“What’s New” Medical Pharmaceutical Policy March 2020 Updates MBP 48.0 Rituxan (rituximab) and Truxima (rituximab-abbs)- Updated policy

Rituxan (rituximab) and Truxima (rituximab-abbs) are is a genetically engineered chimeric murine/human monoclonal antibodies directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. Rituximab has been shown to be effective in rheumatoid arthritis in three randomized controlled trials and is now FDA-approved for use in combination with methotrexate (MTX) for reducing signs and symptoms in adult patients with moderately- to severely-active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

CRITERIA FOR USE: Requires Prior Authorization by Medical Director or Designee

Rituxan (rituximab) and Truxima (rituximab-abbs) will be considered medically necessary when all of the following criteria are met: 1. For Rheumatoid Arthritis: All of the following criteria must be met: • Physician documentation of a diagnosis of moderate to severe rheumatoid arthritis in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis; AND • At least 18 years of age or older; AND • Prescription written by a rheumatologist; AND • Medical record documentation that an effective dose of methotrexate will be continued during rituximab therapy; AND • Medical record documentation that Rituxan is not being used concurrently with a TNF blocker AND • Physician documentation of an inadequate response to 12 weeks of therapy with Humira*, Rinvoq*, OR Xeljanz*

MBP 90.0 Benlysta (belimumab)- Updated policy

Benlysta (belimumab) will be considered medically necessary for the treatment of adults insured individuals with active, autoantibody positive, systemic lupus erythematosus (SLE) when ALL of the following criteria are met: • Medical record documentation of age greater than or equal to 5 years. • Physician provided documentation of a diagnosis of active lupus; and • Positive ANA/anti-dsDNA antibody; and • Stable treatment regimen with prednisone, NSAID, anti-malarial or immunosuppressant; and • No active severe nephritis or CNS involvement; and • Must be prescribed by a Rheumatologist

Re-authorization Criteria: Each authorization will be for a period of 12 months. Re-review is required with medical record documentation showing a clinical benefit of one of the following: • Improvement in functional impairment • Decrease in the number of exacerbations since the start of Benlysta • Decrease in the daily required dose of oral corticosteroids such as Prednisone

LIMITATIONS Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.

1 MBP 144.0 Tecentriq (atezolizumab)- Updated policy

2. Non-Small Cell Lung Cancer: • Prescription written by an oncologist AND • Medical record documentation of a diagnosis of non-small cell lung cancer meeting one of the following situations: o Medical record documentation of disease progression during or following platinum- containing chemotherapy OR o Medical record documentation of disease progression on at least one FDA-approved therapy targeting EGFR or ALK if the patient has EGFR or ALK genomic tumor aberrations (e.g. mutation, deletion, insertion, etc.) OR o Medical record documentation of a non-squamous histologic subtype AND o Medical record documentation that Tecentriq will be given as first-line treatment AND o Medical record documentation that Tecentriq will be given in combination with bevacizumab, paclitaxel, AND carboplatin AND OR paclitaxel protein-bound AND carboplatin o Medical record documentation that the patient does not have an EGFR or ALK genomic tumor aberration.

MBP 206.0 Khapzory (Levoleucovorin)- New policy

DESCRIPTION: Khapzory (Levoleucovorin) is a chemotherapy modulating agent, folate analog. Levoleucovorin counteracts the toxic (and therapeutic) effects of folic acid antagonists (eg, methotrexate) which act by inhibiting dihydrofolate reductase. Levoleucovorin is the levo isomeric and pharmacologic active form of leucovorin (levoleucovorin does not require reduction by dihydrofolate reductase). A reduced derivative of folic acid, leucovorin supplies the necessary cofactor blocked by methotrexate. Leucovorin enhances the activity (and toxicity) of fluorouracil by stabilizing the binding of 5-fluoro-2’-deoxyuridine-5’- monophosphate (FdUMP; a fluorouracil metabolite) to thymidylate synthetase resulting in inhibition of this enzyme.

CRITERIA FOR USE: Requires Prior Authorization by Medical Director or Designee

Khapzory (Levoleucovorin) will be considered medically necessary when ALL of the following criteria are met:

• Medical record documentation of intolerance to or contraindication to preferred levoleucovorin calcium products.

Preferred products: levoleucovorin calcium vial, powder for reconstitution, levoleucovorin calcium vial, solution

AUTHORIZATION DURATION: Initial approval will be for 12 months or less if the reviewing provider feels it is medically appropriate. Subsequent approvals will be for an additional 12 months or less if the reviewing provider feels it is medically appropriate and will require medical record documentation of continued disease improvement or lack of disease progression. The medication will no longer be covered if patient experiences toxicity or worsening of disease.

2 MBP 207.0 Xenleta IV (lefamulin)- New policy

DESCRIPTION: Xenleta IV (lefamulin) is a pleuromutilin antibiotic that inhibits bacterial protein synthesis through interactions (hydrogen bonds, hydrophobic interactions, and Van der Waals forces) with the A- and P- sites of the peptidyl transferase center in domain V of the 23s ribosomal RNA of the 50S subunit. The binding pocket of the bacterial ribosome closes around the mutilin core for an induced fit that prevents correct positioning of transfer RNA.

CRITERIA FOR USE: Requires Prior Authorization by Medical Director or Designee

• Prescription is written by or in consultation with Infectious Disease AND • Medical record documentation of a diagnosis of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae AND • Medical record documentation that patient is ≥18 years of age AND • Medical record documentation of a culture and sensitivity showing the patient’s infection is not susceptible to alternative antibiotic treatments OR a documented history of previous intolerance to or contraindication to three (3) alternative antibiotics shown to be susceptible on the culture and sensitivity OR • Medical record documentation that treatment with Xenleta was initiated within an inpatient setting

QUANTITY LIMIT: Facets RX count up to 2100 units, Medimpact QL 14 vials/7 days and RX count of 1.

AUTHORIZATION DURATION: Approvals will be given for up to 7 days of total treatment.

The following policies were reviewed with no changes: • MBP 2.0 Synagis (palivizumab) • MBP 15.0 Zevalin (Ibritumomab) • MBP 36.0 Abraxane (paclitaxel protein bound particles) • MBP 53.0 Eraxis (anidulafungin) • MBP 62.0 Remodulin IV (treprostinil) • MBP 82.0 Jevtana (cabazitaxel) • MBP 134.0 Cresemba IV (isavuconazonium sulfate) • MBP 135.0 Unituxin (dinutuximab) • MBP 154.0 Radicava (edaravone) • MBP 180.0 Kanuma (sebelipase alfa) • MBP 185.0 Poteligeo (mogamulizumab-kpkc) • MBP 188.0 Onpattro (patisiran) • MBP 196.0 Ultomiris (ravulizumab-cwvz) • MBP 197.0 Elzonris (Tagraxofusp-erzs) • MBP 198.0 Gamifant (emapalumab-lzsg)

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