CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medically Administered Step Therapy Policy

Defines step-therapy prior authorization requirements for medically administered drugs under the medical benefit, applying to Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document trials/failures or contraindications to required predecessor therapies; members with the same medication within 365 days are exempt from step therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medicarescope population

10/01/2020effective date

365prior-use exemption days

1–3typical predecessor trials

~20+listed therapies

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General coverage conditions

Covered when ALL of the following are met:

General: Request is for a medically administered drug covered under the Medical Benefit and prior authorization has been obtained.

Medically administered drugs will be reviewed prospectively via the prior authorization process (see product-specific criteria).

Recent therapy exemption: Member has received the requested medication within the past 365 days; if yes, step therapy requirements do not apply.within 365 days

Medicare members who previously received the requested medication within 365 days are not subject to step therapy requirements.

Examples of drug-class specific step criteria

Per-product step requirements (examples from document):

Aralast/Glassia for AAT deficiency: Documented failure, intolerance, or contraindication to Prolastin or Zemaira.

Alpha-1 proteinase inhibitor class requirement.

Duopa for Parkinson's Disease: Trial of all of the following: oral levodopa/carbidopa, a dopamine agonist, AND a COMT inhibitor OR an MAO-B inhibitor.

All listed agents required prior to Duopa.

Xenleta (antibiotic): Trial of an alternative antibiotic to which the organism is susceptible (examples: moxifloxacin, levofloxacin, beta-lactam + macrolide, beta-lactam + doxycycline).

Microbiology-directed alternative required prior to Xenleta.

Linezolid, Meropenem, Vancomycin, Heparin (examples): Trial and failure or documented contraindication to the listed alternative HCPCS-coded agent(s) (e.g., linezolid J2020 before J2021; meropenem J2183/J2185 before J2184; vancomycin J3370/J3371 before J3372; heparin J1644 before J1643).

Examples of class/HCPCS-specific step requirements.

Hemophilia-specific criteria

Hemophilia and antihemophilic agent rules:

Alhemo - Hemophilia A without inhibitors: Member has had a trial of Hemlibra and prior prophylaxis with an antihemophilic Factor VIII product (e.g., Advate, Koate, Hemofil, etc.).

Document trial of listed products or documented contraindication/intolerance.

Alhemo - Hemophilia A with inhibitors: Member has had a trial of Hemlibra and prior prophylaxis with an antihemophilic Factor VIII product plus a bypassing agent (e.g., NovoSeven, FEIBA).

Applies similarly for Hemophilia B with appropriate Factor IX products and bypassing agents.

Hemlibra - Hemophilia A without inhibitors: Member is not a suitable candidate for treatment with shorter half-life Factor VIII products at a total weekly dose ≤100 IU/kg.<=100 IU/kg

Suitability for alternative Factor VIII therapy must be documented to justify Hemlibra.

Biologic and autoimmune medication criteria

Autoimmune / biologic agents: typical sequence requirements

Actemra / Tocilizumab (Rheumatoid Arthritis and related indications): Trial of one oral DMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide) AND at least a 3-month trial of adalimumab at maximum tolerated doses.3 months

Applies to multiple indications; juvenile idiopathic arthritis requires NSAID or systemic steroid plus 3-month adalimumab trial where specified.

Cimzia (Crohn's Disease and other indications): Trial of at least a 3-month trial of adalimumab or infliximab IV at maximum tolerated doses AND at least a 6-month trial of ustekinumab at maximum tolerated doses.3 months, 6 months

Multiple biologic trials required for some GI and dermatologic indications.

Vyepti (Chronic Migraine): Trial of two oral migraine preventive medications from two different drug classes AND trial of at least 12 weeks of one CGRP antagonist AND two quarterly injections of botulinum toxin (for chronic migraine).

Other specialty drug criteria

Other specialty agent examples

Evenity (osteoporosis): Trial of bisphosphonates (oral and/or IV) AND trial of a RANKL‑blocking agent such as denosumab prior to Evenity.

