Value-Based Health InsuranceVBF-eNCT04904055
Evaluating the Impact of a Value-based Prescription Drug Formulary
An observational study of Value-Based Health Insurance, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 64 years
- Conditions the study is for
- Value-Based Health Insurance
- What is being tested?
- Value-based Formulary
- How many people
- 36,333 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All individuals who satisfy the eligibility criteria are included.
Who may be able to join
- 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)
Who cannot join
- Individuals with:
- missing gender information
- missing zip code level demographics at all member months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Value-Based Health Insurance
- Being tested
- Value-based Formulary
- Keywords
- Cost Sharing / economics, Formularies as Topic, Insurance, Health / economics, Value-Based Health Insurance / economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value-based FormularyOther
Prescription drug formulary tiers informed by estimated value
| Study group | Role | What they receive |
|---|---|---|
| Value-based Formulary Beneficiaries | enrolled in the value-based formulary Receives: Other: Value-based Formulary | |
| Standard Formulary Beneficiaries | enrolled in a standard (i.e., non-value-based formulary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 24 months before insurance transition until up to 36 months after transition
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 24 months before insurance transition until up to 36 months after transition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Value-Based Health InsuranceStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Kai Yeung, PharmD, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904055
- Sponsor's protocol ID
- 218066
- Acronym
- VBF-e
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available per data use agreement.
Publications
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.
PubMed 37889867
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value-based Formulary-Essentials: Testing and Expanding on Value in Prescription Drug Benefit Design
- ClinicalTrials.gov ID
- NCT04904055
- Acronym / sponsor ID
- VBF-e / 218066
- Conditions
- Value-Based Health Insurance
- Keywords
- Cost Sharing / economics, Formularies as Topic, Insurance, Health / economics, Value-Based Health Insurance / economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,333 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Value-based Formulary Beneficiaries | – | Other: Value-based Formularyenrolled in the value-based formulary |
| Standard Formulary Beneficiaries | – | –enrolled in a standard (i.e., non-value-based formulary) |
Who may qualify
- Ages
- 0 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All individuals who satisfy the eligibility criteria are included.
Key inclusion criteria (7 listed)
- Individuals:
- Employer groups:
Key exclusion criteria (3 listed)
- Individuals with:
- missing gender information
- missing zip code level demographics at all member months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Value-based FormularyPrescription drug formulary tiers informed by estimated value | Other | Value-based Formulary Beneficiaries |
Primary outcome
Total spending for prescription drugs
Time frame: From 24 months before insurance transition until up to 36 months after transition
Impact of value-based formulary on patient out-of-pocket plus health plan spending on prescription drugs per member per month
7 secondary outcomes
Patient out-of-pocket spending for prescription drugs
Time frame: From 24 months before insurance transition until up to 36 months after transition
Health plan spending for prescription drugs
Time frame: From 24 months before insurance transition until up to 36 months after transition
Total healthcare spending
Time frame: From 24 months before insurance transition until up to 36 months after transition
Number of emergency department visits
Time frame: From 24 months before insurance transition until up to 36 months after transition
Number of days in hospital
Time frame: From 24 months before insurance transition until up to 36 months after transition
Number of outpatient office visits
Time frame: From 24 months before insurance transition until up to 36 months after transition
Days supply of medication
Time frame: From 24 months before insurance transition until up to 36 months after transition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 37889867Yeung 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available per data use agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Yeung, PharmD, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Value-Based Health Insurance, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total spending for prescription drugs (time frame: From 24 months before insurance transition until up to 36 months after transition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.