Clinical Policy: Step Therapy
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Defines drugs subject to step therapy under Arizona Complete Health Medicare Part B and the required prior trials or alternatives before coverage of non-preferred Part B agents.
No material clinical or coverage changes in this revision.
Coverage and Step Therapy Criteria
Initial (new-start) step therapy criteria
Covered when the required prior therapy or condition-specific exception is documented for the requested Part B agent.
From policy header 'NEW STARTS ONLY - member has not received the drug for the past 365 days'
Detailed per-agent lists in policy chunks 4-5
Part B step/prior therapy criteria by agent
Coverage requires meeting specified prior therapy or step criteria for the indicated condition; exceptions are enumerated per agent.
See chunks 21-22 for exception list
See chunk 5 for PD-L1 thresholds and exceptions
See chunk 32
See chunks 11 and 12
See chunks 12,17,30-31 for product-specific line requirements
Certain clinical situations and specific indications are exempt from the general Part B step requirement. Examples in the policy include: abatacept (Orencia) is subject to the TNF‑inhibitor step for all indications except prophylaxis for acute graft‑versus‑host disease; ado‑trastuzumab emtansine (Kadcyla) need not meet the trastuzumab + taxane requirement when prescribed as adjuvant treatment; and multiple agents list transplant ineligibility or other condition‑specific exceptions as allowable pathways instead of completing the usual prior therapy trial. Providers should reference the agent‑specific criteria to confirm whether a listed exception applies for the requested indication.
Some cellular and specialty agents are covered only for the initial treatment dose; subsequent doses are not covered. The policy explicitly states that certain autologous/cellular therapies and other listed agents are limited to the initial dose (for example, multiple cellular therapies are noted as covered only for the initial treatment dose), and requests for additional doses after the initial administration will not meet coverage criteria.
For intra‑articular hyaluronate derivatives used to treat osteoarthritis of the knee, the policy requires prior trial of an intra‑articular glucocorticoid injection and specifies product preference sequencing. If the request is for a hyaluronate product other than Synvisc/Synvisc One or Euflexxa, the member must have tried Synvisc or Synvisc One or Euflexxa first; absence of these prior treatments may be a basis to deny the request.
When an intravitreal anti‑VEGF step is specified, intravitreal bevacizumab solution is the required Part B step for many retinal indications. The policy lists bevacizumab intravitreal solution as the required prior agent for aflibercept and related intravitreal products for neovascular (wet) AMD, DME, and macular edema following RVO, and similarly cites bevacizumab as the Part B step for classic subfoveal CNV due to AMD or pathologic myopia. Requests for non‑preferred intravitreal agents in these settings must document why bevacizumab is not appropriate.
Initial Therapy / Prior Lines Requirements
Initial therapy step examples
Agent-specific initial therapy requirements (examples provided).
See chunk 4
See chunk 4
See chunks 4 and 12
Initial therapy / prior lines for specialty agents
Initial dosing or prior lines required for cellular therapies and some oncology agents.
See chunks 12,17,30
See chunks 31 and 7
See chunk 27
Continuation Therapy Limits
Continuation therapy limits
Some cellular therapies are covered only for the initial treatment dose; subsequent doses are not covered.
