Prior authorization criteria for Medicare Part D formulary drugs
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Defines prior authorization requirements, clinical prerequisites, prescriber restrictions, and coverage durations for drugs on Independent Health's 2026 Medicare Advantage Part D formularies; applies to providers and pharmacies managing prescriptions for affected Medicare members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Part D Drugs
PAH (WHO Group 1) initial therapy
Covered when ALL of the following are met:
Coverage duration 1 year
ARIKAYCE
Covered when ALL of the following are met:
Coverage duration 1 year
Immunomodulators/biologics initial therapy
Covered when ALL of the following are met:
Annual reauthorization may require documentation of continued benefit; TB surveillance when exposure risk present.
NEXLETOL / NEXLIZET
Initial authorization requires ONE of the following options:
Annual reauthorization requires continued use of prior lipid-lowering therapies unless contraindicated.
BYLVAY
Covered when ALL of the following are met:
Initial coverage 6 months then 1 year; submit liver function testing at reauthorization.
CABLIVI
Covered when ALL of the following are met:
Coverage duration 3 months; reauthorization not authorized if >2 recurrences of aTTP while on therapy.
Initial authorization requirements (cholestasis)
Covered when ALL of the following are met:
Must also provide attestation drug-induced pruritus ruled out and submit current or previous therapies used to treat the condition.
Step therapy (cholestasis)
Prior therapy requirement for initial authorization:
Applies to initial authorization only.
Caplacizumab
Covered when ALL of the following are met:
Coverage duration 3 months; if not first use, coverage denied if >2 recurrences while on therapy.
Camzyos (hypertrophic cardiomyopathy)
Covered when ALL of the following are met:
Exclude if LVEF <55% or on disallowed concomitant medications; coverage duration 1 year.
Dupixent (by indication)
Dupixent is covered by indication when ALL of the following are met:
Initial authorization 6 months then 1 year; reauthorization requires documentation of clinical benefit.
Initial authorization 6 months then 1 year; reauthorization requires continued triple therapy and clinical benefit.
Reauthorization requires continued triple therapy and documented clinical benefit.
Reauthorization: confirmation of intranasal corticosteroid use and clinical benefit.
Reauthorization requires documentation of clinical benefit (e.g., histologic remission).
Reauthorization requires documentation of clinical benefit.
Emgality (migraine)
Covered when ALL of the following are met:
Coverage duration 1 year.
Doptelet (thrombocytopenia)
Covered when ALL of the following are met:
Drugs requiring prior 5-HT3 antagonist failure for cancer-related nausea/vomiting
Covered when ALL of the following are met:
If medication is full replacement for IV antiemetic within 48 hours of cancer treatment, may be Part B if prescriber indicates on prescription.
Dupilumab (multiple indications)
Covered when ALL of the following are met:
Initial authorization 6 months then 1 year; reauthorization requires documentation of clinical benefit or maintenance.
Reauthorization requires continued background therapy and documented clinical benefit.
Reauthorization requires continued triple therapy and clinical benefit.
Reauthorization: confirm intranasal steroid use and clinical benefit.
Reauthorization requires documentation of clinical benefit (e.g., histologic remission).
Eltrombopag and indications (ITP, thrombocytopenia with HCV, aplastic anemia)
Covered when ALL of the following are met:
First reauthorization requires updated platelet count showing improvement; subsequent reauth require maintenance of clinical benefit.
Initial authorization 6 months for AA.
FABHALTA and FILSPARI (IgAN, PNH, C3G) coverage
Covered when ALL of the following are met:
Annual reauthorization requires symptomatic or clinical improvement or maintenance of prior benefit.
Reauthorization requires stabilization or improvement of UPCR or 24-hour urine protein from baseline.
GLP-1 receptor agonists and related products
Covered when ALL of the following are met:
Off-label use for weight management is excluded from coverage under Medicare Part D; coverage duration 1 year.
General product-specific PA criteria
Covered when ALL of the following are met (examples across multiple products):
Coverage duration typically 1 year; see product-specific nodes for exact requirements.
GLP-1 agonists (e.g., Mounjaro, Ozempic, Rybelsus)
Covered when ALL of the following are met:
Off-label weight management excluded under Medicare Part D; coverage duration 1 year.
Immune globulin products (e.g., GAMMAGARD, PRIVIGEN)
Covered when ALL of the following are met:
Acute/new starts = 3 months; renewals = 1 year; IV home infusion for primary immune deficiency may be Part B; reauthorization requires documentation of clinical benefit.
JUXTAPID criteria
Covered when ALL of the following are met:
Initial duration 6 months then yearly; exclusions: heterozygous FH, pregnancy, active liver disease, moderate/severe hepatic impairment; prescriber restricted to cardiology/lipidology/endocrinology.
KISQALI — Initial Authorization
Covered when ALL of the following are met:
Coverage duration = 6 months.
