CurrentAmeriHealthPolicy N/A
AmeriHealth Medicare PPO — Partial Formulary Utilization Management Criteria (Pharmacy & Specialty Drugs)
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This document describes utilization management requirements (prior authorization, step therapy, quantity limits) and specific PA criteria for multiple pharmacy products covered under the AmeriHealth Medicare PPO plan; it affects prescribers and pharmacies serving plan members.
Policy Summary
PayerAmeriHealth
PolicyPartial Formulary Utilization Management Criteria — Pharmacy & Specialty Drugs
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization and submit required documentation (diagnosis, prior therapy trials, labs, prescriber specialty) per the drug-specific criteria.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
20+drugs with listed PA criteria
12 monthscommon coverage duration
Yesprerequisite therapy required
Member Help Teamsupport contact
Drug-specific Coverage Criteria
INCRELEX: Initial and Continuation
INCRELEX (mecasermin) — Initial and Continuation criteria
ALL of the following
- Diagnosis of either Growth Hormone Gene Deletion (GHGD) with neutralizing antibodies to growth hormone OR Severe Primary IGF-1 Deficiency (PIGF-1D).
- Member is 2 years of age or older.
- For PIGF-1D: height standard deviation score (SDS) ≤ -3.0 AND basal IGF-1 SDS ≤ -3.0 with normal or elevated growth hormone.
- Known or suspected malignancy, closed epiphyses, or concurrent growth hormone therapy are exclusionary.
- Initial approval duration: 12 months.
- Continuation (Reauthorization) requires: (1) documentation of increase in growth velocity from baseline, (2) annual clinical re-evaluation by an endocrinologist, AND (3) expected adult height has not been obtained with documentation of the expected adult height goal.
TOBI Podhaler Criteria
TOBI Podhaler (tobramycin inhalation powder) — criteria
ALL of the following
- Diagnosis consistent with the requested indication (e.g., cystic fibrosis-related Pseudomonas aeruginosa infection or other medically accepted indication).
- Member is prescribed by or in consultation with a pulmonologist, infectious disease specialist, or a CF center specialist as appropriate.
- For Cystic Fibrosis: evidence of Pseudomonas aeruginosa in the lungs and susceptibility demonstrating sensitivity to tobramycin (when applicable).
- FEV1 and age parameters should meet product labeling and prescriber assessment; specific age limits follow product labeling and CF-center guidance.
- Reauthorization: documentation of positive clinical response (e.g., improvement or stabilization in lung function such as FEV1, reduction in exacerbations, or other clinician-documented benefit).
- Coverage duration: 12 months (or remainder of contract year per contractual rules).
KALYDECO Criteria
KALYDECO (ivacaftor) — Cystic fibrosis criteria
ALL of the following
- Diagnosis of cystic fibrosis with an FDA-labeled CFTR mutation for which ivacaftor is indicated, or other medically-accepted indication supported by evidence.
- Prescribed by or in consultation with a pulmonologist, infectious disease specialist, or CF care center specialist.
- For formulations/ages: follow product labeling for age and weight-based dosing.
- Reauthorization: documentation of clinical benefit (e.g., stabilization or improvement in pulmonary function, reduction in pulmonary exacerbations, reduced need for IV antibiotics, weight gain, or other clinically meaningful outcomes).
KERENDIA Criteria
KERENDIA (finerenone) — Initial criteria
ALL of the following
- Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes as defined by product labeling or other FDA-approved indication.
- Prescribed by or in consultation with a nephrologist or appropriate specialist when indicated.
- Baseline clinical and laboratory parameters consistent with safe use (e.g., serum potassium and eGFR per product labeling); avoid use if hyperkalemia or other contraindications present.
- Coverage duration: 12 months; reauthorization based on ongoing clinical benefit and monitoring of safety labs.
KEVZARA: Initial Rheumatology Coverage
KEVZARA (sarilumab) — Initial therapy (rheumatology)
ALL of the following
- Diagnosis consistent with an indicated inflammatory rheumatologic condition (e.g., rheumatoid arthritis) per product labeling or medically accepted indication.
- Inadequate response or intolerance to at least two conventional DMARDs (e.g., methotrexate, leflunomide, sulfasalazine) unless documentation demonstrates such a trial is inappropriate.
- Not used concomitantly with other biologic DMARDs or other tumor necrosis factor antagonists or JAK inhibitors.
- Prescribed by or in consultation with a rheumatologist for RA, JIA, AS or other rheumatologic indications as appropriate.
- Coverage duration: 12 months; reauthorization requires documentation of positive clinical response to therapy.
Rheumatology Product Initial Coverage Criteria
Rheumatology product initial coverage — biologics and targeted agents
ALL of the following
- Indication-specific diagnosis confirmed by the treating clinician (e.g., RA, PsA, AS, nr-axSpA, JIA, PJIA, PsO, CD, UC, HS).
- Prior inadequate response or intolerance to required number of conventional or targeted therapies as specified by indication (examples include at least ONE DMARD for some agents or TWO prior biologic/TNFi/JAK inhibition trials for others) unless documentation justifies why a trial is inappropriate.
- Exclusion: concurrent therapy with another biologic DMARD, other TNF antagonists, or where specified, concurrent JAK inhibitors or potent immunosuppressants (e.g., azathioprine, cyclosporine).
- Prescriber restrictions: prescribed by or in consultation with a specialist appropriate to the condition (rheumatologist, dermatologist, gastroenterologist, pediatric specialist as applicable).
- Coverage duration: generally 12 months; reauthorization requires documentation of positive clinical response as defined for the specific indication (e.g., decreased joint counts, improved disease activity scores, reduced exacerbations/hospitalizations, or endoscopic improvement for IBD).
Autoinflammatory and Rheumatology Coverage Criteria
Autoinflammatory and rheumatology coverage criteria (rare/auto-inflammatory diseases)
ALL of the following
- Diagnosis confirmed for autoinflammatory conditions when applicable (e.g., NOMID, DIRA, CAPS variants) with genetic testing or clinical criteria per specialty guidance.
- Documentation of active inflammation or disease activity (e.g., clinical symptoms, elevated acute phase reactants ESR/CRP) consistent with the requested agent's labeled or medically-accepted use.
- Prescribed by or in consultation with a rheumatologist or pediatric specialist experienced in these disorders.
- Exclusion: concurrent use with other biologic DMARDs unless specifically allowed; coverage duration typically 12 months with reauthorization based on documented clinical response.
Mifepristone (HCS) Coverage Criteria
Mifepristone (for Hypercortisolism, HCS) — coverage criteria
ALL of the following
- Diagnosis of hyperglycemia secondary to endogenous Cushing syndrome (HCS) in an adult with type 2 diabetes mellitus or glucose intolerance.
- Member has failed surgery or is not a candidate for surgery, or surgery is not expected to correct hypercortisolism.
- Prescribed by or in consultation with an endocrinologist.
- Exclusion: pregnancy.
- Coverage duration: 12 months; reauthorization requires documentation of positive clinical response (e.g., improved or stable glucose tolerance on therapy).
LIVTENCITY (CMV) Coverage via Compendia/Cancer Pathway
LIVTENCITY (maribavir) — CMV treatment coverage (Part D oncology/compendia pathway)
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Wakefulness Agent Coverage Criteria
Wakefulness agents (narcolepsy/cataplexy) — coverage criteria
ALL of the following
- Diagnosis confirmed by polysomnography (PSG) and/or multiple sleep latency test (MSLT) or prescriber's justification if sleep testing is not feasible.
- For cataplexy in narcolepsy: diagnosis of cataplexy with narcolepsy; for excessive daytime sleepiness (EDSN): diagnosis of narcolepsy type 2 or appropriate disorder.
- Inadequate response or intolerance to modafinil or armodafinil for EDSN prior to use of alternative wakefulness agents unless contraindicated or documented intolerance.
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist.
