ModifiedmedimpactPolicy N/A

P&T recommendations for new pharmacy products (Zunveyl, Qfitlia)

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Summarizes P&T Committee recommendations (July 15, 2025) for placement and coverage criteria for new products Zunveyl® and Qfitlia™ including formulary status, approval duration, approval criteria, and quantity limits; intended for MedImpact plan decisioning and provider/pharmacy stakeholders.

Policy Summary

Payermedimpact

PolicyP&T recommendations for new pharmacy products (Zunveyl, Qfitlia)

Policy CodePolicy N/A

Change TypeMaterial update — new product placements and utilization controls

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prophylactic intent, age/diagnosis, prior therapy trials or contraindications, and recent lab evidence of inhibitor status.

SourceLink

POLICY UPDATE CHANGES

Qfitlia™ was recommended as a new product to market with Non-PDL status, approval duration 12 months, and a quantity limit of 2 tablets per day.

Zunveyl® was recommended as a non-preferred Central Nervous System - Alzheimer's agent with an approval duration of 12 months.

Approval criteria for non-preferred agents require trial and failure of preferred agents (minimum ≥1 week) or documented allergy, contraindication (including drug-drug interactions), or intolerance of two preferred agents.

Prescribers must provide documentation (e.g., laboratory result within the past year) and, for hemophilia indications, document presence or absence of Factor VIII/IX inhibitors; some lines require hematologist involvement and attestation that the patient is not on another non-factor prophylactic agent.

2new products

12 months

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ModifiedmedimpactPolicy N/A

P&T recommendations for new pharmacy products (Zunveyl, Qfitlia)

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Policy Summary

Payermedimpact

PolicyP&T recommendations for new pharmacy products (Zunveyl, Qfitlia)

Policy CodePolicy N/A

Change TypeMaterial update — new product placements and utilization controls

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prophylactic intent, age/diagnosis, prior therapy trials or contraindications, and recent lab evidence of inhibitor status.

SourceLink

POLICY UPDATE CHANGES

Qfitlia™ was recommended as a new product to market with Non-PDL status, approval duration 12 months, and a quantity limit of 2 tablets per day.

Zunveyl® was recommended as a non-preferred Central Nervous System - Alzheimer's agent with an approval duration of 12 months.

2new products

12 months

2 tablets/dayquantity limit

≥1 weekmin trial before NPD

8 For, 0 AgainstP&T vote

Coverage Criteria

inv-01: Non-preferred (NPD) approval criteria

Covered when ALL of the following are met for non-preferred (NPD) agents

Non-preferred approval criteria: Documented trial and failure of preferred agent(s) (minimum trial duration >= 1 week) OR documented allergy to preferred agents OR documented contraindication (including potential drug-drug interactions) OR documented intolerance of two preferred agents.>= 1 week trial

Applies to non-preferred (NPD) agents such as Qfitlia™ per committee recommendation.

inv-02: Quantity limits and approval duration

Authorization limits applied when covered

Utilization controls: Quantity limit: 2 tablets per day (specified for Qfitlia™). Approval duration: 12 months.2 tablets/day; 12 months

Applies to Non-PDL decisions recorded in the P&T recommendation.

inv-03: Initial approval criteria

Covered when ALL of the following are met

Diagnosis and age: Diagnosis of hemophilia A or hemophilia B in adult or pediatric patients aged 12 years or older (with or without Factor VIII or Factor IX inhibitors).age >= 12 years

Document diagnosis and age in the medical record

Prior therapy/step requirement: For non-preferred approval: trial and failure of preferred therapy for >= 1 week OR documented allergy OR documented contraindication (including potential drug-drug interactions) OR intolerance to two preferred agents.>= 1 week trial; 2 preferred agents

Document trials, allergies, contraindications, or intolerances

Quantity limit: Requested quantity must not exceed 2 tablets per day.<= 2 tablets/day

inv-05: Initial Approval — Hemophilia A/B prophylaxis

Covered when ALL of the following are met

Age and diagnosis: Patient is aged 12 years or older AND has hemophilia A or hemophilia B (with or without Factor VIII or Factor IX inhibitors).age >= 12 years

Supported by repeated indication statements in the recommendation

Intended use: Qfitlia is prescribed for routine prophylactic treatment to prevent or reduce bleeding episodes.

Prophylactic intent must be documented

inv-06: Initial Approval

Covered when ALL of the following are met:

Initial approval (prophylaxis): 1) Medication is prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with hemophilia A or B; 2) Patient is aged 12 years or older; 3) Prescriber provides supporting documentation (e.g., laboratory result within the past year).age >= 12 years

Includes patients with or without Factor VIII or Factor IX inhibitors.

inv-07: Initial approval (prophylaxis)

Covered when ALL of the following are met

Age: Patient is aged 12 years or older.>= 12 years

Supported in multiple recommendation lines

Diagnosis of hemophilia A or B (with or without Factor VIII or Factor IX inhibitors).

