Blue Cross Blue Shield Tennessee Prior Auth Coverage

Coverage Criteria by Drug / Indication

Abiraterone – combination with GnRH/orchiectomy

Covered when ALL of the following are met

abiraterone baseline: Requested drug will be used in combination with a gonadotropin-releasing hormone (GnRH) analog or after bilateral orchiectomy

From PA criteria

Aimovig – initial and continuation

CGRP receptor antagonist (Aimovig) preventive therapy:

concurrency: Will not be used concurrently with another calcitonin gene-related peptide (CGRP) receptor antagonist

Initial approval duration 3 months

continuation: For continuation: patient received at least 3 months of treatment and had reduction in migraine days per month from baseline3 months

Continuation per PA criteria

ALVAIZ – ITP, HCV thrombocytopenia, severe AA

ALVAIZ (avatrombopag) for ITP, hepatitis C–associated thrombocytopenia, and severe aplastic anemia:

ITP new starts: Inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins) AND untransfused platelet count <30,000/mcL OR 30,000-50,000/mcL with symptomatic bleeding or bleeding risk factors<30,000/mcL or 30,000-50,000/mcL with bleeding

Initial ITP duration 6 months

ITP continuation: Platelet count response: (1) Current platelet count <=200,000/mcL OR (2) Current platelet count >200,000 to <=400,000/mcL with dosing adjusted to avoid clinically important bleeding<=200,000 or up to 400,000 with adjustment

Continuation per PA criteria

HCV-associated thrombocytopenia: Used for initiation and maintenance of interferon-based therapy (new starts) or patient is receiving interferon-based therapy (continuation)

PAH – hemodynamic confirmation criteria for endothelin receptor antagonists (WHO Group 1)

Endothelin receptor antagonists for PAH (WHO Group 1):

PAH confirmation: PAH confirmed by right heart catheterization

Diagnostic confirmation required

new start hemodynamics: Pretreatment mean pulmonary arterial pressure >20 mmHg AND pulmonary capillary wedge pressure <=15 mmHg AND pulmonary vascular resistance >2 Wood units (adults)>20 mmHg; <=15 mmHg; >2 Wood units

Required for new starts

AYVAKIT – genetic and disease-specific requirements

AYVAKIT for specified neoplasms:

myeloid/lymphoid eosinophilia: Disease is FIP1L1-PDGFRA rearrangement-positive AND harbors PDGFRA D842V mutation AND is resistant to imatinib

All conditions required

GIST criteria: Either: 1) Disease harbors PDGFRA exon 18 mutation including D842V OR 2) Requested drug used after failure of >=2 FDA-approved therapies for residual/unresectable/recurrent/metastatic GIST without PDGFRA exon 18 mutation>=2 prior therapies when mutation absent

One of the two options required

systemic mastocytosis: Diagnosis of indolent or advanced systemic mastocytosis AND platelet count >=50,000/mcL>=50,000/mcL

Both required

ARCALYST – gout and pericarditis coverage criteria

ARCALYST coverage criteria:

gout flare prevention new starts: Two or more gout flares in the previous 12 months AND inadequate response/intolerance/contraindication to maximum tolerated NSAID and colchicine AND concurrent use with urate-lowering therapy>=2 flares in 12 months

Continuation requires clinical benefit and continued urate-lowering therapy

recurrent pericarditis: Inadequate response, intolerance, or contraindication to maximum tolerated NSAID and colchicine

Any of these conditions qualifies

CABOMETYX – tumor-specific criteria

CABOMETYX coverage for listed malignancies when disease status matches criteria:

renal cell carcinoma: Disease is advanced, relapsed, or stage IV (including brain metastases)

Indication-specific requirement

NSCLC RET-positive: Disease is RET-positive AND recurrent, advanced, or metastatic

Both required

HCC subsequent therapy: Requested drug will be used as subsequent therapy for hepatocellular carcinoma

Subsequent therapy setting

GIST prior therapy: GIST is residual, unresectable, recurrent, or metastatic AND progressed after at least two FDA-approved therapies

Dupixent - Indication-specific Criteria

Dupixent is covered with criteria specific to each indication when ALL relevant conditions below are met.

Atopic Dermatitis - Initial: Patient has moderate-to-severe disease AND >=10% BSA affected OR crucial body areas involved AND inadequate response/intolerance/contraindication to topical corticosteroid or topical calcineurin inhibitorBSA >=10% or crucial areas

Initial criteria

Atopic Dermatitis - Continuation: Patient achieved or maintained positive clinical responseN/A

Continuation criteria

Asthma - Oral corticosteroid dependent - Initial: Inadequate control despite high-dose inhaled corticosteroid AND additional controller (LABA, LAMA, leukotriene modifier, or sustained-release theophylline) unless intolerance/contraindication

Emgality - Migraine and Cluster Headache Criteria

Emgality covered when ALL applicable criteria are satisfied.

Preventive migraine - Initial: Not used concurrently with another CGRP receptor antagonist

Initial approval 3 months

Preventive migraine - Continuation: At least 3 months of treatment and reduction in migraine days per month from baseline>=3 months and improvement

Continuation requirement

Episodic cluster headache - Initial: Inadequate response/intolerance/contraindication to a triptan 5-HT1 receptor agonist

Initial cluster headache

Episodic cluster headache - Continuation:

Doptelet - Platelet Count Criteria

Doptelet covered when ALL applicable platelet count and clinical context criteria are met.

