CurrentMass General Brigham Health PlanPolicy N/A

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (Jesduvroq - daprodustat; Vafseo - vadadustat) Prior Authorization

Prior authorization policy for Jesduvroq (daprodustat) and Vafseo (vadadustat) under the pharmacy benefit for Commercial/Exchange members, governing initiation and continuation of therapy for anemia of chronic kidney disease in adults on dialysis.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHIF PH inhibitors (daprodustat, vadadustat) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateJan 1, 2025

Next Review DateOct 9, 2025

Key ActionSubmit prior authorization with documentation of CKD diagnosis, age ≥18, dialysis duration (≥4 months for daprodustat; ≥3 months for vadadustat), hemoglobin, and iron studies (ferritin ≥100 mcg/mL or TSAT ≥20%).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum member age

≥4 moJesduvroq dialysis duration

≥3 moVafseo dialysis duration

Ferritin ≥100 OR TSAT ≥20%iron requirement

6 mo

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Coverage Criteria for HIF Prolyl Hydroxylase Inhibitors

Initial Therapy

Authorization may be granted when ALL of the following diagnosis-specific criteria are met:

CKD diagnosis and age: Member has a diagnosis of chronic kidney disease (CKD) AND is 18 years of age or older.age >= 18

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Dialysis duration specific to agent: For Jesduvroq (daprodustat): member has been on dialysis for at least 4 months; For Vafseo (vadadustat): member has been on dialysis for at least 3 months.daprodustat dialysis >=4 months; vadadustat dialysis >=3 months

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Iron stores: Member has adequate iron stores as confirmed by either serum ferritin >= 100 mcg/mL OR TSAT >= 20%.ferritin >=100 OR TSAT >=20%

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ESA hyporesponsiveness: Member is hyporesponsive to erythropoiesis-stimulating agent (ESA) therapy, defined as hemoglobin 8.0-11.5 g/dL.Hgb 8.0-11.5 g/dL

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Prescriber specialty: Requested medication is prescribed by or in consultation with a nephrologist or hematologist.prescriber = nephrologist or hematologist

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No concurrent ESA: Requested medication will not be used concurrently with an ESA (e.g., Aranesp, Epogen, Procrit).no concurrent ESA use

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Continuation Therapy

Continuation of therapy will be approved when ALL of the following are met:

Positive clinical response: Member has had a positive clinical response to therapy, as demonstrated by an increase in hemoglobin.documented increase in hemoglobin

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Ongoing iron adequacy: Member continues to have adequate iron stores as evidenced by serum ferritin >= 100 mcg/mL OR TSAT >= 20%.ferritin >=100 OR TSAT >=20%

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Authorization for Jesduvroq (daprodustat) or Vafseo (vadadustat) under the pharmacy benefit may be granted when the diagnosis-specific criteria are met and the member is new to the plan within the past 90 days, except when the product was obtained only as samples or through the manufacturer's patient assistance program. Requests require prior authorization and must document the CKD diagnosis, member age (must be ≥ 18 years), duration of dialysis specific to the requested agent (Jesduvroq ≥ 4 months; Vafseo ≥ 3 months), evidence of adequate iron stores (serum ferritin ≥ 100 mcg/mL OR TSAT ≥ 20%), and that the prescribing clinician is a nephrologist or hematologist.

Use of the requested HIF prolyl hydroxylase inhibitor concurrently with an erythropoiesis-stimulating agent (ESA) is not permitted. Examples of ESAs include Aranesp, Epogen, and Procrit; concurrent ESA therapy is an exclusion and will render the request not appropriate under this policy.

