CurrentEmblemHealthPolicy N/A

Prior Authorization Criteria Formulary Emblemhealth

This document is the first part of EmblemHealth's 2026 Prior Authorization (PA) Criteria formulary listing medications that may require prior authorization for EmblemHealth Medicare HMO/PPO plans. It includes introductory policy text and a Table of Contents listing covered drugs and their page locations (partial list in this part).

Policy Summary

PayerEmblemHealth

PolicyPrior Authorization Criteria Formulary Emblemhealth

Policy CodePolicy N/A

Change Typeclarified (headers updated 4/2026)

Effective Date

Next Review Date

Key ActionPrescribers must contact EmblemHealth to obtain prior authorization before prescribing listed drugs; provide use/administration details for Part B vs Part D determinations.

SourceLink

POLICY UPDATE CHANGES

Updated 4/2026 headers and MAPD value lines are present.

Part 1Document part

30+Drugs covered (this part)

12 monthsTypical approval duration

90/180 daysLookback periods

variesExceptions (some agents)

Coverage Summary & Scope

This file is Part 1 of EmblemHealth's 2026 Prior Authorization (PA) Criteria for Medicare HMO/PPO plans. It explains that prior authorization (PA) is required for certain drugs — prescribers must contact EmblemHealth to obtain approval before prescribing or the drug may not be covered — and notes some drugs may be covered under Medicare Part B or Part D depending on the drug's use or administration and that the prescriber should provide information about use/administration so EmblemHealth can advise on coverage. The Table of Contents in this part lists numerous medications and supplies covered in this part.

Operational thresholds & defaults

Typical approval duration12 months typical

Common lookback periods for 'currently treated' evidence90 days or 180 days (agent-dependent)

Dynamic PA supply lookbackInsulin use within the past 180 days required for alcohol swabs/insulin supplies

Short-course approvalsLinezolid: 3 months; Posaconazole OPC: 1 month; Sivextro ABSSSI: 6 days

Hemoglobin thresholds for ESA initiationHb <10 g/dL for initiation (varies by indication); stabilized thresholds up to 11–12 g/dL

Osteoporosis thresholds (T-score/FRAX)T-score ≤ -2.5 OR T-score -1.0 to -2.5 plus FRAX major ≥20% or hip ≥3%

Migraine prophylaxis threshold>= 4 migraine headache days per month required for CGRP prophylaxis agents

Arikayce prior therapy requirementFailure to achieve negative sputum cultures after ≥6 consecutive months of standard MAC combination therapy

Pulmonary hemodynamic thresholds (PAH)mPAP >20 mmHg; PCWP ≤15 mmHg; PVR ≥2 Wood units; WHO FC ≥ II

Alpha-1 AAT thresholdPre-treatment AAT <11 micromol/L (80 mg/dL immunodiffusion or 57 mg/dL nephelometry)

Age minimum for armodafinil/modafinil>= 17 years

Initial Therapy Criteria (selected agents in Part)

Prior Authorization Requirement (General)

Covered when ALL of the following are met:

ALL of the following

Request is for an agent listed in the Prior Authorization Criteria (initial therapy) section and the requested use matches an FDA‑approved indication or an EmblemHealth accepted off‑label indication supported by guidelines or compendia.
Prescriber is a licensed provider with expertise in the condition being treated (e.g., oncologist for oncology agents, neurologist for MS agents, endocrinologist for growth hormone, pulmonologist for pulmonary hypertension).
Some agents require specific prescriber specialty — see agent‑specific requirements below.
Documentation provided includes relevant baseline labs, diagnostic tests, and prior medication trials as specified by the agent (e.g., Hepatitis C genotype and prior DAA therapy for Mavyret/Vosevi; CF genotype for Kalydeco; urine pregnancy test and contraceptive measures for teratogenic agents such as isotretinoin/accutane).

Continuation / Renewal Therapy Criteria

Renewal / Continuation Criteria Group

Groups representing renewal/continuation criteria.

Aimovig PA - Renewal Approval Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has a diagnosis of migraine
The requested agent is being used for migraine prophylaxis
Patient has had clinical benefit with the requested agent
Patient will NOT be using the requested agent in combination with another calcitonin gene-related peptide (CGRP) agent for migraine prophylaxis

Combination Therapy Exclusions & Disallowed Uses

Combination / Exclusion Prohibitions Group

Consolidated disallowed combinations, exclusions, and explicit 'will NOT be using' prohibitions across PA groups.

General combination prohibitions

CGRP agents: For migraine prophylaxis agents (Aimovig, Emgality, Nurtec prophylaxis, others), patient will NOT be using the requested agent in combination with another CGRP agent for migraine prophylaxis.
Biologic-with-biologic: For biologic immunomodulators and many biologics (Actemra, Benlysta SC, Cosentyx, Enbrel, Hadlima, Skyrizi, Simlandi, Steqeyma, Tremfya, Tyenne, etc.), patient will NOT be using the requested agent in combination with another biologic immunomodulator.
HAE agents: For hereditary angioedema agents (Haegarda, Icatibant), patient will NOT be using the requested agent in combination with another HAE agent indicated for the same prophylaxis or acute treatment purpose.

