mhn Part B Step Therapy Coverage Update

Coverage & Step Therapy Criteria

General approval eligibility (New starts)

Approval applies to new starts only (member has not received the drug for the past 365 days).

New starts requirement: Member has not received the requested drug in the past 365 days365 days

Applies to approval criteria I (NEW STARTS ONLY)

Per-drug step therapy requirements

Covered when ALL of the following indication-specific step requirements are met (examples shown; full list continues in subsequent parts of document):

Agent-specific step requirements: For each listed Part B drug, coverage is contingent on trial/failure or documented ineligibility of the specified preferred agent(s) or regimens for the given indication as detailed per drug entry.see per-drug entries

Examples include TNF inhibitor trial for abatacept and other biologics; intravitreal bevacizumab as the intravitreal step for many retinal agents; specified prior chemotherapy or lines of therapy for oncology agents; biosimilar preferences for certain supportive care agents.

Examples of Indication-Specific Step Therapy Criteria

Covered when ALL of the following per-indication prior therapy requirements are met (examples from document):

Large B-cell lymphoma (CAR-T / cellular therapy examples): Member has had either: (1) two lines of systemic therapy that include an anti-CD20 therapy (e.g., rituximab) and an anthracycline-containing regimen (e.g., doxorubicin); OR (2) first-line chemoimmunotherapy that included an anti-CD20 and an anthracycline regimen and disease was refractory or relapsed within 12 months of chemoimmunotherapy.

From chunks 18 and 29

Relapsed or refractory follicular lymphoma: Member has had two lines of systemic therapy that include an anti-CD20 monoclonal antibody (e.g., rituximab or obinutuzumab/Gazyva) plus an alkylating agent (e.g., bendamustine, cyclophosphamide, chlorambucil).

From chunks 18 and 29

Mantle cell lymphoma: Member has had two lines of systemic therapy including an anti-CD20 antibody (e.g., rituximab) and an alkylating agent (e.g., bendamustine or cyclophosphamide).

From chunk 18

Certain indications are expressly excluded from the step therapy requirement for specific agents. For example, abatacept (Orencia) is subject to the Part B step requirement for all indications except prophylaxis for acute graft‑versus‑host disease. Cite the drug‑specific entry to confirm any other indication‑level exceptions before denying a request.

Some intravenous chemotherapy or oncology uses have specific agent‑level exceptions to the step requirement. The policy notes that some IV chemotherapy may not require prior authorization and highlights exceptions by drug and indication (for example, neoadjuvant/adjuvant contexts or where prior chemo may be waived). Where listed, prior‑therapy requirements for agents such as lurbinectedin (small cell lung cancer) and tumor‑type specific pathways should be reviewed against the documented exceptions before applying step therapy.

Certain products are covered only for the initial treatment dose and subsequent doses will not be approved. The document specifies that some agents are explicitly limited to an initial dose (for example, wording noting "Only for initial treatment dose; subsequent doses will not be covered"), so prior authorization approvals should reflect initial‑dose‑only coverage where indicated and deny or refer requests for additional doses accordingly.

Initial Therapy (New Starts) Requirements

Initial therapy (New starts)

Initial therapy (NEW STARTS) requirements and examples

Initial therapy new-start requirement: Member must be a new start (no receipt of the requested drug in the prior 365 days) and must meet the drug- and indication-specific step requirements (trial/failure or documented ineligibility of preferred agent(s)) before the requested agent will be approved.365 days

See per-drug entries for required prior therapies and exceptions.

Initial dose rules

Initial-dose limitations noted for specific agents:

Initial-treatment-only: Some agents are covered only for the initial treatment dose; subsequent doses will not be covered when the product-specific entry states 'Only for initial treatment dose; subsequent doses will not be covered.'initial dose only

Continuation and Exception Conditions

Initial-treatment dose coverage — certain cellular / CAR-T agents covered only for initial dose

Certain cellular therapies and CAR-T agents are covered only for initial treatment dose; subsequent doses are not covered.

Initial-dose only for cellular / CAR-T agents: Only the initial treatment dose is covered; subsequent doses will not be covered for specified cellular and CAR-T products (examples include lisocabtagene maraleucel/Breyanzi, idecabtagene vicleucel/Abecma, lurbinectedin listed as initial-dose examples where applicable).initial dose only

From chunks 7, 9, 18, 19; individual agent entries define which products are initial-dose only.

