AmeriHealth Medicare Part D Drug Coverage and Utilization Management Criteria — Pharmacy & Specialty Drugs
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This document lists drugs covered under the AmeriHealth Medicare PPO formulary and details utilization management requirements (prior authorization, step therapy, quantity limits), clinical requirements, prescriber and age restrictions, and coverage durations affecting members and prescribing providers.
No material clinical or coverage changes in this revision.
Coverage Criteria (by product / indication)
Adalimumab (Humira and biosimilars) - Example initial criteria
Covered when ALL of the following are met for the specified indications
Coverage duration: Indefinite where listed.
AIMOVIG (CGRP inhibitor) - Migraine initial criteria
Covered when ONE of the following inclusion pathways is met
Prescriber: neurologist/headache specialist; Initial coverage 6 months.
Prescriber: neurologist/headache specialist; Initial coverage 6 months.
Ampyra (dalfampridine) - Multiple sclerosis
Covered when ALL of the following are met
Coverage: remainder of contract year for initial and reauth; reauth requires documented improvement in walking speed.
ARIKAYCE (amikacin liposome inhalation) - MAC lung disease
Covered when ALL of the following are met
Coverage: remainder of contract year.
Austedo indications and requirements
Coverage when criteria for specific sleep disorders are met
Coverage duration: indefinite.
Tardive Dyskinesia and Chorea (Huntington's)
Coverage when TD or chorea‑Huntington's criteria are met
Initial coverage 3 months; reauth requires documented clinical response (improvement in AIMS).
Coverage indefinite.
Auvelity — MDD criteria
Major Depressive Disorder — prior treatment requirement
Prescriber documents prior trials; coverage indefinite.
Cayston criteria
Cystic Fibrosis specific criteria
Coverage: remainder of contract year; reauth requires evidence of persistent Pseudomonas and positive clinical response (e.g., improved FEV1).
Cholbam criteria
Bile acid synthesis and peroxisomal disorder criteria
Tadalafil (BPH) criteria
Tadalafil for BPH requires prior therapy
Coverage: indefinite.
Cimzia criteria
Cimzia (certolizumab) criteria across multiple indications
Coverage indefinite where listed.
Cinryze criteria
Hereditary angioedema prophylaxis criteria
Coverage indefinite.
Cosentyx criteria
Cosentyx criteria for psoriasis, psoriatic arthritis, ankylosing spondylitis and others
Coverage indefinite.
Dalfampridine criteria
Dalfampridine criteria for multiple sclerosis
Coverage: remainder of contract year for initial and reauth.
Deferasirox criteria
Deferasirox NTDT and transfusional iron overload criteria
Prescriber documents required labs.
Diacomit criteria
Diacomit (stiripentol) criteria for Dravet syndrome
Doptelet criteria
Doptelet criteria for chronic liver disease and chronic immune thrombocytopenia
ITP coverage 12 months initial; CLD coverage 1 month.
Dupixent criteria
Dupixent (dupilumab) diagnosis-specific criteria
Coverage durations vary by indication; many indefinite where listed.
Atopic Dermatitis (AD) - Initial
Covered when ALL of the following are met
Prescriber: dermatologist/allergist/immunologist; coverage indefinite.
Asthma - Initial
Covered when ALL of the following are met
Coverage initial 12 months (where listed).
CRSwNP - Initial
Covered when ALL of the following are met
Coverage durations per product (commonly 12 months).
Eosinophilic Esophagitis (EoE) - Initial
Covered when ALL of the following are met
Prurigo Nodularis (PN) - Initial
Covered when ALL of the following are met
Coverage duration commonly 12 months.
COPD - Initial
Covered when ALL of the following are met
Coverage duration typically 12 months.
Migraine (EMGALITY) - Initial (episodic or chronic)
Covered when ONE of the following inclusion criteria are met
Avoid concomitant use with another injectable CGRP inhibitor (exclusion).
FASENRA - Severe Asthma (Initial)
Covered when ALL of the following are met
Initial and reauth durations commonly 12 months.
Rheumatologic Indications (ENBREL) - Initial
Covered when ALL of the following are met
Coverage indefinite.
EPIDIOLEX - Dravet, LGS, TSC
Covered when ALL of the following are met
Coverage indefinite; continuation requires documented benefit.
High-Dose Opioid Therapy - New to High Dose
Covered when ONE of the following is met
Initial high‑dose requests require opioid tolerance or cancer pain documentation; coverage remainder of contract year.
High Dose Opioid Therapy
Requirements for New to High Dose Opioid Therapy and Continuing High Dose Opioid Therapy
Applies to listed high‑dose opioid products.
Continuation requires documentation as above.
Growth Disorders
Criteria for growth-related products (cartridge 5 mg/1.5 mL, Increlex, etc.)
Prescriber: endocrinologist; continuation typically 12 months.
Applies to Increlex initial approval; coverage 12 months.
Valbenazine (Ingrezza)
Requirements for valbenazine (Ingrezza)
Initial approval 3 months; reauthorization requires documented clinical response (improved AIMS).
Coverage indefinite.
Ivacaftor (Kalydeco)
CFTR mutation–based coverage criteria for ivacaftor
Coverage indefinite where listed.
TOBI Podhaler
Criteria for TOBI Podhaler in cystic fibrosis
Coverage: remainder of contract year.
Livtencity (CMV)
Criteria for Livtencity for CMV
Coverage duration 8 weeks.
Immune Globulin (Gamunex-C)
Indications and continuation criteria for immune globulin (Gamunex-C)
Prescriber with expertise in IG management recommended; subject to Part B vs Part D review where noted.
Kerendia (finerenone)
Kerendia coverage criteria
Coverage indefinite.
Rheumatology Biologics Step Therapy
Prior therapy requirements for certain biologics in rheumatologic conditions
Concurrent biologic therapy is excluded.
