CurrentAgency for Health Care AdministrationPolicy N/A

Accrufer (ferric maltol) Prior Authorization Criteria

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This policy governs prior authorization for Accrufer capsules for adults with iron deficiency anemia associated with inflammatory bowel disease or non-dialysis-dependent chronic kidney disease. It establishes initial authorization, continuation, documentation, laboratory, and oral iron trial requirements.

Policy Summary

PayerAgency for Health Care Administration

PolicyAccrufer (ferric maltol) Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit official laboratory results drawn within 30 days before prior authorization submission and document failure or intolerance of at least two specified oral iron therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum patient age

3 monthsInitial authorization

12 monthsContinuation authorization

2 requiredPrior oral iron therapies

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CurrentAgency for Health Care AdministrationPolicy N/A

Accrufer (ferric maltol) Prior Authorization Criteria

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Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyAccrufer (ferric maltol) Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit official laboratory results drawn within 30 days before prior authorization submission and document failure or intolerance of at least two specified oral iron therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+ yearsMinimum patient age

3 monthsInitial authorization

12 monthsContinuation authorization

2 requiredPrior oral iron therapies

Coverage Criteria

Initial Therapy Criteria

Covered for initial therapy when all of the following are met.

Initial therapy

Age: Patient is at least 18 years of age.≥ 18 years
Qualifying iron deficiency anemia diagnosis
- Inflammatory bowel disease: Patient has inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, with the applicable baseline hemoglobin and serum ferritin results.Women: hemoglobin 9.5–12 g/dL; men: hemoglobin 9.5–13 g/dL; serum ferritin < 30 mcg/L
  Official laboratory results drawn within 30 days of prior authorization submission are required.
- Non-dialysis-dependent chronic kidney disease: Patient has non-dialysis-dependent chronic kidney disease with the applicable baseline hemoglobin and either qualifying ferritin/transferrin saturation combination.Hemoglobin 8–11 g/dL; serum ferritin < 250 mcg/L with TSAT < 25% OR serum ferritin < 500 mcg/L with TSAT < 15%
  Official laboratory results drawn within 30 days of prior authorization submission are required.
Prior oral iron therapy: Patient has documented trial and failure of at least two specified oral iron therapies due to lack of efficacy or inability to tolerate oral iron replacement products.At least 2 therapies
Qualifying therapies are ferrous sulfate, ferrous gluconate, ferrous fumarate, and iron polysaccharide complex.
Concurrent iron treatment: Patient will not receive intravenous iron supplementation while taking Accrufer.No concurrent IV iron

Continuation Therapy Criteria

Covered for continuation therapy when all of the following are met.

Continuation therapy

Initial criteria previously met: Patient met the initial review criteria.
Clinical response: Documentation demonstrates improved clinical response compared with baseline laboratory results.Improvement from baseline
Supporting documentation and official laboratory results are required.
Safety: Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects

The patient will not receive IV iron supplementation while taking Accrufer.

Clinical and Laboratory Parameters

Inflammatory Bowel Disease Baseline Hemoglobin

ConditionInflammatory bowel disease

Patient groupWomen

Baseline hemoglobin9.5 g/dL to 12 g/dL

Inflammatory Bowel Disease Baseline Hemoglobin

ConditionInflammatory bowel disease

Patient groupMen

Baseline hemoglobin9.5 g/dL to 13 g/dL

Authorization and Documentation Requirements

Prior Authorization

Initial Authorization Requirements

Prior authorization is required for Accrufer in adults with iron deficiency anemia associated with qualifying inflammatory bowel disease or non-dialysis-dependent chronic kidney disease. The initial review criteria below must be documented before authorization can be approved.

Patient must be ≥ 18 years of age.
A qualifying diagnosis and required baseline laboratory results must be submitted.
At least two specified oral iron therapies must have been tried and failed.
Accrufer must not be used concurrently with IV iron supplementation.

Prior Authorization

Continuation Authorization Requirements

Continuation authorization requires that the patient met the initial review criteria and demonstrates an improved clinical response compared with baseline laboratory results. Supporting documentation and official laboratory results are required.

Patient must have met the initial authorization criteria.

Policy Background

Accrufer (ferric maltol) is an oral iron replacement product available as 30 mg capsules. This policy applies to adults with iron deficiency anemia associated with inflammatory bowel disease or non-dialysis-dependent chronic kidney disease when specified laboratory thresholds are met and prior oral iron therapies have failed or were not tolerated.

Accrufer Initial Authorization

Initial therapy requires all applicable criteria.

Accrufer initial authorization

Age: Patient is at least 18 years of age.≥ 18 years
Qualifying iron deficiency anemia diagnosis
- Inflammatory bowel disease: Patient has inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, with baseline hemoglobin of 9.5–12 g/dL for women or 9.5–13 g/dL for men and serum ferritin less than 30 mcg/L.Women: hemoglobin 9.5–12 g/dL; men: hemoglobin 9.5–13 g/dL; serum ferritin < 30 mcg/L
  Official laboratory results drawn within 30 days of prior authorization submission are required.

Accrufer Continuation Authorization

Accrufer Continuation

Continuation requires all listed conditions.

Accrufer continuation

Initial criteria previously met: Patient met the initial review criteria.
Improved clinical response: Documentation demonstrates improved clinical response compared with baseline laboratory results.Improvement from baseline
Supporting documentation and official laboratory results are required.
Treatment safety: Patient has not experienced any treatment-restricting adverse effects.No treatment-restricting adverse effects

Required Oral Iron Trial

Step	Requirement	Failure criteria
1
Documented trial and failure of at least two of the following oral iron therapies: ferrous sulfate, ferrous gluconate, ferrous fumarate, or iron polysaccharide complex
Lack of efficacy or inability to tolerate oral iron replacement products

Policy Summary

PayerAgency for Health Care Administration

PolicyAccrufer (ferric maltol) Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit official laboratory results drawn within 30 days before prior authorization submission and document failure or intolerance of at least two specified oral iron therapies.

