CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization criteria, dosing limits, approved indications, prescriber requirements, approval durations, and non-covered situations for medical-benefit use of Nipent (pentostatin) across oncology indications including hairy cell leukemia, graft-versus-host disease, hematopoietic cell transplantation conditioning, hepatosplenic T-cell lymphoma, mycosis fungoides/Sezary syndrome, T-cell large granular lymphocytic leukemia, and T-cell prolymphocytic leukemia.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision; added T-Cell Prolymphocytic Leukemia approval option

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve only patients meeting the policy's criteria and dosing, and ensure prescriber is a specialist or consulted specialist.

SourceLink

POLICY UPDATE CHANGES

Hematopoietic Cell Transplantation: Added new condition of approval: T-Cell Prolymphocytic Leukemia with medication used as single agent as new option for approval.

Annual Revision with no criteria changes noted for 09/11/2024 review.

7Covered Indications Listed

1–6Approval durations vary (months)

1Not recommended: unlisted indications

Coverage Summary & Indications

Coverage stance: covered_with_criteria. Scope summary: policy defines prior authorization criteria, dosing limits, approved indications, prescriber specialty requirements, approval durations (months), and non-covered situations for medical-benefit use of Nipent (pentostatin) across oncology indications including hairy cell leukemia, graft-versus-host disease, hematopoietic cell transplantation conditioning, hepatosplenic T‑cell lymphoma, mycosis fungoides/Sezary syndrome, T‑cell large granular lymphocytic leukemia, and T‑cell prolymphocytic leukemia. Note: there is a boxed warning for dose-limiting severe renal, liver, pulmonary, and CNS toxicities and combination with fludarabine is not recommended due to risk of severe/fatal pulmonary toxicity. Guideline support is provided by NCCN guidelines cited for Hairy Cell Leukemia, Hematopoietic Cell Transplantation, T‑Cell Lymphomas, and Primary Cutaneous Lymphoma (see guideline references).

ALL of the following

ALL of the following
- A) Patient is ≥ 18 years of age: Patient is ≥ 18 years of age
B) Patient meets ONE of the following
- Medication is used as a single agent
- Medication is used in combination with rituximab
  Note: Rituximab products include Rituxan and biosimilars.
Medication is prescribed by or in consultation with an oncologist

ALL of the following

ALL of the following
- A) Patient has steroid-refractory disease: Patient has steroid-refractory disease
- Medication will be used in conjunction with systemic corticosteroids
  Examples of corticosteroids include prednisone and methylprednisolone.
- Medication is prescribed by or in consultation with an oncologist

ALL of the following

ALL of the following
- A) Patient is ≥ 4 years of age: Patient is ≥ 4 years of age
- Medication is used in combination with ONE of the following conditioning regimens
  - Busulfan
  - Busulfan plus cyclophosphamide
  - Cyclophosphamide plus total body irradiation
- Medication is used for reduced intensity conditioning

ALL of the following

ALL of the following
- A) Patient is ≥ 18 years of age: Patient is ≥ 18 years of age
- Medication used as
  - Medication is used as a single agent
  - Medication is in combination with Campath (alemtuzumab)
- Medication is prescribed by or in consultation with an oncologist

ALL of the following

ALL of the following
- A) Patient is ≥ 18 years of age: Patient is ≥ 18 years of age
- Patient has relapsed or refractory disease
- Medication will be used as a single agent
- Medication is prescribed by or in consultation with an oncologist or dermatologist

ALL of the following

ALL of the following
- A) Patient is ≥ 18 years of age: Patient is ≥ 18 years of age
- Patient has progressive or refractory disease
- Medication will be used as a single agent
- Medication is prescribed by or in consultation with an oncologist

ALL of the following

ALL of the following
- A) Patient is ≥ 18 years of age: Patient is ≥ 18 years of age
- Medication used as
  - Medication is used as a single agent
  - Medication will be used in combination with Campath (alemtuzumab)
- Medication is prescribed by or in consultation with an oncologist

Prior Authorization, Prescriber & Billing Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical-benefit coverage of Nipent. Approval is recommended only for patients meeting the policy's criteria and dosing; requests for doses outside the established dosing will be reviewed case-by-case by a clinician.

Documentation Required

Prescriber specialty requirement

Nipent must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., oncologist, transplant specialist, dermatologist as specified by indication).

Billing Rule

Approval duration and month definition

All approvals are provided for the durations noted in the policy (e.g., 6 months for many indications, 1 month for hematopoietic cell transplantation conditioning). Where approval is authorized in months, one month is defined as equal to 30 days.

Denial Risk

Not recommended for unlisted indications

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; claims for unlisted indications may be denied.

Background

Background: Nipent (pentostatin) is an adenosine deaminase inhibitor indicated as a single agent for untreated and alpha‑interferon refractory hairy cell leukemia in patients with active disease. It is also referenced across multiple NCCN guidelines for hematologic malignancies and transplant-related conditions. The drug carries a boxed warning for dose-limiting severe renal, liver, pulmonary, and CNS toxicities at higher-than-recommended doses; additionally, combination with fludarabine is not recommended because of the risk of severe or fatal pulmonary toxicity. Policy guidance also notes combination uses with agents such as rituximab or alemtuzumab in certain indications but highlights the fludarabine interaction caution.

Supplemental scope/context for operations: The policy defines prior authorization requirements and approves Nipent for listed indications with specified approval durations (e.g., Hairy Cell Leukemia: 6 months; Hematopoietic Cell Transplantation conditioning: 1 month; other adult indications commonly 6 months). Approval generally requires prescription by or consultation with a specialist (oncologist, transplant specialist, or dermatologist as indicated). Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; requests for doses outside documented dosing will be reviewed case-by-case by a clinician.

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary & Indications

Prior Authorization, Prescriber & Billing Requirements

Applicable Codes & Notes

Safety & Guideline Support

Background

Revision History