ModifiedBlue Cross Blue Shield - IowaPolicy N/A

Medicare Part B prior authorization & step therapy for medical drugs

A list of Medicare Part B medical drugs with prior authorization and step therapy requirements for Blue Cross Blue Shield - Iowa; directed at providers submitting authorization requests for covered drugs.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMedicare Part B prior authorization & step therapy for medical drugs

Policy CodePolicy N/A

Change TypeMaterial updates to PA and step therapy (effective 5/1/2026)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document required trial/failure of specified preferred agents per step therapy entries before submitting claims.

SourceLink

POLICY UPDATE CHANGES

Authorization requirement effective 5/1/2026 added for multiple codes including J1569, J1599, J2323, J2329, J2350, J2351, J3404, J3590 (multiple), J7601, J7606, J7677, Q5134, Q5161 (Aukelso, Bosaya).

Step therapy requirements added for Izervay effective 5/1/2026.

Step therapy requirements updated for Vyvgart Hytrulo effective 5/1/2026.

Authorization requirement removed effective 5/1/2026 for J1412 Roctavian (withdrawn from U.S. market by manufacturer).

Correction: Infliximab Step Therapy must use Inflectra AND Avsola (correction made 2/27/2026).

100+listed drugs & HCPCS

Manyentries with step therapy

Yesincludes biosimilar preferences

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~120+codes in excerpt

Severalpreferred no-PA entries

DozensPA/step updates

Coverage Criteria and Step Therapy Rules

Step therapy for certain biologics (examples)

Covered when the following step therapy requirements are met for the listed drugs

Orencia (J0129): Trial and failure of Inflectra or Avsola AND Steqeyma, Pyzchiva or Wezlana; trial and failure of adalimumab is also required for members who have an MAPD plan. Note: Trial and failure of Steqeyma/Pyzchiva/Wezlana is not required for rheumatoid arthritis.

Certolizumab pegol (Cimzia): Trial and failure of Inflectra or Avsola AND Steqeyma, Pyzchiva or Wezlana.

Simponi Aria / Guselkumab IV / Mirikizumab IV: Trial and failure of Inflectra or Avsola AND Steqeyma, Pyzchiva or Wezlana required prior to authorization.

IV iron products

Step therapy for ferric derisomaltose and ferric carboxymaltose

Ferric derisomaltose & Ferric carboxymaltose: Try/fail at least TWO of the following preferred medications first: Ferrlecit, Feraheme, Venofer, or INFeD. These preferred drugs do not require prior authorization. Prior authorization is not required when medications are received through a dialysis facility.Try/fail >=2 preferred agents

Immune globulin and supportive growth factors

IVIG/SCIG and colony-stimulating factors have specific preferred products and trial/failure requirements

Filgrastim / Tbo-filgrastim / Eflapegrastim: Use the preferred filgrastim biosimilars Nivestym and Zarxio first. For eflapegrastim, use the preferred pegfilgrastim drugs (e.g., Fulphila and Neulasta/Neulasta OnPro) as specified prior to authorization.

Immune globulin products (IVIG/SCIG): Trial and failure of Gammagard and Octagam is required for many IVIG products; some SCIG entries require Gammagard or Octagam AND Hizentra. Note: Gammagard or Octagam is not required for CIDP in certain SCIG entries.

Step therapy coverage examples

Examples of covered when step therapy criteria are met:

J3247 Secukinumab IV: Covered when ALL of the following are met: trial and failure of Inflectra or Avsola AND trial and failure of Steqeyma, Pyzchiva or Wezlana; additional adalimumab and Cosentyx SC requirements may apply for MAPD members.

These preferred drugs don't require authorization when they're the preferred products.

Preferred products and no-authorization stipulations

Preferred product / biosimilar guidance that affects coverage:

Bevacizumab biosimilars: Use preferred bevacizumab biosimilars Mvasi and Zirabev for bevacizumab (Avastin) — these preferred drugs will not require prior authorization; prior authorization is not required for retinal disorder use.

Applies to bevacizumab (Avastin) entries.

Ustekinumab preferred products: Use preferred ustekinumab drugs Steqeyma, Pyzchiva and Wezlana — these preferred drugs do not require authorization and should be used before non-preferred ustekinumab IV or biosimilars.

