Anthem Blue Cross Connecticut TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors Form

This document addresses hematopoietic stem cell transplantation in the treatment of the following conditions:

• Autoimmune Diseases
• Epithelial Ovarian Cancer
• Breast Cancer
• Malignant Astrocytomas and Gliomas
• Miscellaneous Solid Tumors in Adults

Note: For additional stem cell transplant information and criteria, see the applicable document(s):

• TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors
• TRANS.00030 Hematopoietic Stem Cell Transplantation for Germ Cell Tumors

Position Statement

Autoimmune Diseases

Medically Necessary:

A single autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation is considered medically necessary for individuals with multiple sclerosis when all of the following criteria are met:

1. The transplant is used to treat relapsing-remitting multiple sclerosis; and
2. The individual is between 18 and 45 years of age with disease duration less than 10 years; and
3. The individual is disabled in at least one functional system but able to ambulate for 100 meters without aid or rest (expanded disability status scale [EDSS] score from 2.0 to 5.5); and
4. The individual has highly active and treatment resistant disease meeting criteria 1 and 2 below:
   1. Highly active disease as seen by 1.a or 1.b below:
      1. Two or more clinical relapses at separate times but within the previous 12 months; or
      2. One clinical relapse and one or more magnetic resonance imaging (MRI) lesions typical for MS (gadolinium-enhancing or T2-hyperintenase lesion), with the MRI lesion occurring at a separate time than the clinical relapse but both occurring within the previous 12 months; and
   2. Treatment resistant disease as seen by the disease activity meeting criteria D1 above occurring despite disease-modifying treatment (DMT) meeting all of the following requirements:
      1. Each relapse or episode of new MRI lesion(s) must occur after at least 3 months of treatment with a U.S. Food and Drug Administration-approved DMT; and
      2. At least 1 episode must be a clinical relapse, and MRI evidence of activity must include at least 2 unique or active lesions in the brain or spinal cord; and
      3. At least 1 of those episodes must occur after treatment with a DMT considered to be highly efficacious (natalizumab, ocrelizumab, rituximab, or alemtuzumab).

Investigational and Not Medically Necessary:

A single autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplant is considered investigational and not medically necessary as a treatment of multiple sclerosis when the above criteria are not met, including for primary progressive or secondary progressive forms of multiple sclerosis.

A repeat autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplant is considered investigational and not medically necessary as a treatment of relapsing-remitting multiple sclerosis.

An allogeneic (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, or planned tandem is considered investigational and not medically necessary as a treatment of multiple sclerosis.

An autologous or allogeneic (ablative and non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, single or planned tandem is considered investigational and not medically necessary as a treatment of all other autoimmune diseases including, but not limited to:

• juvenile idiopathic arthritis;
• rheumatoid arthritis;
• systemic lupus erythematosus;
• systemic sclerosis

Epithelial Ovarian Cancer

Investigational and Not Medically Necessary:

An autologous or allogeneic (ablative and non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, single or planned tandem is considered investigational and not medically necessary as a treatment of epithelial ovarian cancer.

Breast Cancer

Investigational and Not Medically Necessary:

An autologous or allogeneic (ablative and non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, single or planned tandem is considered investigational and not medically necessary as a treatment of breast cancer.

Malignant Astrocytomas and Gliomas

Investigational and Not Medically Necessary:

An autologous or allogeneic (ablative and non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, single or planned tandem is considered investigational and not medically necessary as a treatment of malignant astrocytomas and gliomas, including both glioblastoma multiforme and oligodendroglioma.

Other Miscellaneous Solid Tumors in Adults

Investigational and Not Medically Necessary:

An autologous or allogeneic (ablative and non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation, single or planned tandem is considered investigational and not medically necessary as a treatment of adult miscellaneous solid tumors, including but not limited to the following:

• Cancer of the bile duct;
• Cancer of the fallopian tubes;
• Cervical cancer;
• Colon cancer;
• Esophageal cancer;
• Gallbladder cancer;
• Lung cancer, any histology;
• Malignant melanoma;
• Neuroendocrine tumors;
• Nasopharyngeal cancer;
• Pancreas cancer;
• Paranasal sinus cancer;
• Prostate cancer;
• Rectal cancer;
• Renal cell cancer;
• Soft tissue sarcoma;
• Stomach cancer;
• Thyroid tumors;
• Tumors of the thymus;
• Uterine cancer;
• Undifferentiated tumors and tumors of unknown primary origin.