Coverage Policy Manual
Policy #: 2021037
Category: Pharmacy
Initiated: November 2021
Last Review: August 2023
  Samarium SM 153 lexidronam (Quadramet®)
Description:
Samarium SM 153 lexidronam (e.g., Quadramet®) is a therapeutic radiopharmaceutical used to treat bone pain caused by primary bone cancer and other cancers that have spread to the bone. It consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP), which emits both medium-energy beta particles and a gamma photon and has a physical half-life of 46.3 hours (1.93 days). Samarium Sm 153-lexidronam pentasodium collects in bone and gives off radiation that may kill cancer cells. Samarium SM 153-lexidronam has an affinity for bone and concentrates in areas of bone turnover in association with hydroxyapatite. More Samarium SM 153 accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. Samarium Sm 153-lexidronam is also called Sm 153, samarium-153 and Quadramet
 
Regulatory Status
 
Samarium SM 153 lexidronam (e.g., Quadramet®) was first approved by the FDA March 1, 1997, to treat the severe pain associated with cancers that have spread to the bone.  September 21, 2017, a supplemental approval was granted for the addition of a statement regarding the use of Samarium SM 153 lexidronam in renal impairment.
 
Coding
 
See CPT/HCPCS Code section below.
Policy/
Coverage:
Effective August 1, 2021, for members of plans that utilize a radiation oncology benefits management program, Prior Approval is required for this service and is managed through the radiation oncology benefits management program.
 
 
Effective November 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
A single dose of Samarium SM 153 lexidronam (e.g., Quadramet®) [Serafini, 1998; Resche, 1997] meets member benefit certificate primary coverage criteria that there be scientific effectiveness in improving health outcomes as indicated for the treatment of individuals 16 yrs and older for pain relief in those with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan when ALL the following conditions are met:
 
    1. Individual is >16 years old (FDA label 2018). AND
    2. Must have had a positive (enhancement) radionuclide bone scan confirming osteoblastic bone metastases from solid organ cancer (FDA label 2018). AND
    3. Has failed other conventional treatments for bone pain due to skeletal metastases (FDA label 2018). AND
    4. Individual will not receive chemotherapy or external beam radiation therapy concurrently (FDA label 2018). AND
    5. Individual does not have significant bone marrow suppression (i.e., neutropenia, leukopenia, thrombocytopenia, etc.) (FDA label 2018) AND
    6. Must be dosed in accordance with the FDA label.
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
 
Dosage and Administration
Dosing per FDA Guidelines
 
The recommended dosage of Samarium SM 153 lexidronam is 1.0 mCi/kg administered IV over a period of one minute.  Dose adjustment in individuals at the extremes of weight have not been studied.  Caution should be exercised with determining the dose in very thin or very obese individuals.
 
Samarium SM 153 lexidronam is available frozen in a single-dose 10 mL glass vial containing 1850 + 185 MBq/mL (50 + 5 mCi/mL) at calibration.
 
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
 
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of Samarium SM 153 lexidronam (e.g., Quadramet®) for any indication or circumstance other than those described above does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
  
For members with contracts without primary coverage criteria, the use of Samarium SM 153 lexidronam (e.g., Quadramet®) for any indication or circumstance other than those described above is considered investigational.  
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.  
Rationale:
Bone metastasis occurs when neoplastic cells migrate from a primary cancer to a distant bone. The most common primary cancers with a predilection for bone spread are breast, prostate, and lung cancer. Although no bone is exempt, highly vascular areas such as spine, pelvis, and femur are more susceptible to metastases. Bone metastasis can present as pain, fracture, or laboratory abnormalities. Treatment involves control of the underlying systemic cancer and local therapy such as surgery, radiation, and/or bone strengthening agents (bisphosphonates and RANKL monoclonal antibodies). Less frequently used therapies are the beta-emitting radionuclides: strontium 89 and samarium 153.
 
The FDA approved samarium 153 lexidronam (Quadramet®) in 1997 for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. The results of 3 controlled studies have been reported. In the first prospective, multicenter, randomized, double-blind, placebo-controlled study (Study BA-106/110), patients (N = 180) with bone metastases from a variety of primary tumors were treated with single doses of placebo (N = 39) or active drug at doses of 0.5 mCi/kg (N = 40) or 1.0 mCi/kg (N = 39). Patients were followed for up to 16 weeks. The majority (86%) of the patients had either primary prostate (N = 80) or breast (N = 21) cancer. Patients who received the 1.0 mCi/kg dose of active drug had significant improvements when compared with the placebo group in both visual analog assessment scores and in the patient global assessment at each of the first 4 weeks following intervention. In the blinded patient global assessment, 62% to 72% of those in the 1.0 mCi/kg group and 40% to 70% of those in the 0.5 mCi/kg group had pain relief in the first 4 weeks following intervention. A significant correlation (P = .01) was observed between reductions in daily opioid analgesic use and visual analog assessment scores for patients receiving 1.0 mCi/kg [Serafini et al. 1998].
 
In another prospective, multicenter, randomized, double-blind, placebo-controlled study (Study 424Sm10/11), patients (N = 152) with bone metastases from hormone-refractory prostate cancer were randomized to placebo (N = 51) or 1.0 mCi/kg active drug (N = 101). As in the prior study, patients were followed for 16 weeks after intervention. Patients who received active drug had significant decreases in opioid analgesic use at weeks 3 and 4 (P < .0284). Changes in visual analog assessment scores were correlated with reductions in opioid analgesic use in the active treatment group (r = 0.349, P = .0004) [Sartor et al. 2004]. Findings were further corroborated by another multicenter, randomized, single-blind, dose-controlled study of 114 patients with painful bone metastases from various primary tumors. A single dose of either 0.5 mCi/kg (N = 55) or 1.0 mCi/kg (N = 59) resulted in an improvement of physician’s global assessment of 70% for the 1.0 mCi/kg group and 55% in the 0.5 mCi/kg group at week 4. Patients receiving the higher dose also exhibited significant improvements over baseline in both daytime discomfort and sleep at week 4. Long-term follow-up revealed a significantly longer survival among breast cancer patients receiving the higher dose; there was no correlation with survival and dose in the other tumor types [Resche et al. 1997].
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
A9604Samarium sm 153 lexidronam, therapeutic, per treatment dose, up to 150 millicuries
References: Lantheus Medical Imaging Inc(2018) QUADRAMET® (samarium SM 153 lexidronam injection). N. Billerica, MA 01862. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020570s008lbl.pdf. Accessed July 20,2021

Resche I, Chatal JF, Pecking A, et al.(1997) A dose-controlled study of 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP) in the treatment of patients with painful bone metastases. Eur J Cancer. 1997;33(10):1583-91. PMID: 9389919

Sartor O, Reid RH, Hoskin PJ, et al.(2004) Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004;63(5):940-5. PMID: 15134985

Serafini AN, Houston SJ, Resche I, et al.(1998) Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998;16(4):1574-81. PMID: 9552068
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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