CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Accrufer (ferric maltol) — Authorization / Coverage Criteria

Defines medical necessity criteria, quantity limits, and approval duration for Accrufer (ferric maltol) for members of Neighborhood Health Plan of Rhode Island who meet iron deficiency anemia criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAccrufer (ferric maltol) — Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age ≥10, diagnosis of iron deficiency with Hb ≤11 g/dL, ferritin ≤100 ng/mL, TSAT <20%, and trial of at least two oral iron products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization / coverage duration

>=10minimum member age for approval

Hb ≤11hemoglobin threshold

Ferritin ≤100 & TSAT <20%iron indices required

2 caps/dayquantity limit

Coverage Criteria for Accrufer (ferric maltol)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAccrufer (ferric maltol) — Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age ≥10, diagnosis of iron deficiency with Hb ≤11 g/dL, ferritin ≤100 ng/mL, TSAT <20%, and trial of at least two oral iron products.

SourceLink

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Initial Therapy

Covered when ALL of the following are met:

Initial criteria

Member is 10 years or older.
Member has documented diagnosis of iron deficiency.
Iron‑deficiency anemia with Hemoglobin (Hb) ≤ 11 g/dL.
Iron indices
- Ferritin ≤ 100 ng/mL.
- Transferrin saturation (TSAT) < 20%.
Failure, contraindication, or intolerance to at least two oral iron products (e.g., ferrous gluconate, ferrous sulfate).

Continuation Therapy

Continuation of therapy:

Continuation: Refer to initial criteria for continuation of therapy.

No separate continuation criteria provided.

The source document does not list any explicit coverage exclusions. Coverage is defined by the positive approval criteria; requests that do not meet those criteria are considered not medically necessary per the policy language.

No additional coverage criteria are specified beyond the approval requirements. Denial or non‑coverage is based on failure to meet the listed criteria (for example, age < 10 years, laboratory thresholds not met, or lack of documented trials of at least two oral iron products).

Clinical Thresholds and Lab Criteria

Hemoglobin (Hb)

ThresholdHemoglobin (Hb) ≤ 11 g/dL

ContextRequired as part of documented iron deficiency anemia for initial authorization

Approval implicationAuthorization may be granted for up to 6 months when all criteria met

Ferritin

ThresholdFerritin ≤ 100 ng/mL

ContextRequired along with Hb and TSAT to define iron deficiency anemia for authorization

Role in decisionFerritin above this level may lead to denial of request

Transferrin saturation (TSAT)

ThresholdTransferrin saturation (TSAT) < 20%

ContextRequired with Hb and ferritin to establish iron deficiency anemia for approval

Decision noteTSAT ≥ 20% may disqualify member from approval

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for up to 6 months when criteria are met.

Authorization duration: up to 6 months

Step Therapy

Step Therapy / Trials Required

Failure, contraindication, or intolerance to at least two oral iron products is required prior to approval.

Required trials: >= 2 oral iron products (e.g., ferrous gluconate, ferrous sulfate)

Denial Risk

Triggers for Denial

Denial may occur if the member is under 10 years of age, if hemoglobin > 11 g/dL, if ferritin is > 100 ng/mL, if TSAT ≥ 20%, or if documentation of prior trials with ≥2 oral iron products is absent.

Age < 10 years — not eligible
Hemoglobin (Hb) > 11 g/dL — does not meet anemia criterion
Ferritin > 100 ng/mL — does not meet ferritin threshold
TSAT ≥ 20% — does not meet TSAT threshold
No documentation of failure/contraindication/intolerance to ≥2 oral iron products — may be denied

Documentation Required

Required Clinical Documentation

Document and submit evidence of member age (≥10 years), diagnosis of iron deficiency, hemoglobin, ferritin and TSAT laboratory results, and prior trials of oral iron products demonstrating failure, contraindication, or intolerance.

Minimum documentation: age, diagnosis, Hb, ferritin, TSAT, and records of ≥2 oral iron product trials

Background

Ferric maltol (Accrufer) is an oral iron formulation used to treat iron deficiency and iron deficiency anemia. Per the policy, authorization for Accrufer may be granted for up to 6 months when all approval criteria are met, including patient age ≥ 10 years, documented iron deficiency with hemoglobin ≤ 11 g/dL, ferritin ≤ 100 ng/mL, transferrin saturation (TSAT) < 20%, and documented failure, contraindication, or intolerance to at least two oral iron products (e.g., ferrous gluconate, ferrous sulfate).

OpenPayer

Accrufer (ferric maltol) — Authorization / Coverage Criteria

Coverage Criteria for Accrufer (ferric maltol)

Clinical Thresholds and Lab Criteria

Prior Authorization, Documentation, and Denial Triggers

Background

Definitions