Prior Authorization and Coverage Criteria for Part D Formulary Specialty Drugs
Customize your policy alerts
Sign up for all Independent Health policy alerts
Know when Independent Health releases new policies or updates existing guidance.
Monitor payer policy activity
Defines prior authorization requirements and clinical criteria for outpatient prescription specialty drugs on Independent Health Medicare Advantage Part D formularies, including documentation, prescriber restrictions, testing requirements, coverage durations, and reauthorization rules.
No material clinical or coverage changes in this revision.
Coverage Criteria (Product-Specific)
ACTIMMUNE — Covered when specific documentation is provided
Covered when specific documentation is provided
Prescriber and age per product labeling
PAH/CTEPH agents (e.g., Adempas) — Covered when ALL of the following are met
Covered when ALL of the following are met
Submit creatinine clearance (or data to calculate it) and pregnancy status for females of childbearing potential
Coverage duration 1 year
ALK-targeted agents (e.g., Alecensa, Alunbrig)
Submit pregnancy status for females of childbearing potential
Follow product labeling for other exclusions and interactions
ARIKAYCE (MAC lung disease)
Prescriber restricted to infectious disease or pulmonology; age ≥18; coverage duration 1 year
ATTRUBY (transthyretin amyloid cardiomyopathy)
Prescriber restricted to cardiology; patient ≥18 years; coverage duration 1 year
AUSTEDO (tardive dyskinesia / Huntington's chorea)
Prescriber restricted to neurology/psychiatry; age ≥18
Coverage duration 1 year
AUVELITY (depression)
Prescriber restricted to psychiatry; age ≥18
Coverage duration 1 year
AYVAKIT
Prescriber restricted to allergy/hematology/immunology/oncology; age ≥18
Coverage duration 1 year
BALVERSA (FGFR3-altered bladder cancer)
Prescriber restricted to oncology; age ≥18; coverage duration 1 year
NEXLETOL / NEXLIZET
Annual reauthorization requires continued use of prior lipid‑lowering therapies unless new contraindication; coverage duration 1 year
BENLYSTA (systemic lupus erythematosus)
Annual reauthorization requires continued use of some form of standard therapy unless contraindicated; coverage duration 1 year
BESREMI
Prescriber restricted to hematology/oncology; coverage duration varies with hydroxyurea use
Topical/systemic immunomodulators (class rule)
Coverage duration 1 year
BOSULIF (CML)
Coverage duration 1 year
BRAFTOVI + MEKTOVI (BRAF V600E/K melanoma and others)
Prescriber restricted to oncology; age ≥18; coverage duration 1 year
Butalbital-containing products (older patients)
Coverage duration 1 year
BYLVAY (cholestatic liver diseases)
Exclude decompensated cirrhosis; prescriber restricted to gastroenterology/hepatology; initial coverage 6 months then 1 year; reauthorization requires pruritus improvement and LFTs including bilirubin
CABLIVI – Initial and reauthorization criteria
CABLIVI: Covered when ALL of the following are met
Age ≥12 years; prescriber restricted to cardiology/hematology/immunology; coverage duration 3 months; not authorized if >2 recurrences while on therapy
CAPLACIZUMAB – Authorization
Caplacizumab (CABOMETYX entry): Covered when ALL of the following are met
Coverage duration 3 months; if not first use submit prior recurrence history; coverage not authorized if patient has had >2 recurrences while on therapy
CFTR modulators – Mutation-confirmed authorization
CFTR modulators (Kalydeco/Orkambi/Symdeko/Trikafta): Covered when ALL of the following are met
Coverage duration 1 year; coadministration with strong CYP3A inducers excluded; Trikafta excludes severe hepatic impairment
DOPTELET – Procedural and ITP criteria
DOPTELET: Covered when ALL of the following are met (separate logic for procedural vs ITP use)
Coverage duration 5 days; prescriber restricted to gastroenterology/hepatology/surgery
Initial coverage 2 months then 1 year; first reauthorization requires platelet ≥50 x10^9/L after ≥4 weeks on max tolerated dose; annual reauthorization requires maintenance of benefit
Dupixent – Indication-specific criteria
Dupixent: Covered when ALL of the following are met (criteria vary by indication)
Initial authorization 6 months then 1 year; provider must attest continuation of background therapy
Prescriber restrictions apply
Intranasal corticosteroid trial generally required prior to biologic
Prescriber restricted to allergy/gastroenterology/immunology/ENT
Prescriber restricted to dermatology/allergy/etc.
