2026 Medicare Part D Prior Authorization Requirements (selected drugs)
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Portion of a HealthPartners policy listing Medicare Part D prior authorization requirements for specific specialty and pharmacy drugs, including clinical prerequisites, exclusions, prescriber and coverage duration rules for affected products.
No material clinical or coverage changes in this revision.
Drug-specific Coverage Criteria
Abiraterone (250 mg, 500 mg)
Covered when ALL of the following are met:
Coverage duration: six months
Actemra (all formulations)
Covered when ANY of the following indications are met:
May not be used concurrently with other biologic therapies; prescriber is or in consultation with rheumatologist or pulmonologist; coverage duration 12 months
Adbry
Covered when ALL of the following are met:
Coverage duration 12 months
Renewal coverage 12 months
Adempas
Covered when ALL of the following are met:
Coverage duration 12 months
Alpha-1 antitrypsin augmentation
Covered when ALL of the following are met:
Renewal: seen within past 12 months and positive response; coverage duration 12 months
ATTRUBY
Covered when ALL of the following are met:
Coverage duration 12 months; may not be used concurrently with ONPATTRO or TEGSEDI
Coverage duration 12 months
Erythropoiesis-stimulating agents
Covered when ANY of the following are met (indications and renewal thresholds summarized):
Coverage duration 12 months; dosing limited to FDA labeling
Initial therapy for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)
Covered when ALL of the following diagnostic and clinical criteria are met:
Prescriber: cardiologist; coverage duration 12 months
Renewal criteria for ATTR-CM therapy
Renewal covered when ALL of the following are met:
Coverage duration 12 months
Antipsychotics (selected agents) - new start criteria
Covered for new‑start patients when ALL of the following are met:
Prescriptions limited to FDA labeled dosing; coverage duration 12 months
Benlysta (subcutaneous) initial criteria
Covered when ALL of the following are met for active SLE or lupus nephritis:
Renewal requires positive response and visit within last 14 months; prescriber rheumatologist/nephrologist/dermatologist; coverage 12 months
Bosentan (oral) initial criteria for Group 1 PAH
Covered when ALL of the following are met for Group 1 PAH:
Prescriber cardiologist or pulmonologist; coverage 12 months; contraindicated with cyclosporine A or glyburide
Cayston (aztreonam) initial criteria
Covered when ALL of the following are met:
Renewal requires visit within last 12 months and positive response; prescriber from CF center, infectious disease, or pulmonology; coverage 12 months
Cimzia (certolizumab) initial criteria
Covered when ALL of the following are met for the listed autoimmune diseases:
May not be used concurrently with other biologic therapies; prescriber rheumatologist/dermatologist/gastroenterologist; coverage 12 months
Oncology/targeted oral agents - general initial criteria
Covered when ALL of the following are met:
Renewal requires positive response; typical initial coverage six months; dosing limited to FDA labeling
Example: Corlanor
Coverage duration 12 months
Cosentyx
Prerequisite therapy required; coverage 12 months
Cresemba
Prerequisite therapy not required
Deferasirox
Coverage duration 12 months; dose limited to FDA labeling
Deferiprone
Coverage 12 months; dose limited to FDA labeling
Dihydroergotamine
Renewal requires positive response; coverage 12 months
Dronabinol
Coverage duration pending CMS review; prerequisite therapy required
Dupixent
Prerequisite therapy required; dose limited to FDA labeling
Emgality
Prerequisite therapy required
Enbrel
Renewal: treatment goals met; coverage 12 months
Glutamine (sickle cell)
Coverage duration 12 months; dose limited to FDA labeling
Epidiolex
Coverage duration 12 months; dose limited to FDA labeling
Erleada
Coverage duration six months
Eucrisa
Coverage duration 12 months
Specialty antimicrobials and related agents
Default specialty antimicrobial and related agent coverage:
Coverage duration typically 12 months; setting may affect Part B vs Part D determination
Default product criteria
Default coverage applied to many products in this section:
Applies to many listed products
FINTEPLA criteria
Covered when ALL of the following are met for new starts:
Renewal for Dravet requires positive response; coverage 12 months
GATTEX criteria
Covered when ALL of the following are met:
Initial coverage three months then 12 months if renewal criteria met; prescriber gastroenterologist
Concurrency/exclusion rules
Concurrency/exclusion rules (examples):
Prescriber in consultation with appropriate specialist; coverage 12 months
Prescribed by or in consultation with hematology/allergy/immunology; coverage six months
INBRIJA criteria
INBRIJA initial authorization covered when ALL of the following are met:
Age ≥18; prescriber neurologist; renewal requires positive response; dose limited to FDA labeling
IMBRUVICA criteria
Covered when ANY of the following diagnosis‑specific conditions are met:
Coverage duration six months; renewal requires positive response; prescriber specialty as indicated
INBRIJA Initial Therapy
Initial authorization covered when ALL of the following are met:
Prescriber: neurologist or in consultation with neurologist; age ≥18; renewal requires positive response