Policy references both hemophilia A and B

Intent of use: Prescribed for routine prophylactic treatment to prevent or reduce bleeding episodes.

Prophylactic use must be documented

Documentation: Prescriber provides documentation (e.g., laboratory result within the past year) to support the request and inhibitor status as applicable.

inv-08: Initial Approval Criteria

Covered when ALL of the following are met

Initial Approval Criteria: 1) Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with hemophilia A or hemophilia B; AND 2) Patient is aged 12 years or older; AND 3) Prescriber provides documentation (e.g., lab result within the past year) showing presence or absence of Factor VIII or Factor IX inhibitors as applicable.

Approval duration noted as 12 months in the recommendation.

inv-09: Initial Approval — Hemophilia A

Initial Approval Criteria: Hemophilia A

Hemophilia A initial approval: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in Hemophilia A; AND prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor VIII inhibitors.

Approval duration of 12 months stated in multiple sections.

inv-10: Initial Approval

Initial Approval Criteria: Hemophilia A/B

Initial Approval: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with hemophilia A or B; AND prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor VIII (or Factor IX) inhibitors as applicable.

Approval duration: 12 months.

inv-11: Initial Approval

Covered when ALL of the following are met

Initial Approval Criteria: Hemophilia A: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia A or B; AND prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor VIII (or IX) inhibitors as applicable.

Approval duration: 12 months.

inv-12: Initial Approval Criteria

Covered when ALL of the following are met

Initial Approval - Hemophilia A or B: Patient is aged 12 years or older AND Qfitlia is prescribed for routine prophylactic treatment to prevent or reduce bleeding episodes in hemophilia A or B.age >= 12 years

Indication text repeated across recommendation chunks

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

Either presence or absence is acceptable but must be documented

Prescriber specialty: Prescribed by, or in consultation with, a hematologist (appears in portions of the criteria).

Some lines include hematology requirement; documented hematology involvement appears variably

inv-13: Initial Approval Criteria

Covered when ALL of the following are met

Initial Approval Criteria for Hemophilia A: 1) Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia A; AND 2) Prescriber provides documentation (e.g., lab result within the past year) of either presence OR absence of Factor VIII inhibitors; AND 3) Prescribed by, or in consultation with, a hematologist.

Approval duration: 12 months

inv-14: Initial Therapy — Hemophilia A

Initial Approval Criteria: Hemophilia A

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 either 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; AND trial and failure, allergy, contraindication (including potential drug-drug interactions) or intolerance to one appropriate alternative agent as applicable; AND patient meets minimum age (>= 12 years).age >= 12 years

Approval duration: 12 months

inv-15: Initial Therapy — Hemophilia B

Initial Approval Criteria: Hemophilia B

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 either 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; AND trial and failure, allergy, contraindication or intolerance to one appropriate alternative agent as applicable; AND patient meets minimum age (>= 12 years).age >= 12 years

Approval duration: 12 months

inv-16: Renewal Therapy

Renewal Criteria

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) confirming hemophilia A or B with or without respective inhibitors.none

Renewal typically granted for 12 months per recommendation

Coverage for non-preferred agents is contingent on documented prior therapy history. Specifically, approval is not granted unless the request includes a documented trial and failure of preferred agent(s) (minimum trial duration ≥ 1 week), or documentation of a allergy, a contraindication (including potential drug‑drug interactions), or intolerance to two preferred agents as described in the recommendation text.

Requests that exceed the stated utilization controls will not be supported. The recommendation specifies a quantity limit of 2 tablets per day for Qfitlia™; requests for quantities beyond this limit may be denied.

No additional explicit exclusions are provided in this portion of the document beyond the requirement to document intolerance or contraindication to prior agents when applicable.

This extract does not state any explicit exclusions for coverage beyond the general eligibility and documentation requirements described in the approval criteria.

No explicit exclusions are stated in this section of the recommendations; coverage is defined by meeting the initial approval criteria and required documentation.

No explicit exclusions are listed in these chunks; coverage decisions are driven by the stated initial approval criteria and supporting documentation requirements.

None explicitly listed in this section of the document; the policy focuses on meeting initial approval criteria and required documentation rather than enumerating exclusions.

No explicit exclusions are detailed in this extract; requirements emphasize documentation of inhibitor status and hematology involvement where specified.

Prescriber must attest that the patient is not on another non‑factor prophylactic agent (for example, Alhemo, Hemlibra, Hympavzi). This attestation is required as part of the initial approval conditions.

Use of Qfitlia™ without documentation of prior trial and failure or without documented intolerance/allergy/contraindication to preferred agents is not supported for non‑preferred approval. The recommendation requires a trial and failure of preferred agents (minimum ≥ 1 week) or documented substitution reasons (allergy, contraindication, or intolerance to preferred agents).

Requests lacking documentation that the medication is being prescribed for routine prophylaxis, or that do not include required supporting documentation of patient age/diagnosis (e.g., Hemophilia A or B in patients aged ≥ 12 years) or intolerance/contraindication to prior agents, are not supported by the criteria presented.

