CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medically Administered Therapy Policy Step

Defines step therapy and prior authorization requirements for medically administered specialty drugs under the medical benefit for Medicaid and Commercial members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Therapy Policy Step

Policy CodePolicy N/A

Change TypeNo material change

Effective Date10/01/2020

Next Review Date

Key ActionObtain prospective prior authorization with documentation of required prior trials, failures, contraindications, or intolerance to specified preferred agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10/01/2020effective date

11/15/2024most recent review

100+listed step drugs

20+distinct agents in excerpt

multiplecommon prerequisite

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Coverage Criteria for Medically Administered Specialty Drugs

General step therapy criteria

Covered when the following are met for each listed agent:

General step requirement: Prior trial and failure, intolerance, or contraindication to specified preferred agent(s) as listed per drug (examples include trials of adalimumab before certain biologics; trial of alternative oral Parkinson's medications before Duopa; trial of Cortrophin Gel before Acthar Gel).

Specific alternate agents and classes are enumerated per agent in the policy.

Vyepti criteria

Vyepti (chronic migraine) coverage conditions:

Vyepti chronic migraine: Trial of two oral preventive medications from two different classes AND trial of at least 12 weeks of two calcitonin gene-related peptide (CGRP) antagonists AND two quarterly botulinum toxin injections for the chronic migraine indication.12 weeks per CGRP antagonist

For episodic migraines: trial of two oral medications from two different classes AND trial of at least 12 weeks of two CGRP antagonists.

Leqvio criteria

Lipid-lowering agent (Leqvio) coverage conditions:

Leqvio (ASCVD / HeFH): Member has ASCVD or heterozygous familial hypercholesterolemia (HeFH); trial of a maximally tolerated high-intensity statin (e.g., atorvastatin 40–80 mg, rosuvastatin 20–40 mg, or simvastatin 80 mg) AND adherent concomitant therapy with ezetimibe for at least 3 months, with inadequate response, intolerance, or contraindication to these treatments prior to approval.3 months

Maximally tolerated statin doses are enumerated in the policy.

Hemophilia agent criteria

Hemophilia / antihemophilic agents:

Hemophilia agents: Coverage requires documented prior trials as specified per product (examples: trial of Hemlibra and prior prophylaxis with a Factor VIII product for certain Hemophilia A indications; trial of at least one Factor IX product and Hemlibra for some Hemophilia B entries).

Required prior therapies differ by product (Alhemo, Hympavzi, Qfitlia, etc.) and are enumerated per agent.

Lipid-lowering biologics (Leqvio / PCSK9)

Examples of drug-specific covered criteria (selected from excerpt):

Leqvio / PCSK9-class prerequisites: Member has ASCVD or HeFH; trial of the highest available or maximally tolerated dose of a high-intensity statin AND adherent ezetimibe concomitant therapy for at least 3 months; demonstrated inadequate response, intolerance, or contraindication to those treatments.3 months ezetimibe trial

Policy lists exact statin doses and concomitant ezetimibe requirement.

CAR-T therapies

CAR-T therapies — example coverage conditions

Abecma for relapsed/refractory multiple myeloma: Disease progressed after 4 or more prior lines of therapy AND refractory to an immunomodulatory agent (lenalidomide/thalidomide/pomalidomide), a proteasome inhibitor (bortezomib, carfilzomib, ixazomib), and an anti‑CD38 monoclonal antibody (daratumumab, isatuximab).4+ prior lines

Example CAR‑T eligibility criteria from the policy.

Yescarta for Non‑Hodgkin lymphomas: Trial and failure of two or more lines of systemic chemotherapy OR for DLBCL failure of two or more systemic chemotherapy regimens including rituximab and an anthracycline.2+ prior lines

Specific histology‑dependent chemotherapy requirements are enumerated in the policy.

Myasthenia gravis biologics and infusion options

Myasthenia gravis and related neuromuscular disorders — biologic coverage predicates

General MG biologic prerequisite: Trial of conventional agents (eg, corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR chronic IVIG OR chronic plasmapheresis/plasma exchange as specified (often a cumulative ~1‑year total trial or recurring treatment at specified intervals) prior to approval of biologic therapy.

