Priority Health Medicare Prior Authorization Criteria — Pharmacy & Specialty Drugs
Customize your policy alerts
Sign up for priority health Policy 26328 alerts
Get alerted when Policy 26328 changes without checking for updates manually.
Monitor payer policy activity
Governs prior authorization, coverage duration, exclusions, required documentation, and clinical prerequisites for specified pharmacy and specialty drugs for Priority Health Medicare members. Affects prescribers requesting coverage for listed products.
No material clinical or coverage changes in this revision.
Coverage Criteria (Product-specific)
ACTHAR coverage criteria
Covered when ALL of the following are met:
Reauthorization requires demonstrated clinical benefit.
Adalimumab and similar biologics — class criteria and prohibitions
Covered when ALL of the following are met:
Condition-specific prior therapy requirements (RA, AS, psoriasis, HS, uveitis, JIA) apply as detailed in policy (e.g., try and fail one traditional non-biologic immunomodulator for RA).
Aimovig criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of decreased migraine days compared to baseline.
Amvuttra HATTR-PN and ATTR-CM criteria
Covered when ALL of the following are met:
Must not be used in patients with primary (light-chain) amyloidosis; reauthorization requires documentation of positive clinical response vs baseline.
Reauthorization requires documentation of positive clinical response (e.g., reduced CV hospitalizations).
Arikayce MAC lung disease criteria
Covered when ALL of the following are met:
Reauthorization requires negative sputum culture within last 30 days and application of ATS/IDSA guidance.
Benlysta SLE and lupus nephritis criteria
Covered when ALL of the following are met:
For lupus nephritis initial requests: kidney biopsy confirming class 3, 4, and/or 5 disease and standard LN therapy required; reauthorization requires evidence of clinical improvement.
Braftovi
Covered when ALL of the following are met:
Covers medically-accepted indications when mutation documented.
Brivaracetam
Covered when ALL of the following are met:
Prerequisite therapy required.
Brukinsa
Covered when ALL of the following are met:
Prescriber documentation as required.
Calcipotriene-betameth
Covered when ALL of the following are met:
Prerequisite therapy required.
Caplyta
Covered when ALL of the following are met:
Prerequisite therapy required.
Clobazam
Covered when ALL of the following are met:
Prerequisite therapy required.
Clozapine (dispersible)
Covered when ALL of the following are met:
Prerequisite therapy required.
Cobenfy
Covered when ALL of the following are met:
Prerequisite therapy required.
Colistimethate
Covered when ALL of the following are met:
Site-of-care: hospital outpatient or infusion center preferred.
Cortrophin
Covered when ALL of the following are met:
Prescriber documentation of prior trials required.
Cosentyx — biologic criteria and prior-therapy requirements
Covered when ALL of the following are met:
Dosing per FDA label or supported compendia.
Cresemba
Covered when ALL of the following are met:
Prescriber documentation required.
Cystadrops / Cystaran
Covered when ALL of the following are met:
Prescriber documentation as specified.
Dalfampridine ER
Covered when ALL of the following are met:
Prescriber documentation required.
Diacomit
Covered when ALL of the following are met:
Prerequisite therapy required.
Dihydroergotamine nasal
Covered when ALL of the following are met:
Prerequisite therapy required.
Drizalma / Duloxetine-related
Covered when ALL of the following are met:
Prerequisite therapy required.
Droxidopa
Covered when ALL of the following are met:
Prescriber documentation required.
Dupixent — multiple indications and reauthorization examples
Covered when ALL of the following are met:
Prescriber specialist involvement required; dosing per label.
Prescriber specialist required.
Reauthorization requires documented clinical benefit.
Ebglyss — AD initial and reauthorization
Covered when ALL of the following are met:
Reauthorization requires positive clinical response and maintenance dosing details.
Dupixent initial and reauthorization for chronic urticaria and bullous pemphigoid
Covered when ALL of the following are met:
Reauthorization requires clinical benefit compared to baseline.
Bullous pemphigoid coverage
Covered when ALL of the following are met:
Reauthorization requires documentation supporting reduction in blister formation and itching.
Eltrombopag ITP criteria
Covered when ALL of the following are met:
Reauthorization requires platelet count <400 x10^9/L and documentation of positive response.
Emgality criteria
Covered when ALL of the following are met:
Must not be used in combination with other CGRP antagonist therapy.
Dosing per FDA label.
Enbrel condition-specific step requirements
Covered when ALL of the following are met:
Dose per FDA label.
EoE criteria
Covered when ALL of the following are met:
Reauthorization requires positive response (reduced eosinophils or symptoms).
Evrysdi criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of positive clinical response.
Fasenra indications
Covered when ALL of the following are met:
Reauthorization requires documentation of clinical benefit vs baseline; prescriber specialist required.
Reauthorization requires documentation of clinical benefit.
Growth hormone therapy criteria
Covered when ALL of the following are met:
Prescriber must be endocrinologist, gastroenterologist, or nephrologist; coverage duration 1 year.
Prescriber involvement as specified.
Biologic therapy criteria — class-wide rules
Covered when ALL of the following are met:
Documentation of prior therapies and responses required; condition-specific step therapy before many biologics (try and fail traditional non-biologic immunomodulator for RA, etc.).
Prescriber specialist required.
HAE coverage criteria
Covered when ALL of the following are met:
Reauthorization requires decreased attack frequency or documentation of prior approved syringes and favorable clinical response as appropriate.