Use outside the stated indication—such as patients younger than 12 years or for indications other than routine prophylaxis to prevent or reduce bleeding episodes—is not supported in these recommendation excerpts.

There are no explicit 'not medically necessary' statements present in these chunks; however, coverage is conditional on meeting the documented trial, intolerance/contraindication/allergy, and indication criteria described elsewhere in the recommendations.

No explicit 'not medically necessary' conditions are provided in these chunks; the guidance centers on meeting initial approval criteria and documentation requirements for prophylactic use.

No 'not medically necessary' conditions are explicitly stated in this excerpt; lack of required documentation or failure to meet stated indication criteria would effectively render a request unsupported.

No explicit 'not medically necessary' conditions are stated in this extract; denials would be guided by failure to meet the stated approval and documentation criteria.

Provider Actions & Prior Authorization

Prior Authorization

PA required for non‑preferred products; 12‑month approval with 2 tablets/day limit

Prior authorization is required for non‑preferred placement of Qfitlia (Non‑PDL); initial approvals are granted for 12 months and a quantity limit of 2 tablets per day applies.

PA required for non‑preferred agents
Initial approval duration: 12 months
Quantity limit: 2 tablets per day

Prior Authorization

PA requires meeting non‑preferred criteria (trial/failure ≥1 week or documented exception)

Prior authorization for Qfitlia follows non‑preferred (NPD) criteria: trial and failure of preferred agents (minimum ≥1 week) OR documented allergy, contraindication (including drug‑drug interaction) OR intolerance of preferred agents; initial approval duration is 12 months.

Step requirement: trial and failure ≥1 week of preferred agents
Alternatives: documented allergy, contraindication, or intolerance to preferred agents

Initial Therapy Criteria

inv-115: Initial therapy criteria

Initial coverage requirements for non-preferred products

Initial authorization: Documented trial and failure of preferred agents (>= 1 week) OR documented allergy OR documented contraindication (including potential drug-drug interactions) OR intolerance of two preferred agents.>= 1 week

Applies to non-preferred products such as Qfitlia™ per the P&T recommendation.

inv-116: Initial therapy requirements

Initial authorization requirements for non-preferred Qfitlia

Step requirement: Trial and failure of preferred agents for >= 1 week OR documented allergy/contraindication/intolerance to two preferred agents.>= 1 week trial; 2 preferred agents

Continuation / Renewal Criteria

inv-128: Continuation therapy

Continuation/approval duration

Approval duration suggested at 12 months per committee recommendation.12 months

Renewal likely requires ongoing documentation of benefit

inv-129: Renewal / Continuation

Approval duration and quantity limit for continued therapy as presented

Continuation: Authorization may be renewed with approval duration of 12 months and continued quantity limit of 2 tablets per day, consistent with initial approval.12 months; 2 tablets/day

Further continuation criteria not detailed in these chunks

Step Therapy Requirements

Step	Requirement
1	Trial of preferred agent(s) required prior to coverage of non-preferred agents unless a documented allergy, contraindication (including potential drug-drug interactions), or intolerance is provided.

Step	Requirement
1	Trial and failure of preferred agents (minimum trial ≥ 1 week) is required for non-preferred approval unless there is documented allergy, contraindication, or intolerance to two preferred agents.

Step	Requirement
1	Prescriber must document intolerance or contraindication to two preferred agents prior to approval of the non-preferred product.

Step	Requirement
1	No explicit step therapy sequence described in the document; product is noted as a New Product to Market and designated Non‑PDL.

Step	Requirement
1	No step therapy requirements are specified in this excerpt.

Step	Requirement
1	Step 1: (no additional detail provided in the excerpt).

Step	Requirement
1	Prescriber must document prior trial and failure, or provide documentation of contraindication or intolerance, before Qfitlia is approved (attestation that patient is not on another non-factor prophylactic agent is required where specified).

Quantity Limits & Dosing

inv-144: Qfitlia™ — quantity limit value (2)

Quantity limit2 tablets per day

Applies toQfitlia™ (Non-PDL) when authorized

Source guidanceCommittee recommendation and quantity limit statements in policy text

inv-145: Qfitlia — quantity limit (2)

Quantity limit2 tablets per day

Formulary statusNew Product to Market: Non-PDL

Approval duration (related)12 months

Definitions & Mechanisms

inv-99: Benzgalantamine (Zunveyl®) prodrug definition

TermBenzgalantamine (Zunveyl®) is a prodrug of galantamine

MechanismReversible, competitive acetylcholinesterase inhibitor

Clinical intentIntended to increase cholinergic function by preventing acetylcholine breakdown

inv-100: Qfitlia™ — antithrombin-directed small interfering RNA (definition)

DefinitionQfitlia™ is an antithrombin-directed small interfering ribonucleic acid (siRNA)

Therapeutic classAntithrombin-directed siRNA

Formulation context

Background

Benzgalantamine (Zunveyl®) is described as a prodrug of galantamine; galantamine is a reversible, competitive acetylcholinesterase inhibitor intended to increase cholinergic function by preventing acetylcholine breakdown. This background information contextualizes the P&T recommendations, which focus on formulary placement and utilization controls rather than clinical treatment guidance.