Chronic liver disease - Procedure prophylaxis: Untransfused platelet count prior to scheduled procedure is <50,000/mcL<50,000/mcL

Chronic liver disease prophylaxis

ITP - New start: Inadequate response/intolerance to prior therapy (e.g., corticosteroids or IVIG) AND untransfused platelet count <30,000/mcL OR 30,000-50,000/mcL with symptomatic bleeding or bleeding risk<30,000 or 30-50k with bleeding risk

ITP initial criteria

ITP - Continuation: Either current platelet count <=200,000/mcL OR current platelet count >200,000 to <=400,000/mcL with planned dosing adjustment to avoid thrombosis; AND evidence of response<=200,000 or 200-400k with adjustment

Oncology - Subsequent/Mutation-directed Therapy Criteria

Several oncology drugs are covered when used for advanced, recurrent, metastatic, or subsequent therapy per indication-specific conditions.

Cabometyx - RCC/HCC/GIST/other: For RCC: disease advanced, relapsed, or stage IV (including brain metastases). For NSCLC: RET rearrangement positive AND recurrent/advanced/metastatic. For HCC: use as subsequent therapy. For GIST: residual/unresectable/recurrent/metastatic and progressed after at least two FDA-approved therapies. For DTC: locally advanced/metastatic AND progressed after VEGFR-targeted therapy AND refractory/ineligible to RAI. For endometrial carcinoma: recurrent disease AND used as subsequent therapy.

Indication-specific conditions

Cometriq - NSCLC with RET: Disease positive for RET rearrangements for NSCLC indicationRET positive

Mutation-directed requirement

Cotellic - CNS cancer or melanoma: CNS tumors: BRAF V600E mutation AND used with vemurafenib. Melanoma: BRAF V600 mutation AND used with vemurafenib for unresectable/metastatic or adjuvant/neoadjuvant therapy

Infectious Disease - Documentation and Duration Criteria

Antiviral and antifungal agents have documentation and duration requirements tied to diagnosis and guideline-based treatment.

EPCLUSA - HCV: HCV RNA confirmed prior to starting; planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection, resistance-associated substitutions where applicable, transplantation status; coverage per AASLD-IDSA guidance

Documentation required

CRESEMBA - Invasive fungal: Requested drug used orally for indicated invasive fungal infections; for invasive aspergillosis and fluconazole-refractory esophageal candidiasis in HIV: patient experienced inadequate response, intolerance, or contraindication

Oral use and prior treatment history required

GLP-1 agonists - covered with criteria

GLP-1 agonists (MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY) — coverage conditions

GLP-1 coverage: Excluded when used for weight loss only; for type 2 diabetes mellitus, submit medical records confirming T2DM diagnosis OR diagnostic laboratory evidence (A1c >=6.5%, OGTT 2-hr PG >=200 mg/dL, random PG >=200 mg/dL with symptoms, or FPG >=126 mg/dL). Patient must not have FDA-labeled contraindications and must not use concurrent GLP-1 or DPP-4 inhibitor

Quantity limited to 30-day supply

Etanercept / similar biologics - new start criteria

Etanercept (ENBREL family) — new start criteria

Rheumatology and dermatology new-start criteria: For moderately to severely active RA: inadequate response/intolerance/contraindication to methotrexate OR inadequate response/intolerance to a prior biologic DMARD or targeted synthetic DMARD. For ankylosing spondylitis/non-radiographic axial spondyloarthritis: inadequate response/intolerance to NSAID OR contraindication to NSAIDs. For plaque psoriasis: crucial areas involved OR severe disease (>=10% BSA) OR >=3% BSA with prior failure/contraindication to phototherapy or systemic agents. For hidradenitis suppurativa: severe, refractory disease.

Applies to new starts only; prerequisite therapy flags as specified

EXXUA prior therapy requirement

EXXUA (major depressive disorder) — trial requirements

MDD prior therapy requirement: Patient has experienced inadequate response, intolerance, or contraindication to TWO of the following: SNRIs, SSRIs, mirtazapine, bupropion2 agents

Prerequisite therapy required

FULPHILA prophylaxis criteria

FULPHILA (pegfilgrastim biosimilar) — timing and indication

Chemotherapy prophylaxis criteria: If receiving chemotherapy, administer at least 24 hours after chemotherapy AND for prophylaxis of myelosuppressive chemotherapy-induced febrile neutropenia patient must have a solid tumor or non-myeloid cancer and be receiving myelosuppressive anti-cancer therapy

Coverage duration 6 months

GATTEX SBS criteria

GATTEX (teduglutide) — SBS initiation and continuation

SBS criteria: Initial therapy: patient is dependent on parenteral support. Continuation: requirement for parenteral support has decreased from baseline while on therapy with the requested drug.

Prescriber should be or consult gastroenterologist/gastrointestinal surgeon/nutritional support specialist

GAVRETO indication criteria

GAVRETO (pralsetinib) — NSCLC indication requirement

RET fusion positive NSCLC: For non-small cell lung cancer: disease must be recurrent, advanced, or metastatic AND tumor must be RET fusion-positive or RET rearrangement-positive

Age restrictions vary by indication

HER2-targeted oncology agent conditions

HERCEPTIN / HERZUMA and related HER2 agents — oncology stipulations

HER2 agent conditions: Multiple HER2-positive cancer indications with disease-specific requirements (neoadjuvant, recurrent/metastatic, leptomeningeal/brain metastases, organ-specific HER2-positive tumors). For some agents, prior intolerable adverse event to Trazimera is required; for colorectal cancer additional constraints (HER2-amplified and RAS/BRAF wild-type) and combination therapy requirements apply.

