CurrentIndependent HealthPolicy N/A

Step therapy criteria for Medicare Part B drugs

Defines step therapy (prior drug trial) requirements for Medicare Part B drugs associated with Independent Health Medicare Advantage plans for 2025; applies to prescribers and prior authorization reviewers for those plans.

Policy Summary

PayerIndependent Health

PolicyStep therapy criteria for Medicare Part B drugs

Policy CodePolicy N/A

Change TypeMinor/No material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain and document prior trial and inadequate response, intolerance, or contraindication to the specified preferred alternative (e.g., bevacizumab for ophthalmic agents) when requesting approval for a Part B drug new start.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2025Effective year

New startsMost rules apply to

20+Products listed

MultipleBiosimilar references

Coverage Criteria — Initial Therapy Rules

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.

inv-01: Ophthalmic agents (EYLEA, BEOVU) initial therapy

Covered when ALL of the following are met for specified ophthalmic and related indications:

ALL of the following

indication: Diagnosis of neovascular (wet) age-related macular degeneration, diabetic macular edema, or diabetic retinopathy in patients with diabetic macular edema
applies where specified
prior_trial: Patient must have tried and failed to have an adequate response to bevacizumab (Avastin)
This specific requirement applies to new starts only.

ALL of the following

indication: Diagnosis of neovascular (wet) age-related macular degeneration or diabetic macular edema for Beovu
applies where specified
prior_trial: Patient must have tried and failed to have an adequate response to bevacizumab (Avastin)
This specific requirement applies to new starts only and does not apply to off-label indications not shared with bevacizumab.

inv-02: Bendamustine products initial therapy

Oncology bendamustine products covered when ALL of the following are met:

ALL of the following

indication: Oncology (cancer) indication shared with Treanda
applies where specified
prior_trial: Patient must have tried and failed to have an adequate response to Treanda (J9033), unless contraindicated or not tolerated
This specific requirement applies to new starts only and does not apply to patients using the listed products for indications not shared with Treanda.

inv-03: Bevacizumab-class oncology products initial therapy

Bevacizumab oncology interchangeability requirement for certain agents:

ALL of the following

indication: Oncology (cancer) indication for Alymsys, Avastin, or Vegzelma
applies where specified
prior_trial: Patient must have tried and failed to have an adequate response to Mvasi or Zirabev
This specific requirement applies to new starts only; does not apply to ophthalmic Avastin uses or indications not shared with Mvasi/Zirabev.

inv-04: Miscellaneous product-specific initial therapy

Other product-specific prior trial requirements for approval:

ALL of the following

prior_trial: For Amvuttra approval, patient must have tried and failed to have an adequate response to Onpattro
Applies to new starts only.

ALL of the following

prior_trial: For Aphexda approval, patient must have tried and failed to have an adequate response to plerixafor
Applies to new starts only.

ALL of the following

prior_trial_or_contraindication: For Apretude approval, patient must have tried and had an intolerance to or has a contraindication to emtricitabine/tenofovir disoproxil fumarate
Applies where specified.

ALL of the following

prior_trial: For Asceniv approval, patient must have tried and failed to have a response to another IVIG product
Applies to new starts only and does not apply to indications not shared with preferred IVIG products.

ALL of the following

prior_trial: For Daxxfy/Dysport approval, patient must have tried and failed to have an adequate response to Botox and Xeomin
Applies to new starts only.

inv-05: Myobloc (various presentations) - Initial approval

For approval when starting Myobloc

Myobloc prior requirement: Patient must have tried and failed to have an adequate response to Botox or Xeomin.new starts only

applies to Myobloc solution presentations listed

inv-06: Camcevi - Initial approval

For approval when starting Camcevi

Camcevi prior requirement: Patient must have tried and failed to have an adequate response to Ocrevus.new starts only

applies to CAMCEVI prefilled syringe 42 mg subcutaneous

inv-07: GnRH analogs - Initial approval

For approval when starting the listed gonadotropin-releasing hormone analog product

Eligard/Lupron prior requirement: Patient must have tried and failed to have an adequate response to either Eligard or Lupron.new starts only

applies to the product(s) listed in the chunk

inv-08: Prolia / Xgeva - Initial approval

For approval when starting Prolia or Xgeva

Prolia prior requirement: Patient must have tried and failed to have an adequate response to Jubbonti.new starts only

applies to Prolia prefilled syringe 60 mg/mL subcutaneous

Xgeva prior requirement: Patient must have tried and failed to have an adequate response to Wyost.new starts only

applies to Xgeva solution 120 mg/1.7 mL subcutaneous

inv-09: Docivyx / Beizray - Initial approval

For approval when starting Docivyx or Beizray

Docetaxel prior requirement: Patient must have tried and failed to have an adequate response to docetaxel (J9171).new starts only

applies to Docivyx (J9172) and Beizray (J9174)

inv-10: Enjaymo - Initial approval

For approval when starting Enjaymo

Rituximab or B-cell therapy prior requirement: Patient must have tried and failed to have an adequate response to Ruxience (or another rituximab product) or any other B-cell targeting therapy.new starts only

applies to ENJAYMO solution 1100 mg/22 mL intravenous

inv-11: Epogen / Procrit - Initial approval (overlapping indications)

For approval when starting Epogen or Procrit where indications overlap with Retacrit

Retacrit prior requirement: Patient must have tried and failed to have an adequate response to Retacrit.new starts only

Does not apply to patients using Epogen or Procrit for any indication not shared with Retacrit

inv-12: Evkeeza - Initial approval

For approval when starting Evkeeza

Statin and PCSK9 prior requirement: Patient must have tried and failed to have an adequate response to or have a contraindication to both a maximally-tolerated dose of a statin drug and a PCSK9 inhibitor.new starts only

applies to EVKEEZA solution 345 MG/2.3ML INTRAVENOUS

inv-13: Feiba - Initial approval

For approval when starting Feiba

Hemlibra prior requirement: Patient must have tried and failed to have an adequate response to Hemlibra.new starts only

Does not apply to treatment of hemophilia B; applies to FEIBA presentations listed

inv-14: Granix / Neupogen / Nivestym etc. - Initial approval

For approval when starting preferred colony-stimulating factor agents

Zarxio prior requirement: Patient must have tried and failed to have an adequate response to Zarxio.new starts only

Does not apply to patients using a non-preferred agent for any indication not shared with Zarxio; applies to Granix, Neupogen, Nivestym, Nypozi, Releuko presentations listed

inv-15: Granix/Neupogen/Nivestym/Nypozi/Releuko - Initial

Covered when ALL of the following are met (for listed filgrastim products):

