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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsmedimpact pharmacy specialty coverage update | Ope…
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    CurrentmedimpactPolicy N/A

    New products to market — pharmacy & specialty drug coverage criteria

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    Governs initial approval, renewal, age and quantity limits, and clinical criteria for several newly marketed specialty and pharmacy drugs and their PDL status for members covered by MedImpact's managed programs.

    Policy Summary
    Payermedimpact
    PolicyNew products to market — pharmacy & specialty drug coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and required documentation (diagnosis confirmation, specialist attestation, baseline tests) per the listed drug-specific criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    9products listed
    ≥12–adultage ranges
    providedquantity limits
    vary (1–6 mo)approval durations
    PA required

    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.

    PA required (new entities)

    Coverage and Medical Necessity Criteria

    Initial Therapy Criteria

    Brinsupri (brensocatib) — Initial Approval (covered when ALL of the following are met):

    Brensocatib initial: Provider attestation of a non-cystic fibrosis bronchiectasis diagnosis confirmed by chest computed tomography (CT) scan
    Specialist involvement: Prescribed by, or in consultation with, a pulmonologist or other specialist in the treatment of this disease
    Age and exacerbation criteria: Prescriber attestation that the patient meets ONE of: aged ≥18 with ≥2 exacerbations OR aged 12–17 with ≥1 exacerbation
    Antibiotic-treated exacerbations: Patient experienced exacerbations that required antibiotic treatment in the past 12 months
    Smoking status: Provider attestation that the patient is not a current smoker. If a smoker, documentation that they were counseled on harms and informed about smoking cessation options

    Renewal Therapy

    Brensocatib — Renewal (covered when ANY of the following are met):

    Renewal response: Provider attestation of positive response to therapy by ONE of: improvement or stabilization of symptoms; OR reduction in or stabilization of frequency, severity, or duration of exacerbations; OR reduction in decline of FEV1

    Approval duration: renewal 12 months

    Initial Therapy Criteria

    Orlynvah (sulopenem etzadroxil and probenecid) — Approval (covered when ALL of the following are met):

    Demographics: Patient is female AND ≥18 years of age AND weighs ≥40 kg
    Clinical diagnosis: Documented clinical diagnosis of uncomplicated urinary tract infection (uUTI) with at least 2 signs/symptoms (e.g., dysuria, urgency, frequency, lower abdominal pain)
    Lab confirmation: Urinalysis confirming pyuria and/or positive urinary nitrites
    Organism: Urine culture confirming or high clinical suspicion of uUTI caused by Escherichia coli OR Klebsiella pneumoniae OR Proteus mirabilis
    Prior therapy failure:

    Orlynvah (sulopenem etzadroxil and probenecid) is not eligible for coverage when used as step‑down therapy following infections that previously required intravenous (IV) antibiotics. The provider must attest that the requested use is for an uncomplicated uUTI meeting the documented oral‑therapy criteria and explicitly confirm the medication is not being used to complete or transition care after an IV antibiotic course.

    Initial Therapy Criteria

    Donidalorsen (Dawnzera) — Initial Approval (covered when ALL of the following are met):

    Diagnosis of hereditary angioedema (HAE)
    Diagnostic testing: Documentation of confirmed HAE by complement testing OR by C1 inhibitor protein and functional tests
    Use and prescriber: Prescribed for prophylactic use and by or in consultation with an immunologist, hematologist, or other specialist in HAE
    No concurrent prophylactic agent: Patient is not on concurrent alternative prophylactic agents for HAE (e.g., Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo)
    Age per PI: Patient meets the minimum age recommended by the package insert for this FDA-approved indication

    Initial Therapy Criteria

    Leqembi IQLIK (lecanemab-irmb) — Initial Approval (covered when ALL of the following are met):

    Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia due to AD
    Specialist involvement: Prescribed by, or in consultation with, a neurologist, geriatrician, psychiatrist, or other dementia specialist
    Prior IV therapy: Patient has completed 18 months of intravenous (IV) infusions of Leqembi prior to consideration of Leqembi IQLIK
    Amyloid confirmation: Prior confirmation of beta-amyloid plaques before initiation of Leqembi IV
    Baseline assessments: Documentation of baseline disease severity using MMSE OR MoCA OR CDR-Global AND baseline brain MRI AND ApoE ε4 genotype testing

    Renewal Therapy

    Leqembi IQLIK — Renewal (covered when ANY of the following are met):

    Clinical response: Positive clinical response evidenced by stabilization or slowing of disease progression as documented by ONE of: MMSE (e.g., decline ≤3 points/year); OR MoCA (e.g., score ≥15); OR CDR-Global score (0.5 or 1)