SourceLink

On This Page

Dosing is appropriate according to product labeling or is supported by compendia.Labeling- or compendia-supported dosing

Inflammatory Bowel Disease Serum Ferritin

ConditionInflammatory bowel disease

Laboratory testSerum ferritin

Threshold< 30 mcg/L

Chronic Kidney Disease Baseline Hemoglobin

ConditionNon-dialysis-dependent chronic kidney disease

Laboratory testBaseline hemoglobin

Threshold8 g/dL to 11 g/dL

Chronic Kidney Disease Ferritin and TSAT

ConditionNon-dialysis-dependent chronic kidney disease

Serum ferritin< 250 mcg/L

Transferrin saturation (TSAT)< 25%

Chronic Kidney Disease Ferritin and TSAT

ConditionNon-dialysis-dependent chronic kidney disease

Serum ferritin< 500 mcg/L

Transferrin saturation (TSAT)< 15%

Laboratory Recency

Laboratory documentationOfficial laboratory results are required

TimingDrawn within 30 days before prior authorization submission

PurposeConfirm the applicable baseline laboratory criteria

Documentation of improved clinical response compared with baseline is required.

The patient must not have experienced treatment-restricting adverse effects.

Dosing must be consistent with labeling or supported by compendia.

Unsupported block type: documentation自

Documentation Required

Baseline Laboratory Documentation

Submit official baseline laboratory results drawn within 30 days before the prior authorization submission. The results must confirm the applicable hemoglobin, ferritin, and, when required, transferrin saturation criteria.

For inflammatory bowel disease: baseline hemoglobin 9.5–12 g/dL for women or 9.5–13 g/dL for men, with serum ferritin <30 mcg/L.
For non-dialysis-dependent CKD: baseline hemoglobin 8–11 g/dL, with serum ferritin <250 mcg/L and TSAT <25%, or ferritin <500 mcg/L and TSAT <15%.

Documentation Required

Iron Deficiency Anemia With Qualifying Disease

Document a diagnosis of iron deficiency anemia associated with either qualifying inflammatory bowel disease or non-dialysis-dependent chronic kidney disease.

Inflammatory bowel disease may include Crohn's disease or ulcerative colitis.
The patient must be non-dialysis-dependent if the qualifying diagnosis is chronic kidney disease.

Step Therapy

Two Prior Oral Iron Therapies Required

Document a trial and failure of at least two specified oral iron therapies because of lack of efficacy or inability to tolerate oral iron replacement products.

Ferrous sulfate
Ferrous gluconate
Ferrous fumarate
Iron polysaccharide complex

Documentation Required

Continuation Response Documentation

For continuation authorization, submit supporting documentation and official laboratory results showing an improved clinical response compared with the patient's baseline laboratory results.

The response must be compared with documented baseline results.
Documentation must also show no treatment-restricting adverse effects.
Dosing must be appropriate under product labeling or supported by compendia.

Denial Risk

Nonqualifying Patient or Diagnosis

Authorization may be denied when the patient does not meet the adult-age requirement or when the diagnosis is not iron deficiency anemia associated with a qualifying inflammatory bowel disease or non-dialysis-dependent chronic kidney disease.

Patient is younger than 18 years of age.
Diagnosis is not qualifying inflammatory bowel disease or non-dialysis-dependent CKD.
Required diagnosis-specific laboratory criteria are not documented.

Denial Risk

Insufficient Prior Oral Iron Therapy

Authorization may be denied when documentation does not show trial and failure of at least two specified oral iron therapies due to lack of efficacy or inability to tolerate oral iron replacement products.

The two documented therapies must be selected from ferrous sulfate, ferrous gluconate, ferrous fumarate, or iron polysaccharide complex.
Failure or intolerance must be documented for each therapy.

Denial Risk

Concurrent IV Iron Supplementation

Accrufer is not authorized for use with concurrent IV iron supplementation. Confirm that the patient will not receive IV iron while taking Accrufer.

Concurrent IV iron supplementation is a denial condition.

Denial Risk

Continuation Criteria Not Met

Continuation authorization may be denied when the patient did not meet the initial review criteria or when improved clinical response compared with baseline is not documented.

Missing supporting documentation or official laboratory results showing improvement may result in denial.
Treatment-restricting adverse effects may prevent continuation.
Dosing that is not consistent with labeling or supported by compendia may prevent continuation.

Non-dialysis-dependent chronic kidney disease: Patient has non-dialysis-dependent chronic kidney disease with baseline hemoglobin of 8–11 g/dL and either serum ferritin less than 250 mcg/L with TSAT less than 25% or serum ferritin less than 500 mcg/L with TSAT less than 15%.Hemoglobin 8–11 g/dL; serum ferritin < 250 mcg/L with TSAT < 25% OR serum ferritin < 500 mcg/L with TSAT < 15%

Official laboratory results drawn within 30 days of prior authorization submission are required.

Prior oral iron therapy: Patient has documented trial and failure of at least two of the following oral iron therapies due to lack of efficacy or inability to tolerate oral iron replacement products: ferrous sulfate, ferrous gluconate, ferrous fumarate, or iron polysaccharide complex.At least 2 therapies

Concurrent iron treatment: Patient will not receive IV iron supplementation while taking Accrufer.No concurrent IV iron

Dosing is appropriate according to product labeling or is supported by compendia.Labeling- or compendia-supported dosing