2026 Medicare Part D Prior Authorization Requirements — Part D formulary coverage criteria
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Lists prior authorization requirements, criteria, and coverage details for multiple prescription drugs on the HealthPartners 2026 Medicare Part D formulary; applies to Part D benefits and prescribers/providers submitting PA requests.
No material clinical or coverage changes in this revision.
Coverage Criteria (Per-Drug Entries)
Dalfampridine — Initial therapy criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for dalfampridine (e.g., improvement of walking in multiple sclerosis)
- Patient is currently able to walk 25 feet
- Physician attestation that the patient has difficulty walking
Deferasirox — Initial therapy criteria
Covered when ALL of the following are met:
ANY of the following
- Diagnosis of chronic iron overload due to a non‑transfusion dependent thalassemia syndrome with BOTH: (a) liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight, and (b) serum ferritin > 300 mcg/L
- OR diagnosis of chronic iron overload due to blood transfusions with BOTH: (a) ongoing regular blood transfusions for conditions such as thalassemia syndromes, MDS, chronic anemia, or sickle cell disease, and (b) serum ferritin > 1,000 mcg/L prior to starting therapy
Enbrel — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for Enbrel (etanercept)
- For rheumatoid arthritis: moderate–severe disease with medical contraindication or inadequate response to methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine for at least 3 months
- For juvenile idiopathic arthritis: medical contraindication or inadequate response to one NSAID or methotrexate for 1 month (as applicable)
- For plaque psoriasis: ≥3% BSA or involvement of palms/soles/face/scalp/genital regions or pustular psoriasis with inadequate response to topical corticosteroids for 4 weeks or systemic therapies as appropriate
- Patient does not have an FDA‑labeled limitation of use or contraindication to therapy
Glutamine — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for oral glutamine
- Documentation supporting the intended use (e.g., management of chemotherapy‑induced mucositis as per labeled/compendia guidance)
Epidiolex — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for cannabidiol (Epidiolex)
- Documentation of the specific seizure disorder (e.g., Lennox‑Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex) with prior trials of appropriate standard therapies or contraindication/intolerance to them
Teriparatide — Initial and renewal criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of osteoporosis in a patient at high risk for fracture (or other FDA‑approved indication for teriparatide)
- Documentation of prior fracture or failure/intolerance to conventional osteoporosis therapies (e.g., bisphosphonates) unless contraindicated
Immunoglobulin products — Initial coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for the immunoglobulin product (e.g., primary immunodeficiency, CIDP maintenance, MMN, ITP as specified per product)
- Confirmatory diagnostic testing or documentation supporting the indication (e.g., immunoglobulin deficiency testing for primary immunodeficiency; electrophysiologic and clinical confirmation for CIDP/MMN)
- Patient does not have an FDA‑labeled limitation of use or contraindication to therapy
GATTEX — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of short bowel syndrome with intestinal failure requiring parenteral support, with documentation of malabsorption and need for intestinal rehabilitation (GATTEX [teduglutide] indication)
- Documentation that patient is being managed in an appropriate multidisciplinary program and goals for reducing parenteral support are established
GLP‑1 receptor agonists — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for a GLP‑1 receptor agonist (e.g., type 2 diabetes; other FDA‑approved uses)
- Documentation confirming diagnosis of type 2 diabetes (ICD‑10 code, medical records, chart notes, A1C or lab results) when used for diabetes
Hadlima — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis consistent with an FDA‑approved indication for Hadlima (adalimumab) or biosimilar
- Documentation of prior therapy or contraindication per indication and any relevant step‑therapy (as required)
Ibrutinib (Imbruvica) — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for ibrutinib (Imbruvica/Imbruvica tablets) such as CLL/SLL, mantle cell lymphoma, WM, cGVHD after failure of at least one systemic therapy, consistent with product labeling
- For tablet formulations (140 mg, 280 mg) provide rationale if unable to use preferred capsules/tablets or listed preferred strengths/forms
Ibrance — Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for palbociclib (Ibrance) or other indicated agent
- Documentation supporting indication (e.g., HR+/HER2‑ advanced/metastatic breast cancer) and use in accordance with labeled/compendia guidance
Diabetes supplies — Part D coverage condition
Part D coverage condition: covered when ALL of the following are met:
ALL of the following
- Supplies are for use by a patient enrolled in the Part D plan and consistent with a covered outpatient medication under Part D (e.g., insulin administration supplies when insulin is covered under Part D)
- Documentation supports that the supplies are necessary for administration or monitoring of a Part D‑covered drug (e.g., syringes, sharps disposal, glucose test strips when Part D covers the associated medication under plan rules)
Kerendia — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for Kerendia (finerenone), such as chronic kidney disease associated with type 2 diabetes per labeling
