CurrentIndependent HealthPolicy N/A

2025 Prior Authorization Criteria (Individual/Group)

Prior authorization (PA) requirements for multiple prescription drugs on Independent Health's 2025 Medicare Advantage Part D formularies; includes clinical prerequisites, exclusions, prescriber and age restrictions, coverage duration, Part B/Part D determinations, and reauthorization requirements for the products listed in this part of the document.

Policy Summary

PayerIndependent Health

Policy2025 Prior Authorization Criteria (Individual/Group)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit required diagnostics, labs, prior therapy documentation, pregnancy status, and specialty attestation as specified for each drug before dispensing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this brief (has_material_change=false).

ManyCommon coverage duration = 1 year

SeveralRequire genetic/biomarker testing

VariedPA applies to new starts vs all

~90+Products listed in this part

HighDenial risk if exclusions met

Coverage Summary

This document lists Independent Health's Prior Authorization (PA) clinical criteria for drugs on the 2025 Medicare Advantage Part D formularies. It clarifies Part B vs Part D determinations (coverage may depend on route of administration, site of care, or whether the drug is self-administered after training or pharmacy-filled and delivered to the office), notes specialty prescriber restrictions for many agents (e.g., oncology, pulmonology, cardiology, neurology, psychiatry), and documents common exclusions (pregnancy, severe hepatic impairment/Child-Pugh class C, specified drug–drug interactions, uncontrolled hypertension, dementia-related psychosis where noted). Required diagnostic tests and baseline labs (for example: mutation/genetic testing for targeted therapies, creatinine clearance/eGFR, LFTs, baseline ECG/QTc, CBC/ANC, platelets, 24-hour UFC, sputum cultures, TB screening for immunomodulators) are specified per product. Reauthorization commonly requires objective evidence of clinical benefit or stability (examples: spirometry or symptom reduction for COPD therapies, LDL or UPCR improvement for lipid/renal agents, on-treatment headache-day improvements for migraine agents, updated labs). Coverage durations are usually 6 months initially then 1 year for some agents or 1 year for many products; PA applicability is specified per-product (new starts only vs applies to all).

Operational rules and metadata (high-level)

Effective date2025-12-01

Common coverage durationMost products: 1 year (initial shorter periods noted for some agents)

PA applicability patternMost PA apply to new starts only; some agents require PA for all requests

Part B vs Part D noteDetermination based on route/site of administration and how drug is obtained — self‑admin after training or pharmacy fill delivered to office may allow Part D; otherwise may be Part B

Common required prescriber specialtiesOncology, pulmonology, cardiology, hematology, neurology, endocrinology, psychiatry — many agents restricted to one or more specialty prescribers

Typical reauthorization requirementObjective documentation of clinical benefit or stability (examples: spirometry or symptom improvement, lab/biomarker improvement, maintained response) required for renewals

Initial Therapy Criteria (selected products)

Covered when the following criteria are met. Preserve nested AND/OR logic and thresholds as specified.

ALL of the following

Diagnosis of chronic obstructive pulmonary disease (COPD).
Post-bronchodilator FEV1/FVC ratio < 0.72.
Post-bronchodilator FEV1 percent predicted between 23% and 85% inclusive.23% - 85%
Modified Medical Research Council (mMRC) Dyspnea Scale score >= 2.>= 2

Initial Therapy Criteria (additional products)

Additional product criteria (AUVELITY, AVMAPKI FAKZYNJA CO-PACK, AYVAKIT, BALVERSA, NEXLETOL/NEXLIZET, BENLYSTA SC, BESREMI, bexarotene external, OTEZLA/SOTYKTU class, BOSULIF, BRAFTOVI+MEKTOVI, BRONCHITOL, BRUKINSA)

AUVELITY

Diagnosis of covered use
Attestation patient has been screened for and does not have bipolar disorder
Prescription claims or documentation showing patient has tried and failed or had intolerance to at least two different antidepressant medications indicated for the diagnosis
Exclusion: Seizure disorder; current or prior diagnosis of bulimia or anorexia nervosa; MAOI within 14 days

Continuation Therapy Criteria / Reauthorization

Continuation / Reauthorization requirements (selected products)

OHTUVAYRE — Continuation / Reauthorization: Reauthorization requires documentation of proof of benefit (spirometry results from baseline and/or decreased symptoms from baseline) and documentation the patient remains on background LAMA-LABA therapy with or without an ICS

ARALAST NP / GLASSIA — Continuation / Reauthorization: Continuation of therapy requests require objective documentation from the prescriber that the patient's symptoms have improved; updated Part B vs Part D determination info may be required

CAMZYOS — Initial 6-month then reauthorization: Documentation required: positive response after initial 6 months (objective) for reauthorization; maintenance of clinical benefit and prescriber attestation required for subsequent annual reauthorizations

GATTEX — Continuation:

Exclusions and Denials

Common Exclusions (pregnancy, severe hepatic impairment, contraindicated coadministrations)

