Currentmedical mutual - ohioPolicy N/A

Hydroxyurea Products

Defines recommended prior authorization criteria, age limits, indications, approval durations, and documentation requirements for pharmacy benefit coverage of Siklos (hydroxyurea tablets) and Xromi (hydroxyurea oral solution).

Policy Summary

Payermedical mutual - ohio

PolicyHydroxyurea Products

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective DateN/A

Next Review DateJun 19, 2025

Key ActionPrior authorization is recommended for pharmacy benefit coverage of Siklos and Xromi; approvals are recommended for those who meet the policy's criteria and provided approval durations apply.

POLICY UPDATE CHANGES

No material changes to policy coverage or clinical criteria.

2Products covered

2Age-specific indications

1Initial approval (yrs)

Coverage Summary

Hydroxyurea products (Siklos and Xromi) are covered with criteria. The policy defines recommended prior authorization criteria that specify indications (reduction of painful crises and transfusion need), age-specific product use (Siklos for patients >= 2 years; Xromi for patients 6 months to <2 years), formulation-specific requirements for Siklos (use of 100 mg or 1,000 mg tablets when needed to achieve a dose not achievable with other formulations or when the patient cannot swallow), approval durations, and documentation requirements. Prior authorization is recommended for pharmacy benefit coverage and approvals are provided when the criteria are met.

Initial Therapy Criteria

Sickle Cell Anemia - Recommended Authorization Criteria

Coverage of Siklos and Xromi is recommended in those who meet the following criteria:

ALL of the following

Sickle Cell Anemia criteria
- A: The product is used to reduce the frequency of painful crises
- B: The product is being used to reduce the need for blood transfusions
- C: The patient experiences recurrent, moderate to severe painful crises
- ONE of (formulation/swallowing criteria for Siklos)
  - D.a: For Siklos requests, the 100 mg or 1,000 mg tablets are required to achieve a dosage that cannot be achieved with other available formulations of hydroxyurea (e.g. Droxia capsules)
  - D.b: For Siklos requests, the patient cannot swallow or has difficulty swallowing
- ONE of (age criteria by product)
  - E.a: For Siklos requests the patient is 2 years of age or older
  - E.b: For Xromi requests the patient is aged 6 months to less than 2 years of age

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Continuation Therapy Criteria

Reauthorization (extended approval) requires documentation of a response to therapy unless otherwise noted. Initial approval duration is 1 year, and extended (reauthorization) approval duration is 1 year. Prior authorization is recommended and the company may request additional documentation (patient records, test results, provider credentials) to support medical necessity and may deny reimbursement if documentation is not provided or therapy is not medically necessary.

Unproven / Exclusions

There are no explicit exclusions listed beyond the statement that coverage is limited to the uses and patient populations described in the Recommended Authorization Criteria. Conditions not recommended for approval include circumstances not listed in the Recommended Authorization Criteria and will be updated as new data become available.

Provider Actions

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Siklos and Xromi; approvals are recommended for those who meet the policy's criteria and provided approval durations apply.

Documentation Required

Documentation may be requested

The company may request additional documentation to support medical necessity and may deny reimbursement if documentation is not provided or if therapy is not medically necessary.

Patient records
Test results
Provider credentials

Billing Rule

Initial and extended approval durations

Initial approval duration: 1 year. Extended approval (reauthorization) duration: 1 year; continuation requires a response to therapy unless otherwise noted.

Initial approval duration: 1 year
Extended approval (reauthorization) duration: 1 year; continuation requires response to therapy

Clinical Evidence

DRUGDEX review (updated 2025-03-11); Siklos PI (Nov 2023); Xromi PI (Dec 2024)

Sickle cell disease (SCD) is a multisystem disorder caused by the sickle hemoglobin gene that leads to vaso-occlusive pain crises and multi-organ complications. Hydroxyurea therapy reduces the frequency of painful crises and decreases the need for blood transfusions.

Background

Sickle cell disease is a multisystem disorder characterized by abnormal sickled erythrocytes that can cause acute and chronic pain crises and complications across multiple organs (brain, heart, lungs, kidneys, liver, joints, gallbladder, and increased infection risk). Hydroxyurea reduces painful crises and transfusion requirements and is used to manage recurrent, moderate to severe painful crises. Product-specific notes: Xromi oral solution is indicated for patients aged 6 months to <2 years, while Siklos is a tablet formulation (available in 100 mg and 1,000 mg tablets) intended for patients aged 2 years and older and may be required when dosing cannot be achieved with other formulations or when the patient has difficulty swallowing.

Policy metadata and key dates

Last review2025-06-19

Next review2025-06-19

Policy statusCURRENT

Payermedical mutual - ohio

SubjectHydoxyurea products (Siklos and Xromi)

Prior authorizationRecommended for Siklos and Xromi

Initial approval duration1 year

Policy Summary

Payermedical mutual - ohio

PolicyHydroxyurea Products

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective DateN/A

Next Review DateJun 19, 2025

On This Page

OpenPayer

Hydroxyurea Products

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions

Clinical Evidence

Background

Revision History

Siklos	hydroxyurea tablets (Addmedica/Medunik) - 100 mg and 1,000 mg formulations referenced
Xromi	hydroxyurea oral solution (Nova Laboratories) - for ages 6 months to <2 years
Droxia	hydroxyurea capsule formulation referenced as alternative