Archived Policies - Prescription Drugs


Belinostat (Beleodaq®)

Number:RX502.037

Effective Date:01-01-2015

End Date:04-14-2017

Coverage:

The medical policy is a set of guidelines supporting the current standards of practice based on available peer-reviewed, evidenced based literature. The requested therapy must be proven effective for the diagnosis, procedure, drug dose, frequency and duration, if applicable, and be consistent with recommendations in at least one authoritative source. The Medical Policy is supported by the FDA approved labeling, nationally recognized societies and evidenced base guidelines. These references may include, but are not limited to: MCG care guidelines, Hayes, DrugDex (IIb level of evidence or higher), NCCN (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

Belinostat (Beleodaq®) may be considered medically necessary in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Belinostat (Beleodaq®) is considered experimental, investigational and/or unproven when used in the treatment of any other conditions.

Description:

Lymphoma is a blood cancer and occurs when lymphocytes (cells of the immune system) multiply and grow uncontrollably. Peripheral T-Cell Lymphoma (PTCL) is a form of non-Hodgkin Lymphoma (NHL). Peripheral T-cell Lymphomas are classified into different subtypes. Peripheral T-Cell Lymphoma account for approximately 10-15% of all NHL cases in the United States. (1) These rare and frequently aggressive NHLs develop from mature T-cells. Relapses of PTCL following responses to various treatments may occur. PTCL is a characterized by an aggressive clinical course; with an overall 5-year disease –free survival of less than 30%. Clinical trials to identify new therapies that provide more effective treatments are vital.

Beleodaq is a histone deacetylase (HDAC) inhibitor. The enzyme HDAC, which is responsible for the deacetylation of histone proteins that in turn promotes closed chromatin and inhibits gene transcription. By blocking HDAC enzyme, belinostat has a wide range of effects on malignant cells, including, cell cycle growth arrest, inhibition of angiogenesis, inhibition of cell differentiation, apoptosis, autophagy, and immune modulation. (2)

Regulatory Status

Recently Beleodaq® received accelerated approval from the FDA for treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The indication was approved based on tumor response rate and duration of response. Improvement has not been established for survival or disease-related symptoms. (3) This drug product for this indication has an orphan drug designation. The safety and effectiveness of Beleodaq in pediatric patients have not been established.

Rationale:

Clinical Study

Beleodaq® FDA- approval was based on a non-randomized, single-arm international trial performed at 62 centers. One hundred twenty nine patients with refractory or relapsed Peripheral T-cell Lymphoma (PTCL) were treated with Beleodaq. Treatment consisted of once daily IV infusion on Days 1-5 of a 21-day cycle. Cycles were repeated every three weeks until disease progression or unacceptable toxicity. Primary efficacy endpoint was complete and partial response rate. Duration of response was the secondary efficacy endpoint. Response assessments were conducted up to 2 years from the start of the study treatment. Duration response was evaluated from the first day of recorded response to disease progression or death. The overall response rate per was 25.8% (n=31). Median duration of response was 8.4 months (95% CI:4.5 – 29.4). (3) The median time to response was 5.6 weeks (range 4.3 – 50.4 weeks). The median overall survival was 7.9 months (95% CI:6.1 – 13.9). The one year OS (probability of being alive at one year) was 40.9%. (4)

The National Comprehensive Cancer Network (NCCN)

The NCCN Guidelines for Non-Hodkin’s Lymphoma (3.2014 version) indicated an update from the 2.2014 version to include: Belinostat (category 2B) Second-line therapy: for both candidate and non-candidate for transplant for Peripheral T-cell lymphoma patients. (5)

Ongoing Clinical Trials

Multiple trials of belinostat are currently underway for various cancers. There are currently 34 studies listed using the term “belinostat” at ClinicalTrials.gov website.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

N/A

HCPCS Codes

J9032, [Deleted 1/2016: C9442]

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

N/A

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

N/A


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Peripheral T-Cell Lymphoma (PTCL). Lymphoma Research Foundation. Available at <www.lymphoma.org> Accessed on 2014 November 21.

2. Belinostat (Beleodaq) TEC Specialty Pharmacy Report #12-2014. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (2014 Aug):1-23.

3. Beleodaq® Highlights of Prescribing Information. United States Food and Drug administration. Available at < http://www.accessdata.fda.gov> Accessed 2014 November 21.

4. Beleodaq Summary Review. United States Food and Drug Administration. Available at <www.accessdata.fda.gov> Accessed 2014 December.

5. NCCN – Non-Hodgkin’s Lymphomas 5.2014 (2014 November 21). National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Available at <http://www.nccn.org> (accessed on 2014 November 21).

Policy History:

Date Reason
1/1/2015 New medical document. Belinostat (Beleodaq®) may be considered medically necessary in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Belinostat (Beleodaq®) is considered experimental, investigational and/or unproven when used in the treatment of any other conditions.

Archived Document(s):

Title:Effective Date:End Date:
Belinostat (Beleodaq)04-15-201709-14-2018
Belinostat (Beleodaq)01-01-201504-14-2017
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