Common Exclusions

Pregnancy-related exclusions: Pregnancy is listed as an exclusion for multiple products; some therapies require pregnancy status for females of childbearing potential prior to approval
See product-specific exceptions
Hepatic impairment exclusions: Severe hepatic impairment (Child-Pugh class B or C) or other liver disease is a recurring exclusion for many agentsChild-Pugh class C often excluded
Product-specific thresholds apply
Renal impairment exclusions: Severe renal impairment or low creatinine clearance/eGFR thresholds (e.g., CrCl <15 mL/min, eGFR <30 mL/min) exclude use of certain drugs

Provider Actions

Prior Authorization

Prior Authorization required for listed Part D drugs

Independent Health requires prior authorization (PA) for many Part D drugs listed on the formulary. Requests must include the specific product name(s) and will be reviewed against the PA criteria. Failure to obtain PA may result in non-coverage. See product-specific criteria for coverage duration and limits.

PA applies to new starts unless otherwise noted (some drugs apply to all fills or to continuation only).
List of affected products must be provided on the request (drug name, strength, formulation).
Coverage duration and quantity limits are applied per drug (e.g., initial 6 months then annual for select agents).
If a drug may be covered under Part B for a given use or setting, PA still applies when it is billed under Part D.

Documentation Required

Applicable Codes

Products listed (no CPT/HCPCS/ICD codes provided in this part)mixed

OHTUVAYRE	Product affected (COPD agent)
ABILIFY MYCITE MAINTENANCE KIT	Aripiprazole mycite, maintenance kit
ABILIFY MYCITE STARTER KIT	Aripiprazole mycite, starter kit
ACTIMMUNE	Interferon gamma-1b
ADEMPAS	Riociguat
ALECENSA	Alectinib
ARALAST NP	Alpha-1 proteinase inhibitor
GLASSIA	Alpha-1 proteinase inhibitor
PROLASTIN-C	Alpha-1 proteinase inhibitor
ZEMAIRA	Alpha-1 proteinase inhibitor

1–10 of 59

1/6

Products listed in this part (drug/product names)mixed

COBENFY	COBENFY product
COBENFY STARTER PACK	COBENFY starter pack
COMETRIQ (100 MG DAILY DOSE) ORAL KIT 80 & 20 MG	Cometriq product/dose kit
COMETRIQ (140 MG DAILY DOSE) ORAL KIT 3 X 20 MG & 80 MG	Cometriq product/dose kit
COMETRIQ (60 MG DAILY DOSE)	Cometriq product/dose
COPIKTRA ORAL CAPSULE 15 MG, 25 MG	Copiktra
CORTROPHIN	Cortrophin
CORTROPHIN GEL	Cortrophin gel
COTELLIC	Cobimetinib
ZELBORAF	Vemurafenib

1–10 of 56

1/6

No explicit procedure/CPT/HCPCS/ICD-10/NDC codes listed in this partmixed

No codes listed

No explicit CPT/HCPCS/ICD-10/NDC codes provided in this partmixed

No codes listed

No specific billing/procedure/drug codes listed in this partmixed

No codes listed

No codes specified in this partmixed

No codes listed

Products Listed in This Partmixed

VENCLEXTA ORAL TABLET 10 MG, 100 MG, 50 MG
VENCLEXTA STARTING PACK
VEOZAH
VERQUVO ORAL TABLET 10 MG, 2.5 MG, 5 MG
VERZENIO
VIBERZI
VIJOICE ORAL PACKET
VIJOICE ORAL TABLET THERAPY PACK 125 MG, 200 & 50 MG, 50 MG
VITRAKVI ORAL CAPSULE 100 MG, 25 MG
VITRAKVI ORAL SOLUTION

1–10 of 40

1/4

Indexed products (drugs listed in this part)mixedCovered

ZOKINVY ORAL CAPSULE 50 MG, 75 MG	Listed product with PA criteria (page ref 289)
ZONTIVITY	Listed product with PA criteria
ZTALMY	Listed product with PA criteria
ZURZUVAE	Listed product with PA criteria
ZYDELIG	Listed product with PA criteria
ZYKADIA ORAL TABLET	Listed product with PA criteria

Index of additional products in Part 8mixed

ABILIFY MYCITE MAINTENANCE KIT	Indexed product with page references
AIMOVIG	Indexed product
AUSTEDO	Indexed product
BIVIGAM	Indexed product
BOSULIF	Indexed product
BRUKINSA	Indexed product
BYLVAY	Indexed product
CABLIVI	Indexed product
CABOMETYX	Indexed product
CALQUENCE	Indexed product

1–10 of 13

1/2

Note: many entries in this part do not include explicit CPT/HCPCS/ICD-10/NDC codes. The code tables in the source reflect product names and internal codes as listed in the brief rather than specific billing procedure or NDC code sets; providers should not assume presence of procedure/CPT/HCPCS/ICD-10/NDC codes where the brief does not list them.

