Treatment adherence of single and multidose IV irons in patients with IDA: Results of 4 real-world studies

A retrospective analysis of claims data using the KOMODO’s Healthcare Map was performed to examine how adherence varies among different IV iron regimens, with a 1000-mg reference dose, for the treatment of patients with IDA. Adherence associated with IV iron products in US adults with IDA was analyzed across four separate study populations. The studies did not consider inter-product differentiation by clinical safety and efficacy.

IV iron therapy 6-week adherence in US adults, unadjusted: Results from 4 studies2‑5,a

Study limitations: Data is based on a retrospective analysis of 4 sets of claims data from the KOMODO database.

FCM=ferric carboxymaltose; FG=ferric gluconate; FXT=ferumoxytol; ID=iron dextran; HF=heart failure; IDA=iron deficiency anemia; IS=iron sucrose; IV=intravenous; NDD-CKD=nondialysis-dependent chronic kidney disease..

a Based on the recommended dosing in the Prescribing Information. Number of prescribed infusions can vary.
b May be administered as a single-dose infusion for patients weighing 50 kg or more.
c May require up to 8 weeks to receive 1000 mg of iron.

Retrospective analyses for IV iron adherence in IDA patients across multiple disease states

A retrospective analysis of claims data using the KOMODO’s Healthcare Map was performed to examine how adherence varies among different IV iron regimens, with a 1000-mg reference dose, for the treatment of patients with IDA. Adherence associated with IV iron products in US adults with IDA was analyzed across four separate study populations. The studies did not consider inter-product differentiation by clinical safety and efficacy.

Primary objective

Quantify the rates of adherence to IV iron therapies

Adherence

  • Cumulative 6-week dose ≥1000 mg of iron

Inclusion criteria

  • Treatment with an IV iron product on or after January 1, 2020
  • A diagnosis of IDA (ICD10-CM: D50.0, D50.8, D50.9, E61.1) in the baseline period
  • Age ≥18 years on date of first IV iron infusion
  • Continuous enrollment with both medical and pharmacy coverage in the baseline period, as well as 6 months following the first IV iron infusion (follow-up period)
  • Oncology adherence study: primary diagnosis of cancer (ICD-10-CM: C00-D49)
  • NDD-CKD adherence study: NDD-CKD diagnosis (ICD-10-CM: N18.1x-N18.5x)
  • HF adherence study: HF diagnosis (ICD-10-CM: I50x)

Exclusion criteria

  • Patients with end-stage renal disease or receiving hemodialysis (ICD-10-CM: N18.6x. CPT: 90935, 90937, 90940)
  • Patients with a claim for IV iron during the baseline period
  • Patients with a claim for hospice services

Methods

  1. IDA, commercial coverage2 | N=144,523 patients
    (FG, n=4982; IS, n=36,751; ID, n=17,349; FXT, n=31,663; FCM, n=52,725; Monoferric, n=1053)
  2. IDA, oncology diagnosis, commercial coverage3 | N=28,856 patients
    (FG, n=856; IS, n=6546; ID, n=3419; FXT, n=7144; FCM, n=10,639; Monoferric, n=252)
  3. IDA, NDD-CKD diagnosis, Medicare coverage4 | N=6210 patients
    (FG, n=184; IS, n=1243; ID, n=508; FXT, n=1863; FCM, n=2368; Monoferric, n=44)
  4. IDA, HF diagnosis, Medicare coverage5 | N=5127 patients
    (FG, n=185; IS, n=947; ID, n=528; FXT, n=1341; FCM, n=2081; Monoferric, n=45)

FCM=ferric carboxymaltose; FG=ferric gluconate; FXT=ferumoxytol; HF=heart failure; ID=iron deficiency; IDA=iron deficiency anemia; IS=iron sucrose; NDD-CKD=non-hemodialysis-dependent chronic kidney disease.

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IMPORTANT SAFETY INFORMATION

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.

ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.