Policy Summary

Payermedimpact

PolicyP&T recommendations for new pharmacy products (Zunveyl, Qfitlia)

Policy CodePolicy N/A

Change TypeMaterial update — new product placements and utilization controls

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of prophylactic intent, age/diagnosis, prior therapy trials or contraindications, and recent lab evidence of inhibitor status.

SourceLink

On This Page

Requests exceeding this limit may be denied

lab within past year

Recent lab result requested repeatedly in the text

Approval duration on PA: 12 months

Prior Authorization

Qfitlia PA — 12‑month initial approval and 2 tablets/day limit

Prior authorization is required for Qfitlia; when approved for routine prophylaxis initial authorization is granted for 12 months and quantity limit is 2 tablets per day.

Indication: routine prophylaxis for hemophilia A or B (age ≥12)
Initial approval duration: 12 months
Quantity limit: 2 tablets/day

Prior Authorization

PA implied for Non‑PDL Qfitlia — 12‑month approvals

Qfitlia is managed as a Non‑PDL new product and prior authorization is implied; approvals are typically for 12 months.

Formulary placement: Non‑PDL (non‑preferred)
Approval duration noted repeatedly as 12 months

Prior Authorization

PA required for routine prophylaxis — initial 12‑month approval

Prior authorization is required for Qfitlia when prescribed for routine prophylaxis; initial approvals are granted for 12 months for eligible patients.

Use: routine prophylactic treatment to prevent/reduce bleeding
Patient age: aged 12 years or older
Initial approval duration: 12 months

Prior Authorization

PA required for Qfitlia in patients ≥12 years — 12‑month initial approval

Prior authorization is required for Qfitlia for routine prophylaxis in patients aged 12 years and older; initial authorization duration is 12 months.

Indication: hemophilia A or B in patients ≥12 years
PA requirement: prior authorization needed
Initial approval duration: 12 months

Prior Authorization

PA requires hematology involvement/consultation in some lines; PA required

Prior authorization is required for Qfitlia for routine prophylaxis in patients aged ≥12; some criteria lines require the prescriber be a hematologist or document hematology consultation.

PA required for prophylactic use in hemophilia A/B (age ≥12)
Prescriber specialty: hematologist involvement may be required or requested
Documentation: recent lab results within past year often requested

Prior Authorization

Initial authorization duration: 12 months

Initial authorizations for Qfitlia when used for routine prophylaxis are granted for 12 months.

Typical initial authorization duration: 12 months
Applies to Non‑PDL Qfitlia approvals

Prior Authorization

PA required for prophylactic treatment — 12‑month initial approval

Prior authorization is required for Qfitlia when prescribed for prophylactic treatment to prevent or reduce bleeding episodes in hemophilia A or B; initial approvals are given for 12 months when criteria are met.

Indication: prophylactic use in hemophilia A or B
PA required and initial approval duration: 12 months
Criteria include documentation of inhibitor status as applicable

Prior Authorization

Qfitlia PA for Hemophilia A/B (age ≥12) — 12‑month approvals

Prior authorization is required for Qfitlia for prophylactic treatment of Hemophilia A or B in patients aged ≥12; initial approvals are typically for 12 months.

Age: 12 years and older
Indication: Hemophilia A or B (with or without inhibitors)
Initial approval duration: 12 months

Prior Authorization

Non‑PDL PA for Qfitlia — initial 12‑month approvals

Qfitlia is Non‑PDL and requires prior authorization; initial approvals are granted for 12 months for routine prophylaxis in patients aged ≥12 years.

Formulary status: Non‑PDL (non‑preferred)
PA required with initial approval duration of 12 months
Applies to routine prophylaxis in patients aged ≥12

Prior Authorization

PA required; initial approvals granted for 12 months when criteria met

Prior authorization is required for Qfitlia; when all criteria are met initial approval is granted for 12 months.

PA required
Initial approval duration: 12 months
Approval contingent on meeting documented criteria

Prior Authorization

PA requires inhibitor documentation, hematology involvement, attestation not on other non‑factor prophylaxis

Prior authorization for Qfitlia requires documentation of inhibitor presence/absence, hematologist involvement as applicable, prescriber attestation that the patient is not on another non‑factor prophylactic agent, and evidence of prior trial/failure or contraindication to appropriate alternative therapy.

Document presence OR absence of Factor VIII (or IX) inhibitors (e.g., lab within past year)
Prescriber attests patient is not on another non‑factor prophylactic agent (e.g., Alhemo, Hemlibra, Hympavzi)
Prescriber involvement: hematologist or consult; document trial/failure or contraindication to listed alternatives

Prior Authorization

Non‑preferred agents and new chemical entities require PA until P&T review

Non‑preferred agents across multiple drug classes will require prior authorization; new chemical entities should have PA until reviewed by the P&T Committee.