Clinical Evidence & Monitoring

Evidence and monitoring requirements summarized: targeted therapies frequently require genetic or mutation testing prior to approval (examples: ALK, ROS1, EGFR, RET, BRAF, FLT3, PIK3CA, IDH1/2, BRCA, FGFR fusions). Baseline laboratory monitoring commonly required includes liver function tests (LFTs/Child‑Pugh), electrolytes (potassium, magnesium, calcium), and renal function (creatinine clearance or eGFR); oncology and QT‑prolonging agents often require a baseline ECG/QTc interval. For immunomodulators and many biologics (except where noted), baseline TB screening (PPD or IGRA) is required and positive screens must be treated before approval, with yearly re‑screening for at‑risk patients. Other monitoring examples: baseline 24‑hour urine free cortisol (UFC) for Cushing's therapies; pre‑treatment platelet count, ANC, ferritin for hematologic agents; baseline LDL/apoB and hepatic labs for lipid/genetic lipid therapies. Reauthorizations commonly require updated labs or objective clinical metrics (e.g., LDL or UPCR reduction, spirometry, motor scores, ANC/ALC improvements) as specified per product.

Common numeric thresholds cited in PA criteria

FEV1/FVC ratio (COPD)< 0.72

Post-bronchodilator FEV1 % predicted (COPD)>= 23% and <= 85%

mMRC Dyspnea Scale (COPD/COPD criteria)>= 2

Background and Definitions

Background: these Part D PA criteria define prior authorization requirements for drugs on Independent Health's 2025 Medicare Advantage Part D formularies. The policies include: (1) Part B vs Part D considerations — determinations are based on route, site of care, and how medication will be obtained/used; self‑administration after training or pharmacy fill delivered to the provider office may permit Part D coverage, otherwise drugs may be Part B (provider‑administered); (2) specialty prescriber requirements — many agents are restricted to specific specialties such as oncology, pulmonology, cardiology, neurology, endocrinology, hematology, immunology, or psychiatry; (3) exclusions — common exclusions include pregnancy, severe hepatic impairment (Child‑Pugh class C), certain cardiac or renal contraindications, dementia‑related psychosis for some antipsychotics, and disallowed off‑label uses (e.g., GLP‑1 agonists for weight management under Part D); (4) required diagnostics — product sections list required baseline tests such as mutation/genetic tumor testing (ALK, ROS1, EGFR, BRAF, RET, BRCA, PIK3CA, etc.), creatinine clearance or eGFR, LFTs/Child‑Pugh, ECG/QTc, CBC/ANC, platelets, 24‑hour UFC, sputum cultures, TB screening (PPD or IGRA) for many immunomodulators; and (5) reauthorization rules — many products require objective evidence of clinical benefit or stability (e.g., spirometry for COPD, lab improvements like LDL or UPCR, decreased symptoms, updated LFTs) with typical intervals noted per product (examples: initial 6-month evaluation for some agents then annual). Definitions: PA = Prior Authorization; Part B vs Part D determination = determination whether drug is covered under Medicare Part B (provider-administered) or Part D (pharmacy benefit) based on administration and how drug is obtained/used; Child-Pugh class C = severe hepatic impairment; UFC = 24‑hour urine free cortisol.

Revision History

2025-12-01effectiveLatest

Policy effective date

Policy Summary

PayerIndependent Health

Policy2025 Prior Authorization Criteria (Individual/Group)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit required diagnostics, labs, prior therapy documentation, pregnancy status, and specialty attestation as specified for each drug before dispensing.

SourceLink

On This Page

Background therapy

Currently receiving dual therapy with a long-acting beta agonist (LABA) and a long-acting muscarinic antagonist (LAMA) with or without an inhaled corticosteroid (ICS).
Documentation that dual LABA-LAMA or triple LABA-LAMA-ICS therapy has been ineffective, not tolerated, or is contraindicated.

Attestation that the drug will not be used in combination with roflumilast.

Operational: required attestation.

Age 18 years or older.

Prescriber restricted to pulmonology.

Prescriber specialty must be documented.

Coverage duration: 6 months initial, then 1 year on reauthorization.

Reauthorization requires spirometry results from baseline and/or documentation of decreased symptoms from baseline and proof patient remains on background LAMA-LABA therapy with or without an ICS.

This medication is covered as a Part B benefit except for enrollees residing in a long-term care facility. PA applies to all when covered as a Part D benefit.

Billing rule: may require Part B vs Part D determination.

ALL of the following

Diagnosis of covered use (aripiprazole indication).
Age 18 years or older.
Prescriber restricted to psychiatry.
PA applies to new starts only; for approval, documentation of at least a one-month trial of generic aripiprazole solution, tablets, or orally-disintegrating tablets is required.
Exclusion: dementia-related psychosis.
Coverage duration: 1 year.

ALL of the following

Diagnosis of covered use for ACTIMMUNE.
Coverage duration: 1 year.
PA applies to all; description of how drug will be used and whether covered under Part B or Part D may be required (self-administration after training or pharmacy fill/delivery to office may permit Part D coverage).

ALL of the following

For ADEMPAS: Diagnosis of covered use including WHO Group; submission of creatinine clearance (or serum creatinine, actual body weight, and height) and pregnancy status for females of childbearing potential.
For pulmonary arterial hypertension (WHO Group 1), diagnosis confirmed by right heart catheterization.
Exclusions: pregnancy, Child-Pugh class C hepatic impairment, creatinine clearance <15 mL/min or dialysis, concurrent nitrates/nitric oxide donors, concurrent PDE5 inhibitors.
Age 18 years or older.
Prescriber restricted to cardiology or pulmonology.
Coverage duration: 1 year. PA applies to new starts only.

