EmblemHealth Prior Auth Criteria — Specialty Drugs

Elahere (mirvetuximab soravtansine) — Ovarian/related cancers

Covered when ALL of the following are met:

Ovarian, fallopian tube, or primary peritoneal cancer: patient has folate receptor alpha positive disease and either (1) >= 75% folate receptor alpha positive tumor cells OR (2) medication is being used in combination with bevacizumab; AND patient has platinum-resistant disease.

Elaprase (idursulfase) — Hunter syndrome

Covered when ALL of the following are met:

Diagnosis of Hunter syndrome (Mucopolysaccharidosis II) confirmed by laboratory testing showing deficient iduronate-2-sulfatase activity in leukocytes, fibroblasts, serum, or plasma OR molecular genetic testing demonstrating pathogenic iduronate-2-sulfatase gene variant(s).

Elrexfio (elranatamab-bcmm) — Multiple myeloma

Covered when ALL of the following are met:

Multiple myeloma: patient has tried at least four systemic regimens and among prior regimens the patient has received at least one drug from each class: a proteasome inhibitor; an immunomodulatory drug; and an anti-CD38 monoclonal antibody.

Emrelis (telisotuzumab vedotin) — NSCLC with c-Met overexpression

Covered when ALL of the following are met:

Non–small cell lung cancer (locally advanced or metastatic, non-squamous): tumor demonstrates high c-Met protein overexpression defined as >= 50% tumor cells with strong (3+) staining by an approved test; AND patient has received at least one prior systemic therapy.

Diabetes supplies (alcohol pads, gauze pads, pen needles, syringes)

Covered when ALL of the following are met:

Medical supply is directly associated with delivering insulin to the body (examples: pen needles, insulin syringes).
Prescriber confirms the requested supply is for insulin delivery.
Coverage duration: 12 months.

Emgality - Initial and continuation

Initial and continuation coverage rules:

Migraine

Migraine prevention: patient has >= 4 migraine headache days per month prior to initiating a migraine-preventive medication.
If patient is currently taking Emgality, patient has had significant clinical benefit (e.g., reduction in overall number of migraine days/month or reduction in severe migraine days).

Episodic cluster headache

Episodic cluster headache: patient has between 1 headache every other day and 8 headaches per day.
If continuation request, patient experienced clinical benefit while on therapy.

Emgality - Episodic cluster headache

Covered when ALL of the following are met:

Episodic cluster headache: patient has between one headache every other day and eight headaches per day; prescriber documents frequency and response to therapy for continuation requests.

Enbrel - Initial and continuation

Initial and continuation coverage rules:

Indication: rheumatoid arthritis or other FDA-approved indications as specified by the prescriber and medical record.
Initial therapy for RA: patient has tried TWO of the following: Enbrel, a preferred adalimumab product, Orencia, Rinvoq, or Xeljanz/XR. Trials with Cimzia, infliximab, Kevzara, golimumab SC/IV, or a non-preferred adalimumab product may be counted toward the two required trials when applicable.
Or patient qualifies for exception due to heart failure or a previously treated lymphoproliferative disorder per clinical documentation.
Prescriber restriction: prescribed by or in consultation with a rheumatologist for initial therapy; continuation requests require documentation of response to therapy.

Entyvio - Initial and continuation

Initial and continuation coverage rules:

Indication: inflammatory bowel disease or other FDA-approved indications as documented by prescriber.
Initial therapy: prescribed by or in consultation with a gastroenterologist (or specialty as noted) when initiating therapy; required documentation includes diagnosis and prior medication history.
Continuation: patient had clinical response to vedolizumab therapy as documented by prescriber; approve through the end of the plan year or as specified.

Epidiolex - Indications and continuation

Covered when ALL of the following are met:

Epidiolex (cannabidiol) indications: patient has an FDA‑approved diagnosis (e.g., Lennox‑Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex) documented in the medical record.
Continuation: patient demonstrates clinical benefit on therapy as determined by the prescriber (reduction in seizure frequency or severity).

Retacrit - Anemia criteria

Covered when ALL of the following are met:

Anemia due to chronic kidney disease or other approved indications as documented by prescriber.
Required medical information: hemoglobin and relevant laboratory values; prescriber documents indication and dosing rationale.

ERLEADA / ERLOTINIB / MEKINIST etc. — Oncology criteria (placeholder)

Covered when ALL of the following are met:

Indication per FDA labeling (e.g., medullary thyroid carcinoma, RET‑rearranged NSCLC): tumor demonstrates RET alteration when required and prior therapy requirements met as specified in the product criteria.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for many medications listed in this section. If prior authorization is not obtained, the drug may be denied. Denial triggers include specific concurrent therapy conflicts, missing required prior trials/step therapy, failure to provide required diagnostic or genetic testing, and use for excluded indications (including acute pain or concomitant antiviral/antimicrobial therapies when prohibited).

Failure to obtain prior authorization may result in claim denial.
Part B vs Part D determinations will be made at time of authorization review for drugs where administration/setting affects coverage.

Note

Refer to Index and Submission Requirements

Refer to the drug index at the end of this document for the full product list and details. When submitting an authorization request, include diagnosis, prior and concurrent medications, prescriber specialty/consultation notes, relevant lab/genetic tests, and documentation of prior therapy trials or intolerances as specified for the product.