Applicable Codes (selected drugs/supplies)

Drugs listed in this part (selected)mixedCovered

Actimmune	Interferon gamma-1b - PA group listed
Acyclovir (topical)	Topical antiviral - PA group listed
Aimovig	Erenumab - migraine prophylaxis
Alcohol Swabs	Medical supply - dynamic PA when used with insulin
Alosetron HCl	IBS-D agent (female only per criteria)
Prolastin-C	Alpha-1 proteinase inhibitor
Danazol	Anabolic steroid
Testosterone Cypionate (Depo-Testosterone)	Androgen injectable
Testosterone Enanthate	Androgen injectable
Testosterone (topical/pump)	Androgen topical products

1–10 of 18

1/2

Drugs listed (by name) in this partmixedCovered

Atovaquone	Drug Name(s): Atovaquone; Indications: All Medically-Accepted Indications
Attruby	Drug Name(s): Attruby; Indications: All FDA-Approved Indications (tafamidis)
Austedo	Drug Name(s): Austedo, Austedo Xr, Austedo Xr Patient Titration Kit (deutetrabenazine)
Tadalafil 2.5Mg	Drug Name(s): Tadalafil 2.5Mg - BPH indication
Tadalafil 5Mg	Drug Name(s): Tadalafil 5Mg - BPH indication
Benlysta SC	Belimumab subcutaneous
Clobazam	Benzodiazepine group - Clobazam
Clorazepate Dipotassium	Benzodiazepine group - Clorazepate
Diazepam	Benzodiazepine group - Diazepam, Diazepam Intensol
Lorazepam	Benzodiazepine group - Lorazepam, Lorazepam Intensol

1–10 of 23

1/3

Drugs referenced in this partNDC|mixedCovered

Skyrizi	Risankizumab products (Skyrizi, Skyrizi Pen)
Steqeyma	Steqeyma (biologic immunomodulator)
Tremfya	Guselkumab (Tremfya)
Tyenne	Tyenne (biologic immunomodulator)
Entocort	Budesonide ER (Entocort)
Uceris	Budesonide ER (Uceris)
Carglumic Acid	Carglumic
Cayston	Aztreonam for inhalation
Chenodal	Chenodeoxycholic acid
Chorionic Gonadotropin (Pregnyl)	hCG products

1–10 of 25

1/3

Drugs / Supplies listed in this partmixedCovered

Procrit	Erythropoietin stimulating agent (epoetin alfa)
Retacrit	Biosimilar epoetin alfa-epbx
Fintepla	Fenfluramine
Fentanyl Citrate Oral Transmucosal	Fentanyl lozenge
Flucytosine	Antifungal (5-FC)
Focalin	Dexmethylphenidate HCl
Gammagard Liquid	IVIG product
Gamunex-C	IVIG product
Cerezyme	Imiglucerase
Elelyso	Taliglucerase alfa

1–10 of 30

1/3

No procedure/drug codes listed in this partmixed

No codes listed

No codes listed in this partmixed

No codes listed

No procedure/drug codes listed in this Partmixed

No codes listed

No specific procedure/CPT/HCPCS/ICD/NDC codes listed in this partmixed

No codes listed

Drugs referenced in policy textmixed

Zokinvy	Lonafarnib (Zokinvy) — PA group: Zokinvy PA; Indications: All FDA-Approved Indications
Ztalmy	Ztalmy — PA group: Ztalmy PA; Indications: All FDA-Approved Indications
Dupixent	Dupilumab (referenced: must NOT be used in combination for certain indications)
Cinqair	Reslizumab (example IL-5 inhibitor) referenced as not to be combined
Fasenra	Benralizumab (IL-5 inhibitor) referenced as not to be combined
Nucala	Mepolizumab (IL-5 inhibitor) referenced as not to be combined

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required before prescribing many drugs on the EmblemHealth formulary. Prescribers must obtain PA for listed agents and provide clear administration/use information and evidence supporting the requested therapy. Approvals are typically time-limited and require renewal with documentation of clinical benefit. Some drugs may be covered under Medicare Part B vs Part D depending on route of administration — prescribers should supply administration details so coverage routing can be determined.

Prescriber must obtain prior authorization before prescribing the listed agent(s).
Provide administration/use information (route, setting, infusion vs pharmacy dispensed) to determine Part B vs Part D coverage.
Approvals are time-limited; renewal requires documentation of ongoing benefit.
Prior authorization required per drug-specific PA group; check the table of contents and agent-specific PA requirements.

Clinical Evidence & Operational Metrics

90/180Common lookback periods (evidence of current treatment): 90 or 180 days

12Typical approval duration: 12 months

30+Drugs/supplies listed in this part: 30+

6/1/3Exceptions/short approvals: some short courses (e.g., 3 months linezolid; 1–6 month courses for select agents)

Common clinical validation elements repeated across PA groups include: confirmation of diagnosis or indication per FDA labeled indication or CMS‑approved compendia; documentation of recent treatment or a claims lookback (commonly within 90 or 180 days) or prescriber attestation of current therapy; required laboratory or diagnostic thresholds (examples: pretreatment alpha-1 AAT level < 11 micromol/L for Prolastin‑C; hemoglobin thresholds for ESAs such as < 10 g/dL for initiation; iron overload criteria like LIC ≥ 5 mg Fe/g dry weight for deferasirox); genetic or mutation testing where indicated (e.g., ATTR testing for tafamidis/Attruby, CFTR genotyping for CF modulators, PKLR mutations for Pyrukynd); hemodynamic criteria for pulmonary arterial hypertension including mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 2 Wood units; and fracture risk/T-score rules for osteoporosis agents using T-score ≤ -2.5 or FRAX thresholds (major ≥ 20% or hip ≥ 3%) or recent fragility fracture to establish high risk. Many PAs also require documentation of prior therapy failure, intolerance, or contraindication to preferred or conventional agents before approval.

Background & Definitions

Definitions/glossary used across the policy: Prior authorization (PA) — a requirement that the prescriber contacts EmblemHealth to obtain approval before the plan will cover a drug. MAPD — Medicare Advantage Prescription Drug plan identifiers are included in the document headers for 2026. CMS approved compendia — drug information compendia recognized by CMS to support off‑label indications or dosing. FDA labeled contraindication(s) — contraindications listed in the US FDA‑approved prescribing information for the medication. FDA labeled indication — use approved by the U.S. Food and Drug Administration for the specific agent. FRAX — Fracture Risk Assessment Tool 10‑year probability for major osteoporotic or hip fracture used in osteoporosis decisions. Clinical benefit — improvement or stabilization in disease‑specific signs, symptoms, biomarkers, or function as specified per agent. MAPD (document context) — identifiers for Medicare plan values in 2026. PAH — pulmonary arterial hypertension, WHO Group 1 as determined by right heart catheterization; hemodynamic thresholds (mPAP, PCWP, PVR) are used in PA criteria. These definitions reflect terms and testing referenced throughout the Part 1 PA criteria.

