Anthem Blue Cross California Xofigo (Radium Ra 223 Dichloride) Form

Overview

Clinical criteria Overview Coding Document history References This document addresses the use of radium Ra-223 dichloride (Xofigo) is an alpha particle-emitting radioactive therapeutic agent which mimics calcium to bind with bone minerals in areas of bone metastases primarily used to treat castration-resistant distant metastatic (M1) disease with symptomatic bone metastases and no visceral metastases. The FDA approved indications for radium Ra-223 dichloride (Xofigo) include castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Other Uses

Radium Ra-223 dichloride has been investigated for other uses including treatment of osteosarcoma with relapse or progression after failure of chemotherapy and/or resection. While NCCN provides 2A recommendations for this off-label use, NCCN states that this is based on limited evidence in the form of a case report and review article. Currently there are ongoing phase I/II clinical trials evaluating use for breast cancer, breast cancer with bone metastases, osteosarcoma, and for use in combination with docetaxel for use in treatment of CRPC and bone metastases, but there currently is insufficient published literature to support safety and efficacy for these indications. UPDATE: NCCN Bone Cancer v1.2020 guidelines remove radium-223 as a regimen for second-line relapsed/refractory or metastatic osteosarcoma.

There are warnings for radium Ra-223 dichloride for myelosuppression and increase fractures and mortality when taken in combination with abiraterone plus prednisone or prednisolone. Radium Ra-223 dichloride is contraindicated in pregnancy.

Definitions and Measures

ECOG or Eastern Cooperative Oncology Group Performance Status:

A scale and criteria used by doctors and researchers to assess how an individual’s disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale:

• 0 = Fully active, able to carry on all pre-disease performance without restriction
• 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work
• 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
• 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
• 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
• 5 = Dead

Gleason Grading system:

A prostate cancer grading system. A primary and secondary pattern, the number range of each is from 1 to 5, are assigned and then summed to yield a total score.

Metastasis:

The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

Prostate:

A gland in the male reproductive system; the small walnut sized structure which wraps around the urethra.

Radiotherapy:

Systemic radiotherapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Xofigo (radium Ra 223 dichloride)

Requests for Xofigo (radium Ra-223 dichloride) may be approved if the following criteria are met (Label, NCCN Prostate Cancer Guideline):

1. Individual has a diagnosis of castration-resistant prostate cancer (CRPC) with symptomatic bone metastasis; AND
2. Individual is 18 years or older; AND
3. Individual has planned course of six monthly injections; AND
4. Individual has a serum testosterone level is less than or equal to 50 ng per deciliter ([1.7 nmol per liter] after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist or polyestradiol phosphate); AND
5. Individual has prostate-specific antigen (PSA) level is 5 ng per milliliter or higher with evidence of progressively increasing PSA values (two consecutive increases over the previous reference value) or objective evidence of progression of osseous metastases on imaging studies at time of initiation of Radium Ra 223 dichloride; AND
6. No known history or presence of visceral metastatic disease; AND
7. Individual does not have bulky lymph node metastases (>3-4 cm); AND
8. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2; AND
9. Individual will not use concurrently with other chemotherapy or biologic therapy (Note: this does not include androgen-ablation therapy or other hormonal therapy) for prostate cancer.

Requests for Xofigo (radium Ra-223 dichloride) may not be approved for the following (Label, NCCN Prostate Cancer Guideline):

1. When the above criteria are not met and for all other indications.
2. Individual has imminent or established spinal cord compression; OR
3. Used in combination with Zytiga (abiraterone acetate) plus prednisone/prednisolone; OR
4. Individual has received systemic radiotherapy with radioisotopes within the previous 24 weeks; OR
5. Individual was treated with chemotherapy or biologic therapy within the previous 4 weeks; OR
6. Used in combination with docetaxel or any other systemic therapy except androgen deprivation therapy (ADT); OR
7. Individual has received a previous course of Radium Ra 223 dichloride; OR
8. Individual being treated for a diagnosis other than CRPC; OR

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

• HCPCS
• A9606 Radium Ra-223 dichloride, therapeutic, per microcurie [Xofigo]
• CPT
• 79101 Radiopharmaceutical therapy, by intravenous administration [when specified as injection of Xofigo]
• ICD-10 Diagnosis
• C61 Malignant neoplasm of prostate
• C79.51 Secondary malignant neoplasm of bone
• R97.21 Rising PSA following treatment for malignant neoplasm of prostate
• Z19.2 Hormone resistant malignancy status

Document History

Reviewed: 02/24/2023