Abstract
The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic immunosuppressants using US Medicare Part D Prescription Drug Event (PDE) and Colorado pharmacy claims (including both Part D and non-Part D) data from 2008 to 2013. Data from 26 070 kidney, 15 548 liver, and 6685 heart recipients from Part D, and 1138 kidney and 389 liver recipients from Colorado were analyzed. The proportions of patients with PDEs or claims for generic and brand-name tacrolimus or mycophenolate mofetil were calculated over time by transplanted organ and drug. Among Part D kidney, liver, and heart beneficiaries, the proportion dispensed generic tacrolimus reached 50%-56% at 1 year after first generic approval and 78%-81% by December 2013. The proportion dispensed generic mycophenolate mofetil reached 70%-73% at 1 year after generic market entry and 88%-90% by December 2013. There was wide interstate variability in generic uptake, with faster uptake in Colorado compared with most other states. Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand-name products within a year of market entry.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1764-1773 |
| Number of pages | 10 |
| Journal | American Journal of Transplantation |
| Volume | 18 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 2018 |
Funding
Funding for this research was made possible by the US Food and Drug Administration through grant 1U01FD005274-01. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the US Food and Drug Administration or the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. The Colorado All Payer Claims Database (CO-APCD) is administered by the nonprofit Center for Improving Value in Health Care (CIVHC) in Denver, Colorado. This study used data from the Scientific Registry of Transplant Recipients (SRTR). The SRTR data system includes data on all donors, wait-listed candidates, and transplant recipients in the United States, submitted by the members of the Organ Procurement and Transplantation Network (OPTN). The Health Resources and Services Administration (HRSA), US Department of Health and Human Services provides oversight to the activities of the OPTN and SRTR contractors. This study was deemed exempt from the need for IRB review.
Keywords
- brand-name
- generic
- generic drug substitution
- health services and outcomes research
- heart transplantation
- immunosuppressant
- kidney transplantation
- liver transplantation/hepatology
- organ transplantation in general
ASJC Scopus subject areas
- Immunology and Allergy
- Transplantation
- Pharmacology (medical)