KOMZIFTI — Authorization Criteria
Covered when ALL of the following are met:
Coverage duration 1 year; exclude congenital long QT syndrome, QTcF ≥450 msec, uncorrected electrolyte abnormalities, and coadministration with strong CYP3A4 inducers or QT-prolonging drugs.
l-glutamine for sickle cell disease — Initial Authorization
Covered when ALL of the following are met:
Coverage duration 1 year.
LYNPARZA — Authorization Criteria (selected indications)
Covered when ALL applicable indication-specific criteria are met:
Coverage duration 1 year as applicable.
Mepolizumab (and similar biologics) authorization
Mepolizumab and similar biologics are covered when ALL of the following are met:
Reauthorization requires documentation of clinical improvement or maintenance of benefit.
Reauthorization requires documentation of benefit.
Inbrija authorization
Covered when ALL of the following are met:
Coverage duration 1 year; reauthorization requires confirmation of symptomatic improvement or maintenance.
OFEV authorization
Covered when ALL of the following are met:
Exclusions: moderate or severe hepatic impairment (Child-Pugh B or C) and coadministration of dual P-gp/CYP3A4 inducer; reauthorization requires updated liver testing and confirmation of clinical benefit.
Inbrija — Initial Therapy
Covered when ALL of the following are met:
Coverage duration 1 year.
Lipid management — Initial Therapy (Repatha)
Repatha is covered when ONE of the indication-specific sets is met:
Age ≥10 for some indications; prescriber restrictions apply; coverage 1 year.
Cushing's syndrome — Initial Therapy (Recorlev)
Covered when ALL of the following are met:
Coverage duration 1 year; reauthorization requires documentation of clinically relevant response (UFC reduction or maintenance).
Product-specific initial authorization
Covered when ALL of the following are met:
Coverage duration typically 1 year; reauthorization requires documentation of clinical benefit as specified.
Rivfloza (initial and reauthorization)
Covered when ALL of the following are met:
Initial duration 6 months then 1 year for renewals; first reauthorization requires documentation of clinically relevant response (reduced Uox or plasma oxalate).
Hepatitis C therapy
Covered when ALL of the following are met:
Transthyretin amyloid cardiomyopathy (Vyndamax/Vyndaqel)
Covered when ALL of the following are met:
Coverage duration 1 year; annual reauthorization requires confirmation of symptomatic or clinical improvement or maintenance.
Psychiatric agent step therapy
Covered when ALL of the following are met:
Coverage duration 1 year.
Tafamidis / ATTR cardiomyopathy (example product entry)
Covered when ALL of the following are met:
Initial coverage 1 year; reauthorization requires documentation of symptomatic or clinical improvement or maintenance.
Teriparatide / parathyroid hormone analogs
Covered when ALL of the following are met:
Use >2 years generally not recommended; coverage typically 2 years unless continued high risk and reauthorization requirements met.
VANRAFIA (primary IgA nephropathy)
Covered when ALL of the following are met:
Annual reauthorization requires documentation of clinically relevant response (stabilization or improvement of UPCR/24-hour urine protein).
Tolvaptan (ADPKD vs hyponatremia formulations)
Coverage varies by indication/formulation — covered when ALL applicable criteria are met:
ADPKD formulation only; hyponatremia formulation not approved for ADPKD.
Coverage limited to 30 days initiation setting requirements apply.
Verquvo (vericiguat) — HFrEF
Covered when ALL of the following are met:
Coverage duration 1 year; exclude concurrent use of another sGC stimulator or PDE-5 inhibitor and pregnancy.
VEOZAH (vasomotor symptoms)
Covered when ALL of the following are met:
Exclusions include coadministration with CYP1A2 inhibitors, severe renal impairment/ESRD, known cirrhosis, or aminotransferase/total bilirubin ≥2x ULN; coverage duration 1 year; reauthorization requires documentation of symptomatic or clinical improvement.
Initial Therapy - vasomotor symptoms product
Covered when ALL of the following are met:
Authorization 1 year; reauthorization requires confirmation of symptomatic improvement or maintenance; exclusions as noted for renal/hepatic disease and interacting drugs.
Initial Therapy - VERQUVO
Covered when ALL of the following are met:
Coverage duration 1 year; exclude pregnancy and concomitant use of another sGC stimulator or PDE-5 inhibitor.
Initial Therapy - VIJOICE
Covered when ALL of the following are met:
Initial authorization 6 months then 1 year; reauthorization requires objective documentation of benefit or maintenance.
Initial and Reauthorization Therapy - WEGOVY
Covered when ALL of the following are met (selected indications):
Initial duration 32 weeks then 1 year for reauthorization; weight management indication excluded under Medicare Part D.
Initial duration 32 weeks then 1 year.
Indication-specific Criteria - XIFAXAN
Covered when ALL applicable indication-specific criteria are met:
XOSPATA
Covered when documentation and restrictions below are satisfied:
All FDA-approved indications covered.
XPOVIO
Covered when documentation and prior therapy requirements are met:
All FDA-approved indications covered.
XURIDEN
Covered when baseline labs and follow-up documentation provided:
All FDA-approved indications covered.
ZEJULA
Covered when testing and prior chemotherapy documentation are provided as applicable:
All FDA-approved indications covered.