IVIG criteria
Covered when ALL of the following are met:
Reauthorization requires demonstrated clinical benefit where applicable.
IDHIFA — mutation documentation
Covered when ALL of the following are met:
Prescriber documentation required.
Kerendia coverage criteria
Covered when ALL of the following are met:
CKD with T2DM requests require prior SGLT2i or GLP-1 RA trial or documented rationale for switching; must be on maximally tolerated ACEI or ARB.
Levetiracetam formulation criteria
Covered when ALL of the following are met:
Prescriber documentation required.
Livtencity criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of response (e.g., CMV DNA level).
Nexletol/Nexlizet criteria
Covered when ALL of the following are met:
Coverage duration 2 years.
NURTEC criteria
Covered when ALL of the following are met:
Initial and reauth duration 1 year; reauth requires decreased migraine days.
Prescriber documentation required.
Nulibry criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of beneficial response in neurological or developmental measures.
Representative initial coverage rules
Representative initial coverage rules (examples) — covered when ALL of the following relevant criteria are met:
Reauthorization requires documentation of improvement or stabilization.
Prescriber documentation required.
Rezdiffra initial therapy
Rezdiffra initial authorization — covered when ALL of the following are met:
Policy source text indicates additional 'trial and failure with' requirement (excerpt truncated). Prescriber must be gastroenterologist or hepatologist.
Rezdiffra reauthorization
Rezdiffra reauthorization — covered when ALL of the following are met:
Reauthorization duration one year.
Biologic initial therapy — class and product examples
Covered when ALL of the following are met:
Combination with other biologics, Otezla, or JAK inhibitors for same condition is prohibited.
Sodium oxybate criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of decreased daytime sleepiness or cataplexy.
Tavneos initial and reauthorization
Covered when ALL of the following are met:
Reauthorization requires reduction in BVAS and steroid dose.
Teriparatide coverage
Covered when ALL of the following are met:
Prescriber must be an endocrinologist; coverage two years.
Testosterone therapy criteria
Covered when ALL of the following are met:
Coverage duration two years; prescriber documentation required.
Testosterone (topical/transdermal solution) — Initial coverage
Covered when ALL of the following are met:
Coverage duration two years.
tolvaptan — Indication-specific criteria
Covered when ONE of the following indication-specific branches is met:
Coverage duration for hyponatremia: 30 days.
Coverage duration for ADPKD: 2 years.
tetrabenazine — safety and documentation
Covered when ALL of the following are met:
Coverage duration two years.
TYENNE SUBCUTANEOUS — initial and reauthorization
Covered when ALL of the following are met:
Prescriber must be a specialist or have consulted one; reauthorization requires improvement for SSc‑ILD.
VOYDEYA — PNH criteria
Covered when ALL of the following are met:
Initial and reauth duration one year; reauthorization requires improvement in EVH symptoms and lab markers.
VYNDAMAX — ATTR-CM criteria
Covered when ALL of the following are met:
Initial coverage one year; reauthorization requires clinical response vs baseline.
Winrevair Initial Therapy
Covered when ALL of the following are met:
Prescribed by or in consultation with a specialist; initial one year, reauth two years requiring demonstrated benefit (WHO class, risk status, or 6MWD).
Xolair Initial Therapy
Covered when ALL of the following are met (indication-specific):
Prescriber specialist required; initial 1 year, reauth 2 years; reauth requires documentation of clinical benefit and current weight/IgE.
Reauth requires continued diet use and documentation of benefit.
Reauthorization requires clinical benefit documented.
Reauthorization requires clinical benefit and continued intranasal steroid use.
Xifaxan Coverage Limits
Coverage limits and exclusions:
Prescriber documentation of prior trials required.
Yorvipath Initial Therapy
Covered when ALL of the following are met:
Initial and reauth duration one year; reauth requires improved serum calcium.
Ztalmy Initial Therapy
Covered when ALL of the following are met:
Coverage duration two years.
Biologic/JAKi Combination and Prior Therapy Requirements
Covered when ALL of the following are met (class-wide biologic/JAKi rules):
Failure defined as intolerance or inability to improve the condition; reauthorization requires demonstrated clinical benefit.
Examples of indications expressly excluded for ACTHAR are listed in the policy. ACTHAR is not covered for acute gouty arthritis, severe psoriasis, and atopic dermatitis. (For covered ACTHAR indications, the policy requires documentation of prior therapies and a therapeutic trial of a parenteral glucocorticoid and Cortrophin for all indications except infantile spasms, with quantity limited to FDA-supported dosing and reauthorization requiring demonstrated clinical benefit.)
The policy enforces a class-wide prohibition on combining adalimumab-class and other listed biologic agents with other biologic drugs, Otezla (apremilast), or Janus kinase inhibitors (JAKis). Requests that show concomitant use of these agents for the same condition risk denial; documentation must show prior therapy trials and that the agent will not be administered in combination with excluded therapies.
This same combination prohibition is applied consistently across several biologic product entries (for example, Cosentyx, Dupixent, Ebglyss and other anti‑inflammatory biologics) and is reiterated in the biologics and JAKi coverage sections of the policy; prescribers must follow indication‑specific step/ prior‑therapy requirements and attest no excluded concurrent biologic/JAKi or Otezla use.
Amvuttra is restricted to transthyretin (TTR)-mediated indications and the policy explicitly excludes use in patients with primary (light‑chain) amyloidosis. Initial coverage for HATTR‑PN and ATTR‑CM requires diagnostic confirmation (including genetic testing) and condition‑specific documentation (e.g., baseline PND score ≤ IIIb for HATTR‑PN; tafamidis failure/intolerance and cardiac imaging/NYHA class for ATTR‑CM). Requests for primary (light‑chain) amyloidosis will not be approved.