Applies to Ustekinumab/J3590 and Q9998 entries.

Examples of conditional coverage with step/failure requirements

Coverage is conditional when ALL of the following step or prior authorization requirements are met as listed per drug:

Tyvaso nebulizer: Prior authorization is required for Tyvaso nebulizer (medical benefit).

Tyvaso DPI (J3535) is a pharmacy benefit and not subject to this medical prior authorization list.

Ogapendekin alfa inbakicept-pmln (Anktiva): For BCG-unresponsive non‑muscle invasive bladder cancer, must first try and fail Adstiladrin prior to authorization for Ogapendekin.

Bevacizumab and ophthalmic agents: Trial and failure of bevacizumab (Avastin) or a bevacizumab biosimilar is required before certain ranibizumab or aflibercept products are authorized.

Rituximab‑class/related agents: Preferred rituximab biosimilars (Truxima, Riabni, Ruxience) are listed and do not require prior authorization; some agents require trial and failure of these biosimilars before coverage of alternatives.

Eculizumab step therapy by indication

Eculizumab (Q5151/Q5152): For Myasthenia Gravis: trial and failure of Truxima, Ruxience or Riabni AND Rystiggo AND Vyvgart or Vyvgart Hytrulo is required. For NMOSD: trial and failure of Enspryng and Uplizna. For PNH (Q5152): trial and failure of Empaveli AND Epysqli is required.

Per‑code sequencing differs by indication.

Step therapy-linked coverage criteria

Coverage for listed biosimilars and products is subject to documented trial and failure of specified preferred agents as noted below.

Aflibercept biosimilars (Q5150, Q5153, Q5155): Coverage requires trial and failure of bevacizumab (Avastin) or a bevacizumab biosimilar.N/A

See per‑code entries for effective dates and preferred biosimilar exceptions.

Eculizumab biosimilars (Q5151, Q5152): For Myasthenia Gravis: trial and failure of Truxima, Ruxience or Riabni AND Rystiggo AND Vyvgart or Vyvgart Hytrulo; For NMOSD: trial and failure of Enspryng and Uplizna; For PNH (Q5152): trial and failure of Empaveli AND Epysqli.N/A

Per‑code sequencing differs by indication.

Tocilizumab (Q5156): Step therapy requires trial and failure of Tyenne AND Inflectra or Avsola AND Steqeyma, Pyzchiva, or Wezlana; adalimumab trial required for MAPD members. Exceptions apply for cytokine release syndrome and giant cell arteritis.

For IV iron products (ferric derisomaltose and ferric carboxymaltose), the policy specifies a step requirement of trying and failing at least two preferred agents (Ferrlecit®, Feraheme®, Venofer®, or INFeD®). Importantly, prior authorization is not required when these IV iron medications are administered through a dialysis facility.

The step therapy requirement for Ocrelizumab (Ocrevus) excludes patients with a diagnosis of primary progressive multiple sclerosis. In other words, step therapy does not apply for the primary progressive MS indication for Ocrelizumab as noted in the Ocrevus entries.

The policy treats Tyvaso nebulizer as a medical benefit requiring prior authorization. Tyvaso DPI (J3535), however, is identified as a pharmacy benefit and is not covered under this medical drugs prior authorization list.

Per the revision history, the prior authorization requirement for J1412 (Roctavian) was removed effective 5/1/2026 because the drug was withdrawn from the U.S. market by the manufacturer.

HCPCS / J-code Listings

Sample listed J-codes (partial)HCPCS

J1745	Avsola
J1746	Ibalizumab-uiyk / Trogarzo
J1747	Spesolimab-sbzo / Spevigo IV/SC
J1809	Fosdenopterin / Nulibry

Additional J-codes and J3490/J3590 catch-allsHCPCS

J3111	Romosozumab-aqqg / Evenity
J3590	Multiple drug entries (e.g., Empaveli, Winrevair, Avzivi biosimilars, etc.)
J3402	Remestemcel-L-rknd / Ryoncil