Revision History

2026-04document_updateLatest

Updated 4/2026 headers and MAPD value lines are present (document-level 'Updated 4/2026').

2026-04clarification

Non-material clarifications: multiple MAPD VALUE 2026 lines and header repetitions clarified in index/introduction.

Policy Summary

PayerEmblemHealth

PolicyPrior Authorization Criteria Formulary Emblemhealth

Policy CodePolicy N/A

Change Typeclarified (headers updated 4/2026)

Effective Date

Next Review Date

Key ActionPrescribers must contact EmblemHealth to obtain prior authorization before prescribing listed drugs; provide use/administration details for Part B vs Part D determinations.

SourceLink

On This Page

For drugs with age restrictions, the patient meets the specified age criteria (e.g., Benlysta SC age limits applied where specified).

ONE of

New (initial) therapy: patient has not received the requested agent in the past 12 months or per agent‑specific look‑back period; request is for initiation.
Continuation/renewal: patient has met initial criteria previously and documentation demonstrates clinical benefit or stabilization and absence of unacceptable toxicity as specified by the agent's renewal criteria.

Initial Therapy Criteria (selected agents in Part)

Agent‑specific initial approval criteria. Each group below presents the required items to approve initial therapy.

ALL of the following

Atovaquone PA - Required Medical Information: Diagnosis of the indicated infection with documentation of organism when applicable; documentation of intolerance or contraindication to preferred first‑line agents when applicable; planned dose and duration; relevant lab monitoring plan (e.g., LFTs if concurrent hepatotoxic agents).
Benign Prostatic Hyperplasia PA - Tadalafil: Diagnosis of erectile dysfunction or benign prostatic hyperplasia as appropriate per product labeling; documentation of trial and intolerance or contraindication to alternative BPH therapies when tadalafil is requested specifically for BPH symptom relief; dosing and duration consistent with labeling; consideration of cardiovascular risk (nitrate use contraindication).
Benlysta SC PA - Initial Approval: Diagnosis of systemic lupus erythematosus (SLE) confirmed by an appropriate clinician; documentation of active, moderate‑to‑severe disease despite standard therapy or in combination with standard therapy; baseline evaluation including CBC, renal and hepatic function; plan for ongoing monitoring and documentation of payer‑required outcome measures.
Benlysta SC - Age Restriction: Request meets age restrictions per labeling (e.g., approved ages for subcutaneous Benlysta).
Agent-specific additional requirements (selected examples): Follow agent‑specific documentation: e.g., for self‑administered oncology agents include prior authorization form with diagnosis, prior therapies, performance status, and planned regimen; for specialty biologics include prior failure or intolerance to conventional systemic therapies where applicable; include prior authorization criteria specific to high‑risk medications (opioid ERs, isotretinoin) such as controlled substance agreements or pregnancy prevention programs.
Carglumic (Carglumic Acid) - approval criteria: Genetic or biochemical confirmation of N‑acetylglutamate synthase deficiency or documented hyperammonemia where carglumic acid is clinically indicated; dosing and planned duration per metabolic specialist; monitoring plan for ammonia levels.
Chenodal - approval criteria: Diagnosis of gallstone disease or specific cholestatic liver disease per FDA or accepted compendia indications; documentation that alternative medical and surgical options were considered or are contraindicated; baseline and monitoring liver tests.
Chorionic Gonadotropin - approval criteria: Indication documented (e.g., hypogonadism, infertility) with appropriate baseline evaluation and fertility treatment plan when applicable; female patients of childbearing potential require pregnancy testing and counseling per product labeling.
Cinacalcet - approval criteria: Diagnosis of secondary hyperparathyroidism on dialysis or hypercalcemia in primary hyperparathyroidism as per labeling; documented laboratory values (PTH, calcium, phosphorus) and prior/concurrent therapies; monitoring plan for calcium levels.
Corlanor (Ivabradine) - approval criteria: Documentation of heart failure with left ventricular ejection fraction ≤35% on guideline‑directed medical therapy including beta‑blocker at maximally tolerated dose, sinus rhythm with resting heart rate ≥70 bpm; cardiology evaluation documented.
Cresemba - initial and renewal criteria: Diagnosis of invasive fungal disease caused by susceptible organisms or as salvage therapy per ID specialist; microbiologic or radiographic evidence supporting invasive fungal infection; for renewal, evidence of clinical improvement or stable disease and tolerability; monitoring of hepatic function and drug interactions.
Crysvita - initial and renewal criteria: Diagnosis of X‑linked hypophosphatemia (XLH) or other indicated hypophosphatemic rickets with appropriate biochemical evidence (low serum phosphate, elevated FGF23 where available); pediatric growth/endocrinology or metabolic bone specialist involvement for initiation; for renewal, documentation of clinical benefit (growth parameters, pain reduction, biochemical response) and absence of adverse effects.
Dalfampridine - approval and renewal criteria: Diagnosis of multiple sclerosis with objective documentation of walking impairment; timed walking test baseline and planned re‑assessment; contraindications such as history of seizures or moderate/severe renal impairment addressed; renewal requires documented improvement in walking speed or functional mobility compared to baseline.