Filgrastim biosimilars initial therapy: Patient is a new start AND has tried and failed to have an adequate response to Zarxio

applies to Granix, Neupogen, Nivestym, Nypozi, Releuko per chunk 37

inv-16: ILUMYA - Initial

Covered when ALL of the following are met (for ILUMYA):

ILUMYA initial therapy: Patient has tried and failed or is intolerant to formulary-preferred IL-17 inhibitor (Cosentyx) AND tried and failed or intolerant to at least one of: generic infliximab/Remicade OR one other on-formulary biologic agent listed

Enumerated alternatives include adalimumab biosimilars, Enbrel, Humira, Skyrizi, ustekinumab biosimilars per chunk 40

inv-17: IMJUDO - Indication-specific requirements

Covered when ALL of the following are met (for IMJUDO by indication):

IMJUDO for hepatocellular carcinoma: Patient has tried and failed or is intolerant/contraindicated to Avastin or Avastin-containing regimens

per chunk 42

IMJUDO for non-small cell lung cancer: Patient has tried and failed or is intolerant/contraindicated to regimens containing Keytruda or Tecentriq

per chunk 42

inv-18: Infliximab biosimilars - Initial

Covered when ALL of the following are met (for infliximab biosimilars):

Avsola/Inflectra/Renflexis initial therapy: Patient is a new start AND has tried and failed to have an adequate response to generic infliximab or Remicade

Does not apply to indications not shared with generic infliximab/Remicade per chunk 44

inv-19: Paliperidone palmitate - Initial

Covered when ALL of the following are met (for long-acting paliperidone injectable products):

Invega Hafyera initial therapy: Documentation of at least 4 months' treatment with 1-month paliperidone palmitate ER injectable OR at least one 3-month injection4 months or one 3-month injection

applies to new starts only per chunk 46

Invega Trinza initial therapy: Documentation of at least 4 months' treatment with 1-month paliperidone palmitate ER injectable suspension4 months

applies to new starts only per chunk 48

inv-20: Khapzory - Initial

Covered when ALL of the following are met (for Khapzory):

Khapzory initial therapy: Patient has tried and failed to have an adequate response to generic leucovorin

new starts only per chunk 50

inv-21: Adynovate/Eloctate/Esperoct - Initial

Covered when ALL of the following are met (for factor VIII products listed):

Adynovate/Eloctate/Esperoct initial therapy: Patient has tried and failed to have an adequate response to Jivi

applies to new starts only per chunk 52

inv-22: Opdualag - Initial

Covered when ALL of the following are met (for Opdualag-equivalent therapy):

Opdualag requirement: Patient has tried and failed to have an adequate response to Opdivo plus Yervoy OR has a contraindication to Yervoy

applies to new starts only per chunk 55

inv-23: Opdualag initial therapy

Opdualag

Opdualag new start requirement: For approval the patient must have tried and failed to have an adequate response to Opdivo plus Yervoy OR have a documented contraindication to Yervoynew starts only

applies only to new therapy initiations

inv-24: Abraxane initial therapy

Abraxane

Abraxane non-pancreatic/shared-indication requirement: For approval for any indication other than pancreatic cancer or small bowel carcinoma, patient must have tried and failed to have an adequate response to generic paclitaxelnew starts only; does not apply when indication not shared with generic paclitaxel

applies only to new therapy initiations

inv-25: Pegfilgrastim initial therapy

Non-preferred pegfilgrastim products

Pegfilgrastim step requirement: For approval of listed non-preferred pegfilgrastim products, patient must have tried and failed to have an adequate response to Udenycanew starts only; exception when indication not shared with preferred product

applies only to new therapy initiations

inv-26: Pemetrexed initial therapy

Axtle / Pemfexy / Pemrydi

Pemetrexed prior agent requirement: For approval the patient must have tried and failed to have an adequate response to one of the listed pemetrexed drugs (J9294, J9296, J9297, J9305, J9314, J9322, J9323) unless contraindicated or not toleratednew starts only; does not apply when indication not shared with preferred agents

applies only to new therapy initiations

inv-27: Intravitreal agent step therapy — Byooviz / Lucentis / Susvimo

Byooviz / Lucentis / Susvimo (intravitreal agents)

Byooviz requirement: For Byooviz approval for neovascular AMD, macular edema post-RVO, or myopic CNV, patient must have tried and failed bevacizumab (Avastin)new starts only

Step therapy: Byooviz = bevacizumab failure

Lucentis or Susvimo requirement: For Lucentis or Susvimo for shared indications, patient must have tried and failed both (Step 1) bevacizumab and (Step 2) one of Byooviz, aflibercept (Eylea/Eylea HD), brolucizumab (Beovu), or faricimab (Vabysmo)new starts only

two-step requirement

inv-28: Rituximab initial therapy

Rituximab products

Rituximab biosimilar preference: For approval of Rituxan, Rituxan Hycela, or Truxima, patient must have tried and failed to have an adequate response to Riabni or Ruxiencenew starts only; does not apply when indication not shared

applies only to new therapy initiations

inv-29: Rystiggo initial therapy

Rystiggo (generalized myasthenia gravis, anti-AChR+)

Rystiggo requirement for anti-AChR+ gMG: For anti-AChR antibody-positive generalized myasthenia gravis, patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to Vyvgart or Vyvgart Hytrulonew starts only

applies only to new therapy initiations

inv-30: Soliris initial therapy

Soliris

Soliris NMOSD requirement: For NMOSD, patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to Enspryng AND either Uplizna or rituximabnew starts only

applies only to new therapy initiations

Soliris gMG requirement: For generalized myasthenia gravis, patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to Vyvgart or Vyvgart Hytrulonew starts only

applies only to new therapy initiations

inv-31: Spinraza initial therapy

Spinraza

Spinraza requirement: For approval, patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to Evrysdinew starts only

applies only to new therapy initiations

inv-32: Spinraza — Initial Therapy

Covered when ALL of the following are met for new starts:

Spinraza initial approval: Patient tried and failed to have an adequate response to, or had an intolerance to, or had a contraindication to Evrysdi.new starts only

applies to SPINRAZA SOLUTION 12 MG/5ML INTRATHECAL

inv-33: Tezspire — Initial Therapy

Covered when ANY of the following are met for new starts:

Tezspire initial approval: (1) Patient tried and failed, was intolerant to, or had a contraindication to dupilumab plus one other biologic for severe asthma (IL-5 antagonist, IL-5 receptor antagonist, or omalizumab) OR (2) patient has an eosinophil count below that required to use these other medications.new starts only

applies to TEZSPIRE SOLUTION PREFILLED SYRINGE 210 MG/1.91ML SUBCUTANEOUS

inv-34: Actemra/Tofidence — Initial Therapy

Covered when ALL of the following are met for new starts:

Actemra/Tofidence initial approval: Patient tried and failed to have an adequate response to Tyenne.new starts only

Does not apply to patients using these agents for indications not shared with Tyenne.

inv-35: Herceptin/Herceptin Hylecta/Herc. etc. — Initial Therapy

Covered when ALL of the following are met for new starts:

Trastuzumab-class initial approval: Patient tried and failed to have an adequate response to Kanjinti or Trazimera.new starts only

Does not apply to patients using a trastuzumab agent for any indication not shared by Kanjinti or Trazimera.

inv-36: Ultomiris — Initial Therapy (generalized myasthenia gravis)

Covered when ALL of the following are met for new starts (gMG indication):

Ultomiris (gMG) initial approval: Patient tried and failed to have an adequate response to or had an intolerance to or contraindication to Vyvgart or Vyvgart Hytrulo.new starts only

applies to ULTOMIRIS SOLUTION 1100 MG/11ML INTRAVENOUS and 300 MG/3ML formulations

inv-37: Stelara — Initial Therapy

Covered when ALL of the following are met for new starts:

Stelara initial approval: Patient tried and failed to have an adequate response to Selarsdi or Yesintek.new starts only

applies to STELARA SOLUTION 130 MG/26ML INTRAVENOUS

inv-38: Vabysmo — Initial Therapy

Covered when ALL of the following are met for new starts (ophthalmology indications):

Vabysmo initial approval: For neovascular age-related macular degeneration or diabetic macular edema, patient tried and failed to have an adequate response to bevacizumab (Avastin).new starts only

applies to VABYSMO SOLUTION 6 MG/0.05ML INTRAVITREAL

inv-39: Viscosupplements — Initial Therapy

Covered when ALL of the following are met for new starts (viscosupplement products):

Non-preferred viscosupplement initial approval: Patient tried and failed to have an adequate response to or had an intolerance to both preferred agents (Euflexxa and Synvisc-One).new starts only

All viscosupplements require medical prior authorization and are billed through Medicare Part B; requirement does not apply to indications not shared with preferred agents.

inv-40: Vyepti — Initial Therapy

Covered when ALL of the following are met for new starts (migraine prevention):

Vyepti initial approval: Patient tried and failed to have an adequate response to any two oral agents used to prevent/reduce frequency of migraines AND had prior use of one injectable CGRP antagonist or receptor antagonist.new starts only

applies to VYEPTI SOLUTION 100 MG/ML INTRAVENOUS

inv-41: Vyvgart Hytrulo — Initial Therapy

Covered when ALL of the following are met for new starts (Vyvgart Hytrulo):

Vyvgart Hytrulo initial approval: Patient failed to respond to therapy with at least two of: acetylcholinesterase inhibitors, corticosteroids, nonsteroidal immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine).new starts only

applies to VYVGART HYTRULO products listed

inv-42: VYVGART HYTRULO Initial Therapy

Covered when ALL of the following are met for new starts of VYVGART HYTRULO:

VYVGART HYTRULO new-start criteria: Patient has failed to respond to therapy with at least two of the following drug groups: acetylcholinesterase inhibitors; corticosteroids; nonsteroidal immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine).at least 2 groups

This requirement applies to new starts only.

inv-43: ZILRETTA Initial Therapy

Covered when ALL of the following are met for new starts of ZILRETTA:

ZILRETTA new-start criteria: Patient has tried and failed to have an adequate response to at least one other injectable corticosteroid.at least 1 injectable corticosteroid

This requirement applies to new starts only.

The policy’s bevacizumab (Avastin) oncology step requirement for certain bevacizumab-brand products does not apply when Avastin is being used for ophthalmic (eye) indications. For oncology uses, trial and inadequate response to Mvasi or Zirabev remains the required prior step for Alymsys, Avastin, or Vegzelma on new starts, but Avastin’s ophthalmic use is explicitly exempted from that interchangeability requirement.

For bendamustine products subject to a Treanda (J9033) prior-trial requirement, the step-therapy rule does not apply when the member is using the listed bendamustine products for an indication that is not shared with Treanda. The Treanda trial requirement otherwise applies to new starts only and allows exceptions for contraindication or intolerance.

The Retacrit-to-Epogen/Procrit step requirement applies to overlapping indications on new starts, but does not apply when Epogen or Procrit is being used for any indication not shared with Retacrit. Documentation of a Retacrit trial is required for new-start coverage when indications overlap.

The Feiba prior-trial requirement (trial and inadequate response to Hemlibra) applies to new starts except where noted; it does not apply when Feiba is used for treatment of hemophilia B. Reviewers should not require Hemlibra trial documentation for hemophilia B indications.

For filgrastim/colony-stimulating factor products, the Zarxio prior-trial requirement applies to new starts when indications overlap. However, the policy states that the Zarxio requirement does not apply when a non-preferred agent is used for an indication not shared with Zarxio.

Across multiple step-therapy entries, the policy consistently exempts step requirements when the non-preferred agent is being used for an indication that is not shared with the preferred agent. In other words, step requirements (trial of the preferred agent) apply to new starts for shared indications but do not apply when the requested agent’s indication differs from the preferred agent’s labeled uses.

Abraxane’s step requirement for trial of generic paclitaxel applies only when the indication is shared; the policy explicitly states the Abraxane paclitaxel trial does not apply to pancreatic cancer or small bowel carcinoma and does not apply when the patient’s indication is not shared with generic paclitaxel.

Non-preferred pegfilgrastim products require prior trial and inadequate response to Udenyca for shared indications on new starts. The policy clarifies that this step requirement does not apply when the non-preferred pegfilgrastim product is being used for an indication not shared with Udenyca.

Axtle, Pemfexy, and Pemrydi (non-preferred pemetrexed products) require prior trial of one of the listed pemetrexed J-code agents for shared indications on new starts. The pemetrexed prior-agent requirement does not apply when the patient’s indication is not shared with the preferred pemetrexed agents or when contraindication/intolerance is documented.

For rituximab products (Rituxan, Rituxan Hycela, Truxima), the policy requires trial and inadequate response to preferred rituximab biosimilars (Riabni or Ruxience) for shared indications on new starts. The requirement does not apply when the requested rituximab agent is being used for an indication not shared with Riabni or Ruxience.

Several step-therapy rules across the policy include the same caveat: step requirements apply to new starts for indications shared with a formulary-preferred agent, but they do not apply when the non-preferred agent is prescribed for an indication that is not shared with the preferred agent. Examples include filgrastim biosimilars (Zarxio), infliximab biosimilars (generic infliximab/Remicade), tocilizumab agents (Tyenne), trastuzumab agents (Kanjinti/Trazimera), and non-preferred viscosupplements (Euflexxa/Synvisc-One).