Policy references required trials of conventional immunosuppressants, IVIG, or plasmapheresis for MG biologic eligibility.

Vyvgart IV high‑dose (Medicaid) specific requirement: For Medicaid members requesting Vyvgart IV at weekly doses requiring 3 vials (>800 mg to 1200 mg), documentation that the member is unable to tolerate Vyvgart Hytrulo (SC) is required.>800 mg weekly

This site‑of‑care / formulation tolerance requirement applies to specified Medicaid requests.

Immune globulin therapy

IVIG and subcutaneous IG coverage contexts

Immune globulin (IVIG/SCIG) prerequisites: For indications such as IgG subclass deficiency, myasthenia gravis, dermatomyositis, CIDP and other autoimmune conditions, trial of conventional immunosuppressants or corticosteroids and/or prophylactic antibiotics is required prior to IVIG or SCIG approval; for SCIG products the policy prefers trial of specified IV/SC formulations (eg, Gammaked, Gamunex‑C) first.

Policy enumerates product‑specific sequencing and requirement to trial listed formulations prior to SCIG coverage.

Dysport and other neuromuscular blocker agents

Agent-specific pre-authorization criteria (examples from this section):

Dysport and related neuromuscular blockers: For migraine prevention: trial of two oral preventive medications from different classes (eg, antidepressants, beta‑blockers, ACE inhibitors/ARBs, anti‑epileptics, calcium channel blockers). For chronic anal fissures: trial of conventional pharmacologic therapy (eg, topical nifedipine, diltiazem, topical nitroglycerin). For neurogenic detrusor overactivity/OAB: trial of two medications from antimuscarinic or beta‑adrenergic classes. For severe primary axillary hyperhidrosis: trial and failure of >1 month of a topical agent (eg, aluminum chloride, glycopyrronium) prior to coverage.

Examples of condition‑specific step requirements for Dysport, Myobloc, Xeomin are provided.

Rituximab indications and prior therapy requirements

Rituximab (Rituxan, biosimilars) examples:

Rheumatoid arthritis: Member has tried one oral disease‑modifying antirheumatic drug (DMARD) AND at least one preferred TNF antagonist (one must be self‑injectable) for at least 3 months prior to rituximab approval.3 months

Policy lists disease‑specific prior therapy requirements for rituximab across multiple indications.

Lupus nephritis: Disease non‑responsive or refractory to standard first‑line therapy (eg, mycophenolate mofetil, mycophenolic acid, cyclophosphamide, calcineurin inhibitors) prior to rituximab consideration.

Systemic lupus erythematosus (SLE): Trial of at least two standard therapies such as antimalarials (hydroxychloroquine, chloroquine), corticosteroids, NSAIDs, or immunosuppressives (azathioprine, methotrexate) prior to rituximab.

Ophthalmic agents prior trial requirements

Ophthalmic anti-VEGF and related agents — common step requirements:

Ophthalmic anti‑VEGF agents (Beovu, Eylea, etc.): For neovascular (wet) AMD and other retinal conditions: trial of bevacizumab or ranibizumab per indication is required prior to authorization of higher‑cost agents. For DME: bevacizumab or ranibizumab when baseline visual acuity is 20/50 or worse; bevacizumab preferred when better than 20/50. Susvimo requires prior response to at least two intravitreal VEGF injections and inadequate response to bevacizumab, ranibizumab (Byooviz/Lucentis), and aflibercept (Eylea) prior to approval.

Policy enumerates specific agent sequencing and visual acuity‑based preferences.

Investigational use and P&T rationale

General investigational stance and formulary process:

Investigational use: Therapies used at doses or for conditions not recognized as medically accepted indications in standard compendia (AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or the peer‑reviewed literature are considered investigational and are not covered. Neighborhood considers FDA labeling and relevant clinical literature; P&T Committee reviews and individual consideration is possible based on submitted clinical information.

Investigational use is excluded from coverage per policy.

The Medically Administered Step Therapy Policy provides coverage for preferred medications under the Medical Benefit when use is within the stated guidelines. Use outside of these guidelines may result in non-payment unless approved under an exception process.