Coverage under Part D denied if covered under Part A/B when administered under those parts

ERIVEDGE medulloblastoma criteria

ERIVEDGE (vismodegib) — adult medulloblastoma

Adult medulloblastoma criteria: For adult medulloblastoma off-label use: patient has received prior systemic therapy AND has tumor(s) with mutations in the sonic hedgehog pathway

Prerequisite therapy required

EPIDIOLEX coverage note

EPIDIOLEX: Covers all FDA-approved indications; age restriction: 1 year of age or olderage >=1 year

Coverage duration Plan Year

Switch/intolerance criteria for HER2 agent coverage

Covered when specific indication and prior therapy/intolerance criteria are met:

HER2 agent coverage conditions: Patient had an intolerable adverse event to Trazimera not attributed to the active ingredient AND indication-specific molecular and combination therapy requirements are met (e.g., colorectal: HER2-amplified and RAS/BRAF wild-type and used in combination with pertuzumab/tucatinib/lapatinib)

Applies to multiple HER2 agents

Tasimelteon (HETLIOZ) initiation and continuation

Covered when ALL of the following are met:

Non-24 Sleep-Wake Disorder criteria: Diagnosis of total blindness in both eyes with inability to perceive light AND for initial and continuation if currently on therapy documentation of benefit shown by increased total nighttime sleep or decreased daytime nap duration

Prescriber restriction: sleep disorder specialist/neurologist/psychiatrist; age restrictions apply

High-risk medication approval in older adults

High-risk medications will be approved when ALL of the following are met (for applicable groups):

High-risk medication criteria: a) Patient has an FDA-approved diagnosis or CMS-accepted compendia indication AND b) Prescriber has completed a risk assessment and indicated benefits outweigh risks AND c) Prescriber documented discussion of risks/potential side effects with the patient; additional checks (anticholinergic burden, concurrent CNS-active meds) apply per drug group

PA does NOT apply to patients <65 for many HRM groups; additional criteria for >=65

ICATIBANT for HAE acute attacks criteria

Covered when ANY of the following is met:

ICATIBANT eligibility: 1) HAE with C1 inhibitor deficiency or dysfunction confirmed by lab testing OR 2) HAE with normal C1 inhibitor confirmed by lab testing AND (a) positive genetic testing for listed mutations OR (b) family history of angioedema and refractory to high-dose antihistamine trial for at least one month

Prescriber: immunologist, allergist, or rheumatologist recommended

ICLUSIG coverage conditions for CML/ALL/GIST

Covered when ALL of the following (per indication) are met:

ICLUSIG for CML: For CML: accelerated or blast phase with no other kinase inhibitor indicated OR chronic phase with resistance/intolerance to >=2 prior kinase inhibitors OR positive for T315I mutation; documentation per PA group

Prerequisite therapy: yes; coverage Plan Year

ICLUSIG for ALL: For ALL: diagnosis confirmed by Philadelphia chromosome or BCR-ABL gene

Documentation required

ICLUSIG for GIST: For GIST: residual, unresectable, recurrent, metastatic, or tumor rupture AND progressed after at least two FDA-approved therapies>=2 prior therapies

Indication-specific

Selected oncology criteria (imatinib/others)

Amitriptyline / imatinib-related entries (selected items shown)

Cutaneous melanoma — imatinib/related: Disease is metastatic or unresectable AND disease positive for c-KIT activating mutations AND requested medication used as subsequent therapy AND patient had disease progression/intolerance or risk of progression

Prerequisite therapy required where specified

IVIG clinical criteria

IVIG indication-specific criteria

IVIG clinical criteria: Examples: B-cell CLL with serum IgG <500 mg/dL or recurrent bacterial infections; BMT/HSCT within first 100 days post-transplant or IgG <400 mg/dL; pediatric HIV with IgG <400 mg/dL or recurrent bacterial infections; dermatomyositis/polymyositis after failure/intolerance of corticosteroid or immunosuppressantIgG thresholds as stated

Prior authorization required

LEQEMBI (lecanemab) criteria

LEQEMBI maintenance criteria

LEQEMBI maintenance: Patient has confirmed amyloid beta pathology by baseline PET scan or lumbar puncture AND requested drug will be used as maintenance therapy following a minimum of 18 months of lecanemab-irmb IVminimum 18 months prior therapy

Prerequisite therapy required

Osteoporosis coverage criteria (selected entries)

Osteoporosis and bone disease criteria (selected entries)

Postmenopausal osteoporosis initial: One of: history of fragility fracture OR pre-treatment T-score <= -2.5 OR pre-treatment T-score > -2.5 and < -1 with high FRAX probability; AND additional factors such as failed prior injectable osteoporosis therapy or oral bisphosphonate trial >=1 year or reason to avoid oral bisphosphonatesFRAX >=20% major or >=3% hip

Initial criteria and continuation rules apply

LEQEMBI — Maintenance Therapy

Lecanemab (LEQEMBI / IQLIK SQ) coverage — maintenance use

LEQEMBI maintenance criteria: Patient has confirmed amyloid beta pathology by baseline PET or lumbar puncture AND requested drug used as maintenance following minimum 18 months of lecanemab-irmb IVminimum 18 months IV therapy

