CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medically Administered Step Therapy Policy

Defines prior authorization and step therapy requirements for medically administered 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 Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date10/01/2020

Next Review DateN/A

Key ActionDocument required prior trials, failures, intolerances, or contraindications of specified alternative agents when submitting prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medicaid & CommercialLines of business covered

10/01/2020Effective date

through 05/28/2025Review history

long listDistinct drug entries

>=2Ophthalmic prior trials required

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Coverage Criteria and Drug-Specific Step Requirements

Initial coverage / step requirements (representative selection)

Covered when required prior trials, failures, intolerances, or contraindications to specified alternatives are documented:

General step requirement

Acthar Gel (Infantile Spasms): Trial of Cortrophin Gel required.
(Acthar Gel)
Aralast or Glassia (AAT deficiency, Commercial only): Documented failure, intolerance, or contraindication to Prolastin or Zemaira required for Commercial members.
(Commercial members only)
Duopa (Parkinson's): Trial of oral levodopa/carbidopa, a dopamine agonist, and either a COMT inhibitor OR an MAO-B inhibitor required.
Linezolid (J2021): Trial and failure or contraindication to alternative linezolid J2020 required.
Meropenem (J2184): Trial and failure or contraindication to meropenem alternatives J2183 and J2185 required.
Vancomycin (J3372): Trial and failure or contraindication to vancomycin alternatives J3371 and J3370 required.
Vyepti (Chronic Migraine): Trial of two oral preventive medications from two classes AND trial of at least 12 weeks of two CGRP antagonists AND two quarterly botulinum toxin injections required for chronic migraine indication.
Episodic migraine requires two oral meds from different classes and 12 weeks of two CGRP antagonists.

Biologic/Autoimmune step therapy

Biologic and autoimmune agents: coverage requires trials of specified conventional therapies and formulary biologics in sequence as applicable.

Autoimmune biologics general: Members must have trials of specified oral DMARDs, NSAIDs, corticosteroids, or prior biologics (e.g., adalimumab, infliximab, ustekinumab) per indication before approval of listed agents.

Multiple products list detailed per-indication trial sequences.

Tremfya IV – GI autoimmune diseases

Examples of coverage criteria requiring prior trials:

Tremfya IV for Ulcerative Colitis or Crohn's disease: Trial of at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated AND at least a 6-month trial of ustekinumab at maximum tolerated doses.durations specified

From chunk 18

Evkeeza (HoFH)

Cardiology lipid-lowering therapy prerequisites:

Evkeeza for HoFH: At least a 3-month trial of adherent therapy with ezetimibe plus highest-dose atorvastatin OR rosuvastatin and failed a 3-month trial of combination therapy including statin, ezetimibe, and a PCSK9 inhibitor (e.g., evolocumab, alirocumab).3 months

From chunks 18-19

CAR-T (Abecma, Kymriah, Yescarta)

CAR-T therapy criteria:

Abecma for relapsed/refractory multiple myeloma: Progressed on 4 or more lines of therapy AND refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.lines of therapy specified

From chunk 19

Kymriah for pediatric/young adult B-ALL: Relapsed/refractory disease with progression after specified cycles of standard chemotherapy (2 cycles for initial diagnosis or 1 cycle for relapsed leukemia) or failure of 2 prior regimens including a TKI for Ph+ disease.as specified

From chunk 19

Duchenne muscular dystrophy antisense therapies

Duchenne muscular dystrophy and enzyme replacement prerequisites:

Amondys 45 / Exondys 51 / Viltepso / Vyondys 53: Trial of corticosteroids prior to therapy initiation.