Lidocaine 5% patch (PHN, DPN)
Covered when ALL of the following are met
Coverage duration: indefinite; prior authorization required.
Livtencity (CMV)
Covered when ALL of the following are met
Coverage duration 8 weeks.
Modafinil (Narcolepsy, OSAHS, SWSD, MS fatigue)
Covered when ALL specified diagnostic criteria are met
Coverage indefinite.
Coverage indefinite.
Nexletol / Nexlizet (HeFH / Primary hyperlipidemia / CVD high risk)
Covered when ALL of the following are met
Initial coverage 6 months; continuation 12 months with positive clinical response.
Posaconazole (invasive aspergillosis / prophylaxis)
Covered when ALL of the following are met
Coverage duration: remainder of contract year for many uses; subject to additional review where applicable.
Nucala (mepolizumab) indications and criteria
Part D medically necessary when ONE of the following indication-specific criteria sets are met
Exclusion: concurrent biologic therapy.
Initial/reauth 12 months.
Prescriber and age restrictions vary by indication.
Nurtec (rimegepant)
Covered when ALL of the following are met
Avoid combination with other CGRP inhibitors.
Ofev (nintedanib) — fibrosing ILD/IPF/SSc-ILD
Covered when ALL of the following are met
Olumiant (baricitinib) — RA and Alopecia Areata
Covered when ALL specified criteria are met
Coverage indefinite.
Coverage indefinite.
Tavaborole (onychomycosis)
Covered when ALL of the following are met
Coverage duration: 1 year.
Opiprazole (OPIPZA) — multiple psychiatric indications
Covered when ALL of the following are met
Coverage indefinite for continuation.
Nuplazid (pimavanserin) — Parkinson Disease Psychosis
Covered when specified criteria are met
Coverage indefinite; continuation allowed.
Onychomycosis (OPIPZA) — Initial
Approve when ALL of the following are met:
Initial coverage 1 year.
Aripiprazole product indications
Approve when ALL of the following are met for each indication:
Coverage indefinite; continuation permitted.
Coverage indefinite.
Coverage indefinite.
Coverage indefinite.
Pulmonary Arterial Hypertension agents — Initial and Continuation
PAH therapy is covered when ALL initial criteria are met; continuation requires specialist assessment of stabilization or improvement.
Initial coverage typically 6 months; continuation 12 months.
Continuation coverage duration: 12 months.
Praluent (alirocumab) — Hyperlipidemia / ASCVD / HoFH
Approve when specified LDL‑C thresholds and prior statin trial or documented statin intolerance criteria are met.
Initial 6 months; continuation 12 months; HoFH criteria separate.
Initial 6 months; continuation 12 months.
Continuation requires positive clinical response.
Osteoporosis / Bone / Osteopenia / Glucocorticoid induced osteoporosis — Part D criteria
Part D coverage when ALL listed criteria for each condition are met.
Coverage duration: 12 months.
Coverage duration: 12 months.
Reauth requires positive clinical response.
Eltrombopag (Promacta) — Hematology indications
Approve when ALL initial criteria per indication are met; continuation requires response per indication.
Initial/continuation durations typically 12 months for ITP.
Coverage durations vary by indication.
Diabetes therapies (GLP-1 agonists) — general
Coverage applies with documentation of type 2 diabetes mellitus per diagnostic criteria.
Coverage duration: indefinite where indicated.
Hepatitis C DAAs (Epclusa, Harvoni, Mavyret)
Approve when ALL of the following are met:
Coverage duration applied consistent with guidance.
Yesintek (and similar biologics) — autoimmune/IBD/dermatology
Part D medically necessary when initial criteria per indication are met and no concurrent biologic DMARDs.
Coverage durations commonly 12 months; concurrent biologic therapy excluded.
Quinine sulfate — Malaria and Babesiosis
Approve when ALL initial criteria are met:
Coverage duration: 14 days for uncomplicated malaria.
Coverage duration: 10 days for babesiosis.
Promacta continuation
Promacta (eltrombopag) continuation covered when ONE of the following is met:
Continuation durations vary by indication (commonly 12 months).
Hyperlipidemia/ASCVD initial criteria
PCSK9/Repatha coverage (HLA, ASCVD initial) covered when ONE of the following is met:
Initial 6 months; continuation 12 months.
Cushing's disease (Signifor)
Signifor (pasireotide) for Cushing's disease initial coverage:
Pulmonary arterial hypertension
Sildenafil (oral) coverage for PAH and Raynaud's phenomenon:
Coverage indefinite where listed.
Skyrizi maintenance
Skyrizi (risankizumab) coverage for indications including PsO, PsA, CD, UC:
Maintenance per product labeling; coverage durations per policy.
ATTR-CM (Vyndaqel)
Vyndaqel (tafamidis) coverage for ATTR‑CM initial and reauthorization:
ANCA-associated vasculitis (Tavneos)
Tavneos (avacopan) coverage for severe active ANCA‑associated vasculitis (GPA/MPA):
Teriparatide/Forteo osteoporosis
Teriparatide/Forteo coverage for osteoporosis indications:
Coverage durations vary; reauth per policy.
Rinvoq prior therapy requirements
Rinvoq (upadacitinib) coverage across multiple rheumatologic and GI indications:
Prescribed by relevant specialist; coverage duration often indefinite.
Biologic sequencing requirements
Multiple biologic agents require failure or intolerance to specified prior agents
Concurrent biologic therapy excluded.
Primary or Hypogonadal Osteoporosis (HGO) — Initial
Covered when ALL of the following are met
Age ≥18; coverage per policy.
Postmenopausal Osteoporosis (PMO) — Initial and Reauth
Covered when ALL of the following are met
Coverage duration typically 12 months; reauth per policy.
Glucocorticoid-Induced Osteoporosis (GCO) — Initial
Covered when ALL of the following are met
Reauth requires documented clinical benefit.
