Plan-Sponsor Savings and Member Experience With Point-of-Service Prescription Step Therapy

Published Online: July 01, 2004
Brenda R. Motheral, PhD; Rochelle Henderson, MPA; and Emily R. Cox, PhD

Objective: To examine the effect of prescription step-therapy programs in terms of plan-sponsor savings and member experience at the point of service.

Study Design: Plan-sponsor savings were measured using a quasi-experimental, case-control design. Member experience with step therapy was measured using a self-administered mailed survey.

Methods: A 20 000-member plan implemented 3 step therapy programs in September 2002: proton pump inhibitors, selective serotonin reuptake inhibitors, and nonsteroidal anti-inflammatory drugs. Pharmacy claims from September 1, 2001, through June 30, 2003, were examined to compare changes in per-member-per-month (PMPM) net cost between the intervention group and a random sample of members from commercial plans without the step therapy programs. A mailed, self-administered survey was sent to members with a step edit from September 1, 2002 to December 31, 2002.

Results: The employer experienced a decrease of $0.83 in net cost after implementing step therapy, while the comparison group had an upward trend of $0.10 PMPM for these therapy classes. Member-reported outcomes indicated that approximately 30% of patients received a generic, 23% were granted a medical exception for the brand, 17% received no medication, and 16% paid the full retail price for the brand. If the pharmacist vs the patient contacted the physician, members were 8 times more likely to receive a medication covered by the health plan (OR, 8.10; 95% CI, 2.94-22.33 vs OR, 8.23; 95% CI, 3.11-21.93). Compared with those who received first-line therapy, those who paid out of pocket for the brand medication vs those who did not receive any medication were less likely to be satisfied with their pharmacy benefit (OR, 0.25; 95% CI, 0.08-0.80 vs OR, 0.12; 95% CI, 0.04-0.41).

Conclusions: Step therapy produces significant drug savings. However, there appear to be opportunities to further members' and providers' understanding of these programs.

(Am J Manag Care. 2004;10:457-464)

Faced with continued double-digit growth in prescription drug costs,1,2 plan sponsors are continually looking for ways to promote cost-effective use of medications. The growing availability of generic alternatives in many therapy classes has created an unprecedented opportunity for plan sponsors to better manage pharmacy benefits to the advantage of plan sponsors and their members.

One method of encouraging generic use is through step therapy. Step therapy is a pharmacy benefit program that promotes cost-effective use by requiring a trial of a first-line medication, often a generic alternative, before coverage is granted for a more expensive second-line agent, typically a brand. With the recent availability of generic alternatives in many therapy classes, the use of step therapy has grown dramatically.3 Generic alternatives available for nonsteroidal anti-inflammatory drugs (NSAIDs), gastroprotective agents, and selective serotonin reuptake inhibitors (SSRIs) render these appropriate classes for step therapy. Step therapy programs have been offered for other classes, such as angiotensin-converting enzyme inhibitors and disease-modifying antirheumatic drugs.

Research supports the clinical appropriateness of step therapy programs. For example, the SSRI step-therapy program requires a trial of generic fluoxetine before coverage of brand SSRI step therapy. Supporting this strategy are conclusions from randomized controlled trials suggesting no difference in primary depression outcome measures across SSRIs.4-7 In addition, retrospective analyses using medical chart review or administrative claims data have found no difference in switch rates among SSRIs8 and no difference in depression-related outpatient and hospitalization costs based on initial choice of SSRI.9,10 These findings, together with the fact that the mean cost for a brand SSRI was nearly double that of generic fluoxetine in 2002,2 support an SSRI step-therapy policy with generic fluoxetine as first-line therapy.

Step therapy programs for NSAIDs require a trial of traditional or nonselective NSAIDs (eg, ibuprofen and naproxen) before granting coverage for the higher-cost, selective NSAIDs (ie, cyclooxygenase [COX] 2 agents). Research has shown that, in the management of acute pain and other conditions associated with pain, COX-2 inhibitors and nonselective or traditional NSAIDs are equally effective at equipotent doses.11-22 Although COX-2 therapy has been shown to reduce the risk of gastrointestinal adverse events,23,24 recent pharmacoeconomic analysis suggests that COX-2 agents are not cost effective for the average-risk patient, having a cost per quality-adjusted life-year gained of $275 809.25