    Approval duration: renewal 12 months

    Initial Therapy Criteria

    Wayrilz (rilzabrutinib) — Initial Approval (covered when ALL of the following are met):

    Diagnosis of persistent or chronic immune thrombocytopenia (ITP)
    Specialist: Prescribed by, or in consultation with, a hematologist or liver disease specialist
    Platelet documentation: Documentation (e.g., progress note, laboratory report) of platelet count within the past 30 days
    Prior therapy failure: Trial and failure of at least one other therapy for persistent or chronic ITP (e.g., corticosteroids, IVIG, RhO(D), TPO receptor agonists) defined as not achieving platelet count ≥50 × 10^9/L
    Promacta contraindication: Trial and failure, allergy, contraindication, or intolerance to Promacta (eltrombopag), including potential drug–drug interactions as reasons

    Initial Therapy Criteria

    Blujepa (gepotidacin) — Uncomplicated UTI Approval (covered when ALL of the following are met):

    Demographics: Patient is female AND ≥12 years of age AND weighs ≥40 kg
    Clinical diagnosis: Documented clinical diagnosis of uncomplicated urinary tract infection (uUTI) with at least 2 signs/symptoms (e.g., dysuria, urgency, frequency, lower abdominal pain)
    Lab confirmation: Urinalysis confirming pyuria and/or positive urinary nitrites
    Organism: Urine culture confirming or high clinical suspicion of uUTI caused by Escherichia coli OR Klebsiella pneumoniae OR Citrobacter freundii complex OR Staphylococcus saprophyticus OR Enterococcus faecalis
    Prior therapy failure:

    Uncomplicated Urinary Tract Infection (uUTI)

    Covered when ALL of the following are met:

    uUTI initial coverage: Patient is female; AND patient is ≥12 years and weighs ≥40 kg; AND documented clinical diagnosis of uUTI with ≥2 signs/symptoms; AND urinalysis confirming pyuria and/or positive urinary nitrites; AND urine culture confirming or high clinical suspicion of uUTI caused by Escherichia coli OR Klebsiella pneumoniae OR Citrobacter freundii complex OR Staphylococcus saprophyticus OR Enterococcus faecalis; AND documented allergy, intolerance, contraindication, or therapeutic failure to ≥2 first-line oral agents appropriate to susceptibilities.

    Uncomplicated Urogenital Gonorrhea

    Covered when ALL of the following are met:

    Gonorrhea initial coverage: Patient is ≥12 years and weighs ≥45 kg; AND documented clinical diagnosis of uncomplicated urogenital gonorrhea confirmed by positive NAAT, culture, or Gram stain demonstrating susceptible Neisseria gonorrhoeae; AND patient has limited or no alternative treatment options (documented allergy, intolerance, contraindication, treatment failure, or resistance to standard therapies).

    Quantity limit: 20 tablets per 5-day course.

    Remibrutinib (Rhapsido) — CSU

    Covered when ALL of the following are met:

    Remibrutinib initial coverage: Diagnosis of chronic spontaneous urticaria (CSU); AND trial and failure of a ≥14-day course (or documented contraindication/intolerance) to an H1 antihistamine; AND trial and failure of a ≥1-month course (or documented contraindication/intolerance) to Xolair (omalizumab); AND prescribed by, or in consultation with, an allergist/immunologist or other applicable specialist; AND patient meets minimum age per package insert.

    Approval duration: 12 months initial and 12 months renewal; quantity limit: 2 tablets per day. DMS recommends step through one preferred agent (e.g., Xolair) prior to remibrutinib.

    Nerandomilast (Jascayd) — IPF/PPF

    Covered when ALL of the following are met:

    Nerandomilast initial coverage: Diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) consistent with current guidelines; AND provider attests other underlying causes for pulmonary fibrosis have been ruled out; AND Forced Vital Capacity (FVC) ≥45% of predicted; AND prescribed by, or in consultation with, a pulmonologist or specialist; AND patient meets minimum age per package insert.

    Approval duration: 12 months initial and 12 months renewal.

    Gepirone (Exxua) — MDD

    Covered when ALL of the following are met:

    Gepirone initial coverage: Diagnosis of major depressive disorder (MDD); AND prescriber attests to EKG monitoring during dosage titration and periodically during treatment; AND prescribed by, or in consultation with, a psychiatrist, neurologist, or qualified provider experienced in treating depression; AND patient has had at least a 2-week trial and failure, allergy, contraindication, or intolerance to 2 SSRIs OR 2 SNRIs; AND patient meets minimum age per package insert.

    Approval duration: 6 months initial, 12 months renewal; quantity limit: 2 tablets per day.

