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Switching to generic tacrolimus increased drug variability, rejection rates, and costs in renal transplant patients. This policy may not be suitable for narrow therapeutic index immunosuppressants.

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Area of Science:

  • Nephrology
  • Pharmacology
  • Transplantation Medicine

Background:

  • The Affordable Care Act promoted generic drug use, including for immunosuppressants.
  • Limited data existed on the impact of generic conversion for narrow therapeutic index drugs like tacrolimus.

Purpose of the Study:

  • To evaluate the effect of programmatic conversion from brand-name to generic tacrolimus on renal transplant recipients.
  • To analyze the impact on drug variability, rejection incidence, and healthcare costs.

Main Methods:

  • Retrospective analysis of 39 renal transplant recipients converted to generic tacrolimus.
  • Comparison with a control cohort of 159 patients receiving brand-name tacrolimus.
  • Analysis of drug trough levels, dosage adjustments, rejection rates, and institutional costs.

Main Results:

  • Generic tacrolimus group showed increased drug variability (20% change in trough levels) and more dosage adjustments.
  • Higher incidence of rejection (23.1% vs 10.2%) and increased magnesium wasting in the generic group.
  • Significant increase in institutional costs due to higher rejection rates, despite pharmacy cost savings.

Conclusions:

  • Programmatic conversion to generic tacrolimus led to increased drug variability, rejection, and costs.
  • The cost-containment policy may be inappropriate for narrow therapeutic index immunosuppressants.
  • Reconsideration of generic conversion policies for critical medications like tacrolimus is recommended.