Oncologic Indications for Histone deacetylase (HDAC) inhibitors

Policy ID: I-159-008

Effective Date: February 01, 2019

Revised Date: January 08, 2024

Revision Effective Date: March 01, 2024

Last Reviewed: January 16, 2024

Applies To: Commercial and Medicaid Expansion

Description

Histone deacetylase (HDAC) inhibitors are a group of agents that inhibit the histone deacetylase enzymes. As a result, medications like belinostat (Beleodaq®) and romidepsin (Istodax®) induce cell cycle arrest and apoptosis.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Belinostat (Beleodaq) may be considered medically necessary for ANY of the following conditions:

Peripheral T-Cell Lymphoma

As treatment of individuals 18 years of age and older with relapsed or refractory peripheral T-cell lymphoma; or

Compendia Sources

Belinostat (Beleodaq) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of belinostat (Beleodaq) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9032

Romidepsin (Istodax) may be considered medically necessary for ANY of the following conditions:

Cutaneous T-Cell Lymphoma

In individuals 18 years of age and older who have received at least one prior systemic therapy; or

Compendia Sources

Romidepsin (Istodax) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of romidepsin (Istodax) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9318

J9319

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered diagnosis codes for J9032

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C84.60

C84.61

C84.62

C84.63

C84.64

C84.65

C84.66

C84.67

C84.68

C84.69

C84.70

C84.71

C84.72

C84.73

C84.74

C84.75

C84.76

C84.77

C84.78

C84.79

C84.7A

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.A0

C84.A1

C84.A2

C84.A3

C84.A4

C84.A5

C84.A6

C84.A7

C84.A8

C84.A9

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C86.2

C86.5

C86.6

C91.50

C91.51

C91.52

Covered Diagnosis codes for J9318 and J9319

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C84.60

C84.61

C84.62

C84.63

C84.64

C84.65

C84.66

C84.67

C84.68

C84.69

C84.70

C84.71

C84.72

C84.73

C84.74

C84.75

C84.76

C84.77

C84.78

C84.79

C84.7A

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.A0

C84.A1

C84.A3

C84.A4

C84.A5

C84.A6

C84.A7

C84.A8

C84.A9

C84.A2

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C86.2

C86.5

C86.6

Professional Statements and Societal Positions Guidelines

Not Applicable

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020 Annual review, no clinical changes,

belinostat (Beleodaq) - J9032,
romidepsin (Istodax) - will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 7-22-2020 Revision

Added additional NCCN recommendations for belinostat (Beleodaq) and romidepsin (Istodax),
Updated formatting, diagnosis codes and references

Internal Medical Policy Committee 9-21-2020 Coding update

Added new code, C9065, to policy

Internal Medical Policy Committee 9-21-2021 Coding update

Added new codes J9318 and J9319 to the policy, and
Removed C9065 and J9315, and
Added Diagnosis code C84.7A

Internal Medical Policy Committee 9-28-2022 Annual review - no change in criteria

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Removed NCCN recommendations and added this statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Removed diagnosis code Z85.72 from J9032 and J9318/J9319
Updated experimental/investigational statement

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-159-007

Effective Date: February 01, 2019

Revised Date: January 16, 2023

Revision Effective Date: March 01, 2023

Last Reviewed: January 26, 2023

Archived Date: February 29, 2024

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Belinostat (Beleodaq) may be considered medically necessary for ANY of the following conditions:

Peripheral T-Cell Lymphoma

As treatment of individuals 18 years of age and older with relapsed or refractory peripheral T-cell lymphoma; or

Compendia Sources

Belinostat (Beleodaq) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Code

J9032

Romidepsin (Istodax) may be considered medically necessary for ANY of the following conditions:

Cutaneous T-Cell Lymphoma

In individuals 18 years of age and older who have received at least one prior systemic therapy; or

Compendia Sources

Romidepsin (Istodax) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Codes

J9318

J9319

Diagnosis Codes

Covered diagnosis codes for J9032

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C84.60

C84.61

C84.62

C84.63

C84.64

C84.65

C84.66

C84.67

C84.68

C84.69

C84.70

C84.71

C84.72

C84.73

C84.74

C84.75

C84.76

C84.77

C84.78

C84.79

C84.7A

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.A0

C84.A1

C84.A2

C84.A3

C84.A4

C84.A5

C84.A6

C84.A7

C84.A8

C84.A9

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C86.2

C86.5

C86.6

C91.50

C91.51

C91.52

Covered Diagnosis codes for J9318 and J9319

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C84.60

C84.61

C84.62

C84.63

C84.64

C84.65

C84.66

C84.67

C84.68

C84.69

C84.70

C84.71

C84.72

C84.73

C84.74

C84.75

C84.76

C84.77

C84.78

C84.79

C84.7A

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C84.A0

C84.A1

C84.A3

C84.A4

C84.A5

C84.A6

C84.A7

C84.A8

C84.A9

C84.A2

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C86.0

C86.1

C86.2

C86.5

C86.6

Professional Statements and Societal Positions Guidelines

Not Applicable

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020 Annual review, no clinical changes,

belinostat (Beleodaq) - J9032,
romidepsin (Istodax) - will require pre-certification as of 2/1/2020

Internal Medical Policy Committee 7-22-2020 Revision

Added additional NCCN recommendations for belinostat (Beleodaq) and romidepsin (Istodax),
Updated formatting, diagnosis codes and references

Internal Medical Policy Committee 9-21-2020 Coding update

Added new code, C9065, to policy

Internal Medical Policy Committee 9-21-2021 Coding update

Added new codes J9318 and J9319 to the policy, and
Removed C9065 and J9315, and
Added Diagnosis code C84.7A

Internal Medical Policy Committee 9-28-2022 Annual review - no change in criteria

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Removed NCCN recommendations and added this statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Removed diagnosis code Z85.72 from J9032 and J9318/J9319
Updated experimental/investigational statement

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