- Exclusion: concurrent use of sedative hypnotics and alcohol for sodium oxybate products; follow product-specific safety exclusions and monitoring requirements.
- Coverage duration: 12 months with annual re-evaluation and documentation of efficacy (e.g., reduction in cataplexy frequency or improvement in Epworth Sleepiness Scale).
Nexletol/Nexlizet; PCSK9 Inhibitors (Initial and HoFH)
Nexletol/Nexlizet (bempedoic acid / bempedoic acid + ezetimibe) and PCSK9 inhibitors — lipid-lowering coverage
ALL of the following
- Indication: primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH]) or clinical atherosclerotic cardiovascular disease requiring additional LDL-C lowering despite maximally tolerated statin therapy, or other FDA-labeled/medically-accepted indications (including HoFH for PCSK9 agents where applicable).
- Documentation of baseline LDL-C and lipid panel, and trial or intolerance to maximally tolerated statin therapy and other indicated agents (e.g., ezetimibe) as appropriate to the requested product.
- For PCSK9 inhibitors (e.g., Repatha, Praluent): for HeFH or clinical ASCVD, inadequate response or intolerance to statins ± ezetimibe; for HoFH, documentation supporting homozygous FH diagnosis and/or genetic testing per labeling; confirm prior use of adjunctive therapies as required by product labeling.
- Prescribed by or in consultation with a cardiologist or lipid specialist when indicated.
- Coverage duration: generally 12 months; reauthorization requires documentation of LDL-C reduction or clinical benefit.
Part D Oncology / Compendia-based Coverage Criteria
Part D oncology and compendia-based coverage — general criteria
ANY of the following
- FDA-approved indication and regimen requested.
- NCCN Drugs and Biologics Compendium lists the indication/regimen as Category 1 or 2A.
- AHFS-Drug Information or Clinical Pharmacology narrative supports the requested use.
- Micromedex lists the indication with Class I/IIa/IIb recommendation for the specific condition.
- Lexi-Drugs lists the indication as off-label with evidence level A or peer-reviewed literature supports the use per Medicare policy.
Exenatide (Type 2 Diabetes) Coverage Criteria
Exenatide (type 2 diabetes) — coverage criteria
ALL of the following
- Diagnosis of type 2 diabetes mellitus requiring further glycemic control beyond diet, exercise, and other oral agents or injectable antihyperglycemics as appropriate per labeling.
- Prescribed according to product labeling and by or in consultation with a specialist (endocrinologist) when indicated.
- Documented intolerance, contraindication, or inadequate response to alternative formulary agents as required by plan step therapy (where applicable).
- Coverage duration: per contractual rules; reauthorization based on clinical response (e.g., HbA1c improvement) and tolerability.
Stelara / Ustekinumab Coverage Criteria
Stelara (ustekinumab) — coverage criteria (psoriasis, IBD, rheumatology)
ALL of the following
- Indication-specific diagnosis confirmed (e.g., moderate-to-severe plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) per product labeling or medically accepted use.
- Prior inadequate response or intolerance to required prior therapies per indication (examples: for PsO, inadequate response to TWO systemic/biologic agents; for CD/UC, inadequate response to conventional therapies and anti-TNF or other indicated agents unless trial is inappropriate).
- Exclusion: concurrent therapy with other biologic DMARDs or TNF antagonists unless otherwise specified (maintenance following IV induction for IBD as labeled may be allowed).
- Prescribed by or in consultation with a specialist appropriate for the indication (dermatologist, rheumatologist, gastroenterologist).
- Coverage duration: typically 12 months; reauthorization requires documentation of positive clinical response (e.g., PASI improvement, joint count improvement, endoscopic/healing evidence for IBD).
Posaconazole / Antifungal Coverage Criteria
Posaconazole (Isavuconazole/antifungal pathway) — coverage criteria
ALL of the following
- Indication: invasive aspergillosis after inadequate response or intolerance to voriconazole OR invasive mucormycosis as indicated by product labeling and specialist recommendation.
- Prescribed by or in consultation with an infectious disease specialist or oncologist, or as part of a chemotherapy prophylaxis protocol when appropriate.
- Age and dosing per product labeling (e.g., member is at least 6 years of age for specified indications where applicable).
- Coverage duration: remainder of contract year or as clinically indicated; subject to additional review for ESRD-related use if applicable.
Nucala: Indication-Specific Coverage Criteria
Nucala (mepolizumab) — indication-specific coverage criteria
ALL of the following
- Indication: severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), or other labeled indications per product labeling.
- For severe asthma: eosinophilic phenotype defined by baseline blood eosinophils ≥150 cells/µL if oral corticosteroid-dependent, or ≥300 cells/µL within past 12 months AND history of exacerbations or hospitalization as specified (e.g., ≥1 exacerbation requiring systemic steroids in past 12 months or prior asthma-related hospitalization/intubation).
- For EGPA: disease relapsed or refractory to standard of care and currently receiving corticosteroid therapy unless contraindicated; specialist involvement required.
- Exclusion: concomitant therapy with other biologic agents for asthma/allergic conditions unless specified exceptions exist.
- Prescribed by or in consultation with a pulmonologist, allergist, or immunologist when indicated.
- Coverage duration: typically 12 months; reauthorization requires documentation of clinical benefit (reduced exacerbations, decreased systemic steroid use, improved lung function).
Nuedexta Coverage Criteria
Nuedexta (for Pseudobulbar Affect) — coverage and exclusion criteria
ALL of the following
- Diagnosis of Pseudobulbar Affect (PBA) with an underlying qualifying neurologic condition (e.g., ALS, MS, Alzheimer's disease, Parkinson's disease, stroke, traumatic brain injury).
- Member is 18 years of age or older and prescribed by or in consultation with a neurologist or psychiatrist.
- Exclusionary conditions: concomitant use with other drugs containing quinidine, quinine, or mefloquine; history of drug-induced thrombocytopenia, hepatitis, bone marrow depression, or lupus-like syndrome from Nuedexta/quinidine/quinine; known hypersensitivity to dextromethorphan; use of MAOIs within prior 14 days; prolonged QT, congenital long QT, torsades risk, heart failure; receiving drugs that prolong QT and are metabolized by CYP2D6; complete AV block without pacemaker or high risk for complete AV block.
- Coverage duration: 12 months; reauthorization requires documentation of clinical benefit (e.g., decrease in laughing/crying episodes).
Nuplazid Coverage Criteria
Nuplazid (pimavanserin) — coverage criteria
ALL of the following
- Diagnosis of hallucinations and delusions associated with Parkinson disease psychosis (PDP) or other medically-accepted labeled indication.
- Prescribed by or in consultation with an appropriate specialist; Part D coverage generally allows continuation for established users.
- Coverage duration: indefinite when approved; reauthorization based on clinical judgment and documented benefit.
PBA: Initial Therapy and Reauthorization
Pseudobulbar Affect (PBA) — Initial and Reauthorization
ALL of the following
- Initial: Diagnosis of PBA with an underlying qualifying neurologic disorder as specified (e.g., ALS, MS, Alzheimer's, Parkinson's disease, stroke, TBI).
- Prescribed by or in consultation with a neurologist or psychiatrist; member is ≥18 years of age.
- Reauthorization: documentation of clinical benefit from ongoing therapy (e.g., decreased frequency/severity of uncontrolled emotional outbursts).
- Exclude concomitant use with contraindicated agents (see Nuedexta exclusions) and assess safety labs/ECG as indicated by product labeling.
NURTEC (rimegepant) — Acute and Preventive Use
NURTEC (rimegepant) — Acute and Preventive migraine criteria
ANY of the following
Acute Treatment (AM)
- Diagnosis of migraine with or without aura in adults with fewer than 15 headache days per month.
- Inadequate response or intolerance to ONE generic formulary triptan OR patient has vascular disease or risk factors making triptans inappropriate.
- Exclusion: use in combination with another CGRP inhibitor for acute treatment.
- Initial approval duration: 6 months; reauthorization requires documentation of positive response (reduced pain, photophobia, phonophobia, nausea).