Continuation / Exception Nodes

Continuation conditions and example exception nodes:

Polatuzumab continuation exception: Polatuzumab may be allowed without prior therapy when prescribed for previously untreated diffuse large B-cell lymphoma in combination with R-CHP and the member has IPI (or stage-modified IPI) ≥ 2.

Step Therapy: Required Trials & Preferred Alternatives

Drug / Indication	Preferred therapeutic alternative(s) (required trial prior to coverage)
Abatacept (Orencia) — All indications except prophylaxis for acute graft‑versus‑host disease	A tumor necrosis factor (TNF) inhibitor (e.g., infliximab). Credit may be given if another TNF inhibitor was tried.
Aflibercept (Eylea and branded formulations) — Neovascular (wet) AMD, DME, RVO, DR	Intravitreal bevacizumab solution.
Brolucizumab (Beovu) — Neovascular (wet) AMD, DME	Intravitreal bevacizumab solution.
Ferric carboxymaltose (Injectafer) — Iron deficiency anemia with CKD	Ferrlecit and Venofer first; if unable to use or failure of both: generic ferumoxytol (Feraheme).
Ferric carboxymaltose / Ferumoxytol / Ferric derisomaltose — Neovascular (wet) AMD, DME, macular edema following RVO (intravitreal context listed across iron entries)	Intravitreal bevacizumab solution for retinal indications.
Trastuzumab products (Trazimera, Kanjinti, Herceptin, Herceptin Hylecta, other biosimilars) — All indications	Prefer Trazimera or Kanjinti; if unable to use those and request is for Herceptin/Herceptin Hylecta, prefer an alternative biosimilar trastuzumab (e.g., Hercessi, Ogivri, Ontruzant).
Pegfilgrastim products (Udenyca, Nyvepria, Neulasta, biosimilars) — All indications	Udenyca or Nyvepria preferred; if member unable to use those, an alternate biosimilar pegfilgrastim (e.g., Fulphila, Fylnetra, Stimufend, Ziextenzo) is acceptable.

Drug / Indication	Documented prior therapies required (per drug & indication)
Lisocabtagene maraleucel (Breyanzi) — Large B‑cell lymphoma	Member has had either: (1) two lines of systemic therapy that include an anti‑CD20 therapy (e.g., rituximab) and an anthracycline‑containing regimen; OR (2) first‑line chemoimmunotherapy including anti‑CD20 and anthracycline if disease was refractory or relapsed within 12 months.
Tisagenlecleucel (Kymriah) — B‑cell precursor acute lymphoblastic leukemia	At least two prior systemic therapies.
Lurbinectedin (Zepzelca) — Small cell lung cancer	Prior platinum‑containing regimen (e.g., cisplatin, carboplatin).
Nivolumab (Opdivo) / Atezolizumab (Tecentriq) / Pembrolizumab (Keytruda) — Non‑small cell lung cancer (selected settings)	Prior platinum‑containing chemotherapy required unless exceptions apply (e.g., high PD‑L1 expression TPS ≥1% or specified neoadjuvant/adjuvant/combination therapy exceptions detailed per agent).
Multiple myeloma cellular and bispecific agents (e.g., Ciltacabtagene autoleucel, Talquetamab, Teclistamab) — Multiple myeloma	Member has received 4 prior lines of therapy that include an immunomodulatory agent (e.g., lenalidomide), a proteasome inhibitor (e.g., bortezomib), and an anti‑CD38 antibody (e.g., daratumumab/Sarclisa) as specified for each agent.
Polatuzumab vedotin (Polivy) — Diffuse large B‑cell lymphoma (including histologic transformation)	One prior therapy required unless all of the following met: prescribed for previously untreated disease in combination with R‑CHP and member has IPI ≥2 (in which case prior therapy may not be required).
Rituximab products (Rituxan, Riabni, Ruxience, Truxima) — All indications (when request is for Rituxan/Riabni)	If request is for Rituxan: prefer Ruxience, Truxima, and Riabni; documentation notes for Rituxan Hycela: member has received at least one full dose of Rituxan, Riabni, Ruxience, or Truxima in some scenarios.