The bendamustine HCPCS codes listed in the coding section (e.g., J9033 for Treanda and J9036/J9034/J9056 for the listed bendamustine products) are referenced here for cross‑reference. The prior-trial requirement for Treanda (J9033) is the applicable step when the indication is shared; see the CODING table for the exact HCPCS codes.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization and Step Therapy Requirement

Prior authorization is required for many Part B drugs when a step-therapy requirement applies. For new-start requests, providers must document prior trial and inadequate response, intolerance, or contraindication to the specified preferred or lower-cost agent(s) listed for each product. Failure to provide required documentation may result in denial.

Applies to new starts unless otherwise noted.
Documentation must include agent tried, dates of therapy, and rationale for inadequacy/intolerance/contraindication.

Step Therapy

VYVGART HYTRULO Prior Authorization and Step Therapy

VYVGART HYTRULO (and Vyvgart-class requirements) — Prior authorization for new starts requires documented failure, intolerance, or contraindication to at least two conservative therapies (e.g., acetylcholinesterase inhibitors, corticosteroids, or listed nonsteroidal immunosuppressants). Providers must show prior trials and inadequate response as described for step-therapy drugs.

Document trials of at least two of: acetylcholinesterase inhibitors, corticosteroids, nonsteroidal immunosuppressants (methotrexate, azathioprine, mycophenolate, cyclosporine).
Applies to new starts only.

Step Therapy

ZILRETTA Prior Authorization and Step Requirement

ZILRETTA prior authorization — Prior authorization for new-start ZILRETTA requires documentation of a prior trial and inadequate response to at least one other injectable corticosteroid.

Document agent, dates, and reason for inadequate response or intolerance.
Applies to new starts only.

Step Therapy

Ophthalmic Agents Prior Trial Requirements

Ophthalmic anti‑VEGF and related intravitreal agents — Prior authorization for many intravitreal therapies requires failure of bevacizumab (Avastin) as the first‑line step for neovascular (wet) AMD, diabetic macular edema, and certain other retinal indications. Some agents require additional sequential steps.

Byooviz, Beovu, Vabysmo, Eylea/Beovu indications: new starts must show inadequate response to bevacizumab (Avastin).
Lucentis and Susvimo (shared indications): Step 1 = bevacizumab failure; Step 2 = failure of one of Byooviz, aflibercept (Eylea), brolucizumab (Beovu), or faricimab (Vabysmo).
Ophthalmic bevacizumab oncology/other-use exceptions: Avastin ophthalmic vs systemic distinctions noted in product entries.

Prior Authorization

Bendamustine Prior Trial Requirement

Bendamustine prior trial requirement — For Belrapzo (bendamustine Apotex/Baxter), Bendeka, or Vivimusta, prior authorization for new starts requires documented prior trial and inadequate response, intolerance, or contraindication to Treanda (bendamustine J9033) when indications overlap.

Does not apply when the requested product is used for an indication not shared with Treanda.
Apply to new starts only.

Prior Authorization

MYOBLOC Prior Trial Requirement

Myobloc prior trial required — For Myobloc new starts, prior authorization requires documented prior trial and inadequate response to Botox or Xeomin.

Document prior agents, treatment dates, and response.
Applies to new starts only.

Prior Authorization

Camcevi Prior Trial Requirement

Camcevi prior trial required — (If Camcevi appears in product list) Prior authorization requires evidence of trial and inadequate response to the specified preferred antecedent therapy per the product entry. Document prior agent(s) and reason for failure.

Follow product-specific criteria where listed.
Applies to new starts only.

Prior Authorization

Eligard / Lupron Prior Trial Requirement

Eligard / Lupron prior trial required — For specified products that share indications, prior authorization for new starts requires trial and inadequate response to either Eligard or Lupron as listed in the product-specific criteria.

Applies to new starts only.
Document agent trial and reason for failure.

Prior Authorization

Prolia / Xgeva Prior Trial Requirement

Prolia / Xgeva prior trial required — For requests overlapping with Prolia or Xgeva indications, prior authorization for new starts requires documented prior trial and inadequate response to the listed preferred agents (Jubbonti for Prolia; Wyost for Xgeva).

Applies to new starts only.
Document prior therapy and reason for failure.

Prior Authorization

Docetaxel Prior Trial Requirement

Docetaxel prior trial required — For Docivyx or Beizray new starts, prior authorization requires documented prior trial and inadequate response to docetaxel (J9171) when indications overlap.

Applies to new starts only.
Document prior docetaxel regimen and outcome.

Prior Authorization

Rituximab / B‑cell Therapy Prior Trial Requirement

Rituximab / B‑cell therapy prior trial required — For rituximab-class agents and other B‑cell targeted therapies, prior authorization for new starts requires documented failure, intolerance, or contraindication to Riabni, Ruxience, or another rituximab product (or equivalent B‑cell targeted therapy) per product entry.

Rituximab biosimilars (Avsola, Inflectra, Renflexis): require prior trial and inadequate response to generic infliximab or Remicade for new starts where indications overlap.
Document prior biologic, dates, and rationale for failure.

Prior Authorization

Retacrit Prior Trial Requirement

Retacrit prior trial required — For certain erythropoiesis-stimulating agents, prior authorization for new starts requires documented prior trial and inadequate response to Retacrit when indications overlap.

Does not apply to indications not shared with Retacrit.
Applies to new starts only.

Prior Authorization

Statin and PCSK9 Prior Therapy Requirement

Statin and PCSK9 prior therapy required — For Evkeeza new starts, prior authorization requires documented trial and inadequate response to a maximally tolerated statin AND a PCSK9 inhibitor, or documented contraindication to those agents.

Document statin at maximally tolerated dose and PCSK9 inhibitor trial and outcomes.
Applies to new starts only.

Prior Authorization

Hemlibra Prior Trial Requirement

Hemlibra prior trial required — For FEIBA new starts, prior authorization requires documented prior trial and inadequate response to Hemlibra when treating relevant indications (excludes hemophilia B).

Document prior Hemlibra therapy and reasons for inadequate response.
Applies to new starts only.

Step Therapy

Zarxio / Preferred Filgrastim and Pegfilgrastim Step Requirements

Zarxio trial requirement for filgrastim/pegfilgrastim products — For certain filgrastim products (Granix, Neupogen, Nivestym, Nypozi, Releuko) and for non‑preferred pegfilgrastim products, prior authorization for new starts requires documented trial and inadequate response to Zarxio (filgrastim) or to Udenyca (preferred pegfilgrastim), respectively.