    Elinzanetant (Lynkuet) — Menopause VMS

    Covered when ALL of the following are met:

    Elinzanetant initial coverage: Diagnosis of menopause with moderate to severe vasomotor symptoms; AND no moderate to severe hepatic impairment; AND no end-stage renal disease; AND if female of childbearing potential, not pregnant or planning pregnancy; AND patient will avoid concomitant strong CYP3A4 inhibitors and grapefruit juice and avoid moderate to strong CYP3A4 inducers; AND prescriber attests baseline liver function tests (total and direct bilirubin, ALT, AST, ALP) are not elevated ≥2× ULN and will perform follow-up liver testing as outlined in PI; AND patient has trialed and failed or is not a candidate for hormone therapy.

    Approval duration: 3 months initial, 12 months renewal; renewal requires symptom improvement and no treatment-limiting liver adverse effects; age limit: ≥18 years; quantity limit: 2 capsules per day.

    Class Selection & PA Requirement

    Covered when following class-level administrative criteria are met:

    Class selection and PA: DMS will select preferred agents based on economic evaluation; at least 2 unique chemical entities should be preferred. Agents not selected as preferred will be considered non-preferred and will require prior authorization (PA). For any new chemical entity in specified classes (e.g., Glucocorticoids, Inhaled; Intranasal Rhinitis Agents; Macrolides/Ketolides; GLP-1 Receptor Agonists; Immunosuppressives, Oral), require PA until reviewed by the P&T Committee.minimum 2 unique chemical entities preferred

    If an agent is not selected as preferred it is non-preferred and will require PA until P&T review

    Elinzanetant (Lynkuet) is excluded from coverage for patients with moderate to severe hepatic impairment and for those with end‑stage renal disease (with or without hemodialysis). Prior to initiation the prescriber must attest that baseline liver function tests (total and direct bilirubin, ALT, AST, ALP) are not elevated ≥ 2× ULN and that planned follow‑up liver testing will occur per the prescribing information; absence of these assessments or evidence of the contraindicating conditions may result in denial.

    Leqembi IQLIK continuation requires documentation that the patient previously completed an 18‑month course of intravenous (IV) Leqembi. In addition, prior initiation of IV Leqembi must have been supported by amyloid confirmation (beta‑amyloid plaque confirmation) and baseline assessments including a cognitive severity score (MMSE, MoCA, or CDR‑Global), a baseline brain MRI, and ApoE ε4 genotype testing. Requests that lack documentation of prior IV therapy completion, baseline amyloid confirmation, or the required baseline testing are subject to denial.

    All newly marketed chemical entities in inhaled bronchodilator and inhaled glucocorticoid classes will require prior authorization (PA) until the P&T Committee completes a clinical and economic review. New products in these classes that are not selected as preferred will be treated as non‑preferred and require PA for coverage; prescribers should include required clinical documentation with PA requests to avoid denial.

    Initial Therapy Requirements

    Brensocatib Initial

    Brinsupri initial therapy criteria

    See Brensocatib initial: Provider attestation of CT-confirmed non-cystic fibrosis bronchiectasis; specialist involvement; age/exacerbation criteria met; antibiotic-treated exacerbations in prior 12 months; smoking status documented.

    Initial approval duration: 6 months

    Orlynvah Initial

    Orlynvah initial therapy criteria

    See Orlynvah initial: Patient female, ≥18 years and ≥40 kg; documented uUTI with ≥2 signs/symptoms; urinalysis and urine culture consistent with susceptible organisms; failure/intolerance to ≥2 first-line oral agents; not used as step-down after IV antibiotics.

    Initial approval duration: 1 month; quantity limit: 10 tablets per 5-day course

    Leqembi Initial

    Renewal / Continuation Requirements

    Continuation Therapy

    Renewal/continuation requirements for covered agents

    Brensocatib renewal: Provider attestation of improvement or stabilization of symptoms OR reduction/stabilization of exacerbations OR reduction in decline of FEV1

    Approval duration: renewal 12 months

    Leqembi renewal: Positive clinical response evidenced by MMSE, MoCA, or CDR-Global criteria as documented by the prescriber

    Approval duration: renewal 12 months

    Wayrilz renewal: Documentation of response to therapy as assessed by the prescriber

    Approval duration: renewal 6 months

    Renewal/Continuation

    Provider Requirements, Prior Authorization, and Documentation

    Prior Authorization

    Brensocatib (Brinsupri) — prior authorization required

    Submit a prior authorization request for Brinsupri (brensocatib) when coverage criteria are met. Initial approvals are granted for 6 months; renewals require documentation supporting continued benefit and are approved for 12 months.

