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Single Agent Reviews — Pharmacy & Specialty Drugs coverage criteria

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This document lists single-agent pharmacy review agenda items and proposed coverage/options for consideration for various new and existing specialty and dermatologic drugs presented to the Pharmacy & Therapeutics Advisory Committee; it affects prescribers, pharmacy reviewers, and payer policy decision-makers.

Policy Summary

Payermedimpact

PolicySingle Agent Reviews — Pharmacy & Specialty Drugs coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic confirmation, prescriber specialty information, and documentation of prior therapy trials and monitoring per agent-specific requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleagents discussed

Oct 14, 2025P&T meeting

examplesquantity limits noted

≥1preferred agents min

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DraftmedimpactPolicy N/A

Single Agent Reviews — Pharmacy & Specialty Drugs coverage criteria

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Sign up for all medimpact policy alerts

Know when medimpact releases new policies or updates existing guidance.

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Policy Summary

Payermedimpact

PolicySingle Agent Reviews — Pharmacy & Specialty Drugs coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic confirmation, prescriber specialty information, and documentation of prior therapy trials and monitoring per agent-specific requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleagents discussed

Oct 14, 2025P&T meeting

examplesquantity limits noted

≥1preferred agents min

Coverage and Medical Necessity Criteria

Vykat XR / topical antiviral agent criteria

Covered when ALL of the following are met

Diagnosis and prior therapies: Patient has a diagnosis appropriate to the topical antiviral indication (e.g., molluscum contagiosum) and has tried conventional therapies where specified (cantharidin, silver nitrate, cryotherapy, or curettage).

Patient risk factors: Patient has atopic dermatitis OR is immunocompromised OR has concomitant bacterial infection.

Concurrent therapy exclusion: Patient is not on concurrent treatment for molluscum contagiosum.

Age limit: Patient meets the minimum age recommended by the package insert (age limit example: 1 year of age or older for Vykat XR).

Diazoxide choline (Vykat XR) for PWS

Covered when ALL of the following are met

Genetic confirmation: Clinical confirmation of Prader-Willi syndrome documented by genetic testing showing abnormal DNA methylation of the 15q11.2–q13 region.

Prescriber specialty: Prescribed by, or in consultation with, an endocrinologist, geneticist, or other specialist in the treatment of PWS.

Baseline monitoring: Baseline fasting plasma glucose (FPG) and HbA1c performed; prescriber attests to ongoing monitoring of FPG, HbA1c, and signs/symptoms of edema during treatment.

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

Andembry (garadacimab-gxii) initial therapy

Covered when ALL of the following are met

Diagnosis confirmation: Diagnosis of hereditary angioedema (HAE) with documentation by complement testing or C1 inhibitor protein and functional tests.

Indication: Prescribed for prophylactic use for C1-INH hereditary angioedema.

Specialist prescriber: Prescribed by, or in consultation with, an immunologist, hematologist, or other specialist in the diagnosis and treatment of HAE.

No concurrent prophylactic agents: Patient is not on concurrent prophylactic HAE agents (examples: Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo).

Age limit:

Sebetralstat for acute HAE

Covered when ALL of the following are met

Diagnosis confirmation: Diagnosis of hereditary angioedema (HAE) with documentation by complement testing or C1 inhibitor protein and functional tests.

Prescriber specialty: Prescribed by, or in consultation with, an immunologist, hematologist, or other specialist in the diagnosis and treatment of HAE.

Concurrent acute therapy exclusion: Patient is not on concurrent acute HAE treatment (examples: Ruconest, Berinert, Kalbitor, Firazyr).

Age limit: Patient meets the minimum age recommended by the package insert for this FDA‑approved indication.

Delgocitinib initial therapy for chronic hand eczema

Covered when ALL of the following are met

Diagnosis and severity: Diagnosis of moderate to severe chronic hand eczema (CHE) with Investigator's Global Assessment for Chronic Hand Eczema (IGACHE) score ≥ 3.IGACHE ≥3

Specialist prescriber: Prescribed by, or in consultation with, a dermatologist, allergist/immunologist, or other specialist in the treatment of chronic hand eczema.

Prior therapy trials: Trial and failure, contraindication, or intolerance to ≥1 agent in 2 or more categories (topical medium‑to‑high potency corticosteroid, topical calcineurin inhibitor, systemic immunosuppressive agent) with total prior agent use ≥90 days; and trial/failure of a preferred JAK inhibitor.≥90 days total prior agent use

Tryptyr (acoltremon) for dry eye disease

Covered when ALL of the following are met

Diagnosis: Patient has a diagnosis of dry eye disease (DED).

Prescriber specialty: Prescribed by, or in consultation with, an ophthalmologist or optometrist.

Conservative therapy trial: Trial and failure of preservative‑free, nonprescription lubricating eye drops (e.g., artificial tears).

Preferred agent failures: ≥1 month trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents.≥1 month

Sepiapterin initial and renewal criteria

Covered when ALL of the following are met

Diagnosis: Confirmed diagnosis of phenylketonuria (PKU) with elevated blood phenylalanine (Phe) levels.

Specialist prescriber: Prescribed by, or in consultation with, a metabolic disease expert or other specialist in the management of PKU.

Dietary management: Provider attests patient is on and will continue a phenylalanine‑restricted diet supervised by a metabolic disease specialist or knowledgeable provider, with a monitoring plan for dietary intake and regular blood Phe assessments.

Dose limit: Requested dose does not exceed the maximum FDA‑approved dose for the condition based on patient weight.

PDL Class Preference and PA Requirements

Covered when PDL preferred agent selection and/or PA criteria are met as determined by DMS/P&T decisions

PDL class preference and PA: DMS will select preferred agent(s) for each PDL class based on economic evaluation; agents not selected as preferred will be considered non‑preferred and require prior authorization.

Minimum preferred agents: For each class, at least the minimum number of unique chemical entities should be designated preferred as specified in class‑level guidance.

New chemical entities: Any new chemical entity in a listed class requires prior authorization until reviewed by the P&T Committee.

Agent Renewal Criteria

Renewal criteria example for a specific agent

Renewal for hereditary angioedema agent: Prescriber must attest to improvement compared to baseline in hereditary angioedema attacks (reduction in attack frequency or severity).

For hereditary angioedema (HAE) prophylaxis and acute-attack therapies, the document specifies that patients receiving one listed HAE agent should not be on concurrent alternative prophylactic or acute HAE treatments. Examples named in the source include prophylactic agents such as Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo (for prophylaxis) and acute therapies such as Ruconest, Berinert, Kalbitor, Firazyr. Concurrent use of these alternative prophylactic or acute HAE agents is an exclusionary condition for approval of the agents discussed.

In the class-level sections cited, the document does not list additional explicit patient- or agent-level exclusions beyond the class-preference and prior authorization rules. Instead, it focuses on PDL preferred agent selection, economic evaluation by DMS, and the requirement that agents not selected as preferred will be considered non-preferred and require prior authorization.

For delgocitinib (Anzupgo®) for chronic hand eczema, the options for consideration require a documented trial and failure (or contraindication/intolerance) to prior therapies before approving delgocitinib. Specifically, prescribers must document trial and failure, contraindication, or intolerance to ≥1 agent in ≥2 categories (topical medium‑to‑high potency corticosteroids, topical calcineurin inhibitors, systemic immunosuppressants) totaling ≥90 days of prior agent use, and trial/failure of a preferred JAK inhibitor. Use of delgocitinib without meeting these prior‑therapy requirements would not meet the stated criteria.

The cited chunks do not contain standalone "not medically necessary" statements for the agents; rather, they set forth criteria, class preferences, and prior authorization rules. Where a therapy would fail to meet specified prior‑therapy or concurrent‑therapy criteria, the document indicates such requests would not meet the approval criteria, but it does not provide separate explicit NMN declarations in these excerpts.

Initial Therapy Requirements

Garadacimab initial therapy

Covered when ALL of the following are met

HAE diagnosis and tests: Diagnosis of hereditary angioedema (HAE) with documentation by complement testing or C1 inhibitor protein and functional tests.

Prophylactic intent: Prescribed for prophylactic use for C1‑INH HAE.

Specialist prescriber: Prescribed by, or in consultation with, an immunologist, hematologist, or other specialist in the diagnosis and treatment of HAE.

No concurrent prophylactics: Patient is not on concurrent prophylactic HAE agents (examples: Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo).

Renewal and Continuation Requirements

Renewal / continuation criteria

Renewal requires continued benefit and documentation

Garadacimab renewal: Prescriber attestation of improvement in HAE attack frequency or severity compared to baseline is required for renewal.

Tryptyr renewal: For Tryptyr, patient must continue to meet initial criteria and demonstrate improvement in signs of dry eye disease (decrease in CFS or increase in Schirmer test).

Sepiapterin renewal: Continued ≥30% reduction in blood phenylalanine (Phe) levels compared to baseline is required for renewal.>=30% reduction

Required Prior Therapies and Step Edges

Required prior therapy (categories)	Minimum trial/failure	Notes
Topical corticosteroid (medium to high potency) e.g., mometasone, fluocinolone
Total prior agent use ≥ 90 days across required categories (trial and failure, contraindication, or intolerance)
Patient must be prescribed by, or in consultation with, a dermatologist, allergist/immunologist, or other CHE specialist

PDL class action	Implication for non-preferred agents	Notes
DMS to select preferred agent(s) based on economic evaluation (minimum preferred chemical entities specified per class)
Agents not selected as preferred will be considered non-preferred and will require prior authorization
For any new chemical entity in the class, require prior authorization until reviewed by the P&T Committee

Prescriber and Pharmacy Actions

Prior Authorization

Prior authorization required with specialty, diagnosis, prior therapy, and monitoring

Prior authorization is required for the listed agents. Requests must meet prescriber specialty requirements, include diagnostic confirmation where specified, document required prior therapy trials, and attest to baseline monitoring as indicated (examples include Vykat XR/diazoxide choline, Tryptyr, Andembry/garadacimab-gxii, sepiapterin, delgocitinib, sebetralstat).

Prescriber specialty or consultation required per agent (e.g., endocrinologist/geneticist for PWS; immunologist/hematologist for HAE; dermatologist or allergist for chronic hand eczema; ophthalmologist/optometrist for Tryptyr).
Diagnostic confirmation required when specified (see diagnostic documentation callouts).
Prescriber must attest to baseline tests and monitoring where required (e.g., FPG and HbA1c for diazoxide choline).

Prior Authorization

PA required for non-preferred agents and new chemical entities

Non-preferred agents across PDL classes require prior authorization. Additionally, any new chemical entity in the listed classes requires PA until reviewed by the P&T Committee.

Quantity Limits and Coding Guidance

Quantity Limit — example

Quantity limit (example)4 tablets per day

ContextListed as a quantity-limit example associated with renewal criteria for an HAE agent

Source noteUsed in renewal example requiring prescriber attestation of improvement

Agent-Specific Quantity Limits

Tryptyr (acoltremon) — quantity limit example

Quantity limit30 grams per month

AgentTryptyr (acoltremon)

Indication contextDry eye disease (DED) — listed with initial/renewal criteria

Vykat XR (diazoxide choline) / topical antiviral examples — quantity limit

Quantity limit1 kit (31 grams) per month

Agent examplesVykat XR (diazoxide choline) / topical antiviral agents (quantity shown with age limit)

Age limit note

Background and Mechanisms

The document summarizes mechanism and intended indications for multiple agents: a topical nitric oxide‑releasing antiviral indicated for molluscum contagiosum; diazoxide choline (Vykat™ XR) for hyperphagia associated with Prader‑Willi syndrome with required baseline metabolic monitoring; garadacimab‑gxii (Andembry®), a monoclonal antibody blocking activated factor XII for prophylactic treatment of C1‑INH hereditary angioedema; sebetralstat (Ekterly®), a reversible plasma kallikrein inhibitor for acute HAE attacks; and delgocitinib (Anzupgo®), a JAK inhibitor under consideration for moderate to severe chronic hand eczema with step‑therapy requirements.

Agent Definitions and Terms

Berdazimer — nitric oxide releasing agent (definition)

DefinitionBerdazimer is a nitric oxide–releasing agent; nitric oxide release may interfere with viral replication by disrupting viral DNA synthesis.

Indication exampleUsed for molluscum contagiosum as a topical antiviral agent

Mechanism noteExact mechanism unknown; antiviral effect attributed to nitric oxide release

Garadacimab‑gxii (Andembry®) — monoclonal antibody (definition)

DefinitionGaradacimab‑gxii (Andembry®) is a monoclonal antibody that blocks the function of activated factor XII, preventing overactivation of the kallikrein‑kinin system and reducing bradykinin production.

IndicationIndicated for prophylactic treatment of C1‑INH hereditary angioedema in patients aged 12 years and older

Policy Summary

Payermedimpact

PolicySingle Agent Reviews — Pharmacy & Specialty Drugs coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic confirmation, prescriber specialty information, and documentation of prior therapy trials and monitoring per agent-specific requirements.

SourceLink

On This Page

Patient meets the minimum age recommended by the package insert for this FDA‑approved indication (example: aged 12 years and older).

No concurrent immunosuppressants:

No concurrent use of other biologics, JAK inhibitors, or systemic immunosuppressants.

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

Objective signs required:

Prescriber has documented at least one objective sign: corneal fluorescein staining (CFS) score ≥ 2 in any field OR Schirmer tear test (STT) of 1–10 mm in 5 minutes.

CFS ≥2 OR STT 1–10 mm/5 min

Renewal criteria: Patient continues to meet criteria and demonstrates improvement in signs of DED (decrease in CFS or increase in Schirmer test mm/5 min).

Renewal biochemical response:

Sustained biochemical response defined as continued ≥30% reduction in blood Phe levels compared to baseline.

Agents not selected as preferred by DMS will be considered non-preferred and will require PA.
For any new chemical entity in a class, require PA until P&T review.

Step Therapy

Step therapy: required prior trials before delgocitinib

For delgocitinib (chronic hand eczema), the prescriber must document trial and failure, contraindication, or intolerance to at least one agent in two or more categories (topical medium–high potency corticosteroid; topical calcineurin inhibitor; or systemic immunosuppressant) totaling ≥90 days of prior agent use, and trial/failure of a preferred JAK inhibitor.

Total prior agent use across required categories must be ≥90 days.
Must document trial and failure, contraindication, or intolerance to a preferred JAK inhibitor (e.g., Opzelura).

Note

Ensure required prior trials and documentation are submitted

Provider must ensure and document all required prior therapies and diagnostic/monitoring information are present; lack of the required documentation or trials will prevent approval.

If required prior trials for chronic hand eczema are not documented, coverage is not supported.
Failure to obtain PA for non-preferred agents or new chemical entities risks denial.

Documentation Required

Provide diagnostic test documentation (PWS and HAE)

Clinical diagnostic confirmation is required per agent: for Prader-Willi syndrome (diazoxide choline) provide genetic test documentation identifying abnormal DNA methylation of chromosome 15q11.2–q13; for hereditary angioedema (garadacimab/sebetralstat) provide complement testing or C1 inhibitor protein and functional test results.

PWS: genetic test identifying abnormal DNA methylation of 15q11.2–q13.
HAE: complement testing OR C1‑INH protein and functional assays to confirm diagnosis.

Documentation Required

Document baseline tests and assessments; attest to monitoring

Prescriber must attest to baseline assessments and monitoring when required: for diazoxide choline, document baseline fasting plasma glucose and HbA1c and attest to monitoring FPG, HbA1c, and signs/symptoms of edema during treatment; for delgocitinib include baseline IGACHE score and any other required baseline assessments.

Diazoxide choline: baseline FPG and HbA1c performed; prescriber attests to ongoing monitoring of FPG, HbA1c, and edema.
Delgocitinib (CHE): document baseline Investigator's Global Assessment for Chronic Hand Eczema (IGACHE) score (≥3 required for initiation).

Documentation Required

Prescriber attestation of clinical improvement required for renewal

For renewal of HAE prophylactic or acute agents, prescriber must attest that the patient has clinically improved compared to baseline (e.g., reductions in attack frequency or severity).

Renewal requires prescriber attestation of improvement or stabilization based on objective measures.
Example renewal attestations include reduced HAE attack frequency or severity compared to baseline.

Denial Risk

Concurrent prophylactic or acute HAE therapies prevent approval

Concurrent use of alternative prophylactic or acute HAE therapies listed in the policy (e.g., Takhzyro, Haegarda, Cinryze, Dawnzera, Orladeyo, Ruconest, Berinert, Kalbitor, Firazyr) is a disqualifying condition and will prevent approval.

Do not request coverage if the patient is on concurrent prophylactic HAE agents (examples listed above).
Do not request coverage if the patient is on concurrent acute HAE treatments when the policy disallows such concurrent therapy.

Denial Risk

Missing prior therapy trials for chronic hand eczema risks denial

Failure to document required prior trials, contraindications, or intolerances for chronic hand eczema (delgocitinib) will result in denial because the policy requires step therapy trials and IGACHE documentation.

Required documentation includes trial and failure (or contraindication/intolerance) of ≥1 agent in ≥2 categories and IGACHE score ≥3.
Total prior agent use must be ≥90 days across categories to meet the step therapy requirement.

Billing Rule

Non-preferred agents will require prior authorization

Agents that are not selected as preferred by DMS for their PDL class will be considered non-preferred and require prior authorization; failure to obtain PA for non-preferred agents may result in denial of coverage.

DMS selects preferred agent(s); agents not selected are non-preferred and require PA.
Obtain PA before dispensing non-preferred agents to avoid denial.

Prior Authorization

New chemical entities require PA until P&T review

Any new chemical entity within the listed PDL classes requires prior authorization until the P&T Committee has reviewed the agent; requests without prior P&T review are subject to PA and possible denial.

New chemical entities in class-level reviews (e.g., Acne Agents Oral, Antiemetics, Immunomodulators) require PA until P&T review is completed.
Submit PA and supporting documentation for new chemical entities to avoid denial.

Minimum age per package insert (Vykat example: age ≥1 year)

Garadacimab-gxii (Andembry) — quantity limit example

Quantity per month (example)1.2 mL (200 mg) per month

AgentGaradacimab-gxii (Andembry) — listed quantity-limit example

Associated useProphylactic treatment of C1‑INH hereditary angioedema (HAE)

Diazoxide choline tablet strengths (examples) — dosing

Tablet-strength dosing examples150 mg: 3 per day; 75 mg: 3 per day; 25 mg: 2 per day

AgentDiazoxide choline tablet strengths (examples)

ContextListed under quantity/dosing examples for diazoxide choline formulations

Ekterly / sebetralstat — quantity limit example

Quantity limit (example)4 tablets per day

AgentEkterly® (sebetralstat)

IndicationAcute, episodic hereditary angioedema (sebetralstat is a plasma kallikrein inhibitor)

Andembry (garadacimab-gxii) — quantity limit example

Quantity limit (example)60 vials per 30 days

AgentAndembry (garadacimab-gxii)

ContextListed as a quantity-limit example in product renewal/quantity guidance

Unspecified agent for hereditary angioedema — quantity example

Quantity example4 (tablets per day)

ContextShown as a quantity example associated with an HAE agent renewal example

Related requirementRenewal requires prescriber attestation of improvement compared to baseline

Clinical effectReduces or prevents HAE attacks by inhibiting activated factor XII activity

Renewal criteria (example) — prescriber attestation definition

Renewal requirement (definition)Prescriber attestation of clinical improvement compared to baseline in hereditary angioedema attacks (reduction in attack frequency or severity).

PurposeUsed as the renewal criterion for prophylactic HAE therapy (e.g., garadacimab‑gxii).

Associated quantity noteQuantity examples (e.g., 4 tablets per day or 1.2 mL/200 mg per month) appear alongside renewal guidance in the document.