New-to-Market Medication List Form

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New-to-Market Medication List

Service: New-to-Market Medications

This accompanies the New-to-Market Medications Medical Guideline

Related Medical Guidelines:

• New-to-Market Medications Medical Guideline • Non-Covered Services and Procedures Medical Guideline

Description:

This medication list applies to certain newly launched medications that are healthcare provider administered and have not been reviewed by the Medical Policy Committee (MPC), Care Continuum, or eviCore, and/or a utilization management strategy has not yet been put in place. The medications may be excluded from coverage while the medication is listed on this document or will be reviewed against available clinical evidence, which includes applicable Medical Benefit Drug Guideline (e.g., Care Continuum MedRx guidelines or eviCore Clinical Guidelines).

Instructions for Use:

This New-to-Market (NTM) Medication List provides the listing of medications that are excluded from the medical benefit until the date the medication is reviewed by WPS or are reviewed against available clinical evidence.

The New-to-Market Medication List applies to commercial (including fully insured and self-funded) and Exchange members. It does not apply to Medicare or Medicare Supplement members.

This list is supported by the New-to-Market Medications Medical Guideline.

When determining whether the New-to-Market applies to the individual member, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Medical Benefit Drug Guideline is based. In the event of a conflict, the member specific benefit plan document supersedes the applicable Medical Benefit Drug Guideline and List. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Medical Benefit Drug Guideline. Other Guidelines and

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Coverage Determination Guidelines may apply. WPS reserves the right, in its sole discretion, to modify its Guidelines as necessary.

Current Medication List:

Date Added HCPCS Codes Medication
09/27/2024 J3590 Kisunla (donanemab-azbt) 11/21/2024 J3590 Kebilidi (eladocagene exuparvovec-tneq) 10/13/2025 J3590 Elevidys (delandistrogene moxeparvovec-rokl) 10/13/2025 J3590 Zevaskyn (prademagene zamikeracel) 10/13/2025 J3590 Encelto (revakinagene taroretcel) 11/14/2025 J3590 Forzinity (elamipretide)

List History/Revision Information:

Date
Summary of Changes
11/18/2021 • Added Aduhelm (aducanumab) 10/27/2022 • Added Relyvrio (sodium phenylbutyrate/taurursodiol) 12/31/2022 • Removed Aduhelm (aducanumab) 1/12/2023 • Added Leqembi (lecanemab-irmb) 11/30/2023 • Removed Relyvrio (sodium phenylbutyrate/taurursodiol) and Leqembi (lecanemab-irmb) 09/27/2024 • Added Kisunla (donanemab-azbt) 11/21/2024 • Added Kebilidi (eladocagene exuparvovec-tneq) 10/13/2025 • Added Elevidys (delandistrogene moxeparvovec-rokl), Zevaskn (prademagene zamikeracel), and Encelto (revakinagene taroretcel) 11/14/2025 • Added Forzinity (elamipretide)

Disclaimer: This guideline is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may or may not provide coverage for all services listed in this guideline. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical guideline in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information.
Medical guidelines are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical guideline and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email medical.policies@wpsic.com. Coverage of all services is subject to medical necessity and services deemed experimental, investigational, and/or unproven are therefore not considered medically necessary under the terms of the clinical guidelines and will not be covered.

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State mandates, laws or benchmark supersede this medical guideline.

New-to-market medication is considered medically necessary only when indicated per the most current medical references and specialty society guidelines, such as MCG, NCCN, etc.

Guideline Review History:

Implemented 12/01/21, 11/01/22, 12/01/23, 11/01/24, 12/01/24, 09/01/25, 03/01/26 Medical Guideline Committee Approval 11/18/21, 10/27/22, 11/30/23, 10/31/24, 11/21/24, 03/27/25, Q4 2025 Reviewed

11/18/21, 10/27/22, 1/12/23, 11/30/23, 10/31/24, 11/21/24, 03/27/25, Q 4 2025 Developed 11/18/21

Approved by the Medical Director