CurrentEmblemHealthPolicy MG.MM.PH.171

Medical Policy: Tepadina (thiotepa)

Defines EmblemHealth/ConnectiCare medical policy for coverage of Tepadina (thiotepa), including initial and renewal medical necessity criteria, limitations/exclusions, dosing reference, applicable procedure/NDC/ICD-10 codes, and authorization length.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Tepadina (thiotepa)

Policy CodePolicy MG.MM.PH.171

Change TypeAnnual review (no criteria changes)

Effective Date

Next Review Date

Key ActionTreating physician must submit clinical evidence that the member meets criteria (indication-specific documentation, HSCT plan, preparative regimen details, age) for preauthorization or post-payment review; without this documentation EmblemHealth cannot properly review the request.

SourceLink

POLICY UPDATE CHANGES

Annual Review: No criteria changes (2/11/2025).

Annual Review: updated NDCs, no criteria changes (1/2/2024).

Annual Review: no changes (4/18/2023).

Transfer to new template (1/13/2023).

New Policy (7/15/2019).

4Covered Indications (listed)

6 moInitial Authorization Duration

2NDCs listed

~16ICD-10 codes listed

Coverage Summary

Defines EmblemHealth/ConnectiCare medical policy for coverage of Tepadina (thiotepa). Coverage is covered with criteria and depends on the member's benefit plan and required documentation meeting the clinical criteria. Authorization is provided for 6 months and may be renewed when renewal criteria are met.

Initial Approval Criteria

Tepadina may be considered medically necessary if ONE of the listed indications is met AND use is consistent with the medical necessity criteria that follows; order must be written by a hematologist/oncologist.

ALL of the following

Specialist order requirement: Order is written by a hematologist/oncologist
Indication (one of)
- Class 3 Beta-Thalassemia
  - Class 3 criteria: Liver size > 2 cm> 2 cm
  - Class 3 criteria: Presence of liver fibrosis
  - Class 3 criteria: Inadequate iron chelation
  - HSCT: Patient is undergoing allogeneic hematopoietic progenitor stem cell transplant (HSCT)
  - Preparative regimen: Tepadina is used as part of a preparative regimen consisting of high-dose busulfan and cyclophosphamide
  - Age requirement: Patient is under 18 years of age
- Adenocarcinoma of the breast or ovary (including malignant effusions)
- Malignant effusions (e.g., malignant pleural effusion J91.0)
- Superficial papillary carcinoma of the urinary bladder (including carcinoma in situ and specified C67.x sites)

Continuation / Renewal Criteria

Renewal Criteria

Renewal for additional 6 months may be approved if:

ALL of the following

Renewal requirements: Patient continues to meet Initial Approval Criteria
Tumor response with disease stabilization or reduction of tumor size and spread

Initial Authorization Duration6 months

Renewal Duration6 months

Liver size threshold

Limitations / Exclusions

Limitations/Exclusions

Tepadina is not considered medically necessary when any of the following apply:

Limitations/Exclusions: Indications not supported by CMS-recognized compendia or acceptable peer-reviewed literature

Applicable Codes

Applicable Procedure Codes (HCPCS/J-codes equivalent description provided in policy)HCPCS|mixedCovered

Injection, Thiotepa, 15 mg (1 billable unit = 15 mg)

Procedure code entry in policy; exact HCPCS/J-code number not specified in document

Applicable NDCsNDCCovered

70121-1631-01	Tepadina single use vial; 15 mg powder for injection
70121-1630-01	Tepadina 15 mg Solution Reconstituted

Applicable ICD-10 Diagnoses (covered indications listed)ICD-10Covered

C50.919	Malignant neoplasm of unspecified site of unspecified female breast
C56.9	Malignant neoplasm of unspecified ovary
C67.0	Malignant neoplasm of trigone of bladder
C67.1	Malignant neoplasm of dome of bladder
C67.2	Malignant neoplasm of lateral wall of bladder
C67.4	Malignant neoplasm of posterior wall of bladder
C67.5	Malignant neoplasm of bladder neck
C67.6	Malignant neoplasm of ureteric orifice
C67.7	Malignant neoplasm of urachus
C67.8	Malignant neoplasm of overlapping sites of bladder

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Provider Actions & Authorization Requirements

Prior Authorization

Preauthorization documentation required

The treating physician must submit clinical evidence that the member meets the coverage criteria for preauthorization or post-payment review. Without this documentation EmblemHealth cannot properly review the request.

Indication-specific documentation
HSCT plan
Preparative regimen details (high-dose busulfan and cyclophosphamide when applicable)
Patient age (e.g., under 18 years for Class 3 beta-thalassemia with HSCT)

Documentation Required

Specialist order requirement

Order must be written by a hematologist/oncologist.

Clinical Evidence & References

Product Information: TEPADINA (thiotepa) intravenous/intracavitary/intravesical injection ADIENNE SA, 2017.

EmblemHealth based the policy criteria on available clinical literature, CMS-recognized compendia, and evidence-based guidelines and professional guidance; treating physicians must submit clinical documentation to support medical necessity for preauthorization or post-payment review.

Revision history notes routine annual reviews and administrative updates with no clinical criteria changes (e.g., annual reviews 2/11/2025; 1/2/2024; 4/18/2023).

Background & Definitions

Tepadina (thiotepa) is an alkylating agent that produces cross-linking of DNA strands, leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent. EmblemHealth's criteria apply to coverage determinations under EmblemHealth/ConnectiCare plans and are based on the available clinical literature, compendia, and guidelines; coverage decisions also depend on the member's benefit program and required supporting documentation. The policy defines initial and renewal medical necessity criteria (including indication-specific documentation and specialist order requirement) and specifies that authorization is for 6 months with possible renewal.

Definitions: Tepadina = brand name for thiotepa, an alkylating chemotherapy agent that cross-links DNA and is cell-cycle independent. One billable unit equals 15 mg thiotepa per policy procedure code; applicable NDCs include 70121-1631-01 (15 mg powder vial) and 70121-1630-01 (15 mg solution reconstituted).

Revision History

2/11/2025revisedLatest

Annual Review: No criteria changes. (material: no)

1/2/2024revised

Annual Review: updated NDCs, no criteria changes. (material: no)

4/18/2023revised

Annual Review: no changes. (material: no)