JAYPIRCA Initial Therapy
JAYPIRCA — Initial authorization covered when ALL of the following are met:
Coverage duration six months; renewal requires positive response; dose limited to FDA labeling
Tolvaptan Initial Therapy
Tolvaptan — Initial authorization covered when ALL of the following are met:
Exclusions: concurrent use with SAMSCA (tolvaptan tablets) and use in stage 5 CKD; prescriber nephrologist; coverage 12 months
KALYDECO Initial Therapy
KALYDECO — Initial authorization covered when ALL of the following are met:
Prescriber CF center specialist or pulmonologist; may not be used concurrently with another CFTR modulator for requested indication; renewal: seen within last 12 months and positive response; coverage 12 months
KINERET Initial Therapy
KINERET — Initial authorization covered when ANY of the following diagnoses are met:
May not be used concurrently with other biologic therapies; prescriber specialist required; coverage 12 months
Linezolid Initial Therapy
Linezolid (including IV formulations) — Initial authorization covered when ANY of the following are met:
Prescriber: infectious disease/transplant/hematology/oncology; coverage duration three months; dose limited to FDA labeling
LIVTENCITY Initial Therapy
LIVTENCITY — Initial authorization covered when ALL of the following are met:
Exclusions: may not be used concurrently with ganciclovir, valganciclovir, foscarnet or cidofovir; coverage eight weeks; dose limited to FDA labeling
MAVYRET Initial Therapy
MAVYRET — Initial authorization covered when ALL of the following are met:
Coverage duration 8–16 weeks per diagnosis or FDA labeling; dose limited to FDA labeling
LYNPARZA Initial Therapy
LYNPARZA — Initial authorization covered when ANY of the following FDA‑approved indications are met:
Coverage duration six months; dose limited to FDA labeling; renewal requires positive response
Nucala (mepolizumab) — Initial and Renewal Coverage
Covered when ALL of the following are met:
Coverage duration 12 months; renewal requires positive response and visit within specified interval
Ofev (nintedanib) — IPF and other fibrosing ILD Coverage
Covered when ALL of the following are met:
Renewal requires visit within last 14 months and positive response; coverage 12 months
Nexletol (bempedoic acid) — Hyperlipidemia Coverage
Covered when ALL of the following are met:
Coverage duration 12 months; dose limited to FDA labeling
IGF-1 therapy for growth failure — Initial and Renewal Coverage
Covered when ALL of the following are met:
Renewal requires positive response; coverage 12 months
Nitazoxanide — Giardiasis/Cryptosporidium
Covered when ALL of the following are met:
Coverage duration 10 days; dose limited to FDA labeling
Mifepristone (300 mg) — Endogenous Cushing's Disease
Covered when ALL of the following are met:
Initial coverage six months then 12 months if renewal criteria met; dose limited to FDA labeling
Nuedexta — Pseudobulbar affect
Covered when ALL of the following are met:
Coverage duration 12 months
Droxidopa — Neurogenic orthostatic hypotension (NOH)
Covered when ALL of the following are met:
Initial one month then three months if renewal criteria met; dose limited to FDA labeling
Nurtec ODT — Migraine
Covered when ALL of the following are met:
Initial six months then 12 months if positive response; dose limited to FDA labeling
Initial criteria for oncology/specialty drugs
General initial coverage for oncology/specialty agents:
Typical initial coverage: six months; renewal requires positive response; dosing limited to FDA labeling
ORKAMBI
ORKAMBI — Initial authorization covered when ALL of the following are met:
Renewal: seen within last 12 months and positive response; coverage 12 months; dose limited to FDA labeling
OPSUMIT (PAH)
OPSUMIT — Initial authorization covered when ALL of the following are met:
Coverage duration 12 months; dose limited to FDA labeling
Pirfenidone / IPF
Pirfenidone — Initial authorization covered when ALL of the following are met:
Coverage duration 12 months; renewal requires follow‑up visit and positive response
PLEGRIDY
PLEGRIDY — Initial authorization covered when ALL of the following are met:
Coverage duration 12 months; specialist involvement required
REPATHA (PCSK9 inhibitors)
REPATHA — Initial coverage when ALL of the following are met:
Document duration of statin/ezetimibe trial; coverage duration 12 months
REPATHA (PCSK9 inhibitor) — Initial coverage criteria
REPATHA — Initial coverage criteria (expanded):
Coverage duration and documentation of trials required
REZDIFFRA (NASH agent) — Initial and renewal criteria
REZDIFFRA — Initial and renewal coverage:
Renewal requires ≥1 year of therapy, no worsening of fibrosis or progression to F4, and prescriber confirmation of ongoing diet/exercise counseling
RETACRIT
RETACRIT — Coverage conditions vary by clinical circumstance:
Documentation of use and setting may be required to determine Part B vs Part D coverage
RUBRACA
RUBRACA — Initial authorization covered when ALL of the following are met:
Coverage duration six months; renewal requires evidence of positive response
Biologic agents with specialist prescriber and concurrent therapy restrictions
Biologic agents with specialist prescriber and concurrent therapy restrictions — covered when ALL of the following are met:
Applies to multiple biologic agents listed in this section
Sodium oxybate (narcolepsy)
Covered when ALL of the following are met:
Coverage duration 12 months
General initial coverage criteria
General initial coverage language applied per product:
Coverage duration and other specifics vary by product
TRIKAFTA
TRIKAFTA — Initial authorization covered when ALL of the following are met:
Patients age ≥2 years; prescriber pulmonologist or CF center specialist; coverage 12 months
Tadalafil (PAH)
Tadalafil (PAH) — Initial authorization covered when ALL of the following are met:
Coverage duration 12 months; dose limited to FDA labeling
Fentanyl buccal lozenge on a handle
Fentanyl buccal lozenge on a handle — Initial authorization covered when ALL of the following are met:
Coverage duration 12 months
Trientine
Trientine — Initial authorization covered when ALL of the following are met:
Initial six months then 12 months if renewal criteria met; dose limited to FDA labeling
Venclexta
Venclexta — Covered when ANY of the following qualifying indications are met:
Initial approval six months; renewal requires positive response
Talzenna
Talzenna — Initial authorization covered when ANY of the following are met:
Coverage duration six months; dose limited to FDA labeling
Somavert
Somavert — Initial authorization covered when ALL of the following are met:
Initial six months then 12 months if renewal met; dose limited to FDA labeling
Valchlor
Valchlor — Covered when ALL of the following are met:
Approvals limited to two 60 g tubes per month; initial six months then 12 months if renewal criteria met
VALCHLOR — Initial and Renewal Criteria
VALCHLOR — Initial and renewal criteria:
Quantity limited to two 60‑gram tubes per month; initial 6 months then 12 months if renewal criteria met
VENCLEXTA — Initial and Renewal Criteria
VENCLEXTA — Initial and renewal coverage:
Dose limited to FDA‑labeled dosing; initial coverage six months; renewal requires positive response
VERQUVO — Initial and Renewal Criteria
VERQUVO — Covered when ALL of the following are met:
Prescriber cardiologist or consult; coverage 12 months; renewal requires positive response
VOWST — Initial Criteria
VOWST — Initial authorization covered when ALL of the following are met:
Limited to a single treatment course; duration 10 days; dose limited to FDA labeling
WINREVAIR (PAH) — Initial Criteria
WINREVAIR (PAH) — Initial authorization covered when ALL of the following are met:
Coverage 12 months; dosing limited to FDA labeling
XALKORI — Initial and Renewal Criteria
XALKORI — Initial and renewal coverage (ANY of the listed qualifying diagnoses):
Genetic testing completed if applicable; coverage 6 months; renewal requires positive response
XELJANZ — Initial Criteria by Indication (step therapy required)
XELJANZ — Covered when ALL of the following are met per indication (step therapy required):
May not be used concurrently with other biologic therapies; prescriber or consult required; coverage 12 months
Prescribed by or in consultation with rheumatologist; coverage 12 months
Prescribed by or in consultation with gastroenterologist; coverage 12 months
XERMELO — Initial and Renewal Criteria
XERMELO — Covered when ALL of the following are met:
Renewal requires positive response (reduction in daily stools); initial six months then 12 months if renewed
XIFAXAN — Indication-specific Criteria and Limits
XIFAXAN — Indication‑specific criteria and limits:
Coverage durations: hepatic encephalopathy 12 months, IBS‑D 14 days (retreatment limits), travelers' diarrhea 3 days
XOLAIR — Initial Criteria by Indication
XOLAIR — Initial criteria by indication (examples):
May not be used concurrently with another monoclonal antibody; prescriber specialist required; coverage 12 months
XOLAIR Coverage Criteria
XOLAIR — Initial and renewal coverage elements:
Renewal requires evidence of positive response (decreased exacerbations, decreased rescue med use, symptom reduction, or improved FEV1); coverage 12 months
May not be used concurrently with another monoclonal antibody
XTANDI Coverage Criteria
XTANDI — Initial and renewal coverage criteria:
Coverage duration six months; dose limited to FDA labeling; renewal requires continued castrate status
ZEJULA Coverage Criteria
ZEJULA — Initial and renewal coverage criteria:
Coverage duration six months; renewal requires positive response; dosing limited to FDA labeling
YESINTEK Coverage Criteria
YESINTEK — Covered when ALL of the following are met:
Coverage duration 12 months; required medical information pending CMS review
ZURZUVAE Coverage Criteria
ZURZUVAE — Covered when ALL of the following are met:
Coverage duration 14 days; further documentation pending CMS review
Many biologic and monoclonal antibody products in this policy are subject to concurrent‑use prohibitions. Examples across product entries include: Actemra, Cimzia, Cosentyx, Benlysta, Enbrel, Hadlima, Haegarda, Kineret, and other listed biologics which may not be used concurrently with other biologic or monoclonal antibody therapies. In addition, several products specify that concurrent use with other agents in the same mechanistic class is disallowed (for example, REPATHA concurrent use with PRALUENT or LEQVIO is prohibited). These concurrency restrictions are enforced as exclusion criteria and may trigger denial if concurrent therapy is documented.