Covered HCPCS / J / Q codes in segmentHCPCSCovered

J9026	Tarlatamab-dlle (Imdelltra™)
J9119	Cemiplimab-rwlc (Libtayo®)
J9144	Daratumumab and hyaluronidase-fihj (Darzalex Faspro®)
J9145	Daratumumab (Darzalex®)
J9161	Lymphir™
J9173	Imfinzi®
J9176	Empliciti®
J9228	Yervoy®
J9311	Rituxan Hycela®
J9312	Rituxan®

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Codes mentioned in this segmentmixed

Q5150	Ahzantive (aflibercept biosimilar)
Q5151	Epquelize (eculizumab-aagh)
Q5152	Bkemv (eculizumab-aeeb)
Q5153	Opuviz / Unbranded aflibercept biosimilar
Q5154	Omlyclo (omalizumab-igec) / unbranded biosimilar
Q5155	Yesafili (aflibercept-jbvf)
Q5156	Avtozma (tocilizumab-anoh)
Q5157	Stoboclo (denosumab-bmwo) / preferred denosumab biosimilar
Q5158	Conexxence / Bomyntra / denosumab-bnht (multiple entries)
Q5159	Ospomyv / Xbryk / denosumab-dssb (multiple entries)

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IV iron step requirement (try/fail >=2 preferred agents)

RequirementTry and fail at least TWO of the following preferred IV iron products before coverage: Ferrlecit®, Feraheme®, Venofer®, or INFeD®.

Preferred productsFerrlecit®, Feraheme®, Venofer®, INFeD® — these preferred drugs do not require prior authorization.

Exception: dialysis facilityPrior authorization is not required when IV iron medications are administered through a dialysis facility.

What Providers Must Do / Authorization & Documentation

Prior Authorization

Prior authorization required for listed HCPCS

Prior authorization is required for many HCPCS (J-/Q-/Q5-/Q51-/Q52-/Q51xx/Q51xxx/Q51xxxx/Q516x/Q515x/Q513x/Q51xx etc.) entries on the Medicare Part B Medical Drugs list. When a code is listed as requiring prior authorization, providers must obtain authorization before administration or risk claim denial. Prior authorization is not a guarantee of payment — eligibility and contract terms still apply.

Affected codes include (examples only): J0129, J1305, J1306, J2267, J3111, J3590 series, J9119, J9311/J9312, J9355, Q5136, Q5150–Q5159, Q5161–Q5162 and many others listed on the policy.
Prior authorization effective dates vary by code (see Authorization requirement history).

Note

Other recent PA code updates

Several codes had authorization requirements added, restored, or removed throughout 2024–2026. Always check the specific code entry and the Revision history for the effective PA date before billing.

Recent additions (effective 5/1/2026): J1569, J1599, J2323, J2329, J2350, J2351, J3404, J3590 (multiple entries), J7601, J7606, J7677, Q5134, Q5161, etc.

Initial Therapy - First-line Requirements

IV iron initial step

Ferric derisomaltose / Ferric carboxymaltose (initial step): Try/fail at least TWO preferred IV iron agents (Ferrlecit, Feraheme, Venofer, or INFeD) before authorization of ferric derisomaltose or ferric carboxymaltose. Prior authorization is not required when administered through a dialysis facility.>=2 failed preferred agents

Dialysis facility administration exempt from prior authorization.

Selected initial therapy requirements

Ogapendekin for BCG‑unresponsive NMIBC: Must try and fail Adstiladrin (nadofaragene firadenovec) prior to authorization for Ogapendekin in BCG‑unresponsive non‑muscle invasive bladder cancer.

Initial therapy step requirements (examples)

Step Therapy Tables and Sequences

Drug / Code	Step requirement	Notes
Orencia (J0129)	Trial and failure of Inflectra or Avsola AND Steqeyma, Pyzchiva or Wezlana	Adalimumab trial also required for MAPD members; Steqeyma/Pyzchiva/Wezlana not required for rheumatoid arthritis
Simponi Aria (J1602) / Guselkumab IV (J1628)	Trial and failure of Inflectra or Avsola AND Steqeyma, Pyzchiva or Wezlana	These preferred drugs do not require authorization; adalimumab trial may be required for MAPD members
Infliximab (Remicade / J1745)	Use preferred infliximab biosimilars Inflectra AND Avsola first	Preferred drugs do not require authorization; correction: Inflectra AND Avsola must be used (2/27/2026)