Within the excerpt provided there are no explicit exclusions listed beyond the drug-specific prerequisites described elsewhere in the policy.

Therapies used at a dose or for a condition that are not recognized as medically accepted indications in standard reference compendia (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs, or peer‑reviewed literature) are considered investigational and are not covered. Requests for such investigational uses may be denied.

No explicit statement labeling therapies as “not medically necessary” appears in the provided excerpt.

Coding and Billing Codes

Selected J-codes (examples)HCPCS

J2021	linezolid
J2020	linezolid (alternate code listed)
J2184	meropenem
J2183	meropenem (alternate)
J2185	meropenem (alternate)
J3372	vancomycin
J3371	vancomycin (alternate)
J3370	vancomycin (alternate)
J1643	heparin
J1644	heparin (alternate)

Antineoplastic J-codes (examples)HCPCS

J9048	bortezomib
J9046	bortezomib (alternate)
J9052	carmustine
J9074	cyclophosphamide
J9394	fulvestrant
J9259	paclitaxel
J9304	pemetrexed

No explicit CPT/HCPCS/ICD-10 codes in this excerptmixed

No codes listed

Vyvgart IV vial threshold — weekly dose requiring 3 vials (>800 mg to 1200 mg)

Threshold>800 mg weekly (requires 3 vials; weekly dose range ~>800 mg to 1200 mg)

ContextApplies to Vyvgart IV requests for myasthenia gravis where weekly dosing requires 3 vials

RequirementDocumentation that the member cannot tolerate Vyvgart Hytrulo (SC formulation) is required for Medicaid members at this dosing level

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medically administered and many specialty agents. Requests must be submitted prospectively (prior to administration) and include a clear clinical rationale demonstrating the medical necessity of the requested therapy.

Authorization must be obtained prior to service for drugs administered in outpatient or physician office settings.
Approval is contingent on meeting the specific clinical coverage criteria listed in this policy (including required prior trials, diagnostics, and diagnosis codes).
Contact Pharmacy Help Desk: 1-401-459-6020 (Medicaid/process) or Member Services: 1-855-321-9244 (Commercial) for authorization submission guidance.

Step Therapy

Step Therapy Requirement

Step therapy (required trials and failures) is enforced for numerous agents. Prior trials of specified preferred or formulary therapies, or documented contraindication/intolerance to those agents, must be shown before non-preferred or later-line therapies will be approved.

Examples: statins and ezetimibe prior to inclisiran/PCSK9 pathway agents; highest tolerated statin + ezetimibe for at least 3 months prior to Leqvio.
For migraine agents and biologics, trials of two different oral preventive classes and trials of CGRP agents or botulinum toxin as specified are required.
For ophthalmic VEGF inhibitors and related agents, trials of bevacizumab and/or ranibizumab/aflibercept are required per indication prior to newer or non-preferred agents.

Documentation Required

Prior Therapy Documentation / Clinical Information Required

Clinical documentation of prior therapies, trials, and failures is required with every authorization request. The prescriber must submit records showing prior medication names, doses, dates of therapy, reason for discontinuation (e.g., lack of efficacy, intolerance, contraindication), and relevant diagnostic information.

Include prior line(s) of systemic chemotherapy where applicable (e.g., CAR-T therapy requests must document number and types of prior chemotherapy regimens).
For specialty biologics and gene or cell therapies, include prior use of required agents such as rituximab, anthracycline exposure, immunomodulators, proteasome inhibitors, or other named drugs per the criteria.
Attach clinic notes, infusion records, imaging, labs, and pathology reports as needed to demonstrate treatment history and current disease status.

Denial Risk

Non-Payment Risk for Non-Guideline Use

Use outside the stated clinical guidelines may result in non-payment unless an exception is approved. Requests that do not meet adopted coverage criteria or lack required documentation may be denied or held for peer review.

Non-guideline use (dose or condition not listed as a medically accepted indication) is at risk for non-payment unless an exception is authorized.
Neighborhood will consider individual exceptions when sufficient prescriber-submitted justification and supporting literature are provided.

