Medical Necessity Guidelines — Xofigo (radium Ra-223 dichloride)
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Medical necessity criteria and prior authorization requirements for use of Xofigo in members with metastatic castration-resistant prostate cancer and symptomatic bone metastases across Mass General Brigham Health Plan product lines.
No material clinical or coverage changes in this revision.
Coverage Criteria for Xofigo (radium Ra-223)
Medicare Advantage — Initial therapy
Medicare Advantage coverage — Covered when ALL of the following are met:
From Medicare Advantage criteria
Commercial — Initial therapy
Commercial and Qualified Health Plans coverage — Covered when ALL of the following are met:
Commercial plan additional requirements include lymph node size limit and bone-protective agent use
Summary of additional coverage criteria and exclusions: Coverage is not available for members who have experienced disease progression on Xofigo. Members who have already received a full treatment course of Xofigo are also excluded from additional coverage for another full course. Additionally, coverage is excluded when the member will be receiving concurrent chemotherapy, biologic therapy, or systemic radiotherapy (see concurrent therapy exclusion for commercial members).
Concurrent systemic therapy exclusion and not medically necessary statement: Use of Xofigo administered concurrently with chemotherapy, biologic therapy, or systemic radiotherapy is considered not medically necessary and is an exclusion for members (commercial plans). Providers must not authorize concurrent use; requests that document planned or ongoing concurrent systemic radiotherapy, chemotherapy, or biologic therapy will be denied.
Dosing and Concomitant Regimen Guidance
| Regimen | Details |
|---|---|
| Dose | 55 kBq (1.49 microcurie) per kg body weight |
| Route and administration | Intravenous slow injection administered over approximately 1 minute |
| Schedule | One dose every 4 weeks for a total of 6 doses (one course) |
| Guidance | Policy implication |
|---|---|
| Fracture risk with Ra-223, especially when combined with NHAs | Ra-223 use in combination with newer hormonal agents (NHAs) is associated with increased skeletal fracture risk; clinicians should be aware of this safety concern |
| Recommended bone-protective agents | Co‑administration of a bone‑protective agent (denosumab or zoledronic acid) is advised to mitigate fracture risk |
| Coverage requirement for commercial members | Commercial plans require use of a bone‑protective agent with Xofigo unless contraindicated or intolerant (see Coverage Criteria) |
Prior Authorization, Documentation, and Billing Actions
Prior authorization required — submit supporting clinical documentation
Prior authorization is required for all product lines. Submit clinical documentation demonstrating that the member meets the plan-specific coverage criteria (see Coverage Criteria sections).
- Applicable to Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial plans.
- When CMS or MassHealth guidance applies, follow those agencies' documentation and determination processes.
No specified step therapy — coverage conditional on clinical criteria and BPA use
No formal step therapy sequence is specified. Coverage is contingent on meeting the listed clinical criteria, including required concomitant bone‑protective agent use for commercial members unless contraindicated or intolerant.
- Commercial criteria require use of a bone‑protective agent (unless documented contraindication or intolerance).
Plan‑specific prior authorization and supporting documentation requirements
Obtain prior authorization and provide plan‑specific supporting documentation: follow CMS guidance for Medicare Advantage and One Care/SCO, follow MassHealth guidance for Mass General Brigham ACO, and submit documentation demonstrating the member meets the applicable plan's criteria.
- Medicare Advantage and One Care/SCO: use CMS NCDs/LCDs/LCAs and Medicare manuals as the basis for determinations.
- Mass General Brigham ACO: use MassHealth guidance when available; otherwise use plan policy.
- Commercial: submit documentation showing all commercial criteria are met (see Commercial Criteria).
Concurrent systemic therapy exclusion — commercial plans
Concurrent receipt of chemotherapy, biologic therapy, or systemic radiotherapy is an exclusion and will result in denial for commercial members.
- Do not initiate Xofigo if the member is receiving concurrent systemic anticancer therapies or systemic radiotherapy for commercial plan members.
Prior Xofigo exposure or progression are exclusions
Prior full course of Xofigo or documented disease progression on Xofigo are exclusions and may trigger denial.
- Members who have already received a full treatment course of Xofigo are excluded.
- Members with disease progression on Xofigo are excluded.
Informational Coding
| A9606 | Radium ra-223 dichloride, therapeutic, per microcurie |
Line of Therapy / Salvage Use
Salvage
Aligned with FDA indication and policy line-of-therapy guidance
Key Definitions
Background — Drug and Indication
Background on Xofigo (radium-223 dichloride): Xofigo is an alpha-emitting radiopharmaceutical indicated for patients with metastatic castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. It delivers targeted alpha radiation to areas of osteoblastic activity in bone. The approved therapeutic regimen is a full course of six intravenous doses given every four weeks; members who have already completed a full treatment course or who experience disease progression on Xofigo are excluded from further coverage.
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