NOW OPEN: Public Comment Period for IVI-MDD Value Model

October 26 – December 15, 2023

The public comment period for the IVI-MDD Value Model (beta version) is now open.

Please see the “Public Comments” section below for details on how to submit your comments.

WEBINAR: IVI-MDD Value Model: Evaluating Treatments for People with Major Depressive Disorder

November 9, 2023 (1:00 PM ET)

Learn about the background and purpose of the IVI-MDD Value Model, areas for which IVI is seeking input, and a demonstration. We will also focus on technical aspects of the model, including challenges, rationale for the model structure, and a preview of planned research projects.

REGISTER HERE

Get Started with the IVI-MDD Value Model

The IVI-Major Depressive Disorder (MDD) Value Model is an open-source simulation model. It uses a web-based interface designed to help healthcare and other decision-makers evaluate treatment strategies (drug and non-drug) for MDD.

The beta version of the IVI-MDD Value Model is available for testing by clicking on the button below.

The model will be revised and released in a final version based on public comments received by IVI. Note that, because this is a beta version released for testing purposes, model results should not be treated as conclusive.

IVI is holding a public comment period on the beta version of the model from October 26 to December 15, 2023.  Please see the “Public Comments” section below for details on how to submit your comments.

VIEW MODEL

An Open-Source Value Model for MDD

Major Depressive Disorder (MDD) affects more than 21 million American adults or about 8.4% of the U.S. population age 18 and older in 2021 (Source: National Institute of Mental Health), and almost 39% of adults with MDD are not receiving treatment following initial diagnosis (Source: National Institute of Mental Health).

Conventional cost-effectiveness models that determine the value of MDD treatments often neglect costs and outcomes that are important to patients, and frequently do not consider the societal impact of these treatments. This can make it difficult for payers, employers, and clinicians to make informed decisions about treatment.

IVI is addressing this problem by developing an open-source value assessment prototype model that emphasizes patient-prioritized factors and outcomes. The model also considers the broader societal impacts of MDD treatments, thus ensuring that these treatments are evaluated in a way that is relevant to all stakeholders.

The IVI-MDD Value Model is a patient-centered simulation model that uses a novel approach to engage stakeholders and obtain patient input. The model can be used to compare the cost-effectiveness of different treatment options or sequences of treatment options for MDD. Unlike traditional health economic models, the IVI-MDD Value Model was developed using a continual engagement approach with a 20-member multi-stakeholder advisory committee from the outset and incorporates both qualitative and quantitative data by integrating patient-centric inputs upstream in the health technology assessment (HTA) process.

Through IVI’s innovative and collaborative approach, the IVI-MDD Value Model is designed to advance patient-centered and equitable care for MDD and implement innovative methods and procedures for HTA in the U.S.

Public Comments

The IVI-Major Depressive Disorder (IVI-MDD) Value Model is now available.

IVI is pleased to hold its third public comment period for the IVI-MD Value Model. Thank you in advance for your comments and suggestions.

During this public comment period, IVI is seeking feedback in four main areas:

  • The model design, including the structure, key assumptions made, and input sources. For example, the internal structure and references for the model.
  • The extent to which the user interface is user-friendly and effective in addressing your decision needs. For example, the front-facing design of the model.
  • Suggested approaches to address data gaps identified in the MDD model, such as databases or research partners.
  • Additional methodological questions or real-world applications that IVI should prioritize following the model’s launch.

A detailed list of questions can be found HERE.

Submission Process

Please send any questions to [email protected]. Official comments should be submitted on letterhead and sent to [email protected] no later than midnight, December 15, 2023.

IVI encourages all stakeholders to participate in the public comment period and to help develop a model that is truly patient-centered and informative.

All submitted comments will be made publicly available on IVI’s website. IVI will provide an overview of how we intend to incorporate the recommendations in January 2024.

Model Resources

Previous Public Comments

Built upon the finalized model scope, the draft model protocol outlines the technical specifications and data sources that will guide the model development in the subsequent modeling phases. The purpose of the public comment period was to obtain feedback in the following three main areas before we finalize the model protocol:

  • Data gaps in key model inputs and potential data sources and partners to address such gaps
  • Prioritization of data sources and technical approaches, when multiple valid approaches exist
  • Potential use cases, particularly how the MDD model can help inform decisions in your organizations

Comments were submitted either on letterhead via email or through an online survey form, which allowed for comments related to the key questions or to provide general feedback. All comments will be published on our website.