    • Prescriber attestation of CT‑confirmed non‑CF bronchiectasis and specialist involvement required.
    • Renewal based on improvement/stabilization or reduction/stabilization of exacerbations or decline in FEV1.
    Prior Authorization

    Orlynvah — prior authorization and quantity limit

    Submit a prior authorization for Orlynvah (sulopenem etzadroxil and probenecid) when criteria are met; initial approvals are for 1 month and quantity is limited to 10 tablets per 5‑day course.

    • Provider must attest Orlynvah is not being used as step‑down therapy after IV antibiotics.
    • Document allergy/intolerance/therapeutic failure to ≥2 first‑line oral agents and required urinalysis/culture.

    Age, Weight, and Clinical Thresholds for Coding

    Weight threshold for uUTI agents (≥ 40 kg)
    uUTI weight thresholdPatient must weigh ≥ 40 kg for uncomplicated UTI agents (Blujepa/Orlynvah).
    Gepotidacin (Blujepa) noteBlujepa uUTI criteria specify female patients ≥12 years and weight ≥40 kg.
    Orlynvah noteOrlynvah initial criteria require patient ≥18 years and weight ≥40 kg (adult female population).
    Age thresholds for multiple agents
    Brinsupri (brensocatib) ageMinimum age: ≥12 years (special criteria: 12–17 with ≥1 exacerbation; ≥18 with ≥2 exacerbations).
    Leqembi IQLIK (lecanemab-irmb) ageAge limits for Leqembi IQLIK continuation/renewal: ≥50 and ≤90 years per policy.

    Step Therapy Tables and Recommendations

    StepRequirementApplies to
    1Documented allergy, intolerance, contraindication, or therapeutic failure to at least 2 first-line oral agents for uncomplicated UTI (examples: sulfamethoxazole/trimethoprim, amoxicillin-clavulanate, cefdinir, fosfomycin, cefpodoxime, nitrofurantoin) as appropriate based on organism susceptibilitiesOrlynvah (sulopenem etzadroxil and probenecid) and Blujepa (gepotidacin) — uUTI
    StepRecommended prior agentNotes / Rationale
    1Step through one preferred agent (example: Xolair [omalizumab])DMS Pharmacy recommends trial of one preferred agent prior to remibrutinib (Rhapsido); recommendation based on clinical evaluation and cost considerations
    PolicyImplicationAction required
    Non-preferred agents require prior authorizationAgents not selected as preferred will be considered non-preferred and require PA until P&T reviewSubmit prior authorization with required documentation per drug-specific criteria; no specific step exchanges specified

    Quantity Limits and Dosing Constraints

    Brinsupri (brensocatib) — quantity limit entry
    Quantity limitBrinsupri (brensocatib) quantity limit: 1 (unit as per product/PI).
    Approval durationsInitial approval 6 months; renewal 12 months (policy context for use).
    MoA summaryBrensocatib is an oral reversible DPP‑1 inhibitor targeting neutrophil serine proteases.
    Leqembi IQLIK (lecanemab-irmb) — 0.8 mL (80 mg) dosing/quantity entry
    Dose/quantity per periodLeqembi IQLIK (lecanemab-irmb) quantity/dose entry: 0.8 mL (80 mg) per 28 days (1 syringe per week referenced in policy).
    Approval durationsInitial approval 6 months; renewal 12 months required with baseline testing and prior IV therapy documentation.

    Definitions and Background

    Background — This policy covers several newly listed agents across multiple therapeutic areas. Key mechanism and indication summaries: Brensocatib is an oral reversible DPP‑1 inhibitor intended to reduce neutrophil serine protease activity for non‑cystic fibrosis bronchiectasis; Donidalorsen is an ASO‑GalNAc conjugate that reduces prekallikrein synthesis for hereditary angioedema prophylaxis; Blujepa (gepotidacin) is a novel bacterial topoisomerase inhibitor for uncomplicated urinary tract infection; Remibrutinib is a BTK inhibitor for chronic spontaneous urticaria; Nerandomilast is a PDE4 inhibitor with antifibrotic properties for IPF/PPF; Gepirone is a selective 5‑HT1A agent for major depressive disorder; and Elinzanetant is an NK1/NK3 receptor antagonist intended for moderate to severe vasomotor symptoms of menopause. Where applicable, coverage is conditioned on specialist involvement, required baseline testing, prior therapy trials/failures, and age or weight thresholds as specified in the criteria.

    Brensocatib (brensocatib) — mechanism of action (short definition)
    Brensocatib (MoA)Brensocatib is an oral, competitive, reversible DPP‑1 inhibitor that reduces activation of neutrophil serine proteases implicated in bronchiectasis.
    Therapeutic intentUsed to reduce neutrophil serine protease activity driving bronchiectasis pathophysiology and airway inflammation.
    Approval durations

    Site of Care and Infusion Requirements

    Note

    Leqembi IQLIK — infusion center/infusion setting implied for IV course

    Leqembi IQLIK continuation assumes prior IV administration and specialist oversight; initial IV course is implied to be delivered in an outpatient infusion/infusion‑center setting.