Droxidopa - initial and renewal criteria: Diagnosis of symptomatic neurogenic orthostatic hypotension with documentation of orthostatic vitals and symptoms; failure or intolerance to nonpharmacologic measures and first‑line agents when applicable (e.g., fludrocortisone, midodrine) unless contraindicated; for renewal, documentation of symptom improvement and tolerability; monitoring for supine hypertension.
Dupixent - initial approval criteria: Diagnosis and indication consistent with labeled uses or accepted off‑label uses (e.g., atopic dermatitis, asthma with eosinophilic phenotype, chronic rhinosinusitis with nasal polyposis) with documentation of disease severity, prior therapies tried and failed or contraindicated, and relevant biomarkers if required (e.g., eosinophil count, IgE).
Dupixent - other indications: For eosinophilic esophagitis (EoE), prurigo nodularis (PN), COPD with eosinophilic phenotype, or chronic spontaneous urticaria (CSU), include disease‑specific objective measures, prior therapy failures, and specialty clinician documentation as required by indication.
Emsam - initial and renewal criteria: Diagnosis of major depressive disorder as per DSM criteria; documentation of prior antidepressant trials or rationale for Emsam selection; for renewal, evidence of clinical response and absence of hypertensive crisis risk factors; adherence to dietary/medication restrictions per patch strength.
Epidiolex - approval criteria: Diagnosis of Lennox‑Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex with refractory seizures as per labeling; documentation of seizure frequency baseline, prior antiepileptic trials, and monitoring plan for liver enzymes and potential drug interactions.
Procrit (epoetin alfa) - approval criteria: Indication documented (e.g., anemia due to chronic kidney disease, chemotherapy‑induced anemia) with baseline hemoglobin and iron studies; documented plan to correct iron deficiency prior to or concurrent with ESAs; oncology protocols aligned when for chemotherapy patients.
Fentanyl Citrate Oral Transmucosal (lozenge) — initial: Use limited to opioid‑tolerant cancer patients for breakthrough pain per labeling; documentation of opioid tolerance and current opioid regimen; not for opioid‑naïve patients.
Flucytosine — initial: Indication of invasive fungal infection where flucytosine in combination therapy is appropriate (e.g., cryptococcal meningitis); infectious disease specialist involvement; baseline renal function and therapeutic drug monitoring plan.
Gammagard / Gamunex‑C (IVIG) — initial: Documented diagnosis for FDA‑approved or guideline‑supported indications (e.g., primary immunodeficiency, CIDP, ITP where applicable); baseline immunoglobulin levels, weight for dosing, and prior therapies; infusion setting and monitoring plan.
Gaucher enzyme replacement (Cerezyme, Elelyso, Vpriv) — initial: Diagnosis of Gaucher disease confirmed by enzyme assay/genetic testing; documentation of disease severity (hematologic, visceral, bone involvement) and specialist involvement (hematology/metabolic).
Growth hormone (Omnitrope) — adult initial: Adult growth hormone deficiency confirmed by appropriate endocrine testing (GH stimulation testing) or documented pituitary disease; baseline IGF‑1 and metabolic parameters; specialist endocrinology prescriber.
Hereditary angioedema prophylaxis (Haegarda) — initial: Diagnosis of hereditary angioedema with C1‑inhibitor deficiency; history of recurrent angioedema attacks impacting quality of life despite on‑demand therapy; specialist documentation and plan for home administration training.
Icatibant (Sajjazir) — initial (acute HAE): Use for acute hereditary angioedema attacks in patients with C1‑INH deficiency; documentation of acute attack and expected benefit; plan for emergency access.
High Risk Medications — All Starts (selected drugs): Prior authorization must include evaluation of risk mitigation: pregnancy prevention program for teratogenic drugs (isotretinoin, thalidomide analogs), controlled substance treatment agreements and PDMP checks for opioid ER agents, baseline ECG and cardiac risk assessment for QT‑prolonging agents, and seizure risk assessment for drugs that lower seizure threshold.
Imiquimod 5% cream — initial: Diagnosis of approved dermatologic indications (e.g., actinic keratosis, superficial basal cell carcinoma, external genital warts) with documentation of lesion location, size, prior local therapies tried when applicable.
Inbrija (inhaled levodopa) — initial: Diagnosis of Parkinson disease with motor OFF episodes despite optimized oral therapy; documentation of current levodopa regimen and motor fluctuations; pulmonary evaluation per product labeling if indicated.
Injectable Oncology (Firmagon) — initial: Diagnosis and indication appropriate for degarelix (Firmagon) use in prostate cancer per oncology guidelines; baseline PSA and testosterone and oncology specialist documentation of treatment plan.
Iron chelating agents (Exjade, Jadenu) — initial: Documented transfusional iron overload with ferritin and liver iron concentration as applicable; prior chelation considerations and plan for monitoring renal and hepatic function.
Isotretinoin products — initial: Enrollment in an approved pregnancy prevention program for females of reproductive potential; documented diagnosis of severe nodular acne refractory to conventional therapy; baseline pregnancy testing and counseling documented.
Ivermectin tablet — initial: Diagnosis of indicated parasitic infection per labeling or accepted guideline; weight‑based dosing and confirmation of parasite species when required; avoidance for nonindicated cosmetic uses.
Jubbonti / Osenvelt (denosumab / biosimilars) — initial (osteoporosis/osteopenia): Documented osteoporosis diagnosis by T‑score criteria or history of osteoporotic fracture; prior therapy trials or contraindications to oral bisphosphonates when required; dental evaluation and plan to mitigate osteonecrosis risk.
