Academic journal article Applied Health Economics and Health Policy

Healthcare Costs in Renal Transplant Recipients Using Branded versus Generic Ciclosporin

Academic journal article Applied Health Economics and Health Policy

Healthcare Costs in Renal Transplant Recipients Using Branded versus Generic Ciclosporin

Article excerpt


The discovery of ciclosporin revolutionized the field of solid organ transplantation; ciclosporin treatment suppresses the immune system and reduces adverse events, graft rejection and morbidity in transplant recipients.[1,2] A ciclosporin A product (CsA) in the form of a microemulsion pre-concentrate (branded CsA) quickly became the formulation of choice.[3] Generic versions of this product (generic CsA) have since been approved based on standard bioequivalence studies and are widely used.[4-7]

However, ciclosporin, a critical-dose drug, is characterized by a narrow therapeutic window and its pharmacokinetic properties, particularly bioavailability and intra-patient variability, significantly affect patient outcome after transplantation.[8] Small changes in dose or concentration of ciclosporin can result in clinically substantial changes in efficacy or toxicity. The use of current bioequivalence guidelines for generic drug approval of critical-dose drugs such as ciclosporin has been questioned.[9-15] There is evidence that the absorption levels of generic CsA differ significantly from the absorption levels of branded CsA.[8,16]

Although generic drugs initially cost less than innovator drugs,[17] patients who receive generic drugs may incur significantly higher costs over the course of treatment than patients initially treated with branded drugs due to aggregate costs associated with therapeutic failures in transplantation, including rehospitalization, acute rejection, graft failure, re-transplantation and return to dialysis. Pharmacoeconomic research in Canada comparing the total healthcare costs of branded CsA with a non-bioequivalent formulation of generic CsA (i.e. Sandimmune® [Novartis, Basel, Switzerland]) showed that patients taking the branded CsA had fewer hospitalization days and lower physician costs for inpatient and outpatient procedures, resulting in lower overall healthcare costs.[18]

No study has compared the medical costs in transplant recipients using branded CsA compared with bioequivalent generic CsA such as Gengraf and Hexal formulations. The objective of this study was to assess whether differences exist in total healthcare cost in the first year for de novo renal transplant recipients in the US treated with branded versus generic bioequivalent CsA, and investigate possible explanations for these differences.


Claims data from eight US private health plans from January 1995 to December 2005 were linked to the Organ Procurement and Transplantation Network (OPTN) data for the same time frame.[19] Members were enrolled in an array of health plan products, including health maintenance organizations, preferred provider organizations, and Medicare traditional and supplementary plans. The average longitudinal record available for members was approximately 2 years. The database included membership information (i.e. date of birth, sex, enrolment history and health insurance product type), pharmacy claims (i.e. National Drug Code and prescription fill date), line-item facility inpatient claims (i.e. Uniform Billing [UB-92] information, including principal and secondary International Classification of Diseases, 9th edition, Clinical Modification [ICD-9-CM] diagnosis and procedure codes, admission and discharge dates) and facility outpatient and professional services claims (i.e. Health Care Financing Administration [HCFA 1500] information, principal and secondary ICD-9 diagnosis codes, Current Procedural Terminology, 4th edition [CPT-4] codes, and date of service). The OPTN records were linked to claims data using patient identifiers in a multi-step merge algorithm.[19]

The study cohort included patients with a de novo renal transplant who filled a prescription for CsA between 1996 and 2004 (n = 227) within the first 30 days after transplantation (figure 1). The index date was set as the date of the initial prescription for CsA. Of note, although the dataset included claims from 1995 to 2005, a 1-year period pre- and post-index date was needed for the analyses; thus, the cohort could only be selected between 1996 and 2004. …

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