Radicava Health Insurance Denial Scott Glovsky

Have You Or A Loved One Received a Radicava Health Insurance Denial? We Can Help.

In May 2022, the United States Food and Drug Administration approved the oral form of Radicava® (edaravone), a breakthrough new drug for the treatment of Amyotrophic Lateral Sclerosis (ALS). Also known as Lou Gehrig’s Disease, ALS is a rare neurodegenerative condition that has very few options for medical treatment. Patients can typically only use medicine to manage the pain of their symptoms but are unable to prevent or delay further degeneration. That was until the approval of Radicava. Considered by the FDA to be first-in-class, Radicava has provided the first real treatment option for those suffering from ALS, has shown to dramatically decrease the rate of an ALS patient’s neural deterioration. But Radicava is expensive and sometimes denied by insurers. This page addresses Radicava health insurance coverage claims. It examines how insurers determine if Radicava is medically necessary and offers steps for patients who receive a Radicava health insurance denial.

If you receive a Radicava health insurance denial, contact the Law Offices of Scott Glovsky. We have successfully been fighting for health insurance policyholders for over 20 years.

What Health Concerns Does Radicava Treat?

Originally developed to prevent brain swelling after a stroke, Radicava is most prominently used to treat ALS. It slows the deterioration of nerve function and prevents further damage from occurring.

What is ALS?

Amyotrophic Lateral Sclerosis (ALS) is a rare disease that attacks and kills the nerve cells that control voluntary muscles. Voluntary muscles produce movements such as walking, talking, chewing, and breathing. In patients with ALS, their nerves lose the ability to activate specific muscles, which causes the muscles to weaken and eventually become paralyzed. Early symptoms can include muscle stiffness, muscle twitches, increasing weakness, and muscle wasting. About half of patients with ALS will also experience cognitive difficulties. The most common symptom is muscle cramping and pain. The neuron damage will progress, and the patient will eventually lose the ability to speak, eat, move, and breathe. Once symptoms first appear, the life expectancy of an ALS patient is usually three to five years. Most patients will ultimately pass away from respiratory failure.

Today, there are approximately 16,000 people in the United States who have ALS. There are a few different classifications of ALS, depending on which nerves are primarily targeted in each person. The cause of ALS is also unknown, but scientists believe that in some cases there may be a genetic component.

What is Radicava?

Radicava (Edaravone) was first developed by Mitsubishi Tanabe Pharma in Japan in the late 1980s as a medication to prevent swelling in the brain that commonly occurs after a stroke. It has been approved and marketed as a treatment for stroke in Japan since 2001. In 2011, Mitsubishi Tanabe began clinical trials in Japan for the use of Radicava to treat ALS. Japan approved it for the treatment of ALS in 2015, and the United States FDA approved it as a treatment for ALS in 2017. At this time, Radicava was only available through intravenous infusion, but in May 2022, an oral version was also approved by the US FDA. The oral form makes the drug much more accessible and cost-effective as patients are no longer required to spend time receiving transfusions in medical facilities.

Radicava is a part of a drug class known as neurologic. It works as a free-radical scavenger, removing reactive and unstable molecules within the body known as free radicals. Free radicals are produced within the body as a result of normal cellular processes. In a healthy person, the body quickly removes or detoxifies these free radicals. If the free radicals remain in the body, they can cause oxidative stress, which results in cell damage and death. Researchers believe that oxidative stress caused by an excess of free radicals is one of the main causes of nerve cell death in ALS. Radicava combats this by removing free radicals in the body to prevent oxidative stress and the cell damage that comes with it.

Can Radicava Cure ALS?

Unfortunately, there is no cure for ALS, and Radicava is unable to restore function that has already been lost. However, Radicava has been shown to slow deterioration, extend lifespan, and significantly improve quality of life. The life expectancy for those taking Radicava can extend from the average 2 to 5 years to a possible 3 to 7 years. The most common side effects of Radicava include bruising, problems walking, and headaches. Radicava has no known drug interactions.

What Other ALS Treatments Are There?