Include prescriber specialty/consultation when required (eg, oncologist, neurologist, rheumatologist, cardiologist, nephrologist, hepatologist).
Provide objective measures when requested (eg, ambulation measures for dalfampridine).

Prior Authorization

Part B / Part D Determination at Authorization

For medications that could be billed under Medicare Part B or Part D, coverage determination (Part B vs Part D) and applicable step/line therapy requirements will be made at authorization review per CMS guidance. Provide administration details (site, infusion vs injection vs oral) to assist in determinating benefit responsibility.

Examples: ANKTIVA, KADCYLA, LOQTORZI, and other oncology agents may require Part B/Part D review.
Provide documentation of setting of administration (office/inpatient vs pharmacy/retail).

Denial Risk

BESREMI — Concomitant Interferon Exclusion

BESREMI is excluded when used concomitantly with other interferon products. Prior authorization requires diagnosis and oncologist involvement; do not combine BESREMI with other interferons.

Age restriction: 18 years and older.
Coverage duration: 1 year.

Denial Risk

MS DMT — Concurrent Use Exclusion / Therapeutic Conflict

BETASERON and other multiple sclerosis (MS) disease-modifying therapies (DMTs) have an exclusion for concurrent use with other DMTs. Prior authorization requires prescriber specialty (neurologist/MS specialist) and documentation of the relapsing form of MS. Do not approve concurrent use of multiple DMTs (therapeutic conflict).

This includes fingolimod, kesimpta, dimethyl fumarate, and other MS DMTs — concurrent use is excluded.
Prescriber must be neurologist or MS specialist; initial and continuation therapy restrictions apply.

Denial Risk

Ibandronate IV — Concurrent Osteoporosis Therapy Exclusion

Ibandronate IV and other osteoporosis agents: prior authorization excludes concurrent use with other medications for osteoporosis. Approvals require documentation of T-score, fracture history, inadequate response or intolerance to oral bisphosphonates, or inability to take oral therapy.

Authorization duration: 12 months.
Document prior bisphosphonate trial of at least 12 months or reasons for inability to use oral agents.

Documentation Required

CAMZYOS — Objective Criteria Required

CAMZYOS prior authorization requires cardiology prescribing and specific objective criteria for obstructive hypertrophic cardiomyopathy (symptoms, NYHA class II–III, LV wall thickness thresholds, and left ventricular outflow tract gradient ≥50 mmHg). Denials can be triggered when these objective measures are not documented.

Initial: 8 months; continuation: 1 year.
Prescriber: cardiologist (initial and continuation).

Documentation Required

CAYSTON — Culture Documentation Required

CAYSTON requires confirmation of Pseudomonas aeruginosa from appropriate airway cultures and prescriber consultation with CF specialists or pulmonology. Lack of culture documentation is a denial trigger.

Coverage duration: 1 year.
Prescriber: pulmonologist, infectious disease specialist, or CF specialist.

Step Therapy

Prior Therapy and Concurrent Immunomodulator Exclusions

CIBINQO and similar agents require documentation of prior systemic therapy trials (eg, at least one systemic therapy for atopic dermatitis) or intolerance. Concurrent use with biologics, other JAK inhibitors, or other immunosuppressants is excluded and will trigger denial.

Initial: Atopic Dermatitis — 3 months; Continuation — 1 year.
Examples of allowable prior systemic therapies: Dupixent, tralokinumab, methotrexate, azathioprine, cyclosporine, mycophenolate.

Denial Risk

Concurrent Biologic / CGRP / Targeted Therapy Exclusions

For many biologic therapies and targeted agents, prior authorization includes step therapy requirements and explicit prohibition on concurrent biologic/targeted therapies. This includes Emgality, Nurtec ODT (preventive CGRP inhibitors), Enbrel, Entyvio, and others — concurrent CGRP inhibitor/monoclonal biologic use is a denial trigger.

Emgality: deny if being used with another cGRP inhibitor for migraine prevention.
Enbrel/Entyvio: concurrent biologic or targeted synthetic DMARD use is excluded.
Nurtec ODT: concurrent use with another CGRP inhibitor for preventive therapy is excluded.

Denial Risk

ANKTIVA — Denial Triggers

ANKTIVA denials are triggered when required clinical criteria are not met — including absence of documented BCG-unresponsive disease, lack of carcinoma in situ (with or without papillary tumors), or failure to document use in combination with BCG where required. Provide oncologist/urology consultation documentation and specify Part B/Part D billing considerations.

Age restriction: 18 and older for initial therapy.
Coverage durations: initial 6 months; maintenance 3 months.

Denial Risk

Concomitant Antiviral / Antimicrobial Exclusions

Medications indicated for antiviral therapy (eg, LIVTENCITY, LEDIPASVIR‑SOFOSBUVIR, others) exclude concomitant use with certain antivirals per product guidance (eg, Livtencity excludes concomitant ganciclovir/valganciclovir; ledipasvir‑sofosbuvir excludes combination with other direct‑acting antivirals except ribavirin). Document all concomitant antivirals or other contraindicated agents to avoid denials.

Provide full medication list including recent antiviral/antimicrobial agents.
Prescriber specialty (ID, hepatology, transplant) may be required.

Denial Risk

Tolvaptan — Duplicate Product Exclusion

Tolvalptan (for ADPKD) is excluded when the patient is currently receiving another tolvaptan product. Prior authorization requires nephrology consultation and documentation of rapidly‑progressing ADPKD and renal function measures.