Preventive Treatment (MP)
- Diagnosis of episodic migraine defined as 4 to 18 migraine days per month.
- Patient meets preventive candidacy per clinician assessment (e.g., frequency/intensity warrants preventive therapy).
- Exclusion: concurrent use with another CGRP inhibitor for preventive therapy.
- Initial approval duration: 6 months; reauthorization requires documented reduction in headache frequency or intensity and decreased use of acute migraine medications.
Octreotide Initial Criteria
Octreotide — Initial therapy criteria
ALL of the following
- Indication-specific diagnosis confirmed (e.g., acromegaly, carcinoid syndrome, vasoactive intestinal peptide tumors, bleeding varices control per labeling).
- Baseline evaluation and specialist involvement (endocrinologist, oncologist, gastroenterologist) as appropriate.
- Coverage duration: as clinically indicated; reauthorization requires documentation of clinical benefit (symptom control, hormone level improvement, reduction in bleeding episodes).
OFEV and PAH Agents: Initial Criteria
OFEV (nintedanib) — Initial criteria (fibrotic lung disease) and PAH-related agents
ALL of the following
- Indication: diagnosis consistent with idiopathic pulmonary fibrosis (IPF), progressive fibrosing interstitial lung disease, or other FDA-labeled fibrotic lung indications per product labeling and specialty guidance.
- Prescribed by or in consultation with a pulmonologist; baseline pulmonary function documented (e.g., FVC).
- Coverage duration: per labeling and contractual rules; reauthorization requires documentation of clinical benefit or stabilization (e.g., pulmonary function tests).
- For PAH agents (see separate PAH criteria): diagnosis confirmed by right-heart catheterization or echocardiography with hemodynamic parameters (mean PAP >20 mm Hg, PVR >2.0 WU, PCWP ≤15 mm Hg), specialist involvement, and exclusion of contraindicated concomitant nitrates or PDE5 inhibitors where applicable.
PRALUENT / PCSK9 Coverage
PRALUENT / Repatha and other PCSK9/LDL-lowering agents — coverage
ALL of the following
- Indication: heterozygous familial hypercholesterolemia (HeFH), clinical atherosclerotic cardiovascular disease needing additional LDL-C lowering despite maximally tolerated statin therapy, or other labeled/medically accepted indications including HoFH where applicable.
- Documentation of baseline LDL-C and demonstration of inadequate response or intolerance to maximally tolerated statin ± ezetimibe per product-specific requirements.
- For HoFH: documentation to support homozygous FH diagnosis/genetic testing and prior use of indicated adjunctive therapies as required by labeling.
- Prescribed by or in consultation with a cardiologist or lipid specialist when indicated.
- Coverage duration: indefinite or 12 months per product and contractual rules; reauthorization based on LDL-C reduction or clinical benefit.
Parathyroid Hormone Therapy: Initial and Reauthorization
Parathyroid hormone therapies (e.g., teriparatide, abaloparatide) — initial and reauthorization rules
ALL of the following
- Indication: osteoporosis with high fracture risk, glucocorticoid-induced osteoporosis, or other labeled indications per product labeling.
- Documentation of osteoporosis by BMD T-score ≤ -2.5 or history of fragility fracture, or glucocorticoid use with increased fracture risk per guideline criteria.
- Prior therapy/contraindication documentation when required by plan step therapy; prescriber is typically an endocrinologist or specialist managing osteoporosis.
- Initial coverage duration per product labeling (commonly up to 24 months total lifetime for anabolic therapy); reauthorization requires documentation of clinical benefit (improved BMD, reduced fracture risk) and adherence to duration limits.
Eltrombopag (Promacta) — ITP and Hematologic Indications
Eltrombopag (Promacta) — coverage for ITP and other hematologic indications
ALL of the following
- Indication-specific diagnosis confirmed (e.g., chronic immune thrombocytopenia with baseline platelet counts and bleeding risk documented).
- For ITP: inadequate response or intolerance to first-line therapies (e.g., corticosteroids, IVIG, splenectomy, rituximab) as appropriate per indication and specialist recommendation.
- Prescribed by or in consultation with a hematologist/oncologist; baseline labs and monitoring per labeling (liver function tests, platelets).
- Reauthorization requires documentation of positive clinical response such as sustained platelet count adequate to avoid clinically important bleeding.
Alpha1-Antitrypsin (AAT) Augmentation Therapy — Initial
Alpha1-antitrypsin augmentation therapy (Prolastin-C, AAT) — initial coverage
ALL of the following
- Diagnosis of congenital alpha1-antitrypsin deficiency confirmed by one of the following: PiZZ, PiZ(null) or Pi(null)(null) protein phenotypes (homozygous) OR other rare disease-causing alleles associated with serum AAT level <11 µM/L or equivalent laboratory value.
- Clinical evidence of chronic emphysema without AAT-associated liver disease and serum AAT concentration below lab-specific thresholds (e.g., <80 mg/dL radial immunodiffusion or <50 mg/dL nephelometry).
- Prescribed by or in consultation with a specialist (pulmonologist/genetics) and documented baseline pulmonary status.
- Coverage duration: indefinite when medically necessary; subject to Part B vs Part D review where applicable.
Signifor: Initial Criteria
Signifor (pasireotide) — initial criteria
note":"Assess for contraindications and required monitoring per product labeling."},{"text":"Coverage duration: indefinite or per contractual rules; reauthorization requires documentation of clinical benefit and monitoring of adverse effects."}]}
PAH: Initial Criteria (General)
Pulmonary Arterial Hypertension (PAH) — initial criteria (general)
ALL of the following
- Diagnosis of PAH WHO Group I confirmed by right-heart catheterization or echocardiography with hemodynamic documentation: mean pulmonary arterial pressure >20 mm Hg, pulmonary vascular resistance >2.0 Wood units, and pulmonary capillary wedge pressure or LVEDP ≤15 mm Hg.
- Prescribed by or in consultation with a pulmonologist or cardiologist experienced in PAH management.
- Exclusion: concurrent use of nitrates, phosphodiesterase inhibitors, or other soluble guanylate cyclase stimulators when contraindicated; pregnancy; other product-specific contraindications.
- Initial coverage duration commonly 6 months; reauthorization 12 months contingent on documented clinical response as assessed by specialist.
Acute Migraine (Ubrelvy) and Related Exclusions
Acute migraine (Ubrelvy) and Ubrelvy/Ubrelvy-related exclusions
ALL of the following
- Acute treatment of migraine: diagnosis of migraine with or without aura; member has fewer than 15 headache days per month and inadequate response or intolerance to at least one generic formulary triptan, or triptans are contraindicated due to vascular disease or risk factors.
- Exclusion: will not be used in combination with another CGRP inhibitor for acute migraine treatment; follow product-specific contraindications and prescriber requirements (neurologist/headache specialist recommended).
- Initial coverage duration typically 6 months with reauthorization based on positive response (reduction in pain and associated symptoms).
Vowst / Xifaxan — IBS-D and SBBO/SIBO Criteria
Vowst (fecal microbiota product), Xifaxan (rifaximin) — IBS-D and SBBO/SIBO criteria
ALL of the following
- IBS-D: diagnosis of irritable bowel syndrome with diarrhea and inadequate response or intolerance to both (A) a tricyclic antidepressant or SSRI AND (B) dicyclomine; limited to no more than 3 total courses (42 days) of therapy; reauthorization only if clinical benefit documented.
- SBBO/SIBO: diagnosis of small bowel bacterial overgrowth with initial course per labeling; reauthorization for recurrence requires documentation of recurrence following successful initial treatment.
- Prescribed by or in consultation with gastroenterology when appropriate; coverage durations follow indication-specific rules (e.g., 2 weeks for IBS/SIBO acute courses).