Hypogonadism (HG) — New Starts and Continuation
Covered when ALL of the following are met
Continuation requires ongoing documentation per policy.
TREMFYA (and other biologics) — Psoriasis, Psoriatic Arthritis, UC, CD
Covered when criteria per indication are met
Coverage durations vary (often indefinite).
Pulmonary Arterial Hypertension (PAH) — multiple products
Covered when ALL of the following are met
Exclusion: combination with prostanoid/prostacyclin analogue for some products.
Vowst — Prevention of recurrent C. difficile infection (PCDI)
Covered when ALL of the following are met
Coverage duration: 14 days; 1 course limit.
Xifaxan — multiple indications
Covered when indication‑specific criteria are met
Coverage durations per indication (HE indefinite; IBS‑D 2 weeks per course).
Xolair (omalizumab) — asthma, chronic urticaria, nasal polyps
Covered when ALL of indication‑specific criteria are met
Coverage durations per policy; concurrent biologic therapy excluded.
Reauth requires reduction in itching/hives from baseline.
Reauth requires positive clinical response (reduced NPS/NCS).
Reauth requires documented positive clinical response and continued avoidance.
Initial Therapy
Covered when ALL of the following are met for each indication
Initial coverage durations typically 6–12 months per product; reauth criteria require documented clinical benefit.
Continuation/Reauthorization
Reauthorization covered when ALL of the following are met for each indication
Reauth durations commonly 12 months; specifics vary by product.
Concurrent therapy with another biologic disease-modifying anti-rheumatic drug (biologic DMARD) or other tumor necrosis factor antagonist is an explicit exclusion across multiple biologic product policies. Requests that document concomitant use of two biologic agents for the same or overlapping immune-mediated indication (for example RA, PsA, AS, JIA, PsO, CD, UC) do not meet the coverage criteria and are subject to denial unless the policy expressly permits combination therapy and documents clinical justification. Prescriber specialty and prior-therapy requirements still apply for eligible single-biologic therapy requests.
Administration of live or live-attenuated vaccines is an exclusion when a member is receiving immunosuppressive doses of certain therapies (for example, high-dose ACTHAR/H.P. Acthar Gel). Providers should not co-administer live vaccines to members on immunosuppressive regimens and must document vaccination history; requests that indicate live vaccine administration while receiving immunosuppressive doses will be excluded from coverage.
Multiple rheumatology and dermatology biologic policies specify that concurrent therapy with other biologic DMARDs or TNF antagonists is an exclusion. For conditions such as ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and related indications, a request that documents ongoing treatment with another biologic agent will not meet medical necessity and is a denial trigger unless an indication-specific exception is documented.
For tadalafil prescribed for benign prostatic hyperplasia (BPH), coverage is excluded when the member is using concomitant nitrates. Documented concurrent nitrate therapy (any formulation) is an exclusion due to known hemodynamic interactions and will result in non-coverage.
Policies for biologics and for CGRP inhibitors consistently prohibit overlapping biologic treatments. Specifically, concurrent use of any other biologic agent is an exclusion for many indications; for CGRP products, documentation of concomitant use with another injectable CGRP inhibitor (or other biologic for the same indication) is a basis for denial. Providers must document cessation of prior biologic therapy before initiating a different biologic unless the policy indicates otherwise.
Growth-related therapies (e.g., for growth hormone gene deletion or severe primary IGF-1 deficiency) include exclusions such as known or suspected malignancy, evidence of closed epiphyses, and concurrent growth hormone therapy. Requests lacking endocrinologist documentation or demonstrating one of these exclusion conditions will not meet coverage criteria.
Use of mifepristone for hyperglycemia in Cushing syndrome is explicitly excluded during pregnancy. Prescribers must confirm pregnancy status and avoid initiating mifepristone in pregnant members; documentation of pregnancy is a contraindication to coverage.
For Nucala (mepolizumab) and similar agents for asthma/allergic conditions, concurrent therapy with any other biologic for asthma/allergic conditions (examples: benralizumab, dupilumab, omalizumab) is an exclusion. Requests must show that no other biologic is being administered for the same disease state to be considered for approval.
Nuedexta (dextromethorphan/quinidine) is excluded in the presence of documented prolonged QT interval, congenital long QT syndrome, or a history of torsades de pointes based on an ECG or other cardiac test. Such cardiac findings are contraindications and will trigger denial.
Olumiant (baricitinib) coverage for rheumatoid arthritis and alopecia areata excludes concurrent use of other biologic DMARDs, JAK inhibitors, or potent immunosuppressants. Requests showing overlap with these therapies will not meet medical necessity and may be denied.
Orkambi (lumacaftor/ivacaftor) coverage is limited to cystic fibrosis patients with the specified genotype; an exclusion applies for CF diagnoses other than those indicated (for example, patients not homozygous for F508del). Confirmatory CFTR mutation testing and genotype documentation are required for coverage consideration.