ZILBRYSQ
Covered when diagnostic confirmation, severity, vaccination, and prior therapy trials are documented:
Initial authorization requires trial and inadequate response to at least one drug in two of three classes (acetylcholinesterase inhibitors, corticosteroids, non-steroidal immunosuppressives); initial 6 months then 1 year; reauthorization requires documented improvement and maintenance plus vaccination status.
ZORYVE
Covered for plaque psoriasis when ALL of the following are met:
Coverage duration 1 year; reauthorization requires confirmation of symptomatic or clinical improvement or maintenance.
ZURZUVAE
Covered with postpartum timing and prescriber restrictions:
Coverage duration 14 days; only one 14-day course allowed per plan year.
ZYDELIG
Covered when safety and prior therapy documentation are provided:
Coverage duration 1 year; exclusions include history of toxic epidermal necrolysis, untreated active infection, or coadministration with strong CYP3A inducers.
ZYKADIA
Covered when ALK testing and safety checks are provided:
Coverage duration 1 year; exclusion for coadministration with strong CYP3A inducers.
Coverage is denied when routine safety or clinical exclusions are met. Examples applicable across multiple products include: pregnancy; severe hepatic impairment (Child‑Pugh class C); severely reduced renal function (creatinine clearance < 15 mL/min or dialysis); and concurrent use of contraindicated agents such as nitrates or nitric oxide donors or phosphodiesterase inhibitors where noted. Prior authorization requests must include required baseline testing (e.g., creatinine clearance or data to calculate it) and pregnancy status for females of childbearing potential; failure to provide required information or presence of these exclusion conditions will result in non‑coverage per the product criteria.
BENLYSTA (belimumab) is not eligible for coverage when the patient has severe active central nervous system lupus or is currently receiving other biologic therapies or intravenous cyclophosphamide. Initial authorization requires documentation the patient is using standard therapy (systemic corticosteroids, antimalarials, or immunosuppressants) and submission of an autoantibody‑positive test (ANA and/or anti‑dsDNA); absence of required documentation or presence of the noted exclusions precludes approval.
Chenodal (chenodeoxycholic acid) will be excluded when standard hepatic or biliary contraindications are present, including pregnancy, known hepatocyte dysfunction, or bile duct abnormalities (for example, intrahepatic cholestasis, primary biliary cirrhosis, or sclerosing cholangitis). Requests are also excluded when imaging or surgical factors (e.g., radiopaque stones, nonvisualizing gallbladder after two dye doses, compelling need for gallbladder surgery) are documented. Safety beyond 24 months is not established and extended use will not be authorized.
Camzyos (mavacamten) is excluded if the patient’s cardiac function does not meet safety thresholds — specifically if LVEF is less than 55%. Coadministration with disallowed interacting cardiac drugs (for example, combinations of non‑DHP calcium channel blockers plus beta‑blockers, disopyramide, ranolazine) or with specified strong CYP inhibitors/inducers also excludes use. Prior authorization requires documentation of LV outflow tract gradient, LV wall thickness, current LVEF and pregnancy status; presence of exclusionary findings prevents approval.
GLP‑1 receptor agonists listed in this policy require coverage for labeled indications only. Off‑label uses are excluded; in particular, requests for GLP‑1 agonists for primary weight management (off‑label weight loss) are not approved under Medicare Part D. Prior authorization for GLP‑1s for diabetes requires documentation of type 2 diabetes per the criteria; absence of an indicated diagnosis or requests for weight‑loss use will be denied.
Independent Health will not authorize GLP‑1 agonists when the sole or primary intent is weight management. Coverage is limited to FDA‑approved metabolic/diabetes indications and requires supporting documentation (e.g., A1c ≥ 6.5% or other laboratory/medical record evidence). Off‑label weight‑loss indications are explicitly excluded and treated as not covered.
JUXTAPID (lomitapide) is excluded for patients with heterozygous familial hypercholesterolemia, for pregnant patients, and for those with moderate or severe hepatic impairment (Child‑Pugh B or C) or active liver disease. Coadministration with moderate or strong CYP3A4 inhibitors is also an exclusion. Baseline hepatic testing and lipid panel are required for any request; presence of the exclusion criteria will result in denial.
For hereditary angioedema (HAE) products, requests for routine prophylactic therapy are excluded where the policy specifies attacks only or limits prophylaxis; approval requires documentation that prophylaxis is medically necessary per the product‑specific criteria (disease activity, attack frequency, and burden). Additionally, select antifungal and hepatic‑risk products required baseline liver testing and exclude patients with acute or chronic liver disease; such hepatic exclusions must be met before authorization will be considered.
