CurrentHealth NetPolicy MCPB.ST.OO

Clinical Policy: Step Therapy

Defines which Part B drugs require step therapy (trial of a preferred alternative) and the criteria for coverage for Medicare Part B members. Affects providers requesting coverage for listed drugs under Health Net Medicare Part B.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Step Therapy

Policy CodePolicy MCPB.ST.OO

Change TypeNo material change

Effective Date01.01.21

Next Review Date

Key ActionRequest prior authorization when indicated and document trials of required preferred agents (for NEW STARTS document no receipt of the drug in past 365 days).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ManyPart B drugs listed with step therapy requirements

Medicare Part BApplies to

365dNEW STARTS lookback

NumerousRequires prior therapies

PresentBiosimilar guidance

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

General step therapy coverage rule

Covered when ALL of the following are met for the requested Part B agent:

general: Member is a Medicare Part B enrollee and the request is for a listed Part B agent subject to step therapy; for NEW STARTS, the member has not received the requested drug in the past 365 days.365 days

See individual drug entries for the exact required prior agent(s) or prior-line therapy.

Ophthalmology step example

Example ophthalmic agents covered only after trial of preferred intravitreal bevacizumab solution:

ophthalmic_step: For neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema following retinal vein occlusion (RVO), requests for listed anti‑VEGF or intravitreal agents require prior trial of intravitreal bevacizumab solution unless an exception applies.

Referenced for agents such as aflibercept, brolucizumab, faricimab, ranibizumab and others.

Agent-specific prior-line criteria

Examples of agent-specific coverage criteria (requirements vary by drug and indication):

Talvey (talquetamab-tgvs) for multiple myeloma: Member has received 4 prior lines of therapy that include an immunomodulatory agent (e.g., lenalidomide, Pomalyst, Thalomid), a proteasome inhibitor (e.g., bortezomib, Kyprolis), and an anti‑CD38 antibody (e.g., daratumumab/Darzalex or Darzalex Faspro).4 prior lines

From policy step requirements for talquetamab (chunk 26)

Tecvayli (teclistamab-cqyv) for multiple myeloma: Member has received 4 prior lines of therapy that include an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 antibody.4 prior lines

From policy step requirements for teclistamab (chunk 26)

Another agent-specific prior-line criteria

Tecvayli (teclistamab-cqyv) top-level: For multiple myeloma, member must have received 4 lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 antibody.4 prior lines

Top-level prior‑line requirement (chunk 26)

Biosimilar preference criteria

Trastuzumab products (biosimilar preference): If the request is for a trastuzumab product other than Trazimera or Kanjinti, Trazimera or Kanjinti must be used first; if the member is unable to use Trazimera or Kanjinti and the request is for Herceptin or Herceptin Hylecta, a biosimilar trastuzumab product (e.g., Hercessi, Ogivri, Ontruzant) is required when possible.

Biosimilar preference and substitution pathway (chunk 28)

The immune globulin step therapy rule excludes use for viral prophylaxis for hepatitis A, measles, varicella, or rubella. Requests for immune globulin products for these prophylactic viral indications are not subject to the usual step requirement when the request is for an agent other than Gammagard or Gamunex-C, per the policy language on immune globulin exceptions.

Some indication-specific entries explicitly list exceptions where prior therapy is not required. For example, urothelial carcinoma may be eligible without a prior platinum-containing therapy if the member is ineligible for such chemotherapy; similarly, certain first-line or untreated disease scenarios (and specific combination regimens) are described as exceptions to the usual prior-therapy requirement.

Certain cellular therapies are covered only for the initial treatment dose; subsequent doses will not be covered. The policy lists examples such as idecabtagene vicleucel and other CAR-T agents where coverage is limited to the first dose delivered.

The document notes that some IV chemotherapy may not require prior authorization, but an explicit, general prior-authorization exemption for IV chemotherapy is not stated in the provided excerpt. Providers should refer to the full agent-specific entries to determine whether prior authorization is required for a particular intravenous chemotherapy.