- Documentation of baseline eGFR and albuminuria consistent with labeled indication and that patient is on optimized renin‑angiotensin system therapy as appropriate
Kesimpta — Initial
Covered when ALL of the following are met:
ALL of the following
- Diagnosis consistent with an FDA‑approved indication for Kesimpta (ofatumumab) and documentation of prior therapies or contraindications per disease‑specific requirements
Kineret — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for anakinra (Kineret) such as rheumatoid arthritis or other labeled inflammatory disorders
- Documentation of prior therapies and medical necessity where applicable
Kisqali / Femara — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication requiring combination endocrine therapy such as HR+ advanced/metastatic breast cancer where ribociclib (Kisqali) and letrozole (Femara) use is indicated
- Documentation supporting indication and prior/concurrent therapies per guideline or compendia recommendations
Lidocaine patch & Linezolid — Initial and renewal
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and intended use consistent with labeled indications for lidocaine patch or linezolid
- Documentation of prior therapies, medical necessity, and appropriate monitoring (e.g., for linezolid: duration limits, drug interaction review) as clinically indicated
LIVTENCITY — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for Livtencity (maribavir) such as treatment of post‑transplant CMV infection that is refractory to or resistant to available antivirals
- Documentation of CMV viremia and prior antiviral therapy/resistance testing as appropriate per labeling
MAVYRET — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of chronic hepatitis C infection for which MAVYRET (glecaprevir/pibrentasvir) is indicated per labeling
- Documentation of genotype and prior treatment history per labeling/compendia and absence of contraindications
LYNPARZA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for olaparib (LYNPARZA) such as BRCA‑mutated ovarian or breast cancer per labeling
- Documentation of genetic testing results when indicated and prior therapy history consistent with labeled use
Nitazoxanide — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of nitazoxanide‑responsive condition per FDA or compendia (e.g., cryptosporidiosis in certain populations) and documentation supporting need
Nitisinone — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for nitisinone and supporting confirmatory testing (e.g., hereditary tyrosinemia type 1) per labeling
Otezla — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of psoriasis or psoriatic arthritis where apremilast (Otezla) is indicated, or other FDA‑approved indication
- Documentation of prior topical and/or systemic therapy trials or contraindications per indication
Pirfenidone — Initial therapy for IPF
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of idiopathic pulmonary fibrosis (IPF) where pirfenidone is indicated
- Documentation of pulmonary function testing and prior therapies as appropriate
Repatha — Hyperlipidemia (HeFH/ASCVD/HoFH)
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of hyperlipidemia consistent with FDA‑labeled indications for Repatha (evolocumab) such as HeFH, clinical ASCVD requiring additional LDL lowering, or HoFH
- Documentation of baseline lipid values and prior trial of maximally tolerated statin therapy (and ezetimibe when appropriate) unless contraindicated
Rezdiffra — Initial and renewal therapy
Initial therapy criteria (covered when ALL are met):
ALL of the following
- Diagnosis of nonalcoholic steatohepatitis (NASH)/MASH with moderate–advanced fibrosis when Rezdiffra (investigational/approved as per labeling) is indicated per labeling or compendia
- Documentation of fibrosis stage and other baseline evaluations supporting therapy selection
Signifor (Cushing's disease) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of Cushing disease where pasireotide (Signifor) is indicated per labeling
- Documentation of biochemical and clinical findings supporting need for therapy and prior surgical/other therapy status per guidelines
Sildenafil (PAH) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of pulmonary arterial hypertension (WHO Group 1) where sildenafil is indicated per labeling, with right heart catheterization confirmation when required
- Documentation that patient does not have contraindications and is managed by a cardiologist or pulmonologist
Sirturo (MDR‑TB) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of multidrug‑resistant tuberculosis (MDR‑TB) for which bedaquiline (Sirturo) is indicated per guidelines
- Documentation of prior TB treatment history, drug susceptibility testing, and specialist (infectious disease/pulmonology) management
Rubraca — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for rucaparib (Rubraca) and supporting genetic testing where indicated
- Documentation of prior therapies per labeling/compendia
NORDITROPIN — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and documentation supporting growth hormone use per FDA‑approved indications for Norditropin (e.g., growth hormone deficiency)
NORDITROPIN — Renewal
Covered when ALL of the following are met:
ALL of the following
- For renewal of NORDITROPIN: documentation of continued clinical benefit, growth velocity or other appropriate markers, and specialist follow‑up
SOMAVERT — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of acromegaly where pegvisomant (Somavert) is indicated per labeling