Codes, Strengths, and Key Numeric Thresholds
| 50-75 & 150 MG, 50-25-37.5 & 75 MG | Dosage strengths listed for Trikafta oral therapy pack |
| 140 MG/ML, 70 MG/ML | Aimovig autoinjector strengths |
| N/A | Drug product list including MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY formulations |
| CORLANOR ORAL SOLUTION | Product listed |
| diclofenac sodium external gel 3 % | Product listed |
| ivabradine hcl oral tablet 5 mg, 7.5 mg | Product listed |
| REPATHA | Product listed |
| REPATHA PUSHTRONEX SYSTEM | Product listed |
| REPATHA SURECLICK | Product listed |
| No codes listed |
| No codes listed |
| XPOVIO (multiple pack/dose listings) | XPOVIO oral tablet therapy packs: multiple dosing schedules listed (10 mg, 40 mg, 50 mg, 60 mg, 80 mg variants). |
| VALTOCO | VALTOCO nasal liquid therapy pack listings referenced |
Actions Required by Prescribers and Pharmacies
Obtain prior authorization before dispensing
Prior authorization is required for drugs listed with 'PA' on the Medicare Advantage Part D formularies; approval must be obtained from the plan before dispensing to avoid non-coverage.
Age‑based PA applies to select analgesic combos (65+)
PA applies to certain analgesic combination products only for patients aged 65 years and older; these PA requirements do not apply to patients 64 years or younger.
Document failure/intolerance to ≥2 listed therapies before initial approval
For initial authorization of cholestasis-targeted therapy (e.g., BYLVAY), the patient must have tried and failed or been intolerant to at least two of cholestyramine, naltrexone, rifampin, or ursodiol; initial coverage is for 6 months with reauthorization then 1 year.
Authorize caplacizumab only with plasma exchange + immunosuppression; age ≥18; 3‑month limit
Caplacizumab (CABLIVI) requires the requester confirm the drug will be administered with plasma exchange and immunosuppressive therapy, patient age ≥18, and coverage is limited to 3 months; if not first use, prior aTTP recurrences while on caplacizumab must be submitted and >2 recurrences will preclude reauthorization.
Dupixent: 6‑month initial approval, specialty prescriber, and required testing
Dupixent initial authorization is for 6 months (then 1 year on renewal); prescriber specialty is restricted by indication; submit condition‑specific objective data (e.g., ≥10% BSA for AD, pre‑bronchodilator FEV1 and blood eosinophils for asthma) and documentation of current/prior therapies.
Supply prior‑therapy trial/failure documentation with PA requests
Many products require prior authorization and documented evidence that specified prior therapies were tried and failed (or were contraindicated/intolerant) before approval; submit documentation of those prior therapies with the request.
Most PAs grant 1‑year coverage unless noted otherwise
Prior authorization is required for listed products generally; coverage duration is typically 1 year unless a product‑specific exception is noted.
IVIG: acute starts 3 months; renewals 1 year; home IVIG may be Part B
For immune globulin (IVIG/SCIG) products: initial/acute starts are authorized for 3 months and renewals for 1 year; IV formulations administered in the home for primary immune deficiency may be covered under Medicare Part B — submit indication‑specific documentation.
KISQALI PA: baseline LFTs + culture‑proven diagnosis; 6‑month duration
KISQALI for systemic fungal indications requires prior authorization with submission of baseline liver tests and documented culture‑proven diagnosis (blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, or paracoccidioidomycosis); coverage duration 6 months.
KOMZIFTI PA: genetic testing, ECG/electrolytes, age ≥18, oncology prescriber
KOMZIFTI prior authorization requires tumor genetic testing confirming HR‑positive, HER2‑negative disease, submission of QTcF and serum potassium/magnesium within the prior 6 months, patient age ≥18, and oncology prescriber; coverage duration 1 year.
LYNPARZA PA: BRCA/HHRR testing and indication‑specific attestation
LYNPARZA prior authorization requires submission of relevant genetic testing (BRCA or homologous recombination repair genes) and indication‑specific attestations (e.g., response to platinum‑based chemotherapy for ovarian cancer); coverage duration 1 year.
Include diagnosis, prescriber specialty, age, and pregnancy status with PA
Prior authorization requests must include required diagnostic documentation, prescriber specialty when restricted, applicable age limits, and pregnancy status where requested (examples shown across products).
Inbrija PA: neurology prescriber, age ≥18, trial of ≥2 medication classes required
Inbrija requires prior authorization: prescriber restricted to neurology, patient age ≥18, 1‑year coverage; initial approval requires trials/failures or intolerance to at least two classes that reduce 'off' episodes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors) unless contraindicated.
Pemazyre PA: FGFR testing, prior systemic therapy, oncology prescriber, age ≥18
Pemazyre prior authorization requires documentation of FGFR1/FGFR2 genetic testing, prior systemic treatment for the indication, oncology prescriber, patient age ≥18, and excludes coadministration with moderate/strong CYP3A4 inducers; coverage 1 year.
PA requests must include diagnostic tests, prescriber specialty, age; typical 1‑year duration
Prior authorization generally requires submission of specified diagnostic tests, prescriber specialty, age confirmation, and supports coverage for about 1 year for most agents (product exceptions noted).