    Note

    Site‑of‑care — miscellaneous (no specifics)

    No site‑of‑care specifics provided for other agents in this fragment.

    Policy Summary
    Payermedimpact
    PolicyNew products to market — pharmacy & specialty drug coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and required documentation (diagnosis confirmation, specialist attestation, baseline tests) per the listed drug-specific criteria.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaInitial Therapy RequirementsRenewal / Continuation RequirementsProvider Requirements, Prior Authorization, and DocumentationAge, Weight, and Clinical Thresholds for CodingStep Therapy Tables and RecommendationsQuantity Limits and Dosing ConstraintsDefinitions and BackgroundSite of Care and Infusion Requirements
    Documented allergy, intolerance, contraindication, or therapeutic failure to at least 2 first-line oral agents for uUTI as appropriate based on organism susceptibilities
    Not step-down: Provider attests Orlynvah is not being used as step-down therapy after infections that required IV antibiotics

    Initial approval duration: 1 month; quantity limit: 10 tablets per 5-day course

    Monotherapy: Leqembi IQLIK will not be combined with other amyloid beta–directed antibodies

    Quantity limit: 7.2 mL per 28 days (1 syringe per week); age limit: ≥50 and ≤90

    Quantity limit: 2 tablets per day

    Documented allergy, intolerance, contraindication, or therapeutic failure to at least 2 first-line oral agents for uUTI as appropriate based on susceptibilities

    Leqembi IQLIK initial therapy criteria

    See Leqembi initial: Diagnosis of MCI due to AD or mild AD dementia; specialist involvement; completed 18 months of IV Leqembi with prior amyloid confirmation, baseline cognitive testing, brain MRI and ApoE ε4 genotype testing; not combined with other amyloid beta-directed antibodies.

    Quantity limit: 0.8 mL (80 mg) per 28 days; age 50–90

    Initial therapy requirements

    Initial approval requires meeting the specific diagnosis, prior therapy trials/failures, specialist involvement, baseline testing, and age per package insert.

    Cross-cutting initial prerequisites: Prescriber attestation of the documented diagnosis per indication; documentation of trials and failures or contraindications of listed prior therapies where required; prescribed by or in consultation with the indicated specialist; baseline testing and monitoring completed per product labeling (e.g., labs, ECG, imaging); patient meets age requirements per package insert.

    Refer to individual drug sections for details.

    Renewal criteria for listed specialty agents require prescriber attestation of clinical benefit or stability.

    Remibrutinib renewal: Patient has experienced disease improvement and/or stabilization as assessed by the prescriber

    Quantity limit: 2 tablets per day; approval duration: 12 months renewal

    Nerandomilast renewal: Physician attestation that patient has experienced stability or slowing of decline based on an objective measure (e.g., absolute change from baseline in FVC)

    Approval duration: 12 months renewal

    Gepirone renewal: Patient has experienced disease improvement and/or stabilization such as improvement in depressive symptoms, as assessed by the prescriber

    Quantity limit: 2 tablets per day; approval duration: 12 months renewal

    Prior Authorization

    Leqembi IQLIK — prior authorization and baseline testing

    Leqembi IQLIK (lecanemab‑irmb) requires prior authorization; initial approval is 6 months with 12‑month renewals and documentation of prior IV Leqembi and baseline testing is required.

    • Must document completion of 18 months of IV Leqembi prior to IQLIK.
    • Baseline beta‑amyloid confirmation, baseline cognitive testing (MMSE, MoCA, or CDR‑Global), brain MRI, and ApoE ε4 genotype testing required.
    Prior Authorization

    Administrative PA required for new class members

    Prior authorization is required for any new chemical entity in the specified classes until reviewed by the P&T Committee; submit PA requests per administrative rule.

    • This applies to new members of Bronchodilators, Glucocorticoids (Inhaled), Macrolides/Ketolides, GLP‑1 agonists, Immunosuppressives, and other listed classes.
    • Non‑preferred status pending P&T review means PA will be required.
    Prior Authorization

    PA required for listed non‑PDL specialty drugs

    Non‑PDL specialty agents listed (remibrutinib, nerandomilast, gepirone, elinzanetant) require prior authorization and must meet the specified approval criteria.

    • PA requests must include specialist attestation, baseline tests, and prior therapy trials/failures as specified per agent.
    Prior Authorization

    PA required for new chemical entities until P&T review

    For any new chemical entity in the listed classes, require prior authorization until reviewed by the P&T Committee; submit PA per policy.