Adempas (riociguat) has an explicit drug‑interaction exclusion: it must not be used concurrently with nitrates, nitric oxide donors, phosphodiesterase (PDE) inhibitors, or non–specific PDE inhibitors. This interaction is listed as an exclusion and may trigger denial if concurrent use is present; prescribers must document absence of these concomitant agents in the medical record.
Adbry (tralokinumab) is contraindicated for concurrent use with another monoclonal antibody therapy per the policy. Requests documenting simultaneous monoclonal antibody treatment may be denied unless the provider demonstrates a compelling, documented rationale and that such use is consistent with FDA labeling or other policy exceptions.
For the transthyretin amyloid therapy listed (ATTRUBY), the policy specifies an exclusion for combined therapy with RNA‑targeting agents: ATTRUBY may not be used concurrently with Onpattro (patisiran) or Tegsedi (inotersen). Concurrent use is an explicit exclusion and may result in denial.
Where CFTR modulators are addressed (including Trikafta and other CFTR agents), the policy requires that concurrent CFTR modulator therapy is not permitted. Specifically, CFTR modulators must be discontinued prior to initiation of another CFTR modulator product; concurrent use is listed as an exclusion and may lead to denial.
The policy repeatedly states that certain biologic treatments are not to be combined with other biologics. Examples include Benlysta, Cimzia, Cosentyx, and similar agents — each entry notes that the product may not be used concurrently with other biologic therapies. Providers should document discontinuation of other biologics prior to initiation or risk denial.
Bosentan (oral) carries product‑specific concurrency exclusions: it is contraindicated with cyclosporine A and glyburide. In addition, monitoring and lab thresholds (liver enzymes and bilirubin) are required per the bosentan entry; concurrent contraindicated medications or unacceptable lab values are exclusionary.
Cosentyx (secukinumab) is listed with a clear concurrency prohibition: it may not be used concurrently with other biologic therapies. The entry directs specialist prescribing and limits dosing to FDA‑labeled regimens; concurrent biologic use is an exclusion that may trigger denial.
Dupixent (dupilumab) is explicitly restricted from concurrent use with other monoclonal antibody therapies. Indication‑specific prerequisites and specialist involvement are required, and documentation of absence of concurrent monoclonal therapy should accompany requests.
Emgality (galcanezumab) for migraine prevention is subject to a class concurrency exclusion: the policy states Emgality may not be used concurrently with other CGRP antagonists for migraine prevention. Age and prerequisite therapy requirements also apply for initial approvals.
Enbrel (etanercept) is identified as a biologic that may not be used concurrently with other biologic therapies. The Enbrel criteria also require prior inadequate response or contraindication to a preferred adalimumab biosimilar (e.g., Hadlima or Simlandi) before approval in many indications.
Dihydroergotamine for acute migraine is listed with a concurrency exclusion against other acute migraine agents: it may not be used concurrently with triptans or acute CGRP antagonists. Prior triptan trials and specialist prescribing are required elements of initial authorization.
The policy contains a broad exclusion that any product will not be approved when the patient has an FDA‑labeled limitation of use or contraindication. This is applied across many entries — requests documenting an FDA‑labeled contraindication or limitation to the requested therapy are excluded and may be denied.