PA and documentation required

MAVYRET — HCV Treatment

MAVYRET coverage for HCV

MAVYRET initial therapy: HCV infection confirmed by HCV RNA in serum prior to starting therapy AND planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection status, resistance-associated substitutions if applicable, and transplant status documented; decompensated cirrhosis (CTP class B or C) excludedexclude CTP class B or C

Apply AASLD-IDSA guidance

Long-acting opioids — Medical Necessity criteria

Long-acting opioid approval criteria

Long-acting opioid initial approval: Patient has an FDA-approved or CMS-accepted indication AND documentation including diagnosis, nature/intensity of pain, past/current treatments, effect on functioning, history/physical/labs, signed pain agreement within past year, aberrant behavior risk assessment, state controlled substance database check within 90 days, treatment plan with goals/monitoring, AND prior treatment with short-acting opioids at lowest dose possible (MME)

All elements required for approval

NURTEC — Acute and Preventive Criteria

NURTEC indications and continuation criteria

NURTEC acute treatment: For acute migraine: inadequate response/intolerance/contraindication to at least one triptan 5-HT1 receptor agonist

Initial criteria

NURTEC preventive therapy continuation: Initial preventive treatment requires at least 3 months; continuation requires >=3 months of treatment with reduction in migraine days per month from baseline>=3 months

Step/sequence requirement applies

OGIVRI — Indication-specific Criteria

OGIVRI specific conditions and Part D denial rule

OGIVRI indications and prior trastuzumab intolerance: All indications: patient had an intolerable adverse event to Trazimera not attributed to the active ingredient; colorectal/hepatobiliary/endometrial cancers have specific tumor marker and combination therapy requirements

Part D denial if covered under Part A or B for administration

Idiopathic pulmonary fibrosis (IPF) initial coverage

Idiopathic pulmonary fibrosis (new starts) covered when ALL of the following are met

IPF diagnostic criteria: Other causes of pulmonary fibrosis excluded AND either (a) HRCT or lung biopsy shows UIP pattern OR (b) HRCT not UIP and diagnosis is supported by lung biopsy or multidisciplinary discussion between experienced radiologist and pulmonologist if no biopsy

New starts only

Progressive pulmonary fibrosis criteria

Chronic fibrosing interstitial lung diseases with progressive phenotype covered when ALL of the following are met

Progressive pulmonary fibrosis: Patient has confirmed progressive disease (e.g., FVC decline, worsening respiratory symptoms, increased extent of fibrosis on HRCT)

Progressive phenotype required

HER2-targeted therapy criteria

HER2-targeted agents (selected biosimilars/brands) covered when conditions apply

HER2 agent intolerance to Trazimera: Patient had an intolerable adverse event to Trazimera not attributed to the active ingredient AND indication-specific molecular and combination therapy requirements are met

Applies across HER2 agents

Colorectal cancer specific: Disease is HER2-amplified and RAS and BRAF wild-type AND requested drug used in combination with pertuzumab, tucatinib or lapatinib AND patient has not had prior HER2 inhibitor OR patient has metachronous metastases

Colorectal-specific

Hepatobiliary carcinoma: Disease is HER2-positive AND requested drug used in combination with pertuzumab or tucatinib

Indication-specific

Thrombopoietic agents (ITP/AA/HCV) criteria

Eltrombopag / thrombopoietic agent coverage criteria

Chronic or persistent ITP initial: Inadequate response/intolerance to prior therapy (e.g., corticosteroids or IVIG) AND untransfused platelet count <30,000/mcL OR 30,000-50,000/mcL with symptomatic bleeding or bleeding risk factors AND for chronic ITP adults inadequate response/intolerance to avatrombopag or eltrombopag as applicable<30,000 or 30-50k with bleeding risk

New starts criteria

Continuation ITP: Platelet response: current platelet count <=200,000/mcL OR current platelet count >200,000 to <=400,000/mcL with dose adjustment to avoid bleeding<=400,000/mcL

Continuation criteria

Severe aplastic anemia: New starts: use with standard immunosuppressive therapy OR insufficient response to immunosuppressive therapy AND for adults inadequate response/intolerance to eltrombopag

RINVOQ and related agents coverage criteria

RINVOQ (and similar) coverage criteria for rheumatologic/dermatologic/IBD indications

Rheumatologic indications (new starts): For RA, PsA, polyarticular JIA, ankylosing spondylitis: inadequate response/intolerance/contraindication to at least one TNF inhibitor (e.g., adalimumab)

New starts only; prerequisite TNF trial required

IBD indications: For UC and Crohn's disease: inadequate response/intolerance/contraindication to a TNF inhibitor OR if TNF inhibitor clinically inadvisable, patient tried at least one systemic therapy

Indication-specific

Atopic dermatitis initial: Refractory moderate-to-severe disease AND >=10% BSA or crucial areas affected AND inadequate response to at least one other systemic drug (including biologics) or such therapies inadvisable>=10% BSA

Initial therapy criteria

Selected Initial Therapy Criteria

Examples of new-start criteria for biologic and targeted therapies

Atopic dermatitis (new starts): Refractory, moderate-to-severe disease AND >=10% BSA or crucial body areas involved AND inadequate response to at least one other systemic drug product including biologics or therapies inadvisableBSA >=10% or crucial areas

