CurrentCentenePolicy CPMP.108

Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and B-Thalassemia

Defines medical necessity criteria for allogeneic hematopoietic cell transplants for members with sickle cell anemia or homozygous beta-thalassemia, lists absolute contraindications, and states procedures considered insufficiently evidenced (autologous HCT and AHCT outside specified indications). Includes coding examples for informational purposes.

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and B-Thalassemia

Policy CodePolicy CPMP.108

Change TypeRevised (minor format/verbiage updates)

Effective Date

Next Review Date

Key ActionProviders must document HLA-matching donor availability and the stem cell source (cord blood, bone marrow, or peripheral blood) to meet indication-specific criteria.

POLICY UPDATE CHANGES

Removed age limit criteria and removed first-degree relative donor requirement for cord blood; removed serial blood and urine testing details; added note regarding younger recipients having better outcomes.

2Primary Conditions Addressed

3Stem Cell Sources Enumerated

3Absolute Contraindications Listed

Coverage Summary

Medical-Necessity Criteria

Medically Necessary Indications

Allogeneic hematopoietic cell transplants for sickle cell anemia and homozygous beta-thalassemia are medically necessary when ALL of the following for the respective indication are met:

One of the following indications

Sickle cell anemia
- Diagnosis of sickle cell anemia
- History of stroke or is at high risk of stroke or end-organ damage
  - Prior stroke
  - Recurrent acute chest syndrome
  - Recurrent vaso-occlusive crises
  - Red blood cell alloimmunization on chronic transfusion therapy
- An HLA-matched, first-degree relative donor is available
Homozygous B-thalassemia
- Acceptable stem cell source and donor availability
  - Cord blood source
    Cord blood is the source of stem cells
    An HLA-matched donor is available
  - Bone marrow source
    Bone marrow is the source of stem cells
    An HLA-matched donor is available
  - Peripheral blood source

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Absolute Contraindications (Not Eligible)

The member must NOT have ANY of the following absolute contraindications:

Absolute contraindications

Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support
Infections with highly virulent and/or resistant microbes that are poorly controlled pre-transplant
Active substance use or dependence including current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), or IV use without convincing evidence of risk reduction behaviors (unless urgent transplant timelines are present, in which case a commitment to reducing behaviors is acceptable)

Insufficient Evidence / Not Covered

The following are considered insufficient evidence regarding safety and efficacy:

Insufficient evidence items

Autologous hematopoietic cell transplant for B-thalassemia not in the context of gene therapy
Autologous hematopoietic cell transplant for sickle cell anemia not in the context of gene therapy
Allogeneic hematopoietic cell transplants for sickle cell anemia or homozygous B-thalassemia for any indications other than those specified above

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Provider Actions & Documentation Requirements

Documentation Required

Document donor match and stem cell source

Providers must document HLA-matching donor availability and the stem cell source (cord blood, bone marrow, or peripheral blood) to meet indication-specific criteria.

Documentation Required

Document history of complications in sickle cell candidates

For sickle cell anemia candidates, providers must document prior stroke or evidence of high risk of stroke/end-organ damage via prior stroke, recurrent acute chest syndrome, recurrent vaso-occlusive crises, or red blood cell alloimmunization on chronic transfusion therapy.

Documentation Required

Document transfusion dependence and conditioning plan for B-thalassemia

For homozygous B-thalassemia candidates, providers must document transfusion dependence, planned use of a standard myeloablative conditioning regimen, and rationale for the chosen stem cell source.

Background & Evidence

Allogeneic hematopoietic cell transplant (AHCT) is described as the only curative therapy for sickle cell disease and is recognized as a cure for these hemoglobinopathies; pediatric success rates in specific groups have been reported at 85–90% and three-year survival in series is reported at approximately 90%.

Outcomes vary by age, donor availability, conditioning regimen, and disease-specific organ complications (for thalassemia: iron overload and organ dysfunction; for sickle cell anemia: history of cerebral events and chronic inflammation).

Major risks and limitations include graft-versus-host disease (GvHD), rejection, HCT-related organ toxicities, and long-term morbidities such as infertility/gonadal failure.

Evidence Highlights

Pediatric success rate cited85-90% success in specific pediatric groups

Three-year survival citedApproximately 90% overall in reviewed series

Thalassemia survival rangeOverall survival and thalassemia-free survival approx. 65-90% in reports

AHCT: Allogeneic hematopoietic cell transplant — transplantation of hematopoietic stem/progenitor cells from a donor to replace a recipient's defective hematopoiesis; cited as the only curative therapy for sickle cell disease and used for B-thalassemia.

HLA-matched donor: A donor with compatible human leukocyte antigen typing to reduce graft-versus-host disease risk; use of HLA-matched donors (particularly siblings) lowers GvHD risk and is a stated requirement in indication-specific criteria.

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.

OpenPayer

Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and B-Thalassemia

Coverage Summary

Medical-Necessity Criteria

Provider Actions & Documentation Requirements

Coding

Background & Evidence

Revision History