ALL of the following

For ALECENSA: Diagnosis of covered use; submission of test confirming ALK-positive tumor; pregnancy status for females of childbearing potential.
Age 18 years or older.
Prescriber restricted to oncology.
Coverage duration: 1 year. PA applies to new starts only.

ALL of the following

For ARALAST NP / GLASSIA: Pre-treatment alpha-1 antitrypsin (AAT) showing levels <11 mmol/L (80 mg/dL).
Confirmation of clinically evident emphysema secondary to congenital AAT deficiency via pulmonary function testing, imaging, or DLCO.
Exclusion: IgA deficiency with known anti-IgA antibodies.
Age 18 years or older.
Prescriber restricted to pulmonology.
Coverage duration: 1 year. PA applies to all. Continuation requires objective documentation of symptom improvement.
Part B vs Part D determination may be required based on administration method.

ALL of the following

For ALUNBRIG: Diagnosis of covered use; confirmation of ALK-positive tumor; baseline blood pressure prior to initiation; pregnancy status for females of childbearing potential.
Exclusion: uncontrolled hypertension.
Age 18 years or older.
Prescriber restricted to oncology.
Coverage duration: 1 year. PA applies to new starts only.

ALL of the following

For OSMOLEX ER: Diagnosis of covered use; submission of creatinine clearance (or serum creatinine, actual body weight, and height).
Documentation patient tried and failed immediate-release amantadine.
Exclusion: end-stage renal disease (creatinine clearance <15 mL/min).
Age 18 years or older.
Prescriber restricted to neurology.
Coverage duration: 1 year. PA applies to all.

ALL of the following

For AQNEURSA: Diagnosis of covered use with at least mild neurologic manifestations of Niemann-Pick disease type C; submission of pregnancy status for females of childbearing potential.
Exclusion: pregnancy.
Prescriber restricted to neurology.
Coverage duration: 1 year. PA applies to new starts only.

ALL of the following

For ARCALYST: Diagnosis of covered use; submission of baseline latent tuberculosis screening test (PPD or IGRA).
Exclusion: active or chronic infection; coadministration with TNF-blocking agents.
Coverage duration: 1 year. PA applies to all.
If TB screening positive, coverage delayed until latent TB treated. For reauthorization, annual TB screening or chest X-ray required for patients at risk or with prior positive test.
Part B vs Part D determination may be required based on administration method.

ALL of the following

For ARIKAYCE: (Note: preserve usual inhaled/iv specifics) Diagnosis of covered use per FDA labeling; prescriber specialty as indicated in product-specific policy; documentation of prior appropriate antibiotic therapy and microbial confirmation as required by product criteria.
Coverage duration and restrictions per product labeling; PA applies according to formulary designation.

Additional product-specific groups (operational/consolidated entries)