Age restriction: 18 years and older.
Coverage duration: 1 year.

Denial Risk

Ledipasvir‑Sofosbuvir — Combination Antiviral Exclusion

Ledipasvir‑sofosbuvir (and other DAAs) exclude combination use with other direct‑acting antivirals (except where allowed, e.g., ribavirin). Authorization requires specialist prescriber documentation and adherence to current AASLD/IDSA guidance.

Age: 3 years and older for ledipasvir‑sofosbuvir.
Prescriber: GI/hepatology/ID or transplant specialist.

Denial Risk

Acute Pain Exclusion

Acute pain indications are excluded for certain agents and formulations; verify that requested use is for an approved chronic or disease‑specific indication. Provide indication details to prevent denial for acute pain claims.

Lidocaine topical products: coverage limited to FDA‑approved and some medically accepted chronic pain indications.
Acute pain or short‑term procedures without meeting policy criteria may be denied.

Documentation Required

LYNPARZA — Genetic Testing Requirement

LYNPARZA requires documentation of germline or somatic BRCA mutation (or other biomarker as required by indication) confirmed by an approved test prior to maintenance or therapy approvals. Lack of appropriate genetic testing documentation can trigger denial.

Indications require BRCA or HRD testing as specified (eg, ovarian maintenance, breast, pancreatic indications).
Provide test name, result, and laboratory performing the test.

Documentation Required

LYTGOBI — Genetic and Prior Therapy Requirement

LYTGOBI prior authorization requires documentation of FGFR2 gene fusions or rearrangements detected by an approved test and evidence of prior systemic therapy. Both genetic testing and prior line therapy must be documented to approve.

Age restriction: 18 years and older.
Require prior treatment with at least one systemic regimen for cholangiocarcinoma.

Denial Risk

Nurtec ODT — Concurrent CGRP Inhibitor Exclusion

Nurtec ODT used as preventive therapy is excluded if taken concurrently with another CGRP inhibitor; confirm whether use is for acute vs preventive indication and document prior preventive therapy trials or benefit.

Preventive indication requires ≥4 and <15 migraine days per month and demonstration of clinical benefit for continuation.
Concurrent CGRP inhibitor use for prevention is a denial trigger.

Documentation Required

Nitisinone / Metabolic Therapy Documentation Requirement

Nitisinone and other metabolic therapies require specific diagnostic and monitoring documentation (eg, genetic or biochemical test results). Provide required laboratory/diagnostic documentation with the authorization request.

Prescriber specialty (geneticist, metabolic disorder specialist, endocrinologist) may be required.
Include specific enzyme activity or molecular genetic testing where applicable.

Step Therapy

Step Therapy / Prior Trial Requirements

Step therapy and prior trial requirements apply broadly across many drug classes (oncology lines of therapy, biologic step requirements for rheumatologic and dermatologic indications, JAK inhibitor and other targeted agent sequencing). Authorization requests must document all prior therapies tried, durations, responses, and reasons for discontinuation (lack of efficacy or intolerance).

Examples: Actemra and other RA agents often require trials of Enbrel, preferred adalimumab products, Orencia, Rinvoq, or Xeljanz/XR.
Statin-step requirements apply for NEXLETOL/NEXLIZET: document high-intensity statin ± ezetimibe trials or statin intolerance.

Step Therapy

Agent‑Specific Prior Therapy / Line‑of‑Therapy Requirements

Specific agents have defined prior‑therapy rules: Bizengri requires prior systemic therapy documentation; CABOMETYX and Iclusig require prior lines of systemic therapy as specified by oncology criteria; Jakafi, Everolimus, Firmagon, Lapatinib, and NINLARO have step or line‑of‑therapy requirements — include prior regimens, dates, and responses.

Columvi/Loqtorzi/ErbB-targeted agents: document prior systemic regimens and lines of therapy.
Provide regimen names and dates for prior lines (eg, R-CHOP, platinum regimens).

Denial Risk

Therapeutic Conflict / Concurrent Therapy Exclusions

Concurrent use exclusions for multiple classes (e.g., biologic + tsDMARD, multiple monoclonal antibodies, JAK inhibitors with biologics) are enforced to avoid therapeutic conflict and increased immunosuppression risk. Denials will be issued if concurrent, conflicting therapies are active unless explicit clinical justification is provided and aligns with policy exceptions.

Concurrent biologic therapy exclusion applies across rheumatology, dermatology, asthma, EGPA and related indications.
Document washout periods or reasons for switching; indicate whether prior therapy was discontinued before initiating the new agent.

Documentation Required

Phenobarbital / Concomitant Antiseizure Medication Documentation

Phenobarbital (when required as part of anti‑seizure regimens) often must be documented as part of combination/concomitant therapy for certain indications (eg, Diacomit, Epidiolex rules referencing concomitant clobazam). Ensure documentation of current antiseizure medications and concomitant clobazam or phenobarbital use where policy requires.

Diacomit: initial therapy for Dravet requires concomitant clobazam or documentation that clobazam cannot be used.
Epidiolex/Fintepla/Diacomit: document concurrent antiseizure drugs and prior trials.