Xolair: Indication-Specific Initial and Reauthorization Criteria
Xolair (omalizumab) — indication-specific initial and reauthorization criteria
ALL of the following
- Indication-specific diagnosis confirmed: moderate to severe persistent allergic asthma with positive skin test or in vitro reactivity to perennial aeroallergen and baseline IgE within product range; chronic urticaria meeting criteria of inadequate response to maximally tolerated second-generation H1 antihistamine plus adjunctive therapies; nasal polyps requiring concurrent intranasal corticosteroid and prior intranasal steroid failure.
- Prescribed by or in consultation with an allergist/immunologist, pulmonologist, or ENT specialist as appropriate.
- Exclusion: concurrent use with other biologic agents for asthma/allergic conditions unless specified exceptions exist.
- Coverage duration: typically 12 months; reauthorization requires documentation of clinical benefit (reduced exacerbations, improved urticaria symptoms, or reduction in polyp burden).
Sodium Oxybate — Narcolepsy Indications and Reauthorization
Sodium oxybate (Xyrem) — narcolepsy indications and reauthorization
ALL of the following
- Indications: cataplexy in narcolepsy and excessive daytime sleepiness in narcolepsy (EDSN) with diagnosis confirmed by PSG/MSLT or prescriber's justification if testing not feasible.
- For EDSN: inadequate response or intolerance to modafinil or armodafinil prior to initiation unless contraindicated (adult use only).
- Exclusion: concomitant use with sedative-hypnotics and alcohol; follow strict REMS and product-specific safety monitoring.
- Prescribed by or in consultation with a neurologist, psychiatrist, or sleep specialist; coverage duration 12 months with annual re-evaluation and documentation of efficacy (e.g., Epworth Sleepiness Scale improvement, reduction in cataplexy events).
Miglustat — Type 1 Gaucher's Disease
Miglustat — Type 1 Gaucher's disease initial and reauthorization criteria
ALL of the following
- Indication: treatment of type 1 Gaucher's disease as per product labeling and specialist recommendation.
- Prescribed by or in consultation with a genetics specialist or hematologist experienced in lysosomal storage disorders.
- Reauthorization requires documentation of clinical benefit and tolerability per treating specialist.
Miglustat — Reauthorization
Miglustat — Reauthorization
ALL of the following
- Documentation of ongoing clinical benefit and tolerability as assessed by the treating specialist.
- Coverage duration and monitoring per product labeling and specialist guidance.
Ztalmy — CDKL5 Deficiency Disorder
Ztalmy (fenfluramine) — CDKL5 deficiency disorder coverage criteria
ALL of the following
- Diagnosis of CDKL5 deficiency disorder with seizures as per specialist evaluation; prescribed by or in consultation with a neurologist or epilepsy specialist.
- Initial and continuation approvals require documentation of seizure frequency and clinical response; follow product-specific safety monitoring and exclusion criteria.
Zurzuvae — Postpartum Depression
Zurzuvae (zuranolone) — postpartum depression coverage criteria
ALL of the following
- Diagnosis of postpartum depression per clinician assessment and appropriate screening instruments.
- Prescribed by or in consultation with a psychiatrist, obstetrician, or primary care clinician experienced in perinatal mental health; ensure safety planning and monitoring.
- Coverage and reauthorization per product labeling and documented clinical response.
Codes and Key Clinical Thresholds
High-dose opioid productsmixed
| fentanyl transdermal patch 72 hour 100 mcg/hr | fentanyl transdermal patch 72 hour 100 mcg/hr (listed product) |
| 25 mcg/hr | fentanyl transdermal patch 25 mcg/hr (listed product) |
| 37.5 mcg/hr | fentanyl transdermal patch 37.5 mcg/hr (listed product) |
| 50 mcg/hr | fentanyl transdermal patch 50 mcg/hr (listed product) |
| 75 mcg/hr | fentanyl transdermal patch 75 mcg/hr (listed product) |
| methadone hcl oral tablet | methadone HCl oral tablet |
| morphine sulfate er oral tablet extended release | morphine sulfate extended release oral tablet |
HAE productNDC|brandCovered
| HAEGARDA | HAEGARDA (C1 esterase inhibitor) for HAE prophylaxis |
Cystic fibrosis inhaled antibioticbrandCovered
| TOBI PODHALER | TOBI Podhaler (tobramycin inhalation powder) |
Growth disorder therapiesbrandCovered
| INCRELEX | INCRELEX (mecasermin) for GHGD and PIGF-1D |
CFTR modulatorbrandCovered
| KALYDECO | Kalydeco (ivacaftor) |
Rheumatology biologicbrandCovered
| KEVZARA SUBCUTANEOUS SOLUTION AUTOINJECTOR 150 MG/1.14ML | Kevzara (sarilumab) autoinjector |
Covered products requiring PAmixedCovered
| mifepristone oral tablet 300 mg | Product name as listed |
Covered products requiring PAmixedCovered
| LIVTENCITY | Product name as listed |
Covered products requiring PAmixedCovered
| exenatide | Product name as listed |
Covered products requiring PA (immunology/GI/derm)mixedCovered
| STELARA SUBCUTANEOUS SOLUTION 45 MG/0.5ML | Product name as listed |
| STELARA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE | Product name as listed |
| ustekinumab subcutaneous | Product name as listed |
Covered products requiring PA (asthma/allergic indications)mixedCovered
| NUCALA | Product name as listed |
Covered products requiring PA (neurologic)mixedCovered
| NUEDEXTA | Product name as listed |
Listed specialty drugs (partial list)mixed
| NUPLAZID | NUPLAZID ORAL CAPSULE/TABLET 34 MG (pimavanserin) listed as covered with continuation allowed |
Oncology and targeted therapies (sample)mixed
| MEKINIST | MEKINIST listed |
| NERLYNX | NERLYNX listed |
| XPOVIO | XPOVIO multiple dosing packs listed |
Referenced comparator biologics and agentsmixed
| Adalimumab-AACF | Adalimumab biosimilar reference in document |
| Enbrel | Etanercept (referenced) |
| Cosentyx | Secukinumab (referenced) |
| Rinvoq | Upadacitinib (referenced) |
| Xeljanz/Xeljanz XR | Tofacitinib (referenced) |
| Skyrizi | Risankizumab (referenced) |
| Yesintek | Ustekinumab (referenced) |
| Otezla | Apremilast (referenced) |
Product strengthsmixed
| 560 mcg/2.24ml | Product strength referenced for FORTEO pen |
| 100 mg/ml, 200 mg/ml | Testosterone cypionate IM solution strengths |
| various transdermal strengths | Testosterone transdermal gel strengths listed |
TYVASO productsNDC | product
| TYVASO DPI MAINTENANCE KIT | Multiple strengths listed (112 x 32mcg & 112 x 64mcg, etc.) |
| TYVASO DPI TITRATION KIT | 16 & 32 & 48 mcg |
Trikaftabrand
| TRIKAFTA | CFTR modulator therapy |
Xifaxanbrand
| XIFAXAN 550 MG | Rifaximin 550 mg tablet |
Xolairbrand
| XOLAIR | Omalizumab |
FEV1 — example threshold
FEV1 threshold25% to 75% of predicted (required for CAYSTON and TOBI Podhaler criteria)
Use caseDocumented FEV1 used to confirm lung function for CF inhaled antibiotic coverage
Supporting actionPrescribe/consult pulmonologist or CF center specialist and include FEV1 in PA submission
LIC (deferasirox NTDT)
LIC threshold (NTDT)>= 5 mg Fe/g dry weight
IndicationChronic iron overload in non–transfusion-dependent thalassemia (NTDT)
AgeMember must be ≥10 years for NTDT
Serum ferritin (NTDT)
Serum ferritin (NTDT)> 300 mcg/L, demonstrated by at least two lab values within the previous two months
ContextRequired for deferasirox coverage in NTDT
Continuation requirementReauth requires decreased ferritin or LIC
Serum ferritin (CIO-BT)
Serum ferritin (CIO-BT)> 1000 mcg/L (consistent values)
IndicationChronic iron overload due to blood transfusions (CIO-BT)
AgeMember must be ≥2 years for CIO-BT
Blood eosinophils (asthma/COPD criteria)
Asthma eosinophil threshold>= 150 cells/µL at initiation OR >=300 cells/µL within past 12 months (supports severe eosinophilic asthma criteria)
COPD eosinophil threshold>= 300 cells/mcL for COPD Type 2 inflammation (baseline)
DocumentationProvide blood eosinophil count and history of exacerbations/hospitalizations in PA submission
Minimum weight for Diacomit (Dravet)