    • Agents not selected as preferred will be considered non‑preferred and require PA.
    Step Therapy

    uUTI — step therapy (failure of ≥2 preferred oral agents required)

    Before Orlynvah or Blujepa will be authorized for uUTI, document allergy/intolerance/contraindication or therapeutic failure to at least two first‑line oral agents.

    • Acceptable first‑line agents examples listed in policy (e.g., sulfamethoxazole/trimethoprim, amoxicillin‑clavulanate, cefdinir, fosfomycin, cefpodoxime, nitrofurantoin).
    Step Therapy

    Remibrutinib — recommended step through preferred agent

    DMS Pharmacy recommends stepping through one preferred agent (example: Xolair) prior to initiating remibrutinib (Rhapsido); document prior trial or reason for not using the preferred agent.

    • Provide documentation of trial/failure, contraindication, or intolerance to the preferred agent when applicable.
    Step Therapy

    Step therapy — non‑preferred agents require PA

    Non‑preferred agents require prior authorization; formulary status and PA will apply where agents are not selected as preferred — no specific step exchanges are defined in this fragment.

    • If an agent is non‑preferred, submit PA with supporting documentation per class and drug criteria.
    Documentation Required

    ITP — recent platelet count required for Wayrilz

    For Wayrilz (rilzabrutinib) initial authorization, include documentation of platelet count within the past 30 days.

    • Attach recent laboratory report or progress note showing platelet count.
    Documentation Required

    Bronchiectasis confirmation and specialist attestation for Brinsupri

    For Brinsupri (brensocatib) PA, include provider attestation that bronchiectasis is confirmed by chest CT and note pulmonologist or specialist involvement and exacerbation history.

    • Document number of exacerbations and antibiotic‑treated events in the prior 12 months and smoking status/counseling.
    Documentation Required

    uUTI diagnostic documentation required

    For uUTI agent requests (Orlynvah, Blujepa), include urinalysis and urine culture results plus documentation of at least two characteristic signs or symptoms.

    • Urinalysis must confirm pyuria and/or positive nitrites; urine culture should identify organism and susceptibilities when available.
    Documentation Required

    uUTI — required documentation for authorization

    uUTI PA requests must include a clinical diagnosis with ≥2 signs/symptoms, urinalysis confirming pyuria and/or positive nitrites, urine culture results (organism and susceptibilities when available), and documentation of allergy/intolerance/therapeutic failure to ≥2 first‑line oral agents.

    • Ensure patient demographics meet criteria (female; age and weight thresholds) before submission.
    Documentation Required

    Gonorrhea — required diagnostic documentation

    For uncomplicated urogenital gonorrhea, include documented positive NAAT, culture, or Gram stain confirming susceptible Neisseria gonorrhoeae and documentation that limited or no alternative treatments are available.

    • Document allergy, intolerance, contraindication, treatment failure, or resistance to standard therapies as justification.
    Documentation Required

    Specialty drug — prescriber/specialist attestation and baseline testing

    For specialty drug PA requests, include prescriber attestation of specialist involvement, patient age per the package insert, and required baseline testing (e.g., liver tests for elinzanetant, EKG monitoring for gepirone) as specified in the policy.

    • Attach specialist consultation notes and baseline test results referenced in the drug‑specific criteria.
    Prior Authorization

    PA required for new chemical entities (administrative)

    New chemical entities in a class require prior authorization until reviewed by the P&T Committee; submit PA per class‑level administrative guidance.

    • This administrative PA requirement applies across the listed therapeutic classes until the P&T Committee review is complete.
    Denial Risk

    Brensocatib — denial triggers (missing CT or specialist attestation)

    Brinsupri (Brensocatib) may be denied if the PA lacks provider attestation of CT‑confirmed non‑CF bronchiectasis or documentation of pulmonologist/specialist consultation.

    • Ensure imaging confirmation and specialist involvement are in the submitted record to avoid denial.
    Denial Risk

    Orlynvah — denial triggers (missing susceptibilities or prior trials)

    Orlynvah may be denied if the request does not document organism susceptibility or does not show allergy/intolerance/therapeutic failure to at least two first‑line oral agents.

    • Lack of urinalysis/culture or missing prior therapy documentation are common denial reasons.
    Denial Risk

    Leqembi IQLIK — denial triggers (missing prior IV course or baseline testing)

    Leqembi IQLIK requests will be denied if documentation does not show prior 18 months of IV Leqembi, baseline amyloid confirmation, baseline cognitive testing, brain MRI, and ApoE ε4 genotype testing.

