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whatiscelltherapy.org

What are cell and gene therapies?

Check how your stop-loss treats them before you renew.

What they are

Cell therapy uses living cells as the treatment. Gene therapy replaces a gene, turns one off, or adds one. CAR-T is both.

The cells can be the patient’s or a donor’s. Cell therapy includes immune-cell treatments, cancer vaccines made from cells, and stem cells, including blood-forming stem cells. Each approved product is for particular diseases.1

Some gene therapies use a modified virus to carry the new gene into the patient’s cells. The virus is changed so it can no longer cause infectious disease.2

A patient’s own T cells, a type of immune cell, are taken out, changed so they make receptors, called CARs, that recognize a specific protein on cancer cells, and given back.2,3 Every CAR-T cell therapy approved in the U.S. is made this way. All are approved for certain blood cancers: some leukemias and lymphomas, and multiple myeloma.3

FDA’s list of approved cell and gene therapy products had 55 entries as of October 30, 2026. The list includes cord blood products, which are blood-forming stem cells collected from umbilical cord blood. It is not a count of CAR-T treatments.4

Stop-loss

Your stop-loss can cover cell and gene therapy like any other claim. Check yours before you carve it out.

If your plan is self-funded, the check is whether your policy covers the same treatments as the health plan. Insurers call that plan mirroring. Stop-loss then pays the company back after the specific deductible. Some policies exclude or limit these therapies.5

Keep it in stop-loss

For each person, the company pays up to the specific deductible. Stop-loss pays the rest.

Carve it out of stop-loss

The health plan still covers it. The company pays these claims itself or through a separate program. It can make sense if the insurer cuts the stop-loss price enough.5

Insurers' records99–100%of commercial plan sponsors broadly cover gene and cell therapies.5
2026 survey, 53 employers74%of those employers said they currently cover cell and gene therapies.6

These measure different things. Carriers are reporting their book of business. The employers are describing their own plan.5,6

For employees

  • Who pays for complications after treatment?
  • Would employees have to change where they get care?

What else employers use

The other tools are centers of excellence, reinsurance, and value-based agreements or warranties.5,6

In a 2026 survey of 47 employers, 40% named carve-outs as something they may try next. The same share named centers of excellence.7

Sources: Mercer, 2025; Midwest Business Group on Health, 2026.5,6,7

Cost

Cell and gene therapy is rare and a small share of plan spending.

That counts all of their care. It is an average, not a forecast.

9 in 100,000people in employer health plans received a cell or gene therapy in a year8
0.5%of total plan spending went to all of those patients’ care, not to the therapy alone8

For your finance team

The whole course of care

The price of the therapy is not the whole bill. Considerable procedural and administration costs may also apply.5 Many therapies also need extended monitoring, time near a specialized treatment center, and significant caregiver support.9

Cash timing

Stop-loss reimbursement can come after the company has paid, so one large claim can mean a big draw on cash at once.10

Ask whether the insurer can pay its share when the claim is due. Some policies call this advance funding.

Renewal

At renewal, an insurer may set a higher deductible or lower coverage for people it expects to have high costs. This is called lasering.5

Where these figures come from

EBRI studied employer plan claims from 2018 to 2022.8 The rate was 7.9 in 100,000 in 2018 and 9.2 in 2022. Use is rising slowly, and more therapies are coming.

Sources: EBRI, 2026; Mercer, 2025; Lockton, 2026; Leader’s Edge, 2025.8,5,9,10

Time away

Most CAR-T cell therapies now have a 2-week minimum stay near care, down from 4.

It is a minimum, not total time away from work. This label change is for CAR-T, not for every cell or gene therapy. The stay is there because side effects can be serious, including infections, high fevers, a drop in blood pressure, and confusion or trouble speaking.3

Down from 4 weeks2 weeksMinimum time near a healthcare facility after the cells are given back, for most approved CAR-T cell therapies. One product’s label says at least 1 week.11,12,13
Down from 8 weeks2 weeksMinimum time the label advises patients not to drive, for most approved CAR-T cell therapies.11,12,13
Where it can be givenNo REMS certificationTreatment centers no longer need REMS certification to give CAR-T. FDA expects that to make it easier to get, especially in rural areas.11 Manufacturers and health plans still decide which centers give it.

FDA updated the labels in June 2025.11 Monitoring continues, and some side effects can start later.11,13 Before that stay, collecting the cells, making the treatment and giving it back takes about 3 to 5 weeks.3 That includes a few days of chemotherapy just before the infusion.13 Ask whether the plan pays for travel and lodging, and how leave and disability apply.

Sources: FDA, 2025; RAPS, 2025; DailyMed; National Cancer Institute, 2025.11,12,13,3

Questions

5 questions for your stop-loss insurer

Ask before you renew. Your broker or consultant can help.

  1. Does our stop-loss policy cover cell and gene therapy claims?5
  2. What happens at renewal after a large claim?5
  3. Will a gene therapy claim raise our price? Experience rating sets next year’s price from your own claims.5
  4. If we carve it out, what do we get?5
  5. What else can manage the cost?5

Download the 5 questions as a worksheet

Source: Mercer, 2025.5

Get a short briefing

What CAR-T treatment involves, where it’s given, and how long patients are away. Leave your name and work email.

Legend Biotech, which sponsors this site, gives these briefings. Your details go to Legend Biotech to arrange one.The biopharmaceutical company that sponsors this site gives these briefings. Your details go to that company to arrange one.

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Thanks. Someone will be in touch within 2 business days to find a time.

Sources

  1. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Cellular & Gene Therapy Products. fda.gov
  2. U.S. Food and Drug Administration. What is Gene Therapy? fda.gov
  3. National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. Updated February 26, 2025. cancer.gov
  4. U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. Content current as of October 30, 2026. fda.gov
  5. Belousova A, Brown R, Peel A. Employers' top four questions about cell and gene therapies. Mercer. August 13, 2025. mercer.com
  6. Midwest Business Group on Health. Employer Survey on Cell & Gene Therapies. June 2026 (53 employers). PDF
  7. Midwest Business Group on Health. Employer survey release. September 9, 2026 (47 employer members). PDF
  8. Employee Benefit Research Institute. Cell and Gene Therapies in Employment-Based Health Insurance: Financing the High-Cost, High-Impact Future. Issue Brief. February 12, 2026. ebri.org
  9. Buck S, Akers RK, Kordella R. Cell & gene therapy: Preparing for the next phase of employer health plan risk. Lockton. June 30, 2026. lockton.com
  10. Worth T. Gene therapy: Rarely needed but massively expensive. Leader’s Edge (Council of Insurance Agents & Brokers). April 30, 2025. leadersedge.com
  11. U.S. Food and Drug Administration. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T Cell Immunotherapies. June 26, 2025. fda.gov
  12. Regulatory Affairs Professionals Society. FDA eliminates REMS for approved CAR-T therapies. June 30, 2025. raps.org
  13. Prescribing information for approved CAR-T cell therapies, section 2.2. DailyMed, U.S. National Library of Medicine. Accessed November 6, 2026. dailymed.nlm.nih.gov

All sources on this site

Are you a patient or caregiver? Visit the National Cancer Institute for information about CAR-T cell therapy.