Initial Therapy (Dupilumab)
Dupilumab — Covered when ALL of the following are met:
Provider must attest continuation of background therapy where required
Reauthorization (Dupilumab)
Dupilumab — Reauthorization requirements:
Reauthorization intervals typically annually after initial period
Eltrombopag ITP
Eltrombopag — Covered when ALL of the following are met for ITP:
First reauthorization requires updated platelet count showing improvement; coverage durations per indication
EoE
Eohilia/EoE — Covered when ALL of the following are met:
Age restriction ≥11 years; coverage duration 12 weeks; maximum one 12‑week course every 365 days
Fabhalta PNH
Fabhalta (PNH, IgAN, C3G) — Initial authorization criteria:
Prescriber restricted to hematology; reauthorization requires confirmation of symptomatic/clinical improvement or maintenance
GLP-1 and related diabetes products
Covered when ALL of the following are met (example: GLP-1 agents listed)
Coverage duration 1 year; applies to Mounjaro, Ozempic, Rybelsus, Trulicity, etc.
Hereditary angioedema prophylaxis
Covered when ALL of the following are met (example: HAE prophylaxis agents)
Requests for acute HAE attack treatment are excluded
Oncology targeted therapies
Covered when ALL of the following are met (oncology-targeted agents)
Some agents additionally require prior systemic therapy failure or specified prior lines of therapy
Immune globulins
Covered when ALL of the following are met (immune globulin products)
IV formulations may be covered as Part B if administered in the home for primary immune deficiency; site of care may affect Part B vs Part D determination
JUXTAPID (lomitapide) coverage
Covered when ALL of the following are met (JUXTAPID)
Reauthorization requires LDL reduction from baseline and documented ongoing benefit
KERENDIA (finerenone) coverage
Covered when ALL of the following are met (KERENDIA)
Reauthorization requires documented maintenance or improvement
KOMZIFTI — Initial Authorization
Covered when ALL of the following are met
Coadministration cautions: congenital long QT syndrome, QTcF ≥450 msec, uncorrected hypokalemia/hypomagnesemia, strong CYP3A4 inducers or QT‑prolonging drugs are exclusionary
KRAZATI — Authorization
Covered when ALL of the following are met
Exclude congenital long QT syndrome or coadministration with strong CYP3A4 inducers or QT‑prolonging drugs
LYNPARZA — Authorization
Covered when ALL of the following are met
l-glutamine — Initial Authorization
Covered when ALL of the following are met
Submit prior therapy details
MAVYRET — Authorization
Covered when ALL of the following are met
No prerequisite therapy required
Initial therapy - eosinophil-targeted biologics
Covered when ALL of the following are met for mepolizumab and other eosinophil-targeted biologics:
Provider must attest continuation of background therapy (eg triple inhaler) where specified
Reauthorization criteria (eosinophil-targeted biologics)
Reauthorization requirements (annual):
Coverage typically renewed for 1 year
Prerequisite therapy
Step therapy / prerequisite therapy for select drugs:
Annual reauthorization requires confirmation of clinical improvement
Prescriber restricted to neurology/psychiatry/sleep medicine; age >=7 for sodium oxybate
Testing and organ function criteria
Genetic/mutation and organ function prerequisites for oncology and other specialty products:
If testing negative, documentation of intolerance/contraindication to alternatives may be required
Coadministration with certain CYP or P‑gp inhibitors/inducers may be exclusionary
Kaposi sarcoma related agents
Covered when the following requirements specific to the drug are met:
Coverage duration 1 year
Inbrija (levodopa inhalation) criteria
Covered when ALL of the following are met for Inbrija:
Coverage duration 1 year; annual reauthorization requires confirmation of symptomatic/clinical improvement or maintenance
PEMAZYRE criteria
Covered when ALL of the following are met for PEMAZYRE:
Coverage duration 1 year
REPATHA coverage criteria
Covered when criteria for the specific indication are satisfied:
Indication‑specific documentation required
Coverage duration 1 year
RECORLEV criteria
Covered when ALL of the following are met for RECORLEV:
Coverage duration 1 year; exclusion: severe hepatic impairment (Child‑Pugh C) and certain QT‑related conditions; reauthorization requires clinically relevant response or maintenance
REVUFORJ initial therapy
Covered when ALL of the following are met:
QT/electrolyte monitoring required; exclusions apply
RIVFLOZA initial therapy
Covered when ALL of the following are met:
First reauthorization requires evidence of response (reduced Uox or plasma oxalate)
Atypical antipsychotics criteria
Covered when ALL of the following are met for certain psychiatric indications:
Step therapy requirements apply
Sedative-hypnotics (older adults)
Covered when ALL of the following are met for sedative-hypnotic approvals in older adults:
PA applies only to patients 65 and older; coverage duration 1 year
BPH product — initial authorization
Covered when ALL of the following are met for the listed BPH product(s):
Annual reauthorization requires confirmation of symptomatic/clinical improvement; erectile dysfunction indication excluded
ATTR cardiomyopathy — initial authorization
Covered when ALL of the following are met for transthyretin amyloid cardiomyopathy products:
No prerequisite therapy required
Oncology molecularly-targeted agents — initial authorization
Covered when ALL of the following are met for oncology-targeted therapies requiring mutation testing:
Some products additionally require prior therapy (eg prior endocrine regimen, prior chemotherapy) as specified per product
Parathyroid hormone analogs — initial and continuation
Covered when ALL of the following are met for parathyroid hormone analogs (osteoporosis):
Annual reauthorization beyond 2 years requires updated serum calcium and evidence patient remains high risk
Tolvaptan — ADPKD and hyponatremia formulations
Covered when ALL of the following are met for tolvaptan formulations:
Certain tolvaptan formulations (hyponatremia formulation) are limited and NOT approved for ADPKD
This formulation will not be approved for ADPKD
Vanrafia — IgA nephropathy
Covered when ALL of the following are met for VANRAFIA (IgA nephropathy):
Submit liver function testing/Child‑Pugh if indicated
Verquvo — HFrEF
Covered when ALL of the following are met for verquvo (sGC stimulator):
Coverage duration 1 year; annual reauthorization requires demonstration of clinical benefit or maintenance
Initial Therapy — Vasomotor symptoms product
Covered when ALL of the following are met for the vasomotor symptoms product:
Drugs tried must be from different medication classes
Initial Therapy — PIK3CA-targeted product
Covered when ALL of the following are met for the PIK3CA-targeted product:
Initial Therapy — IgA nephropathy
Covered when ALL of the following are met for IgA nephropathy (VOYXACT):
Biopsy confirmation required
XIFAXAN coverage criteria
Covered when ALL of the following are met for Xifaxan (rifaximin) 550 mg:
Prescriber restricted to gastroenterology/hepatology
Documentation of prior therapies required
Submit dates of prior rifaximin courses and breath test results
Wegovy (non-weight-management) coverage
Covered when ALL of the following are met for Wegovy indications included here (non-weight-management uses such as MACE or MASH):
Weight management use excluded under Medicare Part D
Coverage not approved for weight management under Part D
XOLAIR coverage criteria
Covered when ALL of the following are met for omalizumab (Xolair):
Initial coverage 6 months then 1 year; reauthorization requires documented clinical benefit or maintenance
Initial and Reauthorization Criteria (selected examples)
Reauthorization and initial authorization requirements summarized for listed indications
Applies to asthma biologics including omalizumab
Provider Actions, Documentation & Prior Authorization
General prior authorization required
Prior authorization is required for drugs on the formularies marked 'PA'; approval must be obtained before dispensing or the drug may not be covered.
AUSTEDO — tetrabenazine trial required
For AUSTEDO (including AUSTEDO XR) initial authorization for Huntington's chorea requires that the patient tried and failed, or was intolerant to, tetrabenazine; prescriber specialty and exclusion criteria must also be satisfied.