Agents not selected as preferred will be considered non‑preferred and require PA
New chemical entities require PA until P&T review

Step Therapy

Step therapy: trial/failure of preferred agents ≥1 week (exceptions for documented intolerance/allergy/contraindication)

Step therapy: non‑preferred approval requires trial and failure of preferred agents for a minimum of ≥1 week unless a documented allergy, contraindication, or intolerance to preferred agents is provided.

Minimum trial duration of preferred agent(s): ≥1 week
Exceptions: documented allergy, contraindication (including drug‑drug interactions), or intolerance to preferred agents
Intolerance may require documentation of failure or contraindication to two preferred agents in some criteria

Step Therapy

Step therapy requires ≥1 week trial/failure; intolerance/allergy/contraindication may substitute

Step therapy requires a trial and failure of preferred agents (≥1 week); intolerance/allergy/contraindication to preferred agents may substitute, and documentation of intolerance to two preferred agents is referenced in initial criteria.

Trial and failure of preferred agents ≥1 week to qualify for non‑preferred approval
Substitution allowed for documented intolerance/allergy/contraindication
Some criteria reference intolerance/contraindication to two preferred agents

Step Therapy

Document and confirm intolerance/contraindication to two preferred agents when cited

Initial approval criteria reference the need to document intolerance or contraindication to two preferred agents in some situations before approval of a non‑preferred product.

Documented intolerance/contraindication to two preferred agents may be required
This supports non‑preferred approval when trials of preferred agents are not possible or tolerated

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Step Therapy

No explicit step therapy specified in portions of the document

No step therapy sequence is specified for some entries in this extract; where step therapy is not defined, PA and documentation rules still apply.

No explicit step sequence described in these chunks
PA and documentation requirements continue to govern coverage

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Step Therapy

No explicit step therapy sequence; follow PA/documentation requirements for Qfitlia

Step therapy is not specified in some excerpts; however, for Qfitlia non‑preferred approval the documented trial/failure or exception must be provided per PA rules.

No step sequence described in these chunks
PA and documentation rules apply for non‑preferred Qfitlia

Documentation Required

Attest trial/failure or contraindication/intolerance to required prior agents (attestation allowed)

Prescribers must attest to trial/failure, allergy, contraindication, or intolerance to one appropriate agent for the hemophilia indication when required by the criteria (attestation may be used in lieu of full chart documentation where specified).

Attestation that patient is not on another non‑factor prophylactic agent
Document trial/failure or contraindication/intolerance to one listed alternative agent as applicable

Note

No explicit provider action in this extract

(Placeholder — no additional provider action stated in these inventory lines.)

Documentation Required

Required documentation to support non‑preferred approval (trial/failure ≥1 week or documented exception)

Prescribers seeking approval for non‑preferred Qfitlia must provide documentation to support trial and failure of preferred agents (minimum ≥1 week), or documentation of allergy, contraindication (including drug‑drug interaction) or intolerance to preferred agents.

Document prior trial(s) and failure(s) of preferred agents (≥1 week)
Or provide documentation of allergy, contraindication, or intolerance to preferred therapies

Documentation Required

Document patient age (≥12) and hemophilia A or B diagnosis

Prescribers should document patient age (adult or pediatric ≥12 years) and the diagnosis of hemophilia A or B when requesting Qfitlia.

Document patient age (≥12 years)
Document diagnosis: Hemophilia A or B (with or without inhibitors)

Documentation Required

Document prophylactic intent and indication for Qfitlia

Requests for Qfitlia must include documentation that the medication is intended for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A or B; this intent should be documented in the medical record.

Document prophylactic intent to prevent or reduce bleeding
Include indication and clinical rationale in the record

Documentation Required

Provide recent lab results (within past year) and supporting documentation

Prescribers must provide supporting documentation (for example, a laboratory result within the past year) to support the Qfitlia request, including evidence needed for initial approval.

Provide a recent lab result (within the past year) as applicable
Include documentation supporting need for prophylactic therapy

Documentation Required

Provide lab results within past year to support diagnosis and prophylactic need

Prescribers must provide documentation (e.g., lab result within the past year) supporting diagnosis and need for prophylactic use when requesting Qfitlia prior authorization.

Lab result within the past year documenting inhibitor status or other relevant evidence
Documentation of diagnosis and prophylactic need

Documentation Required

Document presence or absence of Factor VIII/IX inhibitors (lab within past year)

Prescribers must provide documentation (e.g., lab result within the past year) supporting presence or absence of Factor VIII inhibitors (or Factor IX inhibitors for Hemophilia B) as part of the PA request.

Laboratory result within past year showing presence OR absence of Factor VIII (or IX) inhibitors
Include this documentation with the PA submission

Documentation Required

Required lab documentation of Factor VIII inhibitor status; missing labs may trigger denial

Prescribers must provide documentation (e.g., lab within the past year) of presence or absence of Factor VIII inhibitors for Hemophilia A patients; lack of this documentation may trigger denial.