Initial Authorization / Start-of-Therapy Criteria
Renewal / Ongoing Therapy Criteria
Required Prior / Alternative Therapy (Step) Rules
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Antidepressant agents (new starts) | ||
| Inadequate response or medical contraindication to two preferred alternative antidepressants (examples: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, venlafaxine, duloxetine) | ||
| Required for new-start patients; coverage duration typically 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Actemra (selected indications) | ||
| Inadequate response or medical contraindication to at least two preferred drugs (examples: Hadlima, Simlandi, Rinvoq) depending on indication; prescriber is or in consultation with rheumatologist or pulmonologist | ||
| May not be used concurrently with other biologic therapies; coverage duration 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| General step therapy for listed agents (examples: antipsychotics, Cimzia) | ||
| Inadequate response or medical contraindication to two specified preferred alternative therapies (lists provided per indication) | ||
| Applies to new-start patients; prescriber specialty and 12-month coverage common |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Enbrel (etanercept) | ||
| Prior inadequate response or contraindication to at least one preferred adalimumab biosimilar (preferred agents include Hadlima or Simlandi) | ||
| May not be used concurrently with other biologic therapies; prescriber specialty required; coverage duration 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Dronabinol (for CINV) | ||
| Inadequate response or contraindication to a 5-HT3 receptor antagonist (e.g., ondansetron) AND inadequate response or contraindication to prochlorperazine; patient is receiving chemotherapy | ||
| May be covered under Part B or Part D depending on setting; coverage pending CMS review |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| FINTEPLA and similar agents | ||
| Prior inadequate response or medical contraindication to specified alternatives (e.g., for LGS: failure of ≥2 other antiseizure medications) | ||
| Prerequisite therapy required; prescriber specialty often required; coverage duration commonly 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| INBRIJA (inhaled levodopa) | ||
| Trial and failure of at least one adjunct agent for ≥4 weeks in combination with carbidopa/levodopa (examples: rasagiline, ropinirole, entacapone, pramipexole, rotigotine, selegiline); provider attestation of inhaler education and pulmonary assessment | ||
| Patient must be taking carbidopa/levodopa; age ≥18; prescriber neurologist or consult; renewal requires positive response |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| JAYPIRCA (zanubrutinib) | ||
| For CLL/SLL: prior exposure to at least two prior therapies including a BTK inhibitor and a BCL-2 inhibitor; for MCL: ≥2 prior systemic therapies including a BTK inhibitor | ||
| Documentation required; coverage duration six months; dose limited to FDA-labeled dosing; prerequisite therapy requirement noted pending CMS review |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| KISQALI (ribociclib) regimens | ||
| Medical contraindication or inadequate response to at least one preferred drug (examples: Verzenio or Ibrance) prior to approval | ||
| Prescriber specialty and documentation required; typical initial coverage six months; renewal with positive response |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Nexletol (bempedoic acid) | ||
| Trial of one high-intensity statin plus ezetimibe concomitantly for specified minimum weeks with LDL remaining >70 mg/dL OR documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin) | ||
| Prescribed by or in consultation with cardiology/endocrinology; documentation of statin/ezetimibe trial duration required; coverage 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Trial and failure documentation (general) | ||
| Documentation that prior therapies were tried and failed or were contraindicated (examples: trials of first-line agents with clinical response noted) | ||
| Required prior therapy documentation is necessary for initial authorization decisions |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Documentation of prior therapy or contraindication | ||
| Provide documentation of prior therapy trials and outcomes or documented medical contraindications to those therapies (examples vary by product) | ||
| Documentation often required to demonstrate failure of preferred alternatives prior to approval |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| REPATHA (PCSK9 inhibitor) | ||
| Trial of one high-intensity statin plus ezetimibe concomitantly for specified minimum weeks with LDL remaining >70 mg/dL OR documented statin intolerance as defined; prescriber specialty documentation required | ||
| May not be used concurrently with Praluent or Leqvio; document duration of statin/ezetimibe trial; dose limited to FDA labeling |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| TYENNE (example biologic) prior therapy requirement | ||
| Inadequate response or medical contraindication to preferred drugs (usually at least two preferred agents such as Hadlima, Simlandi, Rinvoq depending on indication) | ||
| Prescribed by or in consultation with rheumatologist; coverage duration 12 months; not to be used concurrently with other biologics |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Valchlor (topical mechlorethamine) | ||
| Patient must have received at least one prior skin-directed therapy (examples: topical corticosteroids or bexarotene topical gel) | ||
| Approvals limited to two 60 g tubes per month; initial 6 months then 12 months if renewal criteria met |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| XELJANZ (tofacitinib) step therapy | ||
| Prior inadequate response or medical contraindication to at least two preferred drugs (lists provided by indication) before approval | ||
| May not be used concurrently with other biologic therapies; prescriber specialty required; coverage duration 12 months |
| Step therapy requirement | Required prior trial(s) / documentation | Notes |
|---|---|---|
| Prerequisite therapy for several products (examples aggregated) | ||
| Many products require prior or concomitant use of standard therapies before approval (examples: Xolair requires inadequate control despite inhaled steroid plus at least one other maintenance med; other agents require prior specific drug trials) | ||
| Prescriber specialty and diagnostic documentation often required; coverage and step details product-specific |
Index and Code Listings
| VENCLEXTA ORAL TABLET 10 MG | VENCLEXTA product listing |
| VENCLEXTA STARTING PACK | VENCLEXTA starting pack |
| 100 MG | VENCLEXTA strength |
| 50 MG | VENCLEXTA strength |
| VALCHLOR | Product affected |
| VERQUVO | Product affected |
| VERZENIO | Product affected |
| VOSEVI | Product affected |
| VOWST | Product affected |
| VUMERITY | Product affected |
| WINREVAIR | Product affected |
| XALKORI | Product affected |
| XATMEP | Product affected |
| XDEMVY | Product affected |
| No codes listed |
| INTRALIPID 20% | Intralipid intravenous emulsion 20% (indexed entries) |
| INTRALIPID 30% | Intralipid intravenous emulsion 30% (indexed entries) |
| ipratropium bromide inhalation solution 0.02% | Index entries listing ipratropium bromide inhalation solution 0.02% across many index numbers |
| ipratropium-albuterol inhalation solution | Index entries listing ipratropium-albuterol inhalation solution across many index numbers |
| ml | multiple numeric index entries referencing milliliters (ml) across index |
| ITOVEBI ORAL TABLET 3 MG, 9 MG | Index entry for Itovebi oral tablet strengths 3 mg and 9 mg |
Actions, Documentation & Denial Risks for Providers
Abiraterone prior authorization & dose substitution
Abiraterone (oral) prior authorization: PA required. Initial requests must document diagnosis of metastatic high‑risk castration‑sensitive prostate cancer (MCSPC) or metastatic castration‑resistant prostate cancer (mCRPC). If the request is for the 500 mg tablet, the provider must document why the 250 mg tablet cannot be used (dose‑substitution rationale). Limit approvals limited to FDA‑labeled dosing. Coverage duration: 6 months. Note: patient must not have any FDA‑labeled contraindication or limitation of use.