- Documentation of prior therapies, IGF‑1 levels, and specialist management
STELARA — Initial therapy and step therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for ustekinumab (Stelara) and documentation of prior therapies or contraindications per step‑therapy requirements
- For initial therapy, failure or intolerance to preferred agents as specified in disease‑specific criteria (step therapy) must be documented
TRIKAFTA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of cystic fibrosis with at least one F508del mutation or other mutation responsive to elexacaftor/tezacaftor/ivacaftor (Trikafta) per labeling
- Documentation of genetic testing confirming mutation(s) and prior therapy history as appropriate
TRIKAFTA — Renewal
Renewal criteria (covered when ALL are met):
ALL of the following
- For Trikafta renewal: documentation that patient has been seen by prescriber within the past 12 months and that medication has demonstrated efficacy (e.g., stabilized or improved pulmonary function)
Tadalafil (PAH) — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of PAH where tadalafil is indicated and right heart catheterization confirmation provided when required by indication
- Documentation of prior/contraindicated therapies and specialist management
VENCLEXTA — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for venetoclax (VENCLEXTA) with appropriate disease and molecular testing as required (e.g., CLL with 17p deletion, AML with IDH mutation where indicated)
- Documentation of prior therapies and treatment plan including dose ramp‑up and tumor lysis prophylaxis as clinically required
VERQUVO — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of heart failure with reduced ejection fraction where Verquvo (vericiguat) is indicated per labeling
- Documentation of guideline‑directed medical therapy trials or intolerance to components and specialist/cardiology involvement
Voriconazole — Indications
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for voriconazole and documentation of invasive fungal infection requiring therapy
- Prior therapy trials or contraindications documented per indication (e.g., intolerance to other azoles) when required
Vosevi — Initial therapy
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and documentation supporting use of Vosevi (sofosbuvir/velpatasvir/voxilaprevir) per labeled hepatitis C treatment indications
- Documentation of prior DAA therapy and resistance profile when applicable
Initial coverage criteria — rifaximin / DIFICID
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of recurrent C. difficile infection where rifaximin or fidaxomicin (DIFICID) criteria apply
- Documentation of prior therapies and clinical course per product‑specific initial coverage criteria
Initial coverage criteria — XOLAIR (omalizumab)
Covered when ALL of the following are met:
ALL of the following
- Diagnosis of eosinophilic or allergic disease for which omalizumab (Xolair) is indicated and documentation of prior therapies or biomarkers as required (e.g., IgE levels, eosinophil counts) per labeling
Initial coverage criteria — YESINTEK
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and documentation supporting use of YESINTEK per labeled indications
Initial coverage criteria — Zejula
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and documentation supporting use of Zejula (niraparib) per labeled indications, including genetic testing when indicated
Initial coverage criteria — Zurzuvae
Covered when ALL of the following are met:
ALL of the following
- Diagnosis and documentation supporting use of Zurzuvae per labeled indications
Initial Therapy Criteria (Grouped Examples)
Imbruvica — Initial and Renewal
Covered when ALL of the following are met:
For some entries prescriber must be or consult a hematologist; renewal requires seen within last 12 months and positive response
Coverage duration varies by entry (6 or 12 months)
Inqovi — Initial and Renewal
Covered when ALL of the following are met:
Renewal requires positive response; coverage duration six months; limited to FDA dosing
Neurogenic Orthostatic Hypotension (NOH) initial criteria
Covered when ALL of the following are met
Coverage one month then three months if renewal criteria met
Inbrija — Initial and Renewal
Covered when ALL of the following are met:
Prescribed by or in consultation with a neurologist; renewal requires positive response; coverage 12 months
Tolvaptan — Initial
Covered when ALL of the following are met:
Exclusions: concurrent use with Samsca (tolvaptan tablets) and patients with stage 5 CKD; prescribed by or in consultation with nephrology
INCRELEX - Initial therapy
Covered when ALL of the following are met:
Prescribed by or in consultation with an endocrinologist; coverage 12 months
NEXLETOL - Initial therapy
Covered when ALL of the following are met:
Prescriber preferably cardiology/endocrinology; coverage 12 months; limited to FDA dosing
Nucala (mepolizumab) severe asthma initial criteria
Covered when ALL of the following are met
Renewal requires evidence of response
OFEV (nintedanib) initial criteria
Covered when ALL of the following are met (per indication):
Prescribed by or in consultation with pulmonology/rheumatology; coverage 12 months; renewal requires visit within 14 months and positive response
Renewal: positive response
Modafinil and related agents - Initial therapy
Modafinil and related agents covered with criteria for multiple indications:
Initial coverage 6 months then 12 months if renewal criteria met; may not be used concurrently with armodafinil
Continuation and Renewal Criteria
Abiraterone continuation
Renewal/continuation rules noted where specified.