Lab result within past year documenting inhibitor status
Failure to provide may lead to denial

Documentation Required

Inhibitor status documentation required for initial approval and renewal

Prescribers must provide documentation (e.g., lab within the past year) showing presence or absence of Factor VIII inhibitors; documentation of inhibitor status is required for initial approval and renewal.

Document presence OR absence of inhibitors with recent lab
Required for initial approval and renewal documentation

Documentation Required

Provide lab evidence of inhibitor presence/absence within past year

Prescribers must provide documentation (e.g., lab within the past year) showing presence or absence of Factor VIII inhibitors; this is explicitly required in several criteria lines.

Provide lab evidence of inhibitor presence or absence within the past year
Attach to PA request

Documentation Required

Inhibitor lab documentation required — absence may trigger denial

Prescribers must provide documentation (e.g., lab within past year) showing presence or absence of Factor VIII inhibitors; failure to provide required documentation may trigger denial.

Lab documenting inhibitor status within past year
Lack of this documentation may lead to denial

Documentation Required

Document hematologist prescriber or hematology consultation when required

Some criteria require that Qfitlia be prescribed by, or in consultation with, a hematologist; prescribers should document specialty or consultation as applicable.

Indicate if prescriber is a hematologist or include documentation of hematology consultation
Hematology involvement appears in multiple criterion lines

Documentation Required

Include inhibitor lab result and renewal clinical benefit documentation

Prescribers must provide documentation (e.g., lab result within the past year) showing presence or absence of Factor VIII/IX inhibitors for initial approval; documentation is required for renewal and may include clinical benefit evidence.

Lab result within past year for inhibitor status (Factor VIII or IX as applicable)
Documentation of clinical benefit required for renewal

Prior Authorization

PA required for new chemical entities until P&T Committee review

For any new chemical entity in listed drug classes, prior authorization is required until the P&T Committee reviews the product.

New chemical entities require PA until P&T Committee review
Applies across enumerated drug classes

Denial Risk

Denial risk: missing documented trial/failure or exception for non‑preferred agents

Requests for non‑preferred agents may be denied if there is no documented trial and failure of preferred agents (≥1 week), no documented allergy/contraindication, or no documented intolerance to preferred agents.

Denial trigger: absence of documented trial/failure of preferred agents (≥1 week)
Denial trigger: absence of documented allergy or contraindication
Denial trigger: absence of documented intolerance to preferred agents

Denial Risk

Denial risk for exceeding quantity limit (>2 tablets/day)

Requests exceeding the stated quantity limit (greater than 2 tablets per day) may be denied.

Quantity limit: 2 tablets per day
Requests >2 tablets/day may be denied

Denial Risk

Denial risk if prior agent intolerance/contraindication not documented

Failure to document contraindication or intolerance to required prior agents (including documentation that two preferred agents were intolerable where referenced) may lead to non‑approval.

Lack of documented contraindication/intolerance to required prior agents risks denial
Some criteria require documentation that two preferred agents were intolerable

Denial Risk

Denial risk for indication mismatch (not prophylaxis or age <12)

Requests that do not support use for routine prophylaxis in patients aged ≥12 with hemophilia A or B (with or without inhibitors) may be denied as an indication mismatch.

Indication must support routine prophylaxis in hemophilia A or B
Patient must meet age requirement (≥12 years)

Denial Risk

Denial risk if initial criteria or required documentation (e.g., labs) are missing

Requests that do not meet initial approval criteria or that lack required documentation (for example, a lab result within the past year) may be denied.

Denial trigger: failure to meet initial approval criteria
Denial trigger: missing required documentation such as recent lab results

Denial Risk

Documentation‑dependent denial risk: missing recent labs may cause denial

Lack of required prescriber documentation (for example, a recent lab result within the past year) may trigger denial of initial approval.

Provide recent lab results (within past year) or PA may be denied
Documentation supports initial approval decisions

Denial Risk

Denials possible when authorization criteria are unmet

Not explicitly stated in every line, but denials could be triggered if authorization criteria are not met (see prior authorization and documentation blocks).

If criteria are unmet, PA may be denied
Refer to PA and documentation requirements for specifics

Denial Risk

Denial risk if inhibitor documentation is missing

Lack of prescriber documentation—such as a missing lab within the past year demonstrating presence or absence of Factor VIII inhibitors—may trigger denial.

Missing inhibitor lab within past year risks denial
Ensure lab is attached to PA request

Denial Risk

Coverage contingent on meeting criteria; missing docs may cause denial

Coverage depends on meeting initial approval criteria; absence of required documentation (for example, lab results within the past year) may result in denial.

Coverage contingent on meeting criteria
Absence of required documentation may trigger denial

Denial Risk

Denial risk if inhibitor status or hematology consultation not documented

Lack of documentation of presence/absence of Factor VIII inhibitors or absence of hematologist prescribing/consultation may trigger denial of the PA request.