    • Include all baseline assessments and prior IV treatment documentation to meet initial criteria.
    Denial Risk

    uUTI — potential denial triggers (missing demographics, symptoms, labs, or prior trials)

    uUTI requests may be denied if they do not document female sex, age ≥12 years, weight ≥40 kg, at least two signs/symptoms, and required urinalysis/culture or prior therapy failures to ≥2 first‑line oral agents.

    • Verify demographics, symptom documentation, urinalysis/culture, and prior therapy history before submission.
    Denial Risk

    Remibrutinib — potential denial triggers (missing prior trials or specialist involvement)

    Remibrutinib (Rhapsido) requests lacking documentation of trial/failure of an H1 antihistamine and Xolair (omalizumab), or lacking specialist prescription/consultation, may be denied.

    • Include treatment history and specialist attestation to reduce risk of denial.
    Denial Risk

    Nerandomilast — potential denial triggers (FVC, specialist, exclusion of other causes)

    Nerandomilast (Jascayd) requests may be denied if they do not document FVC ≥45% predicted, specialist involvement, or that alternative causes of pulmonary fibrosis have been excluded.

    • Provide recent pulmonary function testing and pulmonologist consultation notes in the PA.
    Denial Risk

    Elinzanetant — potential denial triggers (missing liver tests or prior therapy evidence)

    Elinzanetant (Lynkuet) requests lacking baseline liver tests within acceptable limits, evidence of trial/failure of hormone therapy, or documentation of avoidance of contraindicated concomitant drugs may be denied.

    • Attach baseline LFTs showing values <2× ULN and documentation of prior hormone therapy trial or contraindication.
    Denial Risk

    Non‑preferred agents — require prior authorization

    Drugs not selected as preferred will be considered non‑preferred and will require prior authorization; submit PA with supporting documentation when requesting non‑preferred agents.