Provider Responsibilities & Authorization Notes

Prior Authorization

Prior Authorization May Be Required

Part B step therapies may require prior authorization. Providers should verify PA requirements before submitting requests and include supporting clinical documentation that demonstrates medical necessity and adherence to step-therapy requirements.

Prior authorization may be required for many Part B step agents.
Confirm PA requirements before treatment and submission.

Documentation Required

Proof of Trial of Preferred Agent(s)

Providers must document proof of trial and failure (or intolerance/ineligibility) of specified preferred agent(s) listed as step requirements. Documentation should include agent name, dates of therapy, reason for discontinuation (e.g., lack of efficacy, adverse event), and any objective response data when available.

Include medication name(s), start/stop dates, and reason for failure or intolerance.

Clinical Thresholds & Scoring

PD‑L1 TPS or CPS thresholds

NSCLC (Tumor Proportion Score)TPS ≥ 1% qualifies for specified exceptions when referenced in NSCLC coverage criteria

General CPS thresholdCPS ≥ 1 is an indicated threshold for several tumor types listed under PD‑1/PD‑L1 criteria

Higher CPS thresholdCPS ≥ 10 is used as a specified threshold for selected cancers as noted in per‑indication entries

Very high fracture risk criteria

Recent osteoporotic fractureFracture within the past 12 months meets 'very high fracture risk' criteria

Low BMD T‑scoreBMD T‑score at the hip or spine ≤ -3.0 meets 'very high fracture risk' criteria

Biosimilar Preferences & Substitution Guidance

Billing Rule

Prefer Mvasi or Zirabev for Avastin/Alymsys/Vegzelma

For requests involving Avastin, Alymsys, or Vegzelma, the policy prefers the bevacizumab biosimilars Mvasi and Zirabev as the step/biosimilar options.

Billing Rule

Zarxio preferred for filgrastim (then Nivestym)

For filgrastim requests the policy lists Zarxio as the preferred product; if Zarxio cannot be used, Nivestym is the next preferred option, then other biosimilars.

Billing Rule

Prefer Trazimera or Kanjinti for trastuzumab

For trastuzumab requests (Herceptin/Herceptin Hylecta), Trazimera or Kanjinti are preferred for all indications; if those cannot be used, other biosimilar trastuzumab products are preferred as noted.

Administration & Infusion Notes

Note

Infusion-center (Part B) administration; some IV chemo exceptions

Most listed agents are Part B–administered (infused or injected); note that some IV chemotherapy entries in the policy are identified as possibly not requiring prior authorization (see specific drug/indication entries).

Policy Definitions

Step therapy (Step-Through) definition

DefinitionA utilization management requirement that a trial of a preferred therapeutic alternative be completed prior to coverage of a listed non‑preferred Part B drug for the specified indication

Applies toRequests for new starts (member has not received the requested drug in the prior 365 days) per the policy's approval criteria

Provider responsibilityDocument trial, failure, or contraindication to the preferred agent(s) as specified for the drug and indication

Prior therapy — prior systemic therapy / lines of therapy

Prior systemic therapy (lines of therapy)Requirement to show prior systemic therapy or specified lines of therapy (e.g., 2 lines including anti‑CD20 + anthracycline for certain lymphomas) per the drug and indication

Line‑specific examples

Background & Rationale

Step therapy is a utilization‑management strategy that requires a documented trial of a preferred therapeutic alternative before approving a non‑preferred Part B drug for a given indication. The policy applies to new starts only (member has not received the requested drug in the prior 365 days), and providers must document prior therapies, trials, or clinical ineligibility for the preferred agents to support coverage of the requested agent.

OpenPayer

Clinical Policy: Step Therapy

Coverage & Step Therapy Criteria

Initial Therapy (New Starts) Requirements

Continuation and Exception Conditions

Step Therapy: Required Trials & Preferred Alternatives

Provider Responsibilities & Authorization Notes

Clinical Thresholds & Scoring

Biosimilar Preferences & Substitution Guidance

Administration & Infusion Notes

Policy Definitions

Background & Rationale