infections. The economic burden on patients affects compliance in developing countries like India. Therefore, the prices of drugs should be controlled effectively. Hence, this study was done to assess the cost variation of branded oral fluoroquinolones available in India compared with generic counterparts. The maximum and minimum cost of oral fluoroquinolones (INR per 10 tablets) of the same strength and dosage form manufactured by different companies was obtained from Drug Today April to July 2021 Volume 1, MIMS, and 1mg.com. The cost ratio and the percentage cost variation of individual drug brands were calculated. Prices of generic fluoroquinolones from the Jan Aushadhi scheme (JAS) were compared with branded drugs. Of 11 different oral fluoroquinolones, levofloxacin 500 mg had the highest percentage variation of 11.100%, and three formulations marketed by a few manufacturers have a percentage reduction of less than 100%. Of 23 different combinations available as 33 different dosages, the highest cost variations were observed in Norfloxacin 400 mg plus tinidazole 600 mg combination (1317%). When compared, some generic fluoroquinolones available under JAS were not cheaper than the minimum cost of their branded counterparts. Wide variation in the cost of the different brands of the same oral fluoroquinolones manufactured by other companies was observed. This adds to the economic burden for the patients. Hence, stakeholders should aim to decrease the cost variation among different brands while maintaining therapeutic efficacy

Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study.

The primary objectives of this study were to evaluate the effect of hearing implant (HI) use on quality of life (QoL) and to determine which QoL measure(s) quantify QoL with greater sensitivity in users of different types of HIs. Participants were adult cochlear implant (CI), active middle ear implant (VIBRANT SOUNDBRIDGE (VSB)), or active transcutaneous bone conduction implant (the BONEBRIDGE (BB)) recipients. Generic QoL and disease-specific QoL were assessed at three intervals: pre-activation, 6 months of device use, and 12 months of device use. 169 participants completed the study (110 CI, 18VSB, and 41BB). CI users’ QoL significantly increased from 0–6 m device use on both the generic- and the disease-specific measures. On some device-specific measures, their QoL also significantly increased between 6 and 12 m device use. VSB users’ QoL significantly increased between all tested intervals with the disease-specific measure but not the generic measure. BB users’ QoL significantly increased from 0–6 m device use on both the generic- and the disease-specific measures. In sum, HI users experienced significant postoperative increases in QoL within their first 12 m of device use, especially when disease-specific measures were used. Disease-specific QoL measures appeared to be more sensitive than their generic counterparts.

Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China.

Background: The substitution of generic drugs can effectively alleviate the rapid growth of drug costs; however, the clinical effectiveness and medical costs of originator products and generics were barely studied in China. Objectives: To compare the effectiveness of antihypertensive drugs and hypertension-related medical costs between originator and generic initiators in Yinzhou, China. Methods: We conducted a population-based retrospective cohort study using the Chinese Electronic Health Records Research in Yinzhou (CHERRY), from July 1, 2011, to December 31, 2018. Hypertension patients initiating with originator products were compared with patients initiating with generic counterparts. We used 1:1 propensity score matching to pair the two groups based on sociodemographic, clinical, and health service utilization variables. Cox proportional regression was adopted to compare the rate of hospitalization for hypertension-related cardiovascular disease between matched originator and generic initiators. Wilcoxon matched-pairs signed-rank test was used to compare annual hypertension-related medical costs. Results: Matched pairs (10,535) of patients were included in the comparative study of originator products and generics, corresponding to seven antihypertensive drugs including amlodipine, felodipine, nifedipine, irbesartan, losartan, valsartan, and metoprolol. The average age of patients included in the analysis was around 60 years (originator vs. generics initiators: from 59.0 vs. 59.1 years in losartan to 62.9 vs. 63.6 years in nifedipine). Higher hospitalization rates among originator initiators were observed for three calcium channel blockers (hazard ratio[95% CI]: amlodipine, 3.18[1.43, 7.11]; felodipine, 3.60[1.63, 7.98]; and nifedipine, 3.86[1.26, 11.81]; respectively). The remaining four out of seven drugs of the clinical endpoint estimates showed comparable outcomes between originator products and generics (hazard ratio[95% CI]: irbesartan, 1.19[0.50, 2.84]; losartan, 1.84[0.84, 4.07]; valsartan, 2.04[0.72, 5.78]; and metoprolol, 1.25[0.56, 2.80]; respectively). Higher median annual hypertension-related medical costs were observed in originator initiators (all p < 0.001), except for metoprolol (p = 0.646). Conclusion: We observed comparable or even better clinical outcomes and less medical cost associated with the use of antihypertensive generics compared to originator counterparts. This could help increase patient and provider confidence in the efficacy of generic medicines to manage hypertension diseases.