Drug / Class	Step requirement	Preferred products / Notes
Filgrastim (short-acting CSFs, J1442 and related)	Use both preferred filgrastim biosimilars Nivestym and Zarxio before other filgrastim products	Preferred filgrastim biosimilars don't require prior authorization
Tbo-filgrastim (Granix, J1447)	Use Nivestym and Zarxio as preferred filgrastim biosimilars	Preferred biosimilars don't require prior authorization
Eflapegrastim (Rolvedon, J1449)	Use preferred pegfilgrastim drugs first (Fulphila and Neulasta/Neulasta OnPro)	Step therapy effective 6/1/2023 for eflapegrastim

Product / Code	Step requirement	Notes
High molecular weight hyaluronan products (examples: Orthovisc, J7326-J7331)	Trial and failure of all the following preferred hyaluronic acid drugs: Durolane, Euflexxa, Gelsyn-3, and Supartz FX	These preferred drugs do not require authorization; initial effective date 6/1/2023
Gel-one (J7326) / Monovisc (J7327) / TriVisc (J7329) etc.	Trial and failure of Durolane, Euflexxa, Gelsyn-3 and Supartz FX required prior to coverage	Preferred products listed above don't require prior authorization

Drug / Code	Prior preventive failures required	Notes
Vyepti (J3032)	Try/fail botulinum toxins AND an oral or subcutaneous CGRP antagonist before Vyepti	Initial effective date 5/1/2023

Drug / Code	Step requirement	Notes
Aflibercept products (e.g., Eylea J0177/J0178; Pavblu Aflibercept-ayyh; Q5149 Enzeevu; Q5150/Q5153 biosimilars)	Trial and failure of bevacizumab (Avastin) or a bevacizumab biosimilar required prior to coverage	See per-code entries for effective dates (various 2022–2025); exceptions for retinal disorder use noted for bevacizumab
Ranibizumab products (Lucentis J2778, Byooviz Q5124, Cimerli Q5128)	Trial and failure of bevacizumab (Avastin) or a bevacizumab biosimilar required	Some entries also require trial/failure of aflibercept, ranibizumab or Beovu depending on product

Agent / Code	Step requirement	Notes
Eculizumab biosimilars (Q5151 Epysqli; Q5152 Bkemv)	For Myasthenia Gravis: trial and failure of Truxima, Ruxience or Riabni AND Rystiggo AND Vyvgart or Vyvgart Hytrulo required	For NMOSD: trial and failure of Enspryng and Uplizna; PNH has additional sequencing (Empaveli and Epysqli)
Efgartigimod / Fc-targeting agents (Vyvgart / Vyvgart Hytrulo / Rystiggo)	Trial and failure of Truxima, Ruxience or Riabni required for myasthenia gravis prior to some agents	Preferred products listed do not require prior authorization

Product / Code	Step requirement / Preference	Notes
Trastuzumab (Herceptin / J9355) and trastuzumab biosimilars (multiple Q-codes and J-codes)	Use preferred trastuzumab biosimilars Ontruzant and Trazimera first; these preferred biosimilars do not require prior authorization	Per-code entries list preferred biosimilars and effective dates (preferred use effective 6/1/2023 and related dates)
Trastuzumab-strf (Hercessi), Trastuzumab-pkrb (Herzuma), Trastuzumab-dkst (Ogivri)	Use Ontruzant and Trazimera as preferred trastuzumab biosimilars prior to other trastuzumab products	Preferred trastuzumab biosimilars don't require prior authorization

Scenario	Requirement	Supporting detail / Notes
Non-preferred or later-step biologic/agent coverage	Prior trial and documented failure of the specified preferred agents is required before coverage	Examples include bevacizumab required before certain aflibercept/ranibizumab biosimilars; Steqeyma/Pyzchiva/Wezlana required before ustekinumab IV or related biosimilars
IVIG / immune modulators and other classes	Document trial and failure of named preferred IVIG products (e.g., Gammagard and Octagam) prior to authorization	CIDP exception may apply where Gammagard or Octagam is not required (see per-entry notes)