Jynarque (Tolvaptan) - ADPKD: Diagnosis of autosomal dominant polycystic kidney disease with evidence of rapidly progressing disease per guideline criteria; baseline liver function tests and monitoring plan due to hepatotoxicity risk; nephrology prescriber.
Kalydeco (Ivacaftor) - Cystic Fibrosis: Documented CFTR mutation(s) responsive to ivacaftor per labeling or CFTR testing report; specialist in cystic fibrosis involvement and baseline hepatic testing; monitoring plan for efficacy and safety.
Eligard / Leuprolide (Leuprolide groups): Indication consistent with prostate cancer or other labeled uses; oncology/urology prescriber; baseline PSA/testosterone and monitoring plan.
L‑glutamine (for sickle cell disease): Diagnosis of sickle cell disease with history of vaso‑occlusive crises; documentation of prior therapies and expected benefit; hematology prescriber.
Lidocaine Topical - Patch: Indication for postherpetic neuralgia or localized neuropathic pain per labeling; documentation of prior topical/systemic neuropathic pain therapy trials when required.
Lidocaine/Prilocaine cream: Indication for local anesthesia per labeling with documentation of planned procedure and dosing.
Mavyret (HCV): Documented hepatitis C infection with genotype and prior treatment history; pretreatment viral load and hepatic fibrosis staging when applicable; dosing per renal/hepatic function.
Methylphenidate (Methylin; ER tablet): Diagnosis of ADHD with comprehensive evaluation and documentation of functional impairment; prior stimulant trials and monitoring plan for cardiovascular risk and potential abuse.
Mifepristone (Cushing's syndrome): Diagnosis of Cushing's syndrome where mifepristone is indicated; endocrinology prescriber and monitoring plan for clinical response and adverse effects.
Migranal (Dihydroergotamine nasal spray): Indication for acute migraine with documentation of prior triptan trial failure or contraindication when required; cardiovascular risk assessment due to vasoconstrictive properties.
Multiple Sclerosis agents (selected): Agent‑specific criteria: diagnosis of relapsing MS by neurologist, prior disease‑modifying therapy history, baseline EDSS or relapse history, monitoring plan for labs/imaging and infection risk (e.g., JC‑virus for natalizumab).
Nuedexta (dextromethorphan/quinidine): Diagnosis of pseudobulbar affect with documentation of underlying neurologic condition and impact on function; trial and intolerance to alternative symptomatic measures when applicable.
Ofev (nintedanib): Diagnosis of idiopathic pulmonary fibrosis or other labeled progressive fibrosing interstitial lung disease with pulmonary function testing and specialist pulmonology involvement; monitoring plan for hepatic function and adverse effects.
Omnipod (insulin pump): For insulin pump coverage, documentation of diabetes requiring intensive insulin therapy with frequent glucose variability/hypoglycemia or failure of multiple daily injections; diabetes educator training plan and durable medical equipment criteria met.
Opioids ER (selected fentanyl patch, morphine ER, tramadol ER): Opioid‑tolerant chronic pain patients only, with documentation of prior analgesic trials, functional goals, opioid risk assessment, controlled substance agreement, and PDMP review; quantity limits and combination rules apply.
Otezla / Otezla XR (apremilast): Indication (psoriasis, psoriatic arthritis) with documentation of disease severity and prior therapy failures to conventional systemic agents or biologics where required; dermatology/rheumatology prescriber.
Pegylated Interferon (Pegasys): Indication for hepatitis B/C or other labeled uses with baseline blood counts and psychiatric history screening; monitoring plan for adverse events.
Eltrombopag (Promacta): Indication such as chronic immune thrombocytopenia with documented platelet counts and prior therapy trials; hepatotoxicity monitoring and hematology prescriber.
Pulmonary Hypertension agents (selected): Diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization and specialty pulmonology/cardiology involvement; documentation of WHO functional class and prior/combination therapy rationale.
Pyrukynd (pyruvate kinase deficiency, PKD) - Initial criteria: Diagnosis of PKD confirmed by genetic testing or enzymatic assay; documentation of symptomatic hemolytic anemia requiring intervention; hematology prescriber and monitoring plan.
Quinine (Quinine Sulfate): Indication limited to FDA‑approved uses (e.g., malaria); avoid use for nocturnal leg cramps unless compelling justification per guideline; document prior therapies.
Repatha (evolocumab) - Initial criteria: Documentation of clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia with LDL‑C above threshold despite maximally tolerated statin therapy and lifestyle measures; baseline LDL and prior lipid‑lowering therapy history.
Revcovi (ADA‑SCID) - Initial criteria: Diagnosis of adenosine deaminase severe combined immunodeficiency confirmed by lab/genetic testing; specialist immunology or transplant team documentation and treatment plan.
Rezdiffra (NASH with fibrosis) - Initial criteria: Diagnosis of nonalcoholic steatohepatitis with fibrosis stage per liver biopsy or validated noninvasive testing meeting payer thresholds; documentation of lifestyle interventions and metabolic risk optimization.
Sapropterin (Zelvsia) - Initial criteria: Diagnosis of phenylketonuria (PKU) with demonstrated BH4 responsiveness testing or clinical response trial where applicable; metabolic specialist involvement.
Self‑Administered Oncology PA - Agent‑specific exceptions: When an oncology injectable is self‑administered at home, documentation must demonstrate appropriateness for home use, patient/caregiver education, and safety monitoring; some agents may be excluded from home self‑administration per policy.