Coverage duration: six months per authorization
Prolastin-C continuation
Prolastin‑C continuation requirements
Coverage duration 12 months
Continuation/Renewal
Renewal/continuation requirements (examples):
Coverage durations commonly 12 months on renewal
Renewal requirements
Renewal conditions across listed biologics:
CRESEMBA continuation
CRESEMBA renewal:
General renewal requirements
Renewal/continuation commonly requires:
Venclexta continuation
Venclexta renewal
Coverage duration six months
Renewal rules
Renewal/continuation requirements where specified
Coverage duration varies by entry
Coverage duration 12 months
CONTINUATION CRITERIA
RETACRIT renewal rules
See product page for details
Verzenio continuation
Verzenio renewal
Coverage duration six months
Voriconazole continuation
Voriconazole renewal
Prescriber specialist consultation recommended
Xdemvy continuation
Xdemvy renewal
Coverage duration six weeks
Provider Actions, Prior Authorization & Documentation
Abiraterone — prior authorization & documentation
Prior authorization required. Initial requests must document diagnosis of an FDA‑approved indication not excluded from Part D, completion of genetic testing if required with results supporting abiraterone use (when applicable), and absence of any FDA‑labeled limitation of use or contraindication unless supported by NCCN. If requesting the 500 mg tablet provide rationale why the 250 mg tablet cannot be used. Limit dosing to within FDA‑labeled guidelines; coverage duration: six months. Renewal requires documented positive response to therapy.
Actemra — step therapy and PA
Prior authorization required. Initial approval requires diagnosis of one of the listed indications and inadequate response or medical contraindication to preferred drugs as specified (e.g., RA or polyarticular JIA: inadequate response to at least two preferred agents). Prescriber should be or consult a rheumatologist or pulmonologist. Do not use concurrently with other biologic therapies. Coverage duration: 12 months.
Adempas — hemodynamics & PA
Prior authorization required for PAH/CTEPH. Submit diagnostic confirmation (right heart catheterization showing mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units for Group 1 PAH) and prescriber specialty (cardiology or pulmonology). Do not use concurrently with nitrates, nitric oxide donors, PDE inhibitors, or non‑specific PDE inhibitors. Coverage duration: 12 months.
Armodafinil — sleep study & concurrency
Prior authorization required. For OSA, provide sleep study showing ≥15 obstructive events/hour or ≥5 events/hour plus qualifying symptoms (or prescriber statement if study not feasible). Do not use concurrently with modafinil or other target agents. Initial coverage 6 months; renewal to 12 months if response.
ATTRUBY — diagnostic confirmation & exclusions
Prior authorization required for ATTR‑CM. Provide cardiac biopsy or noninvasive diagnostic evidence (serum/urine immunofixation and free light chain ratio within 0.26–1.65 and myocardial 99mTc‑PYP uptake heart‑to‑contralateral ratio >1.5 or visual grade ≥2), HF history and NYHA class I–III documentation, and prescriber cardiology involvement. Do not use concurrently with ONPATTRO or TEGSEDI. Coverage: 12 months; renewal requires seen within 12 months and demonstrated efficacy.
BENLYSTA — serology, prior therapy & renewal
Prior authorization required for BENLYSTA SC. Provide serologic evidence (anti‑dsDNA >30 IU/mL, low complement C3/C4, or anti‑Smith), documentation of continuation of standard‑of‑care therapy, and inadequate response or contraindication to two listed alternatives. Do not use concurrently with another biologic agent. Renewal requires positive response and visit within 14 months; coverage duration: 12 months.
Bosentan — hemodynamics & liver labs
Prior authorization required for bosentan. Provide right heart catheterization hemodynamics confirming Group 1 PAH (mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units) and liver tests showing ALT/AST ≤3×ULN and bilirubin not ≥2×ULN prior to start. Do not use concurrently with cyclosporine A or glyburide. Coverage duration: 12 months.
