Evaluating the Impact of a Value-based Prescription Drug Formulary (VBF-e)

Value-based Formulary-Essentials: Testing and Expanding on Value in Prescription Drug Benefit Design

The objective of this study is to evaluate the impact of the value-based formulary on patient out-of-pocket spending and health plan spending as well as the impact of the value-based formulary on medication use, emergency department visits, hospitalizations, and outpatient office visits.

Study Overview

• Status: Completed
• Conditions: Value-Based Health Insurance
• Intervention / Treatment: Other: Value-based Formulary

• Study Type: Observational
• Enrollment (Actual): 36333

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals who satisfy the eligibility criteria are included.

Description

Inclusion Criteria:

• Individuals:

  • aged 0-64

  • Continuously enrolled in an employer-sponsored health plan for at least 12 months (with one-month allowable gap) prior to the index date

    • For individuals in the exposed group, the index date is defined as the start date of value-based formulary implementation at the employer group level
    • For individuals in the control group, the index date is defined as the index date of the matched exposed individual

• Employer groups:

  • that transition to the value-based formulary if they transitioned all enrollees in that employer group (no individual selection)

Exclusion Criteria:

- Individuals with:

• missing gender information
• missing zip code level demographics at all member months

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Value-based Formulary Beneficiaries; enrolled in the value-based formulary	Other: Value-based Formulary; Prescription drug formulary tiers informed by estimated value
Standard Formulary Beneficiaries; enrolled in a standard (i.e., non-value-based formulary)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total spending for prescription drugs	Impact of value-based formulary on patient out-of-pocket plus health plan spending on prescription drugs per member per month	From 24 months before insurance transition until up to 36 months after transition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient out-of-pocket spending for prescription drugs	Impact of value-based formulary on patient out-of-pocket spending for prescription drugs per member per month	From 24 months before insurance transition until up to 36 months after transition
Health plan spending for prescription drugs	Impact of value-based formulary on health plan spending for prescription drugs per member per month	From 24 months before insurance transition until up to 36 months after transition
Total healthcare spending	Impact of value-based formulary on total healthcare spending per member per month	From 24 months before insurance transition until up to 36 months after transition
Number of emergency department visits	Impact of value-based formulary on number of emergency department visits per member per month	From 24 months before insurance transition until up to 36 months after transition
Number of days in hospital	Impact of value-based formulary on number of days in hospital per member per month	From 24 months before insurance transition until up to 36 months after transition
Number of outpatient office visits	Impact of value-based formulary on number of outpatient office visits per member per month	From 24 months before insurance transition until up to 36 months after transition
Days supply of medication	Impact of value-based formulary on days supply of medication per member per month	From 24 months before insurance transition until up to 36 months after transition

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Donaghue Medical Research Foundation
• Investigators: Principal Investigator: Kai Yeung, PharmD, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cost Sharing / economics; Formularies as Topic; Insurance, Health / economics; Value-Based Health Insurance / economics
• Other Study ID Numbers: 218066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available per data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No