Step Therapy Requirements and Drug Lists

Part B Drug	Required prior trial(s) or preferred agent(s) before approval
Abatacept (Orencia)
A tumor necrosis factor (TNF) inhibitor (e.g., infliximab); credit may be given if another TNF inhibitor was tried.
Ado-trastuzumab emtansine (Kadcyla)
Trastuzumab-based therapy and a taxane unless prescribed as adjuvant treatment.
Aflibercept (Eylea and related intravitreal products)
Prior trial of intravitreal bevacizumab solution for neovascular (wet) AMD, DME, or macular edema following RVO.
Ferric carboxymaltose (Injectafer) / Ferumoxytol (Feraheme) / Ferric derisomaltose (Monoferric)
For ophthalmic indications: prior trial of intravitreal bevacizumab solution; for iron-deficiency indications follow listed IV iron sequencing (e.g., Ferrlecit and Venofer first per indication specifics).
Immune globulins (e.g., Hizentra, Privigen, Xembify)
For listed autoimmune indications: prior systemic corticosteroid (or other specified agents such as rituximab for dermatomyositis) per indication-specific requirements.
IncobotulinumtoxinA (Xeomin)
Trial of Botox or Dysport for indicated spasticity, cervical dystonia, blepharospasm, overactive bladder, chronic migraine, primary axillary hyperhidrosis.
Lisocabtagene maraleucel (Breyanzi)
Large B-cell lymphoma: at least 2 lines of systemic therapy including an anti-CD20 therapy (e.g., rituximab) and one anthracycline-containing regimen (e.g., doxorubicin).

Example agent or class	Specified prior agents or lines of therapy required
Talquetamab‑tgvs (Talvey) — multiple myeloma
Member must have received 4 prior lines of therapy that include an immunomodulatory agent (e.g., lenalidomide, Pomalyst, Thalomid), a proteasome inhibitor (e.g., bortezomib, Kyprolis), and an anti‑CD38 antibody (e.g., Darzalex/Darzalex Faspro, Sarclisa).
Teclistamab‑cqyv (Tecvayli) — multiple myeloma
Member must have received 4 lines of therapy that include an immunomodulatory agent, a proteasome inhibitor (e.g., bortezomib, Kyprolis, Ninlaro), and an anti‑CD38 antibody (e.g., Darzalex/Darzalex Faspro, Sarclisa).
Pegfilgrastim products (Neulasta and biosimilars)
Preferred: Udenyca or Nyvepria for all indications; if request is for Neulasta, member must be unable to use Udenyca or Nyvepria — other biosimilars may be considered if unable to use preferred biosimilars.
Polatuzumab vedotin‑piiq (Polivy) — diffuse large B‑cell lymphoma
One prior therapy is required unless prescribed for previously untreated disease in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone and member has IPI or modified IPI > 2 (then initial use allowed).
Trastuzumab products (Herceptin, Herceptin Hylecta, biosimilars)
If request is for a trastuzumab other than Trazimera or Kanjinti, Trazimera or Kanjinti must be used first; if unable to use those and request is for Herceptin or Herceptin Hylecta, a biosimilar trastuzumab product (e.g., Hercessi, Ogivri, Ontruzant) is required when possible.
Vedolizumab (Entyvio)
All indications: trial of a TNF inhibitor (e.g., infliximab); credit may be given if another TNF inhibitor was tried.

Initial Therapy and Exceptions

Initial dose-only coverage

Cellular therapies initial dose rule:

cellular_initial: Certain cellular therapies (e.g., idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel) are covered only for the initial treatment dose; subsequent doses will not be covered.

Applies to specified CAR‑T/cellular therapies (chunk 16)

Initial treatment exceptions

Polivy initial treatment exception: Polatuzumab vedotin‑piiq (Polivy) may be used for previously untreated diffuse large B‑cell lymphoma (DLBCL) when prescribed in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone and the member has an International Prognostic Index (IPI) or modified IPI score > 2.IPI > 2

Initial‑treatment exception for Polivy (chunk 23)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for many Part B agents designated as "Part B Required Step-Through Agents." Requests for these agents will be reviewed to ensure required prior steps (step therapy) or prior-line therapy have been met before approval.

Prior authorization is required when step therapy or prior-line requirements apply.
Many agents listed as Part B Required Step-Through Agents specify the preferred agents or classes that must be tried first (see policy drug-specific requirements).

Step Therapy

Step Therapy and New-Start Documentation

Approval for non-preferred (step) agents requires documentation of prior trials of the specified preferred alternatives. Operationally, the request must show the agent(s) and dates of trial(s), the reason for discontinuation (e.g., lack of efficacy or intolerance), and that the member has not received the requested drug within the past 365 days for new-start requests.

Document prior trial(s) of specified preferred agent(s) including agent name, start/end dates, and clinical rationale for failure or intolerance.
For new starts, member must not have received the same drug in the prior 365 days.

Documentation Required

Biosimilar Substitution Documentation

Requests for originator biologics when preferred biosimilar(s) are listed must include documentation supporting why the biosimilar cannot be used (e.g., clinical contraindication, documented adverse reaction, or formulary restriction). Without such documentation, requests for originator biologics may be denied.