The policy excludes nebulized or inhalation administration of colistimethate. Coverage is limited to intravenous (IV) or intramuscular (IM) use only and requires documentation that the infection is proven or strongly suspected to be caused by susceptible organisms (culture and susceptibility or supporting local epidemiology); infectious disease specialist prescribing or consultation is required.
The document provides multiple examples of biologic/JAK inhibitor combination prohibitions. Specific biologic products (for example, Cosentyx, Dupixent, Ebglyss and other listed biologics) state they must not be used in combination with other biologic drugs or JAK inhibitors for the same condition. Such combination use is an explicit exclusion and may be a basis for denial if documented in a request.
Providers must therefore document prior therapy trials and that the requested biologic will be used alone (or per permitted sequencing) — the policy repeatedly cites this combination prohibition and treats concurrent biologic + JAKi (or biologic + biologic, or biologic + Otezla where stated) as a disqualifying scenario.
Summary: the policy applies product- and class-wide combination restrictions for many biologic and immunomodulatory agents. In practice this means the requested biologic cannot be co‑prescribed with other biologics, Otezla, or JAK inhibitors for the same condition unless the product entry explicitly permits it. These product combination restrictions are reiterated throughout the biologics and JAKi sections and are enforced during prior authorization review.
Coding and Measurable Thresholds
| 337 | Page or internal identifier shown on document |
| N/A | Product list includes many NDC/brand entries; no explicit CPT/HCPCS/ICD-10 codes listed in this segment. |
| KISQALI FEMARA (200 MG DOSE) | listed product entry |
| KISQALI FEMARA (400 MG DOSE) | listed product entry |
| KISQALI FEMARA (600 MG DOSE) | listed product entry |
| levetiracetam oral tablet disintegrating soluble 250 mg, 500 mg | formulation-specific product entry |
| LIVTENCITY | product entry |
| NEXLETOL | product entry |
| NEXLIZET | product entry |
| NURTEC | product entry |
| No codes listed |
| 300 ng/dL | testosterone threshold referenced for hypogonadism |
| No codes listed |
Provider Actions, Prior Authorization & Documentation
General prior authorization and duration
Submit a prior authorization for specialty products and include documentation of prior therapies and responses; quantity/dosing must follow FDA labeling and reauthorization generally requires demonstrated clinical benefit (durations vary by product).
- Prior authorization required for listed specialty products.
- Provide documentation of prior therapies and responses to treatment.
- Quantity/dosing limited to FDA-approved label; reauthorization requires evidence of clinical benefit; typical durations 1–2 years.
Aimovig prior authorization
For Aimovig initial migraine prevention requests, prior authorization requires documentation of at least four migraine days per month; initial approval is 1 year and reauthorization requires documentation of decreased migraine days (reauth 2 years in some entries).
- Must document ≥4 migraine days per month for prevention.
- Dosing must align with FDA labeling.
- Initial authorization: 1 year; reauthorization requires decreased migraine days per month.
Prior authorization requirement for listed products
Submit a prior authorization for each listed product in the index portion of the policy and include the product-specific required documentation (diagnosis confirmation, prior trial/failure documentation, prescriber specialty) as specified in each product entry.
- Prior authorization required for the listed products; follow each product’s criteria.
- Typical coverage durations are one or two years depending on product.
Initial prior authorization requirements
For initial authorization requests, include documentation of the diagnosis and evidence of prior therapy failure or intolerance as specified by the product (examples: chronic urticaria >6 weeks plus H1 antihistamine failure; bullous pemphigoid with steroid and steroid‑sparing agent trial).
- Provide diagnosis confirmation per product rules.
- Document prior trial(s) and reason for failure/intolerance as defined by the policy.
Atopic dermatitis prior authorization
For atopic dermatitis products that require it, prior authorization must document moderate‑to‑severe disease and trial/failure of Rinvoq and Dupixent before approval of the specified agent.
- Confirm moderate-to-severe atopic dermatitis.
- Document trial and inadequate response or intolerance to Rinvoq and Dupixent.
Prior authorization required
Many specialty products require prior authorization; submit indication‑specific documentation and note that coverage durations vary (commonly 1–2 years).
- Follow product-specific criteria for labs, trials, and prescriber restrictions.
- Expect initial approvals commonly 1–2 years with reauthorization requirements.
Prior auth for HAE agents
Prior authorization for hereditary angioedema (HAE) agents (e.g., icatibant) requires submission of diagnostic labs (C4, C1‑INH protein, C1‑INH function) and that the prescriber be a specialist experienced in HAE.
- Submit C4, C1‑INH protein, and C1‑INH function lab results confirming diagnosis.
- Prescriber must be an allergist/immunologist/hematologist or other HAE‑experienced specialist.
KISQALI FEMARA PA requirement
KISQALI FEMARA entries require prior authorization; coverage duration is two years and indications are the medically‑accepted or FDA‑approved indications listed in the policy.
- Submit PA for KISQALI FEMARA formulations.
- Coverage duration: two years; indications: medically‑accepted/FDA‑approved per entry.
Levetiracetam disintegrating tablet PA
Levetiracetam disintegrating/soluble tablet formulations require prior authorization documenting inability to use the generic tablet and a trial and failure of one other generic anticonvulsant.
