Help navigating step therapya

Many US states have enacted step therapy laws, and other states and territories may have introduced step therapy legislation.1 State-specific step therapy laws vary in scope.1

  • These legislative efforts are brand-agnostic and apply broadly across therapeutic classes
  • To help your patients with step therapy restrictions receive their prescribed medications, consider reviewing step therapy protections in their areab
  • Patients may potentially qualify for step therapy protection if a first-step medication was contraindicated, expected to be ineffective, known or likely to cause an adverse reaction, or not in the best interest of the individual2

You may review the state-specific legislation to see which step therapy protections are available in your or your patient’s state of residence

  • Legislation With Form
    This state has step therapy protections, backed by enacted legislation and reinforced through a state-specific request form tailored to ensure compliance with these state regulations.
  • Legislation Only
    This state has step therapy protections, backed by enacted legislation that can be used as supportive reasoning when requesting a step therapy exception from a payor. Currently there is not a state-specific request form available.
  • No Legislation
    There are no step therapy protections enacted or pending legislation in this state.
Download the Step Therapy Exception Request Flashcard

Learn more about state-level step therapy protections and download step therapy exception request formsa,b,c

Visit StepTherapy.com

a Step therapy exception requirements and eligibility may vary. This information is intended for educational use only and is not a guarantee of coverage or reimbursement. Pharmacosmos Therapeutics makes no guarantees regarding the timeliness or appropriateness of this information for your particular use. The accurate completion of coverage or reimbursement-related documentation is the sole responsibility of the provider. Providers should consult with individual payors for all relevant coding, reimbursement, and coverage requirements. Contact a legal professional for information about step therapy laws in your jurisdiction.
b StepTherapy.com is a third-party website unaffiliated with Pharmacosmos Therapeutics Inc. This information was developed by StepTherapy.com and is for general educational purposes only. Pharmacosmos Therapeutics assumes no responsibility for errors or omissions in the content or for any actions taken based on the information provided. Links to external third-party websites are provided for convenience and do not imply endorsement. Pharmacosmos Therapeutics is not responsible for the accuracy, reliability, or content of third-party websites.
c For patients insured through national carriers, such as Aetna, Cigna, UnitedHealthcare, or Humana, consider using a step therapy exception request for the state in which treatment is rendered. For patients insured through regional associations, such as Blue Cross Blue Shield (BCBS), consider using a step therapy exception request for the home state of the network affiliate, as indicated on the patient’s insurance card. For more information, contact the state’s insurance regulator.

If you have questions specific to Step Therapy or you would like to locate a Field Reimbursement Manager in your area, please contact us via email at STER@pharmacosmos.us

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References: 1. McBath, colleagues reintroduce bipartisan Safe Step Act to improve patient access to treatments. Lucy McBath (D-GA). April 13, 2023. Accessed August 2025. https://mcbath.house.gov/2023/4/mcbath-colleagues-reintroduce-bipartisan-safe-step-act-to-improve-patient-access-to-treatments 2. Tharp L, Rothblatt Z. Health Econ Policy Law. 2022;17(3):282-297.

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.