Minimum weight>= 7 kg
IndicationDiacomit (stiripentol) for Dravet syndrome must be used in combination with clobazam
PrescriberPrescribed by or in consultation with a neurologist
Minimum age for Diacomit (Dravet)
Minimum age>= 6 months
IndicationDravet syndrome (Diacomit) initiation age requirement
Combination therapyMust be used with clobazam
blood eosinophils (COPD threshold examples)
COPD eosinophil examples>=300 cells/mcL for COPD Type 2 inflammation; >=150 cells/mcL may be used as alternate threshold (e.g., if on daily oral corticosteroids)
Required background therapyMember must be on triple therapy (ICS+LAMA+LABA) for ≥3 months or LAMA+LABA if ICS contraindicated
Clinical contextInclude exacerbation history (≥2 requiring systemic steroids or COPD-related hospitalization) with PA
morphine equivalent dose for continuing high dose opioid therapy
Morphine equivalent dose (continuing HDOT)≥ 90 mg per day (morphine equivalent)
Continuation conditionsPain assessed within last 6 months and clinically meaningful improvement documented; not receiving substance abuse treatment
New-to-high dose requirementMember must be opioid tolerant per defined equivalencies before initiating high-dose therapy
FEV1 (TOBI Podhaler)
FEV1 requirement (TOBI Podhaler)25% to 75% of predicted FEV1 required for TOBI Podhaler initial coverage
IndicationCystic fibrosis with Pseudomonas aeruginosa; member not colonized with Burkholderia cepacia
PrescriberPrescribed by or in consultation with pulmonologist/ID/CF specialist
Continuing high dose opioid therapy threshold
Continuing HDOT thresholdMorphine equivalent dose ≥90 mg/day
Continuation requirementsPain assessment within prior 6 months and documented clinically meaningful improvement in pain/functioning
Exclusions for continuationMember not being treated for substance abuse
Ivabradine resting heart rate threshold
Ivabradine resting heart rate≥ 70 beats per minute
Indication contextUsed in chronic heart failure with reduced ejection fraction when criteria met
PrescriberPrescribed by or in consultation with cardiologist
KERENDIA serum potassium limit
Serum potassium limit (KERENDIA)≤ 5.0 mEq/L prior to initiation
IndicationChronic kidney disease associated with type 2 diabetes (CKD-T2D)
MonitoringBaseline labs as applicable prior to initiation and for reauth
Eosinophil count (Nucala etc.)
Eosinophil count for biologics (e.g., Nucala)>=150 cells/µL at initiation OR >=300 cells/µL within past 12 months
Clinical linkageUsed to support severe eosinophilic asthma and other eosinophil-driven indications
DocumentationInclude eosinophil lab results in PA; timing requirements noted (within prior 12 months or at initiation)
LDL-C threshold example
LDL-C example thresholds>=55 mg/dL with ASCVD OR >=100 mg/dL without ASCVD (measured within last 120 days)
Statin trial requirementLDL thresholds applied after minimum 8-week trial of at least moderate-intensity statin or documented statin intolerance
Use caseSupports PCSK9/other lipid-lowering agent PA decisions
LDL-C threshold for ASCVD (PRALUENT)
LDL-C threshold for ASCVD (PRALUENT)LDL-C ≥55 mg/dL after a minimum 8-week trial of at least moderate-intensity statin
DocumentationSubmit evidence of statin trial or documented statin intolerance with PA request
Coverage timingInitial approval periods typically 6 months; continuation per product rules
HRCT fibrosis extent threshold
HRCT fibrosis extent>=10% of lung volume with fibrotic features on HRCT (supports chronic fibrosing ILD progressive phenotype)
IndicationsUsed to establish eligibility for antifibrotic therapy (e.g., OFEV) in progressive ILD
PrescriberPrescribed by or in consultation with pulmonologist/rheumatologist or lung transplant specialist
LDL-C threshold (primary hyperlipidemia)
LDL-C threshold (primary hyperlipidemia)LDL-C ≥70 mg/dL after ≥8-week trial of at least moderate-intensity statin
Prerequisite therapyContinue statin at maximally tolerated dose or document intolerance
IndicationHeFH or primary hyperlipidemia initial coverage context
LDL-C threshold (ASCVD)
LDL-C threshold (ASCVD)LDL-C ≥55 mg/dL after ≥8-week trial of at least moderate-intensity statin
ContinuationPositive clinical response (LDL reduction) required for reauth; continuation durations vary (e.g., 2 years for some PCSK9s)
HoFH noteHoFH criteria include untreated LDL-C >400 mg/dL plus ongoing lipid-lowering therapy
Baseline platelet count for ITP
Baseline platelet count (ITP)<30,000/mcL required for chronic ITP initial coverage (e.g., Doptelet/eltrombopag entries)
Periprocedural useFor chronic liver disease periprocedural thrombocytopenia, baseline platelets <50,000/mcL may apply
PrescriberPrescribed by or in consultation with hematologist/oncologist
Diabetes diagnostic A1c
Diabetes diagnostic A1cA1C ≥6.5% (or FPG ≥126 mg/dL or 2-hour OGTT ≥200 mg/dL) to document type 2 diabetes for PA
DocumentationSubmit chart notes or lab evidence with PA for diabetes agents
Coverage durationTypically 12 months for diabetes agents per policy
Serum AAT level
Serum AAT level<80 mg/dL (radial immunodiffusion) or <11 uM/L (disease-supporting threshold)
Genotype confirmationDiagnosis confirmed by PiZZ or other disease-causing alleles as required for AAT augmentation therapy
PrescriberSubmit records confirming genotype and serum AAT level; Part B vs Part D review may apply
Mean pulmonary arterial pressure
Mean pulmonary arterial pressure (mPAP)> 20 mm Hg (hemodynamic confirmation for PAH WHO Group I)
Pulmonary vascular resistance (PVR)> 2.0 Woods Units (WU)
PCWP/LVEDPPCWP or LVEDP ≤15 mm Hg required to support precapillary PH diagnosis
Pulmonary vascular resistance (PVR)
Pulmonary vascular resistance (PVR)> 2.0 Woods Units (WU) (required for PAH hemodynamic confirmation)
mPAP threshold> 20 mm Hg
Diagnostic methodRight-heart catheterization or echocardiography used to confirm hemodynamics
Serum sodium for tolvaptan
Serum sodium for tolvaptanSerum sodium <125 mEq/L OR 125–134 mEq/L with symptoms (e.g., nausea, vomiting, headache, lethargy, confusion)
Initiation settingTreatment must be initiated or re-initiated in hospital within past 30 days prior to PA
ExclusionsNot for patients unable to sense thirst, hypovolemic hyponatremia, concomitant strong CYP3A inhibitors, anuria, ADPKD
Mean pulmonary arterial pressure (duplicate ref)
Mean pulmonary arterial pressure (mPAP)> 20 mm Hg (PAH diagnostic threshold)
Diagnostic confirmationRight-heart catheterization or echocardiography with full hemodynamic profile
PrescriberCardiologist or pulmonologist involvement required
Pulmonary vascular resistance (PVR) (duplicate ref)
Pulmonary vascular resistance (PVR)> 2.0 Woods Units (WU) (PAH documentation)
mPAP> 20 mm Hg
PCWP/LVEDP≤15 mm Hg to confirm precapillary PH
Baseline serum IgE
Baseline serum IgE (Xolair)30 IU/mL to 1300 IU/mL for allergic asthma criteria (baseline) — document pre-treatment IgE
IMFA range>=30 IU/mL and <=1850 IU/mL for IgE-mediated food allergy dosing considerations
Weight-based dosingDosing based on serum total IgE and body weight where applicable
Transaminase limits for Veozah reauth
Transaminase limits (Veozah reauth)≤5 x ULN OR ≤3 x ULN with total bilirubin ≤2 x ULN
Use caseApplied when assessing reauthorization safety for Veozah (or similar) per policy
MonitoringCheck aminotransferases and total bilirubin prior to and during therapy as required
Baseline total serum IgE
Baseline total serum IgE (IMFA)>= 30 IU/mL and <= 1850 IU/mL (for IgE-mediated food allergy dosing); some Xolair indications use 30–1300 IU/mL
Dosing noteDosing based on total IgE and patient weight; include baseline IgE in PA request
ReauthorizationDocument clinical response for continued coverage
Prior Authorization, Documentation, and Denial Triggers
Prior Authorization
Prior Authorization Required
Prior Authorization Required: Many drugs listed require prior authorization (PA). Failure to document required trials of specified prior therapies or required lab/diagnostic thresholds may result in denial.
