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Prepare for new Embarc additions in January

Review the four new gene therapies being added to Embarc Benefit Protection effective January 1, 2027 and what the updates may mean for eligible clients.

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Embarc Benefit Protection® is adding four new gene therapies—FAYUVI™, GENGLYCOS™, KRESLADI™, and OTARMENI™

Effective January 1, 2027, new therapies will be added to Embarc that support conditions including Sanfilippo syndrome type A, glycogen storage disease type Ia (GSDIa), severe leukocyte adhesion deficiency type I (LAD-I) and OTOF-related hearing loss. These four therapies will be added with no increase to the current $2.45 PMPM price.

New drug inclusions effective January 1, 2027

Clients should ensure their medical carriers are aware of the additions to Embarc’s drug list so utilization management can be routed correctly.

FAYUVITM

A gene therapy for the treatment of neurologic manifestations in pediatric patients with pre-served neurodevelopmental function who have mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. Fayuvi is the first and only treatment for individuals who have MPS IIIA.

GENGLYCOSTM

A gene therapy used along with nutritional management to help reduce daily corn-starch intake for adults and children eight years and older with glycogen storage disease type Ia (GSDIa). Genglycos is the first therapy that targets the underlying cause of the disease by delivering a functional copy of the G6PC gene.

KRESLADITM

A stem cell-based gene therapy for the treatment of patients who have severe leukocyte adhesion deficiency type I (LAD-I) and who do not have a matched sibling donor for stem cell transplantation. LAD-I is a lifelong genetic condition caused by changes in both copies of the ITGB2 gene which cause the body to produce blood cells that cannot fight infections.

OTARMENITM

A gene therapy for use in children and adults who have severe-to-profound and pro-found inherited sensorineural hearing loss due to confirmed variants in both copies of the OTOF gene, preserved outer hair cell function and no prior cochlear implant in the same ear.

You can find more information on the gene therapies included in Embarc here.

Help clients prepare for the additions

To better serve you and your clients, we continue to expand our provider network.

The most up-to-date provider information is always available here

Previous updates

Embarc Benefit Protection added four new gene therapies—ELEVIDYS™, ITVISMA®, ENCELTO™, and WASKYRA™

Effective July 1, 2026, the new therapies will support conditions including Duchenne muscular dystrophy, spinal muscular atrophy, macular telangiectasia type 2 (MacTel) and Wiskott-Aldrich syndrome. One therapy, ROCTAVIAN®, is being removed from the market and the contractual limitations are being removed. The PMPM will increase from $1.75 to $2.45 to reflect the expanded drug list. Account teams will begin client outreach on April 21, notifying all current clients by June 1.

What changed effective July 1, 2026:

Clients should ensure their medical carriers are aware of the additions to Embarc’s drug list so utilization management can be routed correctly. New drug inclusions:

ELEVIDYSTM

The first FDA-approved (June 2023) gene therapy for Duchenne muscular dystrophy (DMD), a rare and progressive condition that leads to muscle degeneration and early mortality. Expanded FDA approval has broadened access to a wider pediatric population, positioning ELEVIDYS as a foundational therapy in the evolving DMD treatment landscape.1

ITVISMA®

A gene therapy designed to address the underlying genetic cause of spinal muscular atrophy (SMA). Its approval (November 2025) significantly expands access beyond infants to include older children, adolescents and adults—addressing a substantial unmet need within the SMA population.

ENCELTOTM

The first and only FDA-approved (March 2025) treatment for idiopathic macular telangiectasia type 2 (MacTel), a rare neurodegenerative retinal disease that causes irreversible central vision loss. ENCELTO is a cell-based implant that delivers a continuous supply of a neuroprotective protein directly to the retina to help slow disease progression.

WASKYRATM

A one-time gene therapy FDA-approved (December 2025) for patients six months of age and older with Wiskott-Aldrich syndrome, a rare X-linked genetic disorder caused by mutations in the WAS gene.

Additional impact to the Embarc drug list

ROCTAVIAN® - the gene therapy for treatment of hemophilia A is being voluntarily withdrawn from the market by its manufacturer due to low utilization, effective May 29, 2026. It will be removed accordingly from the Embarc drug list.

Removal of contractual limitations

Current contractual limitations are being removed, including the new to plan eligibility requirement dates for CASGEVY® and LYFGENIATM, as well as the birthday rule for ZOLGESMA®. Each newly added therapy will be individually evaluated for any applicable contractual limitations.2

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Pricing update

To reflect the expanded scope of Embarc and the increased number of members eligible for gene therapy treatment, the price will increase from $1.75 per-member-per-month (PMPM) to $2.45 PMPM. 

Embarc Benefit Protection® surplus

The shared surplus is generated across Embarc’s enrolled book of business, helping maintain transparency and ensuring PMPM fees remain aligned with actual gene therapy utilization.

What drove the 2025 surplus:

Embarc pricing assumed utilization of 10 high‑cost FDA‑approved gene therapies.

Actual utilization was lower, primarily due to the extensive preparation required for stem‑cell‑based treatments.

While there was a significant increase in patients pursuing sickle cell gene therapy in 2025, most treatments are expected to occur in 2026 or later.

Client financial impact

Returns will be completed by March 31, 2026 and account teams began client outreach on March 17, 2026. 

$0.60
PMPM will be returned to clients on a pro rata basis

What's next for Embarc

The gene therapy pipeline continues to expand.

Embarc’s PMPM fee remains predictable and not tied to individual client claims experience, though it is subject to change at any point based on new therapy additions, manufacturer pricing changes or shifts in utilization.

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Explore additional Embarc Benefit Protection resources

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Embarc Benefit Protection

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Questions? Contact our team.

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Sources

  1. Updated clinical efficacy data released by the manufacturer enabled our clinical team to re-evaluate ELEVIDYS and support its inclusion in Embarc Benefit Protection.
  2. We reserve the right to reinstitute or add contractual limitations to any included gene therapy at any point in time. New therapies may additionally be added with contractual limitations.