- Exclusion examples: congenital long QT syndrome, history of arrhythmia with prolonged QT, MAOI coadministration, active suicidal or untreated depression, hepatic impairment.
- Coverage duration: 1 year; prescriber restrictions: neurology or psychiatry.
CABLIVI — PA and reauthorization documentation
CABLIVI initial authorization is limited (initial 6 months then 1 year) and requires documented cholestasis, prior trials (cholestyramine, naltrexone, rifampin, or ursodiol), prescriber restricted to gastroenterology/hepatology, and reauthorization requires pruritus improvement and updated liver function testing.
- Initial authorization requires failure/intolerance to at least two of: cholestyramine, naltrexone, rifampin, ursodiol.
- First reauthorization: attestation of pruritus improvement and submission of liver function tests including bilirubin.
Caplacizumab — PA, prescriber and recurrence limits
Caplacizumab prior authorization: age ≥12, prescriber restricted to cardiology/hematology/immunology, confirmation it will be given with plasma exchange and immunosuppression, coverage duration 3 months; if request is not first use, submit prior aTTP recurrence history (coverage not authorized if >2 recurrences while on therapy).
- If not first use, coverage denied when >2 recurrences of aTTP while on caplacizumab.
CFTR modulators — mutation test required
For CFTR modulators (Kalydeco, Orkambi, Symdeko, Trikafta) prior authorization requires submission of a CFTR mutation test confirming the drug-specific responsive mutation(s); prescriber restricted to pulmonology and coverage is for 1 year.
- Trikafta: at least one mutation predicted to be responsive based on prescribing information or in vitro data.
- Orkambi and Symdeko: F508del mutation requirements as specified.
PA — age/prescriber confirmation and 1-year duration
Certain products require prior authorization with age and prescriber consistency and commonly have a 1‑year coverage duration; submit diagnosis and required supporting information per product.
- Examples: many specialty drugs in this document require PA and annual coverage duration unless otherwise specified.
Dupilumab — PA, prerequisite therapy and reauthorization
Dupilumab initial authorization is initially approved for 6 months then 1 year; providers must document and submit indication‑specific prior therapies (e.g., topical corticosteroid for AD; guideline-based triple inhaler for asthma; intranasal corticosteroid for CRSwNP) and attest continuation of required background therapy.
- Reauthorization requires documentation of clinical benefit or maintenance of prior benefit; asthma/COPD reauthorization requires confirmation patient remains on triple inhaler therapy where specified.
GAVRETO — RET testing and oncology prescriber required
GAVRETO prior authorization requires submission of RET gene fusion/mutation testing, prescriber restricted to oncology, age ≥12, and coverage duration 1 year.
PA — diagnosis confirmation and product-specific prerequisites
Prior authorization is required with diagnosis confirmation and product‑specific age/prescriber consistency; coverage durations are typically 1 year unless otherwise specified.
KERENDIA — prior SGLT2 trial required and baseline labs
KERENDIA initial authorization requires prior trial/failure or intolerance to an SGLT2 inhibitor (Farxiga or Jardiance); submit eGFR and baseline serum potassium as required.
- Exclusions include adrenal insufficiency, eGFR <25 mL/min/1.73 m2, baseline serum potassium >5.0 mEq/L, severe hepatic impairment, or interacting drugs.
PA with 6‑month initial coverage — baseline labs required
Certain products require PA with an initial coverage period of 6 months (then extension as specified); submit required medical information and baseline labs for the request.
- Example: items listed with 6‑month initial duration in the document require baseline lab submission as part of PA.
Oncology PA — QTcF, electrolytes, mutation testing
Some oncology drugs are restricted to oncology prescribers and require baseline QTcF and electrolytes (within the prior 6 months), tumor genetic testing as applicable, and have a 1‑year coverage duration.
- Provider must submit QTcF interval, serum potassium and magnesium when specified.
PA — mutation testing and indication attestations
Prior authorization for select agents requires submission of mutation testing (BRCA, HRR, etc.) and indication‑specific attestations (for example, response to platinum chemotherapy for some ovarian indications); coverage is typically 1 year.
