Cell and gene therapies (CGTs) can only be administered at specialized, certified treatment centers. Many are concentrated in major academic medical centers, meaning employees may need to travel hundreds of miles and remain within two hours of the center for up to four weeks post-infusion. This geographic reality demands that employers proactively address travel, care coordination, and referral pathways before a claim arises.
A COE (Center of Excellence) approach channels employees to a vetted network of high-volume, quality-credentialed providers with expertise in administering specific CGTs. COEs typically hold accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) or are designated through payer-specific networks (e.g., Optum's CAR-T Preferred Provider Network, Blue Cross Blue Shield's Blue Distinction Centers). Employers who direct members to COEs benefit from negotiated case-rate agreements, reduced procedural variation, and stronger outcomes tracking.
For blood cancers treated with CAR-T (Chimeric Antigen Receptor T-cell) therapy, the National Comprehensive Cancer Network (NCCN) guidelines explicitly recommend CAR-T as a Category 1 treatment in second-line and later settings. Yet research shows that a significant portion of eligible patients never receive guideline-concordant care. Employers can address this by embedding oncology navigation programs into benefits design.
Many CGTs are classified as medical benefit drugs, meaning cost controls typically applied through PBMs (Pharmacy Benefit Managers) do not apply. Employers should clarify how CGT drug costs are classified, understand the role of specialty pharmacy distributors (e.g., Accredo, CuraScript), and evaluate whether manufacturer HUB services are accessible to their members.
The National Comprehensive Cancer Network (NCCN) publishes evidence-based guidelines forming the standard of care for CAR-T eligibility. A 2025 simulation found misallocation away from NCCN-recommended CAR-T resulted in an average 25-month reduction in life expectancy per patient.
Outlines current CAR-T cell therapy indications, institutional program requirements, and reimbursement strategies. Useful for benefits professionals and clinical staff supporting oncology navigation.
The Foundation for the Accreditation of Cellular Therapy (FACT) is the primary accrediting body for cellular therapy programs. Employers should require FACT accreditation as a baseline for COE (Center of Excellence) network inclusion. In 2025, FACT convened a Community CAR-T Working Group for community-based providers.
Walks plan sponsors through CGT coverage design: certificate of coverage (COC) review, prior authorization, COE models, travel support, and risk mitigation. Includes structured questions to ask health plan carriers.
The Employee Benefit Research Institute (EBRI) found CGT use rose from 7.9 to 9.2 per 100,000 enrollees between 2018 and 2022. Surveys financing mechanisms including stop-loss, carve-out programs, gene therapy reinsurance, and value-based payment arrangements.
Practical Q&A addressing cost exposure (gene therapies above $1M, cell therapies $400K–$500K), risk assessment, legal considerations around exclusions, and stop-loss alignment. 57% of employers rank CGT cost management as a top priority.
Covers compliance risks of exclusions under ADA (Americans with Disabilities Act), HIPAA (Health Insurance Portability and Accountability Act), and ERISA (Employee Retirement Income Security Act). Includes cancer care navigation and COE network access guidance.
Published by the Midwest Business Group on Health (MBGH), the SpecialtyRx Toolkit provides practical guidance on managing specialty drugs including biologics, biosimilars, pharmacogenomics, and gene therapies across both medical and pharmacy benefits.
Employer coalition report from the Dallas-Fort Worth Business Group on Health (DFWBGH) with real-world action items for specialty pharmacy including gene therapy PA (prior authorization) criteria, outcomes-based contracts, and site-of-care management. Documented savings of 25–60% through specialty PBM carve-outs.
Documents a case where annual infusion costs dropped from $621,000 to $38,385 through site-of-care (SOC) redirection. Outlines step-therapy verification and medical appropriateness evaluation processes.
Physician offices charge 22% more than pharmacies for the same drugs; hospitals charge double. Presents Accredo Convenient Care's redirection pathways for plan sponsors.
Structured review of how gene therapies interact with plan design: cost-sharing, COE approaches with travel coverage, out-of-network risk, prior authorization, and outcomes-based reimbursement. Addresses geographic availability gaps.
Employer plan sponsors pay $1.25 PMPM (per member per month) for coverage of up to 10 FDA-approved gene therapies at $0 member cost. Integrates EviCore prior authorization, Accredo specialty pharmacy, and an annual surplus rebate mechanism.
Includes a CAR-T (Chimeric Antigen Receptor T-cell) Preferred Provider Network, prior authorization criteria, and Gene Therapy Risk Protection (PMPM reinsurance). Optum data: average total billed charges of $2.2M per CAR-T case.
Examines how ERISA employer plans, Medicaid, and commercial reinsurance create access barriers through restrictive PAs (prior authorizations), lasering, and misaligned incentives. Proposes federal reinsurance programs and CGT intermediaries.
Survey of access decision-makers: stop-loss and reinsurance (65%) are the most utilized models; fewer than 25% of employers use subscriptions or warranties. Largest barrier: lack of information about available models.
The Leukemia and Lymphoma Society (LLS) provides the Susan Lang Pre-CAR-T Cell Therapy Travel Assistance Program (up to $2,500), Co-Pay Assistance, and Urgent Need Program ($500 grants). Critical wrap-around resources for CAR-T patients.
A free, nurse navigator-led service helping blood cancer patients identify clinical trials and address enrollment barriers. Complementary to employer benefits navigation programs.
The Academy of Oncology Nurse and Patient Navigators (AONN+) outlines the full navigation role across the CAR-T care continuum: eligibility assessment, insurance authorization, barrier identification, and caregiver coordination.
The National Organization for Rare Disorders (NORD) network comprises 46 centers in 28 states with multi-specialty expertise. Employers can use the NORD network to identify referral destinations and shorten the diagnostic odyssey.
Avoidable per-patient costs of $86,000–$517,000 across seven conditions including ALD (adrenoleukodystrophy), DMD (Duchenne muscular dystrophy), and SCD (sickle cell disease). Delayed diagnosis drives up to tenfold higher annual medical costs.
The Alliance for Regenerative Medicine (ARM) publishes policy briefs, annual state-of-the-industry reports, and reimbursement landscape analyses. Advocated for the FDA's 2025 decision to reduce REMS (Risk Evaluation and Mitigation Strategy) burdens for autologous CAR-T therapies.
The American Society of Gene and Cell Therapy (ASGCT) identifies key access barriers — payer prior authorization practices, cost-sharing, restrictive coverage — and recommends priority solutions for plan sponsors.
Free, science-based educational materials on how approved CGTs work, finding treatment centers, and navigating insurance. Employers can share with employees who may be eligible for CGT.
The Centers for Medicare & Medicaid Services (CMS) multi-year program testing outcomes-based agreements (OBAs) between CGT manufacturers and state Medicaid programs. 34 states and 2 manufacturers participate. A precedent for commercial OBA structures.
Outlines health system infrastructure requirements for equitable gene therapy access: workforce training, patient identification networks, COE capacity, and payer engagement models.
Identifies structural barriers in the current delivery system for CGTs and proposes system-level solutions. Supports the case for employer investment in COE networks and value-based payment models.
Patients with R/R DLBCL (relapsed/refractory diffuse large B-cell lymphoma) who miss NCCN-recommended CAR-T face 42% vs. 54–57% five-year survival — a 25-month life expectancy reduction. Justifies investment in oncology navigation.
Examines logistical and reimbursement challenges in commercializing gene therapies for rare diseases. With over 10,000 identified rare diseases (80% genetic), provides context for employers designing benefits for a rapidly expanding rare disease therapy pipeline.
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