Initial criteria example

Rheumatoid arthritis/psoriatic arthritis/axial spondyloarthritis (new starts): Patient experienced inadequate response/intolerance/contraindication to at least one TNF inhibitorprior TNF inhibitor trial required

New starts example

Ulcerative colitis/Crohn's disease: Inadequate response/intolerance/contraindication to at least one TNF inhibitor OR if TNF inhibitor clinically inadvisable, patient tried at least one systemic therapy

Acromegaly Initial and Continuation Criteria

Acromegaly criteria

Acromegaly (initial): Elevated pretreatment IGF-1 for age/gender AND inadequate or partial response to surgery or radiotherapy OR clinical reason surgery/radiotherapy not doneabnormal IGF-1 per lab

Pretreatment testing and prior treatment documentation required

Acromegaly (continuation): Patient's IGF-1 level has decreased or normalized since therapy initiationdecreased/normalized IGF-1

Continuation requires documented improvement

Hemodynamic and Biomarker Requirements (PAH, oncology)

PAH and oncology biomarker-linked coverage

PAH (new starts): Right heart catheterization-confirmed PAH AND pretreatment mean PAP >20 mmHg AND PCWP <=15 mmHg AND (adults) PVR >2 Wood units>20 mmHg; <=15 mmHg; >2 Wood units

Hemodynamic confirmation required

TAFINLAR biomarker requirement: Tumor positive for BRAF V600 mutation when required and drug use aligns with disease context (e.g., unresectable/metastatic or adjuvant/neoadjuvant); combination with trametinib when specifiedBRAF V600 positive

Mutation testing required

TAGRISSO (NSCLC): Unresectable/metastatic/advanced/recurrent NSCLC with sensitizing EGFR mutation OR adjuvant NSCLC post-resection with EGFR mutationEGFR sensitizing mutation positive

Psoriasis Biologic Initiation Criteria

Psoriasis and dermatology biologic starts

Moderate-to-severe plaque psoriasis (new starts): Crucial body areas affected OR at least 10% BSA affected OR at least 3% BSA affected with inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) or contraindication to those treatmentsBSA thresholds 3% and 10%

Applies to new starts only

CML initial/continuation criteria

Covered when ALL of the following are met

CML diagnostic and mutation criteria: Diagnosis confirmed by Philadelphia chromosome or BCR-ABL gene AND if resistance to alternative TKI document negative status for T315I, Y253H, E255K/V, and F359V/C/I mutations

ALL initial/continuation criteria

Covered when ALL of the following are met

ALL diagnostic and mutation criteria: Diagnosis confirmed by Philadelphia chromosome or BCR-ABL gene AND if resistance to alternative TKI document negative status for T315I, Y253H, E255K/V, F359V/C/I and G250E mutations

GIST

Covered when ALL of the following are met

GIST criteria: Disease is residual, unresectable, recurrent/progressive, or metastatic/tumor rupture AND disease progressed on at least 2 FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)

Cutaneous melanoma (c-KIT mutated) criteria

Covered when ALL of the following are met

c-KIT melanoma criteria: Disease is metastatic or unresectable AND disease is positive for c-KIT activating mutations AND requested drug used as subsequent therapy AND patient has had disease progression, intolerance, or risk of progression

Teriparatide (postmenopausal, male, glucocorticoid-induced osteoporosis)

Initial coverage and continuation criteria

Postmenopausal osteoporosis initial: One of: history of fragility fracture OR pre-treatment T-score <= -2.5 OR pre-treatment T-score > -2.5 and < -1 with high FRAX probability; AND additional indicators such as failed prior injectable therapy or oral bisphosphonate trial >=1 year or reason to avoid oral bisphosphonate

Male primary/hypogonadal osteoporosis initial: One of: history of osteoporotic vertebral or hip fracture OR pre-treatment T-score <= -2.5 OR pre-treatment T-score > -2.5 and < -1 with high FRAX probability; AND failed prior injectable therapy or oral bisphosphonate trial >=1 year or reason to avoid oral bisphosphonate

Glucocorticoid-induced osteoporosis: Oral bisphosphonate trial >=1 year unless contraindicated AND one of: fragility fracture OR pre-treatment T-score <= -2.5 OR pre-treatment T-score > -2.5 and < -1 with high FRAX probability

Continuation after >=24 months:

Truxima (rituximab biosimilar) coverage

Covered when INDICATION-specific criteria are met

Approved hematologic and autoimmune indications: All FDA-approved indications and some medically-accepted indications as listed; hematologic malignancies must be CD20-positive

RA (new starts): Requested drug used in combination with methotrexate OR patient has intolerance/contraindication to methotrexate AND inadequate response/intolerance/contraindication to methotrexate OR prior biologic/targeted synthetic DMARD

Rheumatoid arthritis (RA) new start criteria (example)

For moderately to severely active rheumatoid arthritis (new starts only):

RA new starts: Requested drug used in combination with methotrexate OR patient has intolerance/contraindication to methotrexate AND inadequate response/intolerance to methotrexate OR prior biologic DMARD/targeted synthetic DMARD

Hematologic malignancies must be CD20-positive where relevant

TUKYSA oncology criteria

TUKYSA — colorectal and biliary tract cancer criteria:

Colorectal HER2+: Advanced, unresectable, or metastatic disease AND HER2-positive AND RAS wild-type AND will be used in combination with trastuzumab AND patient has not previously been treated with a HER2 inhibitor

Indication-specific

Biliary tract HER2+: Unresectable or metastatic disease AND HER2-positive disease

Indication-specific

TYENNE criteria

TYENNE — rheumatoid arthritis and systemic sclerosis-associated interstitial lung disease:

RA new starts: Inadequate response/intolerance/contraindication to methotrexate OR inadequate response/intolerance to a prior biologic DMARD or targeted synthetic DMARD

New starts criteria

Sclerosis-associated ILD: Diagnosis confirmed by high-resolution CT of the chest

Diagnostic confirmation required

UPTRAVI PAH criteria

UPTRAVI — pulmonary arterial hypertension:

PAH confirmation: PAH confirmed by right heart catheterization; for new starts: pretreatment mean PAP >20 mmHg AND PCWP <=15 mmHg AND PVR >2 Wood unitshemodynamic values as stated

Hemodynamic confirmation required

VENCLEXTA coverage criteria (selected)

VENCLEXTA — indications and required conditions:

AML FLT3-ITD use: For AML: disease is FLT3-ITD-positive and medication will be used for induction, re-induction, consolidation, or maintenance therapy

Indication-specific

Multiple myeloma t(11;14): For multiple myeloma: relapsed or progressive disease AND requested drug used in combination with specified agents AND patient has t(11;14) translocation

Molecular marker required

VITRAKVI criteria

VITRAKVI — NTRK fusion-positive tumors:

NTRK tumor criteria: For NTRK gene fusion-positive solid tumors: disease without a known acquired resistance mutation

Applies to first-line and other approved settings

HCV drug criteria

VOSEVI — hepatitis C virus treatment:

HCV documentation: Infection confirmed by presence of HCV RNA prior to starting AND planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection status, resistance-associated substitutions if applicable, and transplant status documented; follow AASLD-IDSA guidance

Decompensated cirrhosis (CTP B/C) exclusion applies for some agents

ATTR-CM initial and continuation criteria

VYNDAMAX — transthyretin-mediated amyloidosis (ATTR-CM):

ATTR-CM initial: Clinical manifestations present AND cardiac involvement confirmed by echocardiography or cardiac MRI or myocardial technetium-labeled scintigraphy AND diagnosis confirmed by biopsy or positive bone scintigraphy with systemic light chain amyloidosis ruled out OR variant ATTR-CM with positive TTR gene mutation

Continuation requires demonstration of benefit

XALKORI coverage criteria

XALKORI — NSCLC and related indications:

NSCLC ALK/ROS1/MET criteria: For NSCLC: recurrent/advanced/metastatic ALK-positive disease after inadequate response/intolerance/contraindication to specified ALK inhibitors OR ROS1-positive disease OR MET amplification/exon 14 skipping as appropriate

Prerequisite therapy required in some ALK settings

ALCL: For ALCL: disease relapsed or refractory AND disease is ALK-positive

Indication-specific

XOLAIR indication-specific criteria

XOLAIR — multiple allergic/atopic indications:

Moderate-severe persistent asthma initial: Positive skin or blood test to at least one perennial aeroallergen AND baseline IgE >=30 IU/mL AND inadequate control despite medium-to-high-dose inhaled corticosteroid AND additional controller unless intolerant/contraindicatedIgE >=30 IU/mL

Age >=6 years

Chronic spontaneous urticaria initial: Evaluated for other causes AND spontaneous wheals/angioedema >=6 weeks AND symptomatic despite H1 antihistamine therapyduration >=6 weeks

Age >=12 years; initial approval 6 months

CRSwNP: Requested drug used as add-on maintenance AND inadequate response to Xhance (fluticasone) for adults

Age >=18 years

XIFAXAN coverage rules

XIFAXAN — gastrointestinal indications and recurrence rules:

IBS-D initial/recurrent: For IBS-D: patient has not previously received the requested drug OR previously received it and is experiencing recurrence AND has not already received initial 14-day course; retreatment sequencing applies14 days initial; retreatment sequencing per policy

Coverage durations differ by indication

SIBO: Diagnosis confirmed via quantitative culture of upper gut aspirate OR breath testing (lactulose or glucose hydrogen breath)

Diagnostic confirmation required

Drug-specific coverage criteria (selected)

Selected coverage criteria extracted from drug entries

Narcolepsy/XYWAV initial: Diagnosis confirmed by sleep lab evaluation AND for adults an inadequate response or intolerance to at least one CNS wakefulness-promoting drug (e.g., armodafinil, modafinil) OR contraindicationage >=7 for narcolepsy; adult prior trial requirement

Continuation requires documented benefit

Idiopathic hypersomnia - XYWAV initial: All diagnostic criteria met: daily excessive sleepiness >=3 months; insufficient sleep syndrome excluded; cataplexy absent; appropriate SOREMP/MSLT criteria met (e.g., average sleep latency <=8 min or 24-hr sleep >=11 hrs); other causes excludedMSLT <=8 min or 24-hr >=11 hrs

Failure to provide tests risks denial

ZURZUVAE - Postpartum depression: Diagnosis confirmed using standardized depression rating scales (e.g., HDRS, EPDS, PHQ9, MADRS)