Sequential bone-modifying therapy required before Evenity.

Leqvio (ASCVD / HeFH): Trial of maximally tolerated high‑intensity statin therapy AND at least a 3‑month trial of concomitant ezetimibe with statin with documented inadequate response, intolerance, or contraindication prior to Leqvio.>=3 months

Adherence and maximally tolerated dosing must be documented.

Product-specific initial therapy requirement summaries

Covered when ALL of the following prior-therapy conditions specific to each product are met (product-by-product rules):

Evenity (osteoporosis): Trial of bisphosphonates (oral and/or IV) AND trial of a RANKL-blocking agent (e.g., denosumab).

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Prolia / Xgeva: Trial of Zometa/Reclast or Aredia prior to Prolia or Xgeva.

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Parsabiv: Hyperparathyroidism secondary to CKD: trial of cinacalcet.

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Miacalcin: Hypercalcemic emergency: trial of cinacalcet; Paget's disease: trial of alendronate and pamidronate; Postmenopausal osteoporosis: trial of two of (zoledronic acid, alendronate, teriparatide, Prolia, Xgeva).

Step therapy / prior trial criteria

Covered when ALL of the following are met for the specified drug/indication:

Migraine - neuromuscular blocker agents (e.g., Dysport, Myobloc, Xeomin): Trial and failure of two oral medications for migraine prevention (examples: antidepressants, beta blockers, ACE inhibitors/ARBs, antiepileptics, calcium channel blockers).two medications

Examples of agent classes listed in product sections.

Incontinence due to neurogenic detrusor overactivity and OAB: Trial of two medications from either the antimuscarinic or beta‑adrenergic classes prior to coverage of neuromuscular blocker therapy for bladder indications.two medications

Applies to bladder‑targeted neuromodulators per product listings.

Chronic anal fissures: Trial of conventional pharmacologic therapy (e.g., nifedipine, diltiazem, topical nitroglycerin) prior to coverage of listed agents.

Use of medically administered drugs outside the guideline-based step therapy requirements may result in non-payment unless an exception is approved under the plan's exception process. This policy applies when the requested therapy is covered under the Medical Benefit and is subject to prospective review via the prior authorization process; providers should obtain prior authorization before administration to avoid potential denial or non-payment.

This policy does not list universal product exclusions in a separate section. Instead, coverage limitations are implemented through product-specific prior-therapy requirements; each drug entry specifies the required predecessor trials or alternatives (for example, bisphosphonates and RANKL-blocking agents before Evenity, or corticosteroid trials before exon-skipping therapies). Coverage decisions should be made against the per-product criteria in the policy.

Therapies used at doses or for conditions that are not recognized as medically accepted indications by standard compendia (AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or by sufficient peer-reviewed literature are considered investigational and are excluded from coverage. Requests for such uses will be denied under this policy.

Absence of documented completion of the required prior trials or failure/intolerance to listed alternatives renders a request inconsistent with the policy and may result in denial. The prior authorization process requires submission of objective documentation showing trials, durations, adherence, and reasons for switching (e.g., inadequate response, intolerance, or contraindication) as specified in each product entry (examples include bisphosphonates and denosumab before Evenity, or hydroxyurea and formulary add‑ons before gene therapies).

Initial Therapy Criteria

Initial therapy examples

Initial therapy requirements vary by drug and are specified as required trials of listed agents or classes prior to coverage of the requested product.

Aralast / Glassia initial requirement: Documented failure, intolerance, or contraindication to Prolastin or Zemaira.

Alpha‑1 proteinase inhibitors class requirement (see Aralast/Glassia entries).

Duopa initial requirement: Trial of oral levodopa/carbidopa, a dopamine agonist, AND a COMT inhibitor OR an MAO‑B inhibitor prior to Duopa.

All components listed are required prior trials.

