Does substitution of brand name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France

Molinier, A; Palmaro, Aurore; Rousseau, Vanessa; Sommet, Agnès; Bourrel, Robert; Montastruc, Jean‐Louis; Bagheri, Haleh

doi:10.1007/s00228-016-2185-z

Cited by 6 publications

(6 citation statements)

References 21 publications

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“… 16 Among patients switched from branded to generic drug products, the rates of switching back to branded drug products are reported to be in the range of 12% to 65% for many drug classes including antiepileptics, antipsychotics, and β blockers. 17 18 19 Switching back to the branded drug product when low cost generic drug products are available has important economic implications for the healthcare system. Use of branded drug products when generic drug products are available increases patient expenses by an estimated $1.2bn (£860m; €980m), and overall healthcare system costs by an estimated $7.7bn (£5.5bn; €6.3bn) annually in the US.…”

Section: Introductionmentioning

confidence: 99%

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Desai

Sarpatwari

Dejene

et al. 2018

BMJ

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ObjectivesTo compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients.DesignObservational cohort study.SettingPrivate (a large commercial health plan) and public (Medicaid) insurance programs in the US.ParticipantsBeneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort).Main outcome measuresPatients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products.ResultsA total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine-benazepril capsules), with an overall rate of 8.2 per 100 person years across all drug products. Adjusted switchback rates were consistently lower for patients who switched from branded to authorized generic drug products compared with branded to generic drug products in the primary cohort (pooled hazard ratio 0.72, 95% confidence interval 0.64 to 0.81). Similar results (0.75, 0.62 to 0.91) were observed in the replication cohort.ConclusionSwitching from branded to authorized generic drug products was associated with lower switchback rates compared with switching from branded to generic drug products.

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Section: Introductionmentioning

confidence: 99%

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Desai

Sarpatwari

Dejene

et al. 2018

BMJ

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“…36 French health care data covering almost 10 million individuals in the period from 2009-2012, indicate that the rate for switchback to brands for AEDs was 62%, which was significantly higher than the rate for betablockers (42%) or neuroleptics (45%). 37 In contrast to the findings mentioned above, a population-based case-crossover study using the Medicaid Analytic eXtract and a U.S. commercial health insurance database with 83 001 generic AED users who experienced a seizure-related hospital admission or emergency room visit between 2000 and 2013 did not show an impact of switches among different generics. 38 Refilling a prescription for the same generic AED taken by the patient was associated with an increased risk of a seizure within 36 days (OR 1.08), but changing to a different manufacturer's generic of the same AED-if controlled for refill-was not.…”

Section: Health-care Usage Datamentioning

confidence: 65%

“…Public‐payer pharmacy claims from Ontario, Canada, showed that 12.9% of patients prescribed switch from Lamictal to generic lamotrigine switched back, substantially higher figures than for non‐AEDs such as antihyperlipidemics and antidepressants (1.5%‐2.9%) . French health care data covering almost 10 million individuals in the period from 2009‐2012, indicate that the rate for switchback to brands for AEDs was 62%, which was significantly higher than the rate for beta‐blockers (42%) or neuroleptics (45%) . In contrast to the findings mentioned above, a population‐based case‐crossover study using the Medicaid Analytic eXtract and a U.S. commercial health insurance database with 83 001 generic AED users who experienced a seizure‐related hospital admission or emergency room visit between 2000 and 2013 did not show an impact of switches among different generics .…”

Section: Health‐care Usage Datamentioning

confidence: 99%

Generic antiepileptic drugs—Safe or harmful in patients with epilepsy?

Holtkamp

Theodore

2018

Epilepsia

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Summary Generic antiepileptic drugs (AED) are significantly cheaper than brand name drugs, and may reduce overall health care expenditures. Regulatory bodies in Europe and North America require bioequivalence between generic and innovator drugs with regard to area under the plasma concentration–time curve (AUC) and peak plasma concentration (Cmax); strict cutoff values have been defined. The main issue is if bioequivalence ensures therapeutic equivalence. Are switches from brand to generic, or between generic AEDs entirely safe or potentially harmful in patients with epilepsy? We summarized and evaluated the available evidence from bioequivalence, health care utilization, and clinical studies on safety of generic AEDs. In most cases, variations in AUC and Cmax were negligible when comparing innovator and generic AEDs. Due to interindividual pharmacokinetic and pharmacodynamic variability, measured differences between innovator and generic drugs may be the same as differences between different lots of the same brand. Studies from several countries based on insurance data have reported an increase in health care usage after switch from brand to generic AEDs; switchback rates are significantly higher for AEDs compared to other compounds. Patients may be confused, and nonadherence may increase, when AEDs are switched between manufacturers, perhaps due to changes in medication shape and color. But clinical studies do not report changes in seizure frequency and tolerability attributable to generics. Sufficient evidence indicates that most generics are bioequivalent to innovator AEDs; they do not pose a relevant risk for patients with epilepsy. However, some patients are reluctant towards variations in color and shape of their AEDs which may result in nonadherence. We recommend administering generics when a new AED is initiated. Switches from brand to generic AEDs for cost reduction and between generics, which is rarely required, generally seem to be safe, but should be accompanied by thorough counseling of patients on low risks.

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“…Unfortunately, this perception causes an impact on the attitude of society, both health-care practitioners and consumers, concerning the use of generic drug products [15,32,33]. The low acceptance of the patients to receive generic products after using the branded drugs is also reported [34]. However, this phenomenon can, sometimes, be justified since many studies have confirmed significant differences in terms of pharmacokinetic profile or pharmacological effect between branded and generic drugs [7,35].…”

Section: Based Onmentioning

confidence: 99%

Pharmacodynamics Effect of Methylprednisolone Tablets on the Serum Concentration of Annexin A1: In Vivo Comparative Study Between Generic and Innovator Drug

Nasif¹,

Lucida²,

Yanwirasti³

et al. 2019

Asian J Pharm Clin Res

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Objective: The aims of this study were to investigate the comparative pharmacodynamics effect of methylprednisolone (MP) innovator, MP branded generic, and MP generic products to the serum concentration of annexin A1 (AnxA1).Methods: It was conducted by two-way crossover design in male rabbits. AnxA1 was measured at 0, 0.5, 1, 2, 3, 5, 7, and 9 h after the administration of the drugs. The peak concentration (Cmax), the time at which the peak concentration was achieved (Tmax), and the area under the plasma concentration-time curve (AUC) were also determined.Results: The highest concentration and widest AUC of AnxA1 were obtained in MP innovator drug. MP innovator and branded generic reaches the peak time (Tmax) at the third 3rd h, while the MP generic reaches the peak time at the 5th h. The results showed that there was no significant difference in the serum concentration of AnxA1 between MP tablets after analyzed with a one-way analysis of variance.Conclusion: It could be concluded that the innovator drug of MP tablet gave the same effect on the serum concentration of AnxA1 than its generic counterparts, but an onset of action MP innovator and branded generic is faster than the generic product.

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Does substitution of brand name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France

Abstract: Compared to beta-blocker users, AED users were more likely to switch back to the branded drug, whereas this difference was not observed with neuroleptics. These results could reflect a poor acceptance of switching AEDs to generic compounds in France.

Cited by 6 publications

References 21 publications

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Generic antiepileptic drugs—Safe or harmful in patients with epilepsy?

Pharmacodynamics Effect of Methylprednisolone Tablets on the Serum Concentration of Annexin A1: In Vivo Comparative Study Between Generic and Innovator Drug

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