Initial Therapy Criteria (top-level initial approvals)
Continuation / Reauthorization Criteria
Step Therapy Requirements
| Drug / Indication | Step requirement |
|---|---|
| Aimovig (CGRP inhibitor) — Migraine (episodic or chronic) | |
| Trial and inadequate response or intolerance to TWO specified oral prophylactic medications (each ~4‑week trial) such as topiramate; divalproex/valproic acid; a beta‑blocker (metoprolol, propranolol, timolol, atenolol, nadolol); a tricyclic (amitriptyline, nortriptyline); an SNRI (venlafaxine, duloxetine); or candesartan before approval. Documentation of concomitant use with another injectable CGRP inhibitor is excluded. |
| Drug | Step requirement |
|---|---|
| Auvelity (for Major Depressive Disorder) | |
| Prior inadequate response or intolerance to TWO formulary antidepressants (examples: bupropion, venlafaxine XR, sertraline) required for new starts. | |
| Lybalvi (schizophrenia/related indications) | |
| Trial of TWO generic formulary antipsychotics required for new starts. | |
| Caplyta (schizophrenia, bipolar depression) | |
| Inadequate response or intolerance to TWO generic antipsychotics for schizophrenia, or to TWO medications indicated for bipolar depression, required prior to approval. |
| Context | Required prior medication trials |
|---|---|
| Rheumatology biologics (general) — e.g., Enbrel, Cimzia, others | |
| Inadequate response or intolerance to specified prior conventional DMARD(s) and/or biologic agents as listed per indication — commonly failure of ONE to TWO prior agents (examples: methotrexate or ONE DMARD for RA; two listed biologics for other indications). Concurrent therapy with other biologic DMARDs is excluded. | |
| Biologic sequencing for PsO/PsA/AS/UC/CD | |
| Typically requires inadequate response or intolerance to TWO specified biologic or systemic agents (examples: adalimumab, etanercept, Cosentyx, Skyrizi, ustekinumab) or documentation that trials are inappropriate before approval of another biologic. |
| Rheumatology area | Step requirement / GLP-1 note |
|---|---|
| Rheumatology biologics (RA, AS, PsA, PJIA) | |
| Inadequate response or intolerance to TWO specified prior agents (examples include adalimumab, etanercept, Rinvoq, Xeljanz) or documentation trials are inappropriate; concurrent biologic DMARD therapy is excluded. | |
| GLP‑1 related step (note: GLP‑1 class elsewhere) | |
| For GLP‑1 receptor agonists used in diabetes/weight management, initial approval requires inadequate response or intolerance to a minimum 90‑day supply of TWO preferred GLP‑1 products (e.g., Ozempic, Trulicity, Rybelsus, Mounjaro, Victoza) per the GLP‑1 step rule. |
| Drug | Step requirement |
|---|---|
| Nexletol / Nexlizet (HeFH / Primary hyperlipidemia / CVD high risk) | |
| Prior trial of at least 8 weeks of a maximally tolerated statin AND at least 8–12 weeks of ezetimibe (or documented contraindication/intolerance) before initial approval; documentation of LDL‑C thresholds required. |
| Drug class | Step requirement |
|---|---|
| GLP‑1 receptor agonists (listed preferred brands) | |
| Initial approval requires inadequate response or intolerance to a minimum 90‑day supply of TWO preferred GLP‑1 products (examples: Ozempic, Trulicity, Rybelsus, Mounjaro, Victoza) with medical record documentation. |
| Drug / Use | Step requirement |
|---|---|
| Nurtec (rimegepant) — Preventive use | |
| Failure or intolerance to TWO 4‑week trials of specified oral prophylactic medications for migraine prevention required prior to approval for preventive use. (Acute use has separate single‑triptan failure rule.) |
| Condition / Drug | Step requirement |
|---|---|
| Onychomycosis (topical/systemic agents) — e.g., tavaborole / oral antifungals | |
| Diagnosis confirmed by KOH, culture, or histology AND documentation that condition causes debility/ADL disruption AND inadequate response or intolerance to BOTH: oral generic terbinafine AND (oral generic itraconazole OR topical generic ciclopirox) prior to approval. |
| Drug (Indication) | Required prior therapies |
|---|---|
| Eltrombopag (Promacta) — Chronic ITP | |
| Baseline platelet count <30,000/mcL and inadequate response or intolerance to ONE of: corticosteroids, immune globulin, or splenectomy prior to approval; continuation requires documented platelet response. |
| General rule | Required documentation / trial |
|---|---|
| Required trials of alternative therapies for biologics/specialty agents | |
| Documented inadequate response or intolerance to specified alternative agents (number and agents vary by indication — commonly failure of one or two TNF inhibitors or other listed biologics/systemic agents) is required, or provide documentation why trials are inappropriate. Concurrent use of other biologic DMARDs/JAK inhibitors is excluded. |
| Indication group | Step requirement |
|---|---|
| Biologics for Psoriasis, Psoriatic Arthritis, Ulcerative Colitis, Crohn's Disease (e.g., Tremfya, Yesintek, Skyrizi) | |
| Inadequate response or intolerance to TWO specified biologic or systemic agents (examples listed per indication such as Adalimumab, Enbrel, Cosentyx, Skyrizi, Ustekinumab, Rinvoq, Xeljanz) or documentation that trials are inappropriate before approval; concurrent biologic therapy excluded. |
| Drug / Indication | Step requirement |
|---|---|
| Xifaxan (rifaximin) — IBS‑D | |
| Inadequate response or intolerance to BOTH: (A) ONE tricyclic antidepressant or SSRI AND (B) dicyclomine prior to approval; limit to ≤3 total courses (42 days total). |
| Condition | Step requirement |
|---|---|
| Chronic urticaria | |
| Prior inadequate response, contraindication, or intolerance to ONE second‑generation H1 antihistamine at maximally tolerated dose plus consideration of adjuncts (leukotriene receptor antagonist, H2 antagonist, switching antihistamines, systemic steroids or cyclosporine) required before approval; will be used concurrently with an H1 antihistamine unless contraindicated. |
| Drug | Step / prior therapy requirement |
|---|---|
| Promacta (eltrombopag) — continuation rules (general) | |
| Continuation allowed when ONE of listed continuation scenarios is met (e.g., increased platelet count sufficient to avoid clinically important bleeding) or when specific interferon/antiviral context criteria apply; initial approval requires prior standard therapies tried and failed or not tolerated. |
Provider Actions, Prior Authorization & Documentation
Prior authorization required — follow product-specific PA criteria
Many drugs in this formulary require prior authorization. Providers must submit indication-specific documentation (diagnosis confirmation), prior trial(s) or intolerance to alternative therapies where required, prescriber specialty and age information, and any other required medical information listed for the product requested. Follow the individual product entries for exact PA criteria and required supporting documentation.
