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The change from brand-name to generic aromatase inhibitors and hormone therapy adherence for early-stage breast cancer.

ABSTRACT: Nonadherence to hormonal therapy is common and is associated with increased copayment amount. We investigated the change in adherence after the introduction of generic aromatase inhibitors (AIs) in 2010.Using deidentified pharmacy and claims data from OptumInsight, we identified women older than 50 years on brand-name AIs (BAIs) and/or generic AIs (GAIs) for early breast cancer between January 1, 2007 and December 31, 2012. Clinical, demographic, and financial variables were evaluated. Adherence was defined as a medication possession ratio (MPR) 80% or greater.We identified 5511 women, 2815 (51.1%) on BAI, 1411 (25.6%) on GAI, and 1285 (23.3%) who switched from BAI to GAI. The median 30-day copayment was higher for BAI ($33.3) than for GAI ($9.04). In a multivariable Cox-proportional hazard analysis, women who took GAI were less likely to discontinue therapy (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.57 to 0.84) compared with BAI. Discontinuation was positively associated with a higher monthly copayment of $15 to $30 (HR = 1.21, 95% CI = 1.01 to 1.44) and more than $30 (HR = 1.49, 95% CI = 1.23 to 1.80) compared with less than $15. In a multivariable logistic regression analysis, adherence (medication possession ratio ? 80%) was positively associated with GAI use (odds ratio = 1.53, 95% CI = 1.22 to 1.91) compared with BAI and inversely associated with increased monthly copayment. In addition, adherence was associated with a high annual income of more than $100k/year (odds ratio = 1.58, 95% CI = 1.17 to 2.11).Higher prescription copayment amount was associated with nonadherence and discontinuation of AIs. After controlling for copayment, discontinuation was higher and adherence was lower with Brand AIs. Because nonadherence is associated with worse survival, efforts should be directed towards reducing out-of-pocket costs for these life-saving medications.

SUBMITTER: Hershman DL

PROVIDER: S-EPMC4271034 | biostudies-other | 2014 Nov

REPOSITORIES: biostudies-other

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The change from brand-name to generic aromatase inhibitors and hormone therapy adherence for early-stage breast cancer.

Hershman Dawn L DL Tsui Jennifer J Meyer Jay J Glied Sherry S Hillyer Grace Clarke GC Wright Jason D JD Neugut Alfred I AI

Journal of the National Cancer Institute 20141027 11

<h4>Background</h4>Nonadherence to hormonal therapy is common and is associated with increased copayment amount. We investigated the change in adherence after the introduction of generic aromatase inhibitors (AIs) in 2010.<h4>Methods</h4>Using deidentified pharmacy and claims data from OptumInsight, we identified women older than 50 years on brand-name AIs (BAIs) and/or generic AIs (GAIs) for early breast cancer between January 1, 2007 and December 31, 2012. Clinical, demographic, and financial ...[more]

PMID: 25349080

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Project description:ImportanceWhether the use of generic vs brand levothyroxine affects thyrotropin levels remains unclear.ObjectiveTo compare the effectiveness of generic vs brand levothyroxine in achieving and maintaining normal thyrotropin levels among new users.Design, setting, and participantsThis retrospective, 1:1 propensity score-matched longitudinal cohort study used the OptumLabs Data Warehouse administrative claims database linked to laboratory results from commercially insured and Medicare Advantage enrollees throughout the United States. Eligible patients were adults (aged ≥18 years) with thyrotropin levels ranging from 4.5 to 19.9 mIU/L who initiated use of generic or brand-name levothyroxine from January 1, 2008, to October 1, 2017. Data were analyzed from August 13, 2018, to October 25, 2019.ExposurePatients received generic or brand-name levothyroxine.Main outcomes and measuresProportion of patients with normal vs markedly abnormal thyrotropin levels (<0.1 or >10 mIU/L) within 3 months and with stable thyrotropin levels within 3 months after the thyrotropin value fell into the normal range.ResultsA total of 17 598 patients were included (69.0% female; 74.0% White; mean [SD] age, 55.1 [16.0] years), of whom 15 299 filled generic and 2299 filled brand-name levothyroxine prescriptions during the study period. Among 4570 propensity score-matched patients (mean [SD] age, 50.3 [13.8] years; 3457 [75.6%] female; 3510 [76.8%] White), the proportion with normal thyrotropin levels within 3 months of filling levothyroxine prescriptions was similar for patients who received generic vs brand-name levothyroxine (1722 [75.4%; 95% CI, 71.9%-79.0%] vs 1757 [76.9%; 95% CI, 73.4%-80.6%]; P = .23), as was the proportion with markedly abnormal levels (94 [4.1%; 95% CI, 3.4%-5.0%] vs 88 [3.9%; 95% CI, 3.1%-4.7%]; P = .65). Among 1034 propensity score-matched patients who achieved a normal thyrotropin value within 3 months of initiation of levothyroxine, the proportion maintaining subsequent normal thyrotropin levels during the next 3 months was similar for patients receiving generic vs brand-name levothyroxine (427 [82.6%] vs 433 [83.8%]; P = .62).Conclusions and relevanceInitiation of generic vs brand-name levothyroxine formulations was associated with similar rates of normal and stable thyrotropin levels. These results suggest that generic levothyroxine as initial therapy for mild thyroid dysfunction is as effective as brand-name levothyroxine.

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Project description:BackgroundTo the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications.Methods and findingsFor commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics.ConclusionsIn this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.

Dataset Information

The change from brand-name to generic aromatase inhibitors and hormone therapy adherence for early-stage breast cancer.

Publications

The change from brand-name to generic aromatase inhibitors and hormone therapy adherence for early-stage breast cancer.

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