- Coverage duration: 6 months
- If 500 mg tablet requested, provide rationale why 250 mg tablet unsuitable
- Limited to FDA‑labeled dosing
Actemra prior authorization and preferred‑alternative requirements
Actemra (tocilizumab) — prior authorization required. Initial criteria: document applicable FDA‑approved diagnosis (e.g., rheumatoid arthritis, polyarticular JIA, giant cell arteritis, systemic juvenile idiopathic arthritis, systemic sclerosis–associated ILD) and medical contraindication or inadequate response to required preferred agents (examples include Hadlima, Simlandi, Rinvoq as applicable). Do not use Actemra concurrently with other biologic therapies. Prescriber should be or consult with a rheumatologist or pulmonologist when indicated. Coverage duration: 12 months. Limited to FDA‑labeled dosing.
- Do not combine with other biologic therapies
- Prescribed by or in consultation with rheumatologist/pulmonologist as appropriate
- Preferred‑alternative step requirement: trial of specified preferred agents prior to approval
- Coverage duration: 12 months
ATTRUBY prior authorization and diagnostic documentation (ATTR‑CM)
ATTRUBY prior authorization and documentation: PA requires diagnosis of wild‑type or hereditary transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM) and diagnostic confirmation by either (a) cardiac biopsy with positive Congo red and ATTR confirmation by mass spectrometry or immunofluorescence, or (b) noninvasive workup including serum free light chain ratio and absence of monoclonal protein on serum and urine immunofixation plus myocardial uptake on 99mTc‑PYP (heart‑to‑contralateral ratio >1.5 or visual grade ≥2). Patient must be negative for light‑chain amyloidosis and have NYHA class I–III heart failure with supporting clinical history (e.g., prior HF hospitalization or compatible symptoms). Concurrent use with Onpattro or Tegsedi is prohibited. Renewal requires recent prescriber visit and documented medication efficacy. Coverage duration: 12 months. Prescriber: cardiologist or in consultation with cardiology.
- Diagnostic confirmation: cardiac biopsy OR nuclear imaging + lab exclusion of light‑chain disease
- NYHA class I–III required
- Do not use concurrently with Onpattro or Tegsedi
- Coverage duration: 12 months
- Prescribed by or in consultation with a cardiologist
Adbry prior authorization & concurrent biologic exclusion
Adbry prior authorization and concurrency exclusion: PA requires documented diagnosis for an FDA‑approved indication (e.g., atopic dermatitis) with specified disease severity (moderate–severe AD with ≥10% BSA or involvement of sensitive sites and intractable pruritus/cracking/bleeding) and prior inadequate response or contraindication to topical therapies (prescription‑strength topical corticosteroid or topical calcineurin inhibitor). Do not use Adbry concurrently with another monoclonal antibody therapy (concurrent biologic exclusion). Prescriber should be an allergist, immunologist, or dermatologist. Coverage duration: 12 months.
- May not use concurrent monoclonal antibody therapy
- Prescribed by or in consultation with an allergist/immunologist/dermatologist
- Coverage duration: 12 months
- Limited to FDA‑labeled dosing
Prior authorization requirement and coverage duration (general)
Prior authorization general requirement and duration notes: Many specialty products require PA with initial documentation of diagnosis, prerequisite/step therapies or genetic testing when applicable, and are limited to FDA‑labeled dosing. Typical coverage durations: 3, 6, or 12 months depending on product (examples above: Abiraterone 6 months; Actemra, ATTRUBY, many biologics 12 months; some products have product‑specific shorter initial durations). Ensure required supporting documentation is submitted with initial requests to avoid denials.
- Most approvals limited to FDA‑labeled dosing
- Typical durations: 3, 6, or 12 months (product dependent)
- Genetic testing or prior therapy documentation may be required for oncology/targeted agents
Antipsychotic agents — prior authorization & step therapy
Antipsychotic agent prior authorization and step requirements: New starts require diagnosis of an FDA‑approved indication and documentation of inadequate response or contraindication to two alternatives (examples: lurasidone, risperidone, ziprasidone, olanzapine, quetiapine, aripiprazole). Coverage duration typically 12 months. Ensure prescriber and clinical justification are included.