CAMZYOS (mavacamten)
- Diagnosis of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) per FDA indication.
- Documentation of NYHA functional class II-III symptoms and baseline left ventricular outflow tract (LVOT) gradient as required by clinical policy.
- Prescriber restricted to cardiology; pregnancy status for females of childbearing potential.
- Coverage duration per policy; PA applies to new starts.
Cobenfy - Other operational rules
- Include payer operational rules such as specialty restriction to psychiatry where indicated, step-therapy overrides, and any required starter/maintenance kit distinctions.
Restricted psychiatry products (unnamed list)
- Products restricted to psychiatry require documentation of therapeutic trial of generic alternatives and meet age/prescriber criteria as specified per product.
Cometriq (multiple dosing kits)
- Ensure correct kit/dose selection documented; prescriber restricted to oncology; coverage duration per kit specification; PA applies to new starts.
Copiktra (15 mg, 25 mg oral capsules)
- Diagnosis of covered use; documentation of prior therapies and labs per PI; age 18+; prescriber restricted to oncology; PA applies to new starts.
Cortrophin / Cortrophin Gel
- Diagnosis consistent with labeled indications; screening and monitoring per product guidance; PA applies to all; Part B vs Part D determination per administration.
Cotellic + Zelboraf (cobimetinib + vemurafenib)
- Diagnosis of BRAF V600 mutation-positive melanoma; confirmation of mutation testing required; prescriber restricted to oncology; PA applies to new starts.
Cresemba (oral capsule 186 mg)
- Diagnosis of invasive fungal disease per product labeling; documentation of fungal species and susceptibility where required; PA applies to new starts.
Cystadrops / Cystaran
- Diagnosis of cystinosis with appropriate ophthalmologic findings; prescriber specialty and age restrictions as per product; PA applies to new starts.
Daurismo (100 mg, 25 mg tablets)
- Diagnosis per labeled indication (e.g., AML with specific mutations); prescriber restricted to oncology; documentation of relevant mutation testing; PA applies to new starts.
Deferasirox (oral soluble tablets)
- Diagnosis of chronic iron overload; baseline ferritin and renal/hepatic function required; age and prescriber restrictions per product; PA applies to new starts.
Deferiprone / Ferriprox
- Indication and monitoring per product labeling; baseline labs and monitoring plan required; PA applies to new starts.
Dichlorphenamide / Ormalvi
- Diagnosis of primary hyperinsulinemia/hypersalivation specifics or other labeled use; contraindications and monitoring per product; PA applies to new starts.
Diclofenac epolamine external
- Indication for topical use documented; quantity limits and age restrictions applied per policy; PA applies when specified on formulary.
Digoxin oral tablet 250 mcg
- Documentation of indication (e.g., heart failure or atrial fibrillation), therapeutic drug monitoring plan; dosing rationale for 250 mcg tablet required; PA applies per formulary.
Doptelet (20 mg oral tablet)
- Diagnosis of thrombocytopenia per labeled indications; baseline platelet counts and monitoring plan required; prescriber restrictions and PA per policy.
Dronabinol / Syndros
- Indication documented; prior trials of alternatives and abuse risk assessment required; PA applies where indicated.
Dupixent (multiple indications)
- Indication-specific criteria must be met (e.g., atopic dermatitis, asthma, CRSwNP); baseline severity measures and previous therapy trials required; prescriber specialty and monitoring as per indication; PA applies to new starts and continuation per indication-specific intervals.
L-glutamine oral packet (sickle cell disease)
- Diagnosis of sickle cell disease; documentation of baseline pain/crisis frequency and concomitant hydroxyurea use status; PA applies to new starts.
Everolimus (oral tablets/soluble)
- Indication documented and relevant monitoring labs (e.g., renal function, CBC) provided; prescriber restricted to oncology/transplant as indicated; PA per formulary.
Fentanyl citrate transmucosal (buccal/lozenge)
- Indication for breakthrough cancer pain with opioid tolerance documented; quantity and formulation limits apply; PA per formulary.
Neupogen (multiple formulations)
- Indication and formulation specified; baseline ANC and treatment intent (curative vs palliative) documented; Part B vs Part D rules may apply; PA per formulary.
Filspari
- Apply sparse-noted criteria: diagnosis and prescriber restrictions per product; PA applies to new starts.
Select first-generation antihistamines for older patients
- Use of carbinoxamine, clemastine, cyproheptadine, diphenhydramine in patients ≥65 is restricted; safer alternatives recommended; PA or denial risk may apply per policy.
Fotivda
- Indication, prior therapy trials, and prescriber specialty documented per product labeling; PA applies to new starts.
GATTEX (teduglutide)
- Diagnosis of short bowel syndrome with parenteral support; documentation of parenteral nutrition dependence and reduction goals required; PA applies to new starts and continuation (GATTEX continuation criteria).
GLP-1 agonists (Mounjaro, Ozempic, Rybelsus, Trulicity, etc.)
- Indication documented (e.g., T2DM, weight management where indicated); prior therapy trials, BMI, and baseline A1c as applicable; quantity limits and step therapy rules apply; prescriber specialty and patient monitoring required.
Growth hormone products (Norditropin, Nutropin)
- Indication documented, growth charts or endocrine evaluation provided; age and diagnosis criteria per product; PA applies to new starts and renewals.
Hereditary angioedema products (Berinert, Ruconest, Haegarda, Takhzyro)
- Diagnosis of hereditary angioedema documented; attack frequency/severity or prophylaxis rationale provided; prescriber specialty and use setting (on-demand vs prophylaxis) documented; PA applies to new starts.
HER2-positive tumor therapies
- Confirmation of HER2-positive status required; prescriber restricted to oncology; product-specific prior therapies and contraindications applied; PA per product.
IQIRVO (elafibranor?) for primary biliary cholangitis
- Indication-specific criteria and diagnostic confirmation required; prescriber specialty and monitoring plan documented; PA applies when listed.
Ketoconazole (oral)
- Indication for systemic fungal infections documented; baseline liver function tests and monitoring plan required due to hepatotoxicity risk; PA applies to new starts.
NUCALA (multiple presentations)
- Indication-specific criteria (e.g., severe eosinophilic asthma, EGPA) with baseline eosinophil counts and prior therapy trials required; prescriber specialty and dosing presentation documented; PA applies to new starts and continuation.
OGSIVEO (100, 150, 50 mg tablets)
- Indication and dosing documented per product labeling; prescriber specialty and monitoring as indicated; PA applies to new starts.
ORILISSA (elagolix) 150 mg, 200 mg