Rivfloza: initial 6 months then 1‑year renewals; submit AGXT and Uox/eGFR
Rivfloza initial authorization is for 6 months and reauthorization for 1 year thereafter; submit required genetic/biochemical confirmation (AGXT mutation and 24‑hour urinary oxalate) and baseline eGFR per product criteria.
PA typically authorizes 1‑year coverage
Prior authorization is required for many listed products; coverage duration is commonly 1 year unless the product specifies otherwise.
PA required for VERQUVO and related products; 1‑year coverage
VERQUVO and related products require prior authorization; coverage is generally 1 year and prescriber specialty may be restricted; some related products list prerequisite therapy requirements.
Verquvo PA: cardiology prescriber, LVEF <45% and recent HF event required
Verquvo prior authorization requires adult HFrEF documentation (LVEF <45%, recent HF hospitalization or outpatient IV diuretic), pregnancy status, prescriber restricted to cardiology, and coverage duration 1 year.
XOSPATA PA: FLT3 testing, baseline electrolytes, hematology/oncology prescriber, age ≥18
XOSPATA prior authorization requires documentation of FLT3 mutation, baseline potassium and magnesium, prescriber restricted to hematology/oncology, patient age ≥18, and coverage duration 1 year; uncorrected electrolyte abnormalities or coadministration with dual strong CYP3A/P‑gp inducers are exclusions.
XPOVIO PA: age ≥18, oncology prescriber, prior therapy failures documented
XPOVIO prior authorization requires age ≥18, hematology/oncology prescriber, coverage 1 year, documentation of prior therapy failures for certain indications (e.g., multiple myeloma relapsed/refractory criteria).
XURIDEN PA: baseline CBC, MCV, urine orotic acid; annual lab documentation for reauth
XURIDEN prior authorization requires submission of baseline CBC with neutrophil count and MCV and baseline urine orotic acid; annual reauthorization requires documentation of improvement or stabilization of these labs.
ZEJULA PA: oncology prescriber, platinum response and BRCA testing as applicable
ZEJULA prior authorization requires age ≥18, oncology prescriber restriction, coverage 1 year, documentation of response to platinum‑based chemotherapy, and BRCA testing where applicable.
ZILBRYSQ PA: neurology prescriber; initial 6 months then 1 year; step/rehab requirements
ZILBRYSQ prior authorization is restricted to neurology; initial approval is 6 months then 1 year for renewals; initial trial/failure requirements across medication classes must be met and reauthorization requires documented symptomatic improvement and vaccination status.
ZORYVE PA: plaque psoriasis only, age ≥6, prior topical/systemic therapy required
ZORYVE prior authorization is required for plaque psoriasis (atopic dermatitis excluded); age ≥6, PA not required if requested by dermatology prescribers, coverage 1 year; initial approval requires prior failure/intolerance to a high‑potency topical corticosteroid plus another topical agent or current systemic therapy.
ZURZUVAE PA: postpartum attestation, specialty prescriber, one 14‑day course
ZURZUVAE prior authorization requires prescriber restricted to gynecology/obstetrics/psychiatry, attestation patient is within 12 months postpartum, coverage limited to a single 14‑day course per plan year.
ZYDELIG PA: oncology prescriber, coadministration with rituximab, prior therapy documented
ZYDELIG prior authorization requires age ≥18, hematology/oncology prescriber, attestation therapy will be coadministered with rituximab, documentation of at least one prior systemic therapy, pregnancy status for females of childbearing potential, and coverage duration 1 year.
ZYKADIA PA: ALK testing, oncology prescriber, age ≥18
ZYKADIA prior authorization requires submission of test confirming ALK‑positive tumor, pregnancy status for females of childbearing potential, prescriber restricted to oncology, patient age ≥18, and coverage 1 year.
Biologic step: fail ≥2 preferred agents and complete TB screening when required
For many biologic agents (except Otezla and Velsipity), initial authorization requires failure or intolerance to at least two preferred agents where available; TB screening (PPD or IGRA) is required before initiation when applicable.
NEXLETOL/NEXLIZET: statin ± ezetimibe trial or documented statin failures
NEXLETOL/NEXLIZET initial authorization requires either current statin use (unless contraindicated) plus ezetimibe, or prior failure/intolerance to at least two statins or one statin plus ezetimibe; at least one previously tried statin must be a hydrophilic statin.
Emgality prevention: fail Aimovig and document baseline headache days
Emgality for migraine prevention requires documented failure or intolerance to Aimovig before initial approval; prevention criteria include documentation of <15 headache days/month and reauthorization requires on‑treatment headache days showing improvement.
Camzyos: trial of beta‑blocker and non‑DHP CCB required
Camzyos initial authorization requires trial and inadequate response or intolerance to both a beta‑blocker and a non‑DHP calcium channel blocker prior to approval.
Document trials and failures of specified alternatives before approval
Many specialty products (e.g., dupilumab, FABHALTA/FILSPARI) require documented failure of specified first‑line or alternative therapies prior to approval; provide records showing prior therapies tried and reasons for failure or intolerance.