- Document why the standard generic levetiracetam tablet cannot be used (e.g., dysphagia).
- Provide records showing trial and inadequate response or intolerance to one other generic anticonvulsant.
Livtencity PA and sequencing
For Livtencity, submit a prior authorization with baseline CMV DNA confirming diagnosis, documentation of prior trial/failure with listed antivirals, and note Livtencity must not be used concomitantly with other CMV antivirals; initial coverage duration is 8 weeks and reauthorization requires evidence of response (e.g., CMV DNA).
- Provide baseline CMV DNA level confirming active infection.
- Document trial and failure with ganciclovir, valganciclovir, cidofovir, or foscarnet.
- Do not use concurrently with other CMV antivirals; initial coverage 8 weeks.
Nexletol PA criteria
Nexletol prior authorization requires submission of the most recent LDL‑C and documentation of prior therapy: trial of a high‑intensity statin plus ezetimibe for ≥4 weeks with LDL‑C ≥70 mg/dL, or documented statin intolerance; coverage duration typically two years.
- Submit most recent LDL‑C level (policy threshold ≥70 mg/dL).
- Document trial of high‑intensity statin + ezetimibe ≥4 weeks OR statin intolerance (≥2 statins with symptoms).
Nexlizet PA criteria
Nexlizet prior authorization mirrors Nexletol: submit LDL‑C and prior statin/ezetimibe trial documentation or statin intolerance; Nexlizet must not be used with PCSK9 inhibitors or Juxtapid; coverage duration commonly two years.
- Submit most recent LDL‑C and prior therapy documentation as for Nexletol.
- Do not combine with PCSK9 inhibitors (e.g., Repatha) or Juxtapid.
Nurtec PA requirements
Nurtec prior authorization is required for both episodic prevention and acute use: prevention initial requests require 4–14 migraine days per month; acute use requires trial/failure of a generic triptan unless contraindicated; initial and reauthorization durations are typically 1 year.
- Episodic prevention: document 4–14 migraine days/month.
- Acute use: document trial and failure of a generic triptan unless contraindicated.
- Initial/reauthorization duration: 1 year.
Prior authorization required for listed products
Many listed specialty products require prior authorization with product‑specific documentation (diagnostic confirmation, prior therapy trials, prescriber specialty); follow each product’s criteria when submitting PA requests.
- Review the product entry for required labs, trials, and prescriber qualifications.
- Expect initial approvals commonly 1–2 years with reauthorization requirements.
Rezdiffra prior authorization
Rezdiffra prior authorization requires documentation of MASH diagnosis with fibrosis stage F2–F3 (by biopsy or NITs), current weight and FDA‑aligned dosing (80 mg/day if <100 kg; 100 mg/day if ≥100 kg), and provider attestation that therapy will be used with diet and exercise.
- Provide evidence of MASH and fibrosis stage F2–F3 (biopsy or NITs).
- Submit current weight and confirm dosing per FDA (80 mg/day if <100 kg; 100 mg/day if ≥100 kg).
- Include attestation that diet and exercise accompany therapy.
Biologics prior authorization
Many biologic agents require prior authorization that includes documentation of prior therapies, specialist prescribing or consultation, and adherence to combination‑use prohibitions (no concurrent use with other biologics, Otezla, or JAK inhibitors where stated).
- Provide prior therapy history and reasons for failure/intolerance.
- Prescriber should be a specialist or document specialist consultation.
- Do not combine with other biologics, Otezla, or JAK inhibitors when policy excludes combination use.
Product-specific prior authorization required
Many products require product‑specific prior authorization—include indication‑specific labs, diagnostic confirmation, and prior treatment trials as listed in each product entry.
- Follow each product’s required lab or diagnostic submissions (e.g., IDH2 for IDHIFA, baseline CMV DNA for Livtencity).
- Provide prior therapy trial documentation as required.
Winrevair PA requirement
Winrevair prior authorization requires right heart catheterization confirming WHO Group 1 PAH, WHO functional class II–III, documentation of prior failure of dual PDE5 inhibitor + endothelin receptor antagonist therapy, and that Winrevair will be initiated as add‑on therapy; initial coverage is one year.
- Submit RHC confirming PAH (WHO Group 1) and WHO FC II–III.
- Document failure of dual therapy with a PDE5 inhibitor and an endothelin receptor antagonist.
- Confirm Winrevair will be added to current regimen; initial coverage: 1 year.
Xolair PA requirement
Xolair prior authorization requires baseline testing (IgE ≥30 IU/mL and allergen reactivity for asthma where applicable), patient weight, trial/failure of indicated prior therapies (e.g., ICS/LABA for asthma), specialist prescriber or consultation, and initial authorization is typically one year with reauthorization requirements for documented benefit.
- Provide baseline IgE ≥30 IU/mL (baseline = before IgE‑lowering therapy) and allergen testing as applicable.
- Submit patient weight and documentation of prior therapy trials/failures.
- Prescriber must be or consult a specialist; initial 1 year, reauth typically 2 years with evidence of benefit.
Xifaxan PA requirement
Xifaxan prior authorization excludes coverage for SIBO and limits IBS‑D to no more than three 14‑day courses; traveler’s diarrhea is limited to three days and requires prior trial/failure with azithromycin for TD, and hepatic encephalopathy requires trial/failure with lactulose.
- SIBO: not covered (explicit exclusion).
- IBS‑D: coverage limited to ≤3 total 14‑day courses.