    • Class‑level guidance: DMS will select preferred agents; non‑preferred agents require PA until P&T decisions are made.
    Wayrilz (rilzabrutinib) ageWayrilz (and other specified agents) age requirement: ≥18 years for initial/renewal use where noted.
    Forced Vital Capacity (FVC) requirement (≥ 45% predicted)
    FVC requirementForced Vital Capacity (FVC) must be ≥ 45% of predicted for nerandomilast (Jascayd) initial approval.
    Specialist involvementPrescribed by or in consultation with a pulmonologist or specialist for IPF/PPF cases.
    Exclusion of other causesProvider must attest that other underlying causes of pulmonary fibrosis have been ruled out.
    Patient weight for uUTI (≥ 40 kg)
    uUTI weight (duplicate)Patient must weigh ≥ 40 kg for uncomplicated UTI agents (policy restates female patients ≥12 years and ≥40 kg).
    Clinical contextBlujepa criteria specify female patients ≥12 years and weight ≥40 kg; urinalysis and culture required.
    Step therapy relevanceDocumentation of failure/intolerance to ≥2 first-line oral agents required alongside the weight threshold.
    Patient weight for gonorrhea (≥ 45 kg)
    Gonorrhea weight thresholdPatient must weigh ≥ 45 kg for uncomplicated urogenital gonorrhea therapy.
    Age requirementMinimum age for gonorrhea therapy specified as ≥12 years in policy.
    Quantity contextPolicy pairs the weight/age requirement with a 20-tablet, 5-day quantity limit for therapy.
    Prior SSRI/SNRI trials for gepirone (2 SSRIs or 2 SNRIs required)
    Prior SSRI/SNRI requirementPatient must have trialed and failed (or have intolerance/contraindication to) 2 SSRIs or 2 SNRIs prior to gepirone (Exxua).
    Trial duration examplePolicy specifies at least a 2-week trial and failure for required prior agents where applicable.
    Monitoring notePrescriber must monitor EKG during dose titration and periodically during treatment per gepirone criteria.
    Age limitsAge eligibility noted as ≥50 and ≤90 years for Leqembi IQLIK continuation/renewal.
    Wayrilz (rilzabrutinib) — quantity limit
    Wayrilz quantity limitWayrilz (rilzabrutinib) quantity limit: 2 tablets per day as specified in policy.
    Age requirementAge limit for Wayrilz: ≥18 years.
    Renewal documentationRenewal requires documentation of response to therapy (progress note or lab report).
    Orlynvah (sulopenem etzadroxil and probenecid) — quantity limit 10 tablets per 5-day course
    Orlynvah quantity limitOrlynvah (sulopenem etzadroxil and probenecid) quantity limit: 10 tablets per 5-day course.
    Initial approval durationInitial approval duration noted as 1 month when criteria are met.
    Use restrictionPolicy requires attestation that Orlynvah is not being used as step-down therapy after IV antibiotics.
    Unspecified agent for gonorrhea therapy — quantity limit 20 tablets (5-day course)
    Gonorrhea agent quantity limitQuantity limit for uncomplicated urogenital gonorrhea therapy: 20 tablets per 5-day course.
    Patient eligibilityApplies when patient is ≥12 years and weight ≥45 kg with documented susceptible Neisseria gonorrhoeae and limited alternatives.
    Therapy contextUsed when documented allergy, intolerance, contraindication, treatment failure, or resistance to standard therapies exists.
    Remibrutinib (Rhapsido) — quantity limit 2 tablets/day
    Remibrutinib quantity limitRemibrutinib (Rhapsido) quantity limit: 2 tablets per day.
    Indication/approvalApproved for chronic spontaneous urticaria with initial and renewal durations of 12 months.
    Step recommendationDMS recommends stepping through one preferred agent (e.g., Xolair) prior to remibrutinib per policy guidance.
    Gepirone (Exxua) — quantity limit 2 (units as per PI)
    Gepirone quantity limitGepirone (Exxua) quantity limit: 2 tablets per day as specified in policy.
    Indication and requirementsFor MDD: requires EKG monitoring during titration; prior trial/failure of 2 SSRIs or 2 SNRIs required.
    Approval durationsInitial approval 6 months; renewal 12 months per policy.
    Elinzanetant (Lynkuet) — quantity limit 2 (per day)
    Elinzanetant quantity limitElinzanetant (Lynkuet) quantity limit: 2 capsules per day (policy lists 2 per day).
    Age and contraindicationsAge limit ≥18 years; excluded in moderate-severe hepatic impairment and end-stage renal disease per initial criteria.
    Monitoring requirementBaseline and follow-up liver function testing required; renewal requires symptom improvement and no treatment-limiting liver adverse effects.
    Initial approval 6 months; renewal 12 months per policy context.
    Donidalorsen — mechanism / definition
    Donidalorsen (MoA)Donidalorsen is an ASO‑GalNAc conjugate that mediates RNase H1‑dependent degradation of PKK mRNA, lowering prekallikrein to prevent excessive bradykinin in HAE.
    IndicationUsed for prophylactic treatment of hereditary angioedema (HAE) with specialist involvement required.
    Approval durationsInitial approval 6 months; renewal 12 months as noted in policy.
    Gepotidacin (Blujepa) — mechanism / definition
    Gepotidacin (Blujepa) MoAGepotidacin is a first‑in‑class triazaacenaphthylene bacterial topoisomerase inhibitor with a dual‑target mechanism on DNA gyrase and topoisomerase IV for uUTI.
    Indication specificsApproved for uncomplicated UTI in adults; policy defines use in females ≥12 years and ≥40 kg with lab confirmation and prior therapy failures.
    Resistance advantageMechanism overcomes usual resistance mechanisms affecting current first‑line options (policy language).
    Remibrutinib (Rhapsido) — mechanism / definition
    Remibrutinib (MoA)Remibrutinib inhibits Bruton tyrosine kinase (BTK), blocking mast cell and basophil degranulation and preventing release of histamine and other pro‑inflammatory mediators.
    IndicationPolicy lists remibrutinib for chronic spontaneous urticaria with 12‑month approval durations.
    Quantity limitQuantity limit: 2 tablets per day as specified in policy.
    Nerandomilast (Jascayd) — mechanism / definition
    Nerandomilast (MoA)Nerandomilast is a phosphodiesterase‑4 (PDE4) inhibitor with anti‑fibrotic and immunomodulatory effects relevant to IPF and PPF.
    FVC requirement reminderPolicy requires FVC ≥45% predicted and specialist involvement for initiation.
    Approval durationsInitial and renewal approval durations: 12 months each as listed.
    Gepirone (Exxua) — mechanism / definition
    Gepirone (MoA)Gepirone modulates serotonergic activity via selective 5‑HT1A receptor agonist activity in the CNS.
    Clinical requirementsFor MDD, policy requires EKG monitoring during titration and prior trials/failures of 2 SSRIs or 2 SNRIs.
    Quantity/renewalQuantity limit: 2 tablets per day; initial approval 6 months, renewal 12 months.
    Elinzanetant (Lynkuet) — mechanism / definition
    Elinzanetant (MoA)Elinzanetant is an NK1 and NK3 receptor antagonist that modulates neuronal activity in thermoregulation associated with hot flashes.
    Age and safetyPolicy sets age limit ≥18 years and requires baseline liver function tests and avoidance in moderate‑severe hepatic impairment or ESRD.
    Quantity/renewalQuantity limit: 2 capsules per day; initial approval 3 months, renewal 12 months with symptom improvement and no treatment‑limiting liver effects.