- Requires trial/failure of two alternatives prior to approval
- Coverage duration: 12 months
Cimzia prior authorization & concurrent biologic exclusion
Cimzia prior authorization and concurrent biologic exclusion: PA requires diagnosis consistent with FDA indications (e.g., psoriatic arthritis, RA, Crohn's disease, plaque psoriasis) and prior inadequate response or contraindication to at least two preferred drugs. Cimzia may not be used concurrently with other biologic therapies. Prescriber should be or consult with relevant specialist (rheumatology, dermatology, gastroenterology). Coverage duration: 12 months.
- May not use concurrently with other biologic therapies
- Trial/failure of at least two preferred drugs required
- Prescribed by or in consultation with specialty (rheumatology/dermatology/gastroenterology)
- Coverage duration: 12 months
FINTEPLA prior authorization & prior therapy requirement
FINTEPLA prior authorization: For Lennox‑Gastaut syndrome (LGS), new starts require documented diagnosis and prior inadequate response or contraindication to at least two other seizure medications (examples: felbamate, lamotrigine, topiramate, clobazam, rufinamide). Prescriber should be or consult with a neurologist. Coverage duration: 12 months. Renewal requires evidence of clinical benefit.
- Neurologist involvement recommended
- Requires prior inadequate response to ≥2 antiseizure medications for LGS
- Coverage duration: 12 months
GATTEX prior authorization & required documentation
GATTEX prior authorization and documentation: PA requires diagnosis of short bowel syndrome, dependency on parenteral nutrition for ≥1 year, inability to taper parenteral support, and appropriate pretherapy colonoscopy/fecal occult blood testing per age. Prescriber should be or consult with a gastroenterologist. Initial coverage: 3 months then 12 months if renewal criteria met. Dose limited to FDA‑approved dosing (0.05 mg/kg/day).
- Prescribed by or in consultation with a gastroenterologist
- Initial coverage 3 months, then 12 months if renewal criteria met
- Dose limited to FDA‑approved 0.05 mg/kg/day
Kalydeco prior authorization & CFTR modulator concurrency exclusion
Kalydeco (ivacaftor) prior authorization and exclusion: PA requires diagnosis of cystic fibrosis with at least one CFTR mutation responsive to the drug per in vitro data and that the patient is not homozygous for F508del for applicable products. Do not use concurrently with another CFTR modulator for the same indication. Prescriber should be or consult with a CF specialist or pulmonologist. Coverage duration: 12 months.
- May not use concurrently with another CFTR modulator for the requested indication
- Prescribed by or in consultation with CF treatment center specialist or pulmonologist
- Coverage duration: 12 months
Nucala prior authorization — eosinophil & specialist requirements
Nucala (mepolizumab) prior authorization, specialist prescriber and eosinophil requirement: PA requires documented FDA‑approved diagnosis (e.g., severe eosinophilic asthma) and pre‑treatment blood eosinophil count ≥150 cells/µL within prior 12 months for asthma. Patient must have inadequate control despite medium/high‑dose inhaled corticosteroid plus at least one other maintenance therapy, and documentation of exacerbation history (systemic steroid courses or hospital/ER visits). Nucala may not be used concurrently with another monoclonal antibody therapy. Prescriber should be or consult with an asthma specialist. Coverage duration: 12 months.
- Pre‑treatment eosinophils ≥150 cells/µL within 12 months for asthma
- Do not use concurrently with another monoclonal antibody therapy
- Prescribed by or in consultation with asthma specialist/allergist/pulmonologist
- Coverage duration: 12 months
VENCLEXTA prior authorization & required diagnostics
VENCLEXTA (venetoclax) prior authorization: PA required with documentation of FDA‑approved diagnosis (e.g., CLL/SLL, AML per label) and intended regimen (monotherapy or combination per indication). Genetic testing or disease‑specific diagnostics should be provided if required by the indication. Coverage duration typically 6 months; approvals limited to FDA‑labeled dosing. Ensure no FDA‑labeled contraindications.
- Coverage duration: 6 months
- Provide indication‑specific diagnostics/genetic testing when required
- Limited to FDA‑labeled dosing
VALCHLOR prior authorization, prior therapy & quantity limit
VALCHLOR prior authorization and quantity limit: PA requires diagnosis for an FDA‑approved indication and documentation of prior skin‑directed therapy (e.g., topical corticosteroids, bexarotene topical gel). Initial approval: 6 months then 12 months if renewal criteria met. Approvals limited to quantity of two 60 g tubes per month. Ensure no FDA‑labeled contraindication.
- Initial: 6 months, then 12 months if renewal criteria met
- Quantity limit: two 60 g tubes per month
- Prior trial of at least one skin‑directed therapy required
XALKORI prior authorization & genetic testing requirement
XALKORI (crizotinib) prior authorization: PA requires documentation of appropriate diagnosis (e.g., ROS1‑positive or ALK‑positive metastatic NSCLC as labeled) and that any required genetic testing has been completed with supportive results. Provide documentation of prior therapy/intolerance only where specified by indication. Coverage duration typically 6 months. Limited to FDA‑labeled dosing.