Code Lists and Key Clinical Thresholds

Listed drugs and biologicals in this segmentmixed

HERCEPTIN	HERCEPTIN, HYLECTA
HERNEXEOS	HERNEXEOS
TASIMELTEON	TASIMELTEON (HETLIOZ)
MEGESTROL ACETATE	MEGESTROL ACETATE (HIGH RISK MEDICATION)
PHENOBARBITAL	PHENOBARBITAL (HIGH RISK MEDICATION)
ZALEPLON	ZALEPLON (SEDATIVE HYPNOTIC)
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE (SEDATIVE HYPNOTIC)
AMITRIPTYLINE HCL	AMITRIPTYLINE HCL (HRM-AMITRIPTYLINE)
ICATIBANT ACETATE	ICATIBANT ACETATE (SAJAZIR)
ICLUSIG	ICLUSIG

1–10 of 16

1/2

Prior Authorization Group — LEQEMBI IQLIK SQmixed

LEQEMBI	LEQEMBI (lecanemab)
IQLIK	IQLIK
SQ	subcutaneous formulation indicator listed

Prior Authorization Group — LIDOCAINE PATCHmixed

LIDOCAINE PATCH

Lidocaine patch products (LIDOCAINE, LIDOCAN, TRIDACAINE II/III)

Prior Authorization Group — MAVYRETmixed

MAVYRET

MAVYRET (glecaprevir/pibrentasvir)

BRAF/MEK pathway agentsmixed

MEKINIST	MEKINIST (trametinib)
MEKTOVI	MEKTOVI (binimetinib)

OGIVRI indications and conditionsmixed

OGIVRI

OGIVRI (trastuzumab-dkst)

inv-92: Mean pulmonary arterial pressure — > 20 mmHg

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

ContextRequired pretreatment hemodynamic criterion for PAH (WHO Group 1) confirmation by right heart catheterization

Use caseApplies to PAH new starts for endothelin receptor antagonists and other PAH therapies

inv-93: Pulmonary capillary wedge pressure — ≤ 15 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Context

What Providers Must Submit / Watch For

Prior Authorization

Prior authorization required for specialty drugs — general notice

Prior Authorization Required for Specialty Drugs — general notice: Prior authorization is required for many specialty and biologic agents. Providers must include the specific required medical documentation noted for each drug group (diagnostic confirmation, biomarker/mutation testing, prior therapy trials, platelet counts, sleep studies, HCV RNA, etc.). Coverage durations are typically Plan Year unless otherwise specified. Drugs that are administered or billed under Medicare Part A or B will be denied under Part D when Part A/B coverage applies.

Include diagnosis, relevant laboratory or imaging confirmation, and prior treatment history when applicable.
If the drug is administered in a facility or under Part A/B, indicate whether Part D coverage is applicable; Part D will be denied if Part A/B coverage exists.

Prior Authorization

CGRP agent PA requirements (Aimovig) — avoidance of concurrent CGRP agents and continuation rules

CGRP agents (e.g., Aimovig, Emgality, NURTEC) — avoidance of concurrent agents and continuation rules: For preventive migraine therapy with CGRP monoclonal antibodies or receptor antagonists, the requested agent must not be used concurrently with another CGRP agent. Continuation approval generally requires documentation of clinical benefit after the defined initial trial period (commonly at least 3 months) such as reduction in monthly migraine days or attack frequency.

Initial (New Start) Authorization Requirements

Continuation / Maintenance Authorization Requirements

Step Therapy / Prior-Authorization Sequences

Requirement	Details
Trial of NSAID and colchicine prior to approval
For prevention of gout flares (new starts): documentation of two or more gout flares in the previous 12 months AND inadequate response, intolerance, or contraindication to maximum tolerated doses of an NSAID and colchicine; concurrent use with urate-lowering therapy required. (Continuation: clinical benefit demonstrated)

Requirement	Details
Failure/intolerance/contraindication to specified agents required before new starts
For dermatologic and rheumatologic biologics and similar agents (e.g., moderate-to-severe plaque psoriasis, PsA, ankylosing spondylitis): patient must have had inadequate response, intolerance, or contraindication to the listed prior therapies (examples include etanercept, adalimumab products, methotrexate, phototherapy, systemic agents) before approval of a biologic; applies to new starts only.

Requirement	Documentation Needed
Document prior inadequate response, intolerance, or contraindication
Medical record evidence of inadequate response, intolerance, or contraindication to specified prior therapies (e.g., methotrexate, NSAIDs, phototherapy, systemic agents) must be provided for new-start biologics and other specialty agents as indicated.

Requirement	Details
Document trials of two agents
For EXXUA (major depressive disorder): documentation that the patient experienced inadequate response, intolerance, or contraindication to TWO agents from the list (SNRIs, SSRIs, mirtazapine, bupropion) is required prior to approval.

Requirement	Where Indicated
Required prior therapy or documented intolerance where indicated
For multiple oncology and specialty agents (e.g., HER2-targeted therapies, imatinib-related entries): prior therapy failure or documented intolerance is required as specified by the indication (see individual drug criteria).

Requirement	Details / Indications
Prior BTK inhibitor required for certain JAYPIRCA indications
For JAYPIRCA in CLL/SLL and mantle cell lymphoma and for marginal zone lymphoma: documentation that the patient received prior treatment with a BTK inhibitor (e.g., acalabrutinib) is required; CLL/SLL may also require prior BCL-2 inhibitor exposure as specified.