- Failure to document required trials of specified prior therapies will risk denial (examples across biologic and specialty drug criteria).
- PA may require documentation of lab thresholds, diagnostic tests, or prescriber specialty as noted in individual drug criteria.
Documentation Required
Cystic Fibrosis — microbiology/genotype documentation
Cystic Fibrosis and related agents (e.g., CAYSTON, TOBI Podhaler, KALYDECO, TRIKAFTA): PA requires documentation of CF diagnosis, relevant microbiology (e.g., Pseudomonas aeruginosa presence and susceptibility), genotype/mutation testing when applicable, age/FEV1 limits, and evidence of clinical response on reauthorization.
- CAYSTON: Evidence of Pseudomonas aeruginosa and susceptibility to aztreonam; FEV1 25–75% and not colonized with Burkholderia cepacia.
- TOBI Podhaler: CF diagnosis, Pseudomonas evidence, FEV1 25–75%, age ≥6 years.
- KALYDECO/TRIKAFTA: CF diagnosis with specified CFTR mutation testing or in vitro responsive mutation.
Denial Risk
Concurrent Therapy Exclusions — biologics/DMARDs
Concurrent use exclusions: Many biologic and specialty agents prohibit concomitant use with other biologic DMARDs,other biologic agents, or specific drug classes. Document that the requested agent will not be used concurrently with excluded therapies.
- Examples: exclusion of concurrent biologic DMARDs or other biologics is specified for multiple products (e.g., entailed across rheumatology, dermatology, gastroenterology, and asthma/allergy agents).
- Providers must attest the member is not receiving excluded concurrent biologic or immunosuppressant therapy (or provide rationale why a trial is inappropriate).
Documentation Required
PAH — hemodynamics and nitrate co‑use
Pulmonary arterial hypertension (PAH) agents and certain vasodilators: PA rules often require hemodynamic confirmation and/or prohibit concurrent use with nitrates. For PAH drugs, submit documentation of catheterization/echocardiography and hemodynamics; state whether nitrates are being used.
- SIGNIFOR/Specialty PAH criteria: Documentation that member is not on concomitant nitrate therapy is required; concomitant nitrate use is a contraindication/denial trigger.
- Provide right-heart catheterization or echocardiography confirming mean PAP >20 mmHg, PVR >2 WU, and PCWP ≤15 mmHg where requested.
Prior Authorization
Migraine — CGRP and combination therapy exclusions
Migraine agents (CGRP inhibitors, ubrogepant/Ubrelvy, rimegepant/NURTEC, etc.): PA prohibits combination use of multiple CGRP inhibitors and may limit combination acute/preventive therapies (e.g., Ubrelvy). Document prior trials or contraindications to triptans as specified.
- Concomitant use with another CGRP inhibitor for preventive or acute treatment is excluded.
- For acute agents, document inadequate response or intolerance to a generic formulary triptan unless contraindicated.
- Ubrogepant/Ubrelvy: combination therapy exclusions noted — attest whether combined with excluded migraine agents.
Documentation Required
Nuedexta — PBA documentation and safety exclusions
Nuedexta (dextromethorphan/quinidine) — Documentation and safety exclusions: PA requires diagnosis of Pseudobulbar Affect (PBA) with underlying qualifying neurologic condition and documentation of benefit on reauthorization. Providers must document absence of contraindicated concurrent therapies and cardiac risks.
- Do not combine with other drugs containing quinidine/quinine/mefloquine; avoid in those with prolonged QT, heart failure, or on MAOIs (within 14 days).
- Prescriber should document underlying condition (e.g., ALS, MS, stroke, TBI) and clinical benefit on reauth (reduced laughing/crying episodes).
Documentation Required
Type 2 Diabetes — diagnostic labs and prior therapy documentation
Type 2 diabetes agents (GLP-1s, SGLT2s, etc.): For agents requiring PA, submit medical records confirming the diagnosis of type 2 diabetes (e.g., A1C ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL) and documentation of prior therapy trials or intolerance as specified.
- Document lab evidence (A1C, FPG, OGTT) or chart notes confirming diagnosis.
- For some products, document inadequate response or intolerance to specified GLP‑1 or other preferred agents (e.g., minimum 90‑day supplies).
Documentation Required
Alpha1‑antitrypsin therapy — diagnostic and clinical documentation
Alpha1‑antitrypsin (AAT) therapy: PA requires submission of confirmatory testing and clinical evidence. Provide phenotype/genotype results, serum AAT levels, and documentation of emphysema without significant liver disease.
- Submit medical records confirming AAT deficiency (e.g., PiZZ or other disease‑causing alleles) and serum AAT concentration thresholds (e.g., <80 mg/dL by radial immunodiffusion or <11 µM/L).
- Provide clinical evidence of chronic emphysema and exclude significant AAT‑related liver disease; smoking status may be assessed.
Documentation Required
ANCA‑associated vasculitis — required adjunct therapy and response documentation
ANCA‑associated vasculitis (e.g., TAVNEOS): PA requires documentation that the drug is used as adjunct to standard therapy and concurrent immunosuppressant use (e.g., cyclophosphamide or rituximab) is in place; document BVAS scores and reduction in glucocorticoid use on reauthorization.
- Provide diagnosis of severe active ANCA‑associated vasculitis (GPA or MPA), documentation of use with glucocorticoids and adjunctive immunosuppressant (cyclophosphamide or rituximab).
- Reauthorization requires evidence of sustained remission (e.g., BVAS) and steroid dose reduction.
Documentation Required
Tolvaptan (hyponatremia) — baseline labs and prior therapy documentation
Tolvaptan for hyponatremia: PA requires documentation of clinically significant hyponatremia, prior inpatient initiation, baseline serum sodium, and failure of/contraindication to conservative measures. Exclusions (e.g., inability to sense thirst) must be documented.
- Provide serum sodium values (<125 mEq/L or 125–134 mEq/L with symptoms) and evidence therapy was initiated or re‑initiated in hospital within 30 days of request.
- Document inadequate response or intolerance to fluid restriction and other standard therapies, and rule out contraindications (e.g., inability to sense thirst, hypovolemic hyponatremia).
Note
Index‑only entries — consult product criteria
Index-only and references: This section contains index references only for some products — those entries may not carry independent PA rules here. Consult the referenced criteria pages for full authorization requirements. No authorization requirements may be present on some index pages.
- Index entries list products and page references; where an index-only note appears, there may be no PA rules on that index page.
- Always follow the detailed PA criteria on the product-specific pages referenced in the index.
Step Therapy
Step Therapy / Prior Trials — documentation required
Step therapy and prior trials: Many biologic and specialty agents require documented failure or intolerance to specified prior therapies or step therapy trials before approval. However, some index pages explicitly note no step therapy requirements — verify the specific product criteria.