Denial Risk

Investigational Use Denial

Requests for therapies used for investigational purposes (dose or condition not recognized as medically accepted indications in standard compendia or peer-reviewed literature) will be denied. Neighborhood does not provide coverage for investigational uses.

Medically accepted indications are those supported by AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed published medical literature.
If the requested use is not listed as an accepted indication in these references, provide high-quality evidence and rationale for exception consideration; otherwise the request will be denied.

Denial Risk

Failure to Meet Prior Chemotherapy or Line-of-Therapy Requirements

Specific failure-to-trial requirements apply to certain high-cost therapies such as CAR-T and gene therapies. Failure to document the required number and types of prior systemic chemotherapy lines or other mandated prior treatments will result in denial.

Examples: CAR-T therapies (e.g., Yescarta, Kymriah, Abecma) require documentation of the specified number of prior lines of systemic chemotherapy and failure/refractoriness to named agents (e.g., rituximab + anthracycline for DLBCL).
Gene therapies and other advanced treatments (e.g., Casgevy, Lyfgenia) require documented trial of hydroxyurea and formulary add-on therapy where specified before authorization will be considered.
If required chemotherapy or prior-line criteria are not met, include clinical justification for why standard therapies were not appropriate (contraindication/intolerance) to support an exception review.

Prior Authorization

Prospective Prior Authorization and Required Clinical Rationale

Prospective review is required: authorization decisions are made on submitted clinical information prior to drug administration. Provide a complete rationale that ties the member's diagnosis and prior treatment history to the specific coverage criteria.

Prospective prior authorization ensures coverage under the Medical Benefit; retrospective requests are subject to higher denial risk.
Documentation should explicitly reference the policy criteria being met (e.g., specific required prior agents, durations, doses, and documented intolerances).

Policy Background and Scope

This policy applies step therapy logic to a broad set of medically administered specialty drugs — including anti‑infectives, antineoplastics, biologics, anti‑hemophilic agents, immune modulators and other specialty products — and requires documented trials of specified alternative or preferred agents (with failure, intolerance, or contraindication) before certain higher‑cost or non‑preferred therapies are authorized.

Definitions and Key Terms

Medically administered — Medically administered therapy

DefinitionMedically administered therapy: drugs administered under the medical benefit and reviewed via prospective prior authorization processes.

Review processCoverage is reviewed prospectively via authorization based on drug-specific criteria; prescriber must submit clinical information demonstrating criteria are met.

ExamplesIncludes infusion/medically administered agents such as Acthar Gel, Duopa, enzyme replacement therapies, biologics listed in the policy.

Maximally-tolerated statin therapy

DefinitionMaximally-tolerated statin therapy: use of the highest available dose or the maximally tolerated dose of high-intensity HMG-CoA reductase inhibitors (e.g., atorvastatin 40 mg or 80 mg daily; rosuvastatin 20 mg or 40 mg daily; simvastatin 80 mg daily).

Concomitant therapyAdherence to ezetimibe used concomitantly with a statin at maximally tolerated dose for at least 3 months is required prior to Leqvio/PCSK9-class approval.

PurposeRequired to demonstrate inadequate response, intolerance, or contraindication before approval of certain lipid-lowering biologics.

Investigational use

DefinitionInvestigational use: therapy used at a dose or for a condition not recognized as a medically accepted indication in standard compendia (AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or peer‑reviewed literature.

Coverage stanceNeighborhood does not provide coverage for drugs when used for investigational purposes.

Evidence standardUse is investigational unless sufficient evidence in standard compendia or peer‑reviewed literature supports the indication or dose.

Initial Therapy and Authorization Requirements

Initial therapy requirements

Initial authorization requires documented trials of first-line/preferred agents.

Initial authorization: Documentation of trial and failure, intolerance, or contraindication to specified alternative or preferred agents as listed per drug; prior authorization review is required prospectively.

Specific alternative agents and durations are enumerated for each named agent in the policy.