CIMZIA — step therapy, prescriber restriction
Prior authorization required. Initial CIMZIA requests must document the indication and failure or contraindication to at least two preferred drugs for that indication, and be prescribed by or in consultation with an appropriate specialist (rheumatologist, dermatologist, gastroenterologist). Concurrent use with other biologic therapies is prohibited; dose limited to FDA labeling; coverage: 12 months.
COSENTYX — PA, prescriber restriction
Prior authorization required. COSENTYX requests must document the FDA‑approved indication, prescriber specialty (dermatologist or rheumatologist), and prior therapy failures per indication. Do not use concurrently with other biologic therapies. Limit to FDA‑labeled dosing; coverage duration: 12 months.
CRESEMBA — prior therapy & coverage duration
Prior authorization required for oral isavuconazole (CRESEMBA). Document the FDA‑approved diagnosis and inadequate response or contraindication to voriconazole or posaconazole as indicated. Initial coverage is 3 months and may be extended to 6 months with positive response; prescriber should be or consult ID/transplant/hematology/oncology specialist.
Prior authorization — general requirement
Prior authorization is required for many products; initial and renewal approvals require indication‑specific clinical criteria (diagnosis, severity, required labs, prior therapy failures or contraindications) and dosing limited to FDA‑labeled guidelines.
GAMMAGARD LIQUID — PA & site‑of‑care note
PA applies to GAMMAGARD LIQUID. Submit documentation of the FDA‑approved indication (e.g., primary immunodeficiency, CIDP maintenance) and meet product‑specific exclusions; coverage duration: 12 months. Note: Part B vs Part D determination may be required based on setting.
GAMUNEX‑C — PA & documentation
PA required for GAMUNEX‑C. Provide diagnosis consistent with FDA‑approved indication (primary immunodeficiency, CIDP maintenance, ITP after intolerance to conventional therapy) and required clinical details; coverage duration: 12 months. Part B vs Part D setting may affect coverage.
GATTEX — SBS documentation & dose limit
Prior authorization required for GATTEX. Document short bowel syndrome with ≥1 year parenteral nutrition dependence, inability or plan to taper PN, required colonoscopy/FOBT per age, and limit dose to 0.05 mg/kg/day (FDA dose). Coverage: 12 months.
GLP‑1 agonists — diabetes documentation
PA required for GLP‑1 receptor agonists. Provide documentation confirming diagnosis of type 2 diabetes (ICD‑10, chart notes, A1C or labs). Coverage duration: 12 months.
Hadlima — step therapy & concurrency
Hadlima requires prior authorization. Initial requests must meet disease‑specific criteria and document inadequate response or contraindication to required conventional therapies (step therapy). Do not use concurrently with other biologics; limit dose to FDA‑labeled dosing.
Imbruvica — formulation preference & PA
Imbruvica requires prior authorization. Provide diagnosis consistent with FDA‑approved hematologic or cGVHD indications; for certain tablet strengths (140 mg, 280 mg) document intolerance or contraindication to preferred strengths/forms. Coverage duration: six months; dose limited to FDA‑labeled dosing.
Tolvaptan — ADPKD attestation & exclusions
Prior authorization required for tolvaptan (ADPKD). Submit prescriber attestation of rapidly‑progressing disease, nephrology consultation, and note exclusions (concurrent Samsca use, stage 5 CKD).
Kalydeco — genetic requirement & prescriber
Kalydeco prior authorization: document diagnosis of cystic fibrosis, presence of at least one responsive CFTR mutation per in vitro data, and that patient is not homozygous for F508del. Prescriber should be or consult CF specialist/pulmonologist. Renewal requires visit within 12 months and positive response; coverage 12 months.
Kerendia — labs & prior ACE/ARB trial
Kerendia prior authorization: document UACR ≥30 mg/g, eGFR ≥25 mL/min/1.73 m2, serum potassium ≤5.0 mEq/L prior to start, and trial of (or intolerance to) an ACE inhibitor or ARB. Renewal requires positive response and continued ACE intolerance or continuation; coverage 12 months.
LIVTENCITY — CMV prior therapy & concurrency
Prior authorization required for LIVTENCITY. Document active CMV infection in HSCT or SOT patients and inadequate response or contraindication to ganciclovir, valganciclovir, foscarnet, or cidofovir; prescriber must be or consult transplant/ID specialist. Do not use concurrently with those antivirals. Coverage duration: eight weeks.
