Abstract
Importance: The prescription of generic (non-proprietary) compared to brand-name drugs is increasing worldwide. In many developing and emerging countries, generics companies market products at similar costs as brand-name competitors benefiting from more flexible compliance rules and regulations for marketing their products in the health system. Together, this phenomenon may influence prescriber's behavior (e.g., maintaining the same treatment despite guideline's recommendations or despite evidence of disease progression).Objectives: To compare the prevalence of therapeutic inertia (TI) between primary prescription of brand-name vs. generic drugs in the management of MS in Argentina.Design: We conducted a population-based online study comprising 117 neurologists with expertise in MS. Participants answered questions regarding their clinical practice, most commonly prescribed disease modifying agents, and therapeutic choices of 10 simulated case-scenarios that assessed TI. Inertia was defined as the lack of treatment initiation or escalation despite evidence of clinical and radiological activity (8 case-scenarios, 720 individual responses). We created the generic-brand name score (GBS) according to the 5 most frequently prescribed generic (n = 16) vs. brand-name (n = 9) drugs for MS, where scores higher than 1 indicated higher prescription of generic drugs and scores lower than 1 indicated higher prescription of brand-name agents. Candidate predictors of prescribing generic drugs included demographic data, MS specialist vs. general neurologist, practice setting, years of practice, volume of MS patients, risk preferences, costs of annual treatment.Participants and setting: population-based prospective study using including neurologists who care for patients with multiple sclerosis across Argentina.Exposure: prescription of generic vs. brand-name MS drugsMain outcome of interest: Therapeutic inertia (TI), defined as lack of treatment escalation when goals are unmet. Secondary outcomes included factors associated with generic drug prescription and costs of MS treatment.Results: Ninety participants completed the study (completion rate 76.9%). TI was observed in 153 (21.3%) of participants' responses. The evaluation of aggregate responses revealed a mean GBS score (SD) of 3.44 (2.1), with 46 (51.1%) participants having a GBS equal to or higher than 1. Older age (OR 1.19; 95% CI 1.00–1.42), being a general neurologist (OR 3.91; 95% CI 1.19–12.8), and being more willing to take risks in multiple domains (SOEP score OR 1.06, 95% CI 1.01–1.12) were associated with higher prescription of generic drugs in MS care. Costs of treatment were not associated with prescribing generic drugs. There was no difference in the annual costs of MS treatment for primary prescribers of brand-name vs. generic drugs (67,500 US$ vs. 67,496 US$; p = 0.99).The evaluation of individual responses revealed that participants with higher prescription of generics—reflected by a higher GBS—had higher incident risk of TI (mean GBS 3.61 for TI vs. 2.96 for no TI; p < 0.001). Multivariate analysis revealed that a prescription of generic agents was associated with an increased incident risk of TI (OR 1.56; 95%CI 1.07–2.29). There was no difference in the annual costs of MS treatment for participants that exhibited TI vs. those without TI (67,426 US$ vs. 67,704 US$; p = 0.66).Conclusions: General neurologist, older age, and willingness to take risks were associated with increased prescription of generic drugs despite similar costs compared to brand-name agents. In our study, the prescription of generic-MS drugs was associated with a higher incident risk of therapeutic inertia.
Highlights
Therapeutic decisions in multiple sclerosis (MS) care are becoming more complex with the recent advances of disease modifying agents, varying dosage form, and side-effect profiles, currently counting 14 different therapeutic alternatives [1, 2]
Out of the 117 neurologists with expertise in MS care who were invited to participate in the study, 90 completed the survey
We evaluated factors associated with the primary prescription of generic drugs
Summary
Therapeutic decisions in multiple sclerosis (MS) care are becoming more complex with the recent advances of disease modifying agents, varying dosage form (oral, injectables, infusion), and side-effect profiles, currently counting 14 different therapeutic alternatives [1, 2]. The Food and Drug Administration in the United States defines a generic drug as a medication having the same active principle as the marketed brand-name product in the same dosage form with similar bioequivalence (e.g., efficacy, safety, strength, performance characteristics, route of administration, approved intended use, and quality) [3]. Pharmaceutical manufacturers of generic drugs have more flexible internal rules of compliance and less bureaucracy compared to brand-name companies obliged to report to their head-offices [5]. Together, these phenomena may lead to different marketing strategies and higher profits of generic companies [4, 6,7,8,9,10,11]
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