- Diagnosis confirmation required per product-specific criteria
- Documentation of prior therapy trials or documented intolerance when specified
- Prescriber specialty and age restrictions must be provided when listed
- Additional required medical information (labs, imaging, susceptibility results) as specified per drug
Austedo prior authorization requirements
Austedo and Austedo XR require prior authorization with documentation of the specific sleep disorder diagnosis. Narcolepsy and OSAHS generally require confirmation by a sleep study unless the prescriber documents why a sleep study is not feasible. Prescriptions should be from or in consultation with a neurologist or sleep specialist.
- Narcolepsy: sleep study confirmation unless infeasible
- OSAHS: sleep study confirmation with ≥5 obstructive events/hour plus symptoms unless infeasible
- Prescribed by or in consultation with a neurologist or sleep specialist
Cayston prior authorization specifics
Cayston PA requires documentation of a diagnosis of cystic fibrosis, evidence of Pseudomonas aeruginosa in the lungs with susceptibility showing sensitivity to aztreonam, and FEV1 between 25% and 75% predicted. Prescriptions must be by or in consultation with a pulmonologist, infectious disease specialist, or CF center specialist.
- CF diagnosis and Pseudomonas aeruginosa evidence with aztreonam susceptibility
- FEV1 documented between 25%–75% predicted
- Prescriber: pulmonologist, infectious disease specialist, or CF center specialist
Dupixent prior authorization specifics
Dupixent prior authorization requires indication-specific documentation: e.g., for atopic dermatitis an inadequate response/intolerance to one medium+ potency topical steroid or topical tacrolimus/pimecrolimus/crisaborole; for asthma meet eosinophil/exacerbation criteria and concurrent medium–high dose ICS plus another controller; for EoE provide biopsy with ≥15 eosinophils/HPF and prior PPI or topical steroid trial. Concurrent use with other biologic agents is excluded.
- AD: inadequate response/intolerance to specified topical therapies
- Asthma: eosinophil thresholds and exacerbation history, plus use with medium–high dose ICS + another controller
- EoE: ≥15 eos/HPF, symptoms, exclusion of other causes, and failed ≥8-week PPI or topical esophageal corticosteroid
- Concurrent biologic therapy is an exclusion
PA submissions — include indication-specific documentation
Prior authorization submissions must include the indication-specific documentation listed in the product entry: diagnosis confirmation, required prior therapy trials or documented intolerance, age and prescriber specialty information, and any required objective test results or labs.
- Provide required prior therapy trials or justification why trials are inappropriate
- Include age and prescriber specialty per product requirements
- Attach objective supporting data (labs, imaging, pulmonary function, biopsy, susceptibility testing) when specified
Growth therapy PA duration and annual re-evaluation
Growth-related therapies are authorized for 12 months for initial and continuation approvals; continuation typically requires annual clinical re-evaluation by the treating endocrinologist and documentation of increased growth velocity or other indication-specific response measures.
- Initial and continuation PA durations: 12 months
- Annual clinical re-evaluation by treating endocrinologist required for continuation
- Continuation requires objective evidence of response (e.g., increased growth velocity)
High-dose opioid continuation — documentation required
Continuing high-dose opioid therapy (morphine-equivalent ≥90 mg/day) requires documentation that the member's pain was assessed within the last 6 months, there is clinically meaningful improvement in pain and function outweighing risks, and the member is not being treated for substance abuse.
- Pain assessment within prior 6 months
- Clinically meaningful improvement in pain/function documented
- No current treatment for substance abuse
Lidocaine patch prior authorization
Lidocaine 5% patches require prior authorization with documentation of the qualifying diagnosis (post-herpetic neuralgia or diabetic peripheral neuropathy) per the product entry.
- Document diagnosis of PHN or DPN
- Provide any other required supporting information as listed in the product entry
Livtencity (CMV) prior authorization requirements
Livtencity (letermovir) prior authorization requires documentation of CMV infection/disease in a hematopoietic stem cell or solid organ transplant recipient, failure or intolerance to at least 2 weeks of IV ganciclovir, oral valganciclovir, IV foscarnet, or IV cidofovir, and the member must weigh ≥35 kg and be ≥12 years old.
- Diagnosis of CMV infection/disease in transplant recipient
- Inadequate response or intolerance to ≥2 weeks of listed antivirals
- Age ≥12 years and weight ≥35 kg
Nuedexta prior authorization and cardiac exclusion
Nuedexta for pseudobulbar affect requires PA with documentation of PBA and an underlying qualifying neurologic condition; providers must note the exclusion for prolonged QT, congenital long QT syndrome, or torsades de pointes.
- Document diagnosis of PBA and qualifying neurologic condition (e.g., ALS, MS, stroke, traumatic brain injury)
- Provide prescriber specialty (neurologist or psychiatrist) as requested
- Do not approve if prolonged QT, congenital long QT syndrome, or torsades de pointes is documented
Onychomycosis — PA documentation and prior therapy requirement
Onychomycosis prior authorization requires confirmatory diagnostic testing (KOH, culture, or histology), documentation that the condition causes debility or ADL disruption, and evidence of inadequate response or intolerance to oral terbinafine and either oral itraconazole or topical ciclopirox before approval.
- Confirm diagnosis with KOH, culture, or histology
- Document functional impact or ADL disruption
- Provide prior treatment trials showing failure or intolerance to required agents
PAH agents — PA and specialist documentation
PA for pulmonary arterial hypertension agents requires documentation of WHO Group I PAH with NYHA Functional Class II–IV, confirmatory right-heart catheterization or echocardiography including mean pulmonary artery pressure ≥25 mm Hg at rest (or >30 with exertion), and specialist involvement; initial approvals commonly 6 months with continuation 12 months contingent on stabilization or improvement.
