Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGE

Therapeutic Innovation & Regulatory Science
Kirk W Kerr, Marta E Wosinska

Abstract

The isotretinoin risk management program iPLEDGE places requirements on patients and providers to ensure that the benefits of isotretinoin therapy outweigh the risks. Such burdens have the possibility of limiting patient access through mechanisms such as lowered physician participation. In this study, we utilized prescription claims data to examine changes in patient and provider participation in isotretinoin therapy with iPLEDGE implementation. We examined the change in utilization among patients not targeted by iPLEDGE (male patients) to assess the program's impact on access. We also examined whether provider participation in isotretinoin therapy varies by specialty and isotretinoin prescribing history. Patient access to isotretinoin decreased in the period immediately following iPLEDGE implementation, but recovered to pre-iPLEDGE levels in the succeeding months. In addition, therapy completion rates increased with iPLEDGE implementation, suggesting that patients less committed to isotretinoin therapy may be self-selecting out of therapy. Lastly, iPLEDGE resulted in decreased participation by low-volume, general practitioners, while high-volume, specialists' participation was largely unchanged. We found that participants resp...Continue Reading

References

Feb 10, 1998·Health Affairs·M L Berk, C L Schur
Feb 5, 2004·Social Science & Medicine·Luis Rosero-Bixby
Aug 6, 2013·Pharmacoepidemiology and Drug Safety·Simone P PinheiroTarek A Hammad

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Citations

Jul 2, 2020·Clinical, Cosmetic and Investigational Dermatology·Zainab A RashidMuaed Jamal Alomar
Apr 28, 2021·Journal of the American Academy of Dermatology·Nidhi ShahAnna Yasmine Kirkorian

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Methods Mentioned

BETA
pregnancy
contraception
pregnancy test

Software Mentioned

SAS
IMS Data Extract Tool ( DET )
iPLEDGE
IMS Health Data Extract Tool ( DET )

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