Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve selective internal radiation therapy (SIRT). 
 
You asked the Plan to pre-approve SIRT. You say that SIRT is medically necessary because the patient has 
liver metastases. The Plan denied your request. The Plan says that selective internal radiation therapy (SIRT) is 
not considered reasonable and necessary for stage IV breast cancer. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve SIRT. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case.  Our physician 
reviewer found localized treatment options for liver metastases include resection, cryotherapy, radiofrequency 
ablation embolization (radioembolization or chemoembolization), and stereotactic radiation.  Systemic 
chemotherapy is the standard treatment option for patients with liver metastases. Whole liver radiation is a 
reasonable approach for palliation, though the toxicity and efficacy may be inferior to Y-90 embolization/ 
radioembolization. 
 
There are innumerable prospective and retrospective studies demonstrating the use of radioembolization for 
metastases for colorectal cancer or hepatocellular cancer. The Food and Drug Administration (FDA) has in fact 
approved the use of SIRT for these indications. 
 
Radioembolization with Y90 embedded SIRT is not outside the generally accepted professional medical 
standards as being safe and effective.  There are slight technical differences between SIR-spheres and 
Therapspheres, with SIR spheres being Y90 embedded resin with 20-60 mm beads and Therespheres being 
Y90 embedded glass beads with 20-30 mm size.  SIR Spheres have more embolic effect and less radioactivity 
per sphere. While SIR spheres are FDA approved for colorectal cancer liver metastases and TheraSpheres are 
approved for HCC, the principles of using a radioactive embolizing agent is the same for both, and thus the 
concept of radioembolization applies to both. 
 
Thus, the treatment itself is not investigational.  Radioembolization is not outside the generally accepted 
professional medical standards as being safe and effective. The relevant question in this case is whether or not 
radioembolization is indicated for this patient. 
 
There are no randomized trials for the use of radioembolization with hepatic metastases from breast cancer. 
From a multi-institutional retrospective study of 44 patients, and single institution studies, radioembolization is 
reported to be effective (roughly 30-60% response rate) without significant toxicity.  Breast cancer tends to be 
a radiation responsive disease, and thus the benefit from radioembolization treatment of breast cancer patients 
should be similar to (if not greater than) that of patients with colorectal cancer.   
 
A paper from Northwestern and William Beaumont Hospital) investigated 137 patients who underwent 227 
administrations of Y-90 microspheres for liver metastases.  21 patients had breast cancer.  For all lesions in all patients, 87% experienced a biologic response.  Toxicity was acceptable.  Most patients had less than 25% of 
the liver involved.  The median survival was 12 months for those with non-colorectal and non-
neuroendocrine tumors and the 2-year survival was 27%.  
 
A study of 75 patients with chemorefractory liver metastases from breast cancer documented partial response in 
35.3%, stable disease in 63.2% and progressive disease in 1.5% with a median survival of 6.6 months. Tumor 
burden (less than 25% vs greater than 25%), bilirubin level and unifocal vs. multifocal disease were prognostic. 
 
In a study of 81 patients with unresectable liver metastases from breast cancer refractory to systemic therapy, 
grade 3+ toxicity occurred in 10% of patients, with 2 deaths from radioembolization-induced liver disease. 
Staged treatments were associated with low toxicity risks. The response rate was 61%. Adverse prognostic 
factors included high hepatic tumor burden and liver transaminase levels at baseline. 
 
There is an ongoing prospective trial in Belgium that is examining radioembolization for unresectable liver 
metastases from breast cancer (SIRMITOC) 
 
In a patient with reasonably good performance status, with chemorefractory disease and whose disease burden 
is confined (or mostly) within the liver (i.e. no or stable extra-hepatic visceral metastases) radioembolization 
for the liver disease is an accepted standard of care. In general, liver-directed therapies are warranted when 
chemotherapy options have been exhausted or the patient is not a candidate for systemic therapy.  This patient 
has developed progression of her liver metastases after multiple lines of systemic therapy (most recently on 
clinical trial). Radioembolization would be an accepted standard of care at this point.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of SIRT have been met. Therefore, we decided that the Plan has to pre-approve 
selective internal radiation therapy (SIRT).  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.