Pharmacy and Laboratory Coding / Thresholds

Pharmacy/Drug CodesNDC

NDC	Not specified in document; specialty pharmacy requirement noted

inv-06: Hemoglobin — ESA hyporesponsiveness

Hemoglobin range8.0 - 11.5 g/dL

Use in trials/studiesJesduvroq studied with baseline Hgb 8.0–11.5 g/dL; Vafseo studied with baseline Hgb 8.0–11.0 g/dL

Role in authorizationHgb 8.0–11.5 g/dL is the policy threshold used to define ESA hyporesponsiveness for approval

inv-07: Serum ferritin — iron store requirement

Serum ferritin threshold≥ 100 mcg/mL

Evidence for continuationFerritin ≥100 mcg/mL required to confirm ongoing adequate iron stores for continuation

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members. Requests should be submitted to the pharmacy benefit prior authorization contact listed in the policy.

Program Type: Prior Authorization
Benefit: Pharmacy Benefit
Specialty dispensing: Must be filled at a contracted specialty pharmacy

Step Therapy

No step therapy requirement is specified in this policy.

Background

Jesduvroq (daprodustat) and Vafseo (vadadustat) are oral hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitors indicated to treat anemia due to chronic kidney disease in adults. Clinical trial populations and the policy’s coverage criteria reflect dialysis-duration differences between the agents: daprodustat (Jesduvroq) is evaluated in patients on dialysis for ≥ 4 months, while vadadustat (Vafseo) is evaluated in patients on dialysis for ≥ 3 months. Both agents were studied in patients who were hyporesponsive to erythropoiesis-stimulating agents, with hyporesponsiveness defined here as hemoglobin between 8.0 and 11.5 g/dL.

Definitions

inv-14: Hyporesponsive to ESA — policy definition

Policy definitionHyporesponsive to ESA is defined as hemoglobin 8.0–11.5 g/dL

PurposeThreshold used to identify members who were hyporesponsive to erythropoiesis-stimulating agents for authorization

Study contextBoth agents were studied in patients hyporesponsive to ESAs; Jesduvroq trial baseline hemoglobin 8.0–11.5 g/dL (Vafseo 8.0–11.0 g/dL)

Policy Summary

PayerMass General Brigham Health Plan

PolicyHIF PH inhibitors (daprodustat, vadadustat) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateJan 1, 2025

Next Review DateOct 9, 2025

SourceLink

On This Page

Serves as one of two acceptable measures of iron adequacy (alternate: TSAT ≥20%)

inv-08: Transferrin saturation (TSAT) — iron store requirement

TSAT threshold≥ 20%

Use for continuationTSAT ≥20% acceptable evidence of ongoing adequate iron stores for continuation

Alternative to ferritinServes as one of two acceptable measures of iron adequacy (alternate: ferritin ≥100 mcg/mL)

Denial Risk

Denial Conditions

Requests may be denied if the member is not new to the plan within the past 90 days while already receiving the medication, or if required diagnostic or clinical criteria are not met.

Denial risk if member is not new-to-plan within 90 days and already receiving the requested medication (excluding samples or manufacturer assistance)
Denial risk if diagnosis-specific criteria (e.g., CKD diagnosis, age, dialysis duration, iron stores, ESA hyporesponsiveness, prescriber specialty, concurrent ESA use) are not met

Documentation Required

Documentation Requirements

Documentation must include the diagnosis of chronic kidney disease (CKD) and supporting clinical information: member age, duration of dialysis (Jesduvroq ≥4 months; Vafseo ≥3 months), current hemoglobin indicating ESA hyporesponsiveness (8.0–11.5 g/dL), evidence of adequate iron stores (serum ferritin ≥100 mcg/mL or TSAT ≥20%), prescriber specialty (nephrologist or hematologist) or documentation of consultation, and confirmation that the medication will not be used concurrently with an ESA.

Diagnosis: chronic kidney disease (CKD)
Age: ≥18 years
Dialysis duration: Jesduvroq ≥4 months; Vafseo ≥3 months
Iron studies: serum ferritin ≥100 mcg/mL or TSAT ≥20%
Hemoglobin: 8.0–11.5 g/dL (ESA hyporesponsive)
Prescriber: nephrologist or hematologist (or documentation of consultation)
Statement that therapy will not be used concurrently with an ESA