From chunk 21

Elevidys: Stable dose of a corticosteroid prior to the start of therapy.stable dose required

From chunk 21

IG and CSF step requirements

Immune globulin and colony stimulating factor preferences:

Subcutaneous IG products: Trial of one of the following: Gammaked/Gamunex-C or Gammagard liquid prior to Cuvitru, Cutaquig, Xembify, Hizentra or Hyqvia.preferred products trial

From chunk 26

Long-acting colony stimulating factors (non-preferred): Trial of Neulasta, Neulasta Onpro, or Udenyca required before non-preferred long-acting agents (e.g., Fulphila, Nyvepria).trial required

From chunk 22

Myasthenia gravis advanced therapy criteria

Myasthenia gravis and related neuromuscular disease criteria:

Initial requirement for advanced therapies (general): Trial of one conventional agent used for myasthenia gravis (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate, tacrolimus, methotrexate, cyclophosphamide) OR chronic IVIG OR chronic plasmapheresis/plasma exchange.as specified

From chunks 30-33

Soliris for myasthenia gravis: 1-year total trial with at least two immunosuppressive therapies OR 1-year total trial with one immunosuppressive therapy AND chronic IVIG or chronic plasmapheresis; plus inadequate response or contraindication to both eculizumab-aagh (Epysqli) AND efgartigimod (Vyvgart IV or Vyvgart Hytrulo SC).1 year

From chunk 30

Ultomiris for myasthenia gravis: Trial of one conventional agent OR chronic IVIG OR chronic plasmapheresis; plus inadequate response or contraindication to efgartigimod (Vyvgart IV or Vyvgart Hytrulo SC).

Botulinum toxin and related indications

Botulinum toxins and neuromuscular blocker agent criteria:

Botox/Dysport/Xeomin/Myobloc for migraine: Trial and failure of two oral preventive medications from specified classes (antidepressants, beta blockers, ACEi/ARBs, antiepileptics, calcium channel blockers) prior to coverage.8-week or specified trial durations

From chunks 35-37

Botox for hyperhidrosis: Trial and failure of ≥1 month of a topical agent (e.g., aluminum chloride, glycopyrronium) prior to Botox coverage.>=1 month

From chunk 35

Initial coverage criteria by drug/indication

Coverage requires documented trials of specified alternative medications or demonstrated inadequate response as listed below.

Migraine - neuromuscular blocker agents (e.g., Dysport, Xeomin, Myobloc): Member must have trialed two oral medications for migraine prevention from listed classes (e.g., antidepressants, beta blockers, ACEi/ARBs, antiepileptics, calcium channel blockers)2 medications trialed

applies to Dysport, Xeomin, Myobloc migraine indication

Severe Primary Axillary Hyperhidrosis: Trial and failure of ≥1 month of a topical agent (e.g., aluminum chloride, glycopyrronium) is required>=1 month topical trial

applies to botulinum products for hyperhidrosis

Incontinence due to neurogenic detrusor overactivity / OAB: Trial of two medications from either antimuscarinic or beta-adrenergic classes is required

This policy establishes that coverage of medically administered specialty therapies is contingent on adherence to the guideline requirements described in the document. Use outside of these guidelines may result in non-payment unless approved under an exception process. Providers should obtain prior authorization and document required trials, failures, intolerances, or contraindications to specified alternatives to avoid denial of coverage.

For Xgeva (denosumab) products, a trial of an approved bisphosphonate is required prior to coverage except where explicitly noted. Specifically, a trial of Zometa/Reclast or Aredia is required for all indications except Giant Cell Tumor of Bone. Ensure documentation of prior bisphosphonate therapy or an appropriate contraindication when requesting authorization.

Neighborhood does not provide coverage for drugs when they are used for investigational purposes. Investigational use is defined as use at a dose or for a condition not recognized as a medically accepted indication by standard compendia (e.g., AHFS‑DI, Micromedex, Clinical Pharmacology, Lexi‑Drugs) or by peer‑reviewed literature.

Use of therapies at doses or for conditions outside recognized medically accepted indications is considered investigational and is not covered. Requests for agents using off‑label dosing or indications must demonstrate support in recognized compendia or peer‑reviewed literature; otherwise, off‑label doses and off‑label conditions are considered investigational and not covered.

