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).
• 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.

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).