Factors affecting purchasing behaviors of generic drugs versus originator counterparts in Jordan

Factors affecting purchasing behaviors of generic drugs versus originator counterparts in Jordan

Shaping of the evidence-based substitution conceptual framework of the original medicines to generic counterparts in Ukraine

The aim. To develop conceptual framework of the strategy for a reasonable transition from original to generic medicines by complex implementation of proper bioequivalence studies and sufficient therapeutic drug monitoring management.&#x0D; Materials and methods. To conduct the study, we used the lists of medicines included in the state reimbursement program “Dostupny Liky” (Affordable Medicines), and materials of reports on medicines public procurement provided on the website of the Ministry of Health of Ukraine and the National Health Service of Ukraine, as well as information data on the results of studies of the quality and effectiveness of these drugs provided by the Rx-Index website. In the course of the study, the methods of logical analysis, SWOT analysis, and statistical evaluation of results, Kingdon’s Policy Streams Approach and the method of flowcharts construction were used. The concept of evidence-based medicine substitution formation in Ukraine was designed applying the Policy Streams Approach.&#x0D; Results. The analysis of public procurement programs for drugs for the period 2018–2020, as well as the analysis of drugs included in the new list under the “Dostupny Liky” (Affordable Medicines) program, carried out in the course of the study, showed that the level of evidence of data on assessing their effectiveness remains low. At the same time, more than 1.5 billion UAH (~ 50 mln USD) is spent annually on the purchase of such drugs and reimbursement of their cost, and the question of the optimal selection and monitoring of pharmacotherapy with these drugs remains open. A structural model has been developed, in which three basic levels are identified: provision of regulatory and financial components, executive and the level of implementation of the results. The SWOT-analysis of the strengths and weaknesses, as well as external opportunities and threats for the implementation of the conceptual framework made it possible to substantiate the advantages and reveal the possibilities of attracting clinical centers of universities and research institutions to the implementation of the concept. A framework for the interaction of a research center with health care institutions in the implementation of therapeutic drug monitoring was developed for low-income and low-middle income countries on the example of Ukraine. Distribution of responsibilities was proposed and the basic principles of interaction between performers of therapeutic drug monitoring were highlighted.&#x0D; Conclusions. Based on the results of the analysis of the evidence of the quality and effectiveness of drugs included in public procurement and in reimbursement programs, the key problems of organizing pharmaceutical provision of an appropriate level of quality for a number of chronic diseases requiring lifelong therapy were identified. The conceptual framework of evidence-based original medicines substitution to generic counterparts have been formed; and the ways of its implementation in the conditions of scarce financial resources on the example of Ukraine have been substantiated

Effective one-body model for extreme-mass-ratio spinning binaries on eccentric equatorial orbits: Testing radiation reaction and waveform

We provide a systematic analysis of the multipolar gravitational waveform, energy and angular momentum fluxes emitted by a nonspinning test particle orbiting a Kerr black hole along equatorial, eccentric orbits. These quantities are computed by numerically solving the Teukolsky equation in the time domain and are then used to test and improve the radiation reaction (and waveform) of an effective-one-body (EOB) model. Eccentricity is incorporated into EOB by replacing the quasi-circular Newtonian (or leading-order) prefactors in the EOB-factorized multipolar waveform (and fluxes) with their generic counterparts. The comparison between numerical and analytical quantities is carried out over a large portion of the parameter space, notably for orbits close to the separatrix and with high eccentricities. The analytical model agrees to $\sim 1\%$ with the numerical data for orbits with moderate eccentricities ($e\lesssim 0.3$) and moderate spins ($\hat{a}\lesssim 0.5$), although this increases up to $\sim 33\%$ for large, positive, black hole spins ($\sim 0.9$) and large eccentricities ($\sim 0.9$). For moderate eccentricities, the new EOB fluxes can be used to drive the dynamics through the nonadiabatic transition from eccentric inspiral to plunge, merger and ringdown, thus providing accurate an description of the merger. We also show that the same technique can be applied to hyperbolic encounters. In general, our approach to radiation reaction for eccentric inspirals should be seen as a first step toward EOB modelization of extreme-mass-ratio-inspirals waveforms for LISA.

FDA's Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes.

Poly (lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations which have been approved by the US Food and Drug Administration (FDA). However, generic counterparts for PLGA products have yet to gain FDA approval due to many complexities in formulation, characterization, and evaluation of test products. To address the challenges of generic development of PLGA-based products, the FDA has established an extensive research program to investigate novel methods and tools to aid both product development and regulatory review. The research focus have been: (1) analytical tools for characterization of PLGA polymers; (2) impacts of PLGA characteristics and manufacturing conditions on product performance; (3) in vitro drug release testing and in vitro-in vivo correlation of PLGA-based products, and (4) modeling tools to facilitate formulation design and bioequivalence study design of PLGA-based drugs. This article provides an overview of FDA's PLGA research program and highlights scientific accomplishments as well as regulatory outcomes that have resulted from successful research investigations.

GPU efficient 1D and 3D recursive filtering

This work presents strategies to massively parallelize recursive filters on inputs of one dimension (1D) or three dimensions (3D), complementing and improving on previous state-of-the-art algorithms on two dimensions (2D). Each strategy is reusable on different algorithms for parallel processing with feedback data dependencies, allowing to develop highly optimized algorithms for computing digital filters in general, with double-pass causal-anticausal feedbacks, in one or multiple dimensions. The algorithms are linear in time and memory, exposes a high number of parallel tasks, and they are implemented on graphics processing units, i.e. GPUs. One major barrier in this area is to have such algorithms faster than generic counterparts in available libraries, and another is to have them in an easy-to-use manner. To overcome the latter, the implementation of the presented strategies is available as open source, and, to overcome the former, timing performance and comparison results are provided, including a range of publicly available source codes and libraries, showing that this work outperforms fastest prior algorithms.