Provide inhibitor status documentation
Document hematology prescribing or consultation when required

Denial Risk

Denial risk if attestation not provided or prior‑agent trial/failure not documented

Requests may be denied if the prescriber does not attest the patient is not on another non‑factor prophylactic agent or if required trial/failure or contraindication to prior agents is not documented.

Prescriber attestation that patient is not on another non‑factor prophylactic agent required
Document trial/failure or contraindication to specified prior agents

Prior Authorization

Non‑preferred agents require PA

Agents not selected as preferred will be considered non‑preferred and will require prior authorization.

Non‑preferred placement requires PA
DMS/P&T will select preferred agents; non‑preferred require PA

Required documentation supports non-preferred approval.

inv-117: Initial Therapy

Initial therapy rules captured from document

Initial therapy: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with hemophilia A or B aged >= 12 years.age >= 12 years

Document prior intolerance/contraindication to preferred agents when applicable

inv-118: Initial therapy — prophylaxis

Initial approval criteria reflected in document

Indication: Prescribed for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A or B aged 12 years or older (with or without inhibitors).age >= 12

Repeatedly stated in the recommendation

inv-119: Initial Therapy

Initial authorization criteria for Qfitlia prophylaxis

Initial authorization: Prescribed for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or B; patient is >= 12 years of age; prescriber provides documentation (e.g., lab result within the past year).age >= 12 years

Approval duration stated as 12 months.

inv-120: Initial therapy

Initial approval requirements

Use: Prescribed for routine prophylaxis to prevent or reduce bleeding episodes.

Stated in initial criteria

Documentation: Prescriber provides supporting documentation (e.g., lab result within the past year).lab within past year

Explicit in the recommendation text

inv-121: Initial therapy

Initial authorization

Initial therapy: Prescribed for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or B; patient aged >= 12 years; prescriber provides documentation (e.g., lab result within the past year) supporting indication and inhibitor status.

Approval duration: 12 months.

inv-122: Initial Therapy — Hemophilia A

Initial approval rules as presented in the excerpt

Initial therapy criteria: 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.

Initial approval duration: 12 months.

inv-123: Initial Therapy

Initial therapy: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes; prescriber provides documentation (e.g., lab result within the past year) of presence OR absence of inhibitors.

Approval duration 12 months

inv-124: Initial Therapy

Initial approval conditions

Initial therapy for Hemophilia A/B: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes in patients with Hemophilia A or B; AND prescriber provides documentation (e.g., lab result within the past year) of presence OR absence of Factor VIII or IX inhibitors as applicable.

Approval duration: 12 months

inv-125: Initial Therapy Criteria

Initial approval criteria

Age and indication: Patient is aged 12 years or older and Qfitlia is prescribed for prophylactic treatment to prevent or reduce bleeding episodes in hemophilia A or B.age >= 12

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

Either documented presence or absence is acceptable

Hematology involvement: Prescribed by, or in consultation with, a hematologist (appears in some criterion lines).

Hematologist involvement appears variably across chunks

inv-126: Initial Therapy

Initial approval requirements

Initial therapy: Prescribed for prophylactic treatment to prevent or reduce bleeding episodes; documentation of presence or absence of Factor VIII/IX inhibitors within past year; prescribed by or in consultation with a hematologist.

Approval duration: 12 months

inv-127: Initial Therapy

Initial authorization conditions

Initial: Age >= 12 years; prescribed for prophylaxis in Hemophilia A or B; documentation of inhibitor presence/absence 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 (or contraindication/intolerance) to one listed alternative agent for the appropriate inhibitor status as applicable.age >= 12 years

Approval duration: 12 months

inv-130: Continuation/Approval Duration

Approval duration for continued therapy

Duration: Approval duration given as 12 months for authorized therapy.12 months

Document repeatedly states 12-month approval duration

inv-131: Continuation / duration

Approval duration and continuation

Approval duration: Initial approval duration is 12 months.12 months

Document lists 12 months repeatedly

inv-132: Renewal

Continuation/renewal

Renewal criteria: Authorization duration is typically 12 months; ongoing renewal contingent on continued documentation that prophylactic therapy remains indicated and, if requested, provision of recent lab results or clinical documentation.

Explicit renewal requirements are not detailed beyond duration.

inv-133: Continuation Therapy

Continuation/renewal authorization

Renewal/Continuation: Renewal requires continued indication for routine prophylaxis and appropriate documentation of inhibitor status as available; typical renewal authorization is for 12 months.

