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UNIFORM PHARMACY PRIOR AUTHORIZATION REQUEST FORM

CONTAINS CONFIDENTIAL PATIENT INFORMATION Complete this form in its entirety and send to Rocky Mountain Health Plans at 833-787-9448

Urgent 1 Non-Urgent Requested Drug Name: Beleodaq® (belinostat) – Medicaid

Patient Information: Prescribing Provider Information: Patient Name: Prescriber Name: Member/Subscriber Number: Prescriber Fax: Policy/Group Number: Prescriber Phone: Patient Date of Birth (MM/DD/YYYY): Prescriber Pager: Patient Address: Prescriber Address:

Patient Phone: Prescriber Office Contact: Patient Email Address: Prescriber NPI: Prescriber DEA: Prescription Date: Prescriber Tax ID: Specialty/Facility Name (If applicable): Prescriber Email Address:

Prior Authorization Request for Drug Benefit: New Request Reauthorization Patient Diagnosis and ICD Diagnostic Code(s):

Drug(s) Requested (with J-Code, if applicable):

Strength/Route/Frequency:

Unit/Volume of Named Drug(s):

Start Date and Length of Therapy:

Location of Treatment: (e.g. provider office, facility, home health, etc.) including name, Type 2 NPI (if applicable), address and tax ID:

Clinical Criteria for Approval, Including other Pertinent Information to Support the Request, other Tried, Their Name(s), Duration, and Patient Response:

Beleodaq® (belinostat)

Diagnosis (documentation supportive of diagnosis is required)

Relapsed or refractory peripheral T-cell lymphoma (documentation of diagnosis and prior therapy required)

Other (please state):______

Updated 12/19/2019 Clinical Note (please acknowledge the following)

Initial request

FDA approval is based on tumor response rate and duration of response from a Phase II, open-label, single-arm, non-randomized trial in 120 evaluable patients. Overall response rate was 25.8% (n=31); improvements in survival or disease-related symptoms are not established.

Beleodaq® is metabolized primarily by hepatic UGT1A1. Patients known to be homozygous for the UGT1A1*28 allele should initiate treatment at a reduced dose.

Note: Approval duration is 12 months when all criteria are met

Reauthorization requirement (clinical documentation required): Documentation to support treatment is efficacious for the patient. Attestation that treatment has been effective over previously approved duration.

Note: Approval duration is 12 months when all criteria are met

Physician Specialty Oncology Other (please state): ______

For use in clinical trial? (If yes, provide trial name and registration number):

Drug Name (Brand Name and Scientific Name)/Strength:

Dose: Route: Frequency: Quantity: Number of Refills: Product will be delivered to: Patient’s Home Physician Office Other: Prescriber or Authorized Signature: Date:

Dispensing Pharmacy Name and Phone Number:

Approved Denied If denied, provide reason for denial, and include other potential alternative medications, if applicable, that are found in the formulary of the carrier:

1. A request for prior authorization that if determined in the time allowed for non-urgent requests could seriously jeopardize the life or health of the covered person or the ability of the covered person to regain maximum function, or subject the person to severe pain that cannot be adequately managed without the drug benefit contained in the prior authorization request RMHP Formulary Coverage Policy

THIS INFORMATION IS NOT ALL-INCLUSIVE AND IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY

Beleodaq® (belinostat)

CLASSIFICATION

• (HDAC) inhibitor

DESCRIPTION

• The FDA approved Beleodaq® under the agency’s accelerated approval program for the treatment of patients with peripheral T-cell lymphoma (PTCL). Approval is only based on tumor response rate and duration of response. Survival or disease-related symptom improvement has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. • Beleodaq® is a hydroxamate histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, as an HDACi, Beleodaq® caused accumulation of acetylated histones and other proteins, thus inducing arrest and/or apoptosis of some transformed cells. • In a single phase II, nonrandomized, single-arm, open-label, multicenter, international, pivotal study (BELIEF), 120 patients with relapsed or refractory PTCL received treatment with Beleodaq® as a single agent after failure of at least one prior systemic therapy (excluding prior HDACi therapy). A complete or partial response was achieved in 25.8%, with a median time to response of 5.6 weeks and median duration of response of 8.4 months; 7.5% were able to proceed with stem cell transplant. An improvement in survival or disease-related symptoms has not been established. • The most common AEs in the pivotal clinical trial (incidence ≥ 25%) were nausea, fatigue, pyrexia, anemia, and vomiting. Serious AEs occurred in 47.3% (61/129 patients) and included were pneumonia, pyrexia, infection, anemia, increased serum creatinine, thrombocytopenia, and multi- organ failure. • PTCL therapies: First-line includes multi-agent chemotherapy and is usually with CHOP (, , , and prednisone) or variations of CHOP. Chemotherapy is only curative in a small number of patients with most either not achieving remission or relapsing. Clinical trial enrollment is the preferred treatment option for relapsed or refractory PTCL. When clinical trial is not an option, 2nd line are used. The choice of 2nd line therapy depends on the type of PTCL and whether the patient is a candidate for autologous or allogeneic hematopoietic cell transplantation (HCT). Second-line treatments include traditional regimens such as ICE (, , ), DHAP (dexamethasone, high dose , and ), ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin), single agent , GDP (gemcitabine, cisplatin, and dexamethasone), and gemcitabine plus . Second-line novel agents include Adcetris® (brentuximab vedotin), Folotyn® (), Istodax® () and Beleodaq® (belinostat). • Both NCCN® Non-Hodgkin’s Lymphoma guidelines (version 4.2014) and UpToDate® (online – Treatment of relapsed or refractory peripheral T cell lymphoma – accessed 9/11/14) recommend enrollment in clinical trials when available as the preferred treatment for all patients with PTCL. UpToDate® also prefers administration of a traditional rather than use of a novel agent due to higher response rates seen with the traditional agents and the knowledge that those who achieve a CR have a chance of long-term survival with HCT. They reserve the novel agents for subsequent relapses or patients receiving treatment with non-curative intent. • NCCN® lists Beleodaq® as a 2nd line therapy option in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, PTCL not otherwise specified, anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma in patients who are or who are not candidates for transplant (category 2B recommendation). FORMULARY COVERAGE