Initial therapy prerequisites

Initial therapy prerequisites for several gene therapies, ERTs, and immune globulins

Duchenne gene therapy and ERT prerequisites: For Duchenne agents (Amondys45, Exondys51, Viltepso, Vyondys53, Elevidys): trial of corticosteroids and stable dosing prior to initiation; for some ERTs (Elelyso, VPRIV) a trial of Cerezyme is required; Nexviazyme requires trial of Lumizyme for certain dosing scenarios.

Policy specifies product‑level prerequisite therapies prior to gene therapy or ERT approval.

Subcutaneous immune globulin prerequisites: For SCIG products (Cuvitru, Cutaquig, Xembify, Hizentra, Hyqvia): trial of one of the specified IV/SC formulations (eg, Gammaked, Gamunex‑C, Gammagard liquid) prior to SCIG coverage.

Policy enumerates preferred initial IV/SC products to be trialed before SCIG approval.

Initial therapy requirements

Initial therapy / step requirements for selected agents:

Ophthalmic initial therapy: Higher‑cost ophthalmic agents require prior trial of bevacizumab or other listed anti‑VEGF agents per specific indication prior to authorization of agents such as Eylea, Pavblu, Byooviz, Lucentis, Susvimo, Vabysmo, or Cimerli.

Visual acuity and indication‑specific preferences are provided in the policy.

Glaucoma implants (Durysta, iDose TR): Trial of two ophthalmic prostaglandin analogs and at least one other intraocular pressure‑lowering ophthalmic product from a different class prior to coverage.

Policy requires multi‑agent topical trial prior to implant approval.

Step Therapy Rules and Required Trials

Requirement	Example agents / sequencing
Prior trial and documented failure, intolerance, or contraindication to specified preferred alternatives before approval	Examples: trial of adalimumab (or infliximab where listed) before approval of certain biologics; ustekinumab/ infliximab trials required prior to some IL‑23/IL‑12 agents
At least a 3-month trial at maximum tolerated doses of listed TNF or infusion biologics where specified	Examples: for Crohn’s/ulcerative colitis: 3‑month trial of infliximab IV or adalimumab at maximum tolerated doses prior to ustekinumab or biosimilars
Requirement applies across autoimmune and other specialty biologics per drug‑specific entries	Examples: Cosentyx (psoriatic disease) requires a 3‑month trial of adalimumab at maximum tolerated dose and 6‑month trial of ustekinumab where indicated

Requirement	Illustrative examples
Step-up from conventional, less costly, or formulary options prior to specialty biologic authorization	Examples: Leqvio/PCSK9 pathway requires trial of maximally tolerated high‑intensity statin plus ezetimibe for ≥3 months before approval of siRNA/PCSK9 agents
Trial(s) of standard therapies or oral agents from different classes before advanced treatments	Examples: migraine prevention — trial of two oral preventive medications from two different classes and two CGRP antagonist trials (12 weeks each) before Vyepti for chronic migraine
For some indications, trial and failure of multiple standard systemic therapies required prior to advanced cellular therapies	Examples: CAR‑T (Abecma) requires progression after ≥4 prior lines including specified classes; Yescarta examples require failure of ≥2 systemic chemotherapy lines

Prior therapy required	Documentation expected
Specified prior trials of agents or classes (with documented inadequate response, intolerance, or contraindication)	Examples: ophthalmic agents — trial of bevacizumab or ranibizumab per indication prior to Beovu, Eylea, Cimerli, Susvimo, Vabysmo; documentation of inadequate response where required
Trials of conventional immunosuppressants, IVIG, or plasmapheresis for neuromuscular disorders before biologics	Examples: myasthenia gravis — trial of at least one conventional agent (e.g., mycophenolate, tacrolimus, methotrexate, cyclophosphamide) OR chronic IVIG or chronic plasmapheresis prior to agents like Vyvgart; for high weekly Vyvgart IV doses (>800 mg) Medicaid requires documentation that Hytrulo is not tolerated
Trials of disease‑specific standard therapies (dose/duration specified where applicable) prior to specialty agents	Examples: Cosentyx/other autoimmune agents require specified trials (e.g., 3 months of infliximab or adalimumab and duration of ustekinumab as listed); Leqvio requires ≥3 months of concomitant ezetimibe with maximally tolerated statin

Site of Care and Infusion Considerations

Billing Rule

Vyvgart IV high‑dose: document intolerance to SC Vyvgart Hytrulo

For Vyvgart IV requests at high weekly doses requiring 3 vials (>800 mg to 1200 mg), documentation that the member cannot tolerate the subcutaneous Vyvgart Hytrulo formulation is required for Medicaid members.

