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| Medical Policy: | R-94-001 |
| Topic: | Radiation Treatment with Lutathera |
| Section: | Radiation Therapy & Nuclear Medicine |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | April 2018 |
Lutathera (Lutetium; Lu 177 dotatate) is a radiolabeled somatostatin analog indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Lutetium 177 dotatate may be considered medically necessary in the following:
- The treatment of inoperable somatostatin receptor-positive GEP-NETS of the foregut, midgut and hindgut in adults; or
- The treatment of metastatic somatostatin receptor-positive GEP-NETS of the foregut, midgut and hindgut in adults; or
- The treatment of inoperable somatostatin receptor positive tumors of the pancreas; or
- The treatment of metastatic somatostatin receptor positive tumors of the pancreas.
Lutetium 177 dotatate is considered experimental/investigational, and therefore, non-covered in the treatment of all other neuroendocrine tumors, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
| Place of Service: Inpatient/Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Radiation treatment with Lutathera is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
04/2018, New Policy: Radiation Treatment with Lutathera
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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