Initial therapy requirements

Initial therapy requirements summarized for select agents:

Evenity initial requirement: Trial of bisphosphonate therapy AND trial of a RANKL‑blocking agent.

See Evenity product entry for acceptable agents (e.g., alendronate, zoledronic acid, denosumab).

Evkeeza initial requirement (HoFH): >=3‑month trial of adherent ezetimibe combined with high‑dose atorvastatin or rosuvastatin AND failure of combination therapy including a PCSK9 inhibitor.>=3 months

Adherence and maximally tolerated dosing must be documented.

Nucala initial requirement (asthma): Medium‑high dose inhaled corticosteroid AND an additional controller medication prior to Nucala for asthma indications.

See Nucala product criteria for indication‑specific controller requirements.

Initial therapy examples

Initial therapy requirements for neuromuscular blockers and other agents

Migraine initial requirement: Trial of two oral migraine preventive medications (examples provided: antidepressants, beta blockers, ACE inhibitors/ARBs, antiepileptics, calcium channel blockers) before coverage of Dysport, Myobloc, or Xeomin for migraine.two medications

An 8‑week trial per oral agent class is specified for some botulinum toxin products.

Continuation Criteria

Ophthalmic continuation criteria

Ophthalmic agents continuation considerations

Susvimo continuation: Patient must have responded to at least two intravitreal injections of a VEGF inhibitor and had inadequate response to bevacizumab AND ranibizumab (Lucentis/Byooviz) AND aflibercept (Eylea) prior to Susvimo.>=2 injections and inadequate response

Continuation/coverage requires documented inadequate response to listed prior ophthalmic VEGF inhibitors.

Step Therapy Requirements

Product	Required prior therapy (trial and failure or documented contraindication/intolerance)	Coverage status
Aralast / Glassia	Documented failure, intolerance, or contraindication to Prolastin or Zemaira (alpha-1 proteinase inhibitor products)	Covered with criteria
Duopa	Trial of all of the following: oral levodopa/carbidopa, a dopamine agonist, and a COMT inhibitor OR an MAO-B inhibitor	Covered with criteria
Xenleta	Trial of an alternative antibiotic to which the organism is susceptible (examples: moxifloxacin, levofloxacin, beta-lactam + macrolide, beta-lactam + doxycycline)	Covered with criteria
Vyepti	Trial of two oral preventive medications from two different classes AND at least 12 weeks of a CGRP antagonist AND two quarterly botulinum toxin injections (for chronic migraine)	Covered with criteria
Evenity	Trial of bisphosphonates (oral and/or IV such as alendronate, risedronate, ibandronate, or zoledronic acid) AND trial of a RANKL‑blocking agent such as denosumab	Covered with criteria
Leqvio	Trial of maximally tolerated high‑intensity statin therapy AND at least 3 months of adherent ezetimibe concomitant with statin with inadequate response, intolerance, or contraindication documented	Covered with criteria
Evkeeza (HoFH)	At least a 3‑month trial of adherent ezetimibe with highest available dose atorvastatin or rosuvastatin AND trial/failure of combination therapy including statin + ezetimibe AND a PCSK9 inhibitor	Covered with criteria
Hemophilia products (Alhemo, Hemlibra, Hympavzi, Qfitlia, Novoseven RT, Vonvendi)	Specified factor product trials as applicable: examples include trial of Hemlibra and prior prophylaxis with antihemophilic Factor VIII products (or Factor IX products for Hemophilia B) and where indicated trial of bypassing agents (e.g., NovoSeven, FEIBA); documented failure/intolerance/contraindication required per product	Covered with criteria
CAR‑T and gene therapies (Abecma, Kymriah, Yescarta)	Product‑specific prior‑line requirements (e.g., Abecma: progression on ≥4 prior lines and refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 antibody; Kymriah/Yescarta: required prior lines as specified)	Covered with criteria
Ophthalmic biologics (Beovu, Eylea, Lucentis, Susvimo, Vabysmo, etc.)	Requirement to trial and have inadequate response to bevacizumab and/or ranibizumab and/or aflibercept per indication specifics (some require response to at least two intravitreal injections) before coverage	Covered with criteria