Denial Risk

Safety‑Based Concurrent Therapy Exclusions

Exclusions for concurrent therapies that present specific safety risks (eg, Livtencity with ganciclovir/valganciclovir; BESREMI with other interferons; tolvaptan duplicate product exclusion) will result in denial if present. Review the patient's active medication list and exclude any prohibited combinations before requesting authorization.

Provide complete active medication list including in‑hospital medications when applicable.
Prescriber consultation notes should address prior intolerance or contraindications if concurrent therapy exists.

Document Reference Codes & Key Clinical Thresholds

Document reference codesmixed

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Document/internal reference string present on multiple product entries

Document reference codesmixed

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Internal reference/administrative code shown on product entries

Products Mentionedmixed

EMGALITY PEN	Product name listed
EMGALITY SUBCUTANEOUS SYRINGE 120 MGMML	Product name listed

Products Mentionedmixed

ENBREL MINI	Product name listed
ENBREL SUBCUTANEOUS SOLUTION	Product name listed
ENBREL SUBCUTANEOUS SYRINGE	Product name listed
ENBREL SURECLICK	Product name listed

Products Mentionedmixed

everolimus (antineoplastic) oral tablet

Product name listed

Products Mentionedmixed

EYLEA

Product name listed

Products Mentionedmixed

FABRAZYME

Product name listed

Products Mentionedmixed

FASENRA PEN	Product name listed
FASENRA SUBCUTANEOUS SYRINGE 10 MG/0.5 ML, 30 MGMML	Product name listed

Policy internal reference codesmixed

Y0026_205074_C

Internal PA reference shown on multiple entries in this segment

Internal policy reference codesmixed

Y0026_205074_C

Internal reference present on multiple product entries

inv-165: Left ventricular outflow tract gradient

Threshold>= 50 mmHg

ContextUsed to define LVOT obstruction for obstructive hypertrophic cardiomyopathy eligibility for CAMZYOS (rest or after provocation).

MeasurementMay be measured at rest or after provocation (eg, Valsalva or post-exercise).

inv-166: Left ventricular wall thickness

Threshold>= 15 mm (or >=13 mm with familial HCM)

ContextMaximal left ventricular wall thickness requirement for CAMZYOS initial eligibility (familial HCM lower threshold allowed).

UsePart of diagnostic criteria for obstructive hypertrophic cardiomyopathy in prior authorization review.

inv-167: T-score

ThresholdT-score <= -2.5

AlternativeT-score between -1.0 and -2.5 with physician-determined high fracture risk plus inadequate response/intolerance to oral bisphosphonates or inability to take them after 12 months

Supporting evidenceOr presence of an osteoporotic or fragility fracture regardless of T-score

inv-168: Left ventricular ejection fraction (continuation criteria)

Threshold>= 50% LVEF?

Continuation criterion (documented)Current left ventricular ejection fraction >= 50% required for CAMZYOS continuation; continuation also requires established on therapy >=8 months and objective benefit or stabilization.

ContextPart of CAMZYOS continuation criteria to confirm preserved systolic function prior to ongoing authorization.

inv-169: Left ventricular outflow tract gradient

Threshold>= 50 mmHg

ContextLeft ventricular outflow tract gradient requirement for CAMZYOS initial eligibility (measured at rest or after provocation).

RoleOne of multiple hemodynamic criteria establishing obstructive HCM for prior authorization.

inv-170: Maximal left ventricular wall thickness

Threshold>= 15 mm (general) or >= 13 mm if familial HCM

ContextMaximal LV wall thickness used to define hypertrophy threshold for CAMZYOS eligibility (familial HCM uses lower threshold).

MeasurementMaximal measured LV wall thickness reported in cardiology imaging (e.g., echo or MRI).

inv-171: Blood lead level

Threshold> 45 mcg/dL

ContextRequired pre-treatment blood lead level for Chemet initiation in acute lead poisoning (pediatric 12 months–18 years).

UseConfirmatory lab for authorization of chelation therapy (Chemet).

inv-172: Serum ferritin level (deferasirox transfusion-related chronic iron overload)

Threshold> 1000 mcg/L

IndicationTransfusion-related chronic iron overload: serum ferritin >1000 mcg/L prior to starting deferasirox.

PrescriberMust be prescribed by or in consultation with a hematologist.

inv-173: Serum ferritin level (deferasirox non-transfusion-dependent thalassemia)

Threshold> 300 mcg/L

IndicationNon-transfusion-dependent thalassemia chronic iron overload: serum ferritin >300 mcg/L prior to starting deferasirox.

PrescriberPrescribed by or in consultation with a hematologist.

inv-174: Serum ferritin

ThresholdsInitial transfusion-related iron overload: >1000 mcg/L; Non-transfusion-dependent thalassemia: >300 mcg/L

ContinuationContinuation approved if patient is benefiting from therapy as confirmed by prescribing physician.

PrescriberHematologist involvement required for initiation and management.

inv-175: Blood eosinophil

Threshold>= 150 cells/µL (as part of Dupixent asthma criteria) or >=300 cells/µL for COPD criterion

ContextBlood eosinophil counts required for initiation of biologic therapies (Dupixent and similar agents) in asthma/COPD indications.

TimingEosinophil measurement within previous 6 weeks (or prior to monoclonal antibody therapy that may alter counts).

inv-176: Migraine frequency for Emgality

Threshold>= 4 migraine headache days per month

ContextRequired frequency for initiation of Emgality for migraine prevention; also used for assessing continuation benefit.