Derived from repeated statements of 12-month approval duration in the recommendation.

inv-134: Continuation/Approval Duration

Approval duration for ongoing therapy

Continuation: Approval duration granted is 12 months for routine prophylaxis.12 months

Recommendation specifies 12-month approval duration repeatedly

inv-135: Continuation Therapy

Continuation/renewal

Renewal/Continuation: Not explicitly detailed in this extract; typical approval duration stated as 12 months implying renewals may be requested thereafter.

inv-136: Continuation / Renewal

Renewal requirements for continued coverage

Continuation: Prescriber attests clinical benefit compared to baseline and provides recent documentation of inhibitor status; patient must continue to meet initial criteria for renewal.none

Renewal duration: 12 months

inv-146: Qfitlia — quantity limit (2)

Quantity limit2 tablets per day

Indication contextRoutine prophylaxis for hemophilia A or B (age ≥12)

Committee voteDecision 8 For 0 Against

inv-147: Qfitlia — quantity limit (2)

Quantity limit2 tablets per day

Applies toAdult and pediatric patients aged 12 years and older

NoteExceeding this limit may trigger denial

inv-148: Qfitlia (vial) — 0.2 mL per month

Limit (vial)0.2 mL per month

ContextListed as renewal/quantity specification in renewal criteria section

Product formQfitlia (vial)

inv-149: Qfitlia (pen) — 0.5 mL per month

Limit (pen)0.5 mL per month

ContextListed as renewal/quantity specification in renewal criteria section

Product formQfitlia (pen)

Listed as a new product to market with Non-PDL status

inv-101: Qfitlia mechanism — antithrombin-directed siRNA

MechanismAntithrombin-directed small interfering ribonucleic acid (siRNA)

EffectTargets antithrombin to reduce bleeding frequency in hemophilia prophylaxis context

Document sourcePolicy recommendation text describing Qfitlia mechanism

inv-102: Qfitlia — mechanism and indication summary

Mechanism and indicationQfitlia is an antithrombin-directed siRNA indicated for routine prophylaxis to prevent or reduce bleeding episodes

Patient populationAdult and pediatric patients aged 12 years and older with hemophilia A or B

Inhibitor statusApplies with or without Factor VIII or IX inhibitors

inv-103: Qfitlia — mechanism and indication

IndicationRoutine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or B

MechanismAntithrombin-directed small interfering RNA

Age thresholdPatients aged 12 years and older

inv-104: Qfitlia — mechanism and indication (hemophilia prophylaxis)

Indication (prophylaxis)Prescribed for routine prophylactic treatment to prevent or reduce bleeding episodes

Applicable diagnosesHemophilia A or B

Age groupAdult and pediatric patients aged 12 years and older

inv-105: Qfitlia — mechanism and indication

MechanismAntithrombin-directed siRNA

Indication detailsProvider must supply documentation (e.g., lab within past year) supporting presence or absence of inhibitors when requesting Qfitlia

Approval duration noted12 months (committee recommendation)

inv-106: Qfitlia — mechanism and indication for patients aged 12+

Indication for age ≥12Qfitlia indicated for routine prophylaxis in patients aged 12 years and older with hemophilia A or B

Inhibitor documentationPrescriber must provide lab result within the past year documenting presence OR absence of Factor VIII inhibitors (as applicable)

MechanismAntithrombin-directed siRNA

inv-107: Qfitlia — mechanism and indication for patients aged 12+

MechanismAntithrombin-directed small interfering ribonucleic acid

IndicationRoutine prophylaxis in hemophilia A; prescriber must document presence or absence of inhibitors (lab within past year)

Approval duration12 months

inv-108: Factor VIII inhibitors — definition

DefinitionFactor VIII inhibitors are antibodies that neutralize Factor VIII activity

DocumentationPresence or absence may be documented via recent lab results (within past year)

RelevanceRequired for initial approvals in Hemophilia A lines

inv-109: Qfitlia — mechanism and indication

MechanismAntithrombin-directed siRNA

IndicationRoutine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or B (age ≥12), with or without inhibitors

Authorization notePrescriber documentation and PA requirements apply

inv-110: Qfitlia — mechanism and indication

DefinitionQfitlia is an antithrombin-directed small interfering ribonucleic acid

IndicationUsed for routine prophylaxis to reduce bleeding episodes in patients aged ≥12 with hemophilia A or B

Inhibitor statusApplies with or without Factor VIII or IX inhibitors

inv-111: Qfitlia — mechanism and indication

MechanismAntithrombin-directed siRNA therapeutic class

Clinical useRoutine prophylaxis in hemophilia A or B to prevent or reduce bleeding frequency

Formulary placementNew Product to Market; Non-PDL status

inv-112: Factor VIII inhibitors — definition and documentation acceptance

MechanismAntithrombin-directed small interfering ribonucleic acid

IndicationPrescribed for prophylactic treatment to prevent or reduce bleeding episodes in Hemophilia A; prescriber must document inhibitor status

Prescriber requirementPrescribed by or in consultation with a hematologist in some lines

inv-113: Qfitlia — mechanism and indication

MechanismAntithrombin-directed siRNA

Indication summaryRoutine prophylaxis for hemophilia A or B in patients aged ≥12

Quantity limit2 tablets per day (where specified)

inv-114: Qfitlia — mechanism and indication

MechanismAntithrombin-directed small interfering ribonucleic acid (siRNA)

IndicationRoutine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or B (age ≥12), with or without inhibitors

DocumentationPrescriber must provide supporting lab or clinical documentation (e.g., lab within past year)