See chunks 7,17,32
Step Therapy Rules and Examples
| Example step requirement | Required prior agent(s) / preferred product(s) |
|---|---|
| Abatacept (Orencia) — all indications (except GVHD prophylaxis) | Trial of a tumor necrosis factor (TNF) inhibitor (e.g., infliximab); credit may be given if another TNF inhibitor was tried. |
| Ado‑trastuzumab emtansine (Kadcyla) — breast cancer | Prior trastuzumab‑based therapy and a taxane unless prescribed as adjuvant treatment. |
| Aflibercept (Eylea) / intravitreal anti‑VEGF agents — neovascular AMD, DME, macular edema after RVO | Intravitreal bevacizumab solution required as the Part B step prior to these agents. |
| Pegfilgrastim products (Efbemalenograstim, Eflapegrastim references) | Udenyca or Fulphila preferred for all indications; if member unable to use preferred products, a biosimilar pegfilgrastim product may be used; Neulasta considered only if unable to use preferred products. |
| Filgrastim (Neupogen) and biosimilar hierarchy | If request is for agent other than Zarxio: Zarxio is preferred; if unable to use Zarxio: Nivestym; if unable to use Zarxio and Nivestym and request is for Neupogen: a biosimilar filgrastim product is required. |
| Trastuzumab and trastuzumab biosimilars | Preferred trastuzumab biosimilars Trazimera or Kanjinti required for all indications; if unable to use Trazimera or Kanjinti and request is for Herceptin or Herceptin Hylecta, an alternative trastuzumab biosimilar (e.g., Hercessi, Ogivri, Ontruzant) may be allowed. |
| Documentation required | Examples / policy detail |
|---|---|
| Evidence of trial, failure, intolerance, or ineligibility for required prior agent(s) | Providers must document trial and either failure, intolerance, or ineligibility for the specified preferred therapeutic alternatives per drug (e.g., trial of a TNF inhibitor before abatacept; intravitreal bevacizumab prior to aflibercept/faricimab/ranibizumab). |
| Specific prior systemic therapies or lines of therapy when required | For specialty/oncology agents, document prior lines (e.g., required trastuzumab‑based therapy and a taxane before ado‑trastuzumab emtansine; multiple myeloma CAR/T or bispecifics require specified numbers of prior lines including IMiD, proteasome inhibitor, and anti‑CD38 as applicable). |
| Proof of use of preferred biosimilar or reason unable to use preferred biosimilar | When trastuzumab is requested, document use of Trazimera or Kanjinti first or documentation of inability to use them to justify use of Herceptin/other trastuzumab products; similarly document use of Udenyca or Fulphila (or inability) when requesting alternate pegfilgrastim products. |
| Agent‑specific dose history where required | For rituximab hyaluronidase (Rituxan Hycela), document the member has received at least one full dose of Rituxan, Riabni, Ruxience, or Truxima as applicable; other agents list similar dose/therapy history requirements in the policy. |
| New‑start status where applicable | Requests are subject to the policy's new‑start requirement — member has not received the drug in the past 365 days; providers should document prior administration dates to demonstrate new‑start eligibility or prior treatment history. |
| Prior authorization submission when indicated | Many Part B agents may require prior authorization — submit documentation of the required prior therapies, biosimilar use, or line‑of‑therapy history with the prior authorization request per the policy examples (see drug‑specific sections). |
Biosimilar and Preferred Product Guidance
Use preferred bevacizumab biosimilars (Mvasi, Zirabev)
If the request is for Avastin, Alymsys, or Vegzelma for oncology indications, providers must request or use the preferred bevacizumab biosimilars Mvasi or Zirabev as the Part B step agent.
Retacrit required/preferred for ESAs; Epogen shortage alternative
For all indications of darbepoetin alfa or epoetin alfa, providers must use Retacrit as the Part B step agent; if Retacrit is unavailable due to shortage, Epogen is the designated alternative.
Filgrastim hierarchy — prefer Zarxio, then Nivestym, then biosimilars
When the request is for filgrastim products other than Zarxio, providers must use Zarxio as the Part B step agent; if unable to use Zarxio, use Nivestym, and if both are unavailable and the request is for Neupogen, a biosimilar filgrastim product may be used.
- Primary preferred agent: Zarxio for all indications
- If unable to use Zarxio: Nivestym
- If unable to use Zarxio and Nivestym and request is for Neupogen: accept biosimilar filgrastim products
Preferred trastuzumab biosimilars required (Trazimera, Kanjinti)
For all trastuzumab indications, providers must use the preferred trastuzumab biosimilars Trazimera or Kanjinti as the Part B step agents; if unable to use Trazimera or Kanjinti and the request is for Herceptin or Herceptin Hylecta, other trastuzumab biosimilars (e.g., Hercessi, Ogivri, Ontruzant) may be used.