Indication / Agent	Sequential trial requirement	Notes
Eculizumab biosimilars (Q5151/Q5152) for Myasthenia Gravis	Multi-agent sequential trial required: failure of Truxima/Ruxience/Riabni AND Rystiggo AND Vyvgart or Vyvgart Hytrulo before coverage	Per-code sequencing differs by indication; initial effective dates vary (see code entries)

Site of Care / Benefit Type Notes

Note

Biosimilar Preferences and Impact on Authorization

Note

Policy Purpose and Scope

This document lists Medicare Part B medical drugs and the payer's associated prior authorization and step therapy requirements used to determine coverage. It specifies preferred products and biosimilars that should be tried first, enumerates per-code step therapy sequencing (including required trials/failures of named alternatives), and documents effective dates and recent changes in authorization status. Providers should follow the per-code entries for exact prior authorization and step therapy obligations and submit documentation showing prior trials and failures where required.

Definitions and Benefit Notes

Preferred biosimilar use (preferred agents should be used first)

General policyWhen a preferred biosimilar is specified for a reference biologic, use of the preferred biosimilar is expected before non-preferred products; preferred biosimilars listed do not require prior authorization.

Filgrastim examplePreferred filgrastim biosimilars Nivestym® and Zarxio® should be used first for filgrastim/short-acting CSFs.

Trastuzumab & bevacizumab examplesPreferred trastuzumab biosimilars (Ontruzant, Trazimera) and preferred bevacizumab biosimilars (Mvasi, Zirabev) are specified as preferred and generally do not require prior authorization; check per-code entries for exceptions and indications.

Medical vs Pharmacy benefit for Tyvaso

Tyvaso nebulizer (medical benefit)Tyvaso® nebulizer is a medical benefit and requires prior authorization under this medical drugs PA list.

Policy Revision History

2026-04-20material_changeLatest

Added authorization requirements effective 2026-05-01 for multiple codes (e.g., J1569 Gammagard Liquid ERC; J1599 Qivigy; J2323 Tysabri; J2329 Briumvi; J2350/J2351 Ocrevus entries; J3404 Papzimeos; several J3590 entries including Xtrenbo, Enoby, Starjemza, Loargys; J7601 Ohtuvayre; J7606 Formoterol; J7677 Yuperli; Q5134 Tyruko; Q5161 Aukelso/Bosaya).

2026-04-20material_change

Added step therapy requirements for Izervay effective 2026-05-01.

2026-04-20

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMedicare Part B prior authorization & step therapy for medical drugs

Policy CodePolicy N/A

Change TypeMaterial updates to PA and step therapy (effective 5/1/2026)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document required trial/failure of specified preferred agents per step therapy entries before submitting claims.

SourceLink

On This Page

Rheumatoid arthritis has some exceptions to requiring Steqeyma/Pyzchiva/Wezlana.

Denosumab biosimilars (Q5157–Q5162 etc.): Use the preferred denosumab biosimilar (Stoboclo or Osenvelt) as specified; some preferred products do not require prior authorization.N/A

Per‑code preferred biosimilar stated in entries.

Ustekinumab IV and biosimilars (Q9998 and related): Trial and failure of preferred ustekinumab drugs Steqeyma, Pyzchiva, and Wezlana required prior to coverage; these preferred drugs do not require authorization.N/A

Multiple code entries reference the same preferred‑agent requirement.

Recent removals: J1412 (removed 5/1/2026 — withdrawn by manufacturer); Q5103, Q5112, Q5115 (removed 1/1/2026)

Code changes and corrections occur frequently — use the policy's revision history to confirm current PA status for a given code.

Step Therapy

Orencia (J0129) step therapy

Orencia (J0129) requires documented step therapy: trial and failure of Inflectra® or Avsola® AND Steqeyma®, Pyzchiva® or Wezlana®. For members with an MAPD plan, trial and failure of adalimumab is also required. Note: Trial and failure of Steqeyma/Pyzchiva/Wezlana is not required for rheumatoid arthritis.

Preferred alternatives (Inflectra®/Avsola®, Steqeyma®/Pyzchiva®/Wezlana®) do not require prior authorization when used first.
Document clinical notes showing dates, doses, and reason for failure/intolerance to support step therapy compliance.

