ModifiedmedimpactPolicy N/A

Cobenfy™ (xanomeline–trospium) formulary recommendation for schizophrenia

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P&T Committee recommendations for placing Cobenfy™ (xanomeline with trospium) on the formulary as Non-Preferred within second‑generation antipsychotics; includes initial approval and renewal criteria for coverage of schizophrenia.

Policy Summary

Payermedimpact

PolicyCobenfy™ (xanomeline–trospium) formulary recommendation for schizophrenia

Policy CodePolicy N/A

Change TypeNew product additions & criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior trial/failure of a preferred agent, baseline liver enzymes and bilirubin, and prescriber attestation of clinical benefit for renewals.

SourceLink

POLICY UPDATE CHANGES

New product to market: Cobenfy™ recommended for addition and placement as Non-Preferred within Central Nervous System - Antipsychotics, Second Generation (Atypical) and Injectable.

Initial and renewal medical necessity criteria for Cobenfy™ describing diagnosis requirement, prior trial/failure of a preferred agent, baseline liver enzyme and bilirubin measurement, and age per package insert.

Renewal requires prescriber attestation of clinically significant improvement or stabilization in signs and symptoms.

New product to market: Livdelzi® appears as a covered/non-preferred product with defined initiation and renewal criteria.

Renewal requires prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms.

Age limit specified: 18 years of age or older.

Quantity limit specified: 2 capsules per day.

Multiple new products to market (e.g., Livdelzi, Vyalev, Ebglyss, Xdemvy, Yorvipath, Palopegteriparatide, Duvyzat, Nemluvio) with recommended coverage criteria were introduced.

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ModifiedmedimpactPolicy N/A

Cobenfy™ (xanomeline–trospium) formulary recommendation for schizophrenia

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Policy Summary

Payermedimpact

PolicyCobenfy™ (xanomeline–trospium) formulary recommendation for schizophrenia

Policy CodePolicy N/A

Change TypeNew product additions & criteria

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

New product to market: Cobenfy™ recommended for addition and placement as Non-Preferred within Central Nervous System - Antipsychotics, Second Generation (Atypical) and Injectable.

Renewal requires prescriber attestation of clinically significant improvement or stabilization in signs and symptoms.

New product to market: Livdelzi® appears as a covered/non-preferred product with defined initiation and renewal criteria.

Renewal requires prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms.

Age limit specified: 18 years of age or older.

Quantity limit specified: 2 capsules per day.

Multiple new products to market (e.g., Livdelzi, Vyalev, Ebglyss, Xdemvy, Yorvipath, Palopegteriparatide, Duvyzat, Nemluvio) with recommended coverage criteria were introduced.

1 yearApproval duration

SchizophreniaIndication required

Coverage Criteria and Policy Recommendations

inv-01: Initial Therapy — Initial Approval Criteria: Covered when ALL of the following are met

Initial Approval Criteria: Covered when ALL of the following are met

Initial approval for Cobenfy: Diagnosis of schizophrenia; AND trial and failure, allergy, contraindication (including potential drug–drug interactions) or intolerance to one preferred agent; AND prescriber attests that liver enzymes and bilirubin were measured prior to initiation; AND patient meets the minimum age recommended by the package insert for the provided indication.

Approval duration recommended 1 year.

inv-02: Continuation / Renewal — Renewal Criteria: Covered when ALL of the following are met

Renewal Criteria: Covered when ALL of the following are met

Renewal approval for Cobenfy: Diagnosis of schizophrenia; AND trial and failure, allergy, contraindication or intolerance to one preferred agent (documented); AND prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms; AND prescriber attests that liver enzymes and bilirubin were measured prior to initiation; AND patient continues to meet the minimum age per package insert.

Renewal duration alignment with initial recommendation (1 year suggested).

inv-03: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization: Diagnosis of schizophrenia; AND trial and failure, allergy, contraindication, or intolerance to one preferred agent; AND prescriber attests liver enzymes and bilirubin were measured prior to initiation; AND patient meets the minimum age recommended by the package insert for the indication.age and labs

Minimum age per package insert; baseline hepatic labs required; step therapy = one preferred agent trial

inv-04: Continuation Therapy / Renewal — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met

Renewal Authorization: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms; continued attestation that liver enzymes and bilirubin were measured prior to initiation; patient continues to meet minimum age requirements.clinical improvement attestation

Renewal contingent on documented clinical benefit

inv-05: Initial and Renewal Coverage Criteria — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Baseline labs: Prescriber attests that liver enzymes and bilirubin were measured prior to initiation.

Documented attestation required

Age: Patient meets the minimum age recommended by the package insert for the provided indication.>= package insert minimum

Chunks repeatedly state 18 years as age limit reference

Renewal: For renewal, prescriber attests to clinically significant improvement or stabilization in clinical signs and symptoms.

Attestation required at renewal

Quantity limit: 2 capsules per day.

inv-06: Initial and Renewal Coverage Criteria — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initiation criteria: Patient meets the minimum age recommended by the package insert for the provided indication (document specifies 18 years or older).age >= package insert (document: 18 years)

Initiation requires age per PI

Renewal criteria: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms is provided.attestation present

Required for continued coverage

Quantity limit of 2 capsules per day.<= 2 capsules/day

Hard limit documented in policy

inv-07: Initial coverage and renewal criteria — Covered when ALL of the following are met

Covered when ALL of the following are met

Standard coverage criteria: Patient is 18 years of age or older.18 years

Age limit repeated throughout document

Quantity limit: Dispense up to 2 capsules per day.2 capsules/day

Documented quantity limit

Formulary status and prior auth: Product designated Non-Preferred; prior authorization consistent with non‑preferred placement; approval duration 1 year.1 year

Approval duration stated in multiple chunks

inv-08: Initial and Renewal Coverage — Covered with criteria

Covered with criteria

Initial coverage criteria: Patient is 18 years of age or older AND prescriber submits prior authorization (implied); quantity limited to 2 capsules per day; product is Non‑Preferred; approval duration 1 year.

Initial clinical indication not specified in this excerpt

Renewal criteria: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms is required for renewal.

Renewal approval duration: 1 year

inv-09: Recommendation constraints — Coverage recommendation and constraints as reported in these chunks

Coverage recommendation and constraints as reported in these chunks

Basic coverage constraints: Patient is 18 years of age or older; quantity does not exceed 2 capsules per day; approval duration set to 1 year.age >= 18; qty <= 2 capsules/day

Formulary status listed as Non‑Preferred; multiple 'Against' votes are present in the recommendation text but operational effect not specified

inv-10: Coverage Parameters — Coverage summary derived from recommendations block

Coverage summary derived from recommendations block

General coverage parameters: Product listed as Non‑Preferred in Gastrointestinal, Bile Salts; approval duration 1 year; age limit 18 years or older; quantity limit 2 capsules per day.

No specific clinical indication or step therapy criteria present in these chunks.

inv-11: Livdelzi Initial Therapy — Covered when ALL of the following are met for Livdelzi (seladelpar) initial therapy:

Covered when ALL of the following are met for Livdelzi (seladelpar) initial therapy:

Livdelzi Initial: Diagnosis of primary biliary cholangitis (PBC); AND prescribed by or in consultation with a gastroenterologist, hepatologist, or other disease‑state specialist; AND patient meets one of: (1) 12‑month trial and failure of ursodiol and will take Livdelzi in addition to current therapy OR (2) contraindication/intolerance to ursodiol and will take Livdelzi as monotherapy; AND alkaline phosphatase (ALP) > 200 IU/L; AND no decompensated cirrhosis; AND patient meets the minimum age recommended by the package insert for the provided indication.ALP > 200 IU/L

Approval duration: 1 year; Quantity limit: 2 capsules/day; Age ≥ minimum PI (document lists 18 yrs in section).

inv-12: Livdelzi Renewal — Renewal criteria for Livdelzi:

Renewal criteria for Livdelzi:

Livdelzi Renewal: Documentation (e.g., progress notes, labs) of improvement or stabilization in alkaline phosphatase (ALP); AND patient meets one of: (1) had 12‑month trial and failure of ursodiol and continues Livdelzi in addition to ursodiol OR (2) contraindication/intolerance to ursodiol and continues Livdelzi as monotherapy.

Approval duration on renewal: 1 year.

inv-13: Vyalev Initial Therapy — Covered when ALL of the following are met for Vyalev (foscarbidopa/foslevodopa):

Covered when ALL of the following are met for Vyalev (foscarbidopa/foslevodopa):

Vyalev Initial: Diagnosis of Parkinson's disease; AND receiving PD therapy with carbidopa/levodopa; AND experiencing 'off' episodes with carbidopa/levodopa for at least 2 hours per day; AND trial and failure of at least 2 adjunctive therapies (e.g., dopamine agonists, MAO‑B inhibitors, COMT inhibitors); AND patient will not take within two weeks of a non‑selective MAOI; AND patient meets the minimum age recommended by the package insert for the provided indication.

Approval duration: 1 year; Quantity limit: 1 capsule/day; Age ≥ 18 yrs listed.

inv-14: Ebglyss Initial Therapy — Covered when ALL of the following are met for Ebglyss (lebrikizumab) initial therapy:

Covered when ALL of the following are met for Ebglyss (lebrikizumab) initial therapy:

Ebglyss Initial: Diagnosis of moderate‑to‑severe atopic dermatitis with ≥1 of: BSA ≥10% OR SCORAD ≥25 OR IGA ≥3 OR EASI ≥16 OR incapacitation due to lesion location; AND prescribed by or in consultation with a dermatologist, allergist/immunologist, or other specialist; AND trial and failure, contraindication, or intolerance to ≥1 agent in 2 or more categories (total prior agent use ≥90 days) including medium‑to‑high potency topical corticosteroid AND topical calcineurin inhibitor OR systemic immunosuppressive agent; AND trial and failure/contraindication/intolerance to at least one preferred injectable agent (Adbry or Dupixent); AND patient meets package insert age/weight requirements.

Initial approval duration: 4 months; renewal: 1 year; Quantity limit: 2 vials (20 mL)/day; Age ≥ 18 yrs listed.

inv-15: Xdemvy Initial Therapy — Covered when ALL of the following are met for Xdemvy (lotilaner) initial therapy:

Covered when ALL of the following are met for Xdemvy (lotilaner) initial therapy:

Xdemvy Initial: Diagnosis of Demodex blepharitis; AND prescribed by or in consultation with an ophthalmologist or other specialist for the requested condition; AND prescriber attests that the patient currently has active disease.

Initial approval duration: 3 months; renewal: 1 year; Age ≥ 12 yrs; Quantity limit: 1 pen/syringe (2 mL) per 28 days.

inv-16: Palopegteriparatide Initial Therapy — Covered when ALL of the following are met for Palopegteriparatide initial therapy:

Covered when ALL of the following are met for Palopegteriparatide initial therapy:

Palopegteriparatide Initial: Diagnosis of hypoparathyroidism; AND prescriber attests medication is NOT for acute postoperative hypoparathyroidism; AND patient has not received PTH analogs for ≥24 months cumulative; AND documentation that corrected serum calcium (7.8–10.2 mg/dL) and serum phosphate (2.5–4.5 mg/dL) are within normal limits; AND prescriber attests patient is not well‑controlled despite appropriate utilization (≥3 months) of calcium and active vitamin D; AND prescribed by or in consultation with an endocrinologist or other specialist.

Quantity limit: 2 pens/month; Age ≥ 18 yrs.

inv-17: Duvyzat Initial Therapy — Covered when ALL of the following are met for Duvyzat (givinostat) initial therapy:

Covered when ALL of the following are met for Duvyzat (givinostat) initial therapy:

Duvyzat Initial: Diagnosis of Duchenne muscular dystrophy (DMD) [G71.01]; AND platelet count within the last 30 days ≥ 150 x 10^9/L; AND prescribed by or in consultation with a neuromuscular specialist experienced in DMD; AND patient is ambulatory; AND baseline ambulatory function assessed prior to therapy; AND patient has been on stable systemic corticosteroid therapy for ≥6 months and will continue unless contraindicated; AND prescriber provides patient weight within past 3 months; AND requested dose meets FDA‑approved dosing.

Initial approval duration: 6 months; renewal: 1 year; Age ≥ 18 yrs listed in section header though DMD population typically pediatric — document lists age requirement in header.

inv-18: Initial Therapy — Atopic Dermatitis — Covered when ALL of the following are met for Atopic Dermatitis:

Covered when ALL of the following are met for Atopic Dermatitis:

AD Eligibility: Diagnosis of moderate‑to‑severe atopic dermatitis with ≥1 of: BSA ≥10% OR IGA ≥3 OR EASI ≥16 OR PP‑NRS ≥4 OR incapacitating lesion location; AND prescribed by or in consultation with a dermatologist, allergist/immunologist, or other specialist; AND trial and failure/contraindication/intolerance to ≥1 agent in ≥2 categories with total prior agent use ≥90 days (topical corticosteroid medium‑high potency OR topical calcineurin inhibitor OR systemic immunosuppressive agents); AND trial and failure/allergy/contraindication/intolerance of 1 preferred injectable (Adbry or Dupixent); AND nemolizumab will be used with topical corticosteroids and/or calcineurin inhibitors; AND patient meets package insert minimum age; AND prescriber provides patient weight within 3 months; AND requested dose meets FDA dosing recommendation.AD severity thresholds

Initial approval criteria for nemolizumab (Nemluvio) in AD.

inv-19: Initial Therapy — Prurigo Nodularis — Covered when ALL of the following are met for Prurigo Nodularis:

Covered when ALL of the following are met for Prurigo Nodularis:

PN Eligibility: Diagnosis of prurigo nodularis; AND at least 20 nodular lesions; AND other causes of pruritus have been ruled out; AND trial and failure, contraindication, or intolerance to moderate‑to‑super potent topical corticosteroids for ≥2 weeks OR narrowband UVB/PUVA phototherapy; AND trial and failure, contraindication, or intolerance to Dupixent; AND patient meets the package insert minimum age for the FDA‑approved indication.>= 20 nodular lesions

Initial criteria for nemolizumab in prurigo nodularis.

inv-20: Renewal Therapy — Renewal Criteria:

Renewal Criteria:

Renewal: Documentation (e.g., progress note) of stabilized or improved ambulatory function from baseline; AND patient will continue systemic corticosteroid therapy unless contraindicated or significant adverse effects are experienced; AND prescriber provides a patient weight obtained within the past 3 months; AND the requested dose meets the FDA‑approved dosing recommendation.

Renewal criteria for Duvyzat (givinostat).

Policy places Cobenfy™ (xanomeline–trospium) on the formulary as Non‑Preferred within the Central Nervous System - Antipsychotics, Second Generation (Atypical) and Injectable class. The P&T decision recorded was 8 For, 0 Against and an approval duration of 1 year was recommended. Prior authorization and utilization management consistent with Non‑Preferred placement are implied by this formulary action.

This segment does not provide additional explicit coverage criteria beyond the general initial and renewal nodes already captured elsewhere in the policy. In other words, no further condition‑specific exclusion, step‑therapy, or not‑medically‑necessary language is stated in this excerpt.

The document repeatedly identifies Livdelzi® (seladelpar) under the Gastrointestinal, Bile Salts category as Non‑Preferred. Coverage parameters shown repeatedly include an age limit of 18 years or older, a quantity limit of 2 capsules per day, and an approval duration of 1 year, indicating that formulary tiering and PA processes will apply to this class and product.

Within the provided excerpt there are no explicit clinical exclusions listed beyond the general coverage criteria; the policy text in this segment does not enumerate condition‑specific exclusions that would automatically preclude coverage.

These chunks do not state any explicit exclusion conditions. The content reiterates coverage parameters (formulary status, age, quantity, approval duration) but does not list clinical exclusion rules in the cited segments.

No explicit exclusion conditions are described in these chunks. The text focuses on coverage parameters (e.g., Non‑Preferred placement, age and quantity limits, approval duration) and mechanism statements without enumerating exclusions here.

For Livdelzi (seladelpar) initial approval the policy explicitly excludes patients with decompensated cirrhosis. The Livdelzi initial criteria require diagnosis of primary biliary cholangitis, specialist involvement, prior ursodiol use or documented intolerance, ALP > 200 IU/L, and that the patient does not have decompensated cirrhosis.

The policy excludes patients from coverage when they have not undergone the required prior therapy trials described in the product‑specific criteria. For example, nemolizumab and related immunomodulators require documented trial and failure (or contraindication/intolerance) of specified topical/systemic categories and preferred injectable agents (e.g., Adbry or Dupixent) before approval; failure to document these prior trials is a basis for denial or exclusion.

No explicit not medically necessary (NMN) statements are present in this particular segment of the document. The excerpt focuses on initial and renewal criteria and prescriber attestations rather than listing NMN conditions.

These chunks do not provide explicit statements labeling specific uses as not medically necessary. The repeated content emphasizes age, quantity limits, and renewal attestation without enumerating NMN conditions.

In this excerpt there are no discrete 'not medically necessary' statements. The text repeats formulary placement, age and quantity limits, and renewal attestation requirements but does not define specific NMN conditions here.

The cited excerpt contains notation of voting outcomes (e.g., 'Against, 7' in places) but does not translate those into defined not medically necessary conditions; explicit NMN criteria are not provided in this chunk.

These chunks do not include explicit not‑medically‑necessary statements. The material reiterates Livdelzi's mechanism and formulary parameters but stops short of listing NMN conditions in the cited text.

Initiation of Vyalev (foscarbidopa/foslevodopa) requires objective documentation of disabling 'off' time and prior adjunctive therapy failures. Specifically, requests for Vyalev without documentation of at least 2 hours per day of 'off' episodes on carbidopa/levodopa or without documented trial and failure of at least two adjunctive therapies would not meet initiation criteria and may be denied.

Initial Authorization Criteria (Drug-specific)

inv-99: Initial therapy — Initial authorization criteria for medication therapy

Initial authorization criteria for medication therapy

Initial: Diagnosis of schizophrenia; prior trial and failure/allergy/contraindication/intolerance to one preferred agent; prescriber attests baseline liver enzymes and bilirubin measured; patient meets minimum age in package insert.

Approval duration recommended 1 year.

inv-100: Initial therapy — 1 top-level node

Initial: Diagnosis of schizophrenia; trial and failure/allergy/contraindication/intolerance to one preferred agent; prescriber attests baseline liver enzymes and bilirubin were measured; patient meets minimum package insert age.

Dose or duration not specified here except package insert age; formulation noted as 2 capsules/day elsewhere.

inv-101: Initial Therapy — Initial authorization prerequisites

Renewal and Continuation Requirements

inv-108: Renewal — Renewal requirements

Renewal requirements

Renewal: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms; continued appropriateness of therapy as documented; prior criteria (diagnosis, prior trial of preferred agent, baseline labs, age) remain met.

inv-109: Renewal — 1 top-level node

Renewal: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms required for renewal; patient remains age >= package insert minimum; no additional labs specified beyond baseline hepatic testing.

Renewal frequency not specified in this segment.

inv-110: Continuation Therapy / Renewal — Renewal requires demonstration of ongoing benefit.

Renewal requires demonstration of ongoing benefit.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required for schizophrenia (Cobenfy™)

Prior authorization is required. Submit documentation of a diagnosis of schizophrenia, evidence of trial and failure (or documented allergy, contraindication, or intolerance) to one preferred antipsychotic agent, and a prescriber attestation that baseline liver enzymes and bilirubin were measured; confirm patient meets the minimum age per the package insert.

Diagnosis of schizophrenia must be documented.
Trial and failure (or allergy/contraindication/intolerance) to one preferred agent must be shown.
Prescriber must attest baseline liver enzymes and bilirubin were measured.
Patient must meet package insert minimum age.

Prior Authorization

PA requirements: diagnosis, prior trial/failure, prescriber attestations

Prior authorization requests must document the diagnosis of schizophrenia, a prior trial and failure (or allergy/contraindication/intolerance) to one preferred agent, and include prescriber attestations as specified in the criteria.

Coding, Limits, and Key Clinical Thresholds

DMD ICD-10ICD-10Covered

G71.01

Duchenne muscular dystrophy

Demodex Blepharitis ICD-10ICD-10Covered

H01.00

Demodex blepharitis

Quantity limit

Quantity limit2 capsules per day

Documented in multiple sectionsRepeated across recommendations and quantity limits for Livdelzi and referenced oral agent

Applies toLivdelzi (seladelpar) and referenced oral agent in this segment

Alkaline phosphatase (ALP)

Alkaline phosphatase (ALP) threshold> 200 IU/L

ContextRequired for initial Livdelzi (seladelpar) approval in primary biliary cholangitis (PBC)

Step Therapy Requirements

Step	Requirement
1
Trial and failure, allergy, contraindication or intolerance to one preferred antipsychotic agent (or documented inability to use a preferred agent) prior to approval

Step	Requirement
1
Requires trial and failure (or documented allergy, contraindication, or intolerance) to one preferred agent before coverage

Step	Requirement
1
No explicit prior step therapy required in these chunks; renewal requires prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms

Step	Requirement
1
No explicit step-therapy steps are described in this excerpt

Step	Requirement
1
No step therapy details provided in these chunks; product listed as Non‑Preferred which may imply prior authorization per plan rules

Step	Requirement
1
Livdelzi initial approval requires a 12‑month trial and failure of ursodiol, unless contraindicated or intolerant (in which case documented intolerance/contraindication suffices)

Step	Requirement
1
Ebglyss initial approval requires prior trials and failure/contraindication/intolerance to required topical/systemic therapies (≥90 days cumulative across categories) and failure/contraindication/intolerance to at least one preferred injectable (e.g., Adbry or Dupixent)

Step	Requirement
1
Vyalev initial approval requires trial and failure of at least two adjunctive therapies (e.g., dopamine agonists, MAO‑B inhibitors, COMT inhibitors) prior to approval

Step	Requirement
1
Nemolizumab (nemluvio) requires documentation of trials and failures (or contraindication/intolerance) of the listed topical/systemic therapies and failure of a preferred injectable (Adbry or Dupixent) prior to approval

Quantity Limits by Product

Oral agent referenced in this segment

Referenced oral agent quantity2

InterpretationNumeric quantity as listed in quantity limits for the oral agent segment (2 capsules per day)

Associated drugsApplies to Livdelzi entries and unnamed oral agent references in this document segment

Livdelzi

Product nameLivdelzi

Quantity limit noted2 capsules per day (documented repeatedly)

Formulary statusListed as New Product to Market and Non-Preferred in Gastrointestinal, Bile Salts

Site of Care and Specialist Involvement

Note

Definitions and Key Terms

Xanomeline–trospium (Cobenfy™)

DefinitionCombination of xanomeline (central M1/M4 agonist) with trospium (peripheral muscarinic antagonist to reduce peripheral adverse effects)

BrandCobenfy™ (xanomeline–trospium) referenced in P&T recommendation

Mechanistic roleXanomeline targets CNS muscarinic receptors; trospium mitigates peripheral side effects

Renewal criteria

Renewal criteria (definition)Prescriber must attest to clinically significant improvement or stabilization in clinical signs and symptoms for ongoing therapy

Applies toRenewal requirements across multiple products (e.g., Cobenfy™, Livdelzi, nemolizumab) as stated in document

Background and Clinical Context

Xanomeline is an agonist at central M1 and M4 muscarinic acetylcholine receptors that can influence dopaminergic activity in the central nervous system; trospium is a peripheral muscarinic antagonist used in the combination to reduce peripheral anticholinergic adverse effects. This mechanistic pairing underlies the combination marketed as Cobenfy™ and is the clinical rationale referenced in the policy background.

Policy Revision Notes

as reportedP&T decision / formulary placementLatest

P&T recommended addition of Cobenfy™ (xanomeline–trospium) as a new product to market with placement as Non‑Preferred in Central Nervous System - Antipsychotics, Second Generation (Atypical) and Injectable; P&T vote recorded as 8 For and approval duration recommended 1 year.

as reportedPolicy addition — coverage criteria

Initial and renewal medical necessity criteria for Cobenfy™ were added, requiring diagnosis of schizophrenia, trial and failure (or allergy/contraindication/intolerance) to one preferred agent, prescriber attestation that liver enzymes and bilirubin were measured prior to initiation, and meeting minimum age per the package insert.

Policy Summary

Payermedimpact

PolicyCobenfy™ (xanomeline–trospium) formulary recommendation for schizophrenia

Policy CodePolicy N/A

Change TypeNew product additions & criteria

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Stated repeatedly across chunks

Renewal requirement: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms required for renewal.attestation

Renewal criteria stated repeatedly

Initial authorization prerequisites

Baseline labs and age: Prescriber attests liver enzymes and bilirubin measured prior to initiation AND patient meets the minimum age per package insert.

Stated as requirement in multiple chunks

inv-102: Initial Therapy — Initial approval conditions

Initial approval conditions

Initial approval: Patient meets the minimum age recommended by the package insert for the provided indication (document references 18 years or older).age >= package insert (18 years)

Prescriber must attest to indication as appropriate

inv-103: Initial therapy — Initial authorization conditions captured in recommendations section

Initial authorization conditions captured in recommendations section

Initial therapy: Patient age >= 18 and dispense up to 2 capsules per day; product is Non‑Preferred and requires prior authorization.age>=18; 2 caps/day

Explicit in document

inv-104: Initial — Initial coverage parameters

Initial coverage parameters

Initial: Patient must be 18 years or older; coverage limited to 2 capsules per day; product is Non‑Preferred; approval duration 1 year.

Prior authorization implied

inv-105: Initial therapy — Initial coverage parameters appearing in this segment

Initial coverage parameters appearing in this segment

Initial therapy constraints: Patient age 18 years or older; quantity limit 2 capsules per day; approval duration 1 year; drug is Non‑Preferred.age >= 18; qty <= 2 capsules/day

No specific clinical entry criteria or diagnostic codes provided in this excerpt.

inv-106: Initial Therapy Requirements — Initial therapy criteria are drug-specific and listed above in coverage.criteria_sets.

Initial therapy criteria are drug-specific and listed above in coverage.criteria_sets.

See individual product criteria: Refer to product‑specific initial criteria for Livdelzi, Vyalev, Ebglyss, Xdemvy, Palopegteriparatide, Duvyzat as extracted in coverage.criteria_sets.

inv-107: Initial Therapy Criteria — Initial approval criteria per indication

Initial approval criteria per indication

Initial AD: See Coverage.criteria_sets for detailed AD criteria (severity thresholds, prior therapy requirements, specialist involvement, age/weight requirements).

Refer to product‑specific blocks.

Initial PN: See Coverage.criteria_sets for detailed prurigo nodularis criteria (lesion count, prior therapy trials, specialist involvement, age requirements).

Refer to product‑specific blocks.

Renewal attestation: Prescriber attests to clinically significant improvement or stabilization in clinical signs and symptoms for continuation coverage.

Required for renewal decisions

inv-111: Renewal / Continuation — Renewal requires documentation of ongoing benefit.

Renewal requires documentation of ongoing benefit.

Renewal: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms.attestation

Required for continuation

inv-112: Continuation therapy — Renewal/continuation requirements

Renewal/continuation requirements

Continuation requirement: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms for renewal.attestation

Repeated across document

inv-113: Renewal — Renewal requirements for ongoing therapy

Renewal requirements for ongoing therapy

Renewal: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms required for renewal; approval duration typically 1 year; quantity limit remains 2 capsules per day.

Age limit continues to apply (>=18 years)

inv-114: Continuation Therapy — Renewal/continuation criteria across products generally require objective stabilization or improvement and continued specialist oversight.

Renewal/continuation criteria across products generally require objective stabilization or improvement and continued specialist oversight.

General Renewal: Documentation of disease improvement or stabilization (e.g., ALP for Livdelzi; ambulatory function for Duvyzat) and continued specialist management; continued dosing must meet FDA‑approved recommendations.

Approval durations on renewal vary by product (commonly 1 year).

inv-115: Continuation Therapy — Renewal/continuation requirements for nemolizumab

Renewal/continuation requirements for nemolizumab

Continuation: Patient must continue to meet initial approval criteria; must show disease improvement and/or stabilization based on objective measure; will continue systemic corticosteroid therapy unless contraindicated; prescriber must provide recent weight; requested dose must adhere to FDA dosing.

Nemolizumab renewal operational criteria.

Document diagnosis of schizophrenia.
Provide evidence of trial and failure (or allergy/contraindication/intolerance) to one preferred agent.
Include prescriber attestations required by policy.

Documentation Required

Prescriber attestation: baseline LFTs and bilirubin required

Prior authorization requires a prescriber attestation that baseline liver enzymes and bilirubin were measured prior to initiation of therapy and that the patient meets the minimum age per the package insert.

Attest baseline liver enzymes and bilirubin were measured prior to initiation.
Confirm patient meets package insert minimum age.

Prior Authorization

Age and renewal attestation required

Prior authorization must confirm the patient meets the minimum age per the package insert; for renewals, the prescriber must attest to clinically significant improvement or stabilization in signs and symptoms.

Confirm age meets package insert minimum (documented).
On renewal, include prescriber attestation of clinical benefit (improvement or stabilization).

Prior Authorization

PA and approval duration (Non‑Preferred): 1 year

Prior authorization is required consistent with Non‑Preferred formulary placement; approvals are issued for 1 year and renewals require prescriber attestation of clinical benefit.

Product is Non‑Preferred — PA required per formulary placement.
Approval duration: 1 year.
Renewal requires prescriber attestation of clinically significant improvement or stabilization.

Prior Authorization

Livdelzi listed as Non‑Preferred — PA implied (age/qty limits, 1‑yr)

Livdelzi is listed as a new Non‑Preferred product with age and quantity limits and a 1‑year approval duration — prior authorization is implied and operationalized by the listed coverage parameters.

Age limit: 18 years or older.
Quantity limit: 2 capsules per day.
Approval duration: 1 year.

Prior Authorization

Livdelzi PA context: Non‑Preferred, 1‑yr approval, qty/age limits

Policy lists Livdelzi as 'New Product to Market' and Non‑Preferred with an approval duration of 1 year and a quantity limit of 2 capsules per day for adults 18 years and older; prior authorization is indicated by these coverage parameters.

Non‑Preferred placement.
Approval duration: 1 year.
Quantity limit: 2 capsules per day.
Age: adults 18 years and older.

Prior Authorization

PA likely for Non‑Preferred Livdelzi (seladelpar)

Livdelzi (seladelpar) is listed Non‑Preferred under Gastrointestinal, Bile Salts with a 1‑year approval, age and quantity limits; prior authorization is likely required per formulary placement.

Formulary: Gastrointestinal, Bile Salts — Non‑Preferred.
Approval duration: 1 year.
Age limit: 18 years or older.
Quantity limit: 2 capsules per day.

Prior Authorization

Livdelzi PA: PBC criteria, ursodiol trial/intolerance, ALP>200 IU/L

Prior authorization for Livdelzi: initial approval limited to adults with primary biliary cholangitis (PBC) who meet entry criteria including prior ursodiol trial or documented intolerance, ALP >200 IU/L, absence of decompensated cirrhosis, and specialist prescribing/consultation.

Diagnosis: primary biliary cholangitis (PBC).
Prescribed by or in consultation with gastroenterologist/hepatologist or specialist.
Either 12‑month ursodiol trial and failure OR contraindication/intolerance to ursodiol.
ALP > 200 IU/L.
No decompensated cirrhosis.

Prior Authorization

Vyalev PA: PD on carbidopa/levodopa, ≥2 hrs 'off' time, ≥2 adjunctive failures

Prior authorization for Vyalev requires documented Parkinson's disease while receiving carbidopa/levodopa, 'off' time of at least 2 hours per day, and prior trial and failure of at least two adjunctive therapies.

Diagnosis: Parkinson's disease on carbidopa/levodopa.
Document ≥2 hours/day of 'off' time.
Trial and failure of ≥2 adjunctive therapies (e.g., dopamine agonists, MAO‑B inhibitors, COMT inhibitors).

Prior Authorization

PA requires documented trials/failures of specified topical/systemic/preferred injectables

Prior authorization requires documentation of prior trials and failures (or documented contraindication/intolerance) of the specified topical, systemic, and preferred injectable agents before approval of indicated biologics.

Document trials/failures of topical and systemic therapies as enumerated.
Document failure/contraindication/intolerance to required preferred injectable agents when specified.

Step Therapy

Step therapy: fail one preferred antipsychotic before approval

Step therapy requires a trial and failure (or documented allergy/contraindication/intolerance) to one preferred antipsychotic agent prior to approval of the requested agent.

Trial and failure of one preferred antipsychotic (or documentation of allergy/contraindication/intolerance).

Step Therapy

Step requirement: fail one preferred agent before coverage

Approval is contingent on a documented trial and failure (or allergy/contraindication/intolerance) to one preferred agent prior to approval.

Provide documentation of trial and failure (or allergy/contraindication/intolerance) to one preferred agent.

Note

Context: intolerance/interactions referenced but no extra step steps

Some sections reference intolerance or drug‑drug interactions with preferred agents as clinical context but do not lay out additional explicit step therapy steps beyond the single preferred‑agent trial requirement.

Intolerance or interactions with preferred agents may be documented as reasons a preferred agent cannot be used.
No additional multi‑step protocol is specified in those segments.

Step Therapy

Step therapy: prior failure/trial requirements for several products (e.g., Livdelzi)

Several products require documented prior failure/trials of other therapies; for example, Livdelzi requires a 12‑month ursodiol trial unless the patient is intolerant, and similar multi‑step requirements are specified for other listed agents.

Livdelzi: 12‑month ursodiol trial and failure unless intolerant.
Ebglyss and others: specified prior therapy trials required per criteria.

Step Therapy

Step therapy for AD: fail ≥1 agent in ≥2 categories before biologic

For certain indications (e.g., atopic dermatitis), step therapy requires failure of at least one agent in two or more categories (topical corticosteroids, topical calcineurin inhibitors, systemic immunosuppressants, etc.) prior to approval of the targeted biologic.

Fail ≥1 agent in ≥2 categories with total prior agent use ≥90 days.
Also require failure of at least one preferred injectable when specified.

Documentation Required

Required documentation: baseline LFTs/bilirubin and prior trial history

Prescriber must attest that liver enzymes and bilirubin were measured prior to initiation; provide documentation of prior trial/failure/allergy/contraindication/intolerance to required agents.

Attestation that baseline liver enzymes and bilirubin were measured prior to initiation.
Documentation of prior trial and failure (or allergy/contraindication/intolerance) to required preferred agents.

Documentation Required

Documentation: baseline labs required and renewal attestation

Prescriber attestation that liver enzymes and bilirubin were measured prior to initiation is required; for renewals, include a prescriber attestation of clinically significant improvement or stabilization.

Initial: attest baseline LFTs and bilirubin were measured.
Renewal: attest clinically significant improvement or stabilization.

Documentation Required

Attestations required: baseline labs at start and clinical benefit at renewal

The prescriber must attest that liver enzymes and bilirubin were measured prior to initiation and must provide a renewal attestation that the patient has experienced clinically significant improvement or stabilization in signs and symptoms.

Attest baseline liver enzymes and bilirubin were measured prior to initiation.
On renewal, attest to clinically significant improvement or stabilization.

Documentation Required

Renewal documentation: prescriber attestation of clinical improvement/stabilization

For renewal requests, prescriber attestation documenting clinically significant improvement or stabilization in clinical signs and symptoms is required to continue coverage.

Provide a progress note or attestation of clinically significant improvement or stabilization.
Renewal without this attestation may not meet continuation criteria.

Documentation Required

Renewal requirement: prescriber attestation of benefit

Prescriber must attest to clinically significant improvement or stabilization in clinical signs and symptoms for renewals; include supporting clinical notes or objective measures as appropriate.

Attestation required for renewal decisions.
Attach supporting documentation (progress notes, labs, objective measures) when available.

Documentation Required

Renewal attestation required for continuation

Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms is required for renewal of therapy; absence of this attestation may preclude continued coverage.

Renewal must include attestation of clinical benefit.
Objective measures (labs, symptom scores) may be requested per product.

Denial Risk

Denial risk: missing schizophrenia diagnosis or prior‑agent trial/failure

Requests may be denied if the submission lacks a documented diagnosis of schizophrenia or fails to include documentation of trial and failure (or allergy/contraindication/intolerance) to the required preferred agent(s).

No schizophrenia diagnosis documented → denial risk.
No evidence of required prior preferred‑agent trial/failure → denial risk.

Denial Risk

Denial triggers: missing prior‑agent trial or baseline lab attestation

Denial may occur when the request fails to document trial and failure (or allergy/contraindication/intolerance) to one preferred agent, or when the prescriber does not attest that liver enzymes and bilirubin were measured prior to initiation.

Lack of documented preferred‑agent trial/failure.
Missing prescriber attestation that baseline LFTs and bilirubin were measured.

Denial Risk

Denial triggers: missing baseline LFT/bilirubin attestation or age below PI

Failure to provide the prescriber attestation that liver enzymes and bilirubin were measured prior to initiation, or failure to document the patient meets the package insert minimum age, may trigger denial.

No attestation of baseline LFTs/bilirubin → possible denial.
Patient age below package insert minimum → possible denial.

Denial Risk

Renewal denial risk: missing clinical improvement/stabilization attestation

Failure to provide the required prescriber attestation of clinically significant improvement or stabilization at renewal may result in denial of the renewal request.

Renewal without prescriber attestation of clinical benefit → denial risk.

Denial Risk

Denial risk: outside age/quantity limits or missing renewal attestation

Requests falling outside documented age or quantity limits, or submitted without the required prescriber attestation of clinical improvement/stabilization, may be denied.

Age not meeting policy limits (e.g., < package insert minimum).
Quantity exceeding the stated limit (e.g., >2 capsules/day for Livdelzi).
Missing renewal attestation of clinical benefit.

Denial Risk

Livdelzi denial triggers: non‑PBC diagnosis, missing specialist, labs, or ursodiol trial

Livdelzi requests may be denied if the diagnosis is not primary biliary cholangitis (PBC), the prescriber is not the appropriate specialist or in consultation with one, required ursodiol trial/intolerance or ALP >200 IU/L are not documented, or if decompensated cirrhosis is present.

Diagnosis other than PBC → denial risk.
No specialist prescribing/consultation documented → denial risk.
Missing documentation of 12‑month ursodiol trial/failure or documented intolerance → denial risk.
ALP ≤ 200 IU/L or decompensated cirrhosis → denial risk.

Denial Risk

Vyalev denial triggers: missing PD on carbidopa/levodopa, <2 hrs 'off', or insufficient trials

Vyalev requests may be denied if the patient is not on carbidopa/levodopa for Parkinson's disease, is not experiencing at least 2 hours/day of 'off' time, or lacks documentation of trial and failure of at least two adjunctive therapies.

Not on carbidopa/levodopa → denial risk.
'<2 hours/day' off time documented → denial risk.
Insufficient adjunctive therapy trial history (fewer than 2) → denial risk.

Denial Risk

Ebglyss denial triggers: insufficient severity, missing prior therapy trials, or non‑specialist prescriber

Ebglyss requests may be denied if the patient does not meet objective severity criteria for moderate‑to‑severe atopic dermatitis, has not trialed required topical/systemic therapies and preferred injectables, or if the prescriber is not a relevant specialist.

Does not meet AD severity thresholds (BSA, IGA, EASI, SCORAD, etc.).
Missing trials/failures of required topical/systemic agents or preferred injectable failure.
Prescriber not a dermatologist/allergist/immunologist or not in consultation with one.

Denial Risk

Xdemvy denial triggers: missing diagnosis, specialist involvement, or active disease attestation

Xdemvy requests may be denied if the diagnosis of Demodex blepharitis is not documented, the prescriber is not an ophthalmologist or appropriate specialist (or not in consultation), or the prescriber does not attest the patient has active disease.

No documented diagnosis of Demodex blepharitis → denial risk.
Prescriber not ophthalmologist/specialist or no consultation documented → denial risk.
No prescriber attestation of active disease → denial risk.

Denial Risk

Duvyzat denial triggers: missing DMD diagnosis, low platelets, non‑specialist prescriber, or missing ambulatory/weight docs

Duvyzat (givinostat) requests may be denied if the diagnosis of Duchenne muscular dystrophy (DMD) is not provided, platelet count is below 150 x10^9/L, the prescriber is not a neuromuscular specialist, or required ambulatory/weight documentation is absent.

No DMD diagnosis (G71.01) documented → denial risk.
Platelet count <150 x10^9/L → denial risk.
Prescriber not a neuromuscular specialist or no consultation documented → denial risk.
Missing baseline ambulatory function or recent weight documentation → denial risk.

Denial Risk

Denial triggers: missing documentation of preferred injectable failure or prior topical/systemic trials

Denial may result if the request fails to document trial and failure, contraindication, or intolerance to one required preferred injectable (e.g., Adbry, Dupixent) when specified, or if required prior topical/systemic therapy trials are not documented.

Missing documentation of failure/contraindication/intolerance to required preferred injectable → denial risk.
Missing prior topical/systemic therapy trial documentation where required → denial risk.

