Drug Alerts and Special Reports

Key reimbursement alerts for office-administered drugs — C-Code, J-Code, NDC, and NCCN alerts plus pricing updates, sent on behalf of pharma manufacturers.

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12/05/2023

XACIATO™ for the treatment of Bacterial vaginosis - 12/5/23

Learn more about XACIATO Bacterial vaginosis (BV) can be embarrassing for patients. XACIATO TM (clindamycin phosphate) vaginal gel 2%, a single-dose treatment for BV in females 12 years of age and older, is available in pharmacies. BV affects as many as 21 million women in the United States. Many current treatments need to be used for multiple days. XACIATO treats BV in a single dose . • A single intravaginal dose at any time of day. • Thermosetting formulation for gradual release of clindamycin. 1 - XACIATO vaginal gel increases viscosity at body temperature and gradually releases clindamycin over time. a • Robust efficacy in both new and recurrent BV: - Significantly higher clinical cure at day 21-30 vs placebo in both subsets of patients with ≤3 episodes or >3 episodes (recurrent) of BV in the past 12 months. 2 Treatment difference: ≤3 episodes of BV in the past 12 months: 32.2%; 95% CI: 13.9, 50.4; P =0.001 (XACIATO: N=101, placebo: N=46). Recurrent BV: 46.9%; 95% CI: 10.1…

J-Code 11/30/2023

Permanent J-Code for RYSTIGGO® (rozanolixizumab-noli): Available January 1, 2024 - 11/30/23

Corrected WAC Pricing Effective for claims on or after January 1, 2024 1 : J9333 Injection, rozanolixizumab-noli, 1 mg RYSTIGGO (rozanolixizumab-noli) is the first and only FDA-approved targeted treatment for both anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibody-positive (Ab+) adult patients with generalized myasthenia gravis (gMG). 2 *Corrected WAC Pricing* HCPCS Code 1 J9333 HCPCS Code Descriptor 1 Injection, rozanolixizumab-noli, 1 mg NDC Codes 2 50474-980-79 50474-0980-79* Package Description 2 Each carton of RYSTIGGO contains one single-dose glass vial containing 280 mg/2 mL (140 mg/mL) WAC per HCPCS Unit 3 $21.61 WAC per Package 3 $6,050 ICD-10-CM Codes 4,† G70.00 Myasthenia gravis without (acute) exacerbation G70.01 Myasthenia gravis with (acute) exacerbation *For certain purposes, including the proper billing of drug products, an 11-digit NDC may be required. † These diagnosis codes are informational and not intended to be directive…

FDA Approved 11/14/2023

VABYSMO® (faricimab-svoa): New Indication Now Approved - 11/6/23

View in browser Important Safety Information Prescribing Information Now approved for your members with Macular Edema following Retinal Vein Occlusion (RVO): The first and only dual-pathway inhibitor in retinal disease 1-5 Please refer to the billing and coding information below, and ensure your systems and policies are updated accordingly. Sample Billing and Coding for Macular Edema following RVO TYPE CODE DESCRIPTION ICD-10-CM H34.8110 Central retinal vein occlusion, right eye, with macular edema H34.8120 Central retinal vein occlusion, left eye, with macular edema H34.8130 Central retinal vein occlusion, bilateral, with macular edema H34.8190 Central retinal vein occlusion, unspecified eye, with macular edema H34.8310 Tributary (branch) retinal vein occlusion, right eye, with macular edema H34.8320 Tributary (branch) retinal vein occlusion, left eye, with macular edema H34.8330 Tributary (branch) retinal vein occlusion, bilateral, with macular edema H34.8390 Tributary (branch)…

Biosimilar 10/10/2023

Samsung Bioepis Biosimilar Market Report 3rd Edition, Q4 2023 - 10/10/23

SAMSUNG BIOEPIS Biosimilar Market Report 3 rd Edition, Q4 2023 Download Here I. US Biosimilars Approval and Launch Status II. Biosimilar Price - Medical Benefit Oncology Supportive Care Immunology & Ophthalmology - Pharmacy Benefit Immunology and Endocrinology III. Biosimilar Market Dynamics - Biosimilar Market Adoption & Price Erosion - Market Share & Price Trends Oncology Supportive Care Immunology Endocrinology Ophthalmology IV. Biosimilars Deep Dive Download Here © 2023 Samsung Bioepis Co., Ltd. All Rights Reserved. 9/2023. BuyandBill.com SAMSUNG…

10/05/2023

Setmelanotide as a Protein replacement agent: USP Medicare Modeling Guidelines - 10/5/23

On September 29th, The United States Pharmacopeia (USP) issued the Medicare Modeling Guidelines (MMG) version 9.0 including setmelanotide as a Protein replacement agent Read the USP 9.0 Guidelines Updates to USP Medicare Modelling Guidelines include changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs. Anti-obesity agents are not included in the USP-MMG guidelines. The USP Medicare Model Guidelines (MMG) is an independent drug classification system designed for Centers for Medicare & Medicaid Services (CMS) Part D formulary submissions Being recognized as a “Genetic or Enzyme or Protein Disorder: Replacement, Modifiers, Treatment” means that setmelanotide is not categorized as an anti-obesity agent by USP The members of the USP Council of Experts, the Healthcare Safety and Quality Expert Committee (HSQ EC) comprised of independent pharmacologists, clinical pharmacists, academicians, formulary specialists, providers, beneficiaries, drug…

FDA Approved 10/04/2023

Now Approved: VANFLYTA® (quizartinib) for FLT3-ITD AML - 10/3/23

Learn more about this new treatment option. Review the PI and Boxed WARNINGS. ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ The first and only FLT3 inhibitor to specifically target the FLT3-ITD mutation in acute myeloid leukemia VANFLYTA Package Information Strength Package NDC Code 17.7 mg 28‐count bottle 65597‑0504‑28 14‐count bottle 65597‑0504‑04 26.5 mg 28‐count bottle 65597‑0511‑28 14‐count bottle 65597‑0511‑04…

FDA Approved 10/02/2023

Now Approved: The Latest Treatment For Some Adults With Late-Onset Pompe Disease - 10/02/23

NOW APPROVED: Amicus Therapeutics is pleased to inform you that POMBILITI™ in combination with OPFOLDA™ has been approved for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). Please see full Prescribing Information, including BOXED WARNING, for POMBILITI and full Prescribing Information for OPFOLDA , also available at PombilitiOpfoldaHCP.com . POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use, a bis-M6P enriched enzyme, in combination with OPFOLDA (miglustat) 65 mg capsules for oral use, an oral enzyme stabilizer, is the first and only 2-component therapy in late-onset Pompe disease and is designed to maximize enzyme activity. Late-onset Pompe disease (LOPD) is a rare, hereditary, progressive disorder that is usually characterized by limb-girdle muscle weakness and/or respiratory insufficiency. LOPD is…

J-Code 09/29/2023

Permanent J-Code for ZYNYZ™ (retifanlimab-dlwr): Available October 1st, 2023

Effective for claims on or after October 1, 2023: J9345 Injection, retifanlimab-dlwr, 1 mg ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. PRODUCT SPECIFICATIONS: HCPCS Code J9345 HCPCS Code Descriptor Injec tion, retifanlimab-dlwr, 1 mg NDC Number 10-digit: 50881-006-03 11-digit: 50881-0006-03 WAC Pricing Per Unit $712 per unit WAC Pricing Per Package $14,240 per package For billing and coding or reimbursement questions, or to request support from a Field Access Manager, Call 1-855-452-5234, Monday - Friday 8 AM to 8 PM ET Visit the ZYNYZ HCP website IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Important immune-mediated adverse…

Pricing 09/28/2023

Important Price Change Announcement for Photrexa® - 9/28/23

This email is being sent by BuyandBill.com on behalf of Glaukos ® , Inc. Announcing New Pricing for Photrexa ® Cross-Linking Kit As of October 1, 2023 Item Code/Price Description HCPCS Code J2787 Riboflavin 5'-phosphate, ophthalmic solution, up to 3 ml NDC Number 25357-0025-03 A cross linking kit contains one Photrexa Viscous 3 ml single-patient use syringe and one Photrexa solution 3 ml single-patient use syringe, each in an individual foil pouch New WAC Pricing* $4,150 per kit *Wholesale Acquisition Cost listed in Redbook effective 10/1/23 New WAC Pricing* $2,075 per HCPCS Unit *Wholesale Acquisition Cost listed in Redbook effective 10/1/23 We are respectfully requesting that you update your claims processing system, and fee schedules for PHOTREXA for all claims on or after October 1, 2023 IMPORTANT SAFETY INFORMATION INDICATIONS Photrexa® Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5'-phosphate ophthalmic solution) are indicated…

J-Code 09/19/2023

Permanent J-Code for REZZAYO™ (rezafungin for injection): Effective October 1, 2023 - 9/19/23

REZZAYO™ (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasiv Effective for claims on or after October 1, 2023: J0349 Injection, rezafungin, 1 mg REZZAYO TM (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. Product Specifications: HCPCS Code J0349 HCPCS Code Descriptor Injection, rezafungin, 1 mg 11-Digit NDC 70842-0240-01 Package Description 200 mg as a solid (cake or powder) in a single-dose vial for reconstitution WAC Pricing $9.75 per HCPCS Unit Potential Diagnosis Codes: ICD-10-CM Description B37.1 Pulmonary candidiasis B37.7 Candidal sepsis B37.81 Candidal esophagitis B37.82 Candidal enteritis B37.89 Other…

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