By: Option Care
September 6, 2017

Option Care Selected to Administer First ALS Drug Approved by the FDA

BANNOCKBURN, Ill., Sept. 6, 2017 — Option Care Enterprises, Inc., the nation’s largest independent provider of home and alternate treatment site infusion services, has signed an agreement to become a national contracted home infusion provider for ALS drug RADICAVATM (edaravone), an intravenous (IV) infusion treatment for amyotrophic lateral sclerosis (ALS). RADICAVA, the first ALS treatment option approved by the Food and Drug Administration (FDA) in more than 20 years, is now available for patient treatment in the United States.

Sometimes referred to as Lou Gehrig’s Disease, ALS is a rapidly progressive neurodegenerative condition in which the majority of patients die within two to five years of diagnosis.[*]National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis (ALS) Information Page. https://www.ninds.nih.gov/disorders/all-disorders/amyotrophic-lateral-sclerosis-als-information-page. Accessed July 17, 2017. [*]Mehta P, Kaye W, Bryan L, et al. (2016). Prevalence of Amyotrophic Lateral Sclerosis “United States, 2012—2013. MMWR Surveill Summ; 65(No. SS-8):1—12.

“Our specialized clinical knowledge and rigorous care management support — across multiple therapy areas and patient populations — are the backbone of our expertise as the nation’s home infusion therapy leader for neuromuscular disorders like ALS,” said John Rademacher, CEO of Option Care. “This expertise is why we are a trusted partner for innovators bringing to market new therapies like RADICAVA. By partnering with manufacturers, who trust us to provide critical pharmacy services and care management support, we are able to provide unmatched home infusion services to our patients.”

Option Care’s national payer network includes contracts with more than 800 health plans, ensuring broad access to RADICAVA for patients and clinicians who rely on clinical management of home infusion therapy. Additionally, its national network of clinicians includes more than 1,800 nurses specially trained in care coordination and customized clinical management of complex conditions, including ALS.[*] Option Care data on file.

Approved by the FDA in May 2017, ALS drug RADICAVA is marketed and distributed by Mitsubishi Tanabe Pharma America, Inc.

Currently, about 12,000 to 15,000 Americans have ALS, according to the Centers for Disease Control and Prevention (CDC).4 ALS attacks and kills the nerve cells in the brain and spinal cord that control the voluntary muscles and produce movements such as chewing, walking, breathing and talking. ALS is incurable, and over time, the muscles get weaker and become paralyzed.[*] National Amyotrophic Lateral Sclerosis (ALS) Registry. https://wwwn.cdc.gov/als/whatisals.aspx. Accessed July 17, 2017.

About Option Care

Option Care Enterprises, Inc. (Option Care) is one of the nation’s largest and most trusted providers of home and alternate treatment site infusion services. An industry leader, the company draws on nearly 40 years of clinical care experience to offer patient-centered therapy management. Option Care’s signature Home Infusion Plus services include the clinical management of infusion medicines, nursing support and care coordination. Option Care’s multidisciplinary team of more than 1,800 clinicians — including pharmacists, nurses and dietitians — are able to provide home infusion service coverage for nearly all patients across the United States needing treatment for complex and chronic conditions. Learn more at www.OptionCare.com.

About Mitsubishi Tanabe Pharma America, Inc.

Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in the U.S. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com or follow us on Twitter at https://twitter.com/MTPharmaUS.

IMPORTANT SAFETY INFORMATION

Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:

  • have asthma.
  • are allergic to other medicines.
  • are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA?

  • RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
  • Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
  • RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
  • Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
  • Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com.

Share Post