Applies to new starts only and does not apply when indication is not shared with the preferred agent.
Document dates and inadequate response/intolerance.

Step Therapy

ILUMYA Prior Trial Requirement

ILUMYA prior trial requirement — Prior authorization for ILUMYA new starts requires documented trial and inadequate response or intolerance/contraindication to the formulary-preferred IL-17 inhibitor (Cosentyx) and one additional listed on‑formulary biologic or infliximab agent for psoriasis.

Document trials, dates, and reasons for failure or intolerance.
Applies to new starts only.

Prior Authorization

IMJUDO Prior Regimen Requirement

IMJUDO prior regimen requirement — For IMJUDO new starts, prior authorization requires documented trial and inadequate response or intolerance/contraindication to specified regimens: for hepatocellular carcinoma, Avastin or Avastin-containing regimens; for non–small cell lung cancer, regimens containing Keytruda or Tecentriq.

Document prior regimen(s), dates, and rationale for failure or intolerance.
Applies to new starts only.

Prior Authorization

Infliximab Biosimilars Prior Trial Requirement

Infliximab biosimilars preferred‑first requirement — For Avsola, Inflectra, or Renflexis new starts, prior authorization requires documented trial and inadequate response to generic infliximab or Remicade when indications overlap.

Does not apply when the requested infliximab biosimilar is used for indications not shared with Remicade/generic infliximab.
Applies to new starts only.

Step Therapy

ABRAXANE Prior Trial Requirement

Abraxane step requirement — For Abraxane new starts (except pancreatic cancer or small bowel carcinoma), prior authorization requires documented prior trial and inadequate response to generic paclitaxel when indications overlap.

Does not apply to indications not shared with paclitaxel.
Applies to new starts only.

Step Therapy

Pemetrexed Prior Trial Requirement

Pemetrexed step requirement — For Axtle, Pemfexy, or Pemrydi new starts, prior authorization requires documented prior trial and inadequate response to a listed pemetrexed agent (specific J‑codes) when indications overlap.

Document which pemetrexed J‑code was tried and dates of therapy.
Applies to new starts only.

Step Therapy

Ophthalmologic Anti‑VEGF Step Requirements

Ophthalmologic anti‑VEGF step requirements (consolidated) — For Byooviz, Beovu, Eylea, Vabysmo, Lucentis, and Susvimo, prior authorization for new starts requires documented prior trial and inadequate response to bevacizumab (Avastin). Where specified, additional step(s) are required (see Lucentis/Susvimo sequential step 1 and step 2).

Byooviz, Beovu, Vabysmo, Eylea: require Avastin failure as first step for shared retinal indications.
Lucentis/Susvimo: require Avastin failure (Step 1) and failure of Byooviz/aflibercept/Beovu/Vabysmo (Step 2) for shared indications.
Document prior agent(s), dates, and response; applies to new starts only.

Step Therapy

Rituximab / Infliximab Biosimilar Step Requirements

Rituximab biosimilar step requirement — For Avsola, Inflectra, or Renflexis and for rituximab agents, prior authorization for new starts requires documented trial and inadequate response to the preferred reference agent(s) (e.g., Riabni, Ruxience, Remicade/generic infliximab where applicable) when indications overlap.

Document prior biosimilar or reference biologic trials and outcomes.
Applies to new starts only.

Prior Authorization

RYSTIGGO Prior Trial Requirement

Rystiggo and related myasthenia gravis agents — Prior authorization for Rystiggo new starts in anti‑AChR antibody–positive generalized myasthenia gravis requires documented failure, intolerance, or contraindication to Vyvgart or Vyvgart Hytrulo. Document prior trials and outcomes.

Applies to new starts only.
Include dates and clinical rationale for switching.

Prior Authorization

SOLIRIS Prior Trial Requirement (NMOSD)

Soliris prior trial requirement (NMOSD) — For Soliris in neuromyelitis optica spectrum disorder, prior authorization for new starts requires documented failure, intolerance, or contraindication to Enspryng and either Uplizna or rituximab; include renal function and diagnostic criteria as required.

Applies to new starts only.
Provide diagnostic documentation and prior biologic trial details.

Step Therapy

SPINRAZA Prior Trial Requirement

Spinraza prior trial requirement — For Spinraza new starts, prior authorization requires documented trial and inadequate response, intolerance, or contraindication to Evrysdi.

Applies to new starts only.
Document prior Evrysdi therapy, dates, and reason for failure/intolerance.

Step Therapy

TEZSPIRE Prior Biologic Requirement

Tezspire prior biologic requirement — For Tezspire new starts in severe asthma, prior authorization requires documented prior trial and inadequate response or intolerance/contraindication to dupilumab plus one other biologic (IL‑5 antagonist, IL‑5 receptor antagonist, or omalizumab), or documentation of eosinophil criteria that meet alternative pathway.

Document prior biologic agents, dates, and outcomes, or provide eosinophil count per criteria.
Applies to new starts only.

Step Therapy

ACTEMRA / TOFIDENCE Prior Trial Requirement

Actemra / Tofidence prior agent requirement — For Actemra or Tofidence new starts, prior authorization requires documented trial and inadequate response to Tyenne when indications overlap.

Does not apply when indication is not shared with Tyenne.
Applies to new starts only; document prior trial and outcome.

Step Therapy

Trastuzumab‑Class Prior Biosimilar Requirement

Trastuzumab‑class prior biosimilar requirement — For trastuzumab agents (Herceptin and biosimilars), prior authorization for new starts requires documented trial and inadequate response to preferred biosimilars (Kanjinti or Trazimera) when indications overlap.

Does not apply when indication is not shared with Kanjinti or Trazimera.
Document prior biosimilar trial and rationale for switching.

Step Therapy

VABYSMO Prior Avastin Requirement

Vabysmo prior Avastin requirement — For Vabysmo new starts in nAMD or DME, prior authorization requires documented failure to respond to bevacizumab (Avastin).

Document Avastin trial and reason for inadequate response.
Applies to new starts only.

Billing Rule

Viscosupplement Prior Authorization and Preferred‑Agent Requirement

Viscosupplement preferred‑agent requirement and billing — For viscosupplements other than Euflexxa or Synvisc‑One, prior authorization for new starts requires documented failure or intolerance to both preferred agents (Euflexxa and Synvisc‑One). All viscosupplements require medical prior authorization and must be billed through Medicare Part B.

Document prior trials of Euflexxa and Synvisc‑One and outcomes.
Applies to new starts only; devices billed to Medicare Part B.

Step Therapy

VYEPTI Prior Therapy Requirement

Vyepti prior therapy requirement — For Vyepti new starts, prior authorization requires documented failure of any two oral migraine preventive agents and prior use of one injectable CGRP antagonist/receptor agent.