Oncology PAs: document required prior therapy trials/failures
Selected oncology agents require documentation of prior lines or specific prior therapies (e.g., ROS1 agents require prior crizotinib or entrectinib failure; others require endocrine or chemotherapy trials) before authorization.
l‑glutamine requires prior hydroxyurea trial/failure
For l‑glutamine in sickle cell disease, initial authorization requires prior use, failure, intolerance, or inadequate response to hydroxyurea.
LYBALVI: prior trials of generic olanzapine + another SGA required
LYBALVI initial authorization requires failure or intolerance to generic olanzapine (with documentation of benefit but unacceptable weight gain) and one other specified generic second‑generation antipsychotic before approval.
Mepolizumab (asthma): confirm maximal ICS+LABA+LAMA trial before biologic
For mepolizumab and similar biologics in asthma, initial authorization requires the patient be on a GINA‑recommended maximal ICS+LABA+LAMA regimen prior to biologic initiation; reauthorization requires confirmation the inhaler regimen continues.
Inbrija step: trial of ≥2 different classes required before approval
Inbrija initial authorization requires documented trials/failures or intolerance to at least two different classes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors) unless contraindicated.
Inbrija: provide documentation of prior class trials/failures
Inbrija step therapy requires prior failures of two classes that reduce off episodes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors) unless contraindicated; include documentation of those trials with the PA request.
Psychiatric/neurologic agents: document required prior trials/failures
Prior trials and failures of specified alternatives are required for certain psychiatric and neurologic agents (e.g., aripiprazole plus another SGA for antipsychotics) and must be documented in the PA request.
Teriparatide requires prior bisphosphonate trial/failure
Parathyroid hormone analogs (e.g., teriparatide) require prior trial and failure or intolerance to at least one bisphosphonate for initial authorization; therapeutic failure is defined by fracture or decreased BMD while on bisphosphonate for ≥3 months.
VEOZAH: fail ≥2 systemic/non‑hormonal therapies from different classes
VEOZAH initial authorization requires failure/intolerance to at least two prior systemic hormone or non‑hormonal therapies from different classes for vasomotor symptoms; submit eGFR and liver function testing as requested.
Tumor genetic testing and prior endocrine therapy required (e.g., TRUQAP)
For select targeted therapies (e.g., TRUQAP/alpelisib), tumor genetic testing confirming the target mutation and progression on at least one endocrine‑based regimen (and use with fulvestrant where specified) must be submitted with the PA.
Provide complete prior‑therapy histories when required
Many products (including Verquvo and others) require documentation of prior trials or failures of specified therapies; include exact prior therapy names, dates, and reasons for discontinuation in the PA submission.
ZILBRYSQ step: fail agents in 2 of 3 drug classes before approval
For ZILBRYSQ initial authorization, document failure or inadequate response to at least one drug in two of three classes (acetylcholinesterase inhibitors, corticosteroids, non‑steroidal immunosuppressives) before approval.
ZORYVE: prior topical corticosteroid + another topical agent required
For ZORYVE initial authorization for plaque psoriasis, document prior failure/intolerance to at least one high‑potency topical corticosteroid and one other prescription topical agent (or current systemic therapy) before approval.
XPOVIO: document prior therapy failures per indication (MM criteria)
For XPOVIO in multiple myeloma combinations, document failure of at least one prior therapy; for relapsed/refractory myeloma provide documentation of failure of ≥4 prior systemic therapy lines including required classes.
XURIDEN: baseline CBC/urine orotic acid and annual lab evidence for reauth
For XURIDEN PA, submit baseline CBC with neutrophil count and MCV and baseline urine orotic acid; annual reauthorization must document improvement or stabilization of those labs.
ZEJULA: document platinum response and BRCA testing as applicable
ZEJULA PA requires documentation of response to platinum‑based chemotherapy and, for germline BRCA‑mutated disease, submission of test confirming a deleterious BRCA mutation.
BYLVAY/cholestasis: submit molecular testing + objective cholestasis lab
For cholestasis‑targeted therapies (e.g., BYLVAY) include molecular genetic testing confirming diagnosis and one objective cholestasis marker (age‑adjusted elevated total serum bile acids, increased conjugated bilirubin, GGT > ULN, fat‑soluble vitamin deficiency, or intractable pruritus with drug‑induced causes ruled out).
PAH PA: submit right heart cath, hemodynamics, CrCl, pregnancy status
Diagnosis documentation for PAH drugs must include right heart catheterization results, WHO Group classification, mean pulmonary arterial pressure >20 mm Hg, pulmonary arterial wedge pressure ≤15 mm Hg, PVR >2 Woods units (for WHO Group 1), creatinine clearance (or data to calculate it), and pregnancy status; prescriber restricted to cardiology or pulmonology.
AYVAKIT: PDGFRA exon 18 (GIST) or platelet count (mastocytosis) required
AYVAKIT PA requests for GIST must include test confirming PDGFRA exon 18 mutation; for systemic mastocytosis include platelet count; submit pregnancy status for females of childbearing potential.