Signifor - Renewal criteria: For recurrent Cushing's disease or other indications, renewal requires biochemical and clinical response documentation and tolerability assessment.
Sivextro (tedizolid) - Initial criteria: Indication for acute bacterial skin and skin structure infections with documentation of diagnosis, prior antibiotic therapy or rationale for use, and susceptibility when available.
Sodium Oxybate - Initial criteria: Diagnosis of narcolepsy with cataplexy; prior stimulant/anticataplectic agent use documented and sleep specialist involvement; enrollment in REMS program if applicable.
Octreotide Acetate - Initial criteria: Indication for acromegaly, carcinoid syndrome, or other labeled uses with biochemical evidence (e.g., IGF‑1, 5‑HIAA) and specialist endocrinology/oncology documentation.
Strensiq (asfotase alfa) - Initial criteria: Diagnosis of hypophosphatasia with genetic or biochemical confirmation; specialist metabolic bone disease or genetics prescriber and plan for monitoring response.
Asfotase alfa - prescriber restriction and duration: Initiation by or in consultation with a specialist experienced in hypophosphatasia; initial authorization typically limited to defined duration with reassessment required for continued therapy.
Miglustat (Miglustat/Yargesa) - initial approval criteria: Indications for Gaucher disease type 1 or Niemann‑Pick disease type C with appropriate diagnostic confirmation and specialist prescriber; dosing and monitoring plan specified.
Miglustat - prescriber restriction and duration: Prescriber must be a metabolic disease specialist; initial approvals are time‑limited with requirements for clinical and laboratory reassessment prior to renewal.
Tasimelteon - initial approval criteria: Diagnosis of non‑24‑hour sleep‑wake disorder in totally blind individuals or other approved indications; sleep specialist documentation and baseline sleep assessment.
Teriparatide (Bonsity/Teriparatide) - initial approval criteria: Diagnosis of osteoporosis with T‑score criteria or history of low‑trauma fracture; prior osteoporosis therapy history and contraindications to alternatives documented.
Teriparatide - duration and other criteria: Therapy duration limited per labeling (e.g., cumulative lifetime limits) and requires reassessment for renewal; documentation of fracture risk mitigation plan post‑therapy.
Topical Diclofenac 3% Gel - initial approval criteria: Indication for osteoarthritis of joints amenable to topical treatment with documentation of prior topical/systemic NSAID trial or contraindications to systemic NSAIDs if required; treatment site and planned duration.
Trelstar (Trelstar Mixject) - initial approval criteria: Indication for advanced prostate cancer or other labeled uses with oncology/urology prescriber and baseline PSA/testosterone where applicable.
Trientine HCl (Wilson's disease) - initial approval criteria: Diagnosis of Wilson disease with appropriate copper studies and specialist hepatology or metabolic prescriber; monitoring plan for copper and liver tests.
Tymlos (abaloparatide) - initial approval criteria: Diagnosis of osteoporosis meeting T‑score or fracture criteria; prior therapy considerations and contraindications assessed.
Tymlos - coverage/duration rules: Treatment duration limited per labeling and reauthorization requires reassessment of fracture risk and alternative therapy options.
Valchlor - initial approval criteria: Diagnosis of cutaneous T‑cell lymphoma (mycosis fungoides) localized skin disease appropriate for topical therapy; dermatology oncology prescriber and lesion documentation.
Vosevi (hepatitis C) - initial approval criteria: Documented HCV infection with genotype and prior treatment history; assessment of hepatic fibrosis and HIV/HBV coinfection status; dosing per renal/hepatic function.
Vowst (C. difficile recurrence prevention) - initial approval criteria: History of recurrent C. difficile infection with documentation of prior adequate antibiotic therapy and frequency of recurrences; plan for administration and monitoring for efficacy.
Wyost (denosumab biosimilar/denosumab agent) - initial approval criteria: See denosumab criteria for osteoporosis/oncology skeletal‑related event prophylaxis: documented osteoporosis or indication per labeling, dental evaluation, and prior therapy considerations.
Xdemvy (Demodex blepharitis) - initial approval criteria: Diagnosis of Demodex blepharitis with documented ocular findings and prior topical therapy attempts when applicable; ophthalmology prescriber.
Xermelo (carcinoid syndrome diarrhea) - initial and renewal criteria: Diagnosis of carcinoid syndrome with documented diarrhea refractory to standard somatostatin analog therapy or as adjunctive therapy; for renewal, documentation of symptom improvement and tolerability.
Xifaxan 550 mg - initial approval criteria: Indication such as hepatic encephalopathy prevention or IBS‑D per labeling with documentation of diagnosis, prior therapy trials, and planned duration.
Xolair (omalizumab) - initial approval criteria: Diagnosis of allergic asthma with elevated IgE and sensitivity to perennial aeroallergens, chronic spontaneous urticaria, or other labeled indications; documentation of disease severity, prior therapy failures, and specialist prescriber.
Zokinvy — Common Operational Rules: For progeroid laminopathies or other rare indications, documentation of genetic diagnosis, specialist prescriber, enrollment in registry or monitoring program if required, and clear treatment goals.
Allergic Indication (general referenced criteria): When coverage is requested for allergic conditions (food allergy, asthma, CSU, chronic rhinosinusitis with nasal polyposis), provide disease‑specific objective measures, prior therapy history, and biomarker data where applicable (e.g., IgE, eosinophil counts).