Supporting Documents

Webinar: IVI-MDD Value Model Draft Protocol Public Comment Period

As part of its Open-Source Value Project, IVI held a public comment period on the draft model protocol on major depressive disorder from December 14, 2021 – January 18, 2022. (Deadline was extended to January 25, 2022.) The model protocol is a technical document that outlines the primary inputs we plan to use in the MDD economic model.

View our webinar where we outline the major components of the model protocol and answer initial questions.

The model scope outlines IVI’s preliminary assumptions for the MDD model design. The purpose of the public comment period is to obtain feedback in three main areas:

  • Assumptions and data elements missing from the initial model design
  • Factors most important to include in the model
  • Specific use cases to be built into the first edition of the model

To learn more about the model scope, access the recording of the  informational webinar or view the presentation slides.

VIEW MODEL SCOPE

Public comments were provided in one of two ways:

  1. Compiled comments on organizational letterhead and submitted as a PDF to [email protected]; or
  2. Completing an online survey.

VIEW PUBLIC COMMENTS

Multi-Stakeholder Engagement

Work on this first-of-its-kind MDD model will test a novel approach in building value assessment tools, whereby a multi-stakeholder Advisory Group (AG) is engaged, from the outset and throughout the conceptualization and development process. The Advisory Group is comprised of diverse stakeholders, including patients, employers, payers, clinicians, researchers, and model developers. Their insights will help inform the model’s scope, development, validation, and application. Such an endeavor will also allow IVI to test how such an engagement approach can improve the credibility and relevance of the models.

MDD Advisory Group

Timeline

Model Scope

Q4 2021

The model scope document describes the model objectives, key assumptions, and early specifications. This document will also describe the specific considerations that will be evaluated and confirmed during the protocol development stage.

Model Protocol

Q3 2022

The model protocol is a technical document that outlines all necessary details for model structure and analyses, including the analytic approaches, assumptions, data inputs, and model output.

User Interface Development

Q1 2023

The user interface prototype is an interactive prototype for the MDD model that describes the optimal graphical design of the interface, as well as the granular dynamic components within each screen.

Model Programming, Testing, and Validation

Q3 2023

Based on the finalized model protocol and model architecture document, the MDD model will be programmed using the R language. Detailed technical documentation, along with user manuals and tutorials, will also be developed.

Model Public Release

Q4 2023

The MDD value assessment model will allow users to use the model’s pre-specified inputs or their own data sources to compare treatments for major depressive disorder. All model code is open-source, and we invite users to provide feedback and recommendations for improvement.

Use Case Development and Model Updates

Ongoing

IVI and interested stakeholders will use the MDD model to conduct additional research projects. IVI will update the model as new data sources become available.

Select References

dosReis, S., Bozzi, L.M., Butler, B., Xie, R.Z., Chapman, R.H., Bright, J., Malik, E., and Slejko,  J.F. “Preferences for Treatments for Major Depressive Disorder: Formative Qualitative Research Using the Patient Experience.” The Patient – Patient-Centered Outcomes Research (2022).

Jansen JP, Incerti D, Linthicum MT. “Developing Open-Source Models for the US Health System: Practical Experiences and Challenges to Date with the Open-Source Value Project.” PharmacoEconomics. 2019;37(11):1313-1320.

Pizzicato LN, Xie RZ, Yang Y, Grabner M, Chapman RH. Real-world treatment modalities, healthcare resource utilization, and costs among commercially insured patients with newly diagnosed major depressive disorder in the United States. Journal of Managed Care and Specialty Pharmacy 2023; 29(6):614-25.

Xie RZ, Bright JB, deFur Malik E, Chapman RH. “Early Reflections on Stakeholder Engagement in Economic Model Development to Inform Value Assessment.” Value & Outcomes Spotlight. 2022;8(2):37-40.

Xie RZ, Malik E deFur, Linthicum MT, Bright JL. “Putting Stakeholder Engagement at the Center of Health Economic Modeling for Health Technology Assessment in the United States.” PharmacoEconomics. 2021;39(6):631-638.