Requirement	Continuation / Timeframe
Preventive NURTEC requires trial and objective improvement after 3 months
For preventive migraine treatment with NURTEC: initial preventive approval requires not using another CGRP receptor antagonist concurrently; continuation requires the patient received at least 3 months of treatment and had a reduction in migraine days per month from baseline. Initial preventive treatment duration: 3 months.

Requirement	Documentation
Trial and failure/intolerance documentation before specialty agent approval
Many specialty agents require submission of records documenting prior trials and either inadequate response or intolerance to listed therapies (examples include trials of generics/brands for psychiatric agents and TNF inhibitors for rheumatologic/IBD indications).

Requirement	Details
Document trial of or contraindication to specified prior therapy before approval
For new starts in indications such as atopic dermatitis, psoriasis, and some rheumatologic conditions: document a trial and inadequate response or contraindication to specified prior systemic or biologic therapies (including TNF inhibitors or methotrexate/phototherapy when listed) or an explanation why such therapies are inadvisable.

Requirement	Examples / Scope
Prior trials of listed therapies required
For oncology indications such as GIST: disease must have progressed after at least two FDA‑approved therapies prior to approval; other oncology agents similarly require specified prior lines of therapy per indication.

Requirement	New Starts
Required prior trial or intolerance of TNF inhibitor before approval (new starts)
For multiple inflammatory and rheumatologic indications (new starts): documentation of inadequate response, intolerance, or contraindication to at least one TNF inhibitor (e.g., adalimumab, etanercept) is required prior to authorization.

Requirement	NSCLC ALK Settings
Prerequisite therapy required before approval in some NSCLC ALK settings
For certain NSCLC ALK indications (e.g., XALKORI settings): use is limited to patients who have had inadequate response, intolerance, or contraindication to specific ALK inhibitors such as alectinib or brigatinib prior to approval as specified in the policy.

Requirement	Applicability
Yes for some oncology agents — prerequisite therapy required
Several oncology agents (e.g., ZYKADIA, other ALK/ROS1/targeted therapies) require prior trials of specified agents (or documentation of intolerance/contraindication) before approval; the policy explicitly flags prerequisite therapy required for these settings.

Quantity Limits and Dispensing Rules

inv-251: GLP-1 agonists (MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY) — 30-day supply limit

GLP-1 agonist quantity limit30-day supply limit per dispensing

ApplicabilityApplies to MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY under PA group for GLP‑1 agonists

Additional coverage noteExcluded when used for weight loss only; T2DM documentation or diagnostic lab values required for diabetes indication

Site-of-Care / Administration Notes

Note

Background and Scope

This dossier summarizes the payer's prior authorization (PA) program for specialty pharmacy drugs and biologics across multiple therapeutic areas. It defines the scope of coverage rules (FDA‑approved and selected medically‑accepted indications), identifies groups of drugs subject to PA, and specifies the clinical conditions and documentation required to authorize treatment (for example, genetic or biomarker confirmation, right‑heart catheterization for PAH, or HCV RNA for hepatitis C therapy).

Coverage decisions are expressed as condition‑based criteria that must be met for initial and continuation approvals (examples include minimum trial durations such as 3 months for some CGRP agents and a minimum of 18 months of prior IV lecanemab before maintenance LEQEMBI). Many entries also require prerequisite therapy trials (for example, prior TNF inhibitor failure for select autoimmune agents) and define numeric thresholds where relevant (e.g., hemodynamic values for PAH).

Provider actions required to support PA requests are emphasized throughout: submiters must provide indication‑specific documentation (imaging, mutation testing, laboratory confirmation, prior therapy history, and objective response data where applicable), confirm prescriber specialty when required, and observe program rules such as site‑of‑care or quantity limits (for example, GLP‑1 agents limited to a 30‑day supply on dispensing).

The policy includes explicit exclusions and Part D/Part A‑B coverage interactions: drugs furnished under Part A or B settings may be denied under Part D, and some agents have listed contraindications or population exclusions (for example, decompensated cirrhosis exclusions for some HCV regimens). The document is intended for operational use by prescribers and pharmacy benefit administrators to determine when PA is required and what supporting evidence must be provided.

Definitions and Diagnostic Thresholds

inv-188: PAH hemodynamic confirmation definition

PAH hemodynamic confirmationRight heart catheterization demonstrating: mean PAP >20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units

IndicationRequired to confirm pulmonary arterial hypertension (WHO Group 1) for PA therapies and new starts

DocumentationPretreatment values obtained at right heart catheterization must be provided with PAH requests

inv-189: Platelet thresholds for ITP/AA definition

ITP/AA platelet thresholds (definition)Untransfused platelet count <30,000/mcL or 30,000–50,000/mcL with symptomatic bleeding defines eligibility for new starts; continuation uses APR/IPR targets

APR/IPRAPR >50,000/mcL; IPR <50,000/mcL — used to define adequate vs inadequate platelet response

OpenPayer

Prior authorization criteria for specialty pharmacy drugs

Coverage Criteria by Drug / Indication

Code Lists and Key Clinical Thresholds

What Providers Must Submit / Watch For

Initial (New Start) Authorization Requirements

Continuation / Maintenance Authorization Requirements

Step Therapy / Prior-Authorization Sequences

Quantity Limits and Dispensing Rules

Site-of-Care / Administration Notes

Background and Scope

Definitions and Diagnostic Thresholds