The Food and Drug Administration (FDA) approved the first new Alzheimer’s drug, Aduhelm™, in nearly 20 years on Monday, June 7, 2021. The medication is from Biogen and was developed by Biogen and the Japanese company Eisai Co. The drug’s scientific name is “aducanumab” and it is marketed as “Aduhelm™.” The accelerated approval was based on study results showing Aduhelm was “reasonably likely” to benefit people with Alzheimer’s. This article addresses whether insurance companies will cover this expensive drug or simply deny health insurance claims for Aduhelm. Insurers like Anthem Blue Cross, Blue Shield, Aetna, Healthnet, Cigna, and others approve treatments that are “medically necessary.” Will health insurers view this drug as “medically necessary” or will they say it is “experimental” or “investigational?” If you receive an Aduhelm™ health insurance denial, contact Law Offices of Scott Glovsky.
What is Alzheimer’s Disease?
Over six million Americans 65 and older have Alzheimer’s, an incurable disease. Alzheimer’s is the most common form of dementia. In Alzheimer’s patients, scientists believe that beta-amyloid plaques and tau tangles damage and kill nerve cells. This damage, together with other damage, impacts memory and other cognitive functions and interferes with activities of daily life. Other symptoms can include insomnia, anxiety, language issues, disorientation, confusion, behavior and mood changes, and more. Scientists don’t know exactly what causes Alzheimer’s, but age, family history and chronic conditions likely play a role.
What is the New Drug Aduhelm?
U.S. regulators believe Aduhelm is the only drug that can treat the underlying cause of Alzheimer’s instead of just managing its symptoms. Aduhelm works by helping to clear beta-amyloid protein build up in the brain. It doesn’t cure Alzheimer’s, nor reverse its decline. One study found it simply slows the cognitive and functional decline. While it was studied in people with early stage Alzheimer’s, the FDA initially approved Aduhelm for anyone with the disease. On July 8, 2021, the FDA narrowed its approval. Aduhelm is now approved only for patients with mild Alzheimer’s dementia or mild cognitive impairment. Patients need a Magnetic Resonance Imaging (MRI) within a year of initiating treatment and will need additional MRIs during treatment. It is given as an infusion by a physician or hospital every four weeks. Aduhelm costs $56,000 annually and Biogen will start shipping Aduhelm by mid-June 2021.
The FDA is requiring Biogen to do another study to confirm the drug’s efficacy. Biogen said it will conduct this study within the next ten years. If the additional study doesn’t show efficacy, the FDA could pull Aduhelm from the market. It is important to note that the FDA rarely pulls drugs off the market.
Will Insurance Companies Cover Aduhelm as A Treatment for Alzheimer’s?
Government health insurers like Medicare and Medicaid typically cover medications approved by the FDA. (Note that Medicaid is called “Medi-Cal” in California.) Organizations like Medicare and Medicaid also rely on national guidelines from third-party organizations such as the National Comprehensive Cancer Network for cancer medications and treatments. On April 7, 2022, Medicare announced it will only cover this drug for participants of Aduhelm clinical trials. As of this date, that’s about 1.5 million people. And at the start of May 2022, UnitedHealthcare released a new policy. Starting June 1, 2022, UnitedHealthcare requires prior authorization and only covers patients in approved clinical trials.
But insurance companies like Aetna, Anthem Blue Cross, Blue Shield, Kaiser Permanente, and others will likely approach Aduhelm differently. The reason is that they rely on their own internal guidelines. And different insurers will have different guidelines. It is helpful to understand their process for evaluating new drugs and a potential Aduhelm™ health insurance denial.
How Do Health Insurance Companies Evaluate New Drugs and Treatments?
Health insurance companies set their own policies called “medical” or “pharmacy” policies. These policies include internal clinical guidelines on the parameters and circumstances in which medications and treatments are “medically necessary.” (Approved medications are included in company formularies.) Insurers track new drugs approved by the FDA. Their internal pharmacists do research on the medical literature about the drugs. They then provide a recommendation on whether they are medically necessary or experimental / investigational.
Insurers often then take these recommended policies to a group of external doctors who vote on whether the policies are appropriate. Since the external doctors who vote on policies are often paid by the insurance companies, there can be an incentive to agree with an overly restrictive policy. Also, some of the external doctors may want to ultimately work for the insurance company. These doctors have another incentive to agree with proposed policies. And insurance companies have incentives not to include expensive medications and treatments because they impact the corporate bottom line.
Unfortunately, often insurance company policies are overly restrictive. They may not include what independent physician specialist organizations consider to be safe and effective for treating medical conditions. “Generally accepted standards of medical practice” are standards based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community and that are accepted by other healthcare workers in the community. It is not uncommon for an insurer