If a biosimilar is the required preferred agent (e.g., trastuzumab biosimilars like Trazimera or Kanjinti), include documentation why biosimilar use is not possible when requesting originator products (e.g., Herceptin).
List prior biosimilar trial details or specific contraindications to biosimilar use.

Denial Risk

Denial Risk for Missing Prior Therapy

Requests that do not demonstrate required prior trials, combinations, or number of prior lines of therapy per the drug-specific step criteria risk denial. Examples include requests without documented trials of the specified TNF inhibitor for certain indications or without the required number of prior lines for multiple myeloma therapies.

Missing required prior therapy trials, combinations, or specified number of prior lines may result in denial.
Ensure documentation addresses the exact step requirements listed for the requested agent (e.g., specific agents, combinations, or minimum number of prior lines).

Biosimilar Preferences and Substitution Guidance

Billing Rule

Neulasta requests require inability to use preferred pegfilgrastim biosimilars

Preferred pegfilgrastim biosimilars (Udenyca or Nyvepria) should be used for pegfilgrastim requests; if requesting Neulasta, include documentation that the member is unable to use Udenyca or Nyvepria and consider other biosimilars only if those two are not an option.

Policy lists Udenyca or Nyvepria as the required preferred options; request for Neulasta requires documentation of inability to use those biosimilars (chunk 21).

Billing Rule

Use trastuzumab biosimilars (Trazimera or Kanjinti) before other trastuzumab products

For trastuzumab requests, Trazimera or Kanjinti must be used when the request is for an agent other than those biosimilars; if those biosimilars cannot be used and the request is for Herceptin or Herceptin Hylecta, provide documentation and use an alternate trastuzumab biosimilar when possible.

Policy specifies Trazimera or Kanjinti as the required biosimilars; if unable to use them, a biosimilar trastuzumab (e.g., Hercessi, Ogivri, Ontruzant) is required when requesting Herceptin/Herceptin Hylecta (chunk 28).

Billing Rule

Use preferred rituximab biosimilars; Rituxan Hycela requires prior full-dose rituximab

For Rituxan requests, use the listed rituximab biosimilars (Ruxience, Truxima, Riabni) when indicated; coverage for Rituxan Hycela requires prior receipt of at least one full dose of Rituxan, Riabni, Ruxience, or Truxima in addition to other indication‑specific criteria.

Policy lists Ruxience, Truxima, and Riabni as the preferred products for Rituxan requests (chunk 24).
Rituxan Hycela coverage condition: member must have received at least one full dose of Rituxan, Riabni, Ruxience, or Truxima (chunk 24).

Documentation Required

Provide documentation for inability to use preferred biosimilars (cross-reference)

When requesting an originator biologic instead of a preferred biosimilar, include clinical documentation supporting why the preferred biosimilar(s) cannot be used (cross-referenced guidance applies to trastuzumab, pegfilgrastim, and other agents with biosimilar preference).

The policy explicitly requires documentation of inability to use preferred biosimilars when requesting originator biologics such as trastuzumab (chunk 28).

Definitions and Policy Scope

NEW STARTS

Definition (NEW STARTS)Member has not received the drug for the past 365 days.

ApplicationUsed to determine eligibility for approval under 'NEW STARTS' approval criteria.

Requirement sourcePolicy/Criteria section specifying 'Approval Criteria (NEW STARTS ONLY member has not received the drug for the past 365 days)'

IV chemotherapy prior authorization note

IV chemotherapy prior-authorization noteSome intravenous chemotherapy agents included in step lists may not require prior authorization.

ContextStatement appears alongside multiple Part B step therapy entries indicating variable prior authorization requirements for IV chemotherapy.

Provider action implicationProviders should verify prior-authorization requirements for IV chemotherapy agents despite their inclusion in step lists.

Clinical policy purpose

Purpose of clinical policyProvides guidance to assist in making coverage decisions and administering benefits; not a contract or guarantee of payment or results.

BasisDeveloped by licensed health care professionals using FDA recommendations, peer-reviewed literature, and evidence-based guidelines.

LimitationsCoverage decisions are subject to terms, exclusions, limitations of coverage documents and applicable state/federal requirements.

OpenPayer

Clinical Policy: Step Therapy

Coverage Criteria for Part B Step-Therapy Agents

Step Therapy Requirements and Drug Lists

Initial Therapy and Exceptions

Provider Actions, Prior Authorization, and Documentation

Definitions and Coding Notes

Biosimilar Preferences and Substitution Guidance

Site-of-Care and Infusion Notes

Definitions and Policy Scope

Background on Step Therapy