Step Therapy

PCSK9 / Inclisiran step therapy

PCSK9 inhibitors and inclisiran require step therapy before coverage: providers must document a trial and failure of a high-intensity statin AND trial and failure of a PCSK9 monoclonal (Praluent® or Repatha®) prior to Evkeeza® (J1305) or Leqvio® (J1306).

Ensure statin intolerance or inadequate LDL-C lowering is documented (medication names, doses, durations, and LDL values).
Include prior authorization/denial records for prior agents where applicable to expedite review.

Step Therapy

Supportive care biologics step requirements

Supportive care biologics (CSFs and IV/SC immunoglobulins) have preferred-product requirements and step therapy: use specified preferred biosimilars first or document trial and failure of named IVIG products.

Filgrastim/tbo-filgrastim: use preferred filgrastim biosimilars Nivestym® and Zarxio® first.
Pegfilgrastim/eflapegrastim: use preferred pegfilgrastim products (Fulphila®, Neulasta®/Neulasta OnPro®) first.
IVIG products (eg Privigen®, Alyglo™, Yimmugo®, Asceniv™ etc.) require trial and failure of Gammagard® and Octagam® per listed entries.
Preferred supportive agents do not require prior authorization when used first.

Prior Authorization

Prior authorization required when Step Therapy indicated

When a Step Therapy Requirement is indicated for a J-/Q-/Q5-/Q51- code, prior authorization must accompany documentation of required prior trials/failures. Absence of the required step therapy documentation may result in denial or delay.

If a code's entry shows a checkmark or explicit "Trial and failure of ..." language, include signed clinical notes, dates, doses, and reasons for discontinuation/intolerance for each prior agent.
Some J-codes (eg J3590 J-codes) are catch-alls — confirm the specific product descriptor and step requirements in the line-item entry before submission.

Prior Authorization

Rituximab biosimilar preference

Rituximab-class entries require use of preferred rituximab biosimilars (Truxima, Riabni®, and Ruxience®) first. Not using the preferred rituximab biosimilars may trigger a prior authorization requirement.

J9311/J9312 entries specify use of all preferred rituximab biosimilars; those preferred products do not require prior authorization when used first.
Document clinical rationale if requesting originator rituximab or a non-preferred biosimilar (medically necessary reason, prior failure/intolerance to preferred biosimilars).

Step Therapy

Ophthalmology step requirement

Ophthalmology agents (aflibercept, ranibizumab, aflibercept biosimilars and similar) commonly require trial and failure of bevacizumab (Avastin®) or a preferred bevacizumab biosimilar (Mvasi® or Zirabev®) before coverage.

Products affected include aflibercept (Eylea®/Eylea HD), ranibizumab (various brands and biosimilars), and Q5xxxx aflibercept biosimilars (Q5149, Q5150, Q5153, Q5149 etc.).
Prior authorization is not required for bevacizumab when used for retinal disorders per policy — document indication clearly.
If provider elects a non-preferred ocular agent without the required prior bevacizumab trial, include clinical justification in the PA request.

Documentation Required

Trial / failure documentation

Maintain thorough trial/failure documentation for all step therapy and preferred-agent requirements. Documentation is the primary basis for PA approval when prior trials or contraindications are claimed.

Include dates of therapy, doses, route, duration, and specific reason for discontinuation or inadequate response for each prior agent.
For MAPD members, note any additional step requirements (eg adalimumab for certain biologics).
Attach prior authorization decisions, appeal records, or medical records demonstrating intolerance or contraindication where applicable.

Documentation Required

IV iron documentation

IV iron (ferric derisomaltose, ferric carboxymaltose, etc.) requires documentation that at least two preferred IV iron medications were tried and failed before the non-preferred product is authorized — unless administered in a dialysis facility.

Preferred IV iron products to try/fail include Ferrlecit®, Feraheme®, Venofer®, or INFeD®.
If iron is administered in a dialysis facility, prior authorization for these IV iron products may not be required — document the facility setting on the claim.

Step Therapy

General step therapy requirement

Step therapy requirements vary but commonly require trial and failure of specified preferred agents before coverage of higher-tier biologics. Examples in this policy illustrate the general rule: try preferred biosimilars or named agents first.