- Traveler’s diarrhea: coverage ≤3 days and requires prior azithromycin trial/failure.
- Hepatic encephalopathy: requires prior lactulose trial/failure.
Index — drug/product listings
The product/index listings in the policy are for reference; the index sections list products and formulations but do not themselves state specific prior authorization rules or billing codes—use the product entries elsewhere in the policy for PA actions.
- Index entries list product names/formulations and page references.
- Index sections do not constitute PA rules—submit PA per product criteria.
Index — no PA rules
Do not rely on the index alone for PA rules: this index section does not contain explicit prior authorization requirements or affected billing codes; use the product criteria sections for action.
- Index-only pages do not state prior authorization triggers.
- Refer to individual product entries for PA requirements.
Product-specific prerequisite therapy
Some products require specific prerequisite therapies before authorization (example: ACTHAR and Cortrophin often require a prior trial of a parenteral glucocorticoid; follow each product entry for the exact required prior therapy).
- Include documentation of prerequisite therapy trials (parenteral glucocorticoid for ACTHAR/Cortrophin except infantile spasms).
- Supporting documentation must show inadequate response, intolerance, or contraindication.
Auvelity step therapy
Auvelity requires prior failure of an SSRI or SNRI and one atypical antidepressant (e.g., bupropion, mirtazapine); trials are defined as at least 4 weeks and must be documented when submitting PA.
- Document trials of an SSRI or SNRI and one atypical antidepressant with dates and outcomes.
- Failure defined as inability to improve depressive symptoms after ≥4 weeks.
Step therapy requirements
Many products impose step therapy: before requesting a PA, document completion and failure/intolerance of the specified prior trials (examples include topical steroid + calcipotriene for calcipotriene‑betameth suspension; non‑oral triptan and Nurtec for dihydroergotamine nasal; Rinvoq and Dupixent for Ebglyss).
- Provide evidence of required step trials and reason for failure/intolerance.
- Follow product‑specific trial durations where stated (e.g., 2 months for topical trials, 4 weeks for inhaler trials).
Enbrel step therapy
Enbrel prior authorization requires a trial and failure of one traditional non‑biologic immunomodulator for RA (e.g., methotrexate); document the trial and outcome when submitting PA.
- Document trial and inadequate response or intolerance to a traditional non‑biologic immunomodulator.
- Prescriber should be a specialist or document specialist consultation.
Fasenra step therapy
Fasenra prior authorization requires a blood eosinophil count meeting the policy threshold (≥150 cells/µL within 6 weeks OR ≥300 cells/µL in prior 12 months) and a trial/failure of an ICS/LABA inhaler within the past 6 months; include labs and prior therapy documentation in the PA.
- Submit blood eosinophil count per threshold.
- Document trial and failure of one ICS/LABA within past 6 months.
Step therapy/failure requirements
Biologic agents commonly require step therapy and prior treatment failures (e.g., traditional non‑biologic immunomodulators for psoriasis/RA); document the required prior trials and outcomes to support PA.
- Provide prior‑therapy history showing trial and failure or intolerance.
- Ensure documentation meets condition‑specific step requirements in the product entry.
Levetiracetam step therapy
Levetiracetam disintegrating/soluble tablets require documentation of trial and failure with one other generic anticonvulsant before approval; include medical records showing the trial and outcome.
- Document the prior anticonvulsant trial (agent, dates, dose) and reason for failure/intolerance.
- Include rationale why standard generic tablet cannot be used.
Nexletol/Nexlizet step requirement
Nexletol and Nexlizet step‑therapy requirement: document trial of a high‑intensity statin plus ezetimibe for ≥4 weeks with LDL‑C ≥70 mg/dL OR trial of ezetimibe ≥4 weeks with documented statin intolerance (attempt of ≥2 statins with symptoms).
- Submit LDL‑C and dates/outcomes of statin + ezetimibe trial or ezetimibe trial with documented statin intolerance.
- Statin intolerance defined as trial of ≥2 statins with statin‑related symptoms.
Nurtec step requirement
Nurtec acute use requires documentation of trial and failure of a generic triptan (unless contraindicated) before approval for acute therapy; for prevention document migraine day frequency per policy.
- Acute: document prior triptan trial and failure or contraindication.
- Prevention: document migraine days/month (4–14).
Prior therapy and objective disease documentation
For products requiring objective disease documentation, include prior therapy records and disease activity measures as specified (examples: Crohn's/UC shortened‑interval dosing requires two of symptoms, imaging, fecal calprotectin >120, or CRP ≥300 plus trough levels and initial response).
- Include objective disease measures where required (fecal calprotectin, CRP, imaging).
- Provide prior therapy trough levels and evidence of initial response when relevant.
Amvuttra diagnostic documentation
Amvuttra initial prior authorization must include genetic confirmation of a TTR mutation and a baseline PND score ≤ IIIb, plus supporting diagnostic evidence (biopsy/genetic testing or radionuclide imaging with Grade 2–3 uptake if used).
- Submit genetic test confirming TTR mutation.
- Provide baseline PND score ≤ IIIb and supporting diagnostic documentation.
Arikayce microbiology and treatment history
For Arikayce initial PA, submit a sputum culture confirming MAC lung disease and documentation of ≥6 months of multidrug background regimen with failure to obtain negative sputum cultures; reauthorization requires a negative sputum culture within 30 days.
- Attach sputum culture supporting MAC diagnosis.
- Provide prior multidrug regimen details and evidence of failure after ≥6 months.
- For reauth, supply negative sputum culture within prior 30 days.