PA — required diagnostic/lab data and prescriber specialty
Prior authorization generally requires submission of diagnosis, specified laboratory tests or scores (e.g., Child‑Pugh), prescriber specialty restriction where applicable, and pregnancy status for females of childbearing potential.
- Providers should include required baseline labs and specialty attestations specified per product.
Inbrija — off‑episode attestation and prior trials required
Inbrija prior authorization requires attestation that the patient experiences 'off' episodes despite carbidopa/levodopa and prior trials/failures of at least two different medication classes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors) unless contraindicated; annual reauthorization requires confirmation of symptomatic or clinical improvement.
- Exclusions include recent non‑selective MAOI use within 14 days, asthma, COPD, or other chronic lung disease.
REPATHA — statin trial/intolerance and LDL threshold
REPATHA prior authorization for certain indications requires documentation the patient failed to achieve LDL <70 mg/dL despite ≥8 weeks of high‑intensity statin therapy (or meets statin‑intolerance criteria); coverage duration 1 year.
- Prescriber restriction: cardiology/endocrinology or lipid specialists.
REVUFORJ — diagnostic tests, baseline labs and exclusions
REVUFORJ prior authorization requires submission of diagnostic testing confirming the KMT2A translocation (not 11q23 PTD) or absence of susceptible NPM1 mutation, baseline QTcF, serum potassium and magnesium, baseline WBC, pregnancy status; prescriber restricted to hematology/oncology and coverage duration 1 year.
- Exclusions include QTcF >450 msec, WBC >25 x10^9/L, uncorrected hypokalemia or hypomagnesemia, and coadministration with moderate/strong CYP3A4 inducers.
Atypical antipsychotics — psychiatry prescriber and step therapy
Atypical antipsychotics (e.g., Caplyta, Rexulti) require prior authorization with prescriber restricted to psychiatry, coverage duration 1 year, and specific step‑therapy requirements per Other Criteria.
- Required documentation: current/previous therapies and trials/failures per indication.
SUNOSI — prior stimulant trial and specialty prescriber
SUNOSI prior authorization requires prescriber be a neurologist or sleep medicine specialist; patient must have tried and failed armodafinil or modafinil for initial approval; coverage duration 1 year.
Urology‑restricted product — urologist prescriber and renal data
Prior authorization for the listed urology‑restricted product requires the prescriber be a urologist and patient be ≥18 years; submit creatinine clearance (or data to calculate it) as part of the PA.
Cardiology‑restricted product — cardiologist prescriber and ATTR diagnostics
PA for cardiology‑restricted products (e.g., transthyretin amyloid cardiomyopathy agents) requires prescriber be a cardiologist and patient be ≥18; submit diagnostic confirmation and coverage duration is typically 1 year.
- For ATTR cardiomyopathy provide cardiac biopsy, immunohistochemistry, technetium‑99 SPECT/scintigraphy, or TTR genetic mutation plus cardiac involvement.
VERQUVO — HFrEF event, optimized therapy and cardiology prescriber required
VERQUVO (oral tablets 10, 2.5, 5 mg) prior authorization: initial approval requires qualifying recent HFrEF event and optimized guideline‑directed therapy trials; prescriber restricted to cardiology and coverage duration 1 year.
- Submit hospitalization for HFrEF within 6 months or outpatient IV diuretic use within 3 months, LVEF <45%, and current/previous HFrEF therapies.
HFrEF product — optimized therapy and documentation required
HFrEF product prior authorization requires cardiology prescriber, patient ≥18, qualifying recent hospitalization or IV diuretic use and LVEF <45%; must be on optimized triple therapy (ACEi/ARB/sacubitril‑valsartan, beta‑blocker, MRA) or provide rationale for non‑use; coverage duration 1 year.
Verzenio — tumor testing and CYP interaction exclusions
Verzenio prior authorization requires submission of tumor genetic testing confirming HR‑positive, HER2‑negative disease; exclusions include coadministration with moderate/strong CYP3A4 inducers or ketoconazole.
PIK3CA product — imaging, mutation test and specialist attestation
PIK3CA‑targeted product prior authorization requires imaging demonstrating at least one target lesion, mutation testing confirming PIK3CA, provider attestation of severe or life‑threatening disease, specialist prescriber, and initial duration 6 months then 1 year with reauthorization requiring objective benefit documentation.