This documentation compares tolerability of the SC formulation and supports use of high‑dose IV Vyvgart.

Note

No explicit site‑of‑care restrictions noted

No explicit site‑of‑care restrictions are listed in this section of the policy.

Biosimilar Preference and Substitution Guidance

Billing Rule

Avastin oncology: trial Mvasi or Zirabev first

For oncology indications of bevacizumab (Avastin), a trial of biosimilars Mvasi or Zirabev is referenced prior to coverage of the reference product.

Policy entry: 'All Oncology Indications: Trial of Mvasi Or Zirabev.'

Billing Rule

Herceptin: trial biosimilars Kanjinti or Trazimera

Kanjinti or Trazimera are listed as alternatives for all indications of Herceptin and its Hylecta formulation; prescribers should document prior trial of these biosimilars when applicable.

Policy entry: 'Herceptin and Biosimilars, All indications: Kanjinti Or Trazimera.'

Billing Rule

Rituxan: trial biosimilars Truxima or Ruxience

Truxima or Ruxience are listed as alternatives for all indications of Rituxan (including Rituxan Hycela and Riabni); document prior biosimilar use per policy when applicable.

Policy entry: 'Rituxan... All indications: Truxima or Ruxience.'

Policy Revision History

2024-11-15reviewLatest

Most recent clinical review of the Medically Administered Therapy Step policy was completed.

2024-10-23review

Policy underwent a scheduled review prior to the November 2024 update.

2024-08-28review

Policy review conducted as part of routine maintenance in August 2024.

2024-07-26review

Policy reviewed in July 2024 as recorded in the review history.

2024-06-26review

Policy reviewed in June 2024 per the document review log.

2024-05-29review

Policy review entry recorded on May 29, 2024.

2024-05-08review

Policy review entry recorded on May 8, 2024.

2023-12-27review

Policy review recorded December 27, 2023.

2023-11-30review

Policy review recorded November 30, 2023.

2023-10-19review

Policy review recorded October 19, 2023.

2023-09-28review

Policy review recorded September 28, 2023.

2023-09-14review

Policy review recorded September 14, 2023.

2023-08-10review

Policy review recorded August 10, 2023.

2023-07-27review

Policy review recorded July 27, 2023.

2023-07-06review

Policy review recorded July 6, 2023.

2023-05-31review

Policy review recorded May 31, 2023.

2023-05-19review

Policy review recorded May 19, 2023.

2023-04-27review

Policy review recorded April 27, 2023.

2023-03-23review

Policy review recorded March 23, 2023.

2023-02-16review

Policy review recorded February 16, 2023.

2023-01-27review

Policy review recorded January 27, 2023.

2023-01-03review

Policy review recorded January 3, 2023.

2022-11-10review

Policy review recorded November 10, 2022.

2021-10-28review

Policy review recorded October 28, 2021.

2021-09-28review

Policy review recorded September 28, 2021.

2021-07-29review

Policy review recorded July 29, 2021.

2021-06-24review

Policy review recorded June 24, 2021.

2021-05-27review

Policy review recorded May 27, 2021.

2021-04-29review

Policy review recorded April 29, 2021.

2021-02-25review

Policy review recorded February 25, 2021.

2021-01-28review

Policy review recorded January 28, 2021.

2020-12-28review

Policy review recorded December 28, 2020.

2020-11-23review

Policy review recorded November 23, 2020.

2020-09-21review

Policy review recorded September 21, 2020.

2020-01-01effective

Policy effective date established.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Therapy Policy Step

Policy CodePolicy N/A

Change TypeNo material change

Effective Date10/01/2020

Next Review Date

Key ActionObtain prospective prior authorization with documentation of required prior trials, failures, contraindications, or intolerance to specified preferred agents.

SourceLink

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