Healthcare providers may now begin researching the insurance benefits process for patients in advance of the upcoming availability of Radicava (edaravone), an approved treatment for amyotrophic lateral sclerosis (ALS), according to the therapy’s distributor in the U.S., Mitsubishi Tanabe Pharma America.
The U.S. Food and Drug Administration (FDA) approved Radicava in May 2017, making it the first treatment approved for ALS in more than 20 years. Radicava will be available to patients in the United States in mid-August.
The FDA’s approval was based on results from a Phase 3 clinical trial (NCT01492686) in Japan, where ALS patients given Radicava experienced a significantly lower rate of decline in physical function. The trial led to Radicava’s swift approval in Japan and South Korea in 2015, which caught the FDA’s attention.
Radicava was designed to help control excessive oxidative stress in the body, which is thought to occur at a higher-than-normal rate in people with ALS.
“We have initiated the benefits investigation process now to allow people diagnosed with ALS access to Radicava as soon as it becomes available,” Atsushi Fujimoto, president of MT Pharma America, said in a press release. “We are committed to making the process of accessing Radicava as seamless as possible and encourage healthcare providers to begin the process now for their patients.”
Healthcare providers can initiate the benefits investigation and product-access process using the Searchlight Support hub, which was designed to assist people who are prescribed Radicava.
The process starts when patients visit a healthcare provider who should evaluate if Radicava is the right choice. Before initiating treatment, a patient’s insurance coverage must be confirmed.
Confirming benefits might require that healthcare providers submit a Benefit Investigation and Enrollment Form to connect patients to Searchlight Support, either via email, fax, or regular mail. After confirming a patient’s insurance coverage status, Searchlight Support assigns a patient ID. Then, with the help of a Searchlight Support care coordinator, a patient’s healthcare provider identifies the best location for infusion service based on each patient’s insurance benefits and geographical proximity. In some cases, case managers may contact patients directly to explain benefits and discuss co-pay support options.
After choosing an infusion site or a home infusion provider to schedule the first cycle of treatment, a patient’s healthcare provider should send an order form with the patient’s ID to Searchlight Support to receive Radicava in time for the scheduled treatment.
Radicava is administered intravenously (into the blood stream) in 28-day cycles. The treatment starts with a patient receiving the therapy for 14 consecutive days, followed by a two-week drug-free period. Patients then receive an infusion during 10 of the next 14 days, followed by a two-week drug-free period.
Patients are prescribed 60 mg per treatment, and each treatment takes 60 minutes to administer.
Patients should be aware that Radicava treatment is not risk-free. Severe allergic reactions, known as anaphylactic shock, can occur both during and after an infusion.
Radicava also contains sodium bisulfite, which some patients may be allergic to. People with asthma are especially prone to having a sulfite allergy.
If abnormal symptoms occur after infusion sessions, patients should immediately contact their doctor and seek emergency care, MT Pharma America advises.
Patients also should let their provider know if they are pregnant, or plan to become pregnant, or if they are breastfeeding or plan to breastfeed.