CGT Access Model
Cell and Gene Therapy Access Model
The Cell and Gene Therapy (CGT) Access Model is a multi-year, voluntary model for states and manufacturers to test outcomes-based agreements for cell and gene therapies. It aims to increase Medicaid beneficiaries' access to innovative treatments, improve health outcomes, and reduce health care costs and burden to state Medicaid programs. The initial focus is on gene therapy treatments for sickle cell disease.
Innovation
Instead of each state creating and implementing its own outcomes-based agreements with manufacturers, the model allows CMS to bring states together and negotiate on a multi-state basis, establishing financial and clinical outcome measures, reconciling data, and evaluating results.
The Problem
Cell and gene therapies can transform the lives of people living with rare and severe diseases that are hard to treat, but gaining access to these potentially life-changing treatments is difficult because they can cost millions of dollars.
The Solution
The CGT Access Model supports outcomes-based agreements between states and manufacturers that will provide treatments within a framework that lowers prices for states and ties payment to outcomes.
Expected Outcomes
By increasing access to transformative therapies, this model aims to improve the poor health outcomes and low life expectancy associated with rare and severe diseases like sickle cell disease, as well as make it easier for states to pay for cell and gene therapies.
Strategy
The model underscores CMS’ commitment to accelerating access to innovative therapies, improving patient health, and tying payment to outcomes.
Model Goals
- Increase Medicaid beneficiaries’ access to innovative treatment
- Improve health outcomes for people living with rare and severe diseases
- Reduce health care costs and burden to state Medicaid programs
Patient Eligibility
Medicaid beneficiaries receiving gene therapy for severe sickle cell disease.
- Medicaid is the primary payer
- Living with severe sickle cell disease
- Receiving FDA-approved gene therapy for SCD
Provider Eligibility
Health care providers are not direct participants in the model, but treatment centers must meet specific qualifications to administer the therapies.
- Must be a qualified SCD gene therapy provider
- Must be enrolled in the state Medicaid program
- Must be a member of the CMS-designated patient registry (CIBMTR) and participate in the study
Care Categories
Genetic Blood Disorders
CMS Benchmarks & Thresholds
financial
operational
population
quality
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