Prior to the approval of Radicava, there were very few options for ALS treatment. Aside from Radicava, only one drug has been approved to treat ALS. Riluzole, approved by the FDA in 1995, works by decreasing the release of the neurotransmitter glutamate, but it has only been found to prolong survival by about two or three months. As of April 2023, there are seven ALS FDA-approved drugs. The most recent is Qalsody, granted accelerated approval in April 2023 for ALS patients with mutations of the SOD1 gene (about 2% of US ALS patients). This is the first medication that targets a genetic cause of ALS. Most ALS drugs aim to manage the symptoms and to improve the patient’s quality of life. This includes medications for fatigue, inflammation, muscle cramping, and spasticity.

As a person’s condition worsens, they may also need breathing assistance through either non-invasive or invasive ventilation. Once a person has entered the last phase of their life, palliative care is the focus. Medications such as opioids and benzodiazepines are given to help with pain and anxiety as the patient passes.

A patient can receive Radicava while simultaneously taking Riluzole, but there are only a few small studies that suggest taking the two in conjunction would make them more effective. The results reported have been achieved through the standalone use of Radicava.

Who is Radicava Approved For?

The FDA approved both Radicava IV (infusion) and Radicava ORS (oral suspension) for adults with Amyotrophic Lateral Sclerosis (ALS).

How do ALS patients take Radicava?

There are two different delivery forms of Radicava. When it was first approved in 2017, Radicava was administered by an intravenous infusion. Each dose is 60 mg and each infusion takes about an hour. When a patient starts on Radicava, s/he gets it every day for two weeks. Then the individual takes two weeks off. After this, patients receive daily infusions for ten of the next fourteen days and then take two weeks off. This dosing schedule continues for a year or for however long a doctor prescribes.

Radicava ORS is an oral suspension that is taken by mouth or by feeding tube. Each dose is 5 mL and only takes about 5 minutes to take. Like the IV infusion, patients take Radicava ORS every day for 14 days and then take 14 days off. After this period, an individual takes the oral suspension for ten of the next fourteen days and then nothing for 14 days. This schedule continues. Each dose is taken in the morning on an empty stomach. You can learn about prescribing information here.

How much does Radicava Cost?

The annual cost of infusions is approximately $145,000. Every infusion is about $1,000.

Does Medicare Approve Radicava Claims?

Different insurance companies cover Radicava claims differently. If you have Medicare, the federal government health insurance program for adults 65+, Radicava infusions are usually covered under Medicare Part B and Part D. Keep in mind that Medicare covers the cost of the drug only.

Medicare Part B covers things like physician visits, MRIs, outpatient surgery, lab tests and more. For Radicava, once your deductible is met, Medicare Part B takes care of 80% of the treatment costs. You then pay $29,000 for a year of treatment assuming that the treatment costs $145,000/year. If you also have Medigap (a Medicare Supplement Plan), this coverage might cover your out-of-pocket $29,000.

Medicare Part D usually covers prescriptions. With Medicare Part D, you pay your annual deductible first. Then, Medicare’s coverage is based on the cost. Up to around $4,000 (and this number changes each year), Medicare Part D covers about 67%-75%. From about $4,000 to about $6,300, Medicare Part D covers 75%. And above this amount, Medicare Part D covers 95%.

Do Commercial Insurance Companies Approve Radicava?

Commercial insurers such as Blue Shield, Aetna, UnitedHealthcare, Kaiser, and Anthem have varying coverage policies. These insurance companies approve Radicava when they deem it medically necessary for an individual.

Similar to other drugs, the maker of Radicava offers a co-pay (patient) assistance program. This program, however, depends on your unique situation and the state you live in. Also, you must meet the eligibility criteria. Note that to receive assistance, your insurance provider must consider Radicava medically necessary.

Is Radicava Medically Necessary Or Medically Beneficial?

If your health insurance company approves Radicava, the company considers Radicava medically necessary. When your insurer deems Radicava medically necessary, it considers this medication necessary to treat your ALS. It is not always easy to get a medically necessary decision. In many cases, you must be persistent and get assistance from your doctor. And it may take a fair amount of time.

Medically beneficial, on the other hand, means that Radicava is helpful but not necessarily necessary. There may be other medications or treatments that will help with ALS. Typically these treatments are less expensive than Radicava.

A common practice with health insurers is to have the patient go through step therapy. Step therapy is a process whereby a patient must try alternative therapies or medications rather than the one your doctor prescribed. Then, you must stay on these therapies for a while. If these therapies don’t work (generally after 60 days), then the insurance company will reassess the situation. The challenge for you, the patient, is that these alternative medications or therapies may not work. And this delay might cause issues.

