Evaluating the Impact of a Value-based Prescription Drug Formulary

NCT04904055 | Completed

• 1 other identifier: 218066
• Study Type: observational
• Target: 36,333
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Value-Based Health Insurance

Keywords

Cost Sharing / economics; Formularies as Topic; Insurance, Health / economics; Value-Based Health Insurance / economics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient out-of-pocket spending for prescription drugs

  From 24 months before insurance transition until up to 36 months after transition

• Health plan spending for prescription drugs

  From 24 months before insurance transition until up to 36 months after transition

• Total healthcare spending

  From 24 months before insurance transition until up to 36 months after transition

• Number of emergency department visits

  From 24 months before insurance transition until up to 36 months after transition

• Number of days in hospital

  From 24 months before insurance transition until up to 36 months after transition

Study Arms (2)

Value-based Formulary Beneficiaries

enrolled in the value-based formulary

Other: Value-based Formulary

Standard Formulary Beneficiaries

enrolled in a standard (i.e., non-value-based formulary)

Interventions

Value-based Formulary OTHER

Prescription drug formulary tiers informed by estimated value

Value-based Formulary Beneficiaries

Eligibility Criteria

• Age: 0 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All individuals who satisfy the eligibility criteria are included.

You may qualify if:

• 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)

You may not qualify if:

• \- Individuals with:
• missing gender information
• missing zip code level demographics at all member months

Sponsors & Collaborators

• Kaiser Permanente: lead
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

Kaiser Permanente

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Yeung K, Cruz M, Tsiao E, Watkins JB, Sullivan SD. Drug use and spending under a formulary informed by cost-effectiveness. J Manag Care Spec Pharm. 2023 Nov;29(11):1175-1183. doi: 10.18553/jmcp.2023.29.11.1175.

  PMID: 37889867 DERIVED

Study Officials

• Kai Yeung, PharmD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)