Appeal type: Drugs
Decision: Favorable

 
We decided that the Plan has to pre-approve Selective Internal Radiation Therapy (SIRT). 
 
You asked the Plan to pre-approve Selective Internal Radiation Therapy (SIRT). You say that the requested 
Selective Internal Radiation Therapy (SIRT) is medically necessary. The Plan denied your request. The Plan 
says that the requested Selective Internal Radiation Therapy (SIRT) is not medically necessary. 
 
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 Selective Internal Radiation Therapy 
(SIRT). Our reviewer says that the requested Selective Internal Radiation Therapy (SIRT) is medically 
necessary. 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 are likely inferior 
to Y-90 embolization/radioembolization, because the dose used for whole liver radiation is generally sub-
therapeutic (due to the toxicity with the use of higher whole liver dosing).  
  
There are innumerable prospective and retrospective studies demonstrating the use of of radioembolization for 
metastases for colorectal cancer or hepatocellular cancer. The FDA has in fact approved the use of SIR-
spheres/theraspheres for these indications. 
 
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, whose disease burden is confined (or mostly) within the 
liver (i.e. no or stable extra-hepatic visceral metastases) the liver disease is without doubt life threatening and 
progression will impair quality of life. Liver-directed therapies are warranted when chemotherapy options have 
been exhausted or the patient is not a candidate for systemic therapy.  
  
For this case, it is unclear if she has exhausted systemic options, though she is on 3 drugs (faslodex, ibrance 
and zometa) with controlled bone disease and progression only within the liver. Therefore it would seem to be 
within accepted standards of care to offer liver-directed therapy and radioembolization can be considered 
medically necessary. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Selective Internal Radiation Therapy (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.