Zavzpret
March 10, 2023FDA Approves Zynyz for the Treatment of Metastatic
March 22, 2023
P&T Committee Changes
Effective 4/1/2023
As your Prescription Benefit Facilitator, BeneCard PBF is committed to providing the highest quality service, innovative clinical solutions, and valuable trend management strategies.
BeneCard PBF controls trend through several factors, including our unique pass-through model, generic maximization, clinical programs, and formulary management. The BeneCard PBF Pharmacy and Therapeutics (P&T) Committee continually reviews the latest information available to keep our clinical rules and programs up to date to improve care and reduce costs.
As a result of detailed discussions regarding each medication, its indications, FDA guidelines, and potential member safety issues, the following changes have been approved.
Additions to the Specialty Medication and Standard Clinical Review List
For your reference, we have included the Therapeutic Category as well as the medication use.
ADSTILADRIN (nadofaragene firadenovec-vncg)
- A non-replicating adenoviral vector-based gene therapy.
- Indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)- unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
- It is administered by intravesical instillation once every three months.
- There are warnings for risk of muscle invasive or metastatic bladder cancer with delayed cystectomy and risk of disseminated adenovirus infection.
BRIUMVI (ublituximab)
- A recombinant chimeric monoclonal IgG1 antibody.
- Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- It is administered by intravenous infusion. First Infusion: 150 mg intravenous infusion; Second Infusion: 450 mg intravenous infusion administered two weeks after the first infusion; Subsequent Infusions: 450 mg intravenous infusion administered 24 weeks after the first infusion and every 24 weeks thereafter.
- There are contraindications in patients with active HBV infection, and a history of life-threatening infusion reaction to Briumvi.
- There are warnings infusion reactions, infections, fetal risk, and reduction in immunoglobulins.
ELAHERE (mirvetuximab soravtansine)
- A folate receptor alpha (FRα) -directed antibody and microtubule inhibitor conjugate.
- Indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
- It is administered by intravenous infusion. Administer the initial dose at the rate of 1 mg/min. If well tolerated after 30 minutes at 1 mg/min, the infusion rate can be increased to 3 mg/min. If well tolerated after 30 minutes at 3 mg/min, the infusion rate can be increased to 5 mg/min.
- There is a black box warning for ocular toxicity.
- There are additional warnings for ocular disorders, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity.
IMJUDO (tremelimumab)
- A cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody.
- Indicated in combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC), and in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
- It is administered as an intravenous infusion.
- There are warnings for severe and fatal immune-mediated adverse reactions, infusion-related reactions, and embryo-fetal toxicity.
JAYPIRCA (pirtobrutinib)
- A kinase inhibitor.
- Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
- It is administered orally once daily with water, with or without food. The dose should be reduced in patients with severe renal impairment.
- There are warnings for infections, hemorrhage, cytopenias, atrial fibrillation and atrial flutter, second primary malignancies, and embryo-fetal toxicity.
JESDUVROQ (daprodustat)
- A hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor.
- Indicated for the treatment of anemia due to chronic kidney disease in adults who have been
receiving dialysis for at least four months.
- It has not been shown to improve quality of life, fatigue, or patient well-being.
- It is not indicated for use as a substitute for transfusion in patients requiring immediate correction of anemia or in patients not on dialysis.
- It is administered orally once daily with or without food.
- It is contraindicated in patients taking concomitant strong CYP2C8 inhibitors such as gemfibrozil and in patients with uncontrolled hypertension.
- There is a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
- There are additional warnings for risk of hospitalization for heart failure, hypertension, gastrointestinal erosion, serious adverse events in patients not on dialysis, and malignancy.
KRAZATI (adagrasib)
- An irreversible inhibitor of KRAS G12C.
- Indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
- It is administered orally at 600mg twice daily until disease progression or unacceptable toxicity.
- There are warnings for gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis.
LEQEMBI (lecanemab)
- An amyloid beta-directed antibody.
- Indicated for the treatment of Alzheimer’s disease.
- Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
- It is administered as an intravenous infusion once every two weeks.
- There are warnings for amyloid related imaging abnormalities and infusion-related reactions.
LUNSUMIO (mosunetuzumab)
- A bispecific CD20-directed CD3 T-cell engager.
- Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- It is administered as an intravenous infusion for 8 cycles, unless patients experience unacceptable toxicity or disease progression.
- There is a black box warning for cytokine release syndrome.
- There are additional warnings for neurologic toxicity, infections, cytopenias, tumor flare, and embryo-fetal toxicity.
NEXOBRID (anacaulase-bcdb)
- A mixture of proteolytic enzymes.
- Indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal
burns.
- Safety and effectiveness have not been stablished for treatment of: chemical or electrical burns, burns on the face, perineum, or genitalia, burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease, circumferential burns, or burns in patients with significant cardiopulmonary disease, including inhalation injury.
- NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
- It is applied topically in up to two applications of 4 hours each, with the second application occurring 24 hours after the first application. Total body surface area (BSA) treated must not exceed 20%.
- It is contraindicated in patients with known hypersensitivity to pineapples or any other drug components.
- There are warnings for hypersensitivity reactions, pain management, proteolytic injury to non-target tissues, and coagulopathy.
ORSERDU (elacestrant)
- An estrogen receptor antagonist.
- Indicated for treatment of postmenopausal women or adult men, with ER-positive, HER2- negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
- It is administered orally once daily with food.
- There are warnings for dyslipidemia and embryo-fetal toxicity.
REBYOTA (donor human stool suspension)
- A fecal microbiota suspension.
- Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals
18 years of age and older, following antibiotic treatment for recurrent CDI.
- It is not indicated for treatment of CDI.
- It is administered rectally by a healthcare provider as a single dose 24 to 72 hours after the last dose of antibiotics for CDI.
- There are warnings for transmissible infectious agents, management of acute allergic reactions, and potential presence of food allergens.