DraftmedimpactPolicy N/A

New Products to Market — Preferred Drug List selections and coverage criteria

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Governs coverage designations, approval criteria, quantity limits, and prior authorization requirements for newly reviewed drugs and therapeutic classes affecting Medicaid members and prescribing providers.

Policy Summary

Payermedimpact

PolicyNew Products to Market — Preferred Drug List selections and coverage criteria

Policy CodePolicy N/A

Change TypeMultiple additions to PDL, criteria, and PA rules

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, specialist attestation, documentation of trials/failures, and relevant lab results as specified for the drug.

SourceLink

POLICY UPDATE CHANGES

Multiple new products and class-selection guidelines were added to the Preferred Drug List including Zunveyl, Qfitlia, Ryzneuta, Vanrafia, and new antimigraine class guidance.

Detailed initial and renewal approval criteria and quantity limits were added for Qfitlia (hemophilia A/B) including age limits and specialist prescribing requirements.

Class creation and PA requirements for new antimigraine agent classes were specified with at least 1 unique chemical entity to be preferred.

5+new products/classes listed

≥12Qfitlia age minimum

12 mo

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DraftmedimpactPolicy N/A

New Products to Market — Preferred Drug List selections 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 Products to Market — Preferred Drug List selections and coverage criteria

Policy CodePolicy N/A

Change TypeMultiple additions to PDL, criteria, and PA rules

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, specialist attestation, documentation of trials/failures, and relevant lab results as specified for the drug.

SourceLink

POLICY UPDATE CHANGES

Multiple new products and class-selection guidelines were added to the Preferred Drug List including Zunveyl, Qfitlia, Ryzneuta, Vanrafia, and new antimigraine class guidance.

Detailed initial and renewal approval criteria and quantity limits were added for Qfitlia (hemophilia A/B) including age limits and specialist prescribing requirements.

Class creation and PA requirements for new antimigraine agent classes were specified with at least 1 unique chemical entity to be preferred.

5+new products/classes listed

≥12Qfitlia age minimum

12 mo

Coverage and Approval Criteria

Initial Therapy - Hemophilia A

Covered when ALL of the following are met

Hemophilia A initial: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia A

Inhibitor documentation: Prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor VIII inhibitors

Specialist involvement: Prescribed by, or in consultation with, a hematologist

No other non-factor prophylactic: Prescriber attests patient is not on another non-factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi)

Trial and failure, allergy, contraindication (including potential drug–drug interactions) or intolerance to one agent approved for either: Hemophilia A WITH inhibitors (Alhemo, Hemlibra) OR Hemophilia A WITHOUT inhibitors (Hemlibra, Hympavzi)

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

Initial Therapy - Hemophilia B

Covered when ALL of the following are met

Hemophilia B initial: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia B

Inhibitor documentation: Prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor IX inhibitors

Specialist involvement: Prescribed by, or in consultation with, a hematologist

No other non-factor prophylactic: Prescriber attests patient is not on another non-factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi)

Trial and failure, allergy, contraindication (including potential drug–drug interactions) or intolerance to one agent approved for either: Hemophilia B WITH inhibitors (Alhemo) OR Hemophilia B WITHOUT inhibitors (Hympavzi)

Renewal Criteria - Qfitlia

Covered at renewal when ALL of the following are met

Clinical benefit: Prescriber attests patient has experienced clinical benefit compared to baseline (e.g., reduced bleeding frequency/severity)

Updated documentation: Prescriber provides documentation (e.g., lab result within the past year) of Hemophilia A or B with or without inhibitors as applicable

Initial Therapy - Vanrafia (Atrasentan)

Covered when ALL of the following are met

Indication: Confirmed diagnosis of primary IgA nephropathy (IgAN)

Proteinuria threshold: Proteinuria ≥ 1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g

RAAS inhibitor: Patient is on a stable, maximally tolerated dose of an ACE inhibitor or ARB unless contraindicated or not tolerated

Specialist involvement: Prescribed by, or in consultation with, a nephrologist

Pregnancy testing and counseling: Provider attestation of a negative pregnancy test prior to initiation in females of reproductive potential and attestation of counseling on teratogenic risks and contraception

Initial Therapy - Ryzneuta

Covered when ALL of the following are met

Indication: Used for prophylaxis of neutropenia related to chemotherapy to decrease the incidence of febrile neutropenia

Malignancy type: Patient has a non-myeloid malignancy and is receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Prior agents: Patient has had at least a 7-day trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents

Products designated Non-PDL (non-preferred) are excluded from preferred coverage and therefore require prior authorization. The plan will only consider coverage for these agents when the specific PA criteria listed in this policy are met, including documented trials or contraindications to preferred therapies and any other drug- or indication-specific requirements described in the criteria sets.

Use of a non-preferred agent without required documentation — such as prior trial(s) and therapeutic failure of preferred agent(s), documented allergy/contraindication, or specialist attestation where specified — will be considered not medically necessary and may result in denial of the request. For many newly reviewed products this includes a minimum trial period (for example, ≥ 1 week with trial and failure as noted) or failure of the number of preferred agents required by the policy before a non-preferred product will be approved.

Initial Therapy - Summary

Initial approvals require meeting ALL of the following indication‑specific conditions

See individual criteria: Refer to specific initial therapy criteria for Hemophilia A, Hemophilia B, Ryzneuta, and Vanrafia

Specialty prescribing: Prescribed by, or in consultation with, the appropriate specialist (hematologist for hemophilia; nephrologist for IgAN; oncologist or treating cancer specialist for chemotherapy prophylaxis)

Documentation: Prescriber must provide relevant laboratory or clinical documentation (e.g., inhibitor testing within the past year for hemophilia; proteinuria/UPCR for IgAN; documentation of febrile neutropenia risk and prior agent trials for Ryzneuta)

Prior trial requirements:

Continuation / Renewal Criteria

Qfitlia Renewal

Renewal requires evidence of ongoing benefit

Clinical benefit attestation: Prescriber attests patient has experienced clinical benefit compared to baseline

Updated lab documentation: Provide documentation (e.g., lab result within the past year) confirming inhibitor status or other relevant laboratory measures as applicable

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

PA required for non-preferred / new chemical entities

Agents in newly created classes that are not selected as preferred will be considered non-preferred and require prior authorization until P&T review; any new chemical entity in the specified Antimigraine CGRP acute or prophylaxis classes requires PA.

Prior Authorization

Qfitlia prior authorization requirements

Qfitlia is non‑PDL and requires prior authorization. The PA must document the diagnosis (hemophilia A or B), prescriber specialist involvement (prescribed by or in consultation with a hematologist), trial/failure or contraindication/allergy/intolerance to the specified agents, and an attestation that the patient is not on another non-factor prophylactic agent.

Document presence OR absence of Factor VIII (Hemophilia A) or Factor IX (Hemophilia B) inhibitors with a lab result within the past year.
Attest patient is not on another non-factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi).
Prescribe by or in consultation with a hematologist.

Step Therapy Requirements

Step	Requirement	Notes
1	Trial of 2 preferred agents	Minimum 1 week trial and therapeutic failure, allergy, contraindication, or intolerance required before non‑PDL (non‑preferred) approval
2	Documented reason for bypassing step	Allergy, contraindication (including potential drug–drug interactions), or intolerance to required preferred agents must be documented to qualify without trials
3	Specialist involvement	Prescriptions for hemophilia prophylaxis should be by or in consultation with a hematologist; attestation that patient is not on another non‑factor prophylactic agent is required for Qfitlia

Quantity Limits by Product

Zunveyl — Quantity Limit

Quantity limit2 tablets per day

PDL statusNon-PDL (requires PA)

Approval duration example12 months (as listed for similar new products)

Qfitlia — Quantity Limit (vial)

Quantity limit (vial)0.2 mL per month

Form noteSpecified as vial in source document

PDL statusNon-PDL (requires prior authorization)

Clinical Thresholds and Coding Values

Proteinuria / UPCR — Clinical Thresholds

Proteinuria threshold≥ 1 g/day

UPCR thresholdUPCR ≥ 1.5 g/g

ContextRequired for Vanrafia (atrasentan) initiation in primary IgA nephropathy

Site of Care and Prescribing Requirements

Note

Hematology prescribing and site‑of‑care

For hemophilia prophylaxis, prescriptions must be written by or in consultation with a hematologist; site‑of‑care guidance indicates these therapies are managed in infusion/ specialized centers as appropriate.

Prescriber must be a hematologist or document consultation with a hematologist when requesting prophylactic therapy for Hemophilia A or B.

Product Definitions and Mechanisms

Benzgalantamine / Zunveyl — Definition & Mechanism

DefinitionBenzgalantamine is a prodrug of galantamine

MechanismReversible, competitive acetylcholinesterase inhibitor that increases cholinergic function by preventing acetylcholine breakdown and enhancing acetylcholine pathway responsiveness

Approval duration noteListed with a 12-month approval duration in the source document

Efbemalenograstim alfa-vuxw / Ryzneuta — Definition & Mechanism

DefinitionEfbemalenograstim alfa-vuxw is a colony-stimulating factor

MechanismActs on hematopoietic cells by binding specific cell surface receptors to stimulate proliferation, differentiation, commitment, and end-cell functional activation

Background and Scope

This policy covers multiple newly reviewed agents spanning several therapeutic areas, including central nervous system agents, hemophilia prophylaxis using small interfering RNA non-factor therapies, colony-stimulating factors, and agents for renal disease. To support consistent formulary management, a new class-selection process is used: the Drug Management Services team will select preferred agent(s) based on economic evaluation and any agent not selected will be treated as non-preferred and subject to prior authorization requirements until reviewed by the P&T Committee.

High-Impact Provider Notes

Prior Authorization

Vanrafia initial therapy PA considerations

Vanrafia (Atrasentan) is Non‑PDL and initial therapy requires meeting indication‑specific PA criteria (confirmed IgA nephropathy, proteinuria threshold, RAAS therapy, nephrologist involvement, pregnancy testing/counseling) — ensure all criteria and attestations are documented when seeking PA.

Document confirmed primary IgA nephropathy and proteinuria ≥ 1 g/day or UPCR ≥ 1.5 g/g.
Document patient is on a stable maximally tolerated RAAS inhibitor unless contraindicated.
Prescribed by or in consultation with a nephrologist and include pregnancy test/ counseling attestations as applicable.

Prior Authorization

Ryzneuta initial therapy PA considerations

Ryzneuta is Non‑PDL and initial approval requires documentation that the patient has a qualifying malignancy, is receiving myelosuppressive therapy with febrile neutropenia risk, and has had at least a 7‑day trial and therapeutic failure (or allergy/contraindication/intolerance) of two preferred agents.

Confirm non‑myeloid malignancy and myelosuppressive anti‑cancer drug associated with febrile neutropenia.