Benlysta disease severity and biopsy documentation
Benlysta initial PA requires a SELENA‑SLEDAI score ≥6 and either anti‑dsDNA >30 IU/mL or ANA >1:80; for lupus nephritis include kidney biopsy confirming class 3, 4, and/or 5 disease and evidence of standard LN therapy.
- Provide SELENA‑SLEDAI ≥6 and anti‑dsDNA >30 IU/mL or ANA >1:80 for SLE.
- For LN, include kidney biopsy class and documentation of standard LN therapy.
BRAF V600 mutation documentation
Braftovi prior authorization must include documentation of BRAF V600 mutation status.
- Attach BRAF V600 mutation test results to the PA request.
Topical steroid plus calcipotriene trial
For calcipotriene‑betameth suspension PA, document trial and inadequate response to a generic topical steroid for the scalp in combination with generic calcipotriene solution.
- Provide details of topical steroid trial (agent, duration) and outcome.
- Include trial of generic calcipotriene solution and inadequate response documentation.
Caplyta prior therapy documentation
Caplyta PA requests must include documentation of prior therapies and responses appropriate to the indication (e.g., trials of specified generic atypical antipsychotics for schizophrenia) and patient age (must be ≥18 where required).
- Provide prior therapy trials with dates, doses, and outcomes.
- Confirm patient meets age and indication requirements per product entry.
Colistimethate infection documentation
Colistimethate PA must include culture/susceptibility or local epidemiology supporting use for suspected/proven susceptible bacteria and must document IV or IM use (nebulized/inhalation not covered); prescriber should be or consult an infectious disease specialist.
- Attach culture & susceptibility results or local epidemiology justification.
- Confirm route: IV or IM only; inhalation/nebulization is excluded.
- Document infectious disease specialist involvement.
Cortrophin prerequisite trials and reauth
Cortrophin PA requires documentation of prerequisite trials (e.g., parenteral glucocorticoid plus another agent depending on indication), adherence to FDA dosing limits, and reauthorization requires demonstrated clinical benefit.
- Provide records of required prior parenteral glucocorticoid and other specified trials.
- Quantity limited to FDA‑approved dosing; include rationale and evidence of benefit for reauth.
Cosentyx prior therapy documentation
Cosentyx PA must include documentation of prior therapies/responses and specialist involvement; do not combine Cosentyx with other biologics, Otezla, or JAK inhibitors and follow indication‑specific prior trial requirements (e.g., NSAID for AS, traditional immunomodulator for psoriasis).
- Provide prior therapy history and outcomes; prescriber should be a specialist or consult one.
- Confirm no concurrent excluded biologic/JAKi/Otezla use.
- Document condition‑specific prior trial(s) as required.
Dihydroergotamine prerequisite trials
Dihydroergotamine nasal PA requires documentation of trial and failure of one non‑oral triptan (e.g., sumatriptan nasal/injection) and trial/failure of Nurtec ODT before approval.
- Document non‑oral triptan trial and outcome.
- Document Nurtec ODT trial and outcome.
Duloxetine trial and failure documentation
Drizalma/duloxetine‑related product PA must include documentation of inability to use duloxetine (generic) and trial/failure of one other generic antidepressant.
- Provide reason duloxetine cannot be used.
- Document trial of another generic antidepressant and inadequate response or intolerance.
Dupixent indication-specific documentation
Dupixent PA requests need condition‑specific documentation (e.g., blood eosinophils for asthma, esophageal biopsy ≥15 eos/HPF for EoE, topical steroid trials for AD); reauthorization requires demonstrated clinical benefit versus baseline.
- Include labs/biopsy/imaging as required by indication (e.g., eosinophils, EoE biopsy).
- Document prior therapy trials and outcomes per indication.
- Provide evidence of benefit for reauthorization.
Ebglyss prior therapy documentation
Ebglyss initial PA for atopic dermatitis requires confirmation of moderate‑to‑severe AD and documented trial/failure of Rinvoq and Dupixent; reauthorization requires documentation of positive clinical response and maintenance dosing details.
- Confirm moderate-to-severe AD and include clinical exam/findings.
- Provide evidence of Rinvoq and Dupixent trials and inadequate response or intolerance.
- For reauth, document clinical improvement and specify maintenance dosing schedule.
Diagnosis and prior therapy documentation
Provide diagnosis confirmation and prior trial/failure documentation as required by the product (examples: chronic urticaria >6 weeks plus one H1 antihistamine; bullous pemphigoid with steroid and steroid‑sparing agent trials).
- Attach diagnostic evidence and records of prior therapy trials with dates/outcomes.
- Use policy definitions for 'trial and failure' when documenting.
Fasenra required labs and prior therapy
Fasenra PA must include blood eosinophil lab results meeting policy thresholds (≥150 cells/µL within 6 weeks OR ≥300 cells/µL in prior 12 months) and documentation of trial/failure of an ICS/LABA within the past 6 months.
- Submit recent blood eosinophil count per threshold.
- Provide details of ICS/LABA trial and inadequate response.
Evrysdi documentation
Evrysdi PA for SMA requires genetic test confirmation of the diagnosis and documentation that the patient is not receiving Spinraza or gene therapy (Zolgensma); reauthorization requires evidence of positive clinical response compared to baseline.
- Attach genetic testing confirming SMA.
- Confirm patient is not receiving Spinraza or prior/planned gene therapy.
- For reauth, submit measures showing clinical improvement or slowed progression.