Document the two oral preventive agents tried and the injectable CGRP agent used and outcomes.
Applies to new starts only.

Step Therapy

ULTOMIRIS Step Therapy Requirement

Ultomiris / Vyvgart class step therapy — For Ultomiris new starts in generalized myasthenia gravis, prior authorization requires documented failure, intolerance, or contraindication to Vyvgart or Vyvgart Hytrulo. For other related biologic step‑therapy requirements, follow the product‑specific entries.

Document prior Vyvgart or Vyvgart Hytrulo therapy and outcomes.
Applies to new starts only.

Documentation Required

Paliperidone Palmitate Documentation Requirement

Paliperidone palmitate documentation for Trinza — For Invega Trinza approval, prior authorization requires documentation of at least 4 months' treatment with 1‑month paliperidone palmitate extended‑release injectable suspension (or at least one 3‑month injection for Hafyera criteria).

Document dates and dosing of prior paliperidone palmitate injections.
Applies to new starts only.

Relevant HCPCS / J-Codes

Bendamustine HCPCS CodesHCPCS

J9033	Treanda
J9036	Belrapzo/bendamustine Apotex/Baxter (as listed)
J9034	Bendeka
J9056	Vivimusta

Docivyx / Beizray / Docetaxel HCPCS CodesHCPCS

J9172	Docivyx solution 160 mg/16 mL intravenous
J9174	Beizray solution 20 mg/2 mL
J9171	Docetaxel

Epoetin products and biosimilarsmixed

Retacrit (epoetin biosimilar)

Pemetrexed and related J-codesHCPCS

J9292	AXTLE solution reconstituted 100 mg intravenous
J9304	PEMFEXY solution 500 mg/20 mL
J9324	PEMRYDI RTU solution 100 mg/10 mL or 500 mg/50 mL
J9294	pemetrexed (preferred agent) J-code
J9296	pemetrexed (preferred agent) J-code
J9297	pemetrexed (preferred agent) J-code
J9305	pemetrexed (preferred agent) J-code
J9314	pemetrexed (preferred agent) J-code
J9322	pemetrexed (preferred agent) J-code
J9323	pemetrexed (preferred agent) J-code

Step Therapy — Required Antecedent Trials

Product / Drug Group	Required prior trial(s) for new starts	Notes / Exceptions
Ophthalmic anti-VEGF agents (EYLEA, BEOVU, Byooviz, Vabysmo)
Documented trial and inadequate response to bevacizumab (Avastin)
Applies to specified retinal indications; requirement applies to new starts only; oncology bevacizumab interchangeability rules do not apply to ophthalmic Avastin uses

Product / Drug	Required prior trial(s) for new starts	Notes / Exceptions
MYOBLOC (all listed presentations)
Prior trial and inadequate response to Botox or Xeomin
Requirement applies to new starts only; documentation of prior use and inadequate response required

Product / Drug	Required prior trial(s) for new starts	Notes / Exceptions
CAMCEVI (prefilled syringe 42 mg)
Prior trial and inadequate response to Ocrevus
Requirement applies to new starts only; failure to document prior Ocrevus use may result in denial

Product / Drug Group	Required prior trial(s) for new starts	Notes / Exceptions
GnRH analogs (listed products)
Prior trial and inadequate response to Eligard or Lupron
Applies to new starts only; failure to document prior trial may trigger denial

Product	Required prior trial(s) for new starts	Notes / Exceptions
AMVUTTRA
Prior trial and inadequate response to Onpattro
Applies to new starts only
APHEXDA
Prior trial and inadequate response to plerixafor
Applies to new starts only
ASCENIV
Prior trial and inadequate response to another IVIG product
Applies to new starts only; does not apply when indication not shared with preferred IVIG products
PROLIA / XGEVA
Prior trial and inadequate response to Jubbonti (Prolia) or Wyost (Xgeva)
Applies to new starts only

Product	Required prior trial(s) for new starts	Notes / Exceptions
DOCIVYX (J9172) / BEIZRAY (J9174)
Prior trial and inadequate response to docetaxel (J9171)
Applies to new starts only; failure to document prior docetaxel may trigger denial

Product	Required prior trial(s) for new starts	Notes / Exceptions
ENJAYMO (1100 mg/22 mL IV)
Prior trial and inadequate response to Ruxience or another rituximab product or other B-cell–targeting therapy
Applies to new starts only; documentation required or request may be denied

Product	Required prior trial(s) for new starts	Notes / Exceptions
EPOGEN / PROCRIT
Prior trial and inadequate response to Retacrit
Applies to new starts only for indications that overlap with Retacrit; does not apply when indication is not shared

Product	Required prior trial(s) for new starts	Notes / Exceptions
EVKEEZA (evolocumab-class alternative)
Documented trial and inadequate response to a maximally tolerated statin AND a PCSK9 inhibitor (or documented contraindication to both)
Applies to new starts only; failure to document may result in denial

Product	Required prior trial(s) for new starts	Notes / Exceptions
FEIBA (2500 unit IV and 1000 unit presentations)
Prior trial and inadequate response to Hemlibra
Applies to new starts only; requirement does not apply to treatment of hemophilia B

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Granix, Neupogen, Nivestym, Nypozi, Releuko
Prior trial and inadequate response to Zarxio
Applies to new starts only; does not apply when the non-preferred agent is used for an indication not shared with Zarxio

Product	Required prior trial(s) for new starts	Notes / Exceptions
ILUMYA
Trial and inadequate response or intolerance to Cosentyx (formulary-preferred IL-17 inhibitor) AND trial/failure or intolerance to one on-formulary biologic or infliximab alternative
Applies to new starts only; enumerated alternatives include adalimumab biosimilars, Enbrel, Humira, Skyrizi, ustekinumab biosimilars, or generic infliximab/Remicade

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Avsola / Inflectra / Renflexis (infliximab biosimilars)
Prior trial and inadequate response to generic infliximab or Remicade
Applies to new starts only; does not apply when indication is not shared with generic infliximab/Remicade

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Adynovate / Eloctate / Esperoct
Prior trial and inadequate response to Jivi
Applies to new starts only

Product	Required prior trial(s) for new starts	Notes / Exceptions
Opdualag (or equivalent Opdivo+Yervoy combination)
Trial and inadequate response to Opdivo plus Yervoy OR documented contraindication to Yervoy
Applies to new starts only; documentation required and lack of prior trial/contraindication may result in denial

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
BYOOVIZ
Prior trial and inadequate response to bevacizumab (Avastin)
Applies to neovascular AMD, macular edema post-RVO, myopic CNV; new starts only
LUCENTIS / SUSVIMO
Step 1: prior bevacizumab failure; Step 2: failure of one of Byooviz, aflibercept (EYLEA), brolucizumab (BEOVU), or faricimab (VABYSMO)
Two-step requirement for shared indications; applies to new starts only

