Mitsubishi Tanabe Pharma America announced that they have met their goal of making Radicava (edaravone) available to people with ALS by August 2017. The FDA granted marketing approval for Radicava in May, making it the first drug approved in the US in more than 20 years as a treatment for ALS.
Since August, the drug company created an online support hub called Searchlight Support to help patients and physicians alike become educated about the drug, and begin the process to gain access to it when it would become available. Given the immense unmet medical need faced by people with ALS, it is likely that thousands of people with ALS have expressed interest in trying Radicava, and started the process of gaining access through Searchlight Support. Today, the company announced that those that have completed the necessary steps will start getting access to Radicava in the US.
“After 13 years of clinical research and investment, we have reached a seminal moment, which may shift the treatment paradigm for this terrible disease,” said Tom Larson, Chief Commercial Officer, Mitsubishi Tanabe Pharma America in a press release on the company’s website. “As of today, all across the country, conversations between ALS specialists and patients may be substantially different. We are all extremely proud and excited to be a part of bringing RADICAVA and new hope to patients in the U.S.”
Getting Access to Radicava
Only a qualified healthcare provider can prescribe Radicava. Once a person with ALS and their healthcare provider determine Radicava is something to pursue, they can get assistance accessing it, working with insurance companies for coverage and setting up infusion appointments through Searchlight Support. There are several steps that people with ALS need to take in preparing for Radicava treatment, including determining if their insurance company will cover the treatment; a process called benefits investigation.
Some insurance companies may choose to provide coverage by following the FDA approval label for Radicava, whereas others may place additional restrictions on whom they will cover. The Searchlight Support team can help people with ALS navigate this investigation, and make them aware of Patient Assistance Program options offered by the company to reduce cost, including in some cases providing Radicava at no cost for up to two years.
It is important to note that Radicava is given intravenously daily over cycles, generally speaking two weeks on and two weeks off. For more information about the specific dosing regimen of edaravone, see the approved FDA label or visit Radicava.com. Drug delivery via IV can be done in a variety of scenarios, such as at an ALS clinic, at an infusion center or even at a person’s home. Several factors will play a role in where a person with ALS gets their treatment. All options should be discussed with their prescribing healthcare provider.
Should an infusion center be determined the best for an individual, the Searchlight Support team can assist in finding an infusion center near them and setting up those appointments, finding transportation options to them, and other related matters. In many cases, the costs of where a person with ALS receives their treatment will vary and those seeking Radicava will learn about those through the benefits investigation process with their insurance company.
Immediately following the FDA approval of Radicava, the ALS Therapy Development Institute held a detailed webinar with more than 800 people. A recording of that webinar is available online here, while a summary of the approval and clinical trial data is available online here.
A Strong ALS Drug Development Pipeline
Radicava is an important new treatment option that people with ALS ought to know about. It should be discussed with a person’s doctor to determine if it may be right for them. In clinical trials in Japan, the treatment was found to help some people with ALS maintain function longer. While this approval is a huge milestone in the battle against ALS, not everyone with ALS will react to Radicava in the same way. ALS is a complex disorder, with many subtypes, and will require many different treatments being developed and approved. The current pipeline of potential treatments for ALS, such as Cytokinetic’s tirasemtiv and BrainStorm Cell Therapeutics’ NurOwn, in or soon to emerge from clinical trial, is rich with hope. Results from the phase 3 study on tirasemtiv (VITALITY-ALS) are expected within the next several months, including at the International Research Symposium on ALS/MND in Boston.