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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 6
April 1, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First-In-Class Migraine Nasal Spray

On March 10, 2023, the U.S. Food & Drug Administration (FDA) approved Pfizer’s ZAVZPRET™ (zavegepant) for the acute treatment of migraine headaches in adult patients. ZAVZPRET™ is administered intranasally, offering migraine relief in as soon as 15 minutes. Migraines affect nearly 40 million people in the United States, resulting in painful headaches with nausea and/or vomiting and sensitivity to sound or light. These attacks can last up to 72 hours and have an enormous impact on a patient’s quality of life. ZAVZPRET™ is the first drug in its class to be approved as a nasal spray, and it offers an alternative treatment for patients who are unable to take oral medications due to migraine-associated vomiting. ZAVZPRET™ was approved based on positive results seen in two clinical trials. These trials compared the presence of pain and each patient’s most bothersome symptom at different times following administration. Overall, ZAVZPRET™ was significantly superior to placebo in 13 or 17 outcome measures. The most reported adverse reactions were taste disturbance, nausea, vomiting and nasal discomfort. It is anticipated that ZAVZPRET™ will be available in pharmacies by July 2023.

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Drug Safety

Baxter Issues Urgent Medical Device Correction for Life2000 Ventilation System 

On March 10, 2023, the FDA released an Urgent Medical Device Correction for Life2000 Ventilation System due to potential safety concerns when connected to a third-party oxygen concentrator. These safety concerns create the potential for low blood oxygen levels in users of the device. Low blood oxygen levels may result in serious complications such as hospitalization or death. Symptoms include shortness of breath, confusion, rapid heartbeat or bluish skin and lips. Contributing factors related to this urgent medical device correction can include loose, kinked or disconnected tubing, oxygen flow below desired level, excessive moisture in the hoses or lack of cleaning/maintenance. This correction applies to all Life2000 Ventilation Systems used with a third-party oxygen concentrator. Patients may continue to use the system if they follow the recommended daily checks and preventive maintenance requirements detailed in the patient letter and Instructions for Use with both the Life2000 system and the third-party oxygen concentrator. Consumers with questions may contact Baxter’s Clinical Support Team at 1-800-397-9071. Adverse effects experienced with use of the Life2000 ventilator relating to this correction should be reported to FDA MedWatch or to Baxter Customer Service at 1-800-426-4224, option 3. To date, there have been reports of patients with low blood oxygen levels requiring hospitalization, but no deaths. Baxter is closely monitoring and investigating cases as they are received. Consumers should anticipate receiving a follow-up letter with further information.

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From the Pharmaceutical Industry

Novo Nordisk and Sanofi Follow Lilly in Reducing Insulin Prices

Following Eli Lilly’s March 1st announcement, Novo Nordisk and Sanofi will also cut insulin prices and cap out-of-pocket costs for patients with commercial insurance. These changes have been implemented to mirror the capped monthly insulin costs of $35 for Medicare Part D recipients following the implementation of the Inflation Reduction Act (IRA). Patients with diabetes covered by private insurance were not protected by the IRA changes and were often still required to pay high out-of-pocket costs for insulin, a lifesaving medication. All three companies have now capped out-of-pocket costs at $35 per month for specific insulin products for patients with commercial insurance. Changes have been made for both short-acting and long-acting insulin injectables.

Short-acting insulin is injected by patients before meals or at times when their blood glucose may rise. Three commonly used short-acting insulins include Humalog®, NovoLog® and Apidra®. Eli Lilly produces Humalog® (insulin lispro), which will have costs reduced by 70%. Novo Nordisk produces NovoLog® (insulin aspart), which will have costs decreased by 75%. Sanofi produces Apidra® (insulin glulisine), which will have costs cut by 70%. After these price changes, NovoLog® vials and pens will be the least costly, followed by Humalog® products.

Long-acting insulin is injected by patients to control their blood glucose levels throughout the day. Sanofi and Eli Lilly produce the most used long-acting insulin injectables including Lantus®, Rezvoglar® and their unbranded interchangeable products. Sanofi will decrease Lantus® costs by 78% and Lilly will reduce Rezvoglar® prices by 70%.

Eli Lilly’s initial price cuts will go into effect on April 1, 2023, followed by Novo Nordisk’s and Sanofi’s cuts on January 1, 2024. Eli Lilly, Novo Nordisk and Sanofi control a combined 90% of the insulin market in the United States, so these changes will greatly increase accessibility and affordability for patients with diabetes.

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FDA Approvals

New FDA Approvals

Novel Drug Approval: DaybueTM (trofinetide)

Oral solution approved to treat Rett syndrome in adults and pediatric patients 2 years and older. [3/10/2023 – ACADIA PHARM INC]

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New Generics

New Generics Entering the Marketplace

Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) therapy pack

Indication: Treatment of stomach and intestinal ulcers caused by the bacteria Helicobacter pylori (H. pylori)

Dosage Form/Strength: 10-day therapy pack (120 capsules); each capsule contains bismuth subcitrate potassium 140mg, metronidazole 125mg and tetracycline hydrochloride 125mg

Average Wholesale Price (AWP): Generic = $995 | Brand = $1,106