Vitrakvi — NTRK fusion evidence and oncology prescriber
Vitrakvi (TRK fusion product) PA requires evidence of an NTRK gene fusion without known acquired resistance mutation, attestation tumor is metastatic or unresectable and other systemic therapies are unsatisfactory, prescriber restricted to oncology, coverage 1 year.
Voydeya — extravascular hemolysis criteria and hematology prescriber
Voydeya initial authorization requires evidence of clinically significant extravascular hemolysis (Hgb ≤9.5 g/dL and absolute retic ≥120 x10^9/L) after use of a complement C5 inhibitor and concomitant use of eculizumab or ravulizumab; prescriber restricted to hematology; initial 6 months then 1 year.
VOYXACT — biopsy, proteinuria and prior therapy required
VOYXACT (IgAN product) PA requires biopsy‑confirmed primary IgA nephropathy, 24‑hour urine protein ≥0.5 g/day or UPCR ≥0.8 g/g, and prior failure/intolerance to both a maximally tolerated ACE inhibitor or ARB and atrasentan or sparsentan; prescribers restricted to immunology/nephrology and coverage 1 year.
Wegovy — exclusions for weight management; MACE/MASH documentation required
Wegovy PA: weight‑management use is excluded under Medicare Part D; for MACE indication require documentation of established cardiovascular disease and BMI ≥25 kg/m2, prescribers limited to cardiology/gastroenterology/hepatology/primary care; initial 32‑week induction then 1 year maintenance; for MASH require F2–F3 fibrosis confirmation and baseline/serial liver testing.
- Provider attestations required (e.g., not using semaglutide for diabetes; not on another GLP‑1).
WINREVAIR — right heart cath data and regimen documentation
WINREVAIR (PAH product) PA requires right heart catheterization results (mPAP >20 mm Hg, PAWP ≤15 mm Hg, PVR >2 WU), WHO Group 1 attestation, NYHA/WHO functional class II–IV, baseline platelet count, prescriber restricted to cardiology/pulmonology; initial 6 months then 1 year.
- Regimen must include at minimum a nitric oxide pathway mediator and an endothelin receptor antagonist or documentation why not tolerated/used.
XIFAXAN — indication‑specific prior therapy and course limits
Xifaxan PA: for hepatic encephalopathy (HE) prior lactulose trial failure/intolerance is required (coverage for HE: 1 year); IBS‑D requires failure of at least two medication classes; SIBO requires positive carbohydrate breath test and prior antibiotic trials; course limits apply (IBS‑D max three 14‑day courses lifetime; SIBO max two 14‑day courses per 365 days).
- Documentation must include prior therapy dates and testing results as specified.
XOLAIR — prerequisite background therapy, testing and reauthorization
Omalizumab (Xolair) PA for asthma requires patient be on a GINA‑recommended regimen (ICS + LABA + LAMA) at maximally tolerated doses with provider attestation it will be continued; CRSwNP and CSU require specified prior therapies/trial durations; reauthorization requires documented clinical benefit or maintenance of benefit; initial 6 months then 1 year.
- Pre‑treatment testing (e.g., serum IgE, allergen testing, pre‑bronchodilator FEV1) is required per indication.
PA — document prior therapies and attestations
PA requests must include documented prior therapies and indication‑specific attestations (e.g., continued background therapy, trial durations) as required by each product's Other Criteria; failure to document these prerequisites may result in denial.
- Provider should submit specific prior therapy details, reasons for failure/intolerance, and diagnostic confirmation testing when required.
Preferred‑agent step requirement — two preferred agent failures
For many biologic and immunomodulatory agents, initial authorization generally requires failure of at least two preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz) where feasible.