Growth hormone documentation
Growth hormone PA for children requires an untreated growth velocity curve ≥1 year showing growth velocity <10th percentile for bone age and gender, bone age at least 1 year behind chronological age (with exceptions), and GH deficiency confirmation by two stimulation tests or equivalent labs; prescriber must be a specialist.
- Submit untreated growth velocity curve (≥1 year) and bone age data.
- Provide GH stimulation test results or equivalent IGF‑1/IGFBP3 findings.
- Prescriber must be endocrinologist, gastroenterologist, or nephrologist.
HAE diagnostic labs
For HAE products, include C4, C1‑INH protein, and C1‑INH function lab results confirming the diagnosis when submitting prior authorization.
- Attach C4, C1‑INH protein, and C1‑INH function test results.
- Ensure prescriber specialty requirement is met (HAE‑experienced specialist).
IVIG dosing documentation
IVIG prior authorization must include current weight, requested dose, documentation that dosing follows FDA labeling or accepted standards, and note that dose should be adjusted if BMI ≥30 or actual body weight ≥20% above ideal; IVIG is not covered for chronic/routine use in stable myasthenia gravis (only acute myasthenic crisis).
- Provide current weight and requested dose with dosing rationale.
- Document adherence to FDA label or accepted standards; adjust dosing if BMI ≥30 or weight ≥20% above ideal.
- For myasthenia gravis, IVIG covered only for acute crisis with decompensation.
IDH2 mutation documentation
IDHIFA prior authorization must include documentation of an IDH2 mutation.
- Attach molecular testing confirming IDH2 mutation.
Documentation for levetiracetam formulation
For levetiracetam disintegrating/soluble tablets, include medical records documenting inability to use the generic tablet and trial/failure of one other generic anticonvulsant.
- Document why generic tablet is not usable (e.g., dysphagia).
- Provide trial/failure record for one other generic anticonvulsant.
Livtencity documentation requirements
Livtencity PA must include baseline CMV DNA confirming diagnosis and documentation of prior antiviral trial/failure; reauthorization requires documentation of response such as CMV DNA levels; do not co‑administer other CMV antivirals.
- Submit baseline CMV DNA level and prior antiviral history (ganciclovir, valganciclovir, cidofovir, foscarnet).
- Do not use concurrently with other CMV antivirals; include response data for reauth.
LDL-C and prior therapy documentation
Nexletol/Nexlizet prior authorization requires submission of the most recent LDL‑C and documentation of prior therapies and responses (trial of high‑intensity statin + ezetimibe ≥4 weeks or statin intolerance documented by trial of ≥2 statins); include the LDL value and therapy history.
- Attach most recent LDL‑C value (policy threshold ≥70 mg/dL).
- Provide dates and outcomes of statin/ezetimibe trials or documented statin intolerance.
Nulibry genetic testing and reauth
Nulibry prior authorization requires confirmed diagnosis of MoCD Type A by genetic testing (submit results); reauthorization requires documentation of beneficial response in neurological, motor, or developmental measures.
- Attach genetic test results confirming MoCD Type A.
- For reauth, provide measures demonstrating clinical benefit versus baseline.
Mercaptopurine formulation documentation
Mercaptopurine oral suspension PA requires documentation supporting inability to use the generic mercaptopurine tablet.
- Provide medical justification why the tablet formulation cannot be used.
HRCT documentation
For indications that require HRCT (e.g., pirfenidone, nintedanib, other ILD agents), include High‑Resolution CT imaging confirming the diagnosis; absence of HRCT may trigger denial.
- Attach HRCT demonstrating diagnosis per product requirements.
- Lack of HRCT documentation may lead to denial.
Genetic testing for Orkambi
Orkambi prior authorization requires laboratory confirmation of homozygous F508del CFTR mutation; include the genetic test in the PA.
- Submit genetic testing confirming homozygous F508del mutation.
Radicava clinical documentation
Radicava initial PA requires documentation of definite or probable ALS per revised El Escorial/Arlie House criteria, diagnosis within 2 years, baseline ALSFRS‑R score ≥24, and %FVC ≥80%; reauthorization must show evidence that Radicava is slowing progression.
- Attach ALS diagnostic criteria documentation and timelines.
- Provide baseline ALSFRS‑R and %FVC values meeting thresholds.
Revcovi monitoring data
For Revcovi prior authorization include trough plasma ADA activity and trough dAXP levels, current weight, requested dose, and provider attestation regarding dose adjustment to achieve target monitoring parameters.
- Provide trough ADA activity and trough dAXP monitoring data.
- Include weight, requested dose, and attestation to monitoring/adjustment plan.
Rezdiffra documentation
Rezdiffra initial PA must include MASH diagnosis with biopsy or NIT evidence of fibrosis stage F2–F3, current weight, FDA‑aligned dosing (80 mg/day if <100 kg; 100 mg/day if ≥100 kg), and provider attestation that therapy will be used with diet and exercise; missing these items may trigger denial.
- Submit biopsy or NITs documenting F2–F3 fibrosis and current weight.
- Confirm dosing per weight cutoffs and include provider attestation for diet/exercise.