AgePatient must be 18 years or older for Emgality per policy.

inv-177: c-Met overexpression

Threshold>= 50% tumor cells with strong [3+] staining

ContextDefines high c-Met protein overexpression for Emrelis (telisotuzumab vedotin) eligibility in NSCLC.

TestMust be determined by an approved test per prior authorization documentation requirements.

inv-178: Migraine frequency

Threshold>= 4 migraine headache days per month

ContextUsed to determine eligibility for preventive therapy with CGRP-targeting agents (e.g., Emgality).

ContinuationContinuation requires documented significant clinical benefit (reduction in migraine days/severe days).

inv-179: c-Met overexpression

Threshold>= 50% tumor cells with strong [3+] staining

ContextTumor c-Met overexpression threshold required for Emrelis approvals in non-squamous NSCLC.

DocumentationResult must be from an approved test and included in prior authorization submission.

Definitions & Background

inv-304: BCG-unresponsive disease

DefinitionBCG-unresponsive disease = disease unresponsive to Bacillus Calmette-Guerin (BCG) therapy as used in the ANKTIVA criteria.

Use-caseRequired for initial ANKTIVA eligibility (NMIBC).

AgeInitial therapy restricted to patients 18 years and older.

inv-305: Ongoing complete response (maintenance)

DefinitionOngoing complete response (maintenance) defined as: (a) negative cystoscopy plus either negative urine cytology or acceptable malignant cytology with negative random biopsies, OR (b) positive cystoscopy with biopsy-proven benign or low-grade Ta NMIBC and negative urine cytology.

ContextUsed to determine maintenance eligibility for ANKTIVA in NMIBC when medication is used with BCG.

CoverageMaintenance coverage duration = 3 months per policy.

inv-306: NYHA II/III

DefinitionNYHA II/III = New York Heart Association functional classification II or III, used to define symptom severity for CAMZYOS eligibility.

ContextPatients must have NYHA Class II or III symptoms as part of CAMZYOS initial and continuation criteria.

PrescriberCAMZYOS requests require cardiologist involvement per policy.

inv-307: RET rearrangement status

RequirementRET rearrangement status must be documented (molecular diagnostic) for CABOMETYX requests in RET-positive NSCLC.

ContextRET gene rearrangement testing is part of required medical information for authorization of CABOMETYX.

CoverageCoverage duration typically 1 year; prescriber specialty not specifically restricted in chunk.

inv-308: Obstructive hypertrophic cardiomyopathy (oHCM)

DefinitionObstructive hypertrophic cardiomyopathy (oHCM): LV hypertrophy with LVOT obstruction (LVOT gradient >=50 mmHg) plus symptoms such as dyspnea, chest pain, syncope.

UseDefines the clinical condition for CAMZYOS eligibility and associated threshold requirements (LV wall thickness, LVOT gradient, NYHA class).

PrescriberCAMZYOS requires cardiologist prescriber or consult per policy.

inv-309: Systemic therapy (examples)

ExamplesSystemic therapy examples include RCHOP, DHA + platinum, R-EPOCH, RCEPP as cited for lymphoma prior therapy requirements.

ContextUsed to define prior-line requirements for agents like COLUMVI in lymphoma indications.

PrescriberOncologist involvement required for lymphoma indications.

inv-310: Part B vs Part D determination

DefinitionPart B vs Part D determination: CMS-based coverage channel decision to be made at time of authorization review for certain oncology/infused products.

ContextNoted for multiple agents (e.g., ELAHERE, ELREXFIO) where Part B/Part D may be determined at review.

ActionPrescribers should expect CMS determination during PA process; include infusion/site details if applicable.

inv-311: Uncontrolled asthma

DefinitionUncontrolled asthma defined by one or more: >=1 exacerbation requiring systemic corticosteroid in past year; >=1 exacerbation requiring hospital/urgent care/ED visit in past year; FEV1 <80% predicted (<90% if <18 years); FEV1/FVC <0.80; or worsened asthma with systemic corticosteroid taper.

ContextUsed within monoclonal antibody initiation criteria (eg, Fasenra) to establish inadequate control despite controller therapy.

DocumentationObjective lung function and exacerbation history should be provided in PA documentation.

inv-312: EGPA active disease

DefinitionEGPA active disease: requires systemic corticosteroids for at least 4 weeks and blood eosinophils >=150 cells/µL within previous 4 weeks or prior to other biologic that may alter eosinophils.

ContextUsed to determine initial eligibility for monoclonal antibody therapy in EGPA (eg, Fasenra).

PrescriberPrescribed by or in consultation with allergist/immunologist, pulmonologist, or rheumatologist per indication.

inv-313: HAE type I or II

DefinitionHAE type I or II: hereditary angioedema due to C1-INH deficiency confirmed by functional C1-INH <50% of normal and low baseline serum C4 per lab reference.

ContextDiagnostic requirement for initiation of acute HAE therapies such as icatibant.

PrescriberPrescribed by or in consultation with allergist/immunologist or HAE specialist.

inv-314: IDH2-positive AML

DefinitionIDH2-positive AML: acute myeloid leukemia with IDH2 mutation detected by an approved test.

ContextRequired for IDHIFA authorization in AML indications.