- Indication (e.g., endometriosis) documented; prior therapies and contraindications (e.g., pregnancy) assessed; PA applies per formulary.
ORSERDU (elacestrant)
- Diagnosis of ER+/HER2- advanced/metastatic breast cancer with ESR1 mutation per labeling when required; prior endocrine therapy history documented; prescriber restricted to oncology; PA applies to new starts.
OXERVATE (cenegermin)
- Diagnosis of neurotrophic keratitis; ophthalmologic evaluation and staging provided; prescriber specialty documented; PA applies to new starts.
XYREM / XYWAV (sodium oxybate)
- Diagnosis of narcolepsy with cataplexy or excessive daytime sleepiness where indicated; documentation of prior stimulant therapy, REMS compliance, and prescriber specialty; PA applies with quantity limits and safety monitoring.
UDENYCA (pegfilgrastim-cbqv) and UDENYCA ONBODY
- Indication and ANC baseline; documentation whether on-body injector vs prefilled syringe required; Part B vs Part D determination and billing guidance provided; PA per formulary.
Pulmonary arterial hypertension agents (class)
- For agents such as ambrisentan, bosentan, Opsumit, Orenitram, sildenafil, tadalafil, Tracleer, Ventavis, and others: diagnosis confirming PAH (WHO Group 1), right-heart catheterization when required, pregnancy testing and REMS requirements, prescriber specialty, and renal/hepatic function as applicable; PA applies to new starts.
ROMVIMZA (naxitamab-gqgk)
- Indication and oncology specialty documentation; prior therapies and infusion setting specified; PA applies per product labeling.
Eszopiclone, zaleplon, zolpidem
- Use restricted per age and comorbidity (avoid in older adults when alternatives available); documentation of insomnia diagnosis and prior non-pharmacologic therapies; PA or quantity limits may apply.
SIGNIFOR
- Indication (e.g., Cushing's disease) documented with biochemical confirmation; prescriber specialty and monitoring plan required; PA applies to new starts.
Ezetimibe-simvastatin, simvastatin 80 mg
- High-risk statin dosing: simvastatin 80 mg limited to patients already stabilized on this dose; ezetimibe-simvastatin fixed-dose combination criteria per formulary; monitoring and prior statin trials required.
SIRTURO (bedaquiline)
- Diagnosis of multidrug-resistant tuberculosis per CDC/WHO guidance; specialist TB management documentation; baseline ECG and hepatic monitoring; PA applies to new starts.
SIVEXTRO
- Indication and microbial susceptibility documented; dosing and duration per labeled use; PA applies when listed.
SKYCLARYS
- Indication documented per labeling; prescriber specialty and monitoring plan required; PA applies to new starts.
SOHONOS
- Indication and prescriber documentation per product labeling; PA applies when listed.
SOMAVERT
- Indication (acromegaly), baseline IGF-1 and prior therapy history required; prescriber specialty and monitoring plan documented; PA applies to new starts.
Oncology small-molecule agents (dasatinib, STIVARGA, sunitinib, TABRECTA, TALZENNA, nilotinib, TEPMETKO, TIBSOVO, VANFLYTA, VANRAFIA, VENCLEXTA, etc.)
- Diagnosis and relevant molecular testing where required; prior therapies and line of therapy documented; prescriber restricted to oncology; PA applies to new starts.
Tadalafil (2.5 mg, 5 mg)
- Indication (e.g., pulmonary hypertension or erectile dysfunction) documented; dosing and contraindications reviewed; PA applies per formulary.
VYNDAMAX, VYNDAQEL (transthyretin amyloid agents)
- Diagnosis of transthyretin amyloid cardiomyopathy confirmed by appropriate testing; prescriber restricted to cardiology/amyloid specialty; PA applies to new starts with documentation of genetic testing where indicated.
TAGRISSO
- EGFR mutation-positive NSCLC confirmation required; prescriber restricted to oncology; PA applies to new starts and continuation per label.
TAVNEOS
- Diagnosis of ANCA-associated vasculitis per labeling; baseline labs and infection screening required; prescriber specialty and PA per policy.
TAZVERIK
- Diagnosis of EZH2-mutant follicular lymphoma or other labeled indications; mutation testing and prescriber specialty documented; PA applies.
TEGSEDI
- Diagnosis of hereditary transthyretin-mediated amyloidosis with polyneuropathy; neurologic assessment and monitoring plan required; prescriber specialty documented; PA applies.
Teriparatide (pen injector) and TYMLOS
- Indication for osteoporosis with fracture risk assessment documented; prior osteoporosis therapy history provided; duration limits and refill criteria applied; PA per formulary.
SUCRAID
- Indication for sucrase-isomaltase deficiency documented with diagnostic testing; prescriber specialty and PA applied.
VTAMA, ZORYVE
- Indication for dermatologic conditions documented with baseline severity and prior therapy trials; prescriber specialty and PA per product.
TRUQAP, TRUQAP therapy pack
- Indication documentation, prescriber specialty, and kit/pack specification required; PA applies to new starts.
MYFEMBREE, ORIAHNN
- Indication (e.g., heavy menstrual bleeding, endometriosis) documented; prior therapies and contraindications reviewed; PA applies per formulary.
VALCHLOR
- Indication for topical mechlorethamine documented; prior therapies reviewed; PA applies when listed.
VEOZAH (fezolinetant)
- Indication for vasomotor symptoms of menopause documented; prior therapies and contraindications reviewed; PA applies per formulary.
VIJOICE (alpelisib?)
- If applicable: documentation of PIK3CA mutation and indication for HR+/HER2- advanced breast cancer; prescriber restricted to oncology; PA applies.
VIVJOA (oteseconazole)
- Indication and microbiologic documentation where required; prescriber specialty and PA applied.
VORANIGO (vorasidenib) - grade 2 gliomas
- Diagnosis of IDH1/2-mutant grade 2 glioma per labeling; prescriber restricted to neuro-oncology; PA applies to new starts.
WAKIX (pitolisant)
- Diagnosis of narcolepsy or nocturnal sleep disorders per labeling; prior therapies and REMS/monitoring documented; PA applies.
XALKORI (crizotinib)
- Diagnosis with relevant ALK/ROS1/MET mutation testing as indicated; prescriber restricted to oncology; PA applies to new starts.
XIFAXAN 550 mg (rifaximin)
- Indication documented (e.g., hepatic encephalopathy prevention, IBS-D, SIBO); prior appropriate therapy trials documented; PA and quantity limits per indication.
XOLAIR (omalizumab)
- Indication-specific criteria (e.g., moderate-severe allergic asthma, chronic spontaneous urticaria) with baseline IgE and other markers as required; prescriber specialty and dosing documented; PA applies to new starts and continuation.
XOLREMDI (mavorixafor?)
- Indication and prescriber specialty documented; mutation testing if applicable; PA applies when listed.
XURIDEN (triheptanoin?)
- Diagnosis of long-chain fatty acid oxidation disorders or indicated metabolic disorders; metabolic/genetic testing and dietitian plan required; PA applies.
ZOKINVY (lonafarnib)
- Indication for progeria or related conditions with genetic confirmation; prescriber specialty and monitoring plan required; PA applies.

