Clinical Policy: Deferoxamine (Desferal)

Reference Number: CP.PHAR.146
Effective Date: 11.01.15
Last Review Date: 08.25
Line of Business: Commercial, HIM, Medicaid

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

Deferoxamine (Desferal®) is an iron-chelating agent.

FDA Approved Indication(s)

Desferal is indicated:

• As an adjunct to standard measures for the treatment of acute iron intoxication.
• For the treatment of transfusional iron overload in patients with chronic anemia.

Limitation(s) of use: Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).

Policy/Criteria

II. Continued Therapy

A. Acute Iron Intoxication

1. Re-authorization is not permitted. Members must meet initial approval criteria for new cases of acute iron intoxication.

Approval duration: Not applicable

B. Chronic Iron Overload due to Transfusion-Dependent Anemias (must meet all):

1. Member meets one of the following (a or b):
   a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
   b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline;
3. Current documentation (within the last 30 days) shows a serum ferritin level ≥ 500 mcg/L;
4. If request is for brand Desferal, member must use generic deferoxamine, unless contraindicated or clinically significant adverse effects are experienced;
5. Therapy does not include concurrent use of other iron chelators, unless member has excess cardiac iron as evidence by mT2* ≤ 10 millisecond or iron-induced cardiomyopathy;
6. If request is for a dose increase, new dose does not exceed any of the following (a, b, or c):
   a. SC: 2,000 mg per day;
   b. IV: 40 mg/kg per day for children; 60 mg/kg per day for adults;
   c. IM: 1,000 mg per day.

Approval duration: 12 months

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents;

B. Primary hemochromatosis;

C. Parkinson’s disease.

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

FDA: Food and Drug Administration
mT2*: myocardial T2

Appendix B: Therapeutic Alternatives

Not applicable

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s):
  
  • Known hypersensitivity to the active substance
  • Severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney
• Boxed warning(s): none reported

Appendix D: General Information

• In FAIRPARK-II, deferiprone, an iron chelator, was associated with worse scores in measures of parkinsonism compared to placebo over a 36-week period in participants with newly diagnosed Parkinson’s disease who had never received levodopa.

V. Dosage and Administration

VI. Product Availability

Single-dose vial of lyophilized deferoxamine mesylate: 500 mg, 2 g

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.

Note:
For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

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