CurrentClover HealthPolicy 5564-A

Jurisdiction Specific Medicare Part B Aranesp

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This policy governs prior authorization and medical-necessity requirements for Aranesp (darbepoetin alfa) administered under Medicare Part B for qualifying chemotherapy-related, ESRD or CKD-related, and selected lower-risk MDS anemias.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Aranesp

Policy CodePolicy 5564-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the most recent creatinine obtained within the month before initiation or the next ESA dose for ESRD or CKD therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Covered indication categories

12 monthsMaximum authorization period

6 monthsChemotherapy anemia authorization

<10 g/dL or <30%Initiation threshold

10-12 g/dL / 30-36%Continuation targets

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CurrentClover HealthPolicy 5564-A

Jurisdiction Specific Medicare Part B Aranesp

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Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Aranesp

Policy CodePolicy 5564-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the most recent creatinine obtained within the month before initiation or the next ESA dose for ESRD or CKD therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Covered indication categories

12 monthsMaximum authorization period

6 monthsChemotherapy anemia authorization

<10 g/dL or <30%Initiation threshold

10-12 g/dL / 30-36%Continuation targets

8 weeksPost-chemotherapy treatment

Covered and Excluded Uses

Anemia of End Stage Renal Disease (ESRD) in a Member on Dialysis

Authorization of 12 months may be granted for treatment of anemia of ESRD in a member on dialysis when all of the following criteria are met:

ALL of the following

Member has a diagnosis of end stage renal disease.
Hemoglobin (Hgb) is less than 10 grams per deciliter (g/dL) or hematocrit (HCT) is less than 30% at initiation of therapy.Hgb < 10 g/dL or HCT < 30%
The provider will document the most recent creatinine within the past month prior to initiation or next dosing of ESA.
Documentation is required before initiation or the next ESA dose.

Anemia of Chronic Kidney Disease (CKD) in a Member Not on Dialysis

Authorization of 12 months may be granted for treatment of anemia of CKD in a member not on dialysis when all of the following criteria are met:

ALL of the following

Hemoglobin (Hgb) is less than 10 g/dL or hematocrit (HCT) is less than 30% at initiation of therapy.Hgb < 10 g/dL or HCT < 30%
Glomerular filtration rate (GFR) is less than 45 mL/min/1.73 m².GFR < 45 mL/min/1.73 m²
The provider will document the most recent creatinine within the past month prior to initiation or next dosing of ESA.
Documentation is required before initiation or the next ESA dose.

Anemia Due to Chemotherapy in Members with Non-Myeloid Malignancies

Authorization of 6 months may be granted for treatment of anemia due to chemotherapy in members with non-myeloid malignancies when all of the following criteria are met:

ALL of the following

Member has a diagnosis of a non-myeloid malignancy, including a solid tumor, multiple myeloma, lymphoma, or lymphocytic leukemia.
Hgb level immediately prior to initiation of ESA treatment is less than 10 g/dL or HCT is less than 30%.Hgb < 10 g/dL or HCT < 30%
ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.8 weeks after final dose

Anemia Related to Myelodysplastic Syndrome (MDS)

Authorization of 12 weeks may be granted for treatment of anemia in members with MDS when all of the following criteria are met:

ALL of the following

Member has a diagnosis of MDS confirmed by bone marrow aspiration and/or biopsy report.
Hgb is less than 10 g/dL or HCT is less than 30% at initiation of therapy.Hgb < 10 g/dL or HCT < 30%
ONE of the following risk classifications
- Revised International Prognostic Scoring System (IPSS-R) score correlating to very low or low risk.
- IPSS-R correlating to a low-score intermediate risk.

Continuation: Renal Anemia

Authorization of 12 months may be granted for continuation of therapy for anemia of ESRD in a member on dialysis or anemia of CKD in a member not on dialysis when both of the following criteria are met:

ALL of the following

The goal of therapy is to maintain a stable Hgb and HCT, with target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
The provider will document the most recent creatinine within the past month prior to the next dosing of ESA.
Documentation is required before the next ESA dose.

Continuation: Chemotherapy-Related Anemia

Authorization of 6 months may be granted for continuation of therapy for anemia due to chemotherapy in members with non-myeloid malignancies when all of the following criteria are met:

ALL of the following

Hgb is less than 10 g/dL or HCT is less than 30%.Hgb < 10 g/dL or HCT < 30%
ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.8 weeks after final dose

Continuation: MDS-Related Anemia

Authorization of 12 months may be granted for continuation of therapy for anemia related to MDS when both of the following criteria are met:

ALL of the following

The goal of therapy is to maintain a stable Hgb and HCT, with target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
ESAs should not be continued for more than twelve weeks if no response is observed.≤ 12 weeks without response

Coverage will not be provided for members with any of the following exclusions:

Any anemia in cancer or cancer treatment patients due to folate deficiency, vitamin B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis.

Anemia associated with the treatment of acute or chronic myelogenous leukemias (CML or AML), or erythroid cancers.

Anemia of cancer not related to cancer treatment.

Anemia associated only with radiotherapy.

Prophylactic use to prevent chemotherapy-induced anemia.

Prophylactic use to reduce tumor hypoxia.

Patients with erythropoietin (EPO)-type resistance due to neutralizing antibodies.

Non-ESRD erythropoiesis-stimulating agent (ESA) services in the context of other medical conditions for which resolution would reasonably be expected before starting or continuing ESA administration, including iron, vitamin B12, or folate deficiencies; glucose-6-phosphate dehydrogenase (G6PD) deficiency; pyridoxine deficiency; various forms of hemolysis; hereditary spherocytosis; and pure red cell aplasias.

ESA use in the context of uncontrolled hypertension.

ESA use to replace red blood cell (RBC) transfusions in members who need immediate urgent correction of anemia.

Maintenance of ESA therapy is the starting dose if the Hgb level remains below 10 g/dL or HCT remains less than 30% 4 weeks after initiation of therapy and the rise in Hgb is greater than or equal to 1 g/dL or the HCT rise is greater than or equal to 3%.

For patients whose Hgb rises less than 1 g/dL or HCT rises less than 3% compared with pretreatment baseline over 4 weeks of treatment, and whose Hgb remains less than 10 g/dL or HCT remains less than 30% after 4 weeks of treatment, the recommended FDA label starting dose may be increased once by 25%. Continued use of the drug is not reasonable and necessary if the Hgb rises less than 1 g/dL or HCT rises less than 3% compared with pretreatment baseline by 8 weeks of treatment.

Continued administration of the drug is not reasonable and necessary if there is a rapid rise in Hgb greater than 1 g/dL or HCT greater than 3% over 2 weeks of treatment, unless the Hgb remains below or subsequently falls to less than 10 g/dL or the HCT is less than 30%. Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose.

For all other indications, the starting dose and subsequent dose adjustments must be in accordance with FDA-approved labeling or dosing provided in Billing and Coding: Erythropoiesis Stimulating Agents (A58982) or LCD - Erythropoiesis Stimulating Agents (L39237). Doses must be titrated according to the patient's response.

Clinical Thresholds and Response Measures

Initiation hemoglobin or hematocrit threshold

Hemoglobin criterionHgb less than 10 g/dL at initiation of therapy.

Hematocrit criterionHCT less than 30% at initiation of therapy.

Applicable indicationsThe initiation threshold applies to anemia related to ESRD, nondialysis CKD, chemotherapy in non-myeloid malignancies, and MDS.

Nondialysis CKD GFR threshold

GFR thresholdGFR must be less than 45 mL/min/1.73 m².

PopulationApplies to members with CKD who are not on dialysis.

Required accompanying threshold

Authorization and Documentation Requirements

Prior Authorization

ESRD on Dialysis: 12-Month Authorization

Prior authorization may be approved for 12 months for anemia of ESRD in a member on dialysis when all qualifying conditions are met.

Diagnosis of end-stage renal disease.
Hemoglobin (Hgb) 10 g/dL or hematocrit (HCT) <30% at initiation of therapy.
Document the most recent creatinine within the month before initiation or the next ESA dose.

Prior Authorization

Nondialysis CKD: 12-Month Authorization

Prior authorization may be approved for 12 months for anemia of CKD in a member who is not on dialysis when all qualifying conditions are met.

Hgb 10 g/dL or HCT <30% at initiation of therapy.
Glomerular filtration rate (GFR) 45 mL/min/1.73 m².
Document the most recent creatinine within the month before initiation or the next ESA dose.

Policy Background

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent (ESA) that increases red blood cell production. This Medicare Part B policy addresses ESA therapy for anemia associated with ESRD or advanced CKD, chemotherapy for non-myeloid malignancies, and selected lower-risk myelodysplastic syndromes. Before initiation or continuation, correctable causes of anemia should be addressed, and hemoglobin and hematocrit response must be monitored to support ongoing medical necessity.

Key Clinical Definitions

Chemotherapy-related anemia

Underlying malignancyOccurs in patients with non-myeloid malignancies, including solid tumors, multiple myeloma, lymphoma, or lymphocytic leukemia.

CauseThe anemia is specifically due to concomitantly administered chemotherapy.

Treatment contextESA treatment is associated with a chemotherapy regimen that includes myelosuppressive therapy.

Renal-related anemia

Dialysis-related definitionAnemia associated with end-stage renal disease in a member on dialysis.

Nondialysis definitionAnemia associated with chronic kidney disease in a member who is not on dialysis.

Initial Therapy Requirements

Initial Therapy: ESRD on Dialysis

Initial therapy requires ALL of the following:

ESRD on dialysis initial therapy

Diagnosis: Member has a diagnosis of end-stage renal disease and is on dialysis.
Initiation laboratory threshold: Hemoglobin is less than 10 g/dL or hematocrit is less than 30% at initiation of therapy.Hgb <10 g/dL or HCT <30%
Recent creatinine: The most recent creatinine is documented within the month before initiation or the next ESA dose.Creatinine within 1 month

Continuation Therapy Requirements

Renal Anemia Continuation

Continuation for ESRD on dialysis or nondialysis CKD requires ALL of the following:

Renal anemia continuation

Stable laboratory targets: The goal of therapy is to maintain stable Hgb and HCT within target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
Recent creatinine: The most recent creatinine is documented within the month before the next ESA dose.Creatinine within 1 month

Chemotherapy-Related Anemia Continuation

Continuation for chemotherapy-related anemia requires ALL of the following:

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Aranesp

Policy CodePolicy 5564-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the most recent creatinine obtained within the month before initiation or the next ESA dose for ESRD or CKD therapy.

SourceLink

On This Page

International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk.

WHO (World Health Organization) Prognostic Scoring System (WPSS) score of very low, low, or intermediate risk.

Pretreatment erythropoietin (EPO) is less than or equal to 500 milliunits per milliliter (mU/mL).EPO ≤ 500 mU/mL

ONE of the following MDS cytogenetic or treatment conditions

MDS without del(5q).
MDS with del(5q) and no chromosome 7-associated abnormalities, on or before starting lenalidomide.

Member has documented anemia-related symptoms such as fatigue, pallor, infection, bleeding, or bruising, or is transfusion dependent.

Documentation supports a reasonable expectancy of longer survival with a reduced need for transfusion support.

Hgb must be less than 10 g/dL or HCT less than 30% at initiation of therapy.

Pretreatment EPO threshold

Pretreatment EPO thresholdEPO must be less than or equal to 500 mU/mL.

Applicable conditionApplies to anemia related to qualifying myelodysplastic syndrome (MDS).

TimingThe EPO level must be assessed before treatment.

Continuation hemoglobin and hematocrit targets

Hemoglobin targetMaintain stable Hgb at 10–12 g/dL.

Hematocrit targetMaintain stable HCT at 30–36%.

Applicable continuation settingsApplies to continuation therapy for ESRD or nondialysis CKD anemia and MDS-related anemia.

Chemotherapy response at 4 weeks

Assessment time pointAssess response 4 weeks after initiation of therapy.

Required riseHgb must rise by at least 1 g/dL or HCT by at least 3%.

Remaining anemia thresholdHgb must remain below 10 g/dL or HCT below 30%.

Inadequate response at 8 weeks

Assessment time pointEvaluate response by 8 weeks of treatment.

Inadequate hemoglobin responseHgb rises less than 1 g/dL from the pretreatment baseline.

Inadequate hematocrit responseHCT rises less than 3% from the pretreatment baseline.

Excessive or rapid response over 2 weeks

Assessment intervalEvaluate for a rapid response over 2 weeks of treatment.

Rapid hemoglobin riseHgb rises more than 1 g/dL.

Rapid hematocrit riseHCT rises more than 3%.

Prior Authorization

Chemotherapy-Related Anemia: 6-Month Authorization

Prior authorization may be approved for 6 months for anemia due to chemotherapy in a member with a non-myeloid malignancy when all qualifying conditions are met.

Diagnosis of a non-myeloid malignancy, including a solid tumor, multiple myeloma, lymphoma, or lymphocytic leukemia.
Hgb immediately before ESA initiation 10 g/dL or HCT <30%.
Each chemotherapy course includes ESA treatment through the 8 weeks following the final dose of myelosuppressive chemotherapy in the regimen.

Unsupported block type: prior_auth triage

Unsupported block type: documentation

Denial Risk

Excluded Anemia Causes and Uses

Coverage will be denied when anemia is attributable to excluded causes or when ESA use is for an excluded purpose or condition.

Cancer or cancer-treatment anemia due to folate, B12, or iron deficiency; hemolysis; bleeding; or bone marrow fibrosis.
Anemia associated with CML, AML, erythroid cancers, cancer unrelated to treatment, or radiotherapy alone.
Prophylactic use to prevent chemotherapy-induced anemia or reduce tumor hypoxia.
EPO-type resistance from neutralizing antibodies; uncontrolled hypertension; or use to replace RBC transfusion when immediate urgent correction is required.
Non-ESRD ESA services for conditions reasonably expected to resolve before ESA therapy, including iron, B12, folate, G6PD, or pyridoxine deficiency; hemolysis; hereditary spherocytosis; and pure red cell aplasia.

Denial Risk

Inadequate or Excessive Response

Do not continue ESA administration when the member has an inadequate or excessive response under the policy’s response thresholds.

If Hgb rises 1 g/dL or HCT rises 3% from pretreatment baseline over 4 weeks while Hgb remains <10 g/dL or HCT remains <30%, the FDA-labeled starting dose may be increased once by 25%.
Continued use is not reasonable and necessary if the Hgb rise remains <1 g/dL or HCT rise remains <3% by 8 weeks of treatment.
Continued administration is not reasonable and necessary after a rapid Hgb rise >1 g/dL or HCT rise >3% over 2 weeks unless Hgb remains or subsequently falls below 10 g/dL or HCT below 30%; continuation or reinstitution requires a 25% dose reduction.

Denial Risk

No Response in MDS: Stop Beyond 8 Weeks

For MDS, ESA therapy should not continue beyond the specified response period when there is no adequate hematologic response.

If Hgb rises 1 g/dL or HCT rises 3% from pretreatment baseline by 8 weeks of treatment, continued ESA use is not reasonable and necessary.
Do not extend therapy solely because the member remains anemic when the required response has not occurred.

The policy identifies covered renal anemia related to ESRD and CKD stages IIIb, IV, and V.

Qualifying MDS

Confirmed diagnosisMDS must be confirmed by a bone marrow aspiration and/or biopsy report.

Prognostic riskQualifying classifications include IPSS-R very low or low risk, IPSS-R low-score intermediate risk, IPSS low or intermediate-1 risk, or WHO WPSS very low, low, or intermediate risk.

Cytogenetic requirementMDS must be without del(5q), or must have del(5q) without chromosome 7-associated abnormalities on or before starting lenalidomide.

Initial Therapy: Nondialysis CKD

Initial therapy requires ALL of the following:

Nondialysis CKD initial therapy

Initiation laboratory threshold: Hemoglobin is less than 10 g/dL or hematocrit is less than 30% at initiation of therapy.Hgb <10 g/dL or HCT <30%
Kidney function: Glomerular filtration rate is less than 45 mL/min/1.73 m².GFR <45 mL/min/1.73 m²
Recent creatinine: The most recent creatinine is documented within the month before initiation or the next ESA dose.Creatinine within 1 month

Initial Therapy: Chemotherapy-Related Anemia

Initial therapy requires ALL of the following:

Chemotherapy-related anemia initial therapy

Malignancy: Member has a non-myeloid malignancy, including a solid tumor, multiple myeloma, lymphoma, or lymphocytic leukemia.
Initiation laboratory threshold: Hgb immediately before initiation of ESA treatment is less than 10 g/dL or HCT is less than 30%.Hgb <10 g/dL or HCT <30%
Treatment duration: ESA treatment for each chemotherapy course includes the 8 weeks following the final dose of myelosuppressive chemotherapy in the regimen.8 weeks after final dose

Initial Therapy: MDS

Initial therapy requires ALL of the following, with one qualifying option from each applicable alternative group:

MDS-related anemia initial therapy

Confirmed diagnosis: MDS is confirmed by bone marrow aspiration and/or biopsy report.
Initiation laboratory threshold: Hgb is less than 10 g/dL or HCT is less than 30% at initiation of therapy.Hgb <10 g/dL or HCT <30%
ONE qualifying prognostic-risk classification
- IPSS-R very low or low risk: Revised IPSS-R score correlates to very low or low risk.
- IPSS-R low-score intermediate risk: IPSS-R correlates to a low-score intermediate risk.
- IPSS low or intermediate-1 risk: IPSS score is low or intermediate-1 risk.
- WPSS very low through intermediate risk: WHO WPSS score is very low, low, or intermediate risk.
Pretreatment EPO: Pretreatment erythropoietin is less than or equal to 500 mU/mL.≤500 mU/mL
ONE qualifying cytogenetic condition
- Without del(5q): MDS is without del(5q).
- With del(5q): MDS has del(5q) and no chromosome 7-associated abnormalities, on or before starting lenalidomide.
Clinical impact: Anemia-related symptoms, such as fatigue, pallor, infection, bleeding, or bruising, or transfusion dependence are documented.
Expected benefit: Documentation supports a reasonable expectancy of longer survival with a reduced need for transfusion support.

Chemotherapy-related anemia continuation

Persistent anemia: Hgb remains less than 10 g/dL or HCT remains less than 30%.Hgb <10 g/dL or HCT <30%
Treatment duration: ESA treatment for each chemotherapy course includes the 8 weeks following the final dose of myelosuppressive chemotherapy in the regimen.8 weeks after final dose

MDS Continuation

Continuation for MDS requires ALL of the following:

MDS continuation

Stable laboratory targets: The goal of therapy is to maintain stable Hgb and HCT within target ranges of 10–12 g/dL and 30–36%, respectively.Hgb 10–12 g/dL; HCT 30–36%
Response assessment: ESAs should not be continued for more than 12 weeks if no response is observed.Maximum 12 weeks without response