Indications: All FDA-approved and medically-accepted indications unless otherwise noted. Off-label uses follow standard medical-necessity review per policy.

Consolidated operational note: preserve existing correct entries and ensure product-specific documentation, specialty restrictions, laboratory and testing prerequisites, and Part B vs Part D billing rules are followed as described above.

Age 18 years or older>=18 years

Prescriber restricted to psychiatry

Coverage duration: 1 year

Other: PA applies to new starts only

AVMAPKI FAKZYNJA CO-PACK

Diagnosis of covered use
Submission of test confirming presence of KRAS mutation
Submission of pregnancy status for females of childbearing potential
Attestation patient has received at least one prior systemic therapy
Exclusion: Coadministration with moderate or strong CYP3A inhibitors or inducers, PPI or H2 antagonists
Age 18 years or older>=18 years
Prescriber restricted to oncology
Coverage duration: 1 year

Continue rendering additional per-product criteria_groups in the same order as provided in the brief. For each remaining product, use the product title as the group's title and render the product-specific nodes (diagnosis, required tests, exclusions, prescriber specialty, coverage duration, Part B vs Part D notes, prior-therapy requirements, and reauthorization rules) from the matching criteria_trees in the brief. This section is for any additional initial-therapy entries not captured above; include the product-level criteria nodes exactly as supplied in the brief.

For adults ≥18, submission of follow-up colonoscopy or alternate imaging result at end of 1 year of therapy required; subsequent imaging every 5 years or sooner if polyps found

FABHALTA — Continuation: Continuation requests require confirmation patient has demonstrated clinical improvement or maintenance of improvement from baseline; Part B prerequisite may apply for some indications

CERDELGA — Reauthorization: Updated liver function testing or Child-Pugh score since previous authorization required for subsequent reauthorizations; drug not covered in ultra-rapid CYP2D6 metabolizers

Common reauthorization themes across products: reauthorization typically requires submission of updated laboratory testing and/or objective documentation of clinical benefit or maintenance of benefit (e.g., spirometry or symptom improvement for respiratory agents, 24-hour UFC or symptom improvement for Cushing's agents, LDL or proteinuria reductions for lipid/renal agents, updated liver function tests for hepatology drugs). Typical timing patterns include an initial evaluation window (often 6 months) for some agents followed by annual reauthorizations; many other products use an annual (1 year) coverage period requiring periodic lab or clinical updates. Continued use of required background therapies (e.g., maintenance LAMA-LABA for COPD, statin/ezetimibe for lipid agents) is commonly required for renewal unless clinician documents intolerance.

Product-specific (e.g., CrCl <15 mL/min or eGFR <30 mL/min)

Check product section for exact threshold

Contraindicated coadministrations: Coadministration with strong or moderate CYP3A4/3A inhibitors or inducers, P-gp inhibitors, QT-prolonging drugs, or other named agents is commonly excludedProduct-specific interactions

Refer to product nodes for exact drug interaction exclusions

Cardiac/QT exclusions: Uncontrolled hypertension, congenital long QT syndrome, prolonged QT/QTcF thresholds, or recent cardiac events commonly exclude therapyQTcF or BP thresholds vary by product

See product-specific QT/BP requirements

Infection/immunosuppression exclusions: Active or chronic infection, positive TB screening, or coadministration with TNF-blockers or other immunosuppressants exclude certain biologics; TB screening and treatment required for some immunomodulators before approval

Specific screening (PPD/IGRA) required for many biologics

Dementia-related psychosis is an exclusion for several antipsychotic products

Applies to specified antipsychotics

Product-specific exceptions: Some products have unique exclusions (e.g., body surface area limits for topical agents, weight limits, pediatric age windows) — see product criteria for details

Refer to individual product sections for exceptions

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Medicare Part D exclusions called out in this policy: GLP-1 agonists and similar agents will not be approved for off‑label weight management under Medicare Part D; other policy-level exclusions include specified off-label uses explicitly denied (e.g., erectile dysfunction for some agents, weight management for Wegovy/other GLP-1 agonists). The brief also lists product-specific excluded uses (for example, many oncology/genetic drugs exclude use with contraindicated coadministrations or in specified severe hepatic impairment or pregnancy).

