Nov 5, 2026
Author: Lisa Edwards, PharmD, Senior Director, Access Experience Team
For cell and gene therapy (CGT), FDA approval is only the beginning; access depends on coverage, reimbursement, and an insurer’s operational ability to finance the treatment. A therapy may deliver value over a lifetime yet remain difficult for the payer responsible for its upfront cost to justify. This tension is growing as innovative CGTs offer potentially curative options for diseases with limited or inadequate treatments.
Why, then, are payers hesitant to cover these high-cost, potentially curative treatments? A key reason is portability risk: the payer funding treatment may not retain the member long enough to realize its future value. This risk is particularly consequential for CGTs, where multimillion-dollar upfront costs and uncertain or variable long-term outcomes challenge reimbursement models designed for chronic, recurring treatments.
How Portability Works & Why It’s a Concern
Payers bear the upfront costs of CGT-covered claims at the time of administration. The insurer pays the manufacturer and treatment center at or near the time of treatment, but treatment-attributed reductions in healthcare resource utilization (HCRU), such as hospitalizations, chronic therapy costs, and disease complications, may accrue over several years.
This timing disconnect creates portability risk for one-time therapies: if a patient changes employers, joins a spouse’s plan, or switches insurers, the original risk bearer retains the upfront cost while the new payer may benefit from a healthier, less costly member.
A 2026 U.S. study involving 20 payer decision-makers, including 14 from commercial plans, found that 79% ranked member portability among the top three barriers to innovative payment models. Commercial payers reported average member retention of approximately 1-3 years, compared with 2-5 years for managed Medicare/Medicaid and 5-10 years for integrated delivery networks. Therefore, where CGT coverage is available, portability risk is typically sharper in commercial coverage; Medicare eligibility may be more stable, but restrictive utilization management can still create meaningful access barriers regardless of line of business.
For manufacturers, the implication is clear: assess portability as a launch-planning variable, not only as a contracting objection. Identifying the key questions payers may be using to evaluate their portability risk will help manufacturers understand how it may influence coverage decisions.
How are Payers Assessing Their Portability Risk?
- Patient Mobility: How likely is the patient to move across plans before value is realized?
- Outcome Timing: When do the major clinical and economic benefits appear?
- Risk Concentration: How large is the target population, and is cost front-loaded while savings are back-loaded?
- Tracking Feasibility: Can outcomes be measured well enough to support warranties or outcomes-based agreements?
Understanding how payers are thinking about portability risk will help manufacturers determine whether it should be central to launch planning or can remain secondary. This understanding will also help them anticipate how that concern may surface in payer coverage policies or evidence requirements.
Where Portability Shows Up in Payer Behavior
In commercial coverage, portability risk often appears indirectly through tighter subgroup restrictions, additional evidence requirements, formulary exclusions, or step edits. These controls limit near-term exposure when payers may not retain members long enough to realize a therapy’s full clinical and economic value.
Payers may apply criteria narrower than the FDA-approved indication, which can delay access; a 2025 JAMA study found that more than half of commercial coverage policies for CGT imposed requirements beyond the label. For example, in an analysis of over 500 commercial CGT coverage policies, 52% had requirements beyond FDA labeling and 88% utilized criteria consistent with or similar to pivotal trial eligibility requirements.
In rare disease more broadly, access can also break after coverage because of operational barriers, treatment-center readiness, site-of-care logistics, and local workflow friction. Precision AQ experts Julia Wermerskirchen and Sydney (Sheffield) Murner recently addressed how prior authorization (PA) is utilized “to address payer clinical, economic, and operational uncertainty” within rare and specialty therapeutic areas. These operational barriers reinforce why financial mitigation alone is insufficient and why any access strategy must also be practical to implement.
How Payers are Responding & What is Gaining Traction
Payers are not simply converging on a single solution; instead, the approaches gaining traction address different components of financial risk. Pooled or per-member-per-month carve-outs spread an unpredictable, high-dollar claim across a broader population, giving self-funded employers and smaller plans greater budget predictability. Evernorth’s Embarc Benefit Protection program illustrates this model: employers pay a fixed per-member-per-month fee to create predictable costs and protect plans from eligible high-cost gene therapy claims.
Outcomes-based rebates and warranties preserve upfront payment but return a portion of the cost when predefined clinical or durability outcomes are not achieved. Installment and portability mechanisms seek to align payments more closely with value realization over time, potentially transferring remaining obligations when a member changes plans.
The most viable approach will vary by payer segment, therapy, eligible population, and value realization period. For manufacturers, the next step is to translate those differences into launch-ready evidence, contracting options, and operational strategies.
Manufacturer Launch Readiness
For manufacturers: build portability into access planning before launch, not only after payer objections emerge. Manufacturers can strengthen readiness through three actions:
1. Model Portability Risk Early
Quantify the payer’s expected member-retention period against the timing of clinical benefit and avoided costs. This reveals which payer segments are most exposed to paying upfront while value accrues elsewhere and where risk-sharing options may matter most.
2. Build Outcomes That Can Travel
Identify clinically meaningful endpoints that can be measured in real-world settings and tracked with limited administrative burden. Innovative contracts depend on practical outcomes, reliable data collection, and workable follow-up periods.
3. Prepare Scenarios by Payer Segment
Commercial plans, self-funded employers, Medicaid, Medicare, and integrated delivery networks face different mobility, budgeting, and operational constraints. Build segment-specific value narratives and contract options rather than relying on a single standard payer approach.
Payer Engagement Approach
- Start payer conversations with the value over time messaging that goes beyond list price.
- Bring a population, mobility, and outcomes narrative rather than only clinical efficacy.
- Show how you would help reduce administrative ambiguity through clearer patient identification, provider education, and operational support.
- Where relevant, discuss whether the therapy could fit a reliable outcomes-based framework that is practical without overpromising feasibility.
The Next Access Imperative: Plan for Portability with Precision AQ
Rare disease market access strategies must account for who pays upfront and who ultimately realizes the therapy’s long-term value. Therapies are no longer judged only on whether they work or what they cost, but on whether payers funding the treatment believe they will still be responsible when savings finally arrive. The manufacturers that plan for portability early will not just negotiate better; they will launch smarter.
Precision AQ’s Market Access experts can help manufacturers assess portability risk by payer segment, build compelling value narratives, and design practical access strategies. To continue the conversation around planning for portability, book a call with our team today.