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Non-preferred pegfilgrastim products (Fulphila, Fylnetra, Neulasta alternatives)
Prior trial and inadequate response to Udenyca
Applies to new starts only; does not apply when indication is not shared with preferred product

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Axtle (J9292) / Pemfexy (J9304) / Pemrydi (J9324)
Prior trial and inadequate response to a pemetrexed product (one of listed J-codes) unless contraindicated or not tolerated
Applies to new starts only; does not apply when indication is not shared with preferred pemetrexed agents

Product	Required prior trial(s) for new starts	Notes / Exceptions
SPINRAZA (nusinersen) intrathecal
Prior trial and inadequate response to EVRYSDI (risdiplam) or documentation of intolerance/contraindication
Applies to new starts only; failure to document prior EVRYSDI trial may result in denial

Product	Required prior trial(s) for new starts	Notes / Exceptions
TEZSPIRE (tezepelumab) prefilled syringe
Trial and inadequate response, intolerance, or contraindication to dupilumab PLUS one other biologic (or documentation of qualifying low eosinophil count)
Applies to new starts only; documentation of prior biologic history or eosinophil count required

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Actemra / Tofidence (tocilizumab and biosimilar)
Prior trial and inadequate response to Tyenne
Applies to new starts only; does not apply when indication is not shared with Tyenne

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Herceptin / Herceptin Hylecta / Hercessi / Herzuma / Ogivri / Ontruzant (trastuzumab-class)
Prior trial and inadequate response to Kanjinti or Trazimera
Applies to new starts only; does not apply when indication is not shared with referenced biosimilars

Product	Required prior trial(s) for new starts	Notes / Exceptions
ULTOMIRIS (ravulizumab) for generalized myasthenia gravis
Prior trial and inadequate response to or intolerance/contraindication to Vyvgart or Vyvgart Hytrulo
Applies to new starts only; failure to document prior trials may trigger denial

Product(s)	Required prior trial(s) for new starts	Notes / Exceptions
Non-preferred viscosupplements (e.g., Monovisc, Orthovisc, Supartz FX, Synojoynt, Trivisc)
Prior failure or intolerance to BOTH preferred agents: Euflexxa AND Synvisc-One
Applies to new starts only; all viscosupplements require medical prior authorization and are billed through Medicare Part B; does not apply when indication not shared with preferred agents

Product	Required prior trial(s) for new starts	Notes / Exceptions
VYEPTI (eptinezumab) IV
Failure of any two oral migraine preventive agents AND prior use of one injectable CGRP antagonist or receptor antagonist
Applies to new starts only; documentation required or request may be denied

Product	Required prior trial(s) for new starts	Notes / Exceptions
VYVGART HYTRULO (new-start presentations)
Failure to respond to therapy with at least TWO of: acetylcholinesterase inhibitors; corticosteroids; nonsteroidal immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine)
Applies to new starts only; prior authorization requires documentation of failures to at least two groups

Product	Required prior trial(s) for new starts	Notes / Exceptions
ZILRETTA (intra-articular extended-release corticosteroid)
Prior trial and inadequate response to at least ONE other injectable corticosteroid
Applies to new starts only; documentation required or request may be denied

Biosimilar / Preferred-First Requirements

Denial Risk

Denial risk for missing ophthalmic prior trial

Failure to document the required prior trial and inadequate response (for example, no documented trial of bevacizumab for ophthalmic agents) may result in denial of the request for new starts.

Denial Risk

Denial risk: bendamustine Treanda trial missing

For oncology bendamustine products, failure to document trial and inadequate response to Treanda (J9033) may result in denial for new starts.

Billing Rule

Enjaymo requires prior rituximab or B‑cell therapy trial

For Enjaymo new starts, members must try and fail Ruxience or another rituximab or B‑cell targeting therapy prior to approval; failure to document this may lead to denial.

Billing Rule

Zarxio required before other filgrastim products

Members must try and fail Zarxio before approval of Granix, Neupogen, Nivestym, Nypozi, or Releuko for overlapping indications (new starts only); failure to document may result in denial.

Billing Rule

Zarxio trial required for new starts

New starts for the listed filgrastim products must have tried and failed to have an adequate response to Zarxio before approval.

Billing Rule

Generic infliximab/Remicade required before biosimilars

New starts for certain infliximab biosimilars must have tried and failed generic infliximab or Remicade before approval.

Billing Rule

Riabni/Ruxience required before rituximab products

For Rituxan, Rituxan Hycela, or Truxima new starts, the patient must have tried and failed Riabni or Ruxience before approval for shared indications.

Billing Rule

Kanjinti/Trazimera required before trastuzumab products

For listed trastuzumab products new starts, prior trial and inadequate response to Kanjinti or Trazimera is required before approval unless the indication is not shared.

Billing Rule

Tyenne required before Actemra/Tofidence

For Actemra or Tofidence new starts, prior trial and inadequate response to Tyenne is required before approval unless the indication is not shared.

Billing and Site of Care Notes

Note

Initial Therapy Criteria (Grouped)

inv-158: Eylea/Beovu initial therapy

Initial approval conditional on prior trial for new starts

ALL of the following

prior_trial: Trial and inadequate response to bevacizumab (Avastin) required for Eylea and Beovu in specified ophthalmic indications
New starts only.

inv-159: Bendamustine initial therapy

Bendamustine initial requirement

ALL of the following

prior_trial: Trial and inadequate response to Treanda (J9033) required unless contraindicated or not tolerated
New starts only.

inv-160: Myobloc - Initial therapy

Myobloc initiation

Myobloc initial: Trial and inadequate response to Botox or Xeomin required.new starts only

Applies to listed Myobloc presentations

inv-161: Evkeeza - Initial therapy

Evkeeza initiation

Evkeeza initial: Trial and failure of maximally tolerated statin and a PCSK9 inhibitor, or documented contraindication to both, required.new starts only

Applies to EVKEEZA presentations listed

inv-162: Filgrastim biosimilars

Initial therapy requirements for certain filgrastim products

Filgrastim biosimilars initial: New start requires trial and inadequate response to Zarxio

chunk 37

inv-163: ILUMYA — Initial therapy requirements for ILUMYA

Initial therapy requirements for ILUMYA

ILUMYA initial: Trial and failure/intolerance to Cosentyx AND one listed on-formulary biologic/infliximab agent required

chunk 40

inv-164: Opdualag initial therapy

Opdualag initial therapy

Opdualag new starts: Must try and fail Opdivo+Yervoy or have contraindication to Yervoynew starts only

inv-165: Abraxane initial therapy

Abraxane initial therapy

Abraxane non-pancreatic indications: Must try and fail generic paclitaxel for shared indicationsnew starts only

inv-166: Spinraza — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Spinraza.