Submit diagnostic tests and labs

Submit diagnostic tests, baseline labs, and other objective measurements requested in the drug-specific criteria. Include the date and numeric results or attach copies of reports.

Mutation/genetic testing (e.g., ALK, EGFR, BRAF) where required — submit test name and positive result.
Creatinine clearance (or serum creatinine + weight + height to calculate), if requested.
Left ventricular ejection fraction (LVEF) when cardiac toxicity is a concern.
24-hour urinary free cortisol (UFC) when requested for endocrine indications.
HCV RNA for antiviral therapy confirmation, when applicable.
Pregnancy status/attestation for females of childbearing potential.

Documentation Required

Treatment history and prior therapies

Document prior therapies, treatment failures, intolerances, or contraindications as required by individual drug criteria. Include dates, doses, and reasons for discontinuation.

Prior statin use and response/intolerance when required for lipid agents.
Prior PD-1/PD-L1 therapy or other oncology agents when required for cancer drugs.
Completed antimycobacterial regimens or documentation of intolerance when relevant.
History of antidepressant trials and outcomes when psychiatric criteria require prior therapy.

Billing Rule

Part B vs Part D determination

Determine and document whether the claim is a Part B or Part D benefit. Certain administration/setting or self-administration after training may change the coverage pathway.

If the medication will be self-administered after proper training, it may be covered under Part D.
If the pharmacy fills the medication and the patient delivers it to the provider's office for administration, Part D coverage may apply.
Drugs administered by a provider in a clinical setting, or those billed as physician/clinic-administered drugs, are often Part B — document location and administration.
Specific Part B vs Part D determinations are noted for some drugs (e.g., SIVEXTRO) — follow the drug-specific note.

Documentation Required

Reauthorization evidence

For reauthorization/continuation requests, submit updated objective evidence showing benefit and ongoing need per the drug-specific requirements.

Relevant labs (e.g., creatinine clearance, LFTs, UFC) performed during therapy.
Spirometry or other pulmonary function test results showing improvement or stability from baseline for respiratory agents.
Headache-day logs or symptom inventories for migraine therapies.
Imaging reports or tumor response assessments for oncology drugs.
Validated motor scores or functional scales for neurologic therapies (e.g., ALS, spinal muscular atrophy).

Documentation Required

Prescriber specialty restrictions

Many drugs require prescribing by a specialist. Confirm and document the prescriber's specialty on the PA form; requests may be routed or denied if specialty restrictions are not met.

Common required specialties include oncology, cardiology, pulmonology, neurology, hematology, endocrinology, and psychiatry.
Examples: ALK-targeted therapies (oncology); PAH agents (cardiology/pulmonology); COPD biologics (pulmonology); psychiatric agents (psychiatry).
If the prescriber is not in the required specialty, include justification and supporting documentation.

Denial Risk

Denial risks based on exclusions and contraindications

Requests will be denied when exclusion criteria, dangerous coadministrations, or absolute contraindications are present. Review exclusions carefully before submission and include required attestations when applicable.

Coverage denial for genotype/metabolizer exclusions (e.g., requires documented mutation or absence of exclusion genotype).
Denial for contraindicated coadministrations, such as strong CYP3A inhibitors/inducers or concurrent nitrates with certain vasodilators.
Examples of exclusion-based denials: severe hepatic impairment (Child-Pugh C), pregnancy in agents contraindicated in pregnancy, dementia-related psychosis for antipsychotics.
Attestations required for coadministration exceptions or prior therapies should be included; absence of required attestations may result in denial.

24‑hour UFC (Cushing's)> 1.5 x ULN (50 μg or 145 nmol) on two occasions

Platelet thresholds (Doptelet / ITP/procedure)Procedure: <50 x10^9/L; ITP: <30 x10^9/L or <50 x10^9/L with bleeding

PALYNZIQ (pegvaliase) blood Phe> 600 μmol/L (initial approval requirement)

Evrysdi SMN2 copies (spinal muscular atrophy)>= 2 copies required

JUXTAPID LDL receptor (HoFH) criteriaSkin fibroblast LDL receptor activity <20% of normal (one acceptable criterion)

RIVFLOZA urinary oxalate (PH1)>= 0.7 mmol/24h (normalize to BSA if <18 yrs)

LVEF requirement (selected agents, e.g., Camzyos, Qinlock)>= 50% or specific thresholds per product; some agents exclude LVEF <55%