Product / Indication	Specified trial durations and agent classes required prior to authorization	Coverage status
Leqvio (ASCVD / HeFH)	Trial of maximally tolerated high‑intensity statin therapy AND adherent ezetimibe with statin for at least 3 months with inadequate response, intolerance, or contraindication documented	Covered with criteria
Evkeeza (HoFH)	At least a 3‑month trial of adherent ezetimibe combined with highest available dose atorvastatin or rosuvastatin; and trial/failure of combination therapy including statin + ezetimibe + PCSK9 inhibitor	Covered with criteria
Actemra / other biologics (RA, JIA)	At least a 3‑month trial of adalimumab at maximum tolerated doses plus trial of one oral DMARD (e.g., methotrexate) as specified per indication	Covered with criteria
Vyepti (chronic migraine)	Trial of two oral preventive medications from two different classes AND at least 12 weeks of a CGRP antagonist prior to authorization; plus two quarterly botulinum toxin injections for chronic migraine pathway	Covered with criteria
Botulinum toxins (Dysport, Myobloc, Xeomin) for migraine	8‑week trial of two oral migraine preventive medications (examples listed) prior to coverage	Covered with criteria
Nucala / Fasenra / Cinqair (asthma, EGPA)	Asthma: trial of medium‑to‑high dose inhaled corticosteroid plus an additional controller medication; EGPA: trial of oral corticosteroids for at least 4 weeks where specified	Covered with criteria
Vyvgart / Soliris / related myasthenia gravis agents	Trials required include at least one conventional immunosuppressive agent OR chronic IVIG OR chronic plasmapheresis/plasma exchange; some pathways specify a 1‑year total trial duration	Covered with criteria

Product / Product group	Required trial of alternatives or preferred biosimilars before coverage	Coverage status
Avastin and oncology indications	Trial of preferred bevacizumab biosimilars Mvasi or Zirabev required prior to Avastin (originator) coverage for oncology indications	Covered with criteria
Herceptin (and Herceptin Hylecta)	Trial of preferred biosimilars Kanjinti or Trazimera required prior to Herceptin or Herceptin Hylecta coverage for oncology indications	Covered with criteria
Rituxan / Rituxan Hycela / Riabni	Trial of preferred biosimilars Ruxience or Truxima required prior to Rituxan products for listed indications	Covered with criteria
Ophthalmic VEGF agents (e.g., Susvimo, Vabysmo, Beovu, Eylea)	Requirement to trial bevacizumab and/or ranibizumab and/or aflibercept (or their specified biosimilars) with documented inadequate response prior to coverage of listed agents	Covered with criteria
General oncology biologics	Policy requires trial of preferred biosimilar alternatives for certain originator biologics where specified in the product listing	Covered with criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Coverage of medically administered drugs will be reviewed prospectively via the prior authorization process. Prior authorization is required for medications subject to the medically administered step therapy policy; Medicare members who have received the requested medication within the past 365 days are exempt from step therapy requirements.

Prior authorization required for step therapy products
Medicare members: exemption if same medication received within past 365 days

Documentation Required

Prior-Trial Documentation Required

Requests for medications subject to step therapy must include documentation of prior trials, failures, intolerance, or contraindications to the specified predecessor agents and the duration of those trials where noted. Failure to provide required prior-trial documentation may result in denial of the request.

Documentation must show specific agents tried and duration of therapy where stated
Examples: osteoporosis agents (bisphosphonates, denosumab) and oncology/advanced therapies require explicit prior-trial proof

Documentation Required

Advanced Therapy Prerequisites

Some advanced therapies (CAR-T, gene therapies, enzyme replacement) require documented trials of specified prior therapies and/or documented contraindications to those therapies before prior authorization will be approved. Examples include CAR-T products (e.g., Abecma, Kymriah, Yescarta) with required lines of prior systemic therapy, and gene therapies (e.g., Casgevy, Lyfgenia) with required trials of standard agents such as hydroxyurea or formulary add-on therapy.