Product Codes and Key Clinical Values
| 50-75 & 150 MG, 50-25-37.5 & 75 MG | Strengths listed for TRIKAFTA ORAL THERAPY PACK (dosage/packaging identifiers) |
| DUPIXENT SUBCUTANEOUS SOLUTION AUTO-INJECTOR | Product listed |
| DUPIXENT SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 200 MG/1.14ML, 300 MG/2ML | Product listed |
| MOUNJARO SUBCUTANEOUS SOLUTION AUTO-INJECTOR 10 MG/0.5ML, 12.5 MG/0.5ML, 15 MG/0.5ML, 2.5 MG/0.5ML, 5 MG/0.5ML, 7.5 MG/0.5ML | Product listed |
| OZEMPIC SUBCUTANEOUS SOLUTION PEN-INJECTOR (various strengths) | Product listed |
| KISQALI (200 MG DOSE) | Product listed in PA table |
| KISQALI (400 MG DOSE) | Product listed in PA table |
| KISQALI (600 MG DOSE) | Product listed in PA table |
| LYNPARZA ORAL TABLET | Olaparib product listed |
| miglustat | listed product name |
| yargesa | listed product name |
| MODEYSO | listed product name |
| MYTESI | listed product name |
| NUCALA SUBCUTANEOUS SOLUTION AUTOINJECTOR | product presentation |
| NUCALA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 100 MG/ML | product presentation |
| NUCALA SUBCUTANEOUS SOLUTION RECONSTITUTED | product presentation |
| NUPLAZID ORAL CAPSULE | product name |
| NUPLAZID ORAL TABLET 10 MG | product presentation |
| OGSIVEO ORAL TABLET 100 MG, 150 MG, 50 MG | product presentations |
| INBRIJA | product name |
| apomorphine hcl subcutaneous | product name |
| REVUFORJ ORAL TABLET 110 MG, 160 MG, 25 MG | Product listing as affected medication |
| CAPLYTA ORAL CAPSULE 10.5 MG, 21 MG, 42 MG | Product listing |
| REXULTI ORAL TABLET 0.25 MG - 4 MG | Product listing |
| N/A | This extract lists product names rather than procedure or diagnosis codes; no explicit CPT/HCPCS/ICD-10 codes present in these chunks. |
Initial Therapy Criteria
Continuation and Reauthorization Criteria
Step Therapy and Prior Trials
| Requirement | Details |
|---|---|
| Preferred-agent step requirement | |
| Initial authorization for many biologic/immunomodulatory drugs requires trial/failure or intolerance to at least two preferred agents (examples: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/Xeljanz XR) where possible. |
| Requirement | Details |
|---|---|
| AUSTEDO prerequisite | |
| For treatment of chorea associated with Huntington's disease, initial authorization requires the patient tried and failed to have an adequate response to, or had intolerance/contraindication to, tetrabenazine. |
| Requirement | Details |
|---|---|
| AUVELITY step therapy | |
| For initial authorization the patient must have tried and failed to have an adequate response to or had intolerance to two generic on‑formulary antidepressants (e.g., bupropion, SSRI, SNRI). |
| Product comparison | Step requirement |
|---|---|
| Emgality (migraine prevention) | |
| Initial authorization requires prior trial and inadequate response or intolerance to Aimovig before Emgality. |
| Requirement | Details |
|---|---|
| CAMZYOS step requirement | |
| Initial authorization requires trial and inadequate response or intolerance/contraindication to both a beta‑blocker and a non‑dihydropyridine calcium channel blocker. |
| Context | Prior therapy required |
|---|---|
| Fabhalta — PNH | |
| For PNH: must have tried and failed or had intolerance/contraindication to eculizumab or ravulizumab (failure defined as hemoglobin <10 g/dL after 6 months on stable dose) prior to authorization. |
| Requirement | Details |
|---|---|
| INREBIC step therapy | |
| For initial authorization, the patient must have tried and failed to have an adequate response to or had intolerance/contraindication to ruxolitinib prior to INREBIC. |
| Requirement | Details |
|---|---|
| SGLT2 inhibitor prerequisite | |
| KERENDIA initial authorization requires the patient tried and failed to have an adequate response to or had intolerance/contraindication to an SGLT2 inhibitor (Farxiga or Jardiance). |
| Requirement | Details |
|---|---|
| PCSK9 inhibitor prerequisite | |
| For initial authorization of JUXTAPID in patients ≥10 years, the patient must have tried and failed to have an adequate response to or had intolerance/contraindication to evolocumab (a PCSK9 inhibitor). |
| Scope | Note |
|---|---|
| Step therapy applicability | |
| Yes — step therapy or prerequisite trials are required when specified for a given product; product‑specific Other Criteria detail which prior agents must be tried/failed. |
| Documentation requirement | Details |
|---|---|
| Prior trial documentation | |