Prior authorization: Required Medicaid Formulary: Brand

COVERAGE CRITERIA

Beleodaq® (belinostat) meets the definition of medical necessity for the following: • Relapsed or refractory peripheral T-cell lymphoma o Documentation of diagnosis and prior therapies from the patient’s medical record is required. o Please also acknowledge the following: . FDA approval is based on tumor response rate and duration of response from a Phase II, open-label, single-arm, non-randomized trial in 120 evaluable patients. Overall response rate was 25.8% (n=31). . Improvements in survival or disease-related symptoms are not established. . Beleodaq® is metabolized primarily by hepatic UGT1A1. Patients known to be homozygous for the UGT1A1*28 allele should initiate treatment at a reduced dose. o When criteria are met, approval will be granted in annual increments

Beleodaq® (belinostat) is considered experimental for the following: • Any condition or diagnosis not FDA approved or Compendia supported

Required Provider Specialty: • Oncology

DOSAGE/ADMINISTRATION

Adult Dosing (safety and efficacy has not been determined for pediatric patients less than 18 years): • Note: Evaluate serum chemistry, including renal and hepatic function, prior to the first dose in each cycle and ensure the absolute neutrophil count is 1 x 109/L or greater and platelet count is 50 x 109/L or greater. • Relapsed or refractory peripheral T-cell lymphoma: 1,000mg/m2 IV infusion over 30 minutes once daily on days 1-5 of a 21-day cycle; continue until disease progression or unacceptable toxicity. • Relapsed or refractory peripheral T-cell lymphoma (homozygous for UGT1A1*28 allele): Reduce the starting dose to 750 mg/m2 IV infusion over 30 minutes on days 1 through 5 of a 21-day cycle.

PRECAUTIONS

• Gastrointestinal: nausea, vomiting and diarrhea have been reported. Antiemetic and antidiarrheal medications may be necessary. • Hematologic: thrombocytopenia, leukopenia (neutropenia and lymphopenia) and anemia may occur. Monitor blood counts and modify dosage for hematologic toxicities. • Hepatic: fatal hepatotoxicity and liver function test abnormalities may occur. Monitor liver function tests and omit or modify dosage for hepatic toxicities. • Immunologic: serious and sometimes fatal infections (e.g., pneumonia and sepsis) have been reported. Do not administer to patients with an active infection. • Embryo-fetal toxicity: avoid use during pregnancy. • Tumor lysis syndrome has been reported. Monitor patients with advanced stage disease and/or high tumor burden. Take appropriate precautions. • Avoid concomitant us with strong inhibitors of UGT1A1.

BILLING/CODING INFORMATION

CPT Coding 96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug

HCPCS Coding C9399 Unclassified drugs or biologicals

COST

• AWP (September 2014): Beleodaq® IV 1000mg/m2 (500mg vial): $1,800

COMMITTEE APPROVAL

• September 2014

GUIDELINE UPDATE INFORMATION

September 2014 Prior Authorization and Coverage Policy created August 2018 Renewal criteria added

REFERENCES

• DRUGDEX®, accessed 09/14/2014. • Product Information: Beleodaq® (belinostat), for intravenous injection. Spectrum Pharmaceutical, Inc. Irvine, CA; July 2014. • The NCCN Non-Hodgkin’s Lymphomas Clinical Practice Guidelines in Oncology (Version 4.2014). ©2014 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on September 14, 2014. • Treatment of relapsed or refractory peripheral T cell lymphoma. ©2014 UpToDate®. Available at: www.uptodate.com. Accessed on September 11, 2014.