Submit Dupixent clinical measures (BSA, FEV1, eosinophils) with PA
For Dupixent, submit diagnosis, current/previous therapies, and indication‑specific objective data (e.g., ≥10% BSA for AD; pre‑bronchodilator FEV1 and blood eosinophils or OCS dependence for asthma) as part of the PA request.
Include objective disease‑specific documentation with PA
Always include objective disease‑specific documentation requested per product (e.g., biopsies for eosinophilic esophagitis, platelet counts for ITP, genetic/molecular testing for targeted oncology agents) when submitting a PA.
Provide EGFR mutation testing and pregnancy status when required
Where requested, submit EGFR tumor testing (exon 19 deletions or exon 21 L858R) and pregnancy status for females of childbearing potential for relevant EGFR‑targeted agents.
Submit LFTs/Child‑Pugh score for hepatically metabolized agents
Provide baseline liver function tests or Child‑Pugh score when requested for hepatically metabolized agents or agents with hepatic safety considerations.
JUXTAPID: submit baseline LFTs and lipid/genetic documentation
For JUXTAPID, submit baseline hepatic labs (ALT, AST, alkaline phosphatase, total bilirubin) and lipid panel (LDL‑C, TC, apoB, non‑HDL‑C) and documentation of genetic or functional LDL receptor abnormality as specified.
KISQALI: baseline LFTs, PT/INR and culture‑proven fungal infection required
For antifungal KISQALI use, submit baseline liver tests (ALT, AST, total bilirubin, alkaline phosphatase), PT/INR, and documentation of a culture‑proven systemic fungal infection.
KOMZIFTI: genetic tumor testing + QTcF and electrolytes required
KOMZIFTI authorization requires submission of genetic tumor testing confirming HR+/HER2‑ disease and recent QTcF and electrolyte measurements (serum potassium and magnesium) plus pregnancy status for females of childbearing potential.
LYNPARZA: genetic testing and prior therapy documentation required
For LYNPARZA and similar agents, submit diagnostic genetic testing (BRCA or homologous recombination repair genes) and documentation of prior therapies as applicable for the indication.
Attest surgery non‑option and provide disease‑specific attestations where required
Include diagnosis of covered use and attest when surgery is not an option or not curative where indicated (e.g., selected endocrine or metabolic indications) and document diabetes or glucose intolerance when requested.
Submit enzyme‑replacement exclusion rationale and CrCl when requested
Provide enzyme‑replacement exclusion documentation and creatinine clearance (or data to calculate it) when requested for applicable products.
Initial Therapy Criteria
Reauthorization and Continuation Requirements
Step Therapy and Prior Trial Requirements
| Requirement | Details |
|---|---|
| Required prior use of preferred comparators | |
| For initial authorization of most immunomodulatory/biologic agents (exceptions: Otezla and Velsipity), patient must have tried and failed or been intolerant to at least two preferred agents (examples: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR); baseline TB screening (PPD or IGRA) required prior to initiation where applicable. |
| Requirement | Details |
|---|---|
| Prior statin therapy or statin + ezetimibe required | |
| Initial authorization for NEXLETOL/NEXLIZET requires either (1) current statin use (unless contraindicated) plus ezetimibe, OR (2) prior trial and failure or intolerance to at least two statins OR one statin plus ezetimibe; at least one previously tried statin must be a hydrophilic statin. Annual reauthorization requires continued use of prior lipid-lowering therapies unless contraindicated. |
| Requirement | Details |
|---|---|
| Emgality reauthorization documentation | |
| For migraine prevention with Emgality, initial authorization for prevention requires failure or intolerance to Aimovig and documentation of fewer than 15 headache days per month; the first reauthorization requires submission of on-treatment headache days per month demonstrating improvement from baseline; maintenance reauthorizations require documented maintenance of clinical benefit. |
| Requirement | Details |
|---|---|
| Symptomatic improvement confirmation at reauthorization | |
| For products requiring reauthorization (example: Camzyos), each annual reauthorization must include confirmation of symptomatic or clinical improvement (or maintenance of a previously achieved improvement); documentation of the clinical benefit is required. |
| Requirement | Details |
|---|---|
| Documentation of prior therapies tried and failed required | |
| Initial authorization requests must submit current and prior therapies used to treat the condition; for many agents patients must have tried and failed or been intolerant to specified first-line or alternative therapies (examples: topical corticosteroids for AD, ACE inhibitor/ARB for IgAN, eculizumab/ravulizumab for PNH). |
| Requirement | Details |
|---|---|
| Step therapy example | |
| Some oncology-targeted agents require documented prior failure of specific therapies (example: ROS1-targeted agents require prior trial and failure or intolerance to crizotinib or entrectinib), which must be submitted with the authorization request. |
| Requirement | Details |
|---|---|
| Step therapy example | |
| Certain non-oncology agents require prior trials of indicated alternatives before initiation (example: some cardiometabolic agents require prior therapy such as Farxiga or Jardiance prior to approval where specified). Authorization requires documentation of those prior trials and outcomes. |
| Requirement | Details |
|---|---|
| Prior trial and failure or intolerance required | |
