FDA Approval LIST. WellINFORMED

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1 FDA Approval LIST Formulary management is one way to bring down drug costs, and deciding which medications to include on a formulary is part of this process. New drug releases are generally associated with higher costs, and being aware of new medications coming to market assists with cost containment. Market impact (adoption and use of a new medication) can cause drug costs to increase, but WellDyneRx helps you take proactive measures to manage your plan s drug spend. The Q FDA Approval list is shown below. Tavalisse TM (Rigel) fostamatinib Thrombocytopenia Tavalisse TM is approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Dosage is initiated at 100 mg orally twice daily and after 4 weeks increased to 150 mg twice daily if needed to achieve a platelet count greater than 50 x 10 9 /L. Crysvita (Ultragenyx) burosumabtwza X-linked Hypophosphatemia Crysvita is approved for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older. The recommended dosage is 0.8 mg/kg every 2 weeks for pediatric XLH and 1 mg/kg every 4 weeks for adult XLH. This is the first drug approved for XLH, a rare, inherited form of rickets that does not respond to Vitamin D therapy. Akynzeo (Helsinn Healthcare) fosnetupitant/ palonosetron Nausea/Vomiting Akynzeo is approved in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy. This medication is dosed as 1 vial administered as a 30-minute infusion 30 minutes prior to the start of chemotherapy. Jynarque TM (Otsuka) tolvaptan Slow Kidney Function Decline Jynarque TM is approved to slow kidney function decline in patients at risk of developing rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). This is the first treatment in the U.S. for adult patients with ADPKD. Dosing is titrated to a maintenance dose of 120 mg orally once daily. Due to the risks of serious liver injury, this medication is available only through a Risk Evaluation and Mitigation Strategy (REMS) program and liver function tests must be monitored before, during and after therapy.

2 Retacrit TM (Pfizer Biosimilars) epoetin alfaepbx Anemia Retacrit TM is the first biosimilar to Epogen /Procrit approved by the FDA and is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, anemia due to use of zidovudine in patients with HIV infection, and anemia due to the effects of concomitant myelosuppressive chemotherapy. This biosimilar is also approved for the reduction of allogenic red blood cell transfusion in patients undergoing elective, noncardiac nonvascular surgery. Dosage is based on weight (units/kg) given either intravenously (IV) or subcutaneously (SC) three times weekly. Aimovig TM (Amgen) erenumabaooe Preventive Treatment of Migraine Aimovig TM is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention of migraines. The CGRP-R receptor is believed to play a critical role in the pathology of migraines. This is the first and only FDA-approved treatment specifically developed to prevent migraines. Recommended dosage is 70 mg subcutaneously (SC) once a monthsome patients may benefit from 140 mg SC monthly. Lucemyra TM (US WorldMeds) lofexidine Opioid Withdrawal Symptoms Lucemyra TM is approved for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. This selective centrally-acting alpha-2 adrenergic agonist is the first non-opioid drug to be FDA approved for opioid withdrawal. The recommended treatment regimen is 3 tablets orally four times daily at 5 to 6 hours intervals during the period of peak withdrawal symptoms. Total treatment may continue up to 14 days. Lokelma TM (AstraZeneca) sodium zirconium cyclosilicate Hyperkalemia Lokelma TM is a potassium binder approved for the treatment of hyperkalemia in adults. The recommended starting dosage is 10 grams orally administered three times a day for up to 48 hours and maintenance treatment is 10 grams once daily. Lokelma should not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action.

