Radicava Out-of-pocket Assistance Program Made Easier

Mitsubishi Tanabe Pharma America announced changes to enhance its out-of-pocket assistance program for people with amyotrophic lateral sclerosis (ALS) using Radicava (edaravone).

The changes, aimed at making the program easier and more accessible, include a new “hybrid” card meant to help patients obtain appropriate pharmacy and medical co-pay assistance, and improvements in the efficiency and exchange of information.

“Our modified ‘all-in-one’ out-of-pocket assistance program was designed with our patients in mind, to continue to support appropriate, affordable access to treatment with Radicava, for eligible patients,” Kevin O’Brien, the company’s vice president of market access, said in a press release.

Each infusion of Radicava can cost $1,000.

The Searchlight Support Out-of-Pocket Assistance Program was begun to help certain insured ALS patients afford Radicava by potentially paying nothing per infusion. The program uses applicable out-of-pocket costs for deductibles, co-pay and co-insurance for medication and covers up to $20,000 per calendar year.

“We changed the program processes for handling pharmacy and medical benefit claims to allow patients to use one card, on-the-spot. In addition, we have modified logistical procedures related to co-pay issues for healthcare providers,” added O’Brien.

Radicava is designed to remove reactive oxygen molecules, known as free radicals, that cause damage to nerve cells. These free radicals are byproducts of normal cellular processes that are swiftly removed by the body in healthy people, but that can build up to toxic levels in people with ALS. The accumulation of free radicals causes oxidative stress, which is considered one of the causes of nerve cell death in ALS.

Radicava is administered intravenously (directly into the bloodstream) in 28-day cycles. The first cycle includes 14 consecutive days of therapy, followed by two weeks without treatment. In subsequent cycles, patients receive infusions for 10 of the first 14 days, before another two-week treatment-free period.

The medication’s dose is typically 60 mg, and each treatment takes one hour to administer.

 In 2017 Radicava became the first ALS treatment approved by the U.S. Food and Drug Administration in more than 20 years.

Its approval was based on findings from a Phase 3 clinical trial  (NCT01492686) in which Radicava significantly reduced the rate of functional decline compared to a placebo. Later studies also confirmed that the treatment remained effective for at least one year.

But a post-marketing study examining the treatment in a real-world population questioned its effectiveness, finding few differences in the rate of functional decline and in the loss of lung function in most countries where it is approved.