MAVYRET — HCV labs & drug interactions
MAVYRET prior authorization: ensure adherence to AASLD/IDSA guidance, HCV RNA within past 6 months, and that patient is not concurrently taking listed interacting drugs (e.g., carbamazepine, rifampin, certain statins, cyclosporine >100 mg/day). Prescriber should be or consult GI/hepatology/ID/transplant specialist; coverage 8–16 weeks per guideline.
LYNPARZA — indication‑specific testing & PA
LYNPARZA requires prior authorization. Initial requests must document the FDA‑approved indication and indication‑specific requirements (e.g., BRCA/HRD status or prior therapy responses). Limit dosing to FDA labeling; coverage duration: six months.
Nucala — eosinophil threshold & prior therapy
For severe eosinophilic asthma (Nucala), prior authorization requires pre‑treatment eosinophil ≥150 cells/µL within prior 12 months, inadequate control despite medium/high‑dose inhaled steroid plus another maintenance med, and defined exacerbation history; renewal requires evidence of response.
Rezdiffra — diagnostic confirmation & renewal
Rezdiffra prior authorization: confirm diagnosis of MASH/NASH with moderate‑advanced fibrosis (stage F2 or F3) by liver biopsy or elastography/CT/MRI, document prescriber counseling on diet and exercise, and prescribe by or consult endocrinology/gastro/hepatology. Renewal requires ≥1 year therapy without fibrosis worsening or progression to F4.
Prior authorization — provider documentation required
General prior authorization requirement: providers must submit indication‑specific clinical documentation (diagnosis, labs/imaging, prior therapy trials or contraindications, specialist consults where specified) and requests are generally limited to doses within FDA‑labeled guidelines; many approvals default to 12 months.
Venclexta — PA & contraindication check
Venclexta prior authorization: document FDA‑approved diagnosis (e.g., CLL/SLL or AML in combination regimens), confirm no FDA‑labeled contraindication, and limit dosing to FDA labeling. Renewal requires documented positive response; initial coverage up to six months.
Verquvo — HF criteria & specialist consult
Verquvo prior authorization: document EF <45%, NYHA II–IV, and either ≥1 HF hospitalization in past 6 months or outpatient IV diuretics in past 3 months, plus inadequate response or contraindication to at least two guideline therapies (ACE/ARB/ARNI, beta‑blocker, aldosterone antagonist, or SGLT2). Prescriber should be or consult a cardiologist. Coverage duration: 12 months.
Xalkori — genetic testing & PA
Xalkori prior authorization: provide FDA‑approved indication documentation and completion of required genetic testing with supportive results when applicable (e.g., ROS1 or ALK). Patient must not have unsupported FDA‑labeled limitations; coverage duration: six months; dose limited to FDA labeling.
Xeljanz — step therapy & concurrency exclusion
Xeljanz prior authorization: document diagnosis per indication and inadequate response or contraindication to at least two preferred drugs specific to each indication. Do not use concurrently with other biologic therapies. Prescriber should be or consult rheumatology/dermatology/gastroenterology; coverage duration: 12 months.
Xifaxan/rifaximin — indication‑specific PA & dosing limits
Rifaximin (Xifaxan) PA required per indication. For hepatic encephalopathy document lactulose dose‑limiting side effects and prescriber follow‑up; for IBS‑D document inadequate response/contraindication to first‑line therapies and limit dosing to 550 mg TID for 14 days (retreatment limited to patients with prior positive response, max two 14‑day courses); for travelers' diarrhea document trial/failure or resistance to listed antibiotics (duration 3 days).
Xolair — IgE testing & concurrency exclusion
Xolair prior authorization: initial requests must document the FDA‑approved indication and, for severe asthma, positive allergy testing and baseline IgE ≥30 IU/mL plus inadequate control on inhaled corticosteroid and another maintenance med. Xolair may not be used concurrently with another monoclonal antibody therapy.
Zejula & Zurzuvae — indication‑specific PA
Zejula and Zurzuvae require prior authorization. Zejula: document FDA‑approved indication and population‑specific eligibility (maintenance after response to platinum chemo); coverage six months. Zurzuvae (postpartum depression): document onset timing (third trimester or within 4 weeks postpartum) and prescriber attestation about driving/operating machinery counseling; coverage 14 days.
Index — consult individual drug pages
This index lists drugs and page references only; providers must consult each drug's policy page for specific prior authorization, step therapy, documentation, and denial rules.
