Understanding treatment patterns and patient-reported outcomes associated with the use of authorized generics and corresponding independent generics across multiple therapeutic areas.

OBJECTIVES: To assess patient characteristics, treatment patterns, and patient-reported outcomes (PROs) associated with authorized generics (AGs) and independent generics (IGs) use. METHODS: Prescription claims and National Health and Wellness Survey (NHWS) data were linked. Adults with billable national drug code (AG or IG), NHWS completion from June 2015 to July 2019, AG or IG on-hand at NHWS completion, and continuous insurance eligibility in 12 months pre- and post-NHWS completion were included. To be included, all unique medication formulations had to have at least one AG and one IG observation. PRO index date was NHWS completion; claims index date was defined as the first prescription claim identified during the 180-day period prior to NHWS completion for the same active ingredient and formulation type that was on-hand at NHWS completion. RESULTS: Patients (N = 20,229; 17.2% AG users) in six therapeutic areas (attention deficit-hyperactivity disorder [ADHD], antidepressants, beta blockers [BBs], calcium channel blockers [CCBs], statins, and thyroid) were included. Generally, AG (vs. IG) users were younger and differed in regional access and insurance type (all, p < .05). In multivariable analysis, significant differences were observed for presenteeism and overall work impairment (BBs), healthcare provider visits (BBs), and indirect costs (thyroid) (all, p < .05). AG and IG users differed in persistence (ADHD and statins; both, p < .05) and switch (BBs and CCBs; both, p < .01) rates. CONCLUSIONS: PRO differences were often small in magnitude and varied by therapeutic area. The impact of switching should consider observed PRO differences, patient preferences, and market availability of AG and IG alternatives.

Barriers to generic antiseizure medication use: Results of a global survey by the International League Against Epilepsy Generic Substitution Task Force.

The objective of this study was to identify and quantify barriers to generic substitution of antiseizure medications (ASM). A questionnaire on generic ASM substitution was developed by the International League Against Epilepsy (ILAE) Task Force on Generic Substitution. Questions addressed understanding of bioequivalence, standards for generic products, experiences with substitution, and demographic data. The survey was web-based and distributed to ILAE chapters, their membership, and professional colleagues of task force members. Comparisons in responses were between ILAE regions and country income classification. A total of 800 individuals responded, with 44.2% being from the Asia-Oceania ILAE Region and 38.6% from European Region. The majority of respondents had little or no education in generic substitution or bioequivalence. Many respondents indicated lack of understanding aspects of generic substitution. Common barriers to generic substitution included limited access, poor or inconsistent quality, too expensive, or lack of regulatory control. Increase in seizures was the most common reported adverse outcome of substitution. Of medications on the World Health Organization Essential Medication list, problems with generic products were most frequent with carbamazepine, lamotrigine, and valproic acid. Several barriers with generic substitution of ASM revolved around mistrust of regulatory control and quality of generic ASM. Lack of education on generic substitution is also a concern. Generic ASM products may be the only option in some parts of the world and efforts should address these issues. Efforts to address these barriers should improve access to medications in all parts of the world.

Changes in nationwide Medicare and Medicaid expenditures on lipid-lowering therapies after proprotein convertase/subtilisin type 9 inhibitor availability.

BACKGROUND: Several advances in lipid-lowering pharmacotherapy and changes in generic formulation availability occurred between 2013 and 2017. OBJECTIVE: We sought to examine nationwide trends in Medicare Part D and Medicaid expenditures on lipid-lowering therapies from 2013 to 2017. METHODS: We aggregated 662.2 million Medicare Part D and Medicaid prescription claims with associated expense data for 2013 to 2017 from the Medicare and Medicaid Drug Spending Dashboards for nine therapeutic classes of lipid-lowering therapies. RESULTS: Total Medicare Part D expenditures on lipid-lowering therapies was $7.01 billion in 2013 and $5.07 billion in 2017. Total Medicaid lipid-lowering therapy expenditures decreased from $440.9 million in 2013 to $398.7 million in 2017. Annual Medicare expenditures on Crestor were $2.2 billion in 2013 and $0.31 billion in 2017. Annual Medicaid Crestor expenditures decreased from $92.4 million in 2013 to $30.1 million in 2017. From 2013 to 2016, Medicare expenditures on Zetia decreased from $0.89 billion to $0.70 billion, whereas Medicaid Zetia expenditures decreased from $38.6 million in 2013 to $25.4 million in 2017. In 2017, PCSK9 inhibitors accounted for $317.3 million and $14.2 million in Medicare and Medicaid expenditures, respectively. CONCLUSIONS: Overall Medicare and Medicaid expenditures on lipid-lowering therapies decreased by $2.5 billion from 2013 to 2017.

