Currentblue cross blue shield - michiganPolicy N/A

Step therapy requirements for Anktiva, Herceptin Hylecta, and Onivyde

Announces new step therapy requirements effective Dec. 1, 2025 for administration-site (medical benefit) use of Anktiva, Herceptin Hylecta, and Onivyde for applicable Blue Cross Blue Shield of Michigan and BCN members; describes affected member groups and prior authorization process.

Policy Summary

Payerblue cross blue shield - michigan

PolicyStep therapy requirements for Anktiva, Herceptin Hylecta, and Onivyde

Policy CodePolicy N/A

Change TypeStep therapy and prior authorization added

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests to OncoHealth via the OneUM portal or by calling 1-888-916-2616.

SourceLink

POLICY UPDATE CHANGES

Step therapy requirements for Anktiva, Herceptin Hylecta, and Onivyde for most members starting Dec. 1, 2025.

Anktiva requires prior authorization for most members starting June 1, 2025.

3drugs with new step therapy requirements

2025-12-01effective date

OncoHealthprogram administrator

1-888-916-2616OncoHealth phone

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Coverage Criteria

Initial step therapy conditions

Covered when ALL of the following are met

Anktiva step: For treatment of BCG-unresponsive non-muscle invasive bladder cancer, member must have tried and failed Adstiladrin (J9029) before Anktiva (J9028) is considered medically necessary.

Also: Anktiva requires prior authorization for most members starting June 1, 2025.

Herceptin Hylecta step: Members must try and fail all preferred trastuzumab biosimilar products before Herceptin Hylecta (J9356) is considered medically necessary.

Refer to prior authorization lists for current preferred products.

Onivyde step: For treatment of pancreatic cancer, members must try and fail conventional irinotecan (J9206) before Onivyde (J9205) is considered medically necessary.

Conventional irinotecan does not require prior authorization.

The step therapy requirement described in this policy does not apply to certain member groups. Specifically, it does not apply to Blue Cross commercial members who have coverage through the Blue Cross and Blue Shield Federal Employee Program® or through Blue Cross commercial UAW Retiree Medical Benefits Trust plans. In addition, the policy language distinguishes applicability across product lines and enrollment types; see the program participation lists referenced for self-funded groups. (Refer to the Oncology Value Management participation guidance for details on self-funded group participation.)

Failure to obtain required prior authorization or to meet the specified step therapy requirements does not guarantee payment. Prior authorization is a review process and is not a promise of coverage; health care practitioners must verify member eligibility and benefits. Use of the listed agents without meeting step therapy and prior authorization requirements may be considered not medically necessary and can result in denial of medical benefit payment.

Coding (HCPCS/CPT)

Affected HCPCS codesHCPCS

J9028	Anktiva (nogapendekin alfa inbakicept)
J9029	Adstiladrin (nadofaragene firadenovec-vncg)
J9356	Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
J9205	Onivyde (irinotecan liposome)
J9206	Conventional irinotecan

Provider Actions and Requirements

Step Therapy

Step therapy and prior authorization overview

For dates of service on or after Dec. 1, 2025, select oncology drugs will have step therapy requirements administered through the Oncology Value Management program (OncoHealth). Members must try and fail specified preferred agents before the listed drugs will be considered medically necessary. These requirements apply when drugs are administered in outpatient settings and to applicable Commercial and Medicare Advantage members as specified in the policy.

Step therapy effective date: Dec. 1, 2025
Step therapy applies to outpatient-administered oncology drugs for specified BCBSM and BCN commercial and Medicare Advantage members
Members must try and fail preferred agents (see prior authorization lists) before non-preferred drugs will be medically necessary

Prior Authorization

How to submit prior authorization

Prior authorization requests for oncology drugs managed by the Oncology Value Management program must be submitted to OncoHealth. Prior authorization may be requested through the OncoHealth OneUM portal via the Blue Cross provider portal (Availity Payer Spaces → BCBSM and BCN → OncoHealth Provider Portal tile) or by calling OncoHealth directly.

Initial Therapy — Required Prior Agents

Required prior agents

Initial therapy prior to approval of specified specialty agent

Adstiladrin before Anktiva: Trial and failure of Adstiladrin (J9029) required before Anktiva (J9028) for BCG-unresponsive NMIBC.

Preferred trastuzumab biosimilars before Herceptin Hylecta: Trial and failure of all preferred trastuzumab biosimilars required before Herceptin Hylecta (J9356).

Conventional irinotecan before Onivyde: Trial and failure of conventional irinotecan (J9206) required before Onivyde (J9205) for pancreatic cancer.

Conventional irinotecan does not require prior authorization.

Step Therapy Enforcement

Program / Administrator	Requirement	Prior authorization submission
Oncology Value Management — OncoHealth
Step therapy enforced: members must 'try and fail' specified preferred or conventional agents before the listed specialty agent is considered medically necessary (Anktiva, Herceptin Hylecta, Onivyde).
Prior authorization and step therapy are administered through OncoHealth; prior authorization requests must be submitted via the OncoHealth OneUM portal (payer space on Availity) or by calling OncoHealth at 1-888-916-2616. Note: Anktiva required prior authorization for most members starting June 1, 2025; step therapy effective Dec. 1, 2025.

Site of Care

Note

Outpatient site-of-care applicability

These step therapy and prior authorization requirements apply when the listed drugs are administered in outpatient settings under the medical benefit for applicable Blue Cross Blue Shield of Michigan and BCN commercial and Medicare Advantage members.

Applies to outpatient administration under the medical benefit (fully insured commercial members, except MESSA, and participating self-funded groups as specified).

Biosimilar Requirements

Billing Rule

Try and fail preferred trastuzumab biosimilars before Hylecta

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk, HCPCS J9356) will be considered medically necessary only after the member has tried and failed all preferred trastuzumab biosimilar products.

Refer to the prior authorization lists at the end of the document for the current preferred trastuzumab biosimilar products.

Definitions

BCG-unresponsive NMIBC — definition

DefinitionBCG-unresponsive non-muscle invasive bladder cancer

Context in policyAnktiva (J9028) step therapy applies when used for treatment of BCG-unresponsive non‑muscle invasive bladder cancer — members must try and fail Adstiladrin (J9029) before Anktiva is considered medically necessary.

Related drug codesAnktiva (J9028); Adstiladrin (J9029)

Conventional irinotecan — definition

DefinitionConventional (non-liposomal) irinotecan

Policy useFor treatment of pancreatic cancer, members must try and fail conventional irinotecan (HCPCS J9206) before Onivyde (irinotecan liposome, J9205) is considered medically necessary.

Background

This alert notifies providers that select oncology injectables administered in outpatient settings under the medical benefit will require step therapy and prior authorization through the Oncology Value Management program. These requirements apply when the drugs are given in outpatient settings for Blue Cross Blue Shield of Michigan and Blue Care Network commercial members (all fully insured group and individual members with the exception of MESSA members) and for members whose self-funded groups participate in the Oncology Value Management program.