- PAH WHO Group I diagnosis with NYHA II–IV documented
- Confirmatory catheterization or echocardiography and mPAP ≥25 mm Hg at rest
- Prescribed by or in consultation with a cardiologist or pulmonologist
- Initial coverage typically 6 months; continuation 12 months with stabilization/improvement
Praluent prior authorization — LDL and statin trial documentation
Praluent prior authorization requires LDL-C values meeting the specified thresholds after a minimum 8-week trial of at least moderate-intensity statin therapy, or documented statin intolerance per criteria. Initial authorizations are commonly 6 months with 12-month continuation contingent on positive clinical response.
- LDL‑C ≥70 mg/dL after ≥8-week moderate‑intensity statin trial (or meet HoFH thresholds as specified)
- Document statin intolerance per listed CK/AST/ALT or clinical criteria if applicable
- Initial 6 months; continuation 12 months with evidence of LDL‑C reduction
Promacta continuation — document clinical response
Promacta (eltrombopag) continuation requires evidence of a positive clinical response appropriate to the indication, such as an increase in platelet count sufficient to avoid clinically important bleeding; continuation durations vary by indication (commonly 12 months).
- Provide objective evidence of platelet count increase for ITP
- For hepatitis C/interferon-related use, meet specified interferon therapy continuation criteria
Skyrizi induction required before maintenance; Part B note
Skyrizi maintenance dosing for Crohn's disease and ulcerative colitis is approved only following IV induction; note that Part B may apply for MA‑PD beneficiaries for infusion-related portions of therapy.
- SC maintenance use permitted only after IV induction for CD/UC
- Site-of-care/benefit (Part B vs Part D) may apply for MA‑PD beneficiaries
Osteoporosis PA — severity, prior therapy, and lifetime limits
Osteoporosis (PMO/OSTm) prior authorization requires member ≥18 years and documentation of severe osteoporosis or high fracture risk (e.g., multiple vertebral fractures or BMD T-score ≤ -2.5) and prior inadequate response or intolerance to listed therapies; cumulative lifetime therapy limits may apply to certain agents on reauthorization.
- Document BMD T-score ≤ -2.5 or history of osteoporotic fracture or multiple vertebral fractures
- Provide prior therapy trials or intolerance documentation
- Cumulative lifetime therapy limits (e.g., 2 years) apply for certain agents on reauth
Biologics (PsO/PsA/UC/CD) — PA and sequencing requirements
Biologics for psoriasis, psoriatic arthritis, UC, and Crohn's require prior authorization documenting diagnosis, specialist prescribing/consultation, and inadequate response or intolerance to the specified alternative agents (typically two agents or as listed); concurrent use with other biologic DMARDs or TNF antagonists is excluded.
- Document failure/intolerance to required prior biologic or systemic agents (typically two)
- Prescriber specialty (dermatology, rheumatology, or gastroenterology) per indication
- Concurrent biologic DMARD therapy is excluded
Prior authorization — general provider actions
Prior authorization is required for many specialty agents; providers must supply indication‑specific documentation, required prior therapy trials or intolerance evidence, age and prescriber specialty, and any objective tests or labs specified in the product entry.
- Follow individual product entries for the exact list of required documents
- Include age, prescriber specialty, and objective test results when requested
- If the product page is an index entry, consult the full product policy for PA rules
Index-only — consult individual product pages for PA rules
This index is an index-only section and does not contain prior authorization rules. Providers must review the individual drug policy pages referenced for each product to find PA requirements and documentation instructions.
- Index entries list product names and page references only
- Locate the full product policy page for PA criteria and required documentation
Step therapy used — document required prior trials
Step therapy is applied to selected drugs. For migraine CGRP inhibitors and other listed agents, prior trials of specified oral prophylactic medications or alternative agents must be documented before approval.
- CGRP inhibitors: document trials of specified oral prophylactic medications per migraine frequency
- Follow product-specific step therapy tables for required agents and durations
Auvelity — step therapy requirement
Auvelity for major depressive disorder requires documentation of inadequate response or intolerance to two formulary antidepressants prior to approval.
- Document trials and inadequate response or intolerance to two formulary antidepressants
Lybalvi — step therapy requirement
Lybalvi new starts require documentation of trials of two generic formulary antipsychotics before approval.
- Provide records of two generic antipsychotic trials and inadequate response or intolerance
Caplyta — step therapy requirement
Caplyta requires inadequate response or intolerance to two antipsychotics (schizophrenia) or two medications for bipolar depression as applicable prior to approval.
- Document two failed or intolerant antipsychotic trials (or bipolar depression alternatives) for new starts
Required prior medication trials — document failures/intolerance
Prior medication trials are commonly required: many indications require documented inadequate response or intolerance to specified alternative therapies (examples include two prophylactic agents for migraine or one DMARD for RA) before specialty therapy is approved.
- Document specific prior agents and trials per indication
- Provide justification if trials are inappropriate
Rheumatology biologics — step requirements
Rheumatology biologics often require inadequate response or intolerance to oral methotrexate or specific prior biologics (e.g., adalimumab, etanercept) before coverage; prescriber specialty (rheumatologist) is typically required.
- Document methotrexate and other prior therapy failures/intolerance as specified
- Prescribed by or in consultation with a rheumatologist when listed
Nexletol/Nexlizet — statin and ezetimibe step requirements
Nexletol/Nexlizet initial approval requires at least an 8‑week trial of maximally tolerated statin therapy and 8–12 weeks of ezetimibe when applicable, with LDL‑C documentation per the policy.
- Document ≥8 weeks of statin therapy at maximally tolerated dose
- Document ezetimibe trial of 8–12 weeks or provide contraindication/intolerance
- Include LDL‑C values within required timeframe
GLP‑1 step therapy — two preferred GLP‑1 trials required
GLP‑1 receptor agonist coverage requires documentation of type 2 diabetes and inadequate response or intolerance to a minimum 90‑day supply of two preferred GLP‑1 brands before approval.
