Background/Purpose: Rheumatology practices are increasingly exposed to patient health care benefit plans that include “step therapy” (ST) policies which affect medication choice.  Managed care companies implement ST policies for specialty pharmaceuticals to reduce utilization of infused biologics (IV) in new patients, based on an assumption that there will be cost savings.  To assess whether managed care policies that limit access to infusion biologics in order to shift new patients to injection biologics (SQ) have had the desired effect.

Methods: The share of utilization of biologic products for plans identified with ST policies, were evaluated versus a comparison cohort using three separate methodologies.  ST plans were first identified using data from Symphony Health Solutions Corp.’s ProMetis database.  This database provides a unique opportunity for this type of analysis, as it spans multiple identifiable plans which can be cross-referenced to known ST policies.  Data included payer, prescription and procedure claims with unique anonymised patient identifiers.  Analyses #1 & #2 included data from plans with ST policies throughout 2010. Analysis #1 compared the percentage of patients with biologic claims for plans with ST policies to all other plans in the database during the same time period (ALL OTHER).  Analysis #2 compared the percentage of patients with biologic claims for plans with ST policies to a set of plans matched roughly to the ST plans based on region and relative size (MATCHED).  Analysis #3 included data from 1/1/2006 through 4/30/2011 for plans with a known ST implementation date (index date) and with available biologic claims within 365 days before and after this index date.  Analysis #3 evaluated the period after ST policy implementation to the period before implementation (PRE/POST).  Data for each analysis were descriptive of the number of patients with access and using any biologic in the ST and comparison cohorts.  The net change in percentage of patients with infusion claims is reported.

Results: Sixteen different plans were identified with a ST policy.  The only analysis to demonstrate a shift in patient utilization away from IV biologics was the ALL OTHER comparison (-5.1%).  When comparison plans were MATCHED to ST plans, or when evaluating existing plans using PRE/POST methods, patient access and use of infusion biologics increased (+7.0% and +2.8% respectively).  

Conclusion: These data suggest that policies designed to reduce overall patient proportions using infusion biologics may not have the intended effect, or may at most affect 5.1% of biologic users in any given year.  The limited potential benefit needs to be weighed against the cost of implementing and monitoring this type of policy, as well as the provider resource implications.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/three-approaches-to-evaluating-step-therapy-policies-for-immune-disorder-specialty-pharmaceuticals/