3 Doptelet (AkaRx Inc.) avatrombopag maleate Thrombocytopenia Doptelet is approved to treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first thrombopoietin (TPO) receptor agonist approved in the U.S. for this indication. Dosing begins 10 to 13 days prior to a scheduled procedure and patients should undergo their procedure within 5 to 8 days after the last dose. Duration of treatment is 5 days and dosage is dependent on platelet count; either 40 mg or 60 mg orally daily for 5 days. Olumiant (Lilly) baricitinib Rheumatoid Arthritis Olumiant is a Janus Kinase (JAK) inhibitor approved for the treatment of adult patients with moderately-tosevere active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. The recommended dosage is 2 mg orally daily and may be used as monotherapy or in combination with methotrexate or other disease modifying antirheumatic drugs (DMARDs). Fulphila TM (Mylan) pegfilgrastimjmdb Febrile Neutropenia Fulphila TM is a leukocyte growth factor approved to decrease the incidence of infection (febrile neutropenia) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. This is the first biosimilar to Neulasta (pegfilgrastim) approved in the U.S. Dosage is 6 mg subcutaneously (SC) once per chemotherapy cycle and is not to be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Moxidectin TM (MDGH) moxidectin Parasitic Infection Moxidectin TM is an anthelmintic approved for the treatment of onchocerciasis (river blindness) in patients ages 12 and older. The recommended dosage is 8 mg as a single dose with or without food. Zemdri TM (Achaogen Inc.) plazomicin sulfate Complicated Urinary Tract Infection Zemdri TM is an aminoglycoside antibacterial approved for the treatment of patients 18 years of age or older with complicated urinary tract infections (cuti), including pyelonephritis. Recommended dosage is 15 mg/kg every 24 hours by intravenous (IV) infusion over 30 minutes for 4 to 7 days.

4 Epidiolex (Greenwich Bioscience) cannabidiol Severe Epilepsy Epidiolex is a cannabidiol (CBD) oral solution approved for the treatment of seizures associated with 2 rare and severe forms of epilepsy; Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients 2 years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana, and is also the first FDA approval of a drug for the treatment of patients with DS. The recommended starting dosage is 2.5 mg/kg orally twice daily and increased up to a maximum maintenance dosage of 10 mg/kg twice daily. Braftovi TM (Array BioPharma) encorafenib Metastatic Melanoma Braftovi TM is a kinase inhibitor approved for use in combination with Mektovi in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. The recommended dosage is 450 mg orally once daily in combination with binimetinib and may be taken with or without food. Braftovi is not indicated for treatment of patients with wild-type BRAF melanoma. Mektovi (Array BioPharma) binimetinib Metastatic Melanoma Mektovi is a kinase inhibitor approved for use in combination with Braftovi TM in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. Recommended dosage is 45 mg orally twice daily in combination with encorafenib and may be taken with or with food. Tpoxx (Siga Technologies) Krintafel TM (GSK) tecovirimat Smallpox Tpoxx is approved for the treatment of smallpox in adults and pediatric patients weighing at least 13 kg, and is the first drug with an indication for smallpox. The recommended dosage for adults is 600 mg orally twice daily for 14 days. Pediatric dosing is based on weight for a duration of 14 days. This was a fast track approval in response to experts fears that the virus could be used as a bioweapon. Smallpox was eradicated in 1980 according to the World Health Organization (WHO). tafenoquine Malaria Krintafel TM is an antimalarial approved for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients ages 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax malaria. The recommended dosage is single dose of 300 mg orally taken on the first or second day of the appropriate antimalarial therapy for acute P. vivax malaria. All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to administration of Krintafel.

5 Tibsovo (Agios Pharmaceuticals ivosidenib Leukemia (AML) Tibsovo is an isocitrate dehydrogenase-1 (IDH1) inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. The recommended dosage is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. Orilissa TM (AbbVie Inc.) Mulpleta (Shionogi Inc.) elagolix sodium Endometriosis Pain Orilissa TM is a gonadotropin-releasing hormone (GnRH) receptor antagonist approved for the management of moderate to severe pain associated with endometriosis. The recommended dosage is 150 mg orally once daily for up to 24 months or 200 mg twice daily for up to 6 months. This is the first oral treatment for endometriosis in over a decade. lusutrombopag Thrombocytopenia Mulpleta is small molecule thrombopoietin (TPO) receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. Recommended dosage is 3 mg orally once daily for 7 days beginning 8 to 14 days prior to scheduled procedure. Patients should undergo their procedure 2 to 8 days after the last dose.