This document addresses hematopoietic stem cell transplantation in multiple myeloma, amyloidosis and POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes).

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

• CG-TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies after Allogeneic Hematopoietic Progenitor Cell Transplantation
• TRANS.00016 Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation
• TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome

Note: For information about Waldenström’s Macroglobulinemia, see

TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma

Position Statement

Multiple Myeloma

Medically Necessary:

Autologous hematopoietic stem cell transplantation (AutoHSCT) for treatment of individuals with multiple myeloma is considered medically necessary when used as:

1. As a single transplant (AutoHSCT); or
2. As a tandem* transplant (two AutoHSCTs separated by 30 to 180 days); or
3. As a repeat procedure (AutoHSCT greater than 180 days following a previous AutoHSCT); or
4. As a pretreatment for a non-myeloablative allogeneic hematopoietic stem cell transplant; or
5. As salvage therapy after:
   1. Primary graft failure; or
   2. Failure to engraft; or
   3. Rejection following an allogeneic HSCT.

Allogeneic (ablative or non-myeloablative) stem cell transplantation after a previous autologous stem cell transplant for treatment of individuals with multiple myeloma is considered medically necessary.

A planned tandem non-myeloablative allogeneic transplantation following an autologous transplantation is considered medically necessary for treatment of individuals with multiple myeloma.

A repeat allogeneic (ablative or non-myeloablative) stem cell transplantation due to primary graft failure, failure to engraft or rejection is considered medically necessary.

Hematopoietic stem cell harvesting** for an anticipated but unscheduled transplant is considered medically necessary in individuals with multiple myeloma who meet one of the above criteria and for whom the treating physician documents that a future transplant is likely.

Investigational and Not Medically Necessary:

Allogeneic (ablative or non-myeloablative) stem cell transplantation or autologous stem cell transplantation is considered investigational and not medically necessary for individuals with multiple myeloma who do not meet the above criteria.

Hematopoietic stem cell harvesting for a future but unscheduled transplant is considered investigational and not medically necessary when the criteria above are not met.

A repeat allogeneic (ablative or non-myeloablative) stem cell transplantation due to persistent, progressive or relapsed disease is considered investigational and not medically necessary.

Three or more autologous hematopoietic stem cell transplantations within a 12-month period are considered investigational and not medically necessary.

Amyloidosis

Medically Necessary:

Autologous stem cell transplantation is considered medically necessary for individuals with primary amyloidosis (AL) who meet the following criteria:
Note: (If the individual has a preceding diagnosis of multiple myeloma, use the transplant criteria above for multiple myeloma).

1. If the heart is involved with AL, the individual is asymptomatic or has compensated congestive heart failure; and
2. Left ventricular ejection fraction (LVEF) greater than or equal to 45%; and
3. Must have documented disease on biopsy without a preceding diagnosis of multiple myeloma.

A repeat autologous stem cell transplantation due to primary graft failure or failure to engraft is considered medically necessary.

Hematopoietic stem cell harvesting** for an anticipated but unscheduled transplant is considered medically necessary in individuals with amyloidosis who meet one of the above criteria and for whom the treating physician documents that a future transplant is likely.

Investigational and Not Medically Necessary:

Autologous stem cell transplantation is considered investigational and not medically necessary in the treatment of primary amyloidosis in individuals with symptomatic heart failure regardless of the number of organs involved.

Allogeneic (ablative or non-myeloablative) stem cell transplantation is considered investigational and not medically necessary for treatment of individuals with amyloidosis.

A tandem* autologous stem cell transplantation is considered investigational and not medically necessary for treatment of individuals with amyloidosis.

A repeat autologous stem cell transplantation due to persistent, progressive or relapsed disease is considered investigational and not medically necessary.

Hematopoietic stem cell harvesting for a future but unscheduled transplant is considered investigational and not medically necessary when the criteria above are not met.

POEMS Syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes)

Medically Necessary:

Autologous stem cell transplantation is considered medically necessary for treatment of POEMS Syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes) when diagnostic criteria for that syndrome are met.

A repeat autologous stem cell transplantation due to primary graft failure or failure to engraft is considered medically necessary.

Hematopoietic stem cell harvesting** for an anticipated but unscheduled transplant is considered medically necessary in individuals with POEMS syndrome who meet one of the above criteria and for whom the treating physician documents that a future transplant is likely.

Investigational and Not Medically Necessary:

Autologous stem cell transplantation for treatment of individuals with POEMS Syndrome is considered investigational and not medically necessary when the above criteria are not met.

Allogeneic (ablative or non-myeloablative) stem cell transplantation for treatment of individuals with POEMS Syndrome is considered investigational and not medically necessary.

A tandem* autologous stem cell transplantation for treatment of individuals with POEMS Syndrome is considered investigational and not medically necessary.

A repeat autologous stem cell transplantation due to persistent, progressive or relapsed POEMS is considered investigational and not medically necessary.

Hematopoietic stem cell harvesting for a future but unscheduled transplant is considered investigational and not medically necessary when the criteria above are not met.

* Tandem transplantation refers to a planned infusion (transplant) of previously harvested hematopoietic stem cells with a repeat hematopoietic stem cell infusion (transplant) that is performed within 6 months of the initial transplant. This is distinguished from a repeat transplantation requested or performed more than 6 months after the first transplant, and is used as salvage therapy after failure of initial transplantation or relapsed disease.

** Hematopoietic stem cell harvesting does not include the transplant procedure.