Denial risk — FDA‑labeled limitations/contraindications
Requests may be denied if the patient has an FDA‑labeled limitation of use or a contraindication to the requested therapy; verify product‑specific labeled limitations/contraindications before submission.
Denial risk — concurrent biologic/monoclonal antibody use
Do not approve concurrent use of listed biologic/monoclonal antibody therapies — e.g., Actemra, BENLYSTA, CIMZIA, COSENTYX, DUPIXENT, Nucala, Xolair, YESINTEK and others — unless policy explicitly allows it; concurrent biologic use is an exclusion and may trigger denial.
Denial risk — missing/unsupported genetic testing
Denial risk: requests for targeted oncology agents that require genetic testing (e.g., Xalkori) will be denied if required genetic testing is not completed or results do not support use.
Genetic testing — documentation required
If genetic testing is required for the requested oncology agent, include completed test results demonstrating the appropriate mutation or biomarker prior to PA submission; lack of supporting results may preclude approval (examples: Xalkori, LYNPARZA where BRCA/HRD status is required).
Coding and Affected Products
| GAMUNEX-C | GAMUNEX-C immune globulin |
| GATTEX 30-VIAL | GATTEX (alpha-1 proteinase inhibitor) 30-vial |
| GATTEX ONE-VIAL | GATTEX one-vial presentation |
| HADLIMA | HADLIMA biosimilar (adalimumab) |
| HADLIMA PUSHTOUCH | HADLIMA PushTouch device |
| HADLIMA(CF) | HADLIMA cystic fibrosis presentation |
| HADLIMA(CF) PUSHTOUCH | HADLIMA(CF) with PushTouch |
| HIZENTRA | HIZENTRA subcutaneous immune globulin |
| IBRANCE | IBRANCE (palbociclib) |
| INBRIJA INHALATION CAPSULE | INBRIJA levodopa inhalation capsules |
Step Therapy Requirements
| Step requirement | Details |
|---|---|
| Step through preferred agents before Actemra | |
| Actemra initial criteria require inadequate response or medical contraindication to at least two preferred drugs for the indicated condition (examples: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis — preferred drugs listed include Hadlima, Simlandi, Rinvoq; giant cell arteritis requires inadequate response to at least one preferred drug). Prescriber restriction: prescribed by or in consultation with a rheumatologist or pulmonologist. Coverage duration: 12 months. |
| Step requirement | Details |
|---|---|
| Step through preferred antidepressants before listed agents | |
| For new starts of certain antidepressant products, approval requires diagnosis of an FDA‑approved indication and prior inadequate response or medical contraindication to two preferred alternative antidepressants (examples: trials of two listed alternatives such as SSRI/SNRI/class agents). Prescriber: typically neurology/psychiatry as indicated. Coverage duration: 12 months. |
| Requirement | Examples / Notes |
|---|---|
| Required prior trials of specified alternatives before approval | |
| Several products require documented inadequate response or contraindication to specified alternative therapies prior to approval. Examples: antipsychotics require failure/contraindication to two alternatives (lurasidone, risperidone, ziprasidone, olanzapine, quetiapine, aripiprazole); CIMZIA and similar biologics require failure or contraindication to at least two preferred drugs specific to each indication (preferred lists enumerated per disease). Documentation of prior trials must be submitted with initial PA. |
| Documentation requirement | What to include |
|---|---|
| Documentation of prior therapy trials or contraindications required as part of initial PA. | |
| Initial prior authorization requests must include evidence of prior inadequate response or medical contraindication to the specified preferred or first‑line therapies (e.g., CIMZIA, COSENTYX, DUPIXENT). For biologics and specialty agents include therapy names, durations, and reason for discontinuation (failure or intolerance). Prescriber specialty consultation/notes should be included when required. |
| Prior therapy requirement | Examples / Thresholds |
|---|---|
| Failure or contraindication to specified prior therapies required before coverage. | |
| Examples: Enbrel — inadequate response to at least one preferred adalimumab agent (Hadlima, Simlandi) or specified conventional therapies; Glutamine (sickle cell) — ≥2 painful crises in prior 12 months despite hydroxyurea unless contraindicated; Epidiolex — inadequate response to two antiseizure medications; Teriparatide — inadequate response to another osteoporosis therapy (e.g., bisphosphonates). Documentation of prior trials and durations required. |
| Requirement | Details |
|---|---|
| Trial of specified conventional therapies prior to biologic (Hadlima) | |
| Hadlima initial approval requires prior trial and inadequate response or contraindication to specified conventional therapies depending on indication (examples: methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine for rheumatoid arthritis; NSAID or methotrexate for juvenile idiopathic arthritis; topical/systemic therapy durations noted). Documentation of trials and durations must be provided with PA. |
| Requirement | Policy detail |
|---|---|
| Use preferred Imbruvica strengths/forms unless intolerance or contraindication documented | |
| Imbruvica authorization specifies preferred strengths/formulations (capsules 70 mg/140 mg, 420 mg tablet, 70 mg/mL suspension). Requests for certain tablet strengths (140 mg and 280 mg) require documentation of intolerance or medical contraindication to preferred strengths/forms. Renewal requires recent visit and positive response; coverage duration typically six months. |
| Requirement | Examples |
|---|---|
| Proof of prior therapy failure or contraindication required before approval. | |
| Examples: Inqovi (MDS) — inadequate response or contraindication to azacitidine (Part B before Part D for some beneficiaries); Jaypirca entries — prior therapies including BTK/BCL‑2 inhibitors as specified; Kisqali — prior inadequate response or contraindication to a preferred drug such as Verzenio or Ibrance. Providers must submit documentation of prior trials/failures or contraindications with the PA request. |
| Requirement | Details |
|---|---|
| Trial of high-intensity statin plus ezetimibe for minimum 8 weeks or documented statin intolerance | |
| For PCSK9/adjunct lipid therapies (example NEXLETOL, Repatha), prior trial of a high‑intensity statin plus ezetimibe concomitantly for at least 8 weeks with LDL remaining above goal (e.g., >70 mg/dL) is required unless documented statin intolerance (e.g., rhabdomyolysis to one statin or unresolved muscle symptoms to both atorvastatin and rosuvastatin). Documentation of statin/ezetimibe trial duration and LDL values must be provided. |
| Requirement | Details |
|---|---|
| Required prior antibiotic trial or documented resistance | |
| For travelers' diarrhea due to noninvasive E. coli, approval of rifaximin (or related agents) requires trial and failure or contraindication to one of ciprofloxacin, levofloxacin, ofloxacin, or azithromycin, or documented resistance to all listed antibiotics. Documentation of antibiotic trials or resistance must be submitted with PA. Coverage duration for travelers' diarrhea is typically 3 days; IBS‑D and hepatic encephalopathy have different duration rules. |
Quantity Limits and Duration
Site of Care & Part B vs Part D Determinations
Site‑of‑care — Part B vs Part D may affect coverage
Confirm whether administration or dispensing setting affects benefit (Part B vs Part D). For some drugs (e.g., certain immunoglobulins, amphotericin products, Gammagard Liquid, Vivtencity, Xatmep) providers must supply the setting/use details to determine correct coverage.
Site‑of‑care — provide setting when requested
Some drugs may be covered under Part B or Part D depending on setting; provide information about the administration/dispensing setting when requested to determine the correct benefit (examples include immunoglobulins and certain injectables/infusion drugs).
Immunoglobulins — setting may determine Part B vs Part D
Certain immunoglobulin products may be covered under Part B or Part D depending on circumstance and setting; submit setting details (infusion center vs home) and indication to support correct benefit determination.
Mixed Part B/Part D coverage — provide setting details
Some drugs have mixed site‑of‑care determinations; for products such as paricalcitol, PULMOZYME, or Retacrit, submit details of the dispensing/administration setting to establish benefit responsibility.
Mixed coverage — document use & setting for benefit determination
Coverage may be under Part B or Part D depending on circumstances (e.g., Xatmep); documentation of the clinical use and setting may be requested to determine the correct benefit.
Vowst — bowel prep & single‑course administration
Vowst administration requires completion of bowel preparation (magnesium citrate) the day before and at least 8 hours prior to initiation; confirm patient completed antibiotic therapy 2–4 days prior. Coverage limited to a single 10‑day treatment course.
Background and Rationale
This policy provides clinical context and documentation expectations tied to specific drug indications. It is intended to guide the information required for prior authorization rather than offer full clinical guidance. Key elements include hemodynamic criteria for pulmonary arterial hypertension (right heart catheterization thresholds), pretreatment laboratory thresholds (e.g., alpha‑1 antitrypsin levels), and specialty prescriber recommendations. Providers should supply indication‑specific diagnostics, evidence of prior therapies or contraindications where required, and attestations (for example, inhaler education or diet/exercise counseling) to support PA requests.
Definitions and Diagnostic 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.