- Where step/failure requirements apply, provide documentation of trials (drug names, dates, duration, and reason for failure/intolerance).
- If the product page states no step therapy requirement, document accordingly to avoid unnecessary denials.
Initial Authorization Rules
Reauthorization and Continuation Rules
Step Therapy Tables
| Step therapy requirement | Notes / required trials |
|---|---|
| Step therapy required as noted in product entries | Many products in this document are subject to step therapy; see individual product entries for the specific prerequisite agents and number of trials required before approval. |
| Required trials | Example products / details |
|---|---|
| Trials of specified alternative agents required prior to approval | Psychiatric and many specialty indications require documented inadequate response or intolerance to specified prior agents (e.g., schizophrenia: two generic antipsychotics) — see product-specific criteria. |
| Applies to many products | Implication |
|---|---|
| Yes — step therapy/prerequisite therapy applies to many listed products | Numerous coverage entries indicate prerequisite therapy is required; reauthorization typically requires documented clinical response. |
| Product | Prior trials required |
|---|---|
| ILUMYA (plaque psoriasis) | Prior inadequate response or intolerance to TWO specified alternatives (examples include adalimumab, Enbrel, Skyrizi, Cosentyx, ustekinumab, Otezla) unless trials are inappropriate; dermatologist involvement required. |
| Product | Prior trials required |
|---|---|
| Kevzara (RA / PJIA) | Inadequate response or intolerance to TWO specified biologic or targeted agents (e.g., adalimumab, etanercept/Enbrel, Rinvoq, Xeljanz, Orencia) OR documentation that trials are inappropriate; prescriber rheumatologist or consultation required. |
| Products | Required prior lipid-lowering therapy |
|---|---|
| Nexletol / Nexlizet | Requires diagnosis of HeFH or primary hyperlipidemia and documented LDL thresholds plus prior minimum statin therapy (≥8 weeks) and at least 8–12 weeks of ezetimibe where applicable, or documented statin/ezetimibe intolerance/contraindication before approval. |
| Therapy | Requirement |
|---|---|
| Stelara / ustekinumab indications | Trials of TWO alternative agents are required prior to approval for many indications (e.g., Crohn's, UC, PsA, PsO) unless documentation explains why trials are inappropriate; prescriber specialty restrictions apply. |
| Requirement | Scope / examples |
|---|---|
| Trial of two prior DMARDs or documentation | For certain rheumatology agents (e.g., OLUMIANT, RA indications) inadequate response or intolerance to TWO listed DMARDs is required, or documentation that a trial is inappropriate. |
| Product | Prior trial requirements |
|---|---|
| tavaborole (onychomycosis) | Prior inadequate response or intolerance to BOTH oral terbinafine and either oral itraconazole OR topical ciclopirox is required before approval. |
| Requirement | Examples (statin, TNF, DMARDs) |
|---|---|
| Document prior trials of specified agents | Many authorizations require documentation of prior trials such as statins (and ezetimibe) for lipid agents, and prior TNF inhibitors and conventional DMARDs for rheumatologic/gastroenterologic biologics. |
| Condition | Acceptable documentation |
|---|---|
| Failure or intolerance to listed agents | Approval requires failure or intolerance to specified prior biologic/targeted agents or documentation that such trials are inappropriate; lists vary by drug and indication. |
| General rule | Examples |
|---|---|
| Trial(s) of specified therapies required before approval | Examples include requirement for TNF inhibitors or other biologic DMARDs prior to newer biologics, and one generic triptan trial before certain acute migraine agents. |
| Documentation required | Implication for approval |
|---|---|
| Must document trial and failure or intolerance | For specialty drugs, authorization requires documentation of completed trials of first-line therapies and evidence of inadequate response or intolerance before the requested agent is approved. |
| Product group | Step / quantity context |
|---|---|
| High-dose opioid products | High-dose opioid products are subject to prior authorization and high-dose criteria (opioid-tolerant definition; continuation threshold morphine equivalent dose ≥90 mg/day) and have coverage conditions for new starts and continuation. |
Quantity Limits and Limits by Product
High-dose opioid products (quantity-limit context)
High-dose opioid products (QL context)Subject to high-dose criteria and PA (examples: fentanyl patches, methadone, morphine ER listed)
Quantity-limit implicationCoverage duration often remainder of contract year; PA required for initiation and continuation
Provider actionDocument opioid tolerance and prior non-opioid treatment prior to PA
Orkambi quantity-limit reference
Orkambi quantity-limit noteOrkambi coverage requires CF diagnosis and genotype documentation; quantity limits per formulary may apply
Age/formulationGranules ≥1 year; tablets ≥6 years — include formulation-specific age in PA
PrescriberPrescribed by/with pulmonologist or CF care center specialist
FORTEO (teriparatide) cumulative lifetime therapy limit
FORTEO lifetime limitCumulative lifetime therapy for parathyroid hormone analogs (e.g., FORTEO/teriparatide) not to exceed 2 years on reauthorization unless high fracture risk remains
IndicationHigh-risk osteoporosis or severe osteoporosis when other therapies inadequate
MonitoringAssess fracture risk and prior therapy response when considering reauth beyond cumulative limit
Site of Care and Benefit Assignment
Billing Rule
infusion center — GATTEX parenteral support requirement
Infusion‑site and specialist prescriber requirements: GATTEX requires parenteral support ≥3 times/week (infusion center context); TOBI Podhaler/CF agents and certain ILD/PAH agents require specialist prescribers/consultation (pulmonologist, ID, CF center, cardiologist).
Documentation Required
infusion center — specialist prescriber requirement (TOBI Podhaler)
TOBI Podhaler prescribing must be by or in consultation with a pulmonologist, infectious disease specialist, or CF care center specialist for authorization.
Documentation Required
hospital outpatient — immune globulin prescribing expertise
Immune globulin prescriptions must be by or in consultation with a physician with specialized expertise in immune globulin therapy (e.g., immunologist, hematologist, neurologist) for PA and site‑of‑care considerations.
Billing Rule
infusion center | hospital outpatient | office — Part B vs Part D determinations
Some infused products and oncology therapies are subject to Part B vs Part D review; verify site of care and benefit determination (infusion center, hospital outpatient, office) when submitting PA.
Documentation Required
office — specialist prescriber for ILD agents
Certain ILD agents require prescription by or consultation with a rheumatologist, pulmonologist, or lung transplant specialist (office or specialty clinic) for authorization.
Documentation Required
hospital outpatient — PAH agents prescribed by cardiologist/pulmonologist
PAH agents must be prescribed by or in consultation with a cardiologist or pulmonologist and require diagnostic confirmation per PAH criteria.
Billing Rule
infusion center | home — Part B vs Part D review implications
Part B vs Part D review implications: some infusion or home‑administered products may be billed under Part B rather than Part D depending on administration and setting; include site‑of‑care notes in the PA.
Documentation Required
hospital outpatient — tolvaptan initiation requirement
Tolvaptan must be initiated or re‑initiated in a hospital setting prior to discharge within the past 30 days per PA requirements; include documentation of the inpatient start in the PA submission.
Billing Rule
hospital outpatient — Part B product application note
For some Part B products the PA may specify hospital outpatient application or Part B coverage determination; check the product page for site and benefit notes.
Documentation Required
office | infusion center — Vowst administration prep and implied outpatient setting
Vowst administration requires completion of bowel prep the day before and at least 8 hours prior to initiating; the administration setting is implied outpatient (office/infusion) and should be documented.
Billing Rule
infusion center | office (implied) — Part B vs Part D review (Xolair)
Xolair site‑of‑care note: authorization and Part B vs Part D review may depend on administration setting; document intended site (infusion center vs office) and prescriber specialty in the PA.
Policy Background
This formulary segment pairs listed drugs with the plan's utilization management requirements and summarizes clinical prerequisites (diagnosis confirmation, prior therapy failures, specialist prescriber requirements, laboratory or functional thresholds) that determine coverage. It is intended to be used alongside the plan Formulary and the separate Step Therapy document to guide prior authorization and continuation decisions.
