# Cell and gene therapy pipeline outlook for plan sponsors | Evernorth
Canonical URL: https://biopharmsignal.com/news/ESRX/cell-and-gene-therapy-pipeline-outlook-for-plan-sponsors-evernorth-3b71cebb
Ticker: ESRX
Company: Express Scripts（ESI）
Source: Express Scripts（ESI）
Published: 2026-07-09 00:03 EST
Original Source URL: https://www.express-scripts.com/corporate/newsroom
## Summary

Gene therapy is reshaping treatment options. According to the US Food and Drug Administration (FDA), gene therapy works by modifying genetic material inside a person’s cells to treat disease. Examples include r...

## Article Body
Gene therapy is reshaping treatment options. According to the US Food and Drug Administration (FDA) , gene therapy works by modifying genetic material inside a person’s cells to treat disease. Examples include replacing a faulty gene, inactivating a harmful one, or introducing a new gene to help the body fight illness. Cell therapy, a related approach, uses living cells as the treatment itself, often by modifying or engineering cells to restore, replace, or enhance biological function. Gene and cell therapies are reshaping treatment across a growing number of disease areas. For years, these advanced therapies were limited to a small number of ultra‑rare conditions – such as spinal muscular atrophy (SMA) and hemophilia– which constrained their broader impact.

That picture is starting to change.

From “when” to “where”: Cell and gene therapies gain relevance for employer plans

In 2026, the cell and gene therapy pipeline is expanding to more conditions and becoming more complex. As a result, it’s more relevant for employer-sponsored plans. For plan sponsors, the question is no longer when cell and gene therapies may arrive, but where they will be most relevant. As the year progresses into the second half, understanding both where therapies are emerging and how quickly – and consistently – they are advancing will become increasingly important for planning.

New approvals and pipeline therapies are also showing different delivery methods including localized delivery (intrathecal, intravitreal, direct‑to‑brain and encapsulated ocular cell-based therapies).

This report looks at cell and gene therapy trends and what they mean for benefits and care strategy.

How the cell and gene therapy pipeline is expanding

In the second quarter of 2026, cell and gene therapy activity continued to evolve. More therapies are now in development, and they target a wider range of conditions and routes of administration. At the same time, recent regulatory delays, product shortages, and selective market exits —alongside therapies advancing rapidly through accelerated pathways and CNPV— underscore the volatility of this space and the uncertainty around timing and availability. In some cases, approvals like Otarmeni, completed in just 61 days, highlight the variability in how quickly therapies move to market. This variability in pace will continue to shape how quickly therapies reach broader populations through the remainder of the year.

Historically, this level of activity had limited implications for employer‑sponsored plans because gene therapies were largely confined to ultra‑rare diseases affecting very small numbers of members. Today, that is beginning to change as more gene therapies are being developed for a wider range of conditions. As gene therapies move beyond narrow use cases, the likelihood that employer plans will encounter eligible members increases.

For plans, this means gene therapy is no longer an occasional exception, but an emerging factor that may shape benefit design, cost management, and care strategy over time.

Why oncology is becoming a major focus for gene therapy

In the past, cancer treatment played a smaller role in gene therapy discussions, even as CAR‑T therapies — a form of cell therapy — were already an important focus within oncology.

Today, their prominence is increasing — and in some cases accelerating into nearer-term relevance for employer-sponsored plans — alongside broader cell and gene therapy development in cancer care.

This matters because cancer care already brings high costs and complexity for plans. CAR‑T and other oncology‑focused cell and gene therapies may introduce new considerations, including:

Where and how it’s delivered

How it fits into current care

How plans manage high upfront costs

As CAR‑T therapies and other cell and gene therapies become more common in oncology, plan sponsors must look beyond one-time cases. They must plan for it as part of their broader high‑cost care strategy.

Rare disease continues to drive gene therapy innovation

Rare diseases continue to be a focus of gene therapy development. Many FDA-approved cell and gene therapies on the market today are indicated for small patient populations, often for inherited conditions that require specialized care.

Most currently approved therapies still target rare diseases , reinforcing their continued relevance for plan sponsors. At the same time, rare disease is no longer the only focus.

Plan sponsors must be ready for rare disease cases while also planning for where gene therapy may go next.

Cardiometabolic and neurological gene therapies emerge

Gene therapies for cardiometabolic and neurological conditions are starting to enter later-stage development, signaling expansion beyond historically dominant rare disease areas. For example, while therapies for conditions such as OTOF-related hearing loss have now advanced to market—with Otarmeni recently approved—additional competitors are expected in the coming years. Notably, access models for these therapies may also differ from traditional approaches: Otarmeni is currently being offered at no cost, though associated procedures, such as the surgery required for administration, may still present cost and access considerations. Meanwhile, other therapies under investigation, such as those targeting glycogen storage disease type 1, point to continued momentum across a broader set of conditions.

What plan sponsors should consider beyond FDA approval

As more therapies move closer to commercialization, the focus is shifting beyond clinical promise to real-world delivery. Factors such as manufacturing capacity, site of care, and long-term outcomes are becoming just as important as regulatory approval.

For plan sponsors, this reinforces the need to think beyond coverage alone—and consider how these therapies will be accessed, managed, and integrated into care delivery.

What the progression of gene therapy means for plan sponsors

As gene therapy reaches new areas, it carries greater weight in long‑term benefit strategy.

For plan sponsors, thinking ahead is essential.

Near term: Prepare plans and benefits for gene therapy cases, especially those tied to rare diseases.

Mid term: Plan for continued expansion of more cancer‑related gene therapies and their impact on oncology care and costs.

Long term: Monitor emerging use in more common conditions. This may require new approaches to coverage, cost, and care coordination.

Watching how treatments change may be as important as following new ones in development.

Preparing for the evolving impact of gene therapy on employer-sponsored plans

Gene therapy is having a greater impact on employer‑sponsored plans. Being aware of how gene therapy is evolving – and where it may head next – can help plan sponsors prepare.

This quarterly outlook tracks changes in gene therapy and what they mean for coverage, cost, and care strategy.

To stay informed between reports, subscribe to the Evernorth monthly Gene Therapy Pipeline Report for updates on emerging therapies and market developments.

To better understand how the cell and gene therapy pipeline could impact your organization specifically, engage your account team directly.

This article was created with the assistance of AI tools. It was reviewed, edited, and fact-checked by Evernorth’s editorial team and subject matter experts.
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