The non-medical switching of prescription medications

Dolinar, Richard; Kohn, Christine G.; Lavernia, Frank; Nguyen, Elaine

doi:10.1080/00325481.2019.1618195

Cited by 27 publications

(12 citation statements)

References 17 publications

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“…The interchangeability of a biosimilar (Table 1) for its innovator (or vice versa) is a complex topic that has generated much discussion [1][2][3][4][5][6][7]. Interchangeability is closely linked to nonmedical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons, such as cost (Table 1) [8][9][10]. NMS can involve switching between molecules of the same class (e.g., tumor necrosis factor [TNF] inhibitors) or from an innovator to its biosimilar (or vice versa).…”

Section: Introductionmentioning

confidence: 99%

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

et al. 2021

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In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality.

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Section: Introductionmentioning

confidence: 99%

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

et al. 2021

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“…If worsening of symptoms were to lead to hospital attendance, additional testing and so on, then the savings would soon evaporate, and costs could increase overall [20]. Although this might be somewhat theoretical, with little direct evidence, it is nonetheless plausible, especially because the cost of hospitalization and associated care considerably exceeds the likely savings, even if this is a rare occurrence [76].…”

Section: Economic Considerations and Implicationsmentioning

confidence: 99%

Acceptability of generic versus innovator oral medicines: not only a matter of taste

Tuleu

Hughes

Clapham³

et al. 2021

Drug Discovery Today

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“…When the determination to discontinue coverage of a current formulary medication in favor of a new preferred alternative is made for reasons outside of clinical considerations, this is sometimes called a nonmedical formulary switch (NMFS). 7 An NMFS commonly involves health plans changing preferred medications to those with lower list prices and/or those with available manufacturer rebates and are typically used by health plans to reduce spend. However, an NMFS may have differing effects on clinical and economic outcomes.…”

Section: What This Study Addsmentioning

confidence: 99%

Cost and clinical impact of a nonmedical DPP-4 inhibitor switch in patients with diabetes

Kheloussi

Johns

McLay

et al. 2021

JMCP

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BACKGROUND: Nonmedical formulary switches (NMFS) routinely occur in managed health care plans and involve changing preferred medications for reasons outside of clinical considerations. The cost implications of NMFS are infrequently published and the clinical outcomes rarely assessed. OBJECTIVE:To assess the real-world clinical and cost implications of an NMFS involving sitagliptin and linagliptin. METHODS:An NMFS was made to the Geisinger Health Plan (GHP) commercial, health care reform, and Medicaid formularies on February 1, 2018, involving a change in preferred medication from sitagliptin to linagliptin. Claims data from GHP and clinical information from electronic health records of the Geisinger Health System were used to evaluate the cost and clinical impact of this change. Patients aged 18 years or older who were continuously enrolled in a GHP commercial, health care reform, or Medicaid plan throughout the entire study period and had at least 1 fill for sitagliptin during the preswitch phase were included in the study. We investigated the differences in various clinical and economic outcomes from pre-to postswitch among those who switched and remained adherent to the new preferred therapy throughout the 12-month postperiod ("linagliptin switch" group) and patients who did not ("other switch" group). Clinical outcomes included all-cause hospitalization, diabetes-related hospitalization, and glycosylated hemoglobin (HbA1c), while economic measures included changes in per member per month (PMPM) spending. The negative binomial regression model was used to estimate utilization counts. A generalized linear model with a log link and gamma distribution was used to analyze cost data.RESULTS: 1,203 patients met the inclusion criteria. Of these, 501 (41.6%) individuals switched to and remained at least 80% adherent to linagliptin in the postperiod, while 702 (58.4%) did not. No difference between groups was found when comparing the pre-to postswitch change in all-cause hospitalization (incidence rate ratio (IRR) = 1.46, 95% CI = 0.66-3.23, P = 0.3436) or diabetes-related hospitalization (IRR = 1.39, 95% CI = 0.62-3.10, P = 0.4203). Additionally, no difference was found between groups regarding the change in HbA1c 12-month postswitch compared with baseline (difference between groups = −0.10%,

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The non-medical switching of prescription medications

Cited by 27 publications

References 17 publications

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

Acceptability of generic versus innovator oral medicines: not only a matter of taste

Cost and clinical impact of a nonmedical DPP-4 inhibitor switch in patients with diabetes

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