CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medically Administered Step Therapy Policy

Defines step therapy requirements and prior authorization criteria for medically administered drugs under the Medicare medical benefit; applies to Medicare members and providers seeking coverage for the listed infused/injected therapies.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective Date10/01/2020

Next Review DateN/A

Key ActionSubmit prior authorization including documented trials/failures of specified preferred agents or an exception rationale; members with prior receipt within 365 days are exempt from step therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10/01/2020effective date

Medicarescope population

365 daysprevious receipt exemption

specialtyfocus

multipletrial requirements

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Coverage and Step Therapy Criteria

inv-01: General Prior Authorization and Exemption

Covered when ALL of the following are met

General: Coverage is provided when the requested medically administered medication is medically necessary, covered under the Medicare Medical Benefit, and prior authorization documents required step-therapy trials or documents an approved exception.

Medicare members who have previously received the requested medication within the past 365 days are not subject to Step Therapy Requirements.

inv-02: Drug-specific Step Therapy Criteria (examples)

Drug-specific required prior trials or failures

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

See chunk 3.

Duopa: Trial of all of the following: oral levodopa/carbidopa, a dopamine agonist, and either a COMT inhibitor OR an MAO-B inhibitor.

See chunk 3.

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

See chunk 4.

Vyepti - chronic migraine: Trial of two oral medications from two different classes for prevention, AND trial of at least 12 weeks of one CGRP antagonist, AND two quarterly injections of botulinum toxin.12 weeks for CGRP trial; 2 quarterly botulinum toxin injections

See chunks 6 and 7.

Hemophilia agents (examples): For Hemophilia A and B products: documented trials of specified factor VIII or IX products and trials of Hemlibra or bypassing agents as indicated (e.g., NovoSeven, FEIBA) per product-specific pathways.

See chunks 4-6, 23-24.

inv-03: Agent-specific prior therapy and step requirements

Covered when the specific prior therapy trials or prerequisites listed for each medication are met

Statin-based lipid therapy prerequisite: Member has been treated with a maximally-tolerated high-intensity statin (examples: atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg, simvastatin 80 mg) and adherent to ezetimibe concomitantly for at least three months with inadequate response, intolerance, or contraindication.3 months

Supports eligibility for select lipid-lowering agents (chunk 18).

CAR-T / oncology prior therapy: Member has progressed after or failed the specified number of prior systemic therapy lines and required classes (examples: Abecma requires progression on ≥4 lines including immunomodulatory agent, proteasome inhibitor, and anti‑CD38; Kymriah/Yescarta require specified prior lines including rituximab and an anthracycline where indicated).as specified per agent

See chunks 18-20.

Duchenne exon‑skipping and gene therapies:

inv-04: Initial and step therapy coverage criteria

Coverage of listed specialty agents is allowed when the specific prior trial requirements for the indication are met as follows.

OAB / Neurogenic Detrusor Overactivity: Trial of two medications from either the antimuscarinic or beta‑adrenergic classes is required prior to coverage of neuromuscular blocker agents (e.g., Botox, Dysport, Myobloc, Xeomin).two medications

See chunks 36 and 37.

Migraine prevention (botulinum toxins): Trial of two oral preventive medications (examples: antidepressants, beta blockers, ACE inhibitors/ARBs, anti‑epileptics, calcium channel blockers) is required prior to Botox/Dysport/Myobloc/Xeomin for migraine prevention (commonly 8 weeks per agent).two medications; ~8 weeks per agent

See chunks 34-36.

Ophthalmic VEGF inhibitor sequencing (general): For many ophthalmic indications (wet AMD, DME, DR, RVO, ROP), prior trial(s) of bevacizumab and/or ranibizumab and in some cases aflibercept are required depending on baseline visual acuity and indication before coverage of other agents (examples include Beovu, Eylea variants, Cimerli, Byooviz, Susvimo, Vabysmo).

The policy covers medically administered step therapy under the Medical Benefit. Use outside of the listed guidelines may result in non-payment unless approved under an exception process. Providers should follow the step therapy pathways and request an exception when clinical circumstances justify departure from the guidelines.

This extract does not list explicit broad exclusions; instead it focuses on specific prior-trial and step-therapy requirements for individual agents and indications. Coverage determinations depend on documentation that the required prior therapies, durations, or therapy sequencing have been met for the requested drug.