The impetus for proton pump inhibitor (PPI) step therapy is research showing that 30% to 70% of patients with painful reflux symptoms do not have erosive gastrointestinal conditions for which PPIs are indicated.26 Given that relief of heartburn symptoms occurs in up to 70% of patients taking lower-cost histamine2 (H2) receptor antagonists,27 "stepping up" in those who have not achieved adequate symptom control has been shown to be a cost-effective alternative.28

Given the more recent popularity of step therapy, it is not surprising that no research, to our knowledge, has empirically examined the effect of step therapy programs. Therefore, the objective of this study was to examine the economic effect from the plan sponsor's perspective, as well as the member's experience with step therapy programs. Some key questions included the following: (1) What are the savings associated with a step therapy program from the plan sponsor's perspective, taking into consideration the administrative costs of the program? (2) How do members respond to a step therapy program, in terms of contacts with providers and benefits managers and overall satisfaction? (3) What is the final outcome, in terms of medication received, when members experience step therapy at the point of service?

This research is not subject to Department of Health and Human Services regulations and therefore is exempt from institutional review board approval (§46.101 of the Federal Policy for the Protection of Human Subjects, August 19, 1991). We follow the principles outlined in the Declaration of Helsinki and the recently approved Health Insurance Portability and Accountability Act regulations regarding use of personal health information for program evaluation.


On September 1, 2002, an employer located in the Midwest with approximately 20 000 enrollees and dependents implemented 3 step therapy programs: PPIs, NSAIDs, and SSRIs. The employer had a 20% coinsurance benefit in place at the time of the study, and no other benefit design or clinical program changes were made during the study. The employer did not communicate with employees about the change before program implementation because of the inability to target the information to those likely to experience the edit.

The step criteria were automated and administered at the point of service by the employer's pharmacy benefit management (PBM) company. For all 3 step programs, prior users of the medications, as evidenced by their prescription claims history, were not subject to the step therapy program (ie, they were grandfathered). Therapy-specific criteria for PPIs required patients to try an H2 receptor antagonist before receiving coverage for a PPI. The NSAID program required previous trial of 2 generic NSAIDs before receiving coverage for a brand NSAID, and the SSRI program required previous use of fluoxetine or fluvoxamine maleate before coverage for a brand SSRI would be granted. The program criteria were communicated to pharmacies at the time of adjudication, including instructions to call the physician and documentation of the covered first-line medications. Medical exceptions could be granted for those patients who had previously tried a generic or were already stabilized on the brand but for whom the claim had not been captured by the PBM (eg, because the patient used his or her spouse's insurance). Medical exceptions could also be granted for other clinical reasons (eg, failure with first-line agents not captured in the pharmacy claims data; history of a gastrointestinal bleed, perforation, or obstruction [NSAID step therapy]; and erosive gastrointestinal conditions [PPI step therapy]). To request a medical exception for brand coverage, the physician could call or fax the PBM. The employer paid $20 for each medical exception reviewed. No other program costs were incurred by the employer.

Two data sources were used in the study, member survey data and pharmacy claims data. Pharmacy claims from September 1, 2001, through June 30, 2003, for all members were examined to assess changes in per-member-per-month (PMPM) net cost (ie, ingredient cost plus dispensing fee, minus the member copay) for the 3 therapy classes of interest (intervention group). To allow for comparison with plans that did not implement step therapy, a random sample of members from commercial plans that did not have the 3 step therapy programs during the study was selected (comparison group). This comparison group included approximately 1.9 million members, representing 1021 different health plans.

A mailed survey was sent in February 2003 to adult members who had received a step therapy edit between September 1, 2002, and December 31, 2002. Members with more than 1 edit, including other edits such as refill too soon, were excluded from the sampling frame to avoid possible confounding. A presurvey postcard making members aware of the survey was sent approximately 3 days before the self-administered survey, and a $1 incentive was included with the survey.

The survey contained 22 questions based on sociodemographics (4 questions), satisfaction (3 questions), member's experience with the step therapy program (12 questions), outcome of step edit (1 question), and 2 screener questions. Satisfaction with the pharmacy benefit was measured on a 5-point Likert scale (1, very satisfied; 5, very dissatisfied). "Satisfied" was defined as a response of "1" or "2." Satisfaction with the medication received was also measured. Questions were related to satisfaction with the member's pharmacy benefit, satisfaction with the medication received, and satisfaction with the pharmacy at which most prescriptions were filled. Data reported herein concern satisfaction with the pharmacy benefit and medication received. Questions related to the member's experience with step therapy ascertained what efforts were made to obtain coverage and the member's understanding of the process.

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