Clinical trial NCT04904055: Evaluating the Impact of a Value-based Prescription Drug Formulary
Official title: Value-based Formulary-Essentials: Testing and Expanding on Value in Prescription Drug Benefit Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Value-Based Health Insurance
Keywords: Cost Sharing / economics
Formularies as Topic
Insurance, Health / economics
Value-Based Health Insurance / economics
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
First posted: 2021-05-27
Enrollment: 36333
Sex: ALL
Minimum age (years): 0
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who satisfy the eligibility criteria are included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total spending for prescription drugs
timeFrame: From 24 months before insurance transition until up to 36 months after transition
Secondary outcomes:
measure: Patient out-of-pocket spending for prescription drugs
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Health plan spending for prescription drugs
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Total healthcare spending
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Number of emergency department visits
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Number of days in hospital
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Number of outpatient office visits
timeFrame: From 24 months before insurance transition until up to 36 months after transition
measure: Days supply of medication
timeFrame: From 24 months before insurance transition until up to 36 months after transition
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Kai Yeung, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: