CurrentmedimpactPolicy N/A

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

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Governance of preferred drug list selections, approval durations, quantity limits, and prior authorization (PA) / clinical criteria for newly reviewed prescription products affecting Medicaid beneficiaries and prescribers.

Policy Summary

Payermedimpact

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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must document required trials, specialist consults, and lab results (e.g., inhibitor testing) when submitting prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration example (Zunveyl)

1 yearinitial/renewal example (Qfitlia)

2/dayquantity limit (Zunveyl)

0.2/0.5 mLquantity limits (Qfitlia)

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CurrentmedimpactPolicy N/A

New Products to Market — Preferred Drug List selections and PA 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

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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must document required trials, specialist consults, and lab results (e.g., inhibitor testing) when submitting prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration example (Zunveyl)

1 yearinitial/renewal example (Qfitlia)

2/dayquantity limit (Zunveyl)

0.2/0.5 mLquantity limits (Qfitlia)

Coverage and Medical Necessity Criteria

inv-01: Zunveyl (Alzheimer's agent) Initial Criteria — Non-preferred (NPD) coverage criteria

Zunveyl — Non-preferred (NPD) coverage criteria

Zunveyl NPD criteria: Patient must have >= 1 week trial and failure, or allergy, contraindication (including potential drug‑drug interactions) or intolerance of 2 preferred agents; quantity limit 2 tablets per day; approval duration 12 months.

From Zunveyl entry

inv-02: Qfitlia Hemophilia A — Initial and Renewal criteria for Hemophilia A

Qfitlia — Initial and Renewal criteria for Hemophilia A

Qfitlia Hemophilia A Initial: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia A; AND prescriber provides documentation (e.g., lab result within the past year) of presence OR absence of Factor VIII inhibitors; AND prescribed by, or in consultation with, a hematologist; AND prescriber attests patient is not on another non-factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi); AND trial and failure, allergy, contraindication or intolerance to one agent approved for Hemophilia A WITH inhibitors (Alhemo, Hemlibra) OR WITHOUT inhibitors (Hemlibra, Hympavzi); AND patient meets the minimum age recommended by the package insert for the provided indication.age per PI

Initial criteria

Qfitlia Hemophilia A Renewal: Prescriber attests patient has experienced clinical benefit compared to baseline (e.g., reduced bleeding frequency/severity); AND prescriber provides documentation (e.g., lab result within the past year) of Hemophilia A with or without Factor VIII inhibitors.

Renewal criteria

inv-03: Qfitlia Hemophilia B — Initial and Renewal criteria for Hemophilia B

Qfitlia — Initial and Renewal criteria for Hemophilia B

Qfitlia Hemophilia B Initial: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia B; AND prescriber provides documentation (e.g., lab result within the past year) of presence OR absence of Factor IX inhibitors; AND prescribed by, or in consultation with, a hematologist; AND prescriber attests patient is not on another non-factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi); AND trial and failure, allergy, contraindication or intolerance to one agent approved for Hemophilia B WITH inhibitors (Alhemo) OR WITHOUT inhibitors (Hympavzi); AND patient meets the minimum age recommended by the package insert for the provided indication.age per PI

Initial criteria

Qfitlia Hemophilia B Renewal: Prescriber attests patient has experienced clinical benefit compared to baseline (e.g., reduced bleeding frequency/severity); AND prescriber provides documentation (e.g., lab result within the past year) of Hemophilia B with or without Factor IX inhibitors.

Renewal criteria

inv-04: Other product initial criteria — Ryzneuta / Vanrafia coverage criteria examples

Ryzneuta / Vanrafia coverage criteria examples

Ryzneuta Initial: The medication is being used for prophylaxis of neutropenia related to chemotherapy to decrease the incidence of febrile neutropenia; AND patient has a non-myeloid malignancy and is receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; AND patient has had at least a 7-day trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents.7-day trial

From Ryzneuta entry

Vanrafia Initial: Patient has a confirmed diagnosis of primary IgA nephropathy (IgAN); AND proteinuria ≥ 1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g; AND patient is currently on a stable, maximally tolerated dose of a RAAS inhibitor (ACE inhibitor or ARB) unless contraindicated or not tolerated; AND prescribed by, or in consultation with, a nephrologist; AND provider attestation of a negative pregnancy test prior to initiation in females of reproductive potential; AND provider attestation of patient counseling on teratogenic risks and contraception.UPCR >=1.5 g/g

From Vanrafia entry

inv-05: Antimigraine Agents — Class Rules

Antimigraine agent class guidance

Class selection & PA rules: DMS will create new drug classes and select preferred agent(s) based on economic evaluation; agents not selected as preferred will be considered non-preferred and require prior authorization; any new chemical entity in the specified Antimigraine Agents classes requires prior authorization until reviewed by the P&T Committee.

Class guidelines

No specific population-level exclusions are stated in the provided excerpt beyond the age limitations and therapy-failure or contraindication requirements already specified for individual products. Where applicable, coverage requires documentation of prior trial and failure, allergy, contraindication, or intolerance to preferred agents (for example, the Non-Preferred designation requires a ≥ 1 week trial and failure or intolerance of 2 preferred agents for NPD products). Age eligibility for Qfitlia is limited to patients 12 years and older per the product description. Providers should follow the product-specific criteria (including prescriber specialty, laboratory documentation, and pregnancy testing attestation where required) rather than expecting any additional population exclusions in this excerpt.

The excerpt does not include any explicit statements labeling therapies as not medically necessary. Instead, the document sets forth specific coverage conditions (for example, trial/failure requirements, age limits, and other documentation) that determine prior authorization approval. Absent language declaring treatments as not medically necessary, denial risks are tied to failure to meet the stated criteria (such as insufficient prior therapy documentation or missing required specialist consultation), not to a blanket non‑medical‑necessity determination in this section.

Initial Therapy Requirements

inv-20: Initial therapy nodes — Initial approval criteria per product

Initial approval criteria per product

Qfitlia Hemophilia A initial: Prescribed for prophylaxis; prescriber provides lab documentation of Factor VIII inhibitor presence OR absence (e.g., lab within past year); prescribed by or in consultation with a hematologist; prescriber attests patient is not on another non-factor prophylactic agent; trial and failure, allergy, contraindication or intolerance to one appropriate agent as specified for Hemophilia A; patient meets age per PI.age per PI

Qfitlia Hem A

Qfitlia Hemophilia B initial: Prescribed for prophylaxis; prescriber provides lab documentation of Factor IX inhibitor presence OR absence (e.g., lab within past year); prescribed by or in consultation with a hematologist; prescriber attests patient is not on another non-factor prophylactic agent; trial and failure, allergy, contraindication or intolerance to one appropriate agent as specified for Hemophilia B; patient meets age per PI.age per PI

Qfitlia Hem B

Renewal / Continuation Requirements

inv-21: Renewal Criteria — Renewal / continuation requirements as stated per product

Renewal / continuation requirements as stated per product

Qfitlia renewal: Prescriber attests clinical benefit compared to baseline (e.g., reduced bleeding frequency/severity); AND prescriber provides documentation (e.g., lab result within the past year) of inhibitor status (Factor VIII or IX) within the past year.

Qfitlia renewal

Vanrafia renewal: Patient continues to meet all initial criteria; AND prescriber submits clinical documentation that the patient has experienced a clinical benefit compared to baseline.

Vanrafia renewal

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization required for non‑preferred / new chemical entities

Agents not selected as preferred in newly created classes are considered non-preferred and will require prior authorization; any new chemical entity in the specified Antimigraine Agent classes requires PA until reviewed by the P&T Committee.

DMS will designate preferred agent(s); at least one unique chemical entity should be preferred.
Non-preferred agents require PA.

Prior Authorization

Zunveyl prior authorization requires prior trials or documented intolerance

Zunveyl is designated Non‑Preferred (NPD) and requires documentation of trial and failure, allergy, contraindication (including potential drug‑drug interactions) or intolerance of 2 preferred agents (or ≥1 week trial and failure as listed) prior to approval.

Quantity limit: 2 tablets per day.
Approval duration example: 12 months.

Step Therapy / Required Trials

Product	Step therapy requirement	Notes / examples
Zunveyl	Trial and failure, allergy, contraindication, or intolerance of 2 preferred agents (≥1 week trial where specified)	Designated non-preferred (NPD); quantity limit 2 tablets/day; failure to document required prior trials may trigger denial.
Qfitlia (Hemophilia A)	Trial and failure, allergy, contraindication, or intolerance to one appropriate agent (based on inhibitor status) prior to approval	Prescriber must document inhibitor status, involve/consult a hematologist, attest patient is not on another non-factor prophylactic agent; meets age per PI; renewal requires documentation of clinical benefit.
Qfitlia (Hemophilia B)	Trial and failure, allergy, contraindication, or intolerance to one appropriate agent (based on inhibitor status) prior to approval	Prescriber must document inhibitor status, involve/consult a hematologist, attest patient is not on another non-factor prophylactic agent; meets age per PI; renewal requires documentation of clinical benefit.
Ryzneuta	At least a 7-day trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents	Non-preferred colony-stimulating factor; approval duration 6 months; quantity limit 1 syringe every 14 days.
Vanrafia	Requirement: patient on stable maximally tolerated RAAS inhibitor unless contraindicated (functional prerequisite rather than prior drug failure)	Non-preferred; requires confirmed primary IgAN and proteinuria ≥1 g/day or UPCR ≥1.5 g/g; nephrology consult and pregnancy test/counseling attestation required.

Quantity Limits and Unit Restrictions

Zunveyl — Quantity Limit

DrugZunveyl (benzgalantamine)

Quantity limit2 tablets per day

Formulary statusNon-Preferred (NPD)

Prior authorization requirementRequires documentation of ≥1 week trial and failure, or allergy/contraindication/intolerance of 2 preferred agents

Ryzneuta — Quantity Limit

DrugRyzneuta (efbemalenograstim alfa-vuxw)

Quantity limit1 syringe every 14 days

Clinical Thresholds and Coding-related Criteria

Proteinuria / UPCR thresholds

MeasureUrine protein-to-creatinine ratio (UPCR)

ThresholdUPCR ≥ 1.5 g/g

Alternate metricProteinuria ≥ 1 g/day

Associated medicationVanrafia initiation requires meeting these thresholds

Administration Setting and Site-of-Care Notes

Note

Outpatient vial/pen presentations; no explicit site restriction

Products with vial or pen presentations are implied for outpatient administration (e.g., Qfitlia quantity limits specified by vial/pen) and no explicit site‑of‑care restriction is stated in this excerpt.

Drug Mechanisms and Indication Summaries

Benzgalantamine / galantamine mechanism

AgentBenzgalantamine

RelationshipProdrug of galantamine

MechanismGalantamine is a reversible, competitive acetylcholinesterase inhibitor that increases cholinergic function

Clinical contextUsed as an Alzheimer's agent (Zunveyl)

Qfitlia mechanism and indication

DrugQfitlia

MechanismAntithrombin-directed small interfering RNA (siRNA)

Policy Background and Scope

The document summarizes P&T Committee and DMS actions by describing how newly reviewed products were placed on the formulary and what authorization rules apply. In this excerpt, products identified as non-preferred (NPD or Non‑PDL) are subject to specific prior authorization and step‑therapy requirements; for example, NPD criteria require a ≥ 1 week trial and failure, allergy, contraindication, or intolerance of 2 preferred agents. Qfitlia is noted as a Non‑PDL product with an indication for prophylaxis in hemophilia A or B for patients aged 12 years and older, and a quantity limit is specified. These selections reflect the committee’s process of designating preferred vs non-preferred agents and applying PA, quantity limits, and clinical documentation requirements as part of the final PDL decisions.

Policy Summary

Payermedimpact

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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers must document required trials, specialist consults, and lab results (e.g., inhibitor testing) when submitting prior authorization requests.

