CurrentIndependent HealthPolicy M20200508036

Xofigo (radium Ra 223 dichloride) for Treatment of Castration-Resistant Prostate Cancer

Defines Independent Health's medical necessity and pre-authorization criteria for coverage of Xofigo in adults with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral disease; applies to Medicare Advantage, commercial, MediSource, and Essential Plan.

Policy Summary

PayerIndependent Health

PolicyXofigo (radium Ra 223 dichloride) for Treatment of Castration-Resistant Prostate Cancer

Policy CodePolicy M20200508036

Change TypeNo material change

Effective DateJul 1, 2020

Next Review Date

Key ActionObtain pre-authorization documenting intent for initial coverage limited to six injections.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6maximum covered doses/length of therapy

55 kBq/kgdosage stated

18+minimum age

Pre-authauthorization

No visceralkey eligibility restriction

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Coverage Criteria for Xofigo (radium-223)

Initial Coverage Criteria

Covered when ALL of the following are met

Age: Patient is 18 years or older>=18 years

Prescriber: Must be prescribed by a hematologist/oncologist or radiation oncologist

Diagnosis: Medical record documents castration-resistant prostate cancer (CRPC) with symptomatic bone metastases

Visceral disease exclusion: No known visceral metastatic disease (e.g., liver, lung, adrenal, peritoneal, brain)

Soft tissue/lymph node sites are not considered visceral metastases.

Initial treatment duration: Initial coverage requested for six months (6 injections only); coverage limited to six injections and will not be renewed6 injections

Use of radium-223 is excluded for patients with known visceral metastatic disease. Visceral metastatic disease includes metastases to the liver, lung, adrenal, peritoneal, and brain; soft tissue or lymph node sites are not considered visceral metastases.

Treatment beyond a six‑injection course is not covered and is therefore not medically necessary under this policy. Coverage is limited to an initial course of 6 injections (six months) and may not be renewed for additional injections.

Approved Regimens and Administration

Regimen	Dose / Schedule	Maximum Covered Injections
Radium-223 (Xofigo) — weight‑based intravenous regimen for metastatic castration‑resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease	55 kBq (1.49 microcurie) per kg body weight IV every 4 weeks for 6 injections (document also lists 50 kBq/1.35 microcurie per kg in definitions)	Covered for up to 6 injections; treatment beyond 6 injections is not covered/renewable

Dosing and Coding Notes

Dosing regimen — radium-223

Primary dosing (policy Dosage section)55 kBq (1.49 microcurie) per kg body weight, administered IV at 4-week intervals for a total of 6 injections (coverage limited to six months).

Alternate dosing listed in Definitions50 kBq (1.35 microcurie) per kg body weight, administered IV at 4-week intervals for 6 injections (document definition section).

Administration frequencyOnce every 4 weeks (monthly) for up to 6 doses.

Coverage limitCoverage provided only for six injections; treatment beyond six injections is not covered/renewable.

Provider Requirements and Authorization

Prior Authorization

Pre-Authorization Required

Pre-authorization is required for Xofigo (radium-223). Requests must have an approved pre-authorization prior to the service; requests without pre-authorization risk denial.

Pre-authorization required for initial coverage (six injections)
Requests without prior authorization may be denied

Denial Risk

Clinical Documentation Required — Denial Risk if Absent

Medical record documentation must demonstrate castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and absence of known visceral metastatic disease. Coverage may be denied if clinical documentation does not clearly show these conditions.

Documentation must show CRPC with symptomatic bone metastases
Documentation must show no known visceral metastatic disease (e.g., liver, lung, adrenal, peritoneal, brain)

Placement in Therapy

Salvage

Line of therapy: Not specified by policy; intended for use in metastatic CRPC with symptomatic bone metastases. Policy does not define first- vs second-line use — follow treating clinician judgment and referenced guidelines.

See NCCN and guideline references for recommended sequencing.

Key Definitions

Definition — CRPC

DefinitionCastration-resistant prostate cancer (CRPC) is advanced prostate cancer that progresses while receiving androgen deprivation therapy (ADT).

Clinical contextCRPC is the population specified in this policy for consideration of radium-223 (Xofigo) when symptomatic bone metastases are present.

Age requirementPatient must be 18 years or older for coverage under this policy.

Definition — Visceral metastatic disease

Included visceral sitesVisceral metastases include liver, lung, adrenal, peritoneal, and brain metastases.

Excluded sites (not considered visceral)Soft tissue and lymph node sites are not considered visceral metastases for the purposes of this policy.

Background

Radium‑223 (Xofigo®) is an alpha‑emitting radiopharmaceutical indicated for treatment of metastatic castration‑resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease. It is administered intravenously at weight‑based dosing on a monthly schedule for a total of six injections and is typically delivered in appropriately licensed nuclear medicine or radiation therapy settings.

Policy Summary

PayerIndependent Health

PolicyXofigo (radium Ra 223 dichloride) for Treatment of Castration-Resistant Prostate Cancer

Policy CodePolicy M20200508036

Change TypeNo material change

Effective DateJul 1, 2020

Next Review Date

Key ActionObtain pre-authorization documenting intent for initial coverage limited to six injections.

SourceLink

On This Page

Soft tissue/lymph node sites are not considered visceral metastases

Billing Rule

Limit on Number of Injections

Coverage is limited to a single course of six injections (one injection every 4 weeks). Requests for more than six injections or renewal beyond the 6-month regimen may be denied; coverage will not be renewed beyond six injections.

Limit: 6 injections (one per 4-week interval)
Coverage provided for six months (6 injections only) and may NOT be renewed

Documentation Required

Dosing Documentation

Dosing must be documented consistent with the approved regimen: weight-based dosing at approximately 55 kBq (1.49 microcurie) per kg body weight (source lists 50–55 kBq/kg across sections) administered at 4-week intervals for up to 6 injections. Include the dosing plan and schedule in the record.

Dose: ~55 kBq (1.49 microcurie) per kg body weight (policy notes dose regimen as 50 kBq/1.35 µCi/kg in Definitions)
Administration: intravenous every 4 weeks for up to 6 injections
Documentation should include planned dose per kg and administration schedule

Step Therapy

No explicit step therapy or required prior medication failure sequence is specified in this policy. There is no requirement to try or fail alternate systemic therapies prior to authorization of Xofigo in the criteria presented.

No step therapy sequence required or specified in this policy

Coverage implicationPresence of known visceral metastatic disease (listed organs) excludes use of radium-223 under this policy.

Definition — Xofigo (radium-223)

Agent descriptionXofigo (radium-223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

Regulatory approvalFDA-approved in May 2013 for metastatic CRPC with symptomatic bone metastases and no known visceral metastatic disease.

Administration settingTypically administered intravenously in appropriately licensed facilities such as nuclear medicine or radiation therapy departments.