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: Adcetris® (brentuximab vedotin) – 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 :

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 Medications Tried, Their Name(s), Duration, and Patient Response:

Adcetris® (brentuximab vedotin)

Diagnosis (documentation supportive of diagnosis is required)

Hodgkin’s

Systemic anaplastic large cell lymphoma (ALCL)

Other (please state): ______

Updated 12/11/2019 Clinical Consideration (for approval, please indicate and provide documentation of the following):

Initial request

HODGKIN’S LYMPHOMA

Patient has failed an autologous hematopoietic stem cell transplant (auto-HSCT) Patient has failed at least 2 multi-agent regimens and is not a candidate for auto-HSCT • Potential regimens include but are not limited to: ABVD [, , , ], Stanford V [doxorubicin, vinblastine, mechlorethamine, , , bleomycin, ], BEACOPP [bleomycin, etoposide, doxorubicin, , vincristine, , prednisone] Patient is considered high-risk for relapse or disease progression after auto-HSCT • Defined according to status following frontline therapy: refractory, relapse within 12 months, or relapse > 12 months with extranodal disease

SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL)

Patient has failed at least 1 multi-agent • Potential regimens include but are not limited to: CHOP [cyclophosphamide, doxorubicin, vincristine, prednisone] or CHOEP [cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone]

Note: Approval duration is 12 months with a quantity limit of #4 vials per 21 days 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 with a quantity limit of #4 vials per 21 days when all criteria are met

Physician Specialty: Oncology Other specialty (please state): ______

Coverage Policy: ® Our guideline for BRENTUXIMAB (ADCETRIS ) requires a diagnosis of Hodgkin’s lymphoma or systemic anaplastic large cell lymphoma (ALCL). Our guideline for Hodgkin’s lymphoma requires failure of an auto-HSCT OR failure of at least 2 multi-agent chemotherapy regimens in a patient who is not a candidate for auto-HSCT OR use as consolidation therapy in a patient who is at high-risk for relapse or disease progression after auto-HSCT. Our guideline for ALCL requires failure of at least 1 multi-agent chemotherapy regimen.

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 Adcetris® (brentuximab) CLASSIFICATION

• Antineoplastic Agent • • Monoclonal Antibody DESCRIPTION

• Brentuximab vedotin is a CD30-directed antibody-drug conjugate (ADC) consisting of 3 components: 1) the chimeric IgG1 antibody cAC10 which is specific for human CD30; 2) the disrupting agent MMAE; and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. • The anticancer activity of brentuximab vedotin, is presumed to be due to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex and the release of MMAE via proteolytic cleavage. The microtubule disrupting agent MMAE binds to tubulin, disrupting the microtubule network which leads to arrest and apoptotic death of the cells. • Hodgkin’s lymphoma (HL) and anaplastic large-cell lymphoma (ALCL) are the two most common tumors expressing CD30. • Brentuximab vedotin is FDA-approved for the treatment of HL in patients who have failed autologous hematopoietic stem cell transplantation (auto-HSCT) or who are not auto-HSCT candidates and have failed at least 2 prior multi-agent chemotherapy regimens. Approval is based on overall response rates (ORR) of 73%, with a median duration of response of 6.7 months in a phase II, open-label, single- arm, multicenter trial (n=102). • Brentuximab vedotin is also FDA-approved for the treatment of HL in patients who are at high-risk of relapse or progression as post-auto-HSCT consolidation. Approval is based on progression-free survival (PFS) which was significantly improved with brentuximab vedotin compared with placebo (42.9 vs 24.1 months), but overall survival (OS) was not. However, 85% of patients in the placebo group received brentuximab vedotin after progression, and more patients in the placebo group subsequently received allogeneic stem-cell transplantation (23 vs 12 patients). The study enrolled adults with classical HL who had undergone high-dose chemotherapy and autologous stem-cell transplantation and had at least 1 risk factor for progression after the procedure: primary refractory disease, relapsed disease with initial remission of less than 12 months, or extranodal involvement at the start of pretransplantation salvage chemotherapy. • Brentuximab vedotin is also FDA-approved for the treatment of systemic ALCL in patients who have failed at least 1 multi-agent chemotherapy regimen. Approval is based on ORR of 86%, with a median duration of response of 12.6 months in a phase II, open-label, single-arm, multicenter trial (n=58). • The most common adverse reactions (≥20%) include neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting. FORMULARY COVERAGE

Prior authorization: Required Medicaid Formulary: Brand COVERAGE CRITERIA

Adcetris® (brentuximab) meets the definition of medical necessity for the following: • Hodgkin's lymphoma o Documentation required for 1 of the following: 1. Failure of autologous hematopoietic stem cell transplantation (auto-HSCT) 2. Failure of at least 2 prior multi-agent chemotherapy regimens in a patient who is not an auto-HSCT candidate. Potential regimens include but are not limited to: . ABVD [doxorubicin, bleomycin, vinblastine, dacarbazine] . Stanford V [doxorubicin, vinblastine, mechlorethamine, etoposide, vincristine, bleomycin, prednisone] . BEACOPP [bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone] 3. Use as consolidation therapy in a patient who is at high-risk for relapse or disease progression after auto-HSCT . Defined according to status following frontline therapy: refractory, relapse within 12 months, or relapse > 12 months with extranodal disease • Systemic anaplastic large cell lymphoma (ALCL) o Documentation required: 1. Failure of at least 1 multi-agent chemotherapy regimen. Potential regimens include but are not limited to: . CHOP [cyclophosphamide, doxorubicin, vincristine, prednisone] . CHOEP [cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone]

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

Required Provider Specialty: Oncology APPROVAL DURATION

• 12 months • Quantity limit: #4 vials per 21 days

DOSAGE/ADMINISTRATION

Adult Dosing (safety and efficacy has not been determined in children or in adults ≥ 65 years old):

Hodgkin’s lymphoma • 1.8mg/kg IV infusion over 30 minutes every 3 weeks • Continue until disease progression or unacceptable toxicity

Hodgkin’s lymphoma – as post-auto-HSCT consolidation treatment • 1.8mg/kg IV infusion over 30 minutes every 3 weeks • Initiate treatment within 4 to 6 weeks post-auto-HSCT or upon recovery from auto-HSCT • Continue for a maximum of 16 cycles, disease progression or unacceptable toxicity

Anaplastic large T-cell systemic malignant lymphoma (ALCL) • 1.8mg/kg IV infusion over 30 minutes every 3 weeks • Continue until disease progression or unacceptable toxicity

Dose Adjustments: See product information PRECAUTIONS

• Black Box Warning: Increased risk of progressive multifocal leukoencephalopathy (PML) • Contraindications: Concomitant use with bleomycin due to increased risk of pulmonary toxicity • Warnings/Precautions o Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported; discontinue use o Gastrointestinal: Serious and fatal complications have been reported, including perforation, hemorrhage, intestinal obstruction, and enterocolitis, with increased risk of perforation in patients with lymphoma and preexisting gastrointestinal involvement; monitoring recommended o Hematologic: Prolonged severe neutropenia may occur (dose delay, reduction, or discontinuation should be considered in addition to granulocyte colony stimulating factor prophylaxis with subsequent doses); Grade 3 or 4 thrombocytopenia may occur; Grade 3 or 4 anemia may occur; Febrile neutropenia has been reported; CBC monitoring prior to each treatment recommended o Hepatic: Preexisting moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is associated with an increased frequency of grade 3 or 4 adverse reactions and deaths (avoid use); preexisting mild (Child-Pugh A) hepatic impairment (dosage adjustments required); serious and sometimes fatal cases of hepatotoxicity have been reported and may occur following the first dose or with rechallenge; increased risk in patients with preexisting liver disease, elevated baseline liver enzymes, or receiving concomitant hepatotoxic medications; monitoring of liver enzymes and bilirubin required; interrupt, dose adjust, or discontinue use in patients experiencing new, worsening, or recurrent hepatotoxicity o Immunologic: Infusion-related reactions, including anaphylaxis, have been reported; monitoring required; if an infusion reaction occurs, interrupt administration, and premedicate with subsequent infusions; immediately and permanently discontinue therapy if anaphylaxis occurs; serious infections including opportunistic infections (i.e., pneumonia, bacteremia, and sepsis or septic shock) have been reported and may be fatal in some cases; monitoring recommended; increased risk of tumor lysis syndrome in patients with a rapidly proliferating tumor and high tumor burden; monitoring required o Neurologic: Peripheral neuropathy, predominantly sensory and sometimes motor, has been reported and is cumulative; monitoring required; interrupt, adjust, or discontinue dose if necessary o Renal: Preexisting severe renal impairment (creatinine clearance less than 30 mL/min) is associated with an increased frequency of grade 3 or 4 adverse reactions and deaths; avoid use o Reproductive: Fetal harm may occur; inform the patients of the potential hazard to the fetus should a patient be pregnant or become pregnant while taking this drug o Respiratory: Pulmonary toxicity (pneumonitis, interstitial lung disease, acute respiratory distress syndrome) has been reported; monitoring recommended and withhold if new or worsening respiratory symptoms develop BILLING/CODING INFORMATION

HCPCS Coding J9042 Injection, brentuximab vedotin, 1 mg (For billing prior to 1/1/13 use C9287 or J9999) COST

• AWP (January 2012): Adcetris® 50mg/vial (1): $5400.00 • AWP (February 2014): Adcetris® 50mg/vial (1): $6270.00 • AWP (June 2015): Adcetris® 50mg/vial (1): $7,034.40

COMMITTEE APPROVAL

• March 2012

GUIDELINE UPDATE INFORMATION

January 2012 Medical Policy created June 2014 Medical Policy updated November 2015 Medical Policy reviewed and updated July 2016 Coverage policy reviewed and updated July 2018 Renewal criteria added

REFERENCES

• DRUGDEX®, accessed 1/13/2012, 3/13/2012, 6/29/2014, 11/10/2015, 7/7/2016. • Product Information: Adcetris® (brentuximab vedotin), for IV injection. Seattle Genetics, Inc., Bothell, WA, August 2016. • Younes A, Barlett NL, Leonard JP, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive . N Eng J Med 2010; 363:1812-21.