CurrentFidelis CarePolicy N/A

Clinical Policy: Step Therapy

Defines drugs and indications subject to step therapy requirements for Fidelis Care Medicare Part B members, listing preferred agents that must be tried before non-preferred agents are approved and noting instances where prior authorization may be required.

Policy Summary

PayerFidelis Care

PolicyClinical Policy: Step Therapy

Policy CodePolicy N/A

Change TypeClarified

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionConfirm step therapy requirements and document prior trials or exceptions; ensure member has not received the requested drug in the past 365 days.

SourceLink

POLICY UPDATE CHANGES

Policy provides an updated comprehensive list of Part B agents subject to step therapy and their required preferred step agents or exceptions.

~120Drugs/agents listed

Medicare Part BLine of Business covered

365 daysNew start lookback requirement

What is Changing

This policy clarifies and updates a comprehensive list of Medicare Part B drugs that are subject to step therapy, identifying preferred agents (often biosimilars or lower-cost alternatives) that must be tried prior to coverage of non-preferred agents for specific indications. The policy enumerates many individual agents with indication-specific step requirements and exceptions, and reminds reviewers that some intravenous chemotherapy regimens may not require prior authorization.

Reviewers and providers should confirm step therapy requirements are met — including documented trials of required preferred agents or documentation of applicable exceptions — and note the policy’s 365-day new-start lookback for determining prior use of the requested agent.

Key Operational Facts

Drugs/agents listed~120

Line of Business coveredMedicare Part B

New start lookback requirement365 days

Per-agent Step Therapy Requirements (Selected Examples)

Per-agent Step Therapy Requirements

For each listed agent, approval requires prior trial(s) of specified preferred agent(s) or meeting stated exceptions

Examples (each agent is a separate any-branch)

Abatacept (Orencia): All indications except prophylaxis for acute GVHD require prior 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 requires prior trastuzumab-based therapy and a taxane unless prescribed as adjuvant treatment.
Aflibercept (Eylea and branded variants): PART B STEP for neovascular (wet) AMD; macular edema following RVO; diabetic macular edema (DME): intravitreal bevacizumab intravitreal solution is the required step agent.
Atezolizumab (Tecentriq and Hybreza): Urothelial carcinoma - member ineligible for platinum chemo as first-line systemic therapy; Non-small cell lung cancer high-risk stage IIA/IIIB with PD-L1 >=1% or recurrent/advanced/metastatic and ALK/EGFR negative/unknown: required prior platinum-containing chemotherapy unless listed exceptions are met.
Axicabtagene ciloleucel (Yescarta): Large B-cell lymphoma requires 2 lines of systemic therapy including rituximab and an anthracycline-containing regimen, or specified refractory/relapse criteria.
(only initial treatment dose covered)
Bevacizumab (Avastin/Alymsys/Mvasi/Vegzelma): Oncology indications - if request is for Avastin/Alymsys/Vegzelma, required step is Mvasi and Zirabev.
Brentuximab vedotin (Adcetris): Lymphomatoid papulosis and B-cell lymphomas require prior systemic therapy.
Brexucabtagene autoleucel (Tecartus): Mantle cell lymphoma requires 2–5 regimens including doxorubicin- or bendamustine-containing chemotherapy and anti-CD20 therapy; B-cell precursor ALL requires at least two systemic therapies. Only initial treatment dose covered; subsequent doses not covered.
Brolucizumab-dbll (Beovu): PART B STEP for neovascular (wet) AMD and DME: intravitreal bevacizumab solution required step.
Cemiplimab-rwlc (Libtayo): Cutaneous squamous cell carcinoma requires prior cisplatin unless exceptions (infeasible surgery/radiation or neoadjuvant) are met.
Certolizumab (Cimzia): All indications require trial of a different TNF inhibitor (e.g., infliximab); credit may be given if another TNF inhibitor was tried.
Ciltacabtagene autoleucel (Carvykti): Lenalidomide-refractory multiple myeloma requires at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor; only initial dose covered.
Corticosteroid intravitreal implants (Ozurdex, Iluvien): For macular edema following branch/central RVO (Ozurdex only) and DME (Ozurdex or Iluvien): intravitreal bevacizumab solution is the step therapy agent.
Corticotropin (Acthar Gel): All indications except infantile spasms require trial of other specified agents; for MS, corticosteroid trial required.
Daratumumab (Darzalex/Darzalex Faspro): Multiple myeloma requires 1 systemic therapy if used in specified combinations OR 3 lines if monotherapy, with exceptions for transplant eligibility and specific combinations; systemic light chain amyloidosis requires 1 systemic therapy.
(some single-agent exceptions)

Approval Criteria for New Starts

Approval Criteria (New Starts Only)

Member has not received the drug for the past 365 days

New start lookback: Member has not received the requested drug in the past 365 days365 days
Step requirement: Requested drug has met the specific step requirements listed under the drug & indication (see per-agent entries below)
Refer to Per-agent Step Therapy Requirements

Policy Reference and Codes

Policy Reference Numbermixed

MCPB.ST.OO

Internal reference number for Fidelis Care Clinical Policy: Step Therapy

Action Required / Provider Impact

Prior Authorization

Prior Authorization May Be Required

Many listed Part B agents may require prior authorization; reviewers must confirm that step therapy requirements (preferred agent trials or documented exceptions) are met and member has not received the requested agent within the past 365 days.

Documentation Required

Document Step Failures or Ineligibility

Providers must document prior trials of preferred agents (including agent names and dates), reasons for inability to use preferred agents (e.g., intolerance, contraindication), and any exception criteria met (e.g., transplant eligibility, PD-L1 thresholds, stage-specific exceptions).

Agent names and dates of prior trials
Reason unable to use preferred agents (e.g., intolerance, contraindication)
Exception criteria met (e.g., transplant eligibility, PD-L1 thresholds, stage-specific exceptions)

Billing Rule

Initial Dose Coverage Limits

For several cell and gene therapies (e.g., CAR-T products and certain autologous therapies), only the initial treatment dose is covered; subsequent doses will not be covered.

Definitions

Part B Required Step-Through Agents: agents for which the plan requires a trial of a preferred therapeutic alternative (the specified preferred agent[s]) prior to coverage of the requested non-preferred agent for the listed indication(s).

Document Changes

2021-01-01effective_date

Policy effective date as stated in source: Effective Date: 01.01.21.

2025-06-25last_reviewLatest

Policy last review date as stated in source: Last Review Date: 06.25 (2025).

change_clarified

Clarified: Document lists many individual Part B agents with indication-specific step requirements and exceptions; notes some IV chemotherapy may not require prior authorization. (Non-material change.)