Understanding authorized generics-A review of the published clinical data.

Despite the large body of evidence demonstrating equivalent efficacy and safety for branded drugs and their generic counterparts, some patients and providers have the perception that generics may be less safe and effective than branded agents. Authorized generics (AGs) are a category of generic drugs defined by the United States Food and Drug Administration (FDA) as being the same as the brand-name drug without the brand's name on the label and which may have minor differences, such as tablet or capsule markings for identification. Studies in which AGs are considered along with other generics may increase our understanding of factors that may influence perceptions about generics and shed light on areas where education may be impactful. The objectives of this paper are to provide information about AGs, review studies in which they have been evaluated and explore the role that AGs may fill in the individualized treatment of patients. A literature review was conducted on 30 September 2019 with follow-up search on 4 March 2020. The search was focussed on published papers and meeting abstracts that provided information on AGs with respect to medical and health outcomes of therapy as well as switching in individuals receiving branded, AG, or other generic agents. Information about patients' perceptions of generic medications and adherence to therapy was also included. Additional information, including relevant government sources, such as the FDA website and the Federal Trade Commission Report, was included as appropriate. The literature specific to AGs is limited, but available data clearly highlight the importance of patient perception of generics as well as medication appearance as factors that may affect adherence and potentially more frequent switchbacks to branded agents from generics or AGs. To our knowledge, this is the first narrative review to provide a summary of the published evidence about AGs with respect to clinical and health outcomes and switching. There is a need for more research and education regarding the use of AGs in clinical practice if they are to become more recognized as a potential treatment choice for patients. Generic medications play an important role in the healthcare system, and AGs may be able to provide an option to meet the specific needs of individual patients.

PDG35 Generic Substitution in Lebanon: A Controlled Interrupted Time Series Analysis of Statins

A new generic substitution (GS) policy was implemented in Lebanon in 2015 in order to promote utilization of generics. We aim in this research to assess the impact of this new policy on the consumption of statins. Private sales data for Lipitor®, Crestor®, and their generic counterparts (from January 2014 to December 2016) were obtained from IQVIA, Inc. Monthly sales were converted to defined daily doses per 1000 inhabitants per month (DDD/TIM). Interrupted time-series (ITS) analyses were conducted to estimate the changes in level and trend of use of the studied drugs after the GS policy. A controlled ITS analysis using ratios was also done with Livazo®, a statin with no generic equivalent, as control. Ratios of Livazo/Lipitor and Livazo/Crestor monthly sales were then derived and studied in the controlled ITS. Seasonality was adjusted for by including Fourier terms in the model. The GS policy resulted in a slight increase in the level of utilization of Lipitor® (1.32 DDD/TIM, p=0.847) with a decreasing trend (-0.28 DDD/TIM, p=0.645). The utilization of Crestor decreased (level -8.27 DDD/TIM, p=0.643); slope -0.16 DDD/TIM, p=0.919). There was a decrease in the trend of use of atorvastatin generics by 3.24 DDD/TIM (p=0.038)relatively to the pre-intervention trend whereas no major change was witnessed for rosuvastatin generics (level -9.43 DDD/TIM, p=0.339; slope 0.02 DDD/TIM, p=0.986). The intervention resulted in an increase in the level and trend of Livazo/Lipitor ratio of 7.4% (p=0.563) and 0.5% (p=0.637), respectively. The same was noted for Livazo/Crestor ratio (level 2.5%, p=0.288 and slope 0.09%, p=0.674). We found no decrease in the use of two branded statins after the implementation of the new GS policy in Lebanon. A decrease in the trend of use of atorvastatin generics was noted after the policy.

Changes in Prices and Eye-Care Providers Prescribing Patterns of Glaucoma Medications in the United States Between 2013 and 2019.

Brand glaucoma medication prices vastly increased in the United States over the past 7 years, despite a reduction in eye-care providers' tendency to prescribe brand medications over generics. Determine the changes in prices of brand and generic glaucoma medications and to identify changes in eye-care providers prescribing patterns since 2013. The National Average Drug Acquisition Cost (NADAC) database (2013-2019) was used analyze per-unit drug price. Medicare Part D prescriber profile was used to identify eye-care providers prescribing patterns between 2013 and 2017. Brand-name medication prices increased by 59% between 2013 and 2019, while generic medications decreased by 22%. Brand-name drugs were 13 to 162 times more expensive than their generic counterparts. Eye-care Providers prescribed 25% less brand name medications in 2017 compared with 2013. Brand glaucoma medication prices vastly increased in the United States over the past 7 years, despite a reduction in eye-care providers' tendency to prescribe brand medications over generics. A change in government policy, allowing Medicare medication prices negotiations, could greatly reduce health expenditure on glaucoma treatment.