Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders

Abstract

Objective:

To assess the effectiveness of managed care plans that limited access to infusion biologics via a step therapy policy.

Study design:

This was a retrospective cohort study using Symphony Health Solutions claims databases that included payer, prescription (Rx), diagnosis (Dx) and procedure (Px) information with unique anonymized patient identifiers.

Methods:

The percentage of patients with claims for infusion and subcutaneous (SQ) biologics were evaluated across three increasingly restrictive cohorts: (1) patients in step therapy plans versus all others in the database (population), (2) patients in step therapy plans versus patients that were members of plans that were roughly matched (matched) and (3) a subsample of patients that were members of step therapy plans that had sufficient data for a pre/post analysis (pre/post).

Results:

The population analysis comparison showed 5.1% fewer patients (p < 0.0001) with claims for infusion biologics among step therapy plans than among the overall plans. The more controlled matched and pre/post analyses showed a greater percentage of patients with claims for intravenous products in the plans with step therapy policies versus plans without step therapy policies, differences of +7.0% (p < 0.0001) and +2.8% (p = 0.0522), respectively.

Conclusions:

Policies designed to limit utilization of infusion biologics showed equivocal results. In the near term, the intended effects of implementing step therapy policies may be limited by relatively small numbers of patients that are affected relative to the total number of users.

• Biologics
• Specialty pharmaceuticals
• Step therapy

Transparency

Declaration of funding

This study was funded by Janssen Scientific Affairs LLC.

Declaration of financial/other relationships

C.M.K. has disclosed that she/he is supported by a grant from EMD Serono Inc. A.P. has disclosed the he is supported by a grant from Janssen Scientific Affairs. M.I. and L.E. have disclosed that they are employees of Janssen Scientific Affairs and are shareholders of Johnson & Johnson.

JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Lavonda Miley of Miley Consulting provided medical writing assistance with funding from CK Consulting Associates, LLC. Previous presentations: Ingham MP, Paris A, Ellis L, Kozma CM. Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders. Poster presentation at the 16th Annual International Society for Pharmacoeconomics and Outcomes Research Meeting, 23 May 2011, Baltimore, MD, USA. Ingham MP, Paris A, Ellis L, Kozma CM. Three approaches to evaluating step therapy policies for immune disorder specialty pharmaceuticals. Poster presentation at the 2013 American College of Rheumatology meeting, 27 October 2013, Baltimore, MD, USA.