CAR-T therapies: documented progression after required prior lines of therapy and refractory status to key classes (immunomodulatory agents, proteasome inhibitors, anti-CD38 agents)
Gene therapies: documented trial and intolerance/contraindication to indicated prior therapies (e.g., hydroxyurea for sickle cell)
Enzyme replacement: trial of indicated enzyme therapies when specified

Step Therapy

Step Therapy Requirements Summary

Step therapy requires that members fail, be intolerant to, or have a contraindication to specified alternative or predecessor agents before the requested (non-preferred) medication will be approved. Providers must document completion and failure or intolerance of the required predecessor medications listed per product. Neighborhood will give individual consideration to requests based on prescriber-submitted information.

Providers must document trials and failures, contraindications, or intolerance as specified per medication/class
Neighborhood will consider exceptions or additional clinical information submitted by the prescriber

Denial Risk

Denial Risk and Investigational Use

Use of a drug outside of guideline-based step therapy requirements (for example, without documented required predecessors) may result in non-payment unless an exception is approved. Additionally, therapies used at doses or for indications not supported by standard compendia or peer-reviewed literature are investigational and may be denied.

Noncompliant use may be denied without an approved exception
Investigational use (dose or indication not supported by AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature) may be denied

Coding and Billing

Antibiotic / Anticoagulant HCPCSHCPCS

J2021	Linezolid (per document grouping)
J2020	Linezolid alternative (per document grouping)
J2184	Meropenem (per document grouping)
J2183	Meropenem alternative (per document grouping)
J3372	Vancomycin (per document grouping)
J3371	Vancomycin alternative (per document grouping)
J1643	Heparin (per document grouping)
J1644	Heparin alternative (per document grouping)

Antineoplastic HCPCSHCPCS

J9048	Bortezomib (per document grouping)
J9046	Bortezomib (alternate code per grouping)
J9052	Carmustine (per document grouping)
J9074	Cyclophosphamide (per document grouping)
J9394	Fulvestrant (per document grouping)
J9259	Paclitaxel (per document grouping)
J9304	Pemetrexed (per document grouping)

Referenced alternative HCPCSHCPCS

J9049	Bortezomib alternative (per document grouping)
J9050	Carmustine alternative (per document grouping)
J9073	Cyclophosphamide alternative (per document grouping)

Biosimilar Step Requirements

Billing Rule

Avastin: trial of Mvasi or Zirabev required

Before coverage of Avastin for oncology indications, the provider must document trial of preferred biosimilars Mvasi or Zirabev.

Billing Rule

Herceptin/Herceptin Hylecta: trial of Kanjinti or Trazimera required

Prior authorization for Herceptin (including Herceptin Hylecta) requires documentation of a trial of Kanjinti or Trazimera before Herceptin will be authorized.

Billing Rule

Avastin (all oncology indications): biosimilar trial required

For all oncology indications, Avastin requires a documented trial of Mvasi or Zirabev prior to coverage of Avastin originator products.

Billing Rule

Herceptin products: biosimilar trial required for oncology

For oncology indications, Herceptin and Herceptin Hylecta require a documented trial of Kanjinti or Trazimera before the originator product will be authorized.

Billing Rule

Rituxan products: trial of Ruxience or Truxima required

Prior authorization for Rituxan, Riabni, or Rituxan Hycela requires documentation of trial of preferred biosimilars Ruxience or Truxima prior to coverage for the listed indications.

