Radicava™ (Edaravone) is one of the two treatments approved by the U.S. Food and Drug Administration (FDA) for treating Amyotrophic Lateral Sclerosis (ALS). It is the first treatment for ALS in over 20 years, and was approved by the FDA in May 2017 1. The only other ALS treatment is Rilutek® (Riluzole), which was approved in 1995.

This prescription medication was developed by Mitsubishi Tanabe Pharma, and works by slowing down the deterioration of physical functioning in patients with ALS.

While this drug has been used to treat patients with ALS for only a few years, in Japan edaravone has been available for treating acute stroke since 2001 2.

At the moment Radicava is available in only a few countries, which include the U.S, Canada, South Korea and Japan.

ALS Disease Details

Additionally known as Lou Gehrig’s Disease, ALS is a rare, progressive and terminal neurological disease that causes the death of motor neurons which control voluntary muscles.

ALS gradually deteriorates nerve cells in the brain and the spinal cord, which overtime reduces the patient’s ability to move, resulting in muscle paralysis and an eventual passing of the patient.

At the moment there is no cure for ALS, and only a few treatment options (Radicava and Rilutek) are available for people impacted by ALS.

It is estimated that 4 out of 5 people with ALS pass away within 2 to 5 years of discovering they have this diagnosis, and every 90 minutes someone is either told they have ALS or passes away from the condition 3.

How Radicava Works

Radicava acts as a free-radical scavenger to help prevent damage to neurons from oxidative stress.

Free-radicals are unstable molecules and atoms, which are byproducts of normal cellular metabolism. They can be neutralized by antioxidants, which are compounds that neutralize free-radicals and protect them against oxidative damage.

In the case that the body is unable to regulate the presence of free-radicals on its own, or if an imbalance between free-radicals and antioxidants takes place, the condition known as oxidative stress can occur.

Oxidative stress does damage to the DNA, fatty tissues and proteins in the body, which accelerates aging and can lead to a wide range of diseases. In ALS, oxidative stress because of free-radicals is considered as one of the major causes for the death of motor neurons 4.

The key active ingredient in Radicava is edaravone, which has a neuroprotective effect, and in some patients declines the progression of ALS by eliminating free-radicals from the system 5.

The exact mechanism of action for edaravone in treating ALS is still unknown, although the therapeutic effect may be a result of its antioxidant properties.

Radicava Effectiveness & Results of Clinical Trials

Radicava was approved in the U.S based on the results from Study 19 (NCT01492686), which was a double-blind phase 3 clinical trial conducted in Japan. The goal of the trial was to evaluate the safety and efficacy of this medication in patients with ALS.

The study involved 137 participants who were given either Radicava or a placebo (at random) via intravenous infusions, for a period of 24 weeks.

The results showed the patients that received Radicava experienced a substantially slower decline in the symptoms that impacted their capability to perform daily activities.

The exact difference that was observed between Radicava and the placebo indicated that the worsening of physical symptoms declined by 33% for those that were given the medication.

It is important to note that Radicava does not stop the progression or reverse the damage of ALS. However, some patients may benefit from this medication to increase life expectancy and delay future stages of ALS.

How Radicava is Administered & Dose Information

Radicava is given to patients in 60mg doses, which are administered with an intravenous infusion. It takes approximately one hour to complete a treatment infusion session.

At the beginning of treatment, ALS patients receive the medication on a daily basis for a period of two weeks, which is followed by an additional two weeks of rest. Afterwards, daily infusions are given to patients for 10 day periods, while the period of recovery and rest remains at two weeks, as it is at the start 6.

Radicava Side Effects & Safety Information

Radicava contains sodium bisulfite, which can cause significant allergic responses 7. Allergy symptoms may not appear until after the intravenous infusion is completed.

Signs of an allergic reaction to Radicava may include:

  • Itching
  • Wheezing
  • Hives
  • Challenge breathing
  • Light-headedness
  • Asthma attack (in people that have asthma)
  • Swelling of face, tongue, lips or throat.

In the case that you experience any of these symptoms following a Radicava infusion, inform your healthcare provider as soon as possible or go to the closest emergency room.

Other common side effects of Radicava include:

  • Bruising (contusion)
  • Difficulty walking (gait disturbance)
  • Headache

While the drug has been approved by the FDA, these are not all of the possible side effects, but rather the side effects that have been identified during clinical trials of the drug.

Your physician will monitor you while you go through treatment, and watch for signs and symptoms of side effects to Radicava.

Radicava Drug Interactions

It is possible for other drugs and medicines to interact with Radicava 8.

This includes prescription and over-the-counter medications, herbal supplements, and vitamins.

If you are planning for a Radicava treatment, make your doctor aware of all the medications and supplements you are using at the moment, as well as any that you plan on starting or stopping during treatment.

Radicava Cost

The yearly cost of Radicava treatment is approximately $145,000, and every treatment infusion session costs around $1,000.

However, personal treatment expenses for ALS patients do vary, and depend on whether or not they have health coverage, as well as the details of their insurance plans.

Patients that are planning to participate in clinical trials for Radicava should know that in most clinical trials, the cost of medication is covered by the sponsor in order to incentivize patients to participate.

For some trials, the sponsor may even provide financial compensation for patients in trials to also compensate them for their time and/or cover their costs of traveling to clinical trial sites.

Is Radicava Covered By Medicare?

Since the cost of Radicava is so burdensome and is an unexpected expense, most patients will have difficulty paying for the treatment out-of-pocket.

Depending on your Medicare insurance plan and other factors (such as your age), the cost of Radicava will vary.

Radicava (edaravone) intravenous infusions are typically covered under Medicare Part B, as well as in Medicare Part D, although only the cost of the medication itself is covered.

Medicare Part B Coverage for Radicava -

Under Medicare Part B, 80% of costs for a Radicava treatment are covered (after the annual deductible is paid), while the remaining 20% must be covered either by the patient, or with supplemental coverage 9.

If you have Medicare Part B coverage, you will need to pay out-of-pocket $29,000 for a year of Radicava treatment (based on the estimated cost of treatment before coverage at $145,000 per year)

If you have a Medicare Supplement Plan (Medigap), it may be able to cover most (or all) of the 20% with this coverage plan.

Medicare Part D Coverage for Radicava -

Under Medicare Part D, ALS patients can receive coverage for home infusions of the medication. However, it is important to note that Medicare Part D coverage applies exclusively to the Radicava medication, and doesn’t cover other infusion related services, supplies, or equipment.

Medicare Part D Coverage Schedule10:

1. The patient pays the annual deductible (the amount to be paid before coverage takes effect) - in 2020 the annual deductible for Medicare Part D is $435.00.

2. Up to $4,020 (minus deductible), the patient pays 25%-33% of medications costs, while Medicare covers 67%-75%.

3. Between $4,020 and $6,350, the patient pays 25% of medication costs, while Medicare covers 75%.

4. Above $6,350, the patient pays 5% of medication costs, while Medicare covers 95%.

This coverage schedule takes into account the total amount for prescription medication costs, including Radicava.

Current Radicava Clinical Trials

ALS Clinical Trials Registry

At Clara Health, we have our own [FREE] ALS Clinical Trials Registry where you can stay updated on the latest clinical studies in the ALS space.

Our team members will work with you to help you find the latest and most promising treatments that best suit your ALS journey.

About Clara Health

Clara Health is a patient-centered healthcare platform that was established to help patients find relevant research studies and trials. We believe that everyone should have the power to access the latest healthcare treatments available and everything we do aims to make this process as smooth as possible.

Interested in learning about how Clara can help?

  • Sort through 50,000+ clinical studies to find the studies that fit for you (for free)
  • We are there to offer you personal support in finding the latest and best clinical trials that fit your needs

Learn more about clinical trials & studies:

1"A second ALS treatment, edaravone, has been newly ...." 8 May. 2017, https://www.als.ca/blogs/second-als-treatment-edaravone-newly-approved-united-states/

2"How is edaravone effective against acute ischemic ... - NCBI." 11 Nov. 2017, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773834/

3"Who Gets ALS? | The ALS Association." https://www.als.org/understanding-als/who-gets-als

4"The Roles of Free Radicals in Amyotrophic Lateral ... - PubMed." https://pubmed.ncbi.nlm.nih.gov/8906612/

5"Radicava Effective in Slowing ALS Disability Over Year of Use ...." 30 Mar. 2020, https://alsnewstoday.com/2020/03/30/radicava-effective-slowing-als-progression-across-1-year-use-patients-trial-data/

6"RADICAVA - FDA." https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf

7"RADICAVA® (edaravone)." https://www.radicava.com/

8"Radicava - Everyday Health." 9 Nov. 2018, https://www.everydayhealth.com/drugs/radicava

9"2020 Open Enrollment Information for Patients - RADICAVA." https://www.radicava.com/assets/dist/pdfs/radicava-2020-open-enrollment.pdf

10"Yearly deductible for drug plans | Medicare." https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/yearly-deductible-for-drug-plans