Initial Therapy Criteria (Selected Products)
Continuation / Reauthorization Criteria
Step Therapy Requirements
| Required prior/concurrent therapy |
|---|
| SELENA-SLEDAI score >=6 and either anti-dsDNA >30 IU/mL or ANA >1:80; taking two of steroid, immunosuppressant, and/or hydroxychloroquine for >=12 weeks each |
| For lupus nephritis: kidney biopsy confirming class 3, 4, and/or 5 disease AND receiving standard LN therapy (e.g., mycophenolate or azathioprine plus a steroid) |
| Prior therapy requirement |
|---|
| Must try and fail an SSRI or SNRI (>=4 weeks) and one atypical antidepressant (e.g., bupropion, mirtazapine) before Auvelity |
| Step therapy completion examples |
|---|
| Calcipotriene-betameth: trial and failure with a generic topical steroid for the scalp plus generic calcipotriene solution |
| Brivaracetam: trial and failure with generic levetiracetam and at least one other generic anticonvulsant |
| Cortrophin: trial of a parenteral glucocorticoid plus one other medication for the condition (infantile spasms exempt) |
| Dihydroergotamine nasal: trial and failure of one non-oral triptan AND trial and failure of Nurtec ODT |
| Drizalma/duloxetine-related: inability to use duloxetine AND trial and failure with one other generic antidepressant |
| Dupixent (EOE): PPI or swallowed topical steroid >=2 months then persistent symptoms and biopsy >=15 eos/HPF |
| Ebglyss for AD: trial and failure to Rinvoq AND trial and failure to Dupixent |
| General biologics (RA, PsO, AS): try and fail one traditional non-biologic immunomodulator or condition-specific first-line agent |
| Atopic dermatitis step requirement |
|---|
| Confirmation of moderate-to-severe atopic dermatitis AND trial and failure to Rinvoq AND trial and failure to Dupixent prior to coverage |
| Required prior antidepressant trials for MDD |
|---|
| Trial and failure with two generic antidepressants from different classes |
| One of the two must be either bupropion or mirtazapine |
| Traditional immunomodulator trial before biologics |
|---|
| For RA and psoriasis: trial and failure of one traditional non-biologic immunomodulator (e.g., methotrexate, leflunomide, cyclosporine) required prior to many biologics |
| For ankylosing spondylitis: trial and failure of one NSAID required prior to biologic therapy |
| Kerendia prior therapy / evidence |
|---|
| For HF (LVEF >=40%): patient must be on at least two standard heart failure medications from different classes at appropriate doses and prescribed by/with cardiology involvement |
| For CKD with T2DM: must have tried an SGLT2 inhibitor or GLP-1 RA unless intolerant/contraindicated and be on maximally tolerated ACEI or ARB |
| Levetiracetam disintegrating tablet step flag |
|---|
| Must document inability to use generic levetiracetam tablet AND trial and failure with one other generic anticonvulsant before approval |
| Nexletol / Nexlizet step requirement |
|---|
| Submit most recent LDL-C; must have tried high-intensity statin plus ezetimibe >=4 weeks with LDL-C >=70 mg/dL OR tried ezetimibe >=4 weeks with documented statin intolerance after >=2 statins |
| Must not be used with PCSK9 inhibitors or Juxtapid |
| NURTEC acute step requirement |
|---|
| For acute NURTEC: unless contraindicated, patient must try and fail one generic triptan prior to approval |
| Step therapy yes/no (aggregated examples) |
|---|
| Yes — many products require completion of specified prior trials and documentation of failure/intolerance (examples: biologics, Nexletol/Nexlizet, Livtencity, levetiracetam disintegrating tablet) |
| Yes — acute NURTEC requires prior triptan trial unless contraindicated |
| Yes — certain antidepressant and antipsychotic products require multiple generic trials (see product-specific rules) |
| Antipsychotic / other step requirements |
|---|
| Secuado and similar antipsychotic step: trial and failure with two generic antipsychotics (each >=28 days) required |
| Other products: product-specific step trials of generics required prior to branded alternatives (see individual entries) |
| Sodium oxybate prior stimulant/modafinil trials |
|---|
| Must try and fail amphetamine salts/dextroamphetamine/methylphenidate AND modafinil or armodafinil prior to sodium oxybate coverage |
| Branded antidepressant step examples |
|---|
| Some branded antidepressants require trial and failure of two generic antidepressants (SSRIs, SNRIs, bupropion, mirtazapine or trazodone) before approval |
| Documentation must show inability to improve depressive symptoms after at least 4 weeks on each agent |
| Biologic prior therapy example (ustekinumab-aekn) |
|---|
| For psoriasis biologics (e.g., ustekinumab-aekn): trial and failure of one traditional non-biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) required prior to coverage |
| Aggregated required prior therapy trials (examples) |
|---|
| Winrevair (PAH): trial and failure of dual therapy with a PDE5 inhibitor AND an endothelin receptor antagonist required prior to Winrevair add-on |
| Xeljanz (and other JAKi/biologics): must not be used with other biologics/Otezla/JAKis and often require trial of a traditional non-biologic immunomodulator for RA |
| Various anticonvulsant / CNS agents: require documented trials of specified generics or alternative therapies before branded formulations |
Quantity Limits and Dosing Constraints
Site of Care and Prescriber Qualifications
Background and Scope
This extract summarizes Priority Health Medicare prior authorization rules for pharmacy and specialty drugs. It sets the scope for coverage decisions including indication‑specific eligibility, required documentation (diagnostic tests, prior‑therapy trials, laboratory thresholds), prescriber or specialist requirements, quantity and site‑of‑care constraints, and explicit exclusions (for example, combination biologic/JAKi prohibitions and administration route exclusions). The policy applies to listed specialty and pharmacy products and requires prior authorization with submission of the supporting clinical documentation described in each product section.
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.