Commercial

Policy

MPPolicyPub

Coverage is subject to the terms, conditions, and limitations of the member's contract.

This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program.  For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services.​

MEDICALLY NECESSARY

Radium Ra 223 dichloride (Xofigo®) injection is considered medically necessary and, therefore, covered for a maximum of six injections for the treatment of castration-resistant prostate cancer (also known as hormone-resistant prostate cancer) when all of the following criteria are met:

• The individual has castration (hormone) resistant prostate cancer, as defined by:
  • A serum testosterone level of less than 50 ng/dL and either
    1. Sequential rise of prostate specific antigen (PSA) levels or
    2. Worsening of existing bone metastases or development of new bone metastases on a bone scan performed within the past 60 days despite androgen-deprivation treatment
  • Documented failure of available hormonal therapies. The individual may be kept on their ablative hormonal treatment to maintain castrate levels of serum testosterone.
• The individual has symptomatic skeletal (bone) metastases
• The individual has no evidence of visceral metastases or bulky regional lymph nodes smaller than 3 cm on imaging performed within the past 30 days

EXPERIMENTAL/INVESTIGATIONAL

All other uses for radium Ra 223 dichloride (Xofigo®) injection, including the use of more than six injections, are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Compa​ny upon request. Failure to produce the requested information may result in a denial for the drug.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

If there is no specific HCPCS code available for the drug administered, then the drug must be reported with the most appropriate unlisted code along with the corresponding National Drug Code (NDC).

Guidelines

MPGuidelinesPub

The US Food and Drug Administration (FDA) has approved radium Ra 223 dichloride (Xofigo®) injection in individuals who have castration-resistant prostate cancer (defined as having a testosterone level of <50 ng/dL).

LABORATORY VALUES

According to the FDA-approved label, the individual should have an absolute neutrophil count (ANC) of 1.5 × 10⁹/L or greater, platelet count of 100 × 10⁹/L or greater, and a hemoglobin of 10 g/dL or greater prior to initial dose. Prior to subsequent doses, the individual should have an ANC of 1 × 10⁹/L or greater and a platelet count of 50 × 10⁹/L or greater. If within 6 to 8 weeks after the last administration of radium Ra 223 dichloride (Xofigo®) injection there is no recovery of the absolute neutrophil count (ANC), platelet count, and hemoglobin levels to the values listed above (despite receiving supportive care), further treatment with radium Ra 223 dichloride (Xofigo®) injection should be discontinued.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade	ECOG
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 (eg, 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 percent of waking hours
3	Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5	Dead

​ Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, radium Ra 223 dichloride (Xofigo®) injection is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Radium Ra 223 dichloride (Xofigo®) injection was approved by the FDA on May 15, 2013 for the treatment of individuals with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.

Description

MPDescriptionPub

Prostate cancer is the second leading cause of cancer-related deaths among American men, with an estimated incidence of 233,00 new cases and 29,480 deaths estimated for 2014. The widespread use of the prostate-specific antigen (PSA) test for the screening and monitoring of individuals with prostate cancer has allowed for the majority of prostate cancer cases to be diagnosed at a localized stage. Despite early detection and appropriate treatment, some individuals progress to metastatic, hormone-refractory prostate cancer (mHRPC) after the failure of several lines of antihormonal therapies; furthermore, more than 90% of these individuals have radiologic evidence of bone metastases, which are a major cause of death, disability, decreased quality of life, and increased treatment cost among these individuals. Unlike deaths from many other types of cancer, deaths from prostate cancer are often due to bone disease and its complications. Weakened bones due to cancer metastases can lead to fractures and compression of the spinal cord. They necessitate procedures such as surgery and radiation, which are designed to prevent or manage bone complications. The primary goal of treatment for bone metastases is to prevent the occurrence of debilitating bone complications that can affect an individual's quality of life.

Radium Ra 223 dichloride (Xofigo®) injection is the first alpha particle-emitting radioactive therapeutic agent approved by the US Food and Drug Administration (FDA), on May 15, 2013, for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease.

Radium Ra 223 dichloride (Xofigo®) injection mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover. The high-energy alpha particle radiation causes breaks in the double-stranded DNA of the targeted area, resulting in an anti-tumor effect on the bone metastases. The short path of the alpha particles limits the damage to the surrounding normal tissue and bone marrow.

The dosing regimen of radium Ra 223 dichloride (Xofigo®) injection is 50 kBq (1.35 microcurie) per kg body weight, given at 4-week intervals for a total of six injections. It is administered by a slow intravenous injection over 1 minute. Toxicities resulting from this therapy include a low risk of bone marrow suppression, gastrointestinal symptoms, and the possibility of impaired fertility.

PEER-REVIEWED LITERATURE

SUMMARY

The FDA granted approval of radium Ra 223 dichloride (Xofigo®) injection based on a Phase III, double-blind, randomized, placebo-controlled clinical trial. The ALSYMPCA (ALpharadin in SYMptomatic Prostate Cancer) trial included individuals with castration-resistant prostate cancer who had two or more bone metastases that were symptomatic. In addition, these individuals had received, were not eligible to receive, or declined therapy with, docetaxel. Eighty-six percent of individuals had an Eastern Cooperative Oncology Group (ECOG) performance status of zero to one. Individuals were excluded from the study if they experienced visceral metastases and malignant lymphadenopathy exceeding 3 cm.

A total of 809 individuals were randomly assigned 2:1 to receive radium Ra 223 dichloride (Xofigo®) injection 50 kBq (1.35 microcurie)/kg intravenously every 4 weeks for 6 cycles (n=541) plus best standard of care or matching placebo plus best standard of care (n=268). (Best standard of care included local external beam radiation therapy [EBRT], corticosteroids, antiandrogens, estrogens, estramustine, or ketoconazole.)

Individuals receiving radium Ra 223 dichloride (Xofigo®) injection plus best standard of care experienced a statistically significant increase in median overall survival (14.9 months) when compared to individuals receiving placebo plus best standard of care (11.3 months). A key secondary outcome reported a statistically significant prolonged median tim​e to first symptomatic skeletal event (SSE) for individuals receiving radium Ra 223 dichloride (Xofigo®) injection plus best standard of care (15.6 months) when compared to individuals receiving placebo plus best standard of care (9.8 months).

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)

ICD - 10 Diagnosis Code Number(s)

HCPCS Level II Code Number(s)

Revenue Code Number(s)

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History