Prolastin-C PA - Renewal Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has a diagnosis of alpha-1 antitrypsin deficiency (AATD) with clinically evident emphysema
Patient has had clinical benefit with the requested agent
The requested dose is within FDA labeled dosing for the requested indication

Benlysta SC PA - Renewal Approval

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
ONE of the following disease-specific paths
- SLE path: Patient has diagnosis of active systemic lupus erythematosus (SLE) disease AND will continue standard SLE therapy in combination with the requested agent
- LN path: Patient has diagnosis of active lupus nephritis (LN) AND will continue standard LN therapy in combination with the requested agent
Patient has had clinical benefit with the requested agent
Patient will NOT be using the requested agent in combination with another biologic agent

Arikayce PA - Renewal Approval Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has a diagnosis of Mycobacterium avium complex (MAC) lung disease
Patient has had clinical benefit with the requested agent
Patient will continue treatment with a combination antibiotic therapy for MAC lung disease with the requested agent (e.g., macrolide, rifamycin, ethambutol)

Biologic Immunomodulators - Renewal Approval (general)

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has an FDA labeled indication for the requested agent
Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency)
Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Dupixent - Renewal Criteria (general)

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Disease pathways met and ongoing therapy
- Atopic dermatitis: Patient meets disease-specific conditions for atopic dermatitis and appropriate ongoing therapy/combination constraints (e.g., not combining with other biologic or JAK inhibitor)
- Asthma: Patient meets disease-specific asthma conditions and continues asthma control therapy in combination with the requested agent and not combined with Xolair or IL-5 inhibitors
Patient has had clinical benefit with the requested agent

Emgality - Renewal Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
ANY of the following
- Migraine prophylaxis: Patient continues to meet migraine prophylaxis criteria and will not use another CGRP agent
- Episodic cluster headache: Patient has a diagnosis of episodic cluster headache
Patient has had clinical benefit with the requested agent

Fintepla - Initial/Renewal

Patient has a diagnosis of seizures associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS)
Current treatment evidence or specialist requirements
- There is evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR Prescriber states the patient is currently being treated with the requested agent
- An echocardiogram assessment will be obtained before and during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension; prescriber is a specialist or consulted with one; patient has no FDA labeled contraindications

Procrit/Retacrit - Renewal/Continuation

Indication-specific hemoglobin rules
- Surgery transfusion reduction: Patient's hemoglobin level is greater than 10 g/dL but less than or equal to 13 g/dL for preoperative reduction of transfusion risk
- Chemotherapy anemia: Anemia due to myelosuppressive chemotherapy: Hb <10 g/dL for initiation or <12 g/dL for stabilized patients, concurrent planned chemo, non-curative intent
- CKD anemia: Anemia in CKD not on dialysis: Hb thresholds and risk of transfusion criteria apply

Nurtec - Renewal Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has a diagnosis of migraine
ANY of the following
- Acute path: For acute use: patient has had clinical benefit and will not use with another acute migraine agent
- Prophylaxis path: For prophylaxis: patient has had clinical benefit and will not use with another CGRP agent

Ofev / Pirfenidone - Renewal Criteria

Patient has been previously approved through plan PA criteria
Diagnosis
- IPF: Diagnosis of idiopathic pulmonary fibrosis (IPF)
- SSc-ILD: Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD)
- Chronic fibrosing ILD: Diagnosis of chronic fibrosing interstitial lung disease with progressive phenotype
Patient has had clinical benefit with the requested agent

Trikafta / Kalydeco / Orkambi - Renewal Criteria

Patient has been previously approved through plan PA criteria
Patient has a diagnosis of cystic fibrosis
Patient has had improvement or stabilization with the requested agent (e.g., FEV1, weight/BMI, CFQ-R respiratory domain, symptoms, reduced exacerbations)
Patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication

Somatuline / Octreotide / Somavert - Renewal Criteria

Patient has been previously approved through the plan's Prior Authorization criteria
Patient has an FDA labeled indication or an indication supported in CMS compendia for the requested agent
Patient has had clinical benefit with the requested agent
Requested dose is within FDA labeled dosing or supported compendia dosing

Repatha - Renewal Criteria

Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria
Patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested agent
Patient has had clinical benefit with the requested agent
Patient will NOT be using the requested agent in combination with another PCSK9 agent

Promacta (Eltrombopag) - Renewal Criteria

Patient has been previously approved through plan PA criteria
Indication renewal options
- ITP renewal: For ITP: platelet count >=50 x10^9/L or increase sufficient to avoid clinically significant bleeding
- Hep C thrombocytopenia renewal: For hepatitis C associated thrombocytopenia: platelet count >=90 x10^9/L or increase sufficient to initiate/maintain interferon therapy
- SAA renewal: For severe aplastic anemia: patient has had clinical benefit with the requested agent

CFTR modulators: For CFTR modulators (Kalydeco, Orkambi, Trikafta), patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication.

PCSK9 agents: Patient will NOT be using the requested agent in combination with another PCSK9 agent (Repatha).

ESAs and Part B/D: Some agents (ESAs, IVIG, selected oncology/injectables) are subject to Part B vs Part D review and require appropriate routing; combination checks apply per agent-specific rules.

Linezolid / Sivextro: Linezolid requests: patient will NOT be using linezolid in combination with Sivextro (tedizolid) for the same infection; Sivextro: patient will NOT be using the requested agent in combination with linezolid for the same infection.

Sivextro and linezolid prohibition: Explicit mutual exclusion: do not use Sivextro and linezolid concurrently for the same infection.

Opioid combinations/PDMP: For ER opioid agents (fentanyl lozenge/patch, morphine ER, tramadol ER), prescribers must review PDMP and ensure dosages/combinations do NOT indicate high overdose risk; combination use with other listed opioid products is restricted by indication-specific rules.

GLP-1 / DPP-4 exclusions: GLP-1 agonists (Mounjaro, Ozempic, Rybelsus, Trulicity) must NOT be used in combination with another GLP-1 agonist or with DPP-4 inhibitors per PA criteria.

Androgen / anabolic combos: Androgen/anabolic steroid policies (Danazol, testosterone products) require that the patient will NOT be using the requested agent in combination with another androgen or anabolic steroid unless prescriber justification is provided.

Osteoporosis agents: Osteoporosis/osteopenia agents (denosumab, teriparatide, Tymlos, Stoboclo, Jubbonti) must NOT be used in combination with certain other bone agents (bisphosphonates, another denosumab, romosozumab, or parathyroid hormone analogs) for the same indication.