Definitions and Clinical Terms
Prior Authorization (PA)
Prior Authorization (PA)Approval required from the plan before filling certain prescriptions; lack of approval may lead the plan to not cover the drug
ImplicationDrugs requiring PA are listed in this document; obtain authorization before dispensing
Exception processMembers may request exceptions per Formulary and Evidence of Coverage guidance
Step Therapy (ST)
Step Therapy (ST)Requirement to try specified first-line drugs before the plan will cover another drug for the same condition
ReferenceSee 2026 Utilization Management Criteria: Step Therapy for specific drug step requirements
Provider actionDocument trials and inadequate response or intolerance when submitting PA
Quantity Limits (QL)
Quantity Limits (QL)Plan limits on the amount of drug covered for a given time period (refer to formulary for specific limits)
ImplicationCheck AmeriHealth Medicare PPO Formulary for drug-specific QLs before prescribing or dispensing
ExceptionException requests may be submitted per plan procedures
FEV1 definition
FEV1 definitionForced expiratory volume in 1 second — used to document lung function; policy examples require FEV1 between 25% and 75% predicted for CF inhaled antibiotics
Use in PAInclude most recent FEV1 percent predicted in PA for CF inhaled antibiotic requests
Supporting labsFEV1 improvement may be required for reauthorization evidence of clinical response
LIC definition
LIC definitionLiver iron concentration measured in mg Fe/g dry weight (e.g., ≥5 mg Fe/g dw for deferasirox NTDT)
Measurement contextLIC used to determine need for iron chelation in NTDT patients
DocumentationProvide LIC report when requesting PA for deferasirox
Opioid tolerant definition
Opioid tolerant definitionAt least one week where total daily dose is at least one of: 30 mg oxycodone, 60 mg oral morphine, 8 mg oral hydromorphone, 25 mg oral oxymorphone or equianalgesic dose
PurposeDefines opioid tolerance for initiation of high-dose opioid therapy
Provider actionDocument opioid tolerance and non-opioid treatment evaluation in PA
Severe primary IGF-1 deficiency criteria
Severe primary IGF-1 deficiency criteriaHeight SDS ≤ -3.0 and basal IGF-1 SDS ≤ -3.0 with normal or elevated growth hormone
IndicationUsed to support INCRELEX coverage for severe primary IGF-1 deficiency
PrescriberPrescribed by or in consultation with an endocrinologist
Severe asthma with eosinophilic phenotype
Severe asthma with eosinophilic phenotypeDiagnosis supported by blood eosinophils ≥150 cells/µL at initiation OR ≥300 cells/µL within past 12 months plus history of exacerbations and high-dose ICS plus controller
DocumentationInclude eosinophil counts, exacerbation history, and background controller therapy in PA
PrescriberPulmonologist or allergist/immunologist involvement recommended
NOMID confirmation
NOMID confirmationConfirmed by NLRP3 (CIAS1) mutation OR clinical symptoms plus elevated acute phase reactants (ESR, CRP)
IndicationUsed to support therapy for neonatal-onset multisystem inflammatory disease (NOMID)
PrescriberPrescribed by or in consultation with pediatric specialist/rheumatologist
Severe asthma with eosinophilic phenotype
Severe asthma eosinophilic phenotype criteria (definition)Blood eosinophils ≥150 cells/µL at initiation OR ≥300 cells/µL within past 12 months plus exacerbation history and high-dose ICS + additional controller
Clinical requirementDocument prior exacerbations (systemic steroids, hospitalization, intubation) and maintenance controller therapy
PrescriberPulmonologist or allergy/immunology specialist involvement
PAH (diagnostic criteria)
PAH diagnostic criteriaPAH WHO Group I with NYHA Functional Class II–IV confirmed by right-heart catheterization or echocardiography with mean PAP >20 mm Hg and PVR >2.0 WU; PCWP/LVEDP ≤15 mm Hg
PrescriberPrescribed by or in consultation with cardiologist or pulmonologist
Initial coverageOften 6 months with reauth 12 months upon documented response
Acromegaly (treatment context)
Acromegaly treatment contextDiagnosis after inadequate response to or not candidate for surgery/radiation and inadequate response or intolerance to a dopamine agonist
PrescriberPrescribed by or in consultation with an endocrinologist
ReauthDocument normalization of IGF-1/GH or clinical improvement
Alpha1-antitrypsin deficiency (AATD)
Alpha1-antitrypsin deficiency (AATD)Diagnosis confirmed by PiZZ or other disease-causing alleles and serum AAT <80 mg/dL (radial) or <11 uM/L
CoveragePart D medically necessary when genotype and low serum AAT with clinical emphysema documented
ExclusionsNot for patients with IgA deficiency with anti-IgA antibodies or active smokers
Inability to tolerate statin therapy
Inability to tolerate statin therapy (definition examples)Documented rhabdomyolysis or CK >10x ULN, persistent significant symptoms with statins, or hepatotoxicity (AST/ALT >3x ULN) — supports statin intolerance for PCSK9 PA
Provider actionInclude documentation of statin intolerance or trial when requesting PCSK9 agents
AlternativeIf intolerant, LDL thresholds still apply for PA consideration
PAH WHO Group I NYHA II–IV
PAH WHO Group I NYHA II–IV definitionPulmonary arterial hypertension WHO Group I with NYHA Functional Class II–IV confirmed by catheterization or echocardiography
Hemodynamic thresholdsmean PAP >20 mm Hg; PVR >2.0 WU; PCWP/LVEDP ≤15 mm Hg
PrescriberCardiologist or pulmonologist involvement required for PAH agents
ANCA-associated vasculitis (GPA/MPA)
ANCA-associated vasculitis (GPA/MPA)Severe active ANCA-associated vasculitis including GPA or MPA; therapy used as adjunct to standard therapy and glucocorticoids
Concurrent therapyMember should be on concurrent immunosuppressant therapy (cyclophosphamide or rituximab) per TAVNEOS criteria
PrescriberNephrologist, pulmonologist, or rheumatologist consultation recommended
Pulmonary Vascular Resistance (PVR)
Pulmonary Vascular Resistance (PVR) definition>2.0 Woods Units (WU) — hemodynamic measure required for PAH documentation
ContextMeasured at right-heart catheterization; include PVR data in PA for PAH agents
Related thresholdMean PAP >20 mm Hg and PCWP/LVEDP ≤15 mm Hg
Baseline serum IgE
Baseline serum IgE (definition)Required laboratory parameter for Xolair allergic asthma criteria, specified as 30–1300 IU/mL
Use in PAInclude baseline serum total IgE and body weight for dosing and coverage decisions
Indication-specific rangesIMFA uses 30–1850 IU/mL for dosing considerations
HE definition
HE definitionProphylaxis for Hepatic Encephalopathy (HE) — used when lactulose failed or intolerant
PA requirementDocument inadequate response to lactulose for HE prophylaxis in PA submission
CoverageDuration indefinite when criteria met
IBS-D definition
IBS-D definitionIrritable Bowel Syndrome with diarrhea subtype — requires failure or intolerance to specified prior therapies before Xifaxan
Course limitsMember must not exceed 3 total courses (42 days total) per policy
DocumentationInclude prior therapy trials (TCA/SSRI and dicyclomine) in PA
Exceptions, Exclusions and Site-specific Rules
Note
Note
Note
Note
Note
Policy Revision History
Index onlyindex_entryLatest
This is an index-only entry with no associated prior-authorization rules or dated revision history; used as a placeholder when no explicit revision entries are present.
Policy Summary
PayerAmeriHealth
PolicyPartial Formulary Utilization Management Criteria — Pharmacy & Specialty Drugs
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization and submit required documentation (diagnosis, prior therapy trials, labs, prescriber specialty) per the drug-specific criteria.
SourceLink
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