Anthem Blue Cross California Iron Agents Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of injectable agents for the treatment of iron deficiency anemia (IDA). Agents addressed in this document include: • Feraheme (ferumoxytol) • Ferrlecit (sodium ferric gluconate/sucrose complex) • Infed (iron dextran) • Injectafer (ferric carboxymaltose) • Monoferric (ferric derisomaltose) • • Venofer (iron sucrose) Triferic, Triferic AVNU (ferric pyrophosphate citrate) Iron is a mineral in the body that is an essential component for blood production, enabling them to carry oxygen throughout the body. The majority of body iron are found in circulating red blood cells called hemoglobin, while the remaining is stored as ferritin or bound to myoglobin in muscle cells. Individuals with iron deficiency anemia may have mild to severe symptoms, ranging from fatigue, shortness of breath, and chest pain to heart failure and developmental delays in children (NHLBI 2019). The causes of iron deficiency anemia are numerous, including gastrointestinal bleeding or other blood loss, chronic kidney disease, celiac disease, multiple blood donations, and cancer or chemotherapy related. Diagnosis of IDA is typically confirmed by evaluating levels of serum ferritin, transferrin saturation (TSAT), absence of stainable iron in the bone marrow, or resolution of anemia upon iron administration (Auerbach 2020). While the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines for anemia in chronic kidney disease do not provide any guidance on preference of available IV iron agents over another, they do suggest that a trial oral iron for 1 to 3 months can be appropriate for individuals with IDA prior to initiating IV iron. The National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Growth Factors (version 2.2020) provides a category 2A recommendation for use of Feraheme, Ferrlecit, Infed (IV only; IM not recommended), Injectafer, and Venofer for the management of cancer- and chemotherapy-induced anemia. NCCN had yet to incorporate the use of Monoferric in its guidelines at the time of this review. NCCN also suggests that a trial oral iron for at least 4 weeks can be appropriate prior to initiating IV iron. Both Feraheme and Infed have black box warnings for fatal and serious hypersensitivity reactions including anaphylaxis, and as such, the administration of which should only occur when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Summary of FDA-approved and NCCN 2A recommended indications for agents for Iron Deficiency Anemia (IDA): Agent Feraheme (ferumoxytol) Ferrlecit (sodium ferric gluconate/sucrose complex) Infed (iron dextran) Injectafer (ferric carboxymaltose) Monoferric (ferric derisomaltose) Route IV IV IV, IM IV IV Oral iron intolerant or unresponsive IDA CKD x x* x x x x x Dialysis- dependent CKD only x* NCCN x x x (IV only) x 1 Triferic, Triferic AVNU (ferric pyrophosphate citrate) Venofer (iron sucrose) IV IV *Includes FDA-approved pediatric indication x x* x Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate/sucrose complex), Infed (iron dextran), Injectafer (ferric carboxymaltose), Venofer (iron sucrose) Requests for Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate/sucrose complex), Infed (iron dextran), Injectafer (ferric carboxymaltose), Venofer (iron sucrose) may be approved if the following criteria are met: I. Individual has a diagnosis of chronic kidney disease (CKD); AND A. Individual is dialysis dependent; OR II. III. IV. Individual has a diagnosis of iron deficiency anemia (IDA); AND Individual is non-dialysis dependent; AND Diagnosis is confirmed by one of the following: A. For IDA associated with CKD or inflammatory conditions (for example, inflammatory bowel disease [IBD], heart failure), individual meets one of the following (De Franceschi 2017): 1. Serum ferritin levels less than 100 ng/mL; OR 2. TSAT levels less than 20%; OR 3. Serum ferritin is less than or equal to 500 ng/mL and TSAT is less than or equal to 30% (KDIGO 2012); OR 4. Bone marrow demonstrates inadequate iron stores; OR B. For IDA associated with cancer/chemotherapy or non-inflammatory conditions (for example, blood loss, malabsorption, malnutrition), individual meets one of the following (NCCN 2020, De Franceschi 2017): 1. Serum ferritin levels less than 30 ng/mL; OR 2. TSAT levels less than 20%; OR 3. Bone marrow demonstrates inadequate iron stores; AND V. Individual has had a four (4) week trial of and inadequate response, or intolerance to oral iron supplementation (NCCN 2020, KDIGO 2012). Requests for Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate/sucrose complex), Infed (iron dextran), Injectafer (ferric carboxymaltose), or Venofer (iron sucrose) may not be approved when the above criteria are not met and for all other indications. Approval Duration (dialysis-dependent use excluded) Initial requests: 3 months Continuation requests: 3 months Monoferric (ferric derisomaltose) Requests for Monoferric (ferric derisomaltose) may be approved if the following criteria are met: I. II. III. Individual has a diagnosis of iron deficiency anemia (IDA); AND Individual is non-dialysis dependent; AND Diagnosis is confirmed by one of the following: A. For IDA associated with CKD or inflammatory conditions (for example, inflammatory bowel disease [IBD], heart failure), individual meets one of the following (De Franceschi 2017): 1. Serum ferritin levels less than 100 ng/mL; OR 2. TSAT levels less than 20%; OR 3. Serum ferritin is less than or equal to 500 ng/mL and TSAT is less than or equal to 30% (KDIGO 2012); OR 4. Bone marrow demonstrates inadequate iron stores; OR B. For IDA associated with cancer/chemotherapy or non-inflammatory conditions (for example, blood loss, malabsorption, malnutrition), individual meets one of the following (NCCN 2020, De Franceschi 2017): 1. Serum ferritin levels less than 30 ng/mL; OR 2. TSAT levels less than 20%; OR 3. Bone marrow demonstrates inadequate iron stores; AND IV. Individual has had a four (4) week trial of and inadequate response, or intolerance to oral iron supplementation (NCCN 2020, KDIGO 2012). 2 Requests for Monoferric (ferric derisomaltose) may not be approved when the above criteria are not met and for all other indications Approval Duration (dialysis-dependent use excluded) Initial requests: 3 months Continuation requests: 3 months Triferic/Triferic AVNU (ferric pyrophosphate citrate) Requests for Triferic/Triferic AVNU (ferric pyrophosphate citrate) may be approved if the following criteria are met: I. Individual has a diagnosis of chronic kidney disease (CKD); AND A. Individual is hemodialysis dependent. Requests for Triferic/Triferic AVNU (ferric pyrophosphate citrate) may not be approved for the following: Peritoneal dialysis; OR I. II. When the above criteria are not met and for all other indications. Step Therapy Note: When an IDA agent is deemed approvable based on the clinical criteria above, the benefit plan may have additional criteria requiring the use of a preferred1 agent or agents. Non-Preferred Iron Deficiency Anemia (IDA) Step Therapy A list of the preferred iron deficiency anemia agents is available here. Requests for a non-preferred agent for IDA may be approved when the following criteria are met: I. Individual has had a trial and inadequate response or intolerance to two (2) preferred agents; OR II. OR III. The preferred agent(s) are not acceptable due to concomitant clinical conditions, including but not limited to known hypersensitivity to any active or inactive component which is not also associated with the requested non-preferred agent; Individual is dialysis-dependent and using iron in conjunction with dialysis. 1Preferred, as used herein, refers to agents that were deemed to be clinically comparable to other agents in the same class or disease category but are preferred based upon clinical evidence and cost effectiveness. Quantity Limits Iron Deficiency Anemia Agents Quantity Limits Drug Limit Feraheme (ferumoxytol) 510 mg/17 mL vial* Ferrlecit (sodium ferric gluconate/sucrose complex) 62.5 mg/5 mL vial* Injectafer (ferric carboxymaltose) 750 mg/15 mL vial* Monoferric (ferric derisomaltose) 100 mg/mL vial* Monoferric (ferric derisomaltose) 500 mg/5 mL vial* Monoferric (ferric derisomaltose) 1000 mg/10 mL vial* Venofer (iron sucrose) 50 mg/2.5 mL vial* Venofer (iron sucrose) 100 mg/5 mL vial* Venofer (iron sucrose) 200 mg/10 mL vial* 2 vials per 6 days‡ 16 vials per 8 weeksΔ 2 vials per 14 days‡ 4 vials per day 1 vial per day 1 vial per day ‡ 6 vials per 12 weeks 3 vials per 12 weeks 5 vials per 14 days‡ Override Criteria 3 *Use in dialysis-dependent individuals excluded from quantity limits. ‡Limit represents FDA-approved maximum dose recommendations per course of therapy (excluding dialysis-dependent diagnosis). ΔLimit according to NCCN guidelines for hematopoietic growth factors (v2.2020). Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J1443 J1437 Q0138 J2916 J1750 J1756 J1439 Injection, ferric pyrophosphate citrate solution, 0.1 mg of iron [Triferic] Injection, ferric derisomaltose, 10 mg [Monoferric] Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (for non-ESRD on dialysis) [Feraheme] Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg [Ferrlecit] Injection, iron dextran, 50 mg [Infed] Injection, iron sucrose, 1 mg [Venofer] Injection, ferric carboxymaltose, 1 mg [Injectafer] ICD-10 Diagnosis D50.0-D50.9 D63.0-D63.8 D64.81 Iron deficiency anemia Anemia in chronic diseases classified elsewhere Anemia due to antineoplastic chemotherapy K50.00-K50.919 Crohn‘s disease [regional enteritis] K90.0-K90.9 Celiac disease N18.1-N18.5 Chronic kidney disease, stages I-V Document History New: 08/21/2020