Agent-specific 'will NOT be using' examples

Aimovig / Emgality / Nurtec prophylaxis: Will NOT be used in combination with another CGRP agent for migraine prophylaxis.
Attruby must NOT be used in combination with Amvuttra or another tafamidis agent for the requested indication.
Biologics (multiple): Patient will NOT be using the requested biologic immunomodulator in combination with another biologic immunomodulator.
Sivextro / Linezolid: Sivextro must NOT be used in combination with linezolid for the same infection (and vice versa for linezolid).
Repatha: Patient will NOT be using the requested agent in combination with another PCSK9 agent.
Sapropterin / Palynziq: Sapropterin: patient will NOT be using the requested agent in combination with Palynziq (pegvaliase-pqpz) for the requested indication.
Tetrabenazine / MAOI and reserpine: Tetrabenazine: patient will NOT be using the requested agent in combination with a monoamine oxidase inhibitor (MAOI) or reserpine.
Teriparatide / Tymlos cumulative use: Total cumulative duration of treatment with teriparatide and Tymlos must not exceed 2 years; prior use rules govern approvals and combinations.

Notable exclusions and scope notes: PA groups for many benzodiazepines (e.g., Clobazam, Clorazepate, Diazepam, Lorazepam, Sympazan) state that PA does NOT apply to patients less than 65 years of age. Weight‑loss use is explicitly excluded for some GLP‑1/Tirzepatide agents (e.g., Mounjaro, Ozempic/Rybelsus/Trulicity family) — requests for use solely for weight loss are not eligible. Cosmetic uses are excluded for topical retinoids (e.g., Tazarotene, Tretinoin) — requests for cosmetic purposes will not be approved.

Documentation Required

Documentation requirements

Provide objective clinical documentation as specified for the agent requested. Required documentation commonly includes recent labs, diagnostic testing, prior-therapy claim lookback, specialist opinion, and baseline monitoring. Genetic, enzyme, or specific assay results must be submitted when noted (e.g., CFTR genotype for CF modulators, AAT level for Prolastin‑C, ALPL for Strensiq, genetic/enzyme testing where specified). For renewals, provide evidence of clinical benefit.

Lookback windows: claims or clinical documentation for prior therapy (commonly 90–180 days) as specified per agent.
Laboratory/diagnostic documentation required: e.g., AAT level for Prolastin‑C; ALPL for Strensiq; calcium levels pre‑denosumab (Osenvelt); hemoglobin thresholds for ESAs; baseline ECG for fingolimod; baseline labs/imaging prior to therapy where specified.
Genetic testing: CFTR genotype for Orkambi/other CF modulators; documented genetic/enzyme testing when required for agents.
Specialist prescriber required or consult: Arikayce (specialist prescriber), Orkambi, Panretin, Pirfenidone, Promacta and other selected agents require specialist prescriber or documented specialist consultation.
PDMP review required for opioids and certain tramadol ER products; document PDMP check for Tramadol ER.
Document prior therapy or current use: evidence of trial, intolerance, contraindication, or failure of preferred/prerequisite agents.
Provide administration details and supplies information when applicable (e.g., alcohol swabs, supplies dynamic PA).
For Arikayce: document sputum culture results and prior therapy history consistent with MAC treatment guidelines.
For ATTR‑CM (Attruby): provide diagnostic confirmation.
Document baseline and ongoing lab monitoring requirements (e.g., calcium monitoring, other agent‑specific labs).

Denial Risk

Denial risks and combination prohibitions

Failure to supply required documentation or use of disallowed combinations are common denial reasons. Denials often result from missing specialty prescriber confirmation, absent required labs/genetic tests, lack of prior‑therapy trials, or requests for prohibited combination biologic therapy.

Combination therapy prohibitions: concomitant use of disallowed agents or multiple biologic/ targeted immunomodulators is not permitted (e.g., combination biologic use prohibited; Aimovig combination restrictions).
Denial risks include: missing specialist consult when required; absent lab/genetic test results (AAT, CFTR genotype, ALPL, etc.); failure to document prior therapy trials or intolerance.
Requests lacking administration/use details (to determine Part B vs Part D) risk denial or processing delays.
Supplying only claims without supporting clinical measurements or missing baseline monitoring (ECG for fingolimod, calcium for denosumab) increases denial likelihood.

Step Therapy

Step therapy / prior‑agent requirements

Many biologics and specialty agents require step therapy — documented trial and failure, intolerance, or contraindication to specified preferred or conventional agents before approval. Provide dates and outcomes of prior agent trials and any evidence of intolerance or contraindication. Agent-specific prerequisite therapies must be met as listed in the PA group.

Preferred agent/prerequisite therapy requirements apply to many specialty drugs; document trials of preferred agents or reasons for not using them.
Therapy failure / prior therapy requirements: submit clinical documentation showing lack of response, intolerance, or contraindication to prior agents within the specified lookback period.
Document prior therapy or current treatment (claims and clinical notes) when required for step‑therapy evaluation.
Example restrictions: Aimovig may have combination restrictions and prerequisite therapies; follow agent-specific PA group rules.
Provide evidence of clinical benefit at renewal if continuing therapy is requested.

Billing Rule

Billing rules / coverage durations

Typical approval durations and billing notes: most approvals are 12 months by default unless agent-specific rules specify otherwise. Short-course or agent‑specific coverage durations and billing routing (Part B vs Part D) must be noted on the PA request.

Default coverage duration: 12 months unless otherwise specified by the drug‑specific PA.
Short-course approvals where specified: e.g., linezolid often limited to 3 months; Sivextro for ABSSSI limited to 6 days — follow drug‑specific limits.
Coverage duration per agent must be documented on the PA and supported by clinical notes.
Billing and routing note: include administration setting and supplies to determine Part B vs Part D coverage; supplies and alcohol swabs may have dynamic PA rules.
Part B vs Part D routing: provide administration/use information (infusion, office administration) so eligibility for Part B can be determined.
Prescriber specialty requirement and billing impact: some agents requiring specialist prescribers (e.g., Arikayce, Orkambi, Panretin, Pirfenidone, Promacta) may have specific billing/coverage expectations tied to specialty care.