- Preferred agents for all indications: Trazimera or Kanjinti
- If unable to use preferred biosimilars and request is for Herceptin/Herceptin Hylecta: alternative biosimilars (Hercessi, Ogivri, Ontruzant) allowed
Pegfilgrastim preferred agents (Udenyca, Fulphila); Neulasta only if unable to use preferred
For all pegfilgrastim indications, providers must use Udenyca or Fulphila as the Part B step agents; if the request is for Neulasta, Neulasta may only be considered when the member is unable to use Udenyca or Fulphila, in which case a biosimilar pegfilgrastim product may be used.
- Preferred agents for all indications: Udenyca or Fulphila (Udenyca includes all formulations)
- If member cannot use Udenyca or Fulphila and request is for Neulasta: accept a biosimilar pegfilgrastim product (e.g., Fylnetra, Nyvepria, Stimufend, Ziextenzo)
Provider Requirements, Prior Authorization, and Documentation
Prior authorization may be required for PART B agents
Certain Part B–administered agents may require prior authorization; many entries in the step therapy tables are labeled 'PART B STEP', indicating prior-authorization and step-through agents must be satisfied before coverage.
- Look for 'PART B STEP' notation in the drug-specific table when preparing prior authorization requests.
Part B agents often have prior-auth and step-through requirements
Many Part B–administered agents listed include defined step-through (preferred) agents by indication and may require prior authorization; providers must submit prior authorization when applicable.
Document trial/failure or ineligibility of preferred alternatives
Providers must document a trial and either failure, intolerance, or ineligibility of the specified preferred therapeutic alternatives listed for each drug and indication (the policy lists required agents or regimens to try first).
- Examples include a TNF inhibitor prior to abatacept and trastuzumab-based therapy plus a taxane prior to ado-trastuzumab emtansine.
Follow product- and indication-specific preferred Part B step agents
The policy defines specific preferred Part B step agents per product and indication (for example, Udenyca or Fulphila for pegfilgrastim; Trazimera or Kanjinti for trastuzumab), and providers must follow these step-through choices when seeking coverage.
- Follow the product-specific 'PART B STEP' preferred agent listed in the table for each indication.
Provide evidence of prior therapy per drug-specific steps
Documentation submitted with authorization requests must support prior use or trial of the required preferred agent(s) as specified in the drug-specific step requirements (for example, prior TNF inhibitor for abatacept or trastuzumab-based therapy before ado-trastuzumab emtansine).
Confirm prior full-dose rituximab products before Rituxan Hycela
When requesting Rituxan Hycela, the policy requires that the member has received prior full doses of rituximab products (e.g., Rituxan, Riabni, Ruxience, or Truxima) as specified in the step requirements for all indications.
New-start eligibility: no receipt of drug in prior 365 days
The policy applies to 'NEW STARTS ONLY'—a member is considered a new start if they have not received the drug in the past 365 days; requests for new starts may be denied if the member has received the drug within the past 365 days.
Missing prior therapy documentation may trigger denial
Requests for certain agents will be denied if the required prior systemic therapy is not documented or none of the listed alternatives have been tried and no exception applies (the policy lists prior-therapy prerequisites for specific agents).
- Example: Opdivo requires documentation of prior systemic therapy for non‑small cell lung cancer unless a listed exception applies.
Clinical Thresholds and Key Values
Quantity and Dose Limits
Background
Step therapy is a utilization management approach that requires a trial of a preferred therapeutic alternative before coverage of a non‑preferred drug for a specified indication. This policy applies to Medicare Part B administered infused or injected agents across multiple specialties and defines agent‑specific required prior therapies, exceptions, and documentation expectations that providers must meet to obtain coverage.
Definitions
Quick Provider Callouts
Quick list of preferred Part B step agents (biosimilars and alternatives)
Common preferred Part B agents and their step-through choices include, for quick reference: Udenyca or Fulphila for pegfilgrastim; Trazimera or Kanjinti for trastuzumab; Mvasi or Zirabev for bevacizumab; Zarxio (then Nivestym, then filgrastim biosimilars) for filgrastim; Retacrit for ESAs (Epogen if shortage).
- Use the listed preferred biosimilars first and document trial/failure or ineligibility when requesting non-preferred products.
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