AgePatient must be 18 years or older per policy.

inv-315: KRAS G12C-mutated disease

DefinitionKRAS G12C-mutated disease: tumors with KRAS G12C mutation as determined by an approved test, used for KRAZATI eligibility.

ContextApplies across tumor types (NSCLC, colon/rectal, others) with indication-specific prior therapy requirements.

PrescriberOncologist involvement and molecular testing documentation required for PA.

inv-316: IGF-1 baseline

RequirementPre-treatment (baseline) IGF-1 above the upper limit of normal for age/gender required for lanreotide approval in acromegaly.

ContextUsed to confirm biochemical activity of acromegaly prior to somatostatin analog therapy (lanreotide/Somatuline).

PrescriberPrescribed by or in consultation with an endocrinologist for acromegaly indications.

inv-317: High intensity statin

DefinitionHigh-intensity statin defined as atorvastatin >= 40 mg daily or rosuvastatin >= 20 mg daily.

ContextUsed to define prior statin therapy requirements for NEXLETOL/NEXLIZET and other lipid-lowering step criteria.

ImplicationDocumentation of trials of high-intensity statin (and ezetimibe when required) or statin intolerance required for PA.

inv-318: Statin intolerance

DefinitionStatin intolerance: experiencing statin-related rhabdomyolysis or skeletal muscle symptoms during separate trials of atorvastatin and rosuvastatin with symptom resolution upon discontinuation.

ContextAllows bypassing high-intensity statin requirement for lipid agents when documented.

DocumentationPA requires documentation of statin trials and symptom resolution on discontinuation to establish intolerance.

inv-319: High-intensity statin

DefinitionHigh-intensity statin: atorvastatin >= 40 mg daily or rosuvastatin >= 20 mg daily (duplicate definition within lipid criteria).

ContextUsed in prior therapy/step requirements for lipid-lowering agent authorization.

NoteDocumentation of trial duration (eg, >=8 weeks for some indications) may be required.

inv-320: Statin intolerance

UsePermits approval of alternative lipid agents when intolerance documented per policy definitions.

DocumentationPA should include details of statin trials and adverse event history.

Step Therapy / Prior Trial Requirements

Requirement	Details
Trial requirement
Initial approval requires documented trials of two specified biologic or targeted agents (examples include Enbrel, a preferred adalimumab product, Orencia, Rinvoq, Xeljanz/XR). Non-preferred adalimumab, Cimzia, Kevzara, infliximab, golimumab SC/IV and other listed agents may be counted toward the two‑trial requirement when specified.

Requirement	Details
Prior systemic therapy
For certain oncology agents (example: Bizengri), approval requires documentation that the patient has received prior systemic therapy (at least one systemic regimen) appropriate for the tumor type.

Requirement	Details
Documentation
Requests must include diagnosis and prior therapy history as applicable (e.g., for BOSULIF and everolimus entries the diagnosis, prior treatments and relevant test results such as HER2/HR status are required).

Requirement	Details
Preferred-agent trials
Initial approval for multiple biologic indications requires prior trials of specific preferred agents (counts vary by indication). Examples: AS and Psoriasis initial therapy require trials of two among Enbrel, a preferred adalimumab product, Cosentyx, Tremfya, Skyrizi, etc.; RA initial therapy requires two agents from a specified list.

Requirement	Details
Prior systemic therapy trials
Some indications (e.g., COLUMVI for lymphoma) require documented prior systemic therapy trials before approval — for DLBCL and similar lymphoma indications the patient must have received two or more lines of systemic therapy.

Requirement	Details
Conservative therapy attempted
For biologic initiation in some inflammatory indications (example: COSENTYX), a trial of at least one conventional systemic agent (e.g., methotrexate, cyclosporine, acitretin, PUVA) for approximately 3 months is required unless contraindicated; a trial of another biologic (not Cosentyx) may also count.

Requirement	Details
Prior trial required
Certain products require a specific prior trial before approval (examples: droxidopa requires prior trial of midodrine; Dupixent indications require prior topical/systemic controller trials or specified therapies depending on the indication).

Requirement	Details
Required prior/concomitant therapies
Some indications require specified prior or concomitant therapies (example: Enbrel RA initial therapy requires trial of one conventional synthetic DMARD for at least 3 months and trial of one other systemic therapy, and often concurrent use with MTX or similar is expected when initiating).

Requirement	Details
Prior therapy varies by indication
Prior therapy requirements differ across indications and agents (example: everolimus indications include specific prior lines or agents for breast cancer, GIST, and other tumors; criteria are indication‑specific).

Requirement	Details
Try and fail or contraindication to earlier agents
For some therapies patients new to treatment must have tried and failed earlier alternatives or have documented contraindication/intolerance (example: Firmagon requires trial of Eligard or Orgovyx prior to approval in new patients unless not appropriate).

Requirement	Details
Specified sequence before Iclusig (GIST)
For the GIST indication, Iclusig (ponatinib) approval is contingent on documented prior trials of imatinib (or avapritinib), sunitinib (or dasatinib), regorafenib, and ripretinib in the sequence noted to align with NCCN recommendations.

Requirement	Details
Trials of two alternatives and prescriber risk assessment
For insomnia management prior to certain therapies (example: lorazepam for insomnia), approval may require trials of two alternative sleep agents (ramelteon, low‑dose doxepin, eszopiclone, zolpidem, or zaleplon) plus a prescriber risk‑benefit assessment.