- Genetic testing confirming actionable mutation required when applicable
- Coverage duration: 6 months
- Limited to FDA‑labeled dosing
Concurrent biologic/monoclonal antibody and other therapy exclusions
Concurrent biologic / monoclonal antibody exclusions and incompatible concurrent therapies: Many biologic agents (e.g., Actemra, Cimzia, Tyenne, Enbrel, Xeljanz/others where specified) may not be used concurrently with other biologic therapies; specific agents list concurrent‑use prohibitions (also applies to concurrent monoclonal antibodies, CFTR modulators, select RNA therapies). Check the product‑specific exclusion before approving concurrent coverage. Concurrent use of Inbrija with apomorphine is prohibited; Inbrija also requires provider attestation of inhaler education and pulmonary status (FEV1 and lung disease exclusion).
- Many products: 'May not use concurrently with other biologic therapies' — verify per drug
- Inbrija: may not use with apomorphine; requires inhaler education attestation and pulmonary function assessment
- CFTR modulators: do not use multiple modulators concurrently (e.g., Kalydeco, Orkambi, Trikafta)
Age restrictions, FDA‑labeled contraindications & denial risks
Age‑based and FDA‑labeled contraindication denial risks: Requests must confirm patient meets any age restrictions and has no FDA‑labeled contraindications or labeled limitations of use. An FDA‑labeled contraindication or limitation of use excludes coverage. If product label or guidelines require specialist prescriber, documentation of specialist involvement or consultation should be provided to avoid denial.
- Confirm age eligibility per product labeling
- If FDA‑labeled contraindication exists, coverage excluded
- Specialist prescriber documentation when required
Provider documentation checklist — required tests & attestations
Documentation requirements for specialty products (general examples): Submit diagnosis confirmation, relevant laboratory or diagnostic testing (e.g., genetic testing for targeted oncology agents, cardiac biopsy or 99mTc‑PYP imaging for ATTR‑CM, right heart catheterization for PAH agents, pulmonary function and HRCT for IPF), pre‑treatment labs (e.g., eosinophils for Nucala, hemoglobin for ESAs), prior therapy trials or contraindications, and prescriber attestation of education or technique when required (e.g., Inbrija inhaler education). For some products (e.g., Cayston) documentation must show presence of Pseudomonas aeruginosa. Where no documentation is specified, indicate 'no documentation requirements specified' in request.
- Oncology/targeted agents: provide genetic testing when required
- ATTR‑CM: biopsy or nuclear imaging + lab exclusion of AL amyloidosis
- PAH agents: right heart cath hemodynamics required
- IPF/ILD: HRCT pattern, PFTs (FVC, DLCO) and imaging per policy
- ESA: hemoglobin documentation
- Cayston: documentation of Pseudomonas aeruginosa
Product‑specific exclusions and special handling (examples)
Product‑specific exclusions and single‑use notes: VOWST limited to treatment of recurrent CDI per policy (not for primary CDI), requires definition of recurrent CDI (three or more prior episodes treated with antibiotics) and completion of bowel‑prep/magnesium citrate timing; Tolvaptan excludes concurrent use with Samsca and stage 5 CKD; Trikafta and other CFTR modulators cannot be used concurrently with other CFTR modulators. For certain medications (e.g., ADEM PAS, sodium oxybate, others where noted) check for specified drug interaction or concurrent therapy exclusions.
- VOWST: single treatment course; recurrent CDI definition and bowel prep documentation required
- Tolvaptan: exclude concurrent Samsca and stage 5 CKD
- CFTR modulators: do not combine with other CFTR modulators
Index‑only / no PA specified — operational note
Index‑only / no PA entries: Some index entries are informational only and have no PA rules or denial triggers defined. When a product appears only in the index without accompanying PA criteria, treat as having no authorization/denial criteria specified and refer to formulary/admin guidance.
- This section contains index entries only — no PA criteria provided
- If no PA rules present, follow standard formulary request procedures
Quantity, Duration and Refill Limits
Where Therapy is Administered / Coverage Setting
Biosimilar Preferences and Requirements
Clinical Thresholds and Key Numeric Criteria
Policy Background
This policy excerpt summarizes Medicare Part D prior authorization standards for selected specialty and pharmacy drugs: coverage generally requires documentation of an FDA‑approved diagnosis (or acceptable diagnostic confirmation), evidence of prior trial(s) or contraindication to preferred alternatives when specified, absence of FDA‑labeled contraindications, and dosing limited to FDA‑labeled guidelines. Many biologic agents require specialist prescribing or consultation, and typical initial coverage durations are 6 to 12 months depending on the product; renewals commonly require evidence of clinical benefit and a recent prescriber visit.
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