| Prior trials as specified in the product's Other Criteria must be documented (drug names, dates, duration, reason for discontinuation — failure or intolerance) when submitting a PA request. |
| Requirement | Details |
|---|---|
| Inbrija prerequisite | |
| Initial Inbrija authorization requires attestation patient experiences 'off' episodes despite carbidopa/levodopa and prior trials/failures or intolerance to medications from at least two different classes (COMT inhibitors, dopamine agonists, MAO‑B inhibitors), unless contraindicated. |
| Requirement | Details |
|---|---|
| PIQRAY prerequisite therapy | |
| For PIQRAY, patient must have tried and failed at least one endocrine‑based regimen prior to initiation; genetic tumor testing confirming HR‑positive, HER2‑negative, and PIK3CA mutation must be submitted. |
| Requirement | Details |
|---|---|
| Required prior trials | |
| Certain agents require specified prior trials before approval — e.g., antipsychotic entries require failure/intolerance to specified generic atypical antipsychotics as detailed in Other Criteria. |
| Patient group | Step requirement |
|---|---|
| Older adults (≥65) — sedative‑hypnotics | |
| PA for sedative‑hypnotics applies only to patients age 65 or older and requires documentation that at least two alternatives (Belsomra, doxepin, ramelteon, trazodone) were tried and ineffective or intolerable. |
| Requirement | Details |
|---|---|
| Prior trial(s) required | |
| Some products require prior trials of specified agents or classes before approval (examples: parathyroid hormone analogs require prior bisphosphonate failure; vasomotor symptoms agents require failure/intolerance to at least two prior systemic hormone or non‑hormonal therapies from different classes). |
| Documentation | Details |
|---|---|
| Document prior therapies and testing | |
| PA requests must document prior therapies, reasons for failure or intolerance, and any required diagnostic confirmation testing (e.g., biopsy, genetic testing, 24‑hour urine protein, breath test) as specified in the product's criteria. |
| Requirement | Details |
|---|---|
| Product‑specific prior therapy documentation | |
| Document prior therapies and failures per the product‑specific Other Criteria sections (for example, ZILBRYSQ requires failure of drugs in at least two of three classes; ZORYVE requires prior topical/systemic agents for plaque psoriasis). |
Site of Care and Medicare Part B vs Part D Considerations
Include Site‑of‑Care / Administration Details to Determine Part B vs Part D
For PA submissions that could affect Part B vs Part D billing, include how the drug will be used/obtained and whether it will be self‑administered after training or supplied to the office by the patient, as coverage determination may depend on site‑of‑care.
Exclusions, Contraindications & Denial Triggers
Background
This document lists the clinical and administrative information required to support prior authorization (PA) requests for specialty and other Part D outpatient prescription drugs on Independent Health Medicare Advantage formularies. It explains that prior authorization is required for drugs designated with 'PA' on the formularies and that lack of PA may result in noncoverage, so providers must obtain approval before a prescription is filled (see contact information and formulary applicability).
The policy defines the typical components of PA submissions: a confirmed diagnosis, required objective testing (for example, genetic or tumor testing, hemodynamic data, biopsy or histology, 24‑hour urine or blood biomarkers), baseline safety labs and physiologic measures (e.g., LFTs, electrolytes, creatinine clearance, QTc/QTcF), documentation of prior or concomitant therapies and reasons for failure or intolerance, prescriber specialty consistency, and patient age/ pregnancy status when applicable. Many drug entries also include specific exclusions (for example, pregnancy, moderate/severe hepatic impairment, or contraindicated drug interactions) and explicit coverage durations (commonly 1 year, with some initial shorter durations such as 6 months for selected products).
Providers should follow the product‑specific criteria in this document when preparing PA requests — including the exact diagnostic confirmations, threshold values, prior‑therapy trials, and specialist prescriber requirements — because approvals are granted only when the documented evidence meets the stated criteria.
Definitions and Clinical Thresholds
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.