Requirement	Details
Polycythemia vera prior therapy
For polycythemia vera, Jakafi requires that the patient has tried hydroxyurea or peginterferon alfa‑2a or Besremi (ropeginterferon) prior to approval unless contraindicated or not tolerated.

Requirement	Details
Heart failure prior SGLT‑2 trial
For the heart failure indication, Kerendia requires a trial of an SGLT‑2 inhibitor (for example dapagliflozin, sotagliflozin, or empagliflozin) or documentation of contraindication/intolerance to an SGLT‑2 inhibitor prior to approval; baseline eGFR and potassium requirements also apply.

Requirement	Details
Jaypirca (mantle cell lymphoma) prior requirements
Jaypirca (pirtobrutinib) for mantle cell lymphoma requires prior receipt of at least one systemic regimen and prior use of a BTK inhibitor (or documented intolerance/not being a candidate) before approval.

Requirement	Details
Prior anti‑HER2 therapies
When lapatinib is used in combination with capecitabine or trastuzumab for metastatic HER2‑positive breast cancer, approval requires prior use of at least two anti‑HER2 regimens (per the product‑specific criteria).

Requirement	Details
Prior regimen failures required
Some products require multiple prior regimen failures before approval (example: LYNOZYFIC for multiple myeloma requires at least four prior systemic regimens including specified classes such as a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody).

Requirement	Details
High‑intensity statin and ezetimibe trial
For NEXLETOL/NEXLIZET, prior trials of a high‑intensity statin plus ezetimibe are required unless the patient is statin‑intolerant; LDL‑C thresholds and documentation of prior therapy are required.

Requirement	Details
High‑intensity statin trial (single)
Some lipid‑lowering agents require a trial of at least one high‑intensity statin (defined as atorvastatin ≥40 mg or rosuvastatin ≥20 mg) unless statin intolerance is documented prior to approval.

Administration Setting & Coverage Channel

Note

infusion center | office | hospital outpatient

When the policy specifies a required site of care or that Part B vs Part D determination will be made at authorization review, include the intended administration site and relevant clinician specialty in the PA request.

Examples: infusion center, office, hospital outpatient; some oncology/infused agents require this clarification.

Note

hospital outpatient

For products where the policy notes Part B determination at review, requests for administration in a hospital outpatient setting should indicate that intent so CMS channel determination can be made at authorization.

Note

office

Products that must be administered by or under the supervision of an ophthalmologist (e.g., Byooviz, CIMERLI) require documentation of the administering provider's specialty in the PA.

Include the administering clinician's name and specialty in the PA request.

Note

office | infusion center

When a product entry specifies office or infusion-center administration (e.g., CIMERLI), indicate the planned site of administration in the PA so appropriate Part B/Part D and site-of-care considerations can be addressed.

Note

infusion center | outpatient (implicit)

For therapies commonly administered in infusion centers or outpatient clinics (especially oncology/infused agents), include site-of-care information in the PA; Part B vs Part D determination may be made at authorization review.

Note

hospital outpatient

Certain oncology or infused agents may be administered in the hospital outpatient setting; include that intent in the PA submission for accurate Part B/Part D and site-of-care determination.

Note

infusion center | hospital outpatient

When the policy references Part B vs Part D determination for infusion products, indicate whether administration will occur in an infusion center or hospital outpatient clinic during PA submission.

Note

infusion center

For products typically administered in infusion centers (e.g., Privigen, some oncology supportive agents), include intended site of administration in the PA so CMS determination can be made at review.

Note

infusion center | outpatient

When the policy indicates Part B vs Part D determination will be made at authorization review, include whether the treatment will be given in an infusion center or outpatient clinic to facilitate correct benefit channeling.

Note

infusion center

For cancer/chemotherapy-related supportive agents, indicate that these are prescribed by or in consultation with an oncologist or hematologist and the site of administration (typically infusion center).

Required Documentation for PA

Documentation Required

Required documentation (common)

Providers must include required medical information in PA requests: diagnosis, concurrent medications, prior drugs tried (with dates and durations), and relevant genetic or laboratory test results.

Examples: LDL‑C for lipid agents; serum ferritin for iron chelators; mutation testing for select oncology agents.

Documentation Required

Part B/Part D determination

Part B vs Part D determination will be made at the time of authorization review for some agents; include administration setting and intended billing pathway information in the PA submission.

Documentation Required

BESREMI documentation

For BESREMI PA, include documentation of the diagnosis and that the prescriber is an oncologist or has consulted an oncologist.

Age requirement: ≥18 years.
Authorization duration: 1 year.

Documentation Required

Ibandronate documentation

For IV ibandronate PA, include diagnosis and supportive test results (e.g., T‑score or fracture history) demonstrating one of the policy criteria.

Authorization duration: 12 months.

Documentation Required

CABOMETYX documentation

CABOMETYX PA requests for NSCLC must include histology and RET gene rearrangement status as documented by an approved test.

Documentation Required

CAMZYOS required documentation

CAMZYOS documentation must include diagnosis, NYHA class, relevant symptoms, left ventricular wall thickness measurements, and LVOT gradient (rest or provoked); for continuation include duration on therapy and objective measures of clinical response or stability.

Prescriber must be a cardiologist and patient must be ≥18 years.

