North Carolina Division of Health Benefits Physician Administered Drug Program Catalog North Carolina Division of Health Benefits Physician Administered Drug Program Catalog •Unless otherwise indicated, the catalog contains procedure codes representing drugs, biologics, devices and vaccines which are only covered for FDA approved indications. •11 digit National Drug Codes (NDCs) are required to be billed along with their corresponding procedure code. Drugs and biologics must be classified as CMS covered outpatient drugs from a labeler/manufacturer participating in the Medicaid Drug Rebate Program (MDRP). •The Max Daily Units for radiopharmaceuticals represents one therapeutic dose or diagnostic dose. •The HCPCS Code effective date represents the date the HCPCS code was established •Procedure codes for covered devices and vaccines are not required to be from a rebating labeler/manufacturer as they are not classified as covered outpatient drugs. HCPCS HCPCS HCPCS Code Billing FDA Approved Indications Max Monthly Gender NDC Rebating Labeler Last Modified Category HCPCS Description Effective Brand Name Generic Name Max Daily Units Minimum Age Maximum Age Comments Code Unit (See Package Insert for full FDA approved indication descriptions) Units Restrictions Required Required Date Date Indication specific age restrictions: Periodic Fever Syndromes: • Cryopyrin-Associated Periodic Syndromes (CAPS): 4 Indicated for the treatment of: years of age and older Periodic Fever Syndromes: • Tumor Necrosis Factor • Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including: Familial Cold Autoinflammatory Syndrome (FCAS) and Receptor Associated Periodic Muckle-Wells Syndrome (MWS). Syndrome (TRAPS) in adult and • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. canakinumab for injection, Indication Specific pediatric patients. Biologicals J0638 Injection, canakinumab, 1 mg 1 mg 1/1/2011 Ilaris® • Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients. 300 600 N/A N/A Y Y 7/28/2020 for subcutaneous use (see comments) • Hyperimmunoglobulin D • Familial Mediterranean Fever (FMF) in adult and pediatric patients. Syndrome (HIDS)/Mevalonate Active Still's Disease: Kinase Deficiency (MKD) in Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. adult and pediatric patients. Adult-Onset Still’s Disease (AOSD) • Familial Mediterranean Fever (FMF) in adult and pediatric patients. Active Systemic Juvenile Idiopathic Arthritis (SJIA): 2 years and older Indicated for: • Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). • Patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have avelumab injection, for Biologicals J9023 Injection, avelumab, 10 mg 10 mg 1/1/2018 Bavencio® disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 80 240 12 years N/A N/A Y Y 7/28/2020 intravenous use • Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. • First-line treatment, in combination with axitinib, of patients with advanced renal cell carcinoma (RCC). Indication specific age restrictions: • Newly-diagnosed CD33- Indicated for: positive acute myeloid Injection, gemtuzumab gemtuzumab ozogamicin • the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. Indication Specific Biologicals J9203 0.1 mg 1/1/2018 Mylotarg™ 150 275 N/A N/A Y Y leukemia: 1 month of age and 7/28/2020 ozogamicin, 0.1 mg injection, for intravenous use • the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in pediatric patients 1 month and older. (see comments) older • the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. • Relapsed or refractory CD33- positive AML: 2 years of age and older Indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 • Genital warts (condyloma acuminata) caused by HPV types 6 and 11. The following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: • Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). • Cervical intraepithelial neoplasia (CIN) grade 1. • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. Human Papillomavirus vaccine human papillomavirus 9- • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. types 6, 11, 16, 18, 31, 33, 45, valent vaccine, recombinant Vaccines 90651 52, 58, nonavalent (9vHPV), 2 0.5 mL 7/1/2017 Gardasil® 9 1 1 9 years 45 years N/A Y N 7/28/2020 suspension for intramuscular Indicated in boys and men 9 through 45 years of age for the prevention of the following diseases: or 3 dose schedule, for injection • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. intramuscular use • Genital warts (condyloma acuminata) caused by HPV types 6 and 11. And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. • Indicated in girls and women 9 through 45 years of age for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. • Indicated in boys and men 9 through 45 years of age for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Injection, tedizolid phosphate, tedizolid phosphate for Indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated Drugs J3090 1 mg 1/1/2016 Sivextro® 200 1,200 12 years N/A N/A Y Y 7/28/2020 1 mg injection, for intravenous use susceptible bacteria. Indicated for the treatment of: - Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. secukinumab injection, for Biologicals J3590 Unclassified biologics 150 mg 1/1/2002 Cosentyx® - Adults with active psoriatic arthritis (PsA). 2 10 18 years N/A N/A Y Y 7/28/2020 subcutaneous use - Adults with active ankylosing spondylitis (AS). - Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. 7/30/2020 North Carolina Division of Health Benefits Physician Administered Drug Program Catalog Indication specific age Indicated for: restrictions: Injection, burosumab-twza 1 burosumab-twza injection, • The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. Indication Specific Biologicals J0584 1 mg 1/1/2019 Crysvita® 180 540 N/A N/A Y Y • XLH: 6 months of age and 7/28/2020 mg for subcutaneous use • The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively (see comments) older resected or localized in adult and pediatric patients 2 years of age and older. • TIO: 2 years of age and older Melanoma: Indicated for the treatment of patients with unresectable or metastatic melanoma. indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Non-Small Cell Lung Cancer (NSCLC): 1. Indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. 2. Indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥ 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA- approved therapy for these aberrations prior to receiving Keytruda. 3. Indicated as a single agent for the first-line treatment of patients with stage III NSCLC, who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Injection, pembrolizumab, 1 pembrolizumab injection, for 4. Indicated in combination with carboplatin and either paclitaxel or nab-paclitaxel, as first-line treatment of patients with metastatic squamous NSCLC. Biologicals J9271 1 mg 1/1/2016 Keytruda® 400 400 N/A N/A N/A Y Y 7/28/2020 mg intravenous use Head and Neck Squamous Cell Cancer (HNSCC): 1. Indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 2. Indicated in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. 3. Indicated as a single agent for the first line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.