Definitions

RANKL-blocking agents (e.g., denosumab)

DefinitionRANKL-blocking agents (example: denosumab)

Context in policyRequired as a prior trial option before coverage of certain bone agents (e.g., Evenity requires bisphosphonate AND a RANKL-blocking agent such as denosumab)

Examples listedDenosumab referenced via Prolia/Xgeva in product-specific prior-therapy sequences

Enzyme replacement therapies (referenced as required trial options prior to alternative enzyme therapies)

DefinitionEnzyme replacement therapies (ERTs) — therapies that replace deficient enzymes (examples in policy: Cerezyme, Lumizyme)

Context in policyPolicy requires trial of specified alternative ERTs prior to coverage of some products (e.g., VPRIV and Elelyso require trial of Cerezyme; Nexviazyme requires trial of Lumizyme for certain weights/dosing)

Product examplesCerezyme, Lumizyme, Nexviazyme, VPRIV, Elelyso, Pombiliti, Opfolda

Investigational use — Use not a medically accepted indication as defined by compendia

DefinitionInvestigational use: use of a therapy at a dose or for a condition not recognized as a medically accepted indication by standard compendia or sufficient peer-reviewed literature

Coverage stanceTherapies used investigationally are not covered by Neighborhood under this policy

Reference compendiaAHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed published medical literature

Background

This medically administered step therapy policy is designed to promote the use of preferred, safe, and effective products by requiring documented trials of specified alternative therapies before coverage of non‑preferred or later‑line agents. The criteria focus on demonstration of prior therapy trial and failure, documented intolerance, or contraindication to the listed alternatives; Medicare members who received the requested medication within the prior 365 days are exempt from step therapy per the policy.

Site of Care

Note

Site‑of‑care: infusion/office/hospital implied (no specific rules)

Site-of-care requirements are not specifically listed in the policy; medically administered agents referenced imply administration in typical infusion/injection settings such as infusion center, office, or hospital outpatient.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2020

Next Review DateN/A

SourceLink

On This Page

Distinct criteria for episodic versus chronic migraine are specified in product entries.

Evkeeza (HoFH): At least a 3‑month trial of adherent ezetimibe with high‑dose atorvastatin or rosuvastatin AND trial and failure of combination therapy including statin, ezetimibe, AND a PCSK9 inhibitor.3 months

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Leqvio (ASCVD/HeFH): Trial of maximally tolerated high‑intensity statin AND at least 3 months of concomitant ezetimibe with documented inadequate response/intolerance/contraindication.>=3 months

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Abecma: Relapsed/refractory multiple myeloma: progression after 4 or more lines of therapy AND refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody.4 or more prior lines

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CAR‑T products (Kymriah / Yescarta): Indication‑specific prior‑line requirements (examples: Kymriah for pediatric/young adult B‑ALL requires progression after specified chemotherapy cycles; adult large B‑cell lymphoma requires ≥2 prior lines including rituximab and an anthracycline; Yescarta requires trial and failure of ≥2 lines including anti‑CD20+alkylator for follicular lymphoma).2+ prior lines typical

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Duchenne exon‑skipping agents (Amondys 45, Exondys 51, Viltepso, Vyondys 53): Trial of corticosteroids prior to these agents.

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Enzyme replacement and related therapies (VPRIV, Elelyso, Nexviazyme, Pombiliti, Opfolda): Trial of the specified alternative enzyme replacement(s) (e.g., Cerezyme, Lumizyme) as listed prior to coverage of the requested product.

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Casgevy / Lyfgenia (sickle cell therapies): Trial of hydroxyurea and formulary add‑on therapy (e.g., Adakveo); Lyfgenia additionally requires contraindication to or not indicated for Casgevy.

chunk 21,22

Krystexxa: Trial of allopurinol or probenecid prior to Krystexxa.

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Colony stimulating factors (non‑preferred long‑acting): Trial of preferred agents (Neulasta, Neulasta Onpro, or Udenyca) prior to non‑preferred long‑acting CSFs.

