CurrentmedimpactPolicy N/A

New specialty drug PDL additions and coverage criteria

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.

This document summarizes new products added to the Preferred Drug List (PDL) with their formulary status, approval durations, and specific initial and renewal coverage criteria affecting prescribers, pharmacists, and prior authorization staff.

Policy Summary

Payermedimpact

PolicyNew specialty drug PDL additions and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with required prescriber attestation and supporting documentation per agent-specific criteria (e.g., treatment-resistant hypertension, ursodiol trial/intolerance, genetic confirmation for WHIM, dialysis and hemoglobin criteria for CKD).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 months / 1 yearapproval durations stated for at least one agent

1 yearcommon approval/renewal duration

1 tablet/dayexample quantity limits

150 mg / 300 mgquantity limit examples (tablet counts)

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 specialty drug PDL additions and coverage criteria

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 specialty drug PDL additions and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 months / 1 yearapproval durations stated for at least one agent

1 yearcommon approval/renewal duration

1 tablet/dayexample quantity limits

150 mg / 300 mgquantity limit examples (tablet counts)

manytopical acne non-preferred agents listed (extensive list)

Coverage Criteria Summary

inv-01: Tryvio Initial Therapy

Tryvio (aprocitentan) — Initial Approval

Tryvio initial criteria: Diagnosis of treatment resistant hypertensionBP > 140/90 mmHg

AND patient failed optimal dosing of at least three antihypertensive medications concurrently from different classes for ≥4 weeks including a diuretic; prescribed by or in consultation with a cardiologist or other disease-state specialist; prescriber attests other causes of uncontrolled hypertension have been ruled out; prescriber attests baseline serum aminotransferase and total bilirubin measured prior to initiation and will be repeated periodically during treatment; will be used in combination with ≥3 other antihypertensive drugs at maximally tolerated doses; patient meets the minimum age recommended by the package insert

inv-02: Tryvio Renewal Therapy

Tryvio Renewal

Tryvio renewal criteria: Prescriber attestation of clinically significant improvement or stabilization in clinical signs and symptoms

Continued use in combination with at least three other antihypertensive drugs at maximally tolerated doses; quantity limit 1 tablet per day

inv-03: Iqirvo Initial Therapy

Iqirvo (elafibranor) — Initial Approval

Iqirvo initial criteria: Diagnosis of primary biliary cholangitis (PBC)ALP > 200 IU/L

Prescribed by or in consultation with a gastroenterologist/hepatologist or other disease-state specialist; AND patient has either had a 12-month trial and failure of ursodiol and will take Iqirvo in addition, OR has a contraindication or intolerance to ursodiol and will take Iqirvo as monotherapy; patient does not have decompensated cirrhosis; patient meets the minimum age recommended by the package insert; approval duration 1 year; quantity limit 1 tablet per day

inv-04: Iqirvo Renewal Therapy

Iqirvo Renewal

Iqirvo renewal criteria: Documentation (e.g., progress notes, laboratory reports) of improvement or stabilization in alkaline phosphatase (ALP)

Must continue to meet the initial pathway regarding ursodiol trial and failure or documented contraindication/intolerance; approval duration: 1 year

inv-05: Xolremdi Initial Therapy

Xolremdi (mavorixafor) — Initial Approval

Xolremdi initial criteria: Diagnosis of WHIM syndrome with genetic confirmation of a CXCR4 gene mutation

Prescribed by or in consultation with a hematologist, immunologist, infectious disease specialist, or other relevant specialist; patient meets the minimum age recommended by the package insert; approval duration: 1 year; quantity limit 4 capsules per day

inv-06: Xolremdi Renewal Therapy

Xolremdi Renewal

Xolremdi renewal criteria: Clinically significant improvement or stabilization in signs and symptoms

Approval duration: 1 year; age limit: 12 years or older

inv-07: Vafseo Initial Therapy

Vafseo (vadadustat) — Initial Approval

Vafseo initial criteria: Diagnosis of chronic kidney disease (CKD)Pretreatment hemoglobin ≤ 11 g/dl; patient receiving dialysis ≥ 3 months

Patient does not have uncontrolled hypertension; patient is not receiving other erythropoiesis-stimulating agents; prescribed per package insert minimum age; approval duration: 6 months; quantity limits per product labeling (e.g., 150 mg four tablets/day or 300 mg two tablets/day)

inv-08: Vafseo Renewal Therapy

Vafseo Renewal

Vafseo renewal criteria: Documentation (e.g., progress notes, laboratory report) of a positive response to therapy (for example, hemoglobin response)

Approval duration for renewal: 6 months; quantity limits apply (150 mg four tablets/day or 300 mg two tablets/day)

inv-09: Initial Therapy

Covered when ALL of the following are met:

Diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)

Prior therapy failure: Trial and failure of at least a 2-week trial of standard of care inhaled therapy: either triple therapy (ICS + LABA + LAMA) OR dual therapy (LABA + LAMA)2-week trial

Age requirement: Patient meets the minimum age recommended by the package insertper PI

inv-10: Renewal Therapy

Renewal requires:

Clinical response: Clinically significant improvement or stabilization in signs and symptoms

Documentation required (e.g., progress notes); age and quantity limits as noted in product-specific sections (e.g., ensifentrine age ≥ per PI; Vafseo quantity limits)

inv-11: Class selection & PA

Class selection and PA policy applies as follows:

Class selection and PA requirements: DMS selects preferred agent(s) based on economic evaluation; at least two unique chemical entities should be preferred. Agents not selected as preferred are considered non-preferred and require prior authorization. Any new chemical entity in the class requires prior authorization until reviewed by the P&T Committee.

Applies to listed drug classes in this document (examples include topical antifungals, antipsoriatics, cytokine and CAM antagonists, gastrointestinal motility agents, colony stimulating factors, growth hormones, acne agents).

Products identified on the class selection lists as Non-Preferred Agents are not selected as preferred options and, per the policy, will be treated as non-preferred. Use of these agents may require prior authorization or substitution to a preferred agent according to the plan's formulary management practices. Examples of items designated as non-preferred in this section include multiple topical dermatologic preparations (e.g., Retin-A Micro gel, Onexton, Ovace products, Neuac gel and kits, Klaron, and numerous cleansers and gels).

The document lists numerous topical products and repeatedly identifies a set of items as Non-Preferred Agents. Where a product is designated non-preferred, coverage and prior authorization requirements follow the plan’s class-level rules: non-preferred status typically triggers prior authorization or formulary substitution until a preferred alternative is authorized by the plan.

Ensifentrine (Ohtuvayre) is covered for patients with moderate to severe COPD only when all initial criteria are met, including documented trial and failure of at least a 2-week course of standard-of-care inhaled therapy — either triple therapy (ICS + LABA + LAMA) or dual therapy (LABA + LAMA) — and when the patient meets the package-insert minimum age. Failure to document the required prior inhaled therapy trial will render use inconsistent with the stated initial approval criteria.

Agent-specific Initial Therapy Criteria

inv-60: Tryvio initial therapy

Tryvio (aprocitentan) — Initial Approval

Tryvio initial: See Tryvio initial criteria in coverage criteriaBP > 140/90 mmHg

Approval duration: 6 months initial; quantity limit: 1 tablet per day; prescribed by or in consultation with cardiologist or other disease-state specialist

inv-61: Iqirvo initial therapy

Iqirvo (elafibranor) — Initial Approval

Iqirvo initial: See Iqirvo initial criteria in coverage criteriaALP > 200 IU/L

Approval duration: 1 year; quantity limit: 1 tablet per day; requires 12-month ursodiol trial and failure or documented contraindication/intolerance to ursodiol

Renewal and Continuation Requirements

inv-66: Agent-specific continuation rules

Renewal/continuation requires documentation of clinical benefit or stabilization as specified per agent.

Tryvio continuation: Prescriber attestation of clinically significant improvement or stabilization; continued combination with ≥3 other antihypertensives

Approval duration for renewal: 1 year

Iqirvo continuation: Documentation of ALP improvement or stabilization; continued ursodiol failure/intolerance pathway met

Approval duration: 1 year

Xolremdi continuation: Clinically significant improvement or stabilization in signs and symptoms

Approval duration: 1 year; age ≥ 12 years

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Tryvio prior authorization & prescriber attestation

Prior authorization is required for Tryvio (aprocitentan). The prescriber must attest the patient meets treatment‑resistant hypertension criteria (BP >140/90 mmHg), has failed optimal dosing of ≥3 antihypertensives concurrently for ≥4 weeks including a diuretic, will use Tryvio in combination with ≥3 other antihypertensives at maximally tolerated doses, has had baseline and periodic liver tests, and the prescription is written by or in consultation with a cardiologist or other disease‑state specialist.

Prescriber attestation that other causes of uncontrolled hypertension have been ruled out
Prescriber attests serum aminotransferase and total bilirubin measured prior to initiation and will be repeated periodically
Approval duration: 6 months initial; renewal requires prescriber attestation of clinical improvement/stabilization

Prior Authorization

Iqirvo prior authorization — ursodiol trial/intolerance & ALP threshold

Prior authorization is required for Iqirvo (elafibranor) for primary biliary cholangitis. The prescriber must be a gastroenterologist/hepatologist (or consult one) and document either a 12‑month trial and failure of ursodiol or a documented contraindication/intolerance to ursodiol, and that the patient has an ALP >200 IU/L and no decompensated cirrhosis.

Clinical Thresholds and Key Values

Hypertension threshold

Hypertension thresholdPersistent blood pressure above 140/90 mmHg

Failure requirementFailed optimal dosing of ≥3 antihypertensive medications concurrently from different classes for ≥4 weeks, including a diuretic

Specialist involvementPrescribed by or in consultation with a cardiologist or disease-state specialist

Alkaline phosphatase (ALP)

ALP threshold> 200 IU/L

Indication contextRequired for diagnosis of primary biliary cholangitis (PBC) when requesting Iqirvo

Specialist involvement

Step Therapy / Trial Requirements

Step	Requirement	Notes
1
Trial and documented failure of ursodiol for 12 months OR documented contraindication/intolerance to ursodiol
Iqirvo (elafibranor) initial approval requires ALP > 200 IU/L and prescriber is a gastroenterologist/hepatologist or consultation with specialist; renewal requires documentation of ALP improvement or stabilization and continued meeting of the ursodiol trial/intolerance pathway

Step	Requirement	Notes
1
Trial and failure of at least a 2-week trial of standard of care inhaled therapy: either triple therapy (ICS + LABA + LAMA) OR dual therapy (LABA + LAMA)
Patient must meet minimum age per package insert; renewal requires documentation of clinically significant improvement or stabilization in signs and symptoms

Implication	Policy impact	Action required
Preferred-first selection implied
DMS selects preferred agents based on economic evaluation; at least 2 unique chemical entities should be preferred
Prescribers should expect use of preferred agents first; non-preferred agents will require prior authorization

Implication	Examples / evidence	Policy action
Preferred‑first step therapy is effectively implied for many topical dermatologic products though explicit step edits are not listed
Multiple products are identified as Non-Preferred Agents (e.g., Neuac gel, Onexton, Ovace wash/cream/lotion/shampoo, Retin-A Micro gel, Generic Clindagel) in the class selection lists
Use of listed non‑preferred topical agents will generally require prior authorization or substitution to a preferred agent per formulary policy

Quantity Limits and Examples

Tryvio — quantity limit example

Tryvio quantity limit1 tablet per day (Quantity Limit: 1/day)

Approval duration (initial)6 months initial approval (context)

Renewal requirementPrescriber attestation of clinical improvement or stabilization for renewal

Iqirvo — quantity limit example

Iqirvo quantity limit1 tablet per day (Quantity Limit: 1/day)

Step therapy noteRequires 12-month trial and failure of ursodiol unless contraindicated/intolerant

Renewal requirement

Prescriber and Site-of-Care Requirements

Documentation Required

Office: specialist prescriber or consultation required

Prescriptions for these agents should be written by, or in consultation with, the specified specialist for each indication (e.g., cardiology for resistant hypertension; gastroenterology/hepatology for PBC; hematology/immunology/infectious disease for WHIM; nephrology for CKD/ESAs).

Specialist involvement is a stated requirement for initial approval for several agents

Definitions and Terminology

Treatment-resistant hypertension — definition and criteria

DefinitionPersistent blood pressure above 140/90 mmHg despite optimal dosing of at least three antihypertensive medications concurrently from different classes for a minimum of 4 weeks, including a diuretic

Documentation neededPrescriber attestation that other causes of uncontrolled BP have been ruled out

Specialist involvementPrescribed by or in consultation with a cardiologist or other disease-state specialist

WHIM syndrome — definition and genetic confirmation requirement

DefinitionWHIM syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis

Genetic confirmationDiagnosis must be confirmed through genetic testing identifying a CXCR4 gene mutation

Background and Scope

This update adds several recently marketed agents and clarifies class-selection rules. Notably, multiple topical dermatologic products are listed as Non-Preferred Agents, meaning they will generally require prior authorization or substitution to preferred alternatives under the plan’s formulary. In the respiratory space, the first-in-class agent ensifentrine is subject to targeted coverage criteria: it is covered for moderate to severe COPD when the patient has failed a documented 2‑week trial of standard inhaled therapy and meets the package-insert age requirement. These changes emphasize prescriber documentation of prior therapy trials and support prior authorization review for non-preferred and new chemical entities.

Policy Summary

Payermedimpact

PolicyNew specialty drug PDL additions and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

inv-62: Xolremdi initial therapy

Xolremdi (mavorixafor) — Initial Approval

Xolremdi initial: See Xolremdi initial criteria in coverage criteria

Approval duration: 1 year; age limit ≥ 12 years; quantity limit: 4 capsules per day; requires genetic confirmation of CXCR4 mutation and specialist involvement

inv-63: Vafseo initial therapy

Vafseo (vadadustat) — Initial Approval

Vafseo initial: See Vafseo initial criteria in coverage criteriaPretreatment hemoglobin ≤ 11 g/dl; dialysis ≥ 3 months

Approval duration: 6 months; patient must not have uncontrolled hypertension and must not be receiving other ESAs; quantity limits: 150 mg four tablets/day or 300 mg two tablets/day

inv-64: Ensifentrine (Ohtuvayre) Initial Therapy

Ensifentrine (Ohtuvayre) — Initial Approval

Ensifentrine initial: See Ensifentrine initial criteria in coverage criteria

Initial approval requires diagnosis of moderate to severe COPD, trial and failure of at least a 2-week trial of standard inhaled therapies (ICS+LABA+LAMA or LABA+LAMA), and meets package insert minimum age; approval duration: 6 months initial, 1 year renewal; quantity limit example: 5 mL per day

inv-65: Initial class selection policy

Initial class selection policy

Class selection and PA rules: DMS selects preferred agent(s) based on economic evaluation; however, at least two unique chemical entities should be preferred. Agents not selected as preferred will be considered non-preferred and require prior authorization. Any new chemical entity in the specified classes requires prior authorization until reviewed by the P&T Committee.

Applies across listed classes (e.g., Colony Stimulating Factors, Growth Hormones, Acne Agents).

Vafseo continuation:

Documentation of positive hemoglobin response to therapy

Approval duration for renewal: 6 months

inv-67: Renewal/Continuation

Renewal/continuation requirements noted in document

Renewal documentation: Documentation of a positive response to therapy (e.g., progress notes, laboratory report) or clinically significant improvement/stabilization in signs and symptoms

Approval durations vary by agent (examples: Vafseo renewal 6 months; Tryvio/Iqirvo/Xolremdi renewal 1 year)

If ursodiol trial required: document 12‑month trial and failure (renewal requires continued ursodiol failure/intolerance pathway and ALP improvement/stabilization)
Approval duration: 1 year

Prior Authorization

Xolremdi prior authorization — genetic confirmation & specialist prescriber

Prior authorization is required for Xolremdi (mavorixafor) and the diagnosis must be genetically confirmed WHIM syndrome. The drug must be prescribed by or in consultation with a hematologist, immunologist, infectious disease specialist, or other appropriate specialist.

Documentation of genetic testing identifying a CXCR4 mutation is required
Age limit and quantity limits apply per package insert (renewal requires clinically significant improvement/stabilization)

Prior Authorization

Vafseo prior authorization — CKD on dialysis hemoglobin & duration criteria

Prior authorization is required for Vafseo (vadadustat) for ESA‑eligible CKD patients on dialysis. The provider must document pretreatment hemoglobin ≤11 g/dL, that the patient has been on dialysis ≥3 months, is not receiving other ESAs, and does not have uncontrolled hypertension.

Renewal requires documentation (progress notes or laboratory report) of a positive hemoglobin response to therapy
Approval duration: 6 months; quantity limits stated in policy

Prior Authorization

PA required for new chemical entities and non‑preferred agents

Prior authorization is required for agents designated as non‑preferred and for any new chemical entity in listed classes until review by the P&T Committee. Agents not selected as preferred will be considered non‑preferred and require PA.

Applies across multiple classes (e.g., Muscular Dystrophy Agents, Stimulants, Colony Stimulating Factors, topical classes)
New chemical entities remain subject to PA until P&T Committee review

Step Therapy

Ensifentrine prior authorization — step requirement & trial/failure documentation for COPD

Prior authorization for Ensifentrine (Ohtuvayre) requires documentation of a diagnosis of moderate to severe COPD and a documented trial and failure of at least a 2‑week trial of standard‑of‑care inhaled therapy (either ICS+LABA+LAMA or LABA+LAMA).

Patient must meet the minimum age per the package insert
Renewal requires clinically significant improvement or stabilization with documentation (e.g., progress notes)

Prior Authorization

PA required for non‑preferred agents and new chemical entities until P&T review

Non‑preferred agents and any new chemical entity in the listed classes require prior authorization until reviewed by the P&T Committee; providers should submit standard PA documentation when requesting these agents.

This is a class‑level requirement that applies to topical, biologic, and specialty classes listed in the policy
Documentation supporting medical necessity may be requested during the PA process

Prior Authorization

Non‑preferred topical agents may require prior authorization

Certain topical dermatologic products are listed as Non‑Preferred Agents; prescribing these non‑preferred topical agents may require prior authorization per formulary policy.

Examples of non‑preferred topical agents are listed explicitly (e.g., Neuac gel, Onexton, Ovace products, Retin‑A Micro gel)
Use of listed non‑preferred topical products may require documentation of medical necessity

Prior Authorization

PA required for non‑preferred and new agents (reiteration)

Agents not selected as preferred will be considered non‑preferred and require prior authorization; this policy is reiterated across multiple therapeutic classes in the document.

Preferred‑first selection is based on economic evaluation; providers may be required to try preferred agents first where applicable

Note

Prior authorization — not specified in some excerpts

The document includes PA statements for many lists, but for some excerpts specific prior authorization requirements are not specified; providers should refer to the agent‑specific criteria elsewhere in the policy when PA language is absent.

When PA requirements are not specified in an excerpt, no additional PA instruction is provided in that section

Step Therapy

Iqirvo ursodiol trial/failure or contraindication — step & denial risk

Iqirvo approval requires documentation of either a 12‑month trial and failure of ursodiol or a documented contraindication/intolerance to ursodiol; absence of this documentation may lead to denial.

Renewal also requires documentation of improvement or stabilization in ALP
ALP must be >200 IU/L at baseline

Step Therapy

Ensifentrine step requirement — documented trial/failure of standard COPD therapy

Providers must document trial and failure of at least a 2‑week course of standard COPD inhaled therapy (either triple‑therapy ICS+LABA+LAMA or dual LABA+LAMA) before Ensifentrine will be approved; failure to document this trial may result in denial.

Minimum age per package insert must be met
Renewal requires documentation of clinically significant improvement or stabilization

Note

Preferred‑first implied — economic selection influences PA

The policy selects preferred agents based on economic evaluation and implies preferred‑first use; providers should expect formulary preference to influence authorization decisions and may be required to try preferred agents first.

At least two unique chemical entities should be preferred per class
Non‑preferred status typically triggers PA requirements

Note

Provider actions — follow agent‑specific criteria when unspecified

Where specific provider actions are not explicitly stated in a section, follow the agent‑specific coverage and PA criteria elsewhere in the policy and submit standard PA documentation when requesting non‑preferred or new agents.

If guidance is absent, rely on class‑level PA rules and agent‑specific criteria throughout the document

Note

No step therapy described in certain sections

Some sections state no step therapy requirements; when no step edits are described, providers should not assume additional step trials beyond the agent‑specific criteria.

Verify agent‑specific step requirements (e.g., Iqirvo, Ensifentrine) rather than assuming a general step policy

Documentation Required

Documentation required — baseline and lab results for response/stabilization

For renewals across multiple agents, providers must submit progress notes and laboratory results documenting baseline and follow‑up response or stabilization (examples: blood pressure control for Tryvio; ALP improvement/stabilization for Iqirvo; hemoglobin response for Vafseo).

Renewal documentation is required to demonstrate clinically significant improvement or stabilization
Examples of acceptable documentation include progress notes and laboratory reports

Documentation Required

Renewal documentation — progress notes or labs showing response

Renewal requests require documentation (progress notes or laboratory reports) showing a positive clinical response or stabilization; renewals for some agents also require continued adherence to the initial pathway (e.g., continued ursodiol failure/intolerance pathway for Iqirvo).

Renewal durations vary by agent (e.g., Tryvio renewal: 1 year; Vafseo renewal: 6 months)
Documentation must demonstrate clinically significant improvement or stabilization

Documentation Required

PA documentation — supporting documentation may be required until P&T review

Documentation supporting a PA for non‑preferred agents and new chemical entities may be required until the P&T Committee has reviewed the agent; submit standard PA medical necessity documentation as part of the request.

Class‑level PA documentation expectations apply across listed therapeutic classes
Be prepared to supply clinical rationale and supporting labs or notes

Note

Non‑preferred topical product listings — coverage implications

The policy lists numerous non‑preferred topical agents (examples: Neuac gel, Onexton, Ovace wash/cream/lotion/shampoo, Retin‑A Micro gel); use of these listed non‑preferred products may trigger PA or require substitution to a preferred agent.

Providers should check formulary preference and submit PA documentation for listed non‑preferred topical items when requested

Documentation Required

PA documentation — standard PA documentation for non‑preferred/new agents

When requesting coverage for non‑preferred or new chemical entities, follow standard PA documentation procedures and be prepared to provide clinical justification and supporting records per the class‑level PA rules.

PA documentation requirement is a standard part of the prior authorization process for non‑preferred/new agents

Note

No documentation requirements specified in some sections

Some policy sections do not specify documentation requirements for the agents listed; in those cases, providers should follow agent‑specific guidance elsewhere in the policy or submit a standard PA with supporting clinical records if seeking non‑preferred agents.

Absence of explicit documentation instructions in a section does not negate agent‑specific documentation requirements

Denial Risk

Denial risk — missing antihypertensive trials/attestation for Tryvio

Lack of documentation that the patient failed optimal dosing of at least three antihypertensive medications (including a diuretic), or absence of the required prescriber attestations, may result in denial of Tryvio.

Prescriber attestation that other causes of uncontrolled hypertension have been ruled out is required to avoid denial

Denial Risk

Denial risk — missing ursodiol trial documentation for Iqirvo

Absence of documentation of a 12‑month trial and failure of ursodiol, or lack of a documented contraindication/intolerance to ursodiol when applicable, may lead to denial for Iqirvo.

Renewal also requires documentation of ALP improvement/stabilization

Denial Risk

Denial risk — missing genetic confirmation or specialist prescribing for Xolremdi

For Xolremdi, failure to provide genetic confirmation of a CXCR4 mutation or to show the prescription was written by (or in consultation with) an appropriate specialist may result in denial.

Documentation of genetic testing identifying the CXCR4 mutation is required

Denial Risk

Denial risk — missing dialysis/hemoglobin/ESA documentation for Vafseo

For Vafseo, missing documentation that the patient has been on dialysis ≥3 months, a pretreatment hemoglobin ≤11 g/dL, or that the patient is not receiving other ESAs may trigger denial.

Also required: documentation that the patient does not have uncontrolled hypertension

Denial Risk

Denial risk — lack of documented trial/failure of standard COPD therapy for Ensifentrine

Failure to document trial and failure of the required standard COPD therapies (2‑week trial of triple or dual inhaled therapy) may result in denial of Ensifentrine.

Documentation should include duration and response to the prior inhaled therapies

Billing Rule

Non‑preferred agents require PA

Agents not selected as preferred will be considered non‑preferred and will require prior authorization; providers should expect PA edits for non‑preferred agents.

This applies across the multiple classes listed in the policy

Prior Authorization

New chemical entities require PA until P&T review

Any new chemical entity in the specified classes requires prior authorization until the P&T Committee has reviewed the agent; submit PA requests and supporting documentation accordingly.

This rule is applied to classes such as Colony Stimulating Factors, Growth Hormones, Acne Agents, Antimigraine CGRP inhibitors, etc.

Note

Coverage implications — many non‑preferred topical agents listed

Use of many listed non‑preferred topical agents may lead to non‑coverage or formulary substitution; providers should consult the formulary and submit PA when prescribing listed non‑preferred topical products.

Examples include numerous named topical acne and dermatologic products repeated in the non‑preferred lists

Prior Authorization

Non‑preferred agents require PA (reiterated)

The policy reiterates that agents not selected as preferred will require prior authorization; providers should plan to request PA for non‑preferred agents.

Preferred status is determined by DMS based on economic evaluation

Prior Authorization

New chemical entities require PA (reiterated)

The policy reiterates that any new chemical entity in a listed class requires prior authorization until reviewed by the P&T Committee; providers must submit PA for newly introduced agents.

This applies across multiple therapeutic classes as enumerated in the document

Note

Provider actions — none stated in some chunks; follow full policy

For sections where provider actions are not stated, follow the agent‑specific coverage, step, and PA criteria elsewhere in the policy and provide supporting clinical documentation when submitting PA requests.

When unspecified, rely on class‑level rules and agent‑specific nodes within the policy

Prescribed by or in consultation with a gastroenterologist, hepatologist, or other disease-state specialist

Hemoglobin

Hemoglobin threshold≤ 11 g/dl

Dialysis requirementPatient has been receiving dialysis for at least 3 months (context for Vafseo)

Exclusion notePatient must not have uncontrolled hypertension

Minimum age

Minimum agePer package insert for ensifentrine (Ohtuvayre)

Indication contextApplies when ensifentrine is being used for moderate to severe COPD

Step requirement tie-inMinimum age must be met in addition to trial/failure of required inhaled therapies

Documentation of ALP improvement or stabilization required for renewal

Xolremdi — quantity limit example

Xolremdi quantity limit4 capsules per day (Quantity Limit: 4/day)

Age limitAge 12 years or older for use

Specialist requirementPrescribed by or in consultation with hematology/immunology/infectious disease specialist

Vafseo — tablet quantity examples

Vafseo tablet examples150 mg: four tablets per day; 300 mg: two tablets per day

Renewal documentationDocumentation of positive response to therapy required for renewal

Approval durationInitial approval duration noted as 6 months (context)

Unspecified tablet examples

Tablet dosing examples150 mg: four tablets per day; 300 mg: two tablets per day

Applies toUsed as quantity-limit examples for unspecified tablet products in document

Renewal noteQuantity limits apply and may be enforced at renewal

Unspecified liquid example

Liquid example5 mL per day

ContextQuantity limit example for ensifentrine renewal (5 mL/day) or other inhalation solutions listed

Renewal requirementClinically significant improvement or stabilization required for renewal

Specialist involvementPrescribed by or in consultation with a hematologist, immunologist, infectious disease specialist, or other specialist

Ensifentrine — brief definition

Short definitionEnsifentrine: first-in-class dual phosphodiesterase (PDE)-3 and PDE-4 inhibitor

Mechanism summaryInhibits PDE4 to reduce inflammatory signaling and PDE3 to regulate airway smooth muscle, promoting bronchial relaxation

Indication contextUsed for moderate to severe COPD per document

Non-Preferred Agents — topical dermatologic

DefinitionNon-Preferred Agents: topical dermatologic products (gels, creams, lotions, shampoos, washes, kits) designated non-preferred within the class selection

ImplicationUse of listed non-preferred topical agents may require prior authorization or substitution to preferred agents

ExamplesIncludes products such as Neuac gel, Onexton, Ovace wash, Retin-A Micro gel (extensive list provided)

Preferred agent — selection rule

DefinitionPreferred agent: an agent selected by DMS based on economic evaluation; at least two unique chemical entities should be preferred per class

Policy implicationPreferred agents are expected to be used first where applicable; selection is class-level and economics-driven

Minimum requirementAt least 2 unique chemical entities preferred per class

Non-preferred agent — definition

DefinitionNon-preferred agent: agents not selected as preferred; will require prior authorization

Coverage impactNon-preferred status typically triggers PA and may require documentation of medical necessity

Class-level ruleApplies across listed drug classes until P&T designation changes

Preferred / Non-Preferred agents — general note

General notePreferred vs Non-Preferred status is determined by DMS based on economic evaluation; non-preferred agents require prior authorization

New chemical entitiesAny new chemical entity in listed classes requires PA until reviewed by the P&T Committee

Topical productsExtensive lists of topical non-preferred agents are provided; formulary management may require substitution to preferred items