CurrentmedimpactPolicy N/A

New products to market — coverage criteria for select specialty and pharmacy drugs

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Defines coverage decisions, approval criteria, durations, age and quantity limits, and prescriber requirements for newly reviewed drugs added to the PDL or non‑PDL list affecting Medicaid populations reviewed by the P&T committee.

Policy Summary

Payermedimpact

PolicyNew products to market — coverage criteria for select specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 14, 2025

Next Review DateN/A

Key ActionSubmit required prior‑authorization documentation including diagnosis confirmation, specialist involvement, prior therapy trials, and objective test results as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiple productsnew products summarized

1–12 moapproval durations

presentquantity limits

several classesclass reviews

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.

CurrentmedimpactPolicy N/A

New products to market — coverage criteria for select specialty and pharmacy drugs

Customize your policy alerts

Sign up for all medimpact policy alerts

Know when medimpact releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

Payermedimpact

PolicyNew products to market — coverage criteria for select specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 14, 2025

Next Review DateN/A

Key ActionSubmit required prior‑authorization documentation including diagnosis confirmation, specialist involvement, prior therapy trials, and objective test results as specified for each product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiple productsnew products summarized

1–12 moapproval durations

presentquantity limits

several classesclass reviews

multipleconsent agenda classes

Coverage Criteria and Product Summaries

Zelsuvmi (berdazimer) Initial Therapy

Covered when ALL of the following are met

Zelsuvmi initial approval: Diagnosis of molluscum contagiosum (MC); AND prescribed by, or in consultation with, a dermatologist; AND trial and failure (>= 3 months) of >=1 conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage); AND patient has at least one of: atopic dermatitis OR immunocompromised state OR concomitant bacterial infection; AND patient is not on concurrent treatment for MC; AND meets package insert minimum ageage >= package insert minimum (1 year or older)

Quantity limit 1 kit (31 grams) per month; initial approval duration 3 months

Vykat XR (diazoxide choline) Initial Therapy

Covered when ALL of the following are met

Vykat XR initial approval: Diagnosis of hyperphagia with clinical confirmation of Prader-Willi syndrome (PWS) documented by genetic test identifying abnormal DNA methylation of chromosome 15q11.2-q13; AND prescribed by, or in consultation with, an endocrinologist, geneticist, or other PWS specialist; AND baseline fasting plasma glucose (FPG) and HbA1c performed; AND prescriber attests to ongoing monitoring of FPG, HbA1c, and signs/symptoms of edema during treatment; AND meets package insert minimum agetablet limits: 150 mg = 3/day; 75 mg = 3/day; 25 mg = 2/day

Initial and renewal approval duration 12 months

Tryptyr (acoltremon) Initial and Renewal

Initial approval covered when ALL of the following are met; renewal requires continued criteria plus objective improvement

Tryptyr initial approval: Diagnosis of dry eye disease (DED); AND prescribed by or in consultation with an ophthalmologist or optometrist; AND trial and failure of preservative-free, nonprescription lubricating drops; AND trial and failure (>=1 month each) or documented intolerance/contraindication of 2 preferred agents; AND prescriber documents at least one objective sign: CFS score >=2 in any field OR Schirmer tear test 1-10 mm in 5 minutes; AND meets package insert minimum ageage >= package insert minimum (renewal requires age >=18)

Initial approval 3 months; renewal 12 months; quantity limit 60 vials per 30 days

Tryptyr renewal: Patient continues to meet initial criteria; AND has improvement in signs of DED measured by decreased corneal fluorescein staining score or increased Schirmer mm/5 minobjective improvement documented

Renewal duration 12 months; age >=18 years

Andembry (garadacimab-gxii) Initial and Renewal

Covered when ALL of the following are met

Andembry initial approval: Diagnosis of hereditary angioedema (HAE); AND confirmed diagnosis by complement testing OR C1 inhibitor protein and functional tests; AND prescribed for prophylactic use; AND prescribed by, or in consultation with, an immunologist, hematologist, or other HAE specialist; AND patient is not on concurrent prophylactic HAE agents (e.g., Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo); AND meets package insert minimum ageage >= package insert minimum (12 years or older for FDA indication)

Initial approval 6 months; renewal 12 months

Andembry renewal: Prescriber attests to improvement compared to baseline in HAE attack frequency or severityclinical improvement documented

Renewal duration 12 months

Sephience (sepiapterin) Initial and Renewal

Covered when ALL of the following are met

Sephience initial approval: Confirmed diagnosis of phenylketonuria (PKU) with elevated blood phenylalanine (Phe); AND prescribed by, or in consultation with, a metabolic disease expert; AND provider attests patient is on and will continue a Phe-restricted diet supervised by a specialist; AND provider attests to a monitoring plan for dietary intake and regular blood Phe assessments; AND requested dose does not exceed the maximum FDA-approved dose based on weightage >= package insert minimum

Initial approval 1 month; renewal 12 months; quantity limit 1.2 mL (200 mg) per month

Sephience renewal: Patient continues to meet initial criteria; AND prescriber provides documentation confirming sustained biochemical response defined as >=30% reduction in blood Phe levels>=30% reduction in blood Phe

Age limit 1 month or older; renewal duration 12 months

Anzupgo (delgocitinib) Initial and Renewal

Covered when ALL of the following are met

Anzupgo initial approval: Diagnosis of moderate to severe chronic hand eczema (CHE); AND documented IGACHE score >=3; AND prescribed by, or in consultation with, a dermatologist, allergist/immunologist, or other CHE specialist; AND trial and failure, contraindication, or intolerance to >=1 agent in >=2 categories (including topical medium-high potency corticosteroid AND topical calcineurin inhibitor OR immunosuppressive systemic agent) with total prior agent use >=90 days; AND trial and failure, contraindication, or intolerance to a preferred JAK inhibitor (e.g., Opzelura); AND no concurrent use of other biologics, JAK inhibitors, or immunosuppressants; AND meets package insert minimum agequantity limit 30 grams per month

Renewal requires continued criteria plus disease improvement or stabilization by objective measure

Andembry (garadacimab-gxii) is intended for prophylactic treatment of hereditary angioedema (HAE) and is covered only when all product-specific criteria are met. Per the policy, the patient must have a confirmed diagnosis of HAE documented by complement testing or C1 inhibitor protein and functional tests, the request must be for prophylactic use, and the drug must be prescribed by or in consultation with an immunologist, hematologist, or other HAE specialist. Concurrent prophylactic therapy with alternative HAE agents (for example: Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo) is explicitly not allowed and will exclude coverage. Approval durations follow the product guidance (6 months initial, 12 months renewal).

For Ekterly (sebetralstat), the policy disallows concurrent use with therapies intended for acute HAE attacks. Coverage requires a confirmed HAE diagnosis (complement testing or C1 inhibitor protein and functional tests), specialist prescribing or consultation, and that the patient is not on concurrent acute HAE treatment (e.g., Ruconest, Berinert, Kalbitor, Firazyr). Requests that document concurrent acute HAE therapy will be denied.

The P&T Committee removed the Laxatives and Cathartics therapeutic class from the consent agenda per committee recommendation. This administrative change reflects committee review and is noted in the consent agenda section; it does not itself create new clinical coverage criteria but signals committee-directed modification to the class listing.

Requests that do not document required prior therapy trials, lack specialist involvement, or omit objective diagnostic criteria or monitoring as specified in each product’s criteria will be considered not medically necessary. Examples include: molluscum requests without a documented ≥3-month trial and failure of ≥1 conventional therapy and dermatologist involvement; dry eye disease (Tryptyr) requests without prior preservative-free lubricating drops and failure of two preferred agents or without objective signs (CFS ≥2 in any field or Schirmer 1–10 mm/5 min); and chronic hand eczema (Anzupgo) requests without documented prior trials across the required therapeutic categories and a specialist prescriber. Absence of the specified documentation may result in denial.

Initial Therapy

Covered when ALL of the following are met

Ekterly initial coverage: Diagnosis of hereditary angioedema (HAE); AND documentation of confirmed diagnosis by complement testing OR C1 inhibitor protein and functional tests; AND prescribed by, or in consultation with, an immunologist, hematologist, or other HAE specialist; AND patient is not on concurrent acute HAE treatment (e.g., Ruconest, Berinert, Kalbitor, Firazyr); AND meets package insert minimum age

Initial approval duration 6 months; quantity limit 4 tablets per day specified separately

Renewal Therapy

Renewal requires ALL of the following

Ekterly renewal: Prescriber attestation of improvement compared to baseline in HAE attacks (reductions in attack frequency or severity)

Renewal contingent on prescriber attestation; initial approval duration 6 months

Class selection, non-preferred designation, and interim PA

Class selection and PA rules apply as follows

Class selection: DMS will select preferred agent(s) based on economic evaluationat least specified unique chemical entities per class

Where specified: GLP-1 and COPD classes: at least 2; Oral Antivirals: at least 1

Non-preferred agents: Agents not selected as preferred will be considered non-preferred and will require prior authorization (PA)

Applies across listed classes

New chemical entities: Any new chemical entity in the class requires PA until reviewed by the P&T Committee

Applies to GLP-1, Oral Antivirals, COPD as specified

Product utilization controls

Specific products within classes are annotated with utilization controls

Product-level controls: Listed agents include designations such as QL (quantity limit), CC (clinical criteria), and AE (additional evaluation/authorization) to indicate product-specific utilization controls

See product-level listings for examples and exact designations

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Zelsuvmi (berdazimer) prior authorization — required documentation

Submit a prior authorization request documenting the diagnosis of molluscum contagiosum and that treatment is prescribed by or in consultation with a dermatologist. Include documentation of a trial and failure of at least one conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage) for ≥3 months, the presence of at least one qualifying condition (atopic dermatitis, immunocompromised state, or concomitant bacterial infection), patient age meeting the package insert minimum, and note the quantity limit of 1 kit (31 grams) per month.

Diagnosis of molluscum contagiosum
Prescribed by/consult with dermatologist
Trial and failure ≥3 months of ≥1 conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage)
Document at least one qualifying condition: AD, immunocompromised, or bacterial infection
Age meets package insert minimum
Quantity limit: 1 kit (31 grams)/month

Prior Authorization

Coding, Tests, and Utilization Designations

Corneal fluorescein staining (CFS)

CFS diagnostic threshold>= 2 points in any field on a 0–4 scale

Measurement contextCorneal fluorescein staining recorded per-field on a 0-to-4 point scale

Use in coverage decisionsRequired objective sign for Tryptyr initial approval

Schirmer tear test (STT)

STT diagnostic threshold1 to 10 mm in 5 minutes

Test purposeObjective sign used to document dry eye disease (DED) for Tryptyr coverage

Use in renewal

Product-specific Initial Approval Rules

Product-specific initial therapy

Initial approval rules per product

Zelsuvmi initial: See Zelsuvmi criteria setapproval 3 months; quantity 1 kit/month

Prescriber specialty requirement: dermatologist

Initial Therapy

Initial approval rules: Prescribed for confirmed HAE diagnosis with required testing; prescribed by or in consultation with specified specialists; not on concurrent acute HAE treatment; meets package insert minimum ageinitial approval duration 6 months

Quantity limit specified separately

Renewal and Continuation Requirements

Continuation/Renewal requirements

Renewal/continuation criteria generally require continued meeting of initial criteria plus evidence of improvement or sustained biochemical response.

Tryptyr renewal: Patient continues to meet initial criteria AND demonstrates improvement in signs of DED measured by decreased CFS or increased Schirmer mm/5 minobjective improvement documented

Renewal duration 12 months

Sephience renewal: Patient continues to meet initial criteria AND provides documentation of sustained biochemical response (>=30% reduction in blood Phe)>=30% reduction in blood Phe

Renewal duration 12 months

Andembry renewal:

Step Therapy and Preferred Agent Selection

Product	Required prior therapy trials / duration	Prescriber specialty / other requirements	Supporting policy notes
Zelsuvmi (berdazimer)	Trial and failure of ≥1 conventional therapy for molluscum (cantharidin, silver nitrate, cryotherapy, or curettage) — at least 3 months	Prescribed by or in consultation with a dermatologist; patient must meet PI age minimum	Quantity limit 1 kit (31 grams) per month; coverage requires one of: atopic dermatitis, immunocompromised state, or concomitant bacterial infection; no concurrent MC treatment
Tryptyr (acoltremon)	Trial and failure of preservative‑free, nonprescription lubricating drops; AND trial and failure/contraindication/intolerance of 2 preferred agents (≥1 month each)	Prescribed by or in consultation with an ophthalmologist or optometrist; meets PI age minimum	Prescriber must document ≥1 objective sign: CFS ≥2 in any field OR Schirmer 1–10 mm/5 min; initial approval 3 months, renewal requires objective improvement; quantity limit 60 vials/30 days
Anzupgo (delgocitinib)	Trial and failure, contraindication, or intolerance to ≥1 agent in ≥2 categories with total prior agent use ≥90 days (topical medium‑high potency corticosteroid AND topical calcineurin inhibitor OR systemic immunosuppressive agent); AND trial and failure of a preferred JAK inhibitor	Prescribed by or in consultation with dermatologist, allergist/immunologist, or other CHE specialist; IGACHE ≥3; meets PI age minimum	No concurrent use of other biologics, JAK inhibitors, or immunosuppressants; quantity limit 30 grams/month

Class / Scope	DMS preferred selection rule	Effect on non‑preferred agents	Interim PA for new chemical entities
GLP‑1 Receptor Agonists (class example)	DMS to 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)	Any new chemical entity in the GLP‑1 class requires PA until reviewed by the P&T Committee
COPD Agents (class example)	DMS to 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 PA	New chemical entities in the class require PA until P&T review
Antivirals, Oral (class example)	DMS to select preferred agent(s) based on economic evaluation; minimum preferred unique chemical entities may be lower (e.g., at least 1)	Agents not selected as preferred will be considered non‑preferred and will require PA	Any new chemical entity in the Antivirals, Oral class requires PA until reviewed by the P&T Committee

Quantity and Dosing Limits

Zelsuvmi (berdazimer) quantity limit

Quantity limit1 kit (31 grams)

Per intervalPer month

Associated productZelsuvmi (berdazimer)

Vykat XR (diazoxide choline) quantity limits

150 mg tablets3 tablets per day

75 mg tablets3 tablets per day

25 mg tablets2 tablets per day

Product Mechanisms and Utilization Term Definitions

Berdazimer

MechanismNitric oxide releasing agent

Intended useTopical agent proposed to interfere with viral replication of molluscum contagiosum

Product nameBerdazimer (Zelsuvmi)

Acoltremon

MechanismTRPM8 agonist stimulating trigeminal signaling to increase basal tear production

IndicationTreatment of dry eye disease (DED)

Product nameAcoltremon (Tryptyr)

Background and Context

Background: This document summarizes mechanisms of action and intended indications for several newly reviewed products. Examples include a topical nitric oxide–releasing agent for molluscum contagiosum (berdazimer), a TRPM8 agonist for dry eye disease (acoltremon/Tryptyr), a monoclonal antibody targeting activated factor XII for HAE prophylaxis (garadacimab‑gxii/Andembry), a BH4 precursor to enhance phenylalanine metabolism in PKU (sepiapterin/Sephience), and an oral reversible plasma kallikrein inhibitor for acute HAE attacks (sebetralstat/Ekterly). The policy pairs these clinical summaries with coverage rules requiring specialist prescribers, confirmatory testing or objective measures, and prior therapy trials where appropriate.

Policy Summary

Payermedimpact

PolicyNew products to market — coverage criteria for select specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewOct 14, 2025

Next Review DateN/A

Key ActionSubmit required prior‑authorization documentation including diagnosis confirmation, specialist involvement, prior therapy trials, and objective test results as specified for each product.

SourceLink

On This Page

Vykat XR (diazoxide choline) prior authorization — genetic confirmation and baseline monitoring

Prior authorization must include documentation of clinical confirmation of Prader‑Willi syndrome via genetic testing showing abnormal DNA methylation of chromosome 15q11.2‑q13, that the prescriber is an endocrinologist, geneticist, or PWS specialist, baseline fasting plasma glucose (FPG) and HbA1c results, and the prescriber’s attestation to ongoing monitoring of FPG, HbA1c, and signs/symptoms of edema. Include patient age per the package insert and apply the specified tablet quantity limits.

Genetic test confirming PWS (abnormal DNA methylation of 15q11.2‑q13)
Prescriber specialty: endocrinologist, geneticist, or PWS specialist
Baseline FPG and HbA1c results included
Prescriber attestation to monitor FPG, HbA1c, and edema
Age meets package insert minimum
Quantity limits: 150 mg = 3/day; 75 mg = 3/day; 25 mg = 2/day

Prior Authorization

Tryptyr (acoltremon) prior authorization — diagnosis, prior trials, specialist, and objective tests

For Tryptyr, submit PA showing diagnosis of dry eye disease prescribed by or in consultation with an ophthalmologist or optometrist, documentation of trials and failures (preservative‑free lubricating drops plus two preferred agents), and at least one objective sign (CFS ≥2 in any field or Schirmer 1–10 mm/5 min). Ensure age and quantity limits are included; renewal requires documented objective improvement.

Diagnosis of DED and prescriber specialty (ophthalmologist/optometrist)
Trial and failure of preservative‑free lubricating drops
Trial and failure/contraindication/intolerance of 2 preferred agents (≥1 month each or documented reason)
Documented objective sign: CFS ≥2 in any field OR Schirmer 1–10 mm/5 min
Age per PI (renewal requires ≥18)
Quantity limit: 60 vials per 30 days; renewal requires documented improvement

Prior Authorization

Andembry and Sephience prior authorization — confirmatory testing, specialist prescriber, monitoring plans

Requests for Andembry or Sephience must include confirmatory diagnostic testing and specialist involvement: for Andembry, confirm HAE by complement testing or C1 inhibitor protein/functional tests and indicate prophylactic intent; for Sephience, confirm PKU with elevated blood Phe and document a metabolic disease specialist prescribing and a monitoring/biochemical response plan. Include age and quantity limits as specified.

Andembry: confirm HAE by complement testing OR C1 inhibitor protein and functional tests; prescribed for prophylaxis
Andembry: prescriber is immunologist, hematologist, or HAE specialist; not on concurrent prophylactic HAE agent
Sephience: confirmed PKU with elevated blood Phe; prescribed by metabolic disease expert
Sephience: provider attests to Phe‑restricted diet supervision and monitoring plan; quantity limit 1.2 mL (200 mg)/month; renewal requires ≥30% reduction in blood Phe

Prior Authorization

Anzupgo (delgocitinib) prior authorization — IGACHE threshold, specialist, prior therapy

PA for Anzupgo must document a diagnosis of moderate to severe chronic hand eczema with an IGACHE score ≥3, that the prescriber is a dermatologist, allergist/immunologist, or CHE specialist, and prior therapy failures across required categories including a preferred JAK inhibitor. Attest there is no concurrent use of other biologics, JAK inhibitors, or immunosuppressants, and include age and quantity limits.

IGACHE score ≥3 documented
Prescriber specialty: dermatologist, allergist/immunologist, or CHE specialist
Trial and failure/contraindication/intolerance to ≥1 agent in ≥2 categories (topical medium‑high potency corticosteroid AND topical calcineurin inhibitor OR systemic immunosuppressant) with total prior agent use ≥90 days
Trial and failure/contraindication/intolerance to a preferred JAK inhibitor
No concurrent biologics/JAKs/immunosuppressants
Quantity limit: 30 grams per month; age per PI

Prior Authorization

PA required for Ekterly (sebetralstat) — initial duration and renewal attestation

Ekterly (sebetralstat) requires prior authorization for HAE with an initial approval duration of 6 months. Renewal is contingent on a prescriber attestation of improvement compared to baseline in HAE attack frequency or severity; include the quantity limit of 4 tablets per day and required specialist involvement.

Confirmed HAE diagnosis (see required tests cited elsewhere)
Prescribed by or in consultation with immunologist, hematologist, or HAE specialist
Initial approval duration: 6 months
Renewal requires prescriber attestation of improvement in attack frequency or severity
Quantity limit: 4 tablets per day

Billing Rule

PA and utilization code designations — include QL/CC/AE where applicable

The policy designates utilization codes (examples: QL, CC, AE) for certain products and notes that non‑preferred agents generally require prior authorization with additional review. Include these utilization designations on PA submissions where applicable.

Examples of utilization designations: QL = quantity limit, CC = clinical criteria, AE = additional evaluation/authorization
Non‑preferred agents will require PA and may carry AE/CC/QL flags

Step Therapy

Molluscum therapy requirement — conventional therapy trial required

For molluscum, include documentation of a trial and failure of at least one conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage) of ≥3 months before approving Zelsuvmi.

Trial and failure of ≥1 conventional therapy (cantharidin, silver nitrate, cryotherapy, or curettage) for ≥3 months

Step Therapy

Tryptyr specific trials — lubricants and two preferred agents required

For Tryptyr PA, document a trial and failure of preservative‑free, nonprescription lubricating eye drops and of two preferred agents (each ≥1 month or with documented intolerance/contraindication).

Trial and failure of preservative‑free lubricating drops
Trial and failure/contraindication/intolerance of 2 preferred agents (≥1 month each or documented reason)

Step Therapy

Anzupgo required prior therapy trials — failure across ≥2 categories plus JAK trial

Anzupgo PA must document trial and failure (or intolerance/contraindication) to at least one agent in two distinct categories (topical medium‑to‑high potency corticosteroid AND topical calcineurin inhibitor or systemic immunosuppressant) and failure of a preferred JAK inhibitor prior to approval.

Failure/intolerance/contraindication to ≥1 agent in ≥2 categories with total prior agent use ≥90 days
Failure/intolerance/contraindication to a preferred JAK inhibitor (e.g., Opzelura)

Step Therapy

Step therapy / concurrent therapy — concurrent acute HAE treatments disallowed

No class‑level step therapy is specified in the product criteria. However, concurrent use of sebetralstat with acute HAE treatments (e.g., Ruconest, Berinert, Kalbitor, Firazyr) is disallowed and must be documented as absent.

No step therapy required across products per criteria
Do not prescribe concurrent acute HAE treatments with sebetralstat; document absence of Ruconest, Berinert, Kalbitor, Firazyr

Note

DMS selection of preferred agents — minimum preferred entities and PA implication

DMS will select preferred agents based on economic evaluation; include that at least the minimum number of unique chemical entities per class must be preferred (e.g., at least 2 for GLP‑1 and COPD classes, at least 1 for Oral Antivirals). Non‑preferred agents will require PA.

DMS selects preferred agents based on economic evaluation
Minimum preferred: GLP‑1 and COPD = at least 2 unique chemical entities; Antivirals, Oral = at least 1
Agents not selected as preferred are non‑preferred and require PA

Documentation Required

Documentation requirements — prior therapies and prescriber specialty

Include in the PA the chart documentation of prior conventional molluscum therapies tried and the prescriber specialty or consultation note (dermatologist) to support medical necessity.

Chart documentation of prior conventional MC therapies tried
Prescriber specialty or consultation note (dermatologist)

Documentation Required

Vykat XR lab/genetic documentation — genetic confirmation and baseline glucose/HbA1c

For Vykat XR PA, upload genetic test results confirming PWS (abnormal DNA methylation of chromosome 15q11.2‑q13) and baseline FPG and HbA1c results; include the prescriber’s attestation to ongoing monitoring of FPG, HbA1c, and signs/symptoms of edema.

Genetic test confirming abnormal DNA methylation of 15q11.2‑q13
Baseline fasting plasma glucose (FPG) and HbA1c results
Prescriber attestation to monitor FPG, HbA1c, and edema

Documentation Required

Tryptyr required objective signs and documentation — CFS/Schirmer and consult

For Tryptyr approvals, ensure chart documentation of prior therapies, objective signs of DED (CFS ≥2 or Schirmer 1–10 mm/5 min), and a prescriber specialty consultation note are included; renewal must show objective improvement per the renewal criteria.

Chart documentation of prior preservative‑free lubricants and two preferred agents
Objective sign: CFS ≥2 in any field OR Schirmer 1–10 mm/5 min
Prescriber specialty: ophthalmologist or optometrist
Renewal requires documented improvement in CFS or Schirmer

Documentation Required

Andembry and Sephience confirmatory testing and monitoring requirements

For Andembry and Sephience, include confirmatory diagnostic testing (complement/C1 inhibitor testing for HAE; elevated blood Phe for PKU), prescriber specialty documentation, and monitoring or biochemical response plans (Sephience renewal requires ≥30% Phe reduction).

Andembry: complement testing OR C1 inhibitor protein/functional tests; prescriber specialty and prophylactic intent
Sephience: elevated blood Phe documented; metabolic disease specialist; monitoring plan and diet supervision
Sephience renewal: documentation of ≥30% reduction in blood Phe

Documentation Required

Required documentation for sebetralstat PA — confirmatory testing and prescriber specialty

PA for sebetralstat must include documentation confirming HAE diagnosis by complement testing or C1 inhibitor protein and functional tests, the prescriber specialty or consultation note (immunologist, hematologist, or HAE specialist), confirmation that the patient is not on concurrent acute HAE therapy, and for renewal a prescriber attestation of improvement in attack frequency or severity.

Confirmed HAE diagnosis by complement testing OR C1 inhibitor protein and functional tests
Prescriber specialty or consultation note (immunologist, hematologist, or HAE specialist)
Confirmation patient is not on concurrent acute HAE treatment (e.g., Ruconest, Berinert, Kalbitor, Firazyr)
Renewal requires prescriber attestation of improvement versus baseline

Prior Authorization

New GLP-1 chemical entities require PA until P&T review

Require prior authorization for any new chemical entity in the GLP‑1 class until the P&T Committee has reviewed the agent; include PA submission per usual documentation standards.

Any new chemical entity in GLP‑1 class requires PA until P&T review

Prior Authorization

New Antivirals, Oral chemical entities require PA until P&T review

Require prior authorization for any new chemical entity in the Antivirals, Oral class until the P&T Committee has reviewed the agent.

Any new chemical entity in Antivirals, Oral class requires PA until P&T review

Prior Authorization

New COPD Agents chemical entities require PA until P&T review

Require prior authorization for any new chemical entity in the COPD Agents class until the P&T Committee has reviewed the agent.

Any new chemical entity in COPD Agents class requires PA until P&T review

Denial Risk

Denial risk for molluscum — missing prior trial or specialty consult may cause denial

Requests for molluscum therapy may be denied if the PA does not document a trial and failure of at least one conventional therapy and lacks a dermatologist consultation note showing specialty involvement.

Denial may be triggered by absence of documented trial and failure of ≥1 conventional therapy (cantharidin, silver nitrate, cryotherapy, curettage)
Denial may be triggered by absence of dermatologist prescriber or consultation

Denial Risk

Denial risk for Vykat XR — missing genetic confirmation or baseline labs

PA for Vykat XR may be denied if genetic confirmation of Prader‑Willi syndrome is not provided or if baseline FPG/HbA1c results and a monitoring plan are missing from the submission.

Denial risk if genetic test confirming abnormal DNA methylation of 15q11.2‑q13 is not included
Denial risk if baseline FPG and HbA1c results or prescriber monitoring attestation are missing

Denial Risk

Denial risk for Tryptyr — missing prior trials or objective testing may trigger denial

Tryptyr requests may be denied for failure to document required prior trials (preservative‑free lubricants and two preferred agents) or if objective signs of DED (CFS ≥2 or Schirmer 1–10 mm/5 min) are not provided.

Denial risk for missing trial of preservative‑free lubricating drops or two preferred agents
Denial risk for missing objective DED sign: CFS ≥2 in any field OR Schirmer 1–10 mm/5 min

Denial Risk

Denial risk for Andembry and Sephience — missing confirmatory tests or specialist documentation

Andembry or Sephience PA requests may be denied if confirmatory diagnostic testing is absent (complement/C1 inhibitor testing for HAE; elevated blood Phe for PKU) or if specialist prescribing and monitoring documentation are not included.

Denial risk if confirmatory testing for HAE (complement or C1 inhibitor tests) is missing
Denial risk if elevated blood Phe or metabolic specialist documentation for PKU is missing
Denial risk if monitoring/biochemical response plans are absent

Denial Risk

Denial triggers for sebetralstat — lack of documented HAE diagnosis with confirmatory testing may result in denial

PA for sebetralstat may be denied if the diagnosis of HAE is not documented with confirmatory testing (complement testing or C1 inhibitor protein and functional tests), if not prescribed by or in consultation with an appropriate specialist, if concurrent acute HAE therapy is present, or if package‑insert minimum age is not met.

Denial if no confirmatory complement testing OR C1 inhibitor protein/functional tests
Denial if no immunologist/hematologist/HAE specialist prescriber or consultation
Denial if patient is on concurrent acute HAE treatment (e.g., Ruconest, Berinert, Kalbitor, Firazyr)
Denial if patient does not meet package insert minimum age

Prior Authorization

Non-preferred agents will require prior authorization — general rule

Agents that are not selected as preferred by DMS will be considered non‑preferred and will require prior authorization. Ensure PA submissions include required clinical documentation for non‑preferred agents.

Non‑preferred agents require PA
Include necessary clinical documentation when requesting non‑preferred agents

Prior Authorization

Antivirals, Oral non-preferred agents require PA

Non‑preferred agents in the Antivirals, Oral class will require prior authorization when not selected as preferred by DMS.

Antivirals, Oral agents not selected as preferred require PA

Prior Authorization

COPD Agents non-preferred agents require PA

Non‑preferred agents in the COPD Agents class will require prior authorization when not selected as preferred by DMS.

COPD Agents not selected as preferred require PA

Increase in mm per 5 minutes on Schirmer indicates improvement for renewal

Sephience biochemical response

Biochemical response threshold>= 30% reduction in blood phenylalanine (Phe) levels

ContextDefined as sustained biochemical response required for Sephience renewal

DocumentationPrescriber must provide chart notes or summary confirming sustained >=30% Phe reduction

Preferred agent minimum

Preferred minimum (selected classes)At least 2 unique chemical entities preferred for specified classes (e.g., GLP-1, COPD)

Preferred minimum (oral antivirals)At least 1 unique chemical entity preferred for Oral Antivirals

Policy actionAgents not selected as preferred will be considered non-preferred and require prior authorization

Prescriber attests to improvement compared to baseline in HAE attack frequency or severity

clinical improvement documented

Renewal duration 12 months

Continuation/Renewal

Renewal

Renewal attestation: For renewal of Ekterly (sebetralstat), prescriber must attest to improvement versus baseline in HAE attack frequency or severity

Renewal contingent on prescriber attestation; quantity limit 4 tablets/day

Tryptyr (acoltremon) quantity limit

Quantity limit60 vials per 30 days

IndicationTryptyr (acoltremon) for dry eye disease (DED)

Renewal noteRenewal requires documented objective improvement

Sephience (sepiapterin) quantity limit

Quantity limit1.2 mL (200 mg) per month

IndicationSephience (sepiapterin) for PKU

Renewal requirementDocumentation of sustained biochemical response required

Anzupgo (delgocitinib) quantity limit

Quantity limit30 grams per month

Associated productAnzupgo (delgocitinib)

Use in criteriaQuantity limit applied to initial and renewal approvals

Ekterly (sebetralstat) quantity limit

Quantity limit4 tablets per day

Associated productEkterly (sebetralstat)

Approval durationInitial approval duration 6 months; renewal requires prescriber attestation of improvement

Unspecified product quantity limit

Quantity limit (unspecified product)30 (unit unspecified)

ContextDocument lists an unspecified product-level limit of 30 per month

Related noteMay correspond to a 30-gram monthly limit shown elsewhere

Oseltamivir QL designation

Designation presentOseltamivir is listed with a QL (quantity limit) designation

Class contextAppears under Influenza antivirals with preferred/non-preferred mapping

ImplicationQuantity limit designation may trigger utilization controls and prior authorization for non-preferred agents

Garadacimab-gxii

MechanismMonoclonal antibody that blocks activated factor XII to prevent kallikrein-kinin system overactivation

IndicationProphylactic treatment of hereditary angioedema (HAE)

Product nameGaradacimab-gxii (Andembry)

Sepiapterin

MechanismPrecursor to tetrahydrobiopterin (BH4) enhancing phenylalanine hydroxylase (PAH) activity

IndicationAdjunct to diet to reduce phenylalanine levels in phenylketonuria (PKU)

Product nameSepiapterin (Sephience)

Sebetralstat (Ekterly)

MechanismOral competitive, reversible plasma kallikrein inhibitor that reduces bradykinin production

IndicationTreatment of acute, episodic hereditary angioedema (HAE) attacks

Product nameSebetralstat (Ekterly)

Utilization designations

QLQuantity Limit

CCClinical Criteria

AEAdditional evaluation/authorization