Neighborhood does not provide coverage for drugs when they are used for investigational purposes. Therapies prescribed at doses or for conditions that are not recognized as medically accepted indications in standard reference compendia or peer‑reviewed literature will be considered investigational and may be denied.

Initial Therapy Requirements

inv-25: Initial trials

Initial required trials before coverage of non-preferred or later-line medically administered agents

Aralast/Glassia initial: Documented failure, intolerance, or contraindication to Prolastin or Zemaira is required prior to Aralast or Glassia for AAT deficiency-related emphysema.

See chunk 3.

Duopa initial: Trial of oral levodopa/carbidopa, a dopamine agonist, and either a COMT inhibitor OR an MAO‑B inhibitor is required prior to Duopa.

See chunk 3.

inv-26: Initial therapy requirements

Initial authorization requires documented trials of specified prior therapies.

Statin + ezetimibe prerequisite for select lipid agents:

Step Therapy Tables and Examples

Requirement	Example(s) / Notes
Providers must document prior trials, failures, intolerances, or contraindications to specified preferred or formulary agents as required by the drug-specific step therapy criteria.
Examples throughout the policy include documented failure/intolerance to Prolastin or Zemaira before Aralast/Glassia; trials of oral levodopa/carbidopa ± adjunct agents before Duopa; and 3-month trials of adalimumab/ustekinumab or other specified biologics prior to later-line autoimmune agents.

Requirement	Example(s) / Notes
Trials of lower‑tier, formulary, or alternative agents must be documented prior to coverage of non‑preferred or higher‑line biologics/agents.
Examples: trial of Neulasta or other preferred CSFs before long‑acting colony stimulating factors; trial of inhaled corticosteroid plus an additional controller before biologics for asthma; intranasal corticosteroid (≥8 weeks) and systemic corticosteroid courses for nasal polyps prior to monoclonal antibody therapy.

Requirement	Example(s) / Notes
Sequential trials of preferred or available agents are required before coverage of non‑preferred, newer specialty, or branded agents; documentation of inadequate response, contraindication, or intolerance must be provided.
Examples: trial of two medications from antimuscarinic or beta‑adrenergic classes before neuromuscular blocker agents for OAB; sequential trials of bevacizumab and/or ranibizumab (and aflibercept when specified) before coverage of other ophthalmic VEGF agents (Susvimo requires response to ≥2 VEGF injections and inadequate response to bevacizumab, ranibizumab, and aflibercept); trial of preferred biosimilars (e.g., Mvasi/Zirabev before Avastin; Kanjinti/Trazimera before Herceptin) for oncology indications.

Requirement

Example(s) / Notes

Sequential trials of preferred or available agents are required before coverage of non‑preferred, newer specialty, or branded agents; documentation of inadequate response, contraindication, or intolerance must be provided.

Examples: trial of two medications from antimuscarinic or beta‑adrenergic classes before neuromuscular blocker agents for OAB; sequential trials of bevacizumab and/or ranibizumab (and aflibercept when specified) before coverage of other ophthalmic VEGF agents (Susvimo requires response to ≥2 VEGF injections and inadequate response to bevacizumab, ranibizumab, and aflibercept); trial of preferred biosimilars (e.g., Mvasi/Zirabev before Avastin; Kanjinti/Trazimera before Herceptin) for oncology indications.

Prior Authorization, Documentation, and Payment Risk

Prior Authorization

Prior Authorization Required — Provider Actions

Coverage of medically administered drugs will be reviewed prospectively via the prior authorization process. Prior authorization requires documentation of prior medication trials and/or failures of specified preferred medications or classes before authorization will be granted. Providers must submit detailed prior therapy documentation (drug names, durations, reasons for discontinuation such as intolerance or contraindication) as part of the request.

Medicare members who have previously received the requested medication within the past 365 days are not subject to Step Therapy Requirements.
Prior authorization may require trials of maximally tolerated high-intensity statin plus ezetimibe (and documentation of intolerance or contraindication) where applicable (e.g., lipid-lowering agents such as Leqvio and Evkeeza).
Step/therapeutic alternatives are required for many biologic and specialty agents — providers must document trials of specified preferred agents (examples in policy: trials of Prolastin or Zemaira prior to Aralast/Glassia; trials of adalimumab/infliximab or ustekinumab prior to certain psoriasis/Crohn's agents).
Step therapy/trial requirements often specify number of trials or duration (e.g., two oral preventive migraine agents and a 12-week trial of a CGRP antagonist prior to Vyepti; trials of 3 months or 6 months for various biologics as listed).
Use of drugs for investigational purposes (dose or condition not recognized as medically accepted indications per AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature) is considered investigational and will be denied; Neighborhood does not provide coverage for investigational use.