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Immune globulins (SC and IV): Trial of specified alternative IG products (e.g., Gammaked/Gamunex‑C or Gammagard liquid) for listed SC products; IVIG requires condition‑specific prerequisites or failure of immunosuppressive therapy as indicated (e.g., myasthenia gravis failing conventional immunosuppressants).

chunk 25,26

Hereditary angioedema products (Berinert, Cinryze, Haegarda, Kalbitor, Ruconest): Trial of high‑dose antihistamine for members with normal C1 inhibitor levels and family history; Cinryze additionally requires trial of on‑demand therapy and other prophylactic options for HAE with normal C1INH.

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Neurologic / autoimmune monoclonals (Nucala, Fasenra, Cinqair, Niktimvo): Specified prior controller therapy trials depending on indication (e.g., medium‑high dose ICS plus an additional controller for asthma; oral corticosteroid trial durations for EGPA), with duration requirements where stated (e.g., ≥4 weeks for oral steroids in EGPA).4 weeks or 8 weeks where specified

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Myasthenia gravis targeted agents (Imaavy, Vyvgart, Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris): Trials required include conventional immunosuppressive agents OR chronic IVIG OR chronic plasmapheresis/plasma exchange; some agents require additional trials or inadequate response to other targeted therapies and defined total trial durations (e.g., 1‑year total trial pathways).1 year total trial in certain pathways

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Botulinum toxins (Botox, Dysport, Myobloc, Xeomin): Migraine: trial of two oral preventive medications for 8 weeks prior to coverage; Urinary incontinence/OAB: trial of two medications from antimuscarinic or beta‑adrenergic classes; Chronic anal fissures: trial of conventional pharmacologic therapy.8 weeks for migraine oral medication trials

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Oncology biosimilars and originator biologics (Avastin, Herceptin, Rituxan): For oncology indications, trial of preferred biosimilars or listed alternatives is required prior to coverage of the originator agent (e.g., Mvasi or Zirabev before Avastin; Kanjinti or Trazimera before Herceptin; Ruxience or Truxima before Rituxan products).

chunk 37,38

Other disease‑specific prerequisites: Examples include leucovorin for folate‑antagonist overdose/osteosarcoma/colorectal cancer; corticosteroid trial for chronic/acute GVHD; octreotide or lanreotide trial for acromegaly; pyridoxine trial for primary hyperoxaluria, as listed per product.trial of specified therapy

chunk 38,39,40

trial of conventional therapy

Per product‑specific entries.

Ophthalmic biologics (Beovu, Eylea, Lucentis, Byooviz, Susvimo, Vabysmo): Requirement to trial and have inadequate response to bevacizumab and/or ranibizumab and/or aflibercept per indication-specific criteria (some products require response assessment after at least two intravitreal injections of a VEGF inhibitor).specific prior agents and number of injections where noted

Some products require response to ≥2 intravitreal injections before escalation.

Oncology biologics: Trial of preferred biosimilar alternatives required for certain originator agents (e.g., trial of Mvasi or Zirabev before Avastin; trial of Ruxience or Truxima before Rituxan products).trial of specified biosimilars

Applies to oncology indications listed.

Rheumatologic indications (e.g., Rituxan for RA): Requirement for prior trial of one oral DMARD AND at least one preferred TNF antagonist (one must be self‑injectable) before coverage.DMARD + TNF antagonist

Per Rituxan/Riabni product criteria.

Other disease‑specific requirements: Examples include leucovorin for folate‑antagonist overdose, corticosteroids for GVHD, octreotide/lanreotide for acromegaly, and pyridoxine for primary hyperoxaluria as required per product entries.trial of specified therapy

Per individual product lines in the document.

OpenPayer

Medically Administered Step Therapy Policy

Coverage Criteria

Initial Therapy Criteria

Continuation Criteria

Step Therapy Requirements

Provider Actions and Requirements

Coding and Billing

Biosimilar Step Requirements

Definitions

Background

Site of Care