- Submit diagnostic labs confirming T2DM (A1C/FPG/OGTT) and medical records
- Provide evidence of two 90‑day trials of preferred GLP‑1s with inadequate response or intolerance
Nurtec — step therapy requirements (acute and preventive)
Nurtec preventive use requires failure or intolerance to two 4‑week trials of listed prophylactic medications prior to approval; acute use requires failure or intolerance to one generic triptan.
- Preventive: document two 4‑week prophylactic trials with inadequate response/intolerance
- Acute: document inadequate response/intolerance to one generic triptan
Antipsychotic step requirements — aripiprazole products
Aripiprazole products require documentation of inadequate response or intolerance to aripiprazole and additional generic formulary antipsychotics depending on indication (e.g., schizophrenia, adjunctive MDD, autism irritability, Tourette's) before approval.
- Document trials of aripiprazole and the other required generic antipsychotic(s)
- Provide indication-specific supporting documentation
Required trials of alternative therapies for biologics/specialty agents
Many biologic and specialty agents require trials of specified alternative therapies and documentation of inadequate response or intolerance (e.g., required trials of TNF inhibitors or other named biologics) before approval.
- Provide records of the specified prior biologic/systemic agent trials and outcomes
- If trials are inappropriate, provide clinical justification
Xifaxan — step requirements and quantity limits for IBS‑D
Xifaxan for IBS‑D requires documentation of inadequate response or intolerance to both (A) one tricyclic antidepressant or SSRI and (B) dicyclomine, and course limits apply (≤3 total courses/42 days).
- Document failure/intolerance to one TCA or SSRI and to dicyclomine
- Adhere to quantity limit: up to 3 courses (42 days total)
Chronic urticaria — step therapy requirement
For chronic urticaria, prior inadequate response, contraindication, or intolerance to one second‑generation H1 antihistamine at maximally tolerated dose plus adjuncts (leukotriene receptor antagonist, H2 antagonist, switching antihistamines, systemic steroids, or cyclosporine) is required before approval.
- Document failure/intolerance/contraindication to one maximally tolerated second‑generation H1 antihistamine
- Document trials of or consideration of listed adjunct therapies
Index-only — no step therapy rules listed here
No step therapy rules are present in this index excerpt; consult the individual product policy pages for step therapy requirements.
- Index entries only — see full product pages for ST rules
Denial risk — missing prior authorization
Failure to obtain a required prior authorization may result in the plan not covering the drug. Providers should obtain PA before dispensing to avoid coverage denial.
- Submit PA prior to fill to avoid non‑coverage
- Follow product-specific PA instructions and provide requested documentation
Cayston — denial triggers for missing microbiology or FEV1 criteria
Cayston requests lacking evidence of Pseudomonas aeruginosa in the lungs, susceptibility showing sensitivity to aztreonam, or with FEV1 outside the required 25%–75% predicted range may be denied.
- Ensure documented Pseudomonas culture or other evidence and aztreonam susceptibility
- Provide FEV1 within 25%–75% predicted
Biologic therapy denial triggers — concurrent use or missing prior trials
Concurrent therapy with other biologic DMARDs or TNF antagonists, or failure to document required prior therapy trials, may trigger denial for multiple biologic agents (e.g., Cimzia, Cosentyx, other listed products).
- Do not request approval if member is on another biologic DMARD unless policy explicitly allows
- Provide documentation of required prior biologic or systemic therapy trials
Denial risk — concurrent biologic therapy excluded
Concurrent therapy with any other biologic agent is an exclusion for multiple indications; do not request overlapping biologic therapies as they will be denied.
- Confirm member is not receiving another biologic for the same or related indication
- If concurrent therapy is clinically necessary, document rationale and check policy exceptions
Denial trigger — concomitant injectable CGRP inhibitors
For CGRP inhibitors and related migraine biologics, documented concomitant use of another injectable CGRP inhibitor is an exclusion and may result in denial.
- Do not co‑prescribe multiple injectable CGRP inhibitors
- Provide medication history showing absence of other injectable CGRP agents
High‑dose opioid prerequisite — denial risk if prerequisites missing
New-to‑high‑dose opioid requests that do not document cancer‑related pain or, for chronic non‑cancer pain, opioid tolerance and prior evaluation for non‑opioid pharmacologic treatments may be denied.
- For new high‑dose starts, document cancer pain OR opioid tolerance AND prior non‑opioid evaluation
- Provide evidence of opioid tolerance per the policy example dosing
Growth disorder denial triggers — missing diagnostic thresholds or specialist involvement
For growth hormone gene deletion or severe primary IGF‑1 deficiency, requests missing required diagnostic thresholds (e.g., SDS values) or lacking endocrinologist involvement may be denied.
- Include height and IGF‑1 SDS values when applicable
- Prescriber should be an endocrinologist or document specialist consultation
Nuedexta — cardiac exclusion may cause denial
Nuedexta is excluded for patients with documented prolonged QT interval, congenital long QT syndrome, or torsades de pointes on cardiac testing; presence of these findings may trigger denial.
- Provide ECG/cardiac test results; do not approve if prolonged QT or related conditions are present
Posaconazole — denial risk if prior voriconazole trial not documented
For posaconazole prophylaxis, failure to document an inadequate response or intolerance to voriconazole when required may result in denial of posaconazole for prophylaxis.
- For prophylaxis use, document prior voriconazole failure/intolerance when specified
- Include indication and relevant specialist consultation (ID/transplant)
Nexletol/Nexlizet — LDL and prior therapy denial triggers
Nexletol/Nexlizet requests lacking documentation of required LDL‑C thresholds or failure/intolerance to statins and ezetimibe per the policy may be denied.