| Examples: for l‑glutamine in sickle cell disease, patient must be using, have tried and failed, had inadequate response to, or been intolerant/contraindicated to hydroxyurea prior to initial authorization; for LYBALVI initial authorization requires failure or intolerance to both generic olanzapine (with documentation of benefit but unacceptable weight gain) and one other generic second‑generation antipsychotic. |
| Requirement | Details |
|---|---|
| Step therapy required | |
| For biologic asthma therapies (example: mepolizumab), initial authorization requires failure or inadequate response to maximal inhaler therapy per GINA (ICS+LABA+LAMA) prior to biologic initiation; reauthorization requires confirmation patient remains on background inhaler therapy and documentation of clinical benefit or maintenance. |
| Requirement | Details |
|---|---|
| Step therapy required (Inbrija) | |
| Inbrija initial authorization requires trials and inadequate response or intolerance to medications from at least two different classes that reduce 'off' episodes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors) unless contraindicated; annual reauthorization requires confirmation of symptomatic or clinical improvement or maintenance of benefit. |
| Requirement | Details |
|---|---|
| Step therapy required (example) | |
| For certain targeted therapies (example: PIQRAY), initial authorization requires prior endocrine‑based regimen(s) tried and failed; submission of that prior therapy documentation is required for approval. |
| Requirement | Details |
|---|---|
| Step therapy required (example) | |
| Some oncology agents require failure of specific prior agents before approval (example: Nubeqa requires prior trial and failure of both Erleada and Xtandi for initial authorization). Documentation of prior therapies must be provided. |
| Requirement | Details |
|---|---|
| Prior trial(s) required before approval | |
| For many psychiatric and neurologic agents, initial authorization requires documented prior trials and failures of specified alternatives (examples: aripiprazole plus another SGA before some antipsychotics; trial of ponatinib before SCEMBLIX for T315I mutation). Prior therapy details and outcomes must be submitted. |
| Requirement | Details |
|---|---|
| Prior trial(s) required as specified per product | |
| Many products list product‑specific prerequisite therapy requirements (examples: parathyroid hormone analogs require prior bisphosphonate trial; PI3K inhibitors require progression on endocrine regimens). Requests must include documentation of those prior trials or contraindications/intolerances. |
| Requirement | Details |
|---|---|
| Prior trial(s) required before approval (examples) | |
| Examples include: vasomotor symptom agents (e.g., VEOZAH) require failure/intolerance to at least two prior systemic hormone or non‑hormonal therapies from different classes; XIFAXAN for hepatic encephalopathy requires prior trial/failure of lactulose; some oncology agents require multiple prior systemic therapy lines. Documentation of these prior therapies is required for initial authorization. |
| Requirement | Details |
|---|---|
| See individual drug nodes for exact step requirements | |
| Step therapy and prior‑trial requirements vary by product; reviewers must consult the individual drug-specific criteria (e.g., XPOVIO, ZILBRYSQ, ZORYVE) for exact required prior agents, number of trials, and reauthorization expectations and submit the supporting documentation as specified in each drug's Other Criteria section. |
Site of Care and Medicare Part B vs Part D Considerations
Describe administration and acquisition to determine Part B vs Part D
For products with Part B vs Part D ambiguity (e.g., cortrophin, certain injectables), include a description of how the drug will be used/obtained and administration site to determine coverage under Part B or Part D.
Home IVIG may be billed under Part B — include site‑of‑care details
Home IV administration: IVIG formulations administered in the home for primary immune deficiency may be covered under Part B; include site‑of‑care details when submitting PA to clarify Part B vs Part D applicability.
Provide site‑of‑care and acquisition details for coverage/billing determination
Coverage and billing depend on site of care: infusion center, office, or pharmacy — provide how medication will be obtained and administered to support correct Part B vs Part D coverage determinations.
Document administration/acquisition to determine Part B vs Part D
Whether a drug is covered under Medicare Part B versus Part D may depend on administration and acquisition (self‑administered after training or filled at pharmacy and delivered to office may be Part D); document these details.
Initiate hyponatremia tolvaptan where sodium can be closely monitored; 30‑day limit
Tolvaptan for hyponatremia must be initiated in a setting where serum sodium can be closely monitored (hospital outpatient) and is limited to a 30‑day course per the hyponatremia formulation criteria.
State pharmacy vs provider‑office dispensing to determine Part D vs Part B
Provide a clear statement of intended dispensing (pharmacy) or provider office administration to determine whether the product is covered under Part D or Part B; include who will acquire and administer the drug in PA documentation.
Definitions and Diagnostic Thresholds
Policy Background
Background: This policy compiles the prior authorization criteria for prescription products on Independent Health’s Medicare Advantage Part D formularies effective 2026‑01‑01. It defines required documentation, prescriber specialty limits, age restrictions, product‑specific exclusions, and coverage durations (commonly 1 year, with some initial authorizations shorter). The scope applies to providers and pharmacies submitting PA requests for affected Medicare members and lists the clinical thresholds and test results required to establish medical necessity.
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