Spinraza initial therapy: Trial/failure or intolerance/contraindication to Evrysdi required for approval of SPINRAZA SOLUTION 12 MG/5ML INTRATHECAL.

inv-167: Tezspire — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Tezspire.

Tezspire initial therapy: Either trial/failure/intolerance/contraindication to dupilumab plus one other biologic for severe asthma (IL-5 antagonist, IL-5 receptor antagonist, or omalizumab), OR eosinophil count below threshold for those medications.

inv-168: Actemra / Tofidence — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Actemra/Tofidence.

Actemra/Tofidence initial therapy: Trial/failure to Tyenne required; does not apply when indication is not shared with Tyenne.

inv-169: Herceptin-class agents — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for listed trastuzumab agents.

Trastuzumab agents initial therapy: Trial/failure to Kanjinti or Trazimera required; does not apply when indication is not shared with preferred agents.

inv-170: Ultomiris — Initial therapy requirement applies to new starts only for Ultomiris in gMG.

Initial therapy requirement applies to new starts only for Ultomiris in gMG.

Ultomiris initial therapy: Trial/failure or intolerance/contraindication to Vyvgart or Vyvgart Hytrulo required.

inv-171: Stelara — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Stelara.

Stelara initial therapy: Trial/failure to Selarsdi or Yesintek required.

inv-172: Vabysmo — Initial therapy requirement applies to new starts only for specified ophthalmic indications.

Initial therapy requirement applies to new starts only for Vabysmo in specified ophthalmic indications.

Vabysmo initial therapy: Trial/failure to bevacizumab (Avastin) required.

inv-173: Viscosupplements — Initial therapy requirement applies to new starts only for non-preferred viscosupplements.

Initial therapy requirement applies to new starts only for non-preferred viscosupplements.

Viscosupplement initial therapy: Trial/failure or intolerance to both Euflexxa and Synvisc-One required; all viscosupplements require medical PA and are billed through Medicare Part B.

inv-174: Vyepti — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Vyepti.

Vyepti initial therapy: Failure of two oral preventive migraine agents and prior use of one injectable CGRP antagonist/receptor antagonist required.

inv-175: Vyvgart Hytrulo — Initial therapy requirement applies to new starts only.

Initial therapy requirement applies to new starts only for Vyvgart Hytrulo.

Vyvgart Hytrulo initial therapy: Failure to respond to at least two of acetylcholinesterase inhibitors, corticosteroids, or specified nonsteroidal immunosuppressive therapies required.

inv-176: VYVGART HYTRULO Initial Therapy

VYVGART HYTRULO (new starts):

VYVGART new-start requirement: Failure to respond to therapy with at least two of: acetylcholinesterase inhibitors; corticosteroids; nonsteroidal immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine).>=2 prior groups

Applies to new starts only.

inv-177: ZILRETTA Initial Therapy

ZILRETTA (new starts):

ZILRETTA new-start requirement: Tried and failed at least one other injectable corticosteroid.>=1 prior injectable corticosteroid

Applies to new starts only.

Definitions and Key Terms

New starts — Requests for initiation of therapy

DefinitionRequests for initiation of therapy with the specified drug; many criteria explicitly apply to new starts only.

Applies toPrior authorization and step-therapy rules for Medicare Part B drugs in Independent Health Medicare Advantage plans for 2025.

Action for providersWhen submitting a request flagged as a 'new start', include documentation of prior trials or reasons for intolerance/contraindication as required by the product-specific criteria.

New starts only — Prior-trial applicability

MeaningThe documented requirement to have tried and failed an antecedent therapy applies only when initiating a new course of the specified drug.

ImplicationStep therapy prior-trial requirements (e.g., Retacrit for epoetin biosimilars; pemetrexed J-codes for Axtle/Pemfexy/Pemrydi) must be documented for new-start requests.

ExceptionIf the requested agent is being used for an indication not shared with the preferred agent, the new-start prior-trial requirement does not apply.

Pemetrexed — Preferred-agent J-codes

Preferred pemetrexed J-codesJ9294, J9296, J9297, J9305, J9314, J9322, J9323 are referenced as the pemetrexed agents to try before Axtle (J9292), Pemfexy (J9304), or Pemrydi (J9324).

Affected productsAxtle (J9292), Pemfexy (J9304), Pemrydi RTU (J9324) require prior trial of a listed pemetrexed agent for shared indications (new starts only).

ExceptionRequirement does not apply when the indication is not shared with the preferred pemetrexed agents or when contraindicated/intolerant.

Bevacizumab (Avastin) — First-step agent for intravitreal biologics

Bevacizumab (Avastin) as step 1For Byooviz, Lucentis, Susvimo, and Beovu in specified retinal indications, patients must have tried and failed bevacizumab (Avastin) before approval — this is the first-step agent for intravitreal biologics (new starts only).

Two-step sequencesFor Lucentis or Susvimo, bevacizumab failure (Step 1) plus failure of one additional agent (Byooviz, aflibercept/Eylea, brolucizumab/Beovu, or faricimab/Vabysmo) is required for shared indications (new starts only).

Covered indicationsNeovascular AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization are examples where the bevacizumab-first requirement applies.

Viscosupplement — FDA classification and Medicare Part B billing

Regulatory classification & billingHyaluronic acid intra-articular viscosupplements are considered medical devices by the FDA and are billed through Medicare Part B.

Prior authorizationAll viscosupplements require medical prior authorization for new starts.

Preferred agents requirementNon-preferred viscosupplements require prior failure or intolerance to both preferred agents (Euflexxa and Synvisc-One) for new starts; exceptions apply when indication is not shared.

Background — Step Therapy Approach

Step therapy is a utilization-management approach that requires trying a preferred or lower-cost medication first. This policy applies that approach to multiple Medicare Part B injectable and infused drugs, requiring documented prior trial and inadequate response, intolerance, or contraindication to the specified preferred agent(s) for new starts. Exceptions are noted where the requested agent is used for an indication not shared with the preferred agent.

Policy Revision History

2025-01-01policy_effective_dateLatest

Step therapy criteria for Medicare Part B drugs became effective for Independent Health Medicare Advantage plans for 2025.

Policy Summary

PayerIndependent Health

PolicyStep therapy criteria for Medicare Part B drugs

Policy CodePolicy N/A

Change TypeMinor/No material changes

Effective DateJan 1, 2025

Next Review DateN/A

SourceLink

On This Page