SourceLink

On This Page

Vanrafia initial: Confirmed primary IgAN; proteinuria ≥ 1 g/day OR UPCR ≥ 1.5 g/g; on stable maximally tolerated RAAS inhibitor unless contraindicated; prescribed by or in consultation with a nephrologist; provider attestation of negative pregnancy test prior to initiation in females of reproductive potential; provider attestation of counseling on teratogenic risks and contraception.UPCR >=1.5 g/g

Vanrafia

Prior Authorization

Qfitlia prescriber documentation and attestations required

For Qfitlia initial approvals, the prescriber must document inhibitor status (presence or absence) with a lab result, prescribe or consult with a hematologist, attest the patient is not on another non‑factor prophylactic agent, and confirm trial/failure (or allergy/contraindication/intolerance) of the specified prior agent(s); patient must meet the minimum age per the package insert.

Hemophilia A: documentation of Factor VIII inhibitor presence OR absence; trial/failure of one agent appropriate for with/without inhibitors (Alhemo, Hemlibra, Hympavzi).
Hemophilia B: documentation of Factor IX inhibitor presence OR absence; trial/failure of one agent appropriate for with/without inhibitors (Alhemo, Hympavzi).
Age limit: 12 years of age or older per label guidance in the document.

Step Therapy

Required prior trials and documented therapeutic failure

Multiple products require documented trials and failure of preferred agents before approval. Examples: Zunveyl requires trial/failure or intolerance of 2 preferred agents (or ≥1 week trial/failure); Ryzneuta requires at least a 7‑day trial and therapeutic failure, allergy, contraindication, or intolerance of 2 preferred agents.

Step requirement: therapeutic failure, allergy, contraindication, or intolerance to required number of preferred agents.
Ryzneuta: 7‑day trial and failure of 2 preferred agents.

Documentation Required

Provide lab results and clinical‑benefit documentation

Prescribers must supply lab documentation (e.g., lab results within the past year) of inhibitor testing for hemophilia patients and renewal documentation of clinical benefit compared with baseline.

Hemophilia A: lab result showing presence OR absence of Factor VIII inhibitors (within past year).
Hemophilia B: lab result showing presence OR absence of Factor IX inhibitors (within past year).
Renewal: prescriber attests clinical benefit versus baseline and provides supporting documentation.

Documentation Required

Negative pregnancy test and counseling attestation required for Vanrafia

For Vanrafia initiation in females of reproductive potential, the provider must attest to a negative pregnancy test prior to initiation and attest that counseling was provided on teratogenic risks and contraception.

Provider attestation of negative pregnancy test prior to initiation.
Provider attestation that patient counseling on teratogenic risks and contraception occurred.

Denial Risk

Denial risk if prior‑therapy documentation is insufficient

Failure to document required prior therapy (trial and failure, allergy, contraindication, or intolerance to the required number of preferred agents) may result in denial of the PA (e.g., Zunveyl requires documentation for 2 preferred agents).

Insufficient documentation of prior trials or documented intolerance is a common denial risk.
Examples cited: missing trial/failure documentation for required 2 preferred agents for Zunveyl.

Denial Risk

Denial risk for missing hematologist consult or inhibitor documentation

For Qfitlia, absence of required hematologist involvement/consultation or missing documentation of inhibitor status (Factor VIII or IX) — or failure to attest the patient is not on another non‑factor prophylactic agent — may trigger denial.

Prescriber must be the hematologist or confirm consultation.
Must document presence OR absence of Factor VIII (Hem A) or Factor IX (Hem B) inhibitors (lab within past year).
Must attest patient is not on another non‑factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi).

Formulary statusNon-Preferred

Indication contextProphylaxis of chemotherapy-related neutropenia to decrease febrile neutropenia

Vanrafia — Quantity Limit

DrugVanrafia®

Quantity limit30 tablets per 30 days

Approval duration6 months

Key clinical thresholdProteinuria ≥1 g/day or UPCR ≥1.5 g/g required for initiation

Qfitlia — Quantity Limit (vial)

ProductQfitlia (vial presentation)

Quantity limit0.2 mL per month (vial)

Formulary statusNon-PDL

Administration noteVial presentation quantity specified as monthly limit

Qfitlia — Quantity Limit (pen)

ProductQfitlia (pen presentation)

Quantity limit0.5 mL per month (pen)

Formulary statusNon-PDL

Administration notePen presentation quantity specified as monthly limit

IndicationIndicated for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 years and older with Hemophilia A or B, with or without Factor VIII/IX inhibitors

Formulary statusNon-PDL