Common examples: trial and failure of Inflectra® or Avsola® AND Steqeyma®/Pyzchiva®/Wezlana® for many TNF/IL-targeting biologics; trial and failure of bevacizumab or preferred bevacizumab biosimilars for ophthalmic agents.
Some step rules also add a third required trial for MAPD members (eg adalimumab).
When a preferred biosimilar is available (eg bevacizumab Mvasi® or Zirabev®), use it first to avoid PA.

Step Therapy

Step therapy requirements (examples)

Several entries in the policy list explicit required prior-therapy sets — include these in PA submissions exactly as stated. Failure to provide the required prior-therapy details (names, dates, reasons) will delay review or result in denial.

Examples: Q5150/Q5153/Q5149 require trial/failure of bevacizumab or a bevacizumab biosimilar; multiple denosumab and eculizumab biosimilars require use of specific preferred agents first.
Q5151/Q5152 (eculizumab forms) and related Q-codes have multi-drug prior therapy cascades depending on diagnosis — include each required prior agent in the documentation.
For IVIG and other immunoglobulin products, the policy often requires trial and failure of Gammagard® and Octagam® (or combination with Hizentra® for SC products).

Note

Authorization requirement history

The Revision history documents authorization requirement changes, step therapy additions, removals, and preferred-agent updates; consult it to verify the PA status and effective dates for specific codes.

Notable recent history: Authorization requirements added effective 5/1/2026 for multiple codes (see Revision history); PA removed for J1412 (withdrawn) effective 5/1/2026.
Multiple PA additions and removals occurred across 2024–2026 — check the policy revision list and the individual code entry before submission.

Aflibercept biosimilars initial requirement: Trial and failure of bevacizumab (Avastin) or a bevacizumab biosimilar is required prior to coverage of aflibercept biosimilars (e.g., Q5150, Q5153); effective dates vary by code.N/A

See per‑code entries for effective dates.

Tyvaso DPI (pharmacy benefit)

Tyvaso DPI® (J3535) is a pharmacy benefit drug and is not covered under this medical prior authorization list.

Benefit distinctionProviders should distinguish nebulized (medical) vs DPI (pharmacy) formulations when requesting prior authorization or submitting claims.

Trial and failure (step therapy) — definition and requirements

DefinitionTrial and failure (step therapy) requires documented use and inadequate response to or intolerance of one or more specified preferred agents before coverage of the requested product.

Documentation requirementProviders must document prior trials and failures of the named preferred agents when submitting prior authorization requests.

ExamplesExamples include: preferred filgrastim biosimilars (Nivestym, Zarxio) required before other filgrastim products; trial/failure of Steqeyma/Pyzchiva/Wezlana required before certain ustekinumab or related IV products.

Per-code variationsStep therapy sequencing and required trial agents vary by code and indication — see individual code entries for specific prior agents and exceptions.

Updated step therapy requirements for Vyvgart Hytrulo effective 2026-05-01.

2026-04-20material_change

Removed authorization requirement effective 2026-05-01 for J1412 Roctavian because the product was withdrawn from the U.S. market by the manufacturer.

2026-02-27correction

Corrected infliximab (J1745) step therapy sequencing to require trial of both Inflectra AND Avsola first.

2026-01-23material_change

Added authorization requirements effective 2026-02-01 for multiple J3590 entries (Exdensur, Yartemlea, Bildyos, Bilprevda, Waskyra, Itvisma) and updated several step therapy requirements effective 2026-02-01 (Orencia, Cosentyx IV, Tofidence, Tyenne, and tocilizumab unbranded biosimilar).

2026-01-01material_change

Added preferred eculizumab product and authorization code updates effective 2026-01-01; also added preferred tocilizumab product effective 2026-01-01 and highlighted preferred-agent changes.

2025-12-01material_change

Added preferred ustekinumab products effective 2025-12-01 and removed certain authorization requirements (e.g., Q5138 Wezlana; Q5099 Steqeyma; Q9997 Pyzchiva) with step therapy updates effective the same date.

2025-11-01material_change

Added authorization requirements effective 2025-11-01 for select codes (e.g., J3590 Yimmugo; Q5153 aflibercept-yszy) as noted in the revision history.