Gene and Cell Therapy Claimant Exposure in Self-Funded Health Plans for 2026

A single employee's therapy can now cost more than a mid-sized company's entire annual health spend — and for a growing number of self-funded employers, that is no longer a hypothetical. The FDA approved its first two gene therapies for sickle cell disease, Casgevy and Lyfgenia, in December 2023, carrying list prices of roughly $2.2 million and $3.1 million respectively. Hemgenix, a one-time infusion for hemophilia B, lists near $3.5 million. These are not experimental treatments waiting in a lab — they are approved, marketed, and increasingly present in the census of ordinary employers.

For plan sponsors who fund their own health plans, this is a shift in the shape of the risk, not merely its size. The American Society of Gene and Cell Therapy counts more than 4,200 therapies in development across gene, cell, and RNA categories, roughly 2,100 of them gene therapies. Benefits consultants have projected that 10 to 20 new gene therapies could reach approval each year. The exposure a fiduciary once treated as a rare tail event is becoming a recurring consideration — one that can surface with a single new hire or a dependent's diagnosis.

The catastrophic claimant is no longer rare

Sun Life's 2026 high-cost claims report, drawn from more than 70,000 high-dollar claims across 3,300-plus self-funded employers, found that million-dollar-plus claims rose 46% in frequency from 2022 to 2026. Gene therapy sat among the most expensive treatments studied — the muscular dystrophy therapy Elevidys averaged $3.6 million per claim. Blood cancers averaged $5.45 million in 2025, with a single leukemia case approaching $8 million. The point for a plan sponsor is not any one figure; it is that the catastrophic claimant has moved from the edge of the distribution toward its center.

This is where ownership matters. A self-funded plan gives the employer control over plan design, and that control is precisely the leverage a fully insured arrangement hides. The question is rarely whether to cover these therapies — many are the clinical standard of care, and a fiduciary owes participants a defensible answer — but how to craft the plan so that a multimillion-dollar infusion does not destabilize the budget or the balance sheet. A fully insured plan buries that same risk inside a renewal premium the employer never gets to see or question; self-funding brings it into the open, where it can be measured, priced, and managed on the employer's own terms.

Plan-design levers that illuminate the exposure

Several intentional levers can be built into a plan document before a claim ever arrives. A specialty-drug carve-out moves high-cost therapies under a dedicated management vendor rather than the general medical claim stream, adding clinical review and financing options. Centers of excellence route patients to accredited treatment sites with stronger outcomes and negotiated case rates. Installment and outcomes-based contracts — sometimes described as "no cure, no pay" — tie payment to durability of response and spread a seven-figure cost across years rather than a single plan year. Each lever is a decision the plan owner makes on purpose, not a default inherited from a carrier.

Beneath plan design sits the financing architecture. Stop-loss coverage still absorbs the individual claim above a chosen threshold — with occasional lasers or pooling points on known conditions — but that mechanic is only one part of the structure. A group-health captive lets a company join with other disciplined employers to own a middle layer of risk collectively, sharing the volatility of catastrophic claimants across a pool rather than carrying it alone. The captive layer gives members a genuine seat at the table on how gene-therapy risk is priced, funded, and managed over time — and it builds runway, so a single seven-figure claim is met with a plan rather than a surprise.

None of this is a product to be purchased in isolation. It is a process. At Peoples First Tennessee, we work through the same four steps regardless of a plan's size: Strategic Discovery to understand the workforce and current exposure, Risk Assessment to model where catastrophic claims could land, Solution Design to assemble the plan-design levers and financing layers that fit, and Ongoing Optimization to adjust as the therapy pipeline and the census evolve. A torch is only useful if you carry it into the room you have been avoiding; the aim is to uncover the exposure early, while there is still time to design around it.

Gene and cell therapy is one of medicine's genuine breakthroughs. For self-funded employers, it is also a financial reality that rewards discipline and penalizes avoidance. The plans that fare best in 2026 will not be the ones that got lucky — they will be the ones that surfaced the exposure, owned the decision, and built the structure before the claim arrived.