- Provide LDL‑C values and evidence of ≥8‑week statin trial at maximally tolerated dose
- Document ezetimibe trial (8–12 weeks) or justification for not using ezetimibe
Onychomycosis — denial triggers for missing diagnostics or prior therapy
Onychomycosis PA requests missing confirmatory diagnostic testing (KOH/culture/histology), lack of documentation of ADL impact, or missing prior failure/intolerance to required systemic/topical therapies may be denied.
- Attach KOH, culture, or histology confirming dermatophyte infection
- Document functional impact and prior therapy failures/intolerance
PAH — denial risk if diagnostic hemodynamics or WHO Group I not documented
PAH agent requests without documented WHO Group I PAH diagnosis with NYHA II–IV, confirmatory catheterization/echocardiography, and mean pulmonary artery pressure ≥25 mm Hg at rest (or >30 with exertion) may be denied.
- Provide right‑heart catheterization or echocardiography and mPAP data
- Include NYHA functional class and specialist consultation
PCSK9/Praluent — LDL and statin trial documentation required to avoid denial
For PCSK9 inhibitors (e.g., Praluent), missing documentation of LDL‑C thresholds after an adequate statin trial or lack of documented statin intolerance per specified criteria may lead to denial.
- Include LDL‑C values and evidence of ≥8‑week moderate‑intensity statin trial
- If statin‑intolerant, document clinical criteria (rhabdomyolysis, CK elevations, hepatotoxicity) as specified
Concurrent biologic/JAK therapy excluded — denial risk
Concurrent therapy with other biologic DMARDs or JAK inhibitors is an exclusion for multiple indications and may trigger denial if such concomitant use is documented.
- Verify patient's current biologic/JAK therapy prior to PA submission
- If concurrent therapy is present, the request will generally be denied
Concomitant nitrate use exclusion — sildenafil/PAH
Documentation of concomitant nitrate use is an exclusion for sildenafil (PAH) and can trigger denial; confirm medication list for nitrates before submission.
- Check for concurrent nitrates or nitric oxide donors
- Provide documentation that nitrates are not being used
Concurrent biologic therapy excluded for PsO/PsA/UC/CD
Concurrent therapy with biological DMARDs or TNF antagonists for indications such as psoriasis, psoriatic arthritis, UC, and CD is an exclusion and will result in denial unless the policy permits otherwise.
- Do not request overlapping biologic therapies for listed indications
- Provide evidence patient is not on another biologic for the same disease
PAH — combination with prostanoid/prostacyclin excluded
Use of PAH agents in combination with a prostanoid/prostacyclin analogue is an exclusion and may result in denial; verify current prostanoid therapy before requesting PAH medications covered here.
- Confirm patient is not receiving prostanoid/prostacyclin analogues
- If combined use is clinically required, include justification and check policy exceptions
Asthma/allergy biologics — concurrent biologic therapy excluded
Concurrent therapy with any other biologic agents for asthma/allergic conditions (e.g., benralizumab, dupilumab, mepolizumab, omalizumab) is excluded and may trigger denial for those products.
- Ensure no concurrent biologic for asthma/allergic conditions is being used
- Provide documentation of lack of overlapping biologic therapy
Coding and Clinical Thresholds
| none listed | No explicit CPT/HCPCS/ICD codes present in this segment |
| No codes listed |
| 560 mcg/2.24ml | dosage/packaging listed |
| testosterone cypionate 100 mg/ml | intramuscular solution |
| testosterone cypionate 200 mg/ml | intramuscular solution |
| testosterone enanthate intramuscular solution | product listed |
| transdermal gels/solutions (multiple strengths) | various transdermal testosterone formulations listed |
| XIFAXAN 550 mg | rifaximin oral tablet 550 mg |
| VOWST | fecal microbiota, live-jslm (Vowst) product |
| No codes listed |
Quantity Limits and Course Limits
Site of Care and Billing Considerations
Site-of‑care — Part B vs Part D review for infusion/clinic/home
Site-of-care determinations may affect benefit coverage (Part B vs Part D). For products administered in infusion center, office, or home settings, Part B vs Part D review and billing determinations should be considered when submitting requests.
- Confirm site of care and whether Part B or Part D applies for the product and patient
- Include documentation of administration setting when relevant
PAH prescribing specialty — cardiology/pulmonology requirement
Pulmonary arterial hypertension agents should be prescribed by or in consultation with a cardiologist or pulmonologist; include specialist involvement in the PA submission.
- Document cardiology or pulmonology prescriber or consultation
- Specialist evaluation supports PA approval and continuation assessments
Orkambi — prescribing specialty requirement
Orkambi should be prescribed by or in consultation with a pulmonologist or cystic fibrosis specialist; include this specialty documentation with the prior authorization request.
- Provide pulmonologist or CF specialist prescriber/consultation note
- Attach relevant CF diagnostic and mutation testing information if requested
Specialty prescriber and site-of-care — include specialist and setting
Many specialty products require specialist prescribing or consultation (infusion center, clinic, or provider‑specified specialty). For certain agents, specify the infusion/clinic/specialty site and include the prescribing specialist in the PA documentation.
- For transplant, infectious disease, or GI specialty agents include relevant specialist consultation
- Document site-of-care if product is administered in infusion center, clinic, or specialty setting
Infusion center — Part B vs Part D billing/site‑of‑care note
When the product is administered in an infusion center, Part B vs Part D review may apply; include site-of-care and billing preference information to support correct benefit routing.
- Indicate infusion center administration and whether Part B billing is expected
- Attach documentation supporting site-of-care billing determination where specified
Definitions and Diagnostic Thresholds
Background and Scope
This formulary supplement describes utilization management tools (Prior Authorization, Step Therapy, Quantity Limits) and the clinical criteria used to align specialty drug dispensing with evidence-based practice and safety considerations. It lists indication-specific requirements such as diagnostic confirmation, required prior medication trials, prescriber specialty and age restrictions, safety exclusions (for example concurrent biologic use or cardiac contraindications), and documentation expectations that providers must supply to support coverage decisions.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.