Improvement or stabilization in ALP required at renewal

Platelet count

Platelet count requirement>= 150 x 10^9 /L

ContextBaseline platelet count required within last 30 days for Duvyzat (givinostat) initial approval

PrescriberPrescribed by or in consultation with a neuromuscular specialist

Corrected Serum Calcium

Corrected Serum Calcium (normal range)7.8-10.2 mg/dL

ContextRequired documented normal lab for Palopegteriparatide initial approval in hypoparathyroidism

Related requirementPrescriber must attest medication is not for acute postoperative hypoparathyroidism

Serum Phosphate

Serum Phosphate (normal range)2.5-4.5 mg/dL

ContextRequired documented normal lab for Palopegteriparatide initial approval in hypoparathyroidism

Associated requirementsPrior trial/failure of calcium and active vitamin D; specialist involvement required

Atopic dermatitis severity

Atopic dermatitis severity thresholdsBSA ≥ 10% OR IGA ≥ 3 OR EASI ≥ 16 OR PP-NRS ≥ 4

ContextUsed to establish moderate‑to‑severe AD eligibility for nemolizumab (Nemluvio) initial approval

Additional criteriaPrescribed by/with dermatologist, trial/failure of agents in ≥2 categories and preferred injectable failure required

Prurigo nodularis lesion count

Prurigo nodularis lesion count≥ 20 nodular lesions

ContextRequired for initial approval of nemolizumab for prurigo nodularis

Other requirementsOther causes of pruritus ruled out and required prior therapy trials (topical/phototherapy and Dupixent)

Livdelzi®

Brand styleLivdelzi®

Quantity limit2 capsules per day

Age limit reference18 years of age or older cited in multiple sections

Livdelzi

Product name (repeat)Livdelzi

ContextAppears repeatedly in quantity limit and coverage parameter listings

Approval duration1 year (stated in related chunks)

Livdelzi

Product shorthandLivdelzi

Formulary noteGastrointestinal, Bile Salts: Non-Preferred

Quantity2 capsules per day

Livdelzi (seladelpar)

Generic name with brand contextLivdelzi (seladelpar)

Mechanism noteSeladelpar decreases bile acid synthesis by activating PPAR‑delta (documented MOA)

Quantity limit2 capsules per day (repeated across document)

Livdelzi (seladelpar)

Product and formulationLivdelzi (seladelpar) — 2 capsules

Quantity interpretationDocument lists '2 capsules' as the quantity limit for Livdelzi

Approval duration1 year (associated in Livdelzi entries)

Livdelzi

Product nameLivdelzi

Quantity limit2 capsules per day

Prescriber requirementSpecialist involvement recommended for indication-specific approvals

Vyalev

Vyalev — quantity limit1 capsule per day

Indication contextFor Parkinson's disease as adjunct to carbidopa/levodopa (off episodes ≥2 hours/day)

Approval duration1 year (noted in nearby entries)

Ebglyss

Ebglyss — quantity limit2 vials (20 mL) per day

IndicationLebrikizumab for moderate‑to‑severe atopic dermatitis (requires severity criteria and prior therapy trials)

Approval durationsInitial 4 months; renewal 1 year

Xdemvy

Xdemvy — quantity limit1 pen/syringe (2 mL) per 28 days

IndicationDemodex blepharitis; prescribed by/with ophthalmologist or specialist

Age limit12 years of age or older

Palopegteriparatide

Palopegteriparatide — quantity limit2 pens per month

Indication and labsHypoparathyroidism; requires corrected serum calcium 7.8–10.2 mg/dL and serum phosphate 2.5–4.5 mg/dL

PrescriberPrescribed by or in consultation with an endocrinologist or specialist

Nemluvio

Nemluvio — quantity limit12

Unit12 mL per day (documented quantity)

Age limit6 years of age or older

Nemluvio

Nemluvio — volume limit12 mL

FrequencyPer day as listed in quantity limits

Renewal/approvalInitial 4 months; renewal 1 year (associated entries)

Referenced agent (contextual quantity)

Referenced agent contextual quantity2 pens (60 mg) per 28 days

ContextListed as a contextual quantity for a referenced product in prurigo nodularis section

UsageAppears as a comparator/related quantity in renewal guidance

EvidenceDocumentation such as progress notes or labs may be required for renewal (product-specific)

Prescriber attestation

Prescriber attestation (definition)A documented statement from the prescriber confirming clinically significant improvement or stabilization in the patient's clinical signs and symptoms

UseRequired at renewal for multiple products and noted as a required documentation item

Renewal consequenceAbsence of attestation may trigger denial of renewal

seladelpar (Livdelzi)

seladelpar (Livdelzi) — definitionA drug that decreases bile acid synthesis by activating peroxisome proliferator-activated receptor (PPAR)-delta

Clinical roleUsed for primary biliary cholangitis (PBC) per coverage criteria

Formulary statusListed as Non-Preferred in Gastrointestinal, Bile Salts in this document

PPAR-delta activation

PPAR-delta activation — mechanismPeroxisome proliferator-activated receptor (PPAR)-delta activation reduces bile acid synthesis

Associated drugMechanism attributed to seladelpar (Livdelzi) in document

Clinical implicationReduction in bile acid synthesis is the therapeutic rationale for PBC treatment

Mechanism summaries

Mechanism summariesShort MOA statements provided for listed drugs (e.g., seladelpar decreases bile acid synthesis via PPAR-delta; foscarbidopa/foslevodopa are prodrugs converted to carbidopa/levodopa; lebrikizumab inhibits IL-13 signaling; lotilaner inhibits mite GABA channels; palopegteriparatide mimics PTH)

PurposeConcise MOA descriptions used to support formulary recommendations

ApplicationHelps define clinical rationale within recommendation text

Nemolizumab-ilto

Nemolizumab-ilto — definitionHumanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31RA

Clinical roleUsed for pruritus and inflammation related to atopic dermatitis and prurigo nodularis as described

Approval durationsInitial 4 months; renewal 1 year (associated entry)

Severity thresholds

Severity thresholds — defined measuresBSA ≥ 10%; IGA ≥ 3; EASI ≥ 16; PP-NRS ≥ 4

ContextReferenced as objective criteria to qualify moderate‑to‑severe atopic dermatitis for biologic therapy

UsageRequired alongside specialist involvement and prior therapy trials per document criteria

as reportedPolicy clarification — renewal requirements

Renewal criteria were clarified to require prescriber attestation of clinically significant improvement or stabilization in signs and symptoms for continued coverage.

as reportedNew product entry — Livdelzi (seladelpar)

Livdelzi® was added as a new product to market listed Non‑Preferred in Gastrointestinal, Bile Salts with initiation and renewal criteria, age limit (18+), quantity limit (2 capsules/day), and approval duration of 1 year.

as reportedMultiple new products added

Several additional new products (e.g., Vyalev, Ebglyss, Xdemvy, Palopegteriparatide, Duvyzat, Nemluvio) were introduced with product‑specific coverage criteria, quantity and age limits, and approval durations.