Documentation Required

Ceprotin required documentation

For Ceprotin prior authorization, include diagnostic confirmation of severe protein C deficiency (plasma protein C activity or antigen below lab reference or genetic testing) and exclusion of acquired causes plus symptom history.

Documentation Required

Chemet required documentation

For Chemet, document pre‑treatment blood lead level >45 mcg/dL and that the drug is being used to treat acute lead poisoning; prescriber should be experienced in chelation therapy.

Authorization duration: 2 months.

Documentation Required

Required labs/genetics

Provide baseline laboratory values and genetic test results when specified in the product criteria (examples include serum phosphorus and TmP/GFR for CRYSVITA).

Include lab dates and reference ranges for interpretation.

Documentation Required

Required documentation (examples)

Provide diagnosis, relevant lab/test results (e.g., serum ferritin for deferasirox/deferiprone; genetic/lab confirmation for enzyme replacement therapies), medication history, and prescriber specialty or consult notes where required.

Include objective measures and prior therapy dates to support the request.

Documentation Required

Fabrazyme diagnostic documentation

Fabrazyme PA requires laboratory demonstration of deficient alpha‑galactosidase A activity in leukocytes or fibroblasts OR molecular genetic testing demonstrating a pathogenic GLA variant.

Document exclusion of concurrent Galafold or Elfabrio use per policy.

Documentation Required

Emrelis tumor testing requirement

For Emrelis (telisotuzumab vedotin), tumor high c‑Met protein overexpression must be documented as ≥50% tumor cells with strong [3+] staining by an approved test.

Include approved test report showing the percentage and staining intensity.

Documentation Required

Diagnosis and laboratory documentation

Required documentation for monoclonal antibody therapies includes diagnosis and blood eosinophil counts where specified (e.g., asthma and EGPA criteria require eosinophil thresholds).

Include eosinophil absolute count with date and lab reference range.

Documentation Required

FRUZAQLA prior therapy documentation

For FRUZAQLA PA include documentation of prior systemic chemotherapy and targeted agent history (fluoropyrimidine-, oxaliplatin-, irinotecan-based chemo and anti‑VEGF therapy) and metastatic disease status.

Documentation Required

HAE diagnostic documentation

HAE due to C1 inhibitor deficiency must be confirmed by laboratory documentation of functional C1‑INH protein <50% of normal and low baseline serum C4 per lab reference.

Documentation Required

IDH2 mutation test

IDHIFA coverage requires documentation of IDH2‑mutation status detected by an approved test.

Documentation Required

Kanuma required tests

Kanuma prior authorization requires diagnosis plus genetic and laboratory test results demonstrating deficient lysosomal acid lipase activity or biallelic pathogenic/likely pathogenic gene variants.

Documentation Required

Kerendia baseline labs and prior therapy

Kerendia PA requires baseline labs (eGFR, urine albumin-to-creatinine ratio, serum potassium) and documentation of maximally tolerated ACE inhibitor or ARB therapy or documented contraindication/intolerance.

Documentation Required

Kalydeco diagnostic criteria

Kalydeco requires documentation of a pathogenic/likely pathogenic CFTR mutation, positive newborn screen or family history/clinical presentation, and evidence of abnormal CFTR function (elevated sweat chloride, two CFTR mutations, or abnormal nasal potential difference).

Documentation Required

Diagnosis and prior therapy documentation

Provide diagnosis and prior treatment documentation for somatostatin analogs (lanreotide/Somatuline) and similar specialty agents when requested.

Documentation Required

Lapatinib documentation

For lapatinib PA include diagnosis (metastatic breast cancer), HER2/HR status, and prior anti‑HER2 treatments.

Documentation Required

LUMIZYME diagnostic documentation

Lumizyme requires diagnosis and genetic/laboratory confirmation (deficient acid alpha‑glucosidase activity or biallelic GAA pathogenic variants); include test reports in the PA.

Documentation Required

LORBRENA diagnostic documentation

Lorbreena PA requires documentation of ALK/ROS1 status and prior therapies per indication.

Documentation Required

Naglazyme diagnostic documentation

Naglazyme requires laboratory or genetic documentation demonstrating deficient enzyme activity or biallelic pathogenic variants; include test results with the PA.

Documentation Required

Myfembree documentation

Myfembree PA requires diagnosis and supporting test results (e.g., pelvic ultrasound, prior therapy trials); authorization is limited to a total of 24 months combined Myfembree/Oriahnn.

Document prior contraceptive/oral progestin trials or prior GnRH/Orilissa use where applicable.

Documentation Required

Required medical information (examples)

Required medical information commonly includes diagnosis, LDL‑C for lipid drugs, response to other agents, therapies tried, medication adverse event history, and relevant lab values (e.g., blood eosinophil counts for Nucala).

OpenPayer

Prior Authorization Criteria for Specialty and Infused Drugs — EmblemHealth Medicare Plans

Coverage Criteria (Product-specific)

Initial Therapy — Entry Criteria

Continuation and Maintenance Therapy

Provider Actions, Prior Authorization & Documentation

Document Reference Codes & Key Clinical Thresholds

Definitions & Background

Step Therapy / Prior Trial Requirements

Quantity Limits & Authorization Durations

Administration Setting & Coverage Channel

Required Documentation for PA

Biosimilar Preferences & Preferred Products