Procedure and Billing Codes

Procedure/Billing codes mentionedHCPCS

J2021	Linezolid (non-specific unit) - listed for step therapy
J2020	Linezolid (prior code) - required trial before J2021
J2184	Meropenem (listed)
J2183	Meropenem (prior code trial)
J3372	Vancomycin (listed)
J3371	Vancomycin prior code
J1643	Heparin (listed)
J1644	Heparin prior code
J9048	Bortezomib (listed)
J9046	Bortezomib (listed)

1–10 of 15

1/2

Biosimilar Step Requirements

Billing Rule

Trial of Mvasi or Zirabev required before Avastin

Before Avastin or its listed products (Alymsys, Vegzelma) are authorized for oncology indications, providers must document a trial of the preferred biosimilars Mvasi or Zirabev.

Billing Rule

Trial of Kanjinti or Trazimera required before Herceptin

Prior to Herceptin or Herceptin Hylecta for oncology indications, providers must document a trial of the preferred biosimilars Kanjinti or Trazimera.

Billing Rule

Preferred biosimilar trial required for Avastin products

For oncology indications of Avastin, Alymsys, or Vegzelma, a trial of Mvasi or Zirabev is required before authorization of Avastin or its listed products.

Policy Scope and Context

This policy governs medically administered (infusion or injection) therapies across multiple therapeutic areas and specifies required prior trials, sequencing, and documentation that must be met before coverage is approved. Prior authorization is required and providers must document trials of preferred or alternative agents, specified durations (for example, at least three months of maximally‑tolerated high‑intensity statin therapy with concomitant ezetimibe where applicable), or failure/intolerance to listed therapies. In some conditions (e.g., chronic autoimmune disorders) the policy requires specified totals of prior immunosuppressive therapy or courses of IVIG/plasmapheresis before certain monoclonal antibody agents will be approved.

Key Definitions

inv-23: Preferred Medication(s)

DefinitionMedications designated by the payer as preferred within a class that should generally be tried first under the step therapy framework.

Typical roleServes as the first-line agents that prescribers must document trials of prior to approval of non-preferred or later-line medically administered therapies.

Exemption noteMedicare members with prior receipt of the requested medication within 365 days are exempt from Step Therapy requirements.

Related actionsPrior authorization reviews require documentation of trials, failures, intolerances, or contraindications to preferred medications.

Policy consequenceUse outside the listed step therapy guidelines may result in non-payment unless approved under an exception process.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective Date10/01/2020

Next Review DateN/A

SourceLink

On This Page

Prior trial of corticosteroids (stable dose where specified) required before exon‑skipping agents (Exondys 51, Amondys 45, Viltepso, Vyondys 53) and stable corticosteroid dosing required prior to Elevidys.

stable steroid dosing where specified

Enzyme replacement therapies: Trial of specified enzyme replacement or formulary agent (e.g., trial of Cerezyme or Lumizyme where indicated) required prior to listed replacement products (e.g., VPRIV, Elelyso, Nexviazyme, Pombiliti, Opfolda).agent-specific

See chunk 20.

Sickle cell / gene therapy prerequisites: Documented trial of hydroxyurea and formulary add-on therapy (e.g., Adakveo) required before Casgevy; Lyfgenia allowed when Casgevy is contraindicated.trial documented

See chunks 20-21.

Colony stimulating / erythropoiesis agents: Trials of preferred short- or long-acting CSFs or erythropoiesis agents (e.g., Neulasta; Retacrit or Procrit) are required before coverage of listed non-preferred long-acting CSFs or alternatives.trial documented

See chunks 21-22.

Hereditary angioedema (HAE) pathways: For HAE and HAE with normal C1INH, trials of high-dose antihistamines, antifibrinolytic agents (e.g., tranexamic acid), and/or androgen prophylaxis or on-demand therapies are required per product-specific listing.agent-specific

See chunks 22-24.

Immune globulin (SC/IV) prerequisites: Trial of specified IG products (e.g., Gammaked/Gamunex-C or Gammagard liquid) or prophylactic antibiotics for IgG subclass deficiency is required before certain SC/IV IG products.documented trial

See chunks 25-26.

Neurologic and autoimmune biologics: For disorders such as myasthenia gravis, NMOSD, CIDP and others, trials of conventional immunosuppressants, IVIG, and/or plasmapheresis and specified biologics are required prior to use of newer monoclonal antibodies; some agents require prolonged (e.g., 12‑month) total trials or multiple modalities.agent-specific durations

See chunks 29-33.

specified VEGF trial(s)

Susvimo specific requirement: Coverage requires prior response to at least two intravitreal injections of a VEGF inhibitor and inadequate response to bevacizumab AND ranibizumab (Lucentis/Byooviz) AND aflibercept (Eylea).>=2 intravitreal VEGF injections + inadequate response to bevacizumab, ranibizumab, and aflibercept

See chunk 41.

DME visual acuity stratification: For DME with baseline visual acuity 20/50 or worse: bevacizumab or ranibizumab (Lucentis) preferred; if baseline visual acuity is better than 20/50: bevacizumab preferred.visual acuity 20/50

See chunks 39-40 and 42.

Durysta / iDose TR for glaucoma: Trial of two ophthalmic prostaglandin analogs and at least one other IOP‑reducing ophthalmic product from a different class is required prior to Durysta or iDose TR.trial of 2 prostaglandins + 1 other class

See chunks 39-40.

Oncology biosimilar preference: For certain oncology biologics, trial of specified formulary biosimilars is required prior to reference biologics (examples: trial of Mvasi or Zirabev prior to Avastin/Alymsys/Vegzelma; trial of Kanjinti or Trazimera prior to Herceptin/Herceptin Hylecta).trial of preferred biosimilar

See chunks 37-38.

Member must have been treated with a maximally‑tolerated high‑intensity statin plus ezetimibe concomitantly for at least three months with inadequate response, intolerance, or contraindication before eligibility for certain agents (e.g., Leqvio, Evkeeza pathways).

CAR‑T initial eligibility: Member must have received and progressed on or failed the specified number of prior systemic therapy lines and classes as required per CAR‑T product labeling (examples: Abecma requires progression on >=4 lines including IMiD, proteasome inhibitor, and anti‑CD38; Kymriah/Yescarta require specified prior regimens including rituximab and an anthracycline for DLBCL).as specified per agent

See chunks 18-19.

inv-27: Initial therapy trials

Initial therapy requirements for specific indications

OAB initial therapy: Trial of two medications from either the antimuscarinic or beta‑adrenergic classes is required prior to certain neuromuscular blocker agents for incontinence due to neurogenic detrusor overactivity and OAB.two medications

See chunk 36.

inv-28: Ophthalmic initial therapy

Initial ophthalmic therapy requirements

DME visual‑acuity based initial therapy: For diabetic macular edema (DME): if baseline visual acuity is 20/50 or worse, bevacizumab or ranibizumab (Lucentis) is preferred; if baseline visual acuity is better than 20/50, bevacizumab is preferred.visual acuity 20/50

See chunks 39, 40 and 42.

Use outside listed step therapy guidelines may result in non-payment unless approved under an exception process; Neighborhood will give individual consideration based on information submitted by the prescriber.

Billing Rule

Preferred biosimilar trial required for Herceptin products

For Herceptin indications, a trial of Kanjinti or Trazimera is required prior to coverage of Herceptin or Herceptin Hylecta.

Billing Rule

Trial of Ruxience or Truxima required before Rituxan products

For Rituxan, Rituxan Hycela, or Riabni indications, providers must document a trial of the preferred rituximab biosimilars Ruxience or Truxima prior to authorization.

inv-24: maximally-tolerated high-intensity statin

Definition / examplesMaximally‑tolerated high‑intensity statin — examples include atorvastatin 40 mg or 80 mg daily, rosuvastatin 20 mg or 40 mg daily, or simvastatin 80 mg daily.

Concomitant therapy requirementMember must have been adherent to ezetimibe used concomitantly with a statin at maximally tolerated dose for at least three months.

Duration thresholdMinimum of 3 months of maximally‑tolerated high‑intensity statin plus ezetimibe prior to considering escalation to specified lipid‑lowering biologics.

Failure/intolerance criterionCoverage consideration requires inadequate treatment response, intolerance, or contraindication to maximally‑tolerated statin plus ezetimibe.

Context of useThis prerequisite supports eligibility for specified cardiology/lipid‑lowering agents (e.g., Leqvio) as noted in the policy procedures.