J-codes and HCPCS Alignment

Antibiotic J-codesHCPCS

J2021	Linezolid (per policy line)
J2020	Linezolid alternative (per policy line)
J2184	Meropenem (per policy line)
J2183	Meropenem alternative (per policy line)
J2185	Meropenem alternative (per policy line)
J3372	Vancomycin (per policy line)
J3371	Vancomycin alternative (per policy line)
J3370	Vancomycin alternative (per policy line)

Antineoplastic J-codesHCPCS

J9048	Bortezomib (per policy line)
J9046	Bortezomib (alternate codes listed)
J9052	Carmustine (per policy line)
J9050	Carmustine alternative (per policy line)
J9074	Cyclophosphamide (per policy line)
J9073	Cyclophosphamide alternative (per policy line)
J9071	Cyclophosphamide alternative (per policy line)
J9075	Cyclophosphamide alternative (per policy line)

Additional antineoplastic J-codesHCPCS

J9394	Fulvestrant (per policy line)
J9393	Fulvestrant alternate (per policy line)
J9259	Paclitaxel (per policy line)
J9264	Paclitaxel alternative (per policy line)
J9304	Pemetrexed (per policy line)
J9324	Pemetrexed alternate (per policy line)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Coverage of medically administered drugs is reviewed prospectively via the prior authorization process. Prior authorization (PA) is required and coverage will be provided only when the drug-specific step therapy, prior trial, and documentation criteria in this policy are met. Failure to meet required step/trial criteria or to document prior therapy, failures, intolerances, or contraindications may result in denial or non-payment unless an exception is approved.

Prior authorization is required for medically administered drugs and is reviewed prospectively.
Use outside these guidelines may result in non-payment unless an approved exception exists.

Billing Rule

J‑code Alignment for Prior Authorization

Many J‑coded, medically administered drugs listed in this policy are aligned to specific HCPCS/J‑codes for the purpose of prior authorization and step therapy enforcement. When submitting PA requests, use the appropriate J‑code(s) that correspond to the product and indication to ensure correct processing.

Examples: Linezolid (J2021 vs J2020), Meropenem (J2184 vs J2183/J2185), Vancomycin (J3372 vs J3371/J3370), Bortezomib (J9048/J9046 vs J9049/J9051/J9041).
Submit the J‑code that matches the administered product and review the policy’s J‑code alignment to determine applicable step therapy requirements.

Step Therapy

Prior Therapy Requirements for Specialty Injectables

Many specialty injectables require documented trials of specific alternative or preferred agents prior to approval. For each drug, the required prior trials, durations, and acceptable alternatives are specified and must be documented in the medical record.

Examples: Immune globulins — trial of Gammaked/Gamunex-C or Gammagard liquid prior to SCIG or certain IVIG products.
Hemophilia agents — trials of specified factor products, Hemlibra, or bypassing agents per hemophilia subtype.
Neuromuscular and autoimmune biologics — trials of conventional immunosuppressives, IVIG, plasmapheresis/plasma exchange, or specific biologics (durations noted where required).

Documentation Required

Document Prior Therapy and Contraindications

Document prior therapy, including trials, failures, intolerances, and contraindications to the specified alternative or preferred agents. The prior authorization must include clinical evidence of the trial (dates, agents, doses, duration) and the reason for failure or intolerance when applicable.

Provide documentation of prior medication trials, including start/stop dates, doses, response, and reason for discontinuation (e.g., lack of efficacy, adverse event, allergy).
If a required trial was not completed due to contraindication or intolerance, include supporting clinical documentation.
For step therapy exceptions, document the clinical rationale for bypassing preferred agents.

Documentation Required

Prior Therapy Documentation for Neuromuscular Indications

Specific documentation requirements apply for neuromuscular and related indications. Prior therapy must be clearly documented and may include: trials of listed oral immunosuppressive agents, a specified duration (e.g., 1 year total of immunosuppressive therapy), chronic IVIG, chronic plasmapheresis/plasma exchange, or trials of specified biologics (e.g., Rystiggo, eculizumab, Vyvgart/Vyvgart Hytrulo) where indicated.

Myasthenia gravis: documentation of a 1‑year total trial with at least two immunosuppressive therapies or one immunosuppressive plus chronic IVIG or plasmapheresis, with dates and response.
For maintenance doses requiring >1200 mg, document trial of Rystiggo or eculizumab when applicable.
Neuromyelitis optica spectrum disorder (NMOSD) and similar conditions: document trials of Enspryng, Ultomiris, and Uplizna when required (Medicaid‑specific rules noted where applicable).

Step Therapy

Prior VEGF Trial Requirement and Evidence of Response

For ophthalmic anti‑VEGF and related agents, prior trials of specified VEGF inhibitors and evidence of inadequate response are required before approval of higher‑cost or non‑preferred ophthalmic agents. Document the number, dates, and clinical response to prior intravitreal injections.

Required prior agents commonly include bevacizumab and ranibizumab and/or aflibercept equivalents as specified per product.
Document the number of prior intravitreal injections, the treatment interval, objective measures of inadequate response (e.g., persistent or worsening fluid, vision loss), and any contraindications or intolerances to prior VEGF agents.
Products such as Susvimo, Cimerli, Vabysmo, Byooviz/Lucentis, and others list explicit prior VEGF requirements; ensure those trials and inadequate response are recorded.

Step Therapy

Prior Medication Trials for Neuromuscular Blocker Indications

Prior medication trials for neuromuscular blocker indications (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB) require documented trials of specified oral preventive medications or topical agents depending on the indication. Lack of documented trials may lead to coverage denial.

Chronic migraine: trial of two oral preventive medications from two different classes (examples: antidepressants, beta‑blockers, anti‑epileptics, calcium channel blockers) and prior trials of CGRP antagonists as required (Vyepti and others).
Severe primary axillary hyperhidrosis: trial and failure of ≥1 month of topical agents (e.g., aluminum chloride, glycopyrronium).
Overactive bladder/neurogenic detrusor overactivity: trial of two medications from antimuscarinic or beta‑adrenergic classes prior to neuromuscular blocker therapy.

Step Therapy

Step / Preferred Agent Requirements

Step therapy and preferred agent requirements are enforced across many product groups. Where a specific preferred agent or sequence is listed (e.g., trial of Neulasta before biosimilars, trial of Gammaked/Gamunex prior to certain SCIG/IVIG products, trials of specific antibiotics prior to Xenleta), those steps must be followed or clinically justified in documentation.

Follow the policy’s drug‑specific step therapy sequences (examples include short‑acting colony stimulating factors, immune globulins, antibiotics, and biologics).
When a preferred or lower‑cost alternative exists, document trial and failure or contraindication before requesting a non‑preferred product.
For some agents, specific durations are required (e.g., 3 months for some biologics, 6 months for ustekinumab in certain indications); include duration in documentation.

Note

Prior Authorization Contact and Investigational Use

Pharmacy authorization requests and formulary information are handled through the Pharmacy Help Desk or Member Services. Investigational uses (dosing or indications not recognized as medically accepted in standard compendia or peer‑reviewed literature) are not covered.

Pharmacy Help Desk (Medicaid/formulary inquiries): 1‑401‑459‑6020.
Member Services (Commercial/formulary inquiries): 1‑855‑321‑9244.
Neighborhood does not provide coverage for investigational uses: therapies used at non‑recognized doses or for indications not listed in AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs, or supported by sufficient peer‑reviewed literature.

Initial Therapy Requirements

Initial therapy requirements

Initial coverage conditions reflect required trials of alternatives

General: Documented trial and failure/intolerance/contraindication to specified alternatives per product must be provided for initial coverage.

See per-product entries for specifics.

Initial requirement — DMD therapies

For Duchenne antisense therapies

Amondys 45 / Exondys 51 / Viltepso / Vyondys 53: Trial of corticosteroids prior to therapy.as specified

From chunk 21

Ophthalmic initial therapy

Initial ophthalmic agent coverage expectations

DME with VA 20/50 or worse: Bevacizumab or ranibizumab (Lucentis) required prior to some agentsVA 20/50

applies to Beovu, Eylea, etc

Step Therapy Tables and Preferred Agent Sequencing

Drug / Indication	Required prior trial(s) / failure	Coverage status
Acthar Gel — Infantile Spasms (West Syndrome)
Trial of Cortrophin Gel prior to Acthar Gel
Covered when criteria met
Linezolid (J2021)
Trial and failure or contraindication to alternative linezolid (J2020)
Covered when criteria met
Meropenem (J2184)
Trial and failure or contraindication to meropenem alternatives (J2183 and J2185)
Covered when criteria met
Vancomycin (J3372)
Trial and failure or contraindication to vancomycin alternatives (J3371 and J3370)
Covered when criteria met
Vyepti — Chronic Migraine
Trial of two oral preventive medications from two different classes AND at least 12 weeks of two CGRP antagonists AND two quarterly botulinum toxin injections
Covered when criteria met
Autoimmune biologics (e.g., Actemra, Cimzia, Cosentyx, Stelara, Skyrizi IV, Tremfya IV)
Trials of specified oral DMARDs/NSAIDs/corticosteroids and biologics per indication (e.g., ≥3-month trial of infliximab or adalimumab and ≥6-month trial of ustekinumab where specified)
Covered when criteria met
Tremfya IV — Ulcerative Colitis or Crohn's Disease
At least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses AND at least a 6-month trial of ustekinumab at maximum tolerated doses
Covered when criteria met
Duchenne antisense therapies (e.g., Amondys 45, Exondys 51)
Trial of corticosteroids prior to therapy initiation (stable dose required for some products)
Covered when criteria met

Product group	Preferred agent(s) to try first	Coverage status
Long-acting colony stimulating factors (non-preferred examples: Fulphila, Nyvepria, Ziextenzo, Fylnetra, Rolvedon, Stimufend)
Trial of Neulasta, Neulasta Onpro, or Udenyca required prior to non-preferred long-acting agents
Covered when criteria met
Subcutaneous immune globulins (Cuvitru, Cutaquig, Xembify, Hizentra, Hyqvia)
Trial of one of: Gammaked, Gamunex-C, or Gammagard liquid prior to listed subcutaneous IG products
Covered when criteria met
Colony stimulating factors / erythropoietic agents (e.g., Mircera, Aranesp, Epogen)
Trial of Retacrit or Procrit (for Mircera/Aranesp/Epogen as specified) or other preferred biosimilars prior to listed agents
Covered when criteria met

Ophthalmic agent(s)	Required prior VEGF trial(s) / response documentation	Coverage status
Cimerli — all indications
Trial of Pavblu or Eylea; for DME/DR bevacizumab also required as specified
Covered when criteria met
Susvimo — neovascular (wet) AMD and DME
Responded to at least two intravitreal injections of a VEGF inhibitor AND inadequate treatment response to bevacizumab AND ranibizumab (Lucentis/Byooviz) AND aflibercept (Eylea)
Covered when criteria met
Vabysmo — neovascular (wet) AMD and RVO
Trial of Pavblu or Eylea; bevacizumab and Byooviz (ranibizumab) or Lucentis (ranibizumab) required per indication
Covered when criteria met
Byooviz / Lucentis — all indications
Trial of Pavblu or Eylea; bevacizumab required
Covered when criteria met

Indication	Required prior topical/systemic therapy	Coverage status
Severe primary axillary hyperhidrosis
Trial and failure of ≥1 month of a topical agent (e.g., aluminum chloride, glycopyrronium)
Covered when criteria met

Site of Care and Medicare Applicability

Note

Medicare applicability — subject to NCD/LCD

Per 42 CFR 422.101, this clinical medical policy applies to Medicare only in the absence of an applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD).

Biosimilar Preferences and Required Trials

Billing Rule

Avastin biosimilar preference: trial of Mvasi or Zirabev

For Avastin (bevacizumab) oncology indications, the policy notes a trial of the biosimilars Mvasi or Zirabev is preferred prior to other Avastin biosimilars.

Billing Rule

Herceptin biosimilar preference: Kanjinti or Trazimera

For Herceptin (trastuzumab) and its biosimilars, the policy lists Kanjinti or Trazimera as the preferred biosimilar options for all indications.

Billing Rule

Rituxan biosimilar preference: Truxima or Ruxience

For Rituxan (rituximab) and its biosimilars, the policy lists Truxima or Ruxience as the preferred biosimilar options for all indications.

Policy Background and Scope

This policy governs medically administered (infused or injected) specialty therapies under the medical benefit and sets forth required prior trials of alternative agents and classes prior to approval of specified products. Medically administered drugs are reviewed prospectively via the prior authorization process and, except where otherwise noted, coverage is provided only when the documented prior therapy requirements and other criteria in the policy are met.

Definitions and Terms

HoFH / HeFH — Definitions and prerequisite therapies

HoFH (Homozygous familial hypercholesterolemia)Requires trial of a PCSK9 inhibitor indicated for HoFH (e.g., evolocumab, alirocumab) and prior maximally‑tolerated high‑intensity statin plus ezetimibe for at least 3 months with adherence and inadequate response, intolerance, or contraindication.

HeFH (Heterozygous familial hypercholesterolemia)Requires trial of highest available or maximally‑tolerated dose of a high‑intensity HMG‑CoA reductase inhibitor (e.g., atorvastatin 40–80 mg, rosuvastatin 20–40 mg, or simvastatin 80 mg) plus ezetimibe concomitantly for at least 3 months with inadequate response, intolerance, or contraindication.

Ezetimibe requirementEzetimibe must have been used concomitantly with a statin at maximally tolerated dose for at least 3 months prior to escalation.

Statin dosing examplesHigh‑intensity statin examples specified: atorvastatin 40 or 80 mg daily; rosuvastatin 20 or 40 mg daily; simvastatin 80 mg daily.

Failure/intolerance standardCoverage requires documentation of adherence and inadequate treatment response, intolerance, or contraindication to the above lipid‑lowering therapies before approving advanced therapies for HoFH/HeFH.

Investigational use — definition and policy

Definition of investigational useUse of a drug at a dose or for a condition other than those recognized as medically accepted indications in standard compendia (AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or peer‑reviewed literature is considered investigational and not covered.

Coverage stanceNeighborhood does not provide coverage for drugs when used for investigational purposes (uses not recognized as medically accepted indications).

Reference compendiaAccepted reference sources named: American Hospital Formulary Service Drug Information (AHFS‑DI), Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed published medical literature.

Action for providersRequests for investigational uses will not be approved under standard coverage; contact Pharmacy Help Desk or Member Services for authorization inquiries or formulary information.

Contact for authorizationPharmacy Help Desk: 1‑401‑459‑6020 (Medicaid); Member Services: 1‑855‑321‑9244 (Commercial).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedically Administered Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date10/01/2020

Next Review DateN/A

Key ActionDocument required prior trials, failures, intolerances, or contraindications of specified alternative agents when submitting prior authorization requests.

SourceLink

On This Page

2 medications trialed

applies to neuromuscular blocker agents for bladder indications

Ophthalmic VEGF agents (e.g., Beovu, Eylea, Lucentis, Cimerli, Vabysmo, Susvimo): Require prior trial(s) of bevacizumab and/or ranibizumab/aflibercept (Pavblu/Eylea) per indication; some agents (e.g., Susvimo) require documented inadequate response to bevacizumab and ranibizumab and aflibercept after at least two injections2 prior injections or trials as specified

step therapy emphasizes bevacizumab as first-line for many indications

Durysta / iDose TR for open angle glaucoma: Trial of two ophthalmic prostaglandin analogs and at least one other IOP-reducing ophthalmic product from a different class is required2 prostaglandin analogs + 1 different class

combination therapy should be used if warranted

Rituximab-class non-oncology indications: Require trial of at least one oral DMARD and at least one preferred TNF antagonist (one must be self-injectable) for rheumatoid arthritis; other autoimmune conditions require failure of standard first-line therapiesspecified prior therapies

applies to Rituxan, Riabni entries