Increased topical generic prices by manufacturers.

BACKGROUND: There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. OBJECTIVE: We sought to examine the extent of price changes for topical generic medications. METHODS: A comprehensive review of average wholesale prices (AWPs) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. RESULTS: A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generic medications increased by 273% and the AWP of topical branded medications increased by 379%. The topical generic with the greatest price change increased by 2529%. Eight of the top 20 topical generic medications with the greatest increases in AWP also had an increase in the number of manufacturers. LIMITATIONS: These findings are not generalizable to medications used in other areas of medicine. CONCLUSION: Topical generic prices are rapidly increasing at the manufacturer level.

Choosing a medication brand: Excipients, food intolerance and prescribing in older people.

Multiple brands of the same active ingredient may be available for the same strength, administration route and dose form. Generic brands needs to demonstrate bioequivalence to the originator brand, but the appearance of the generic and originator brands are not required to match. This variation is possible because different brands may vary in the excipients used in the formulation. Excipients are inactive ingredients, and typically make up about 90% of the formulation of an individual medication. Individual preferences or requirements may affect tolerance of particular excipients, such as the use of animal products. The different appearance of brands can affect medication management for some people. This review discusses the potential for excipients to alter the individual response to or tolerance of a medication brand.

Empirical Assessment of the Impact of Low-Cost Generic Programs on Adherence-Based Quality Measures.

In the United States, federally-funded health plans are mandated to measure the quality of care. Adherence-based medication quality metrics depend on completeness of administrative claims data for accurate measurement. Low-cost generic programs (LCGPs) cause medications fills to be missing from claims data as medications are not adjudicated through a patient's insurance. This study sought to assess the magnitude of the impact of LCGPs on these quality measures. Data from the 2012-2013 Medical Expenditure Panel Survey (MEPS) were used. Medication fills for select medication classes were classified as LCGP fills and individuals were classified as never, sometimes, and always users of LCGPs. Individuals were classified based on insurance type (private, Medicare, Medicaid, dual-eligible). The proportion of days covered (PDC) was calculated for each medication class and the proportion of users with PDC ≥ 0.80 was reported as an observed metric for what would be calculated based on claims data and a true metric which included missing medication fills due to LCGPs. True measures of adherence were higher than the observed measures. The effect's magnitude was highest for private insurance and for medication classes utilized more often through LCGPs. Thus, medication-based quality measures may be underestimated due to LCGPs.

Examining patterns in medication documentation of trade and generic names in an academic family practice training centre.

BACKGROUND: Studies in the United States have shown that physicians commonly use brand names when documenting medications in an outpatient setting. However, the prevalence of prescribing and documenting brand name medication has not been assessed in a clinical teaching environment. The purpose of this study was to describe the use of generic versus brand names for a select number of pharmaceutical products in clinical documentation in a large, urban academic family practice centre. METHODS: A retrospective chart review of the electronic medical records of the St. Michael's Hospital Academic Family Health Team (SMHAFHT). Data for twenty commonly prescribed medications were collected from the Cumulative Patient Profile as of August 1, 2014. Each medication name was classified as generic or trade. Associations between documentation patterns and physician characteristics were assessed. RESULTS: Among 9763 patients prescribed any of the twenty medications of interest, 45% of patient charts contained trade nomenclature exclusively. 32% of charts contained only generic nomenclature, and 23% contained a mix of generic and trade nomenclature. There was large variation in use of generic nomenclature amongst physicians, ranging from 19% to 93%. CONCLUSIONS: Trade names in clinical documentation, which likely reflect prescribing habits, continue to be used abundantly in the academic setting. This may become part of the informal curriculum, potentially facilitating undue bias in trainees. Further study is needed to determine characteristics which influence use of generic or trade nomenclature and the impact of this trend on trainees' clinical knowledge and decision-making.

A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

BACKGROUND: Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. METHODS: A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. RESULTS: The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p < 0.001). CONCLUSION: Pharmacists who have expertise in medications were shown to prefer using generic OTC medications rather than brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide consumers the evidence needed to make well-informed choices when choosing between brand and generic medications.