How Do Insurance Companies Evaluate Radicava Coverage Requests?

Because every insurer has its own pharmacy or medical policy, each insurance company has its own standard for reviewing requests. And the pharmacy or medical policy deems whether the medication is medically necessary. Typically, companies review the FDA’s approval of medication first. In this case, Radicava injections were first approved on May 5, 2017, and Radicava ORS (oral suspension) was first approved on May 12, 2022. After internal employees create a policy, external physicians review the policy to decide if it is suitable. Unfortunately, sometimes these external physicians have other incentives when they make their decisions. These incentives could be financial or might be hopes of future employment with the insurer. For these and other reasons, sometimes insurers end up with very restricted policies. Overly restricted policies can be problematic since insurers use them to determine if a medication or treatment is medically necessary or experimental/investigational.

Is Radicava Considered Medically Necessary Or Experimental/Investigational?

Sometimes, if an insurance company establishes a medication or treatment that is not medically necessary, it deems the treatment or medication to be experimental or investigational. There are different reasons why the company may call Radicava experimental or investigational. As mentioned above, a company’s internal pharmacy or medical policy may define Radicava as experimental/investigational. If a medication doesn’t have FDA approval, it is oftentimes considered experimental/investigational. Fortunately, the FDA has approved Radicava. Sometimes unsettled evidence about a drug’s efficacy will give it this definition. In other words, an insurer may feel a medication is helpful but doesn’t meet its standard for efficacy.  Sometimes an insurer will give this designation to a drug when there are other medications that are considered safe and effective. (It is not uncommon for these alternatives to be less expensive.) Another reason a medication might be labeled as experimental or investigational is if the drug does not enhance patient outcomes.

It is important to check each insurance company’s internal policy to see how it defines Radicava. Since policies are different and often open to interpretation, and because individual patients may have different results with the same drug, the claim approval process varies by company. The process is also complicated given that the text of the guidelines is often subjective.

Your Insurer’s Duty When Evaluating Your Radicava Claim

The good news is that all insurance companies have duties when they review claims. If they don’t abide by these duties, you have options including taking legal action. Insurers must review your claim and approve or deny it. When making its decision, it must thoroughly investigate your request. An insurer cannot just look for reasons to deny your claim. It has a duty to consider all potential reasons why Radicava might be medically necessary. Your claim shouldn’t be evaluated by just anyone. It must be assessed by a qualified medical professional. Finally, your insurance company has a duty to respond promptly. Your state sets the definition for “promptly,” but it is often 30 days. If your health situation is urgent, you can request an expedited review which is often 72 hours or less.

What Can You Do If You Receive A Radicava Health Insurance Denial?

Of course, you always have the right to appeal your insurer’s Radicava denial. But before you appeal, it is critical to know if your plan is an ERISA or Non-ERISA plan. ERISA is the acronym for the Employment Retirement Income Security Act of 1974. It essentially protects the interests of employee benefit plan participants and beneficiaries. In ERISA plans, the employer selects investment options, controls the deposit and timing of employee contributions, and sometimes matches contributions. In Non-ERISA plans, your employer only participates in compliance actions. You can reach out to your company’s plan administrator to learn what type of plan you have.

A general rule of thumb is that most plans are ERISA. Exceptions include healthcare plans for government employees, religious institution workers, and business plans that only cover the owner(s). A few other exceptions include individual and family plans purchased on healthcare.gov (Covered California in CA) as well as individual and family plans brought through private insurance companies such as Blue Shield, Cigna, Kaiser, and Anthem.

If you have an ERISA plan, you should definitely appeal your insurance company’s decision. The reason to do so is that you must first use up all of your administrative remedies. We suggest you speak with an attorney who specializes in this area before filing your appeal. You can learn more about ERISA policies here.

If you have a Non-ERISA plan, you have a lot more options. First know why your claim was denied, and then reach out to a Non-ERISA attorney. You can go here for more information.

Contact the Law Offices of Scott Glovsky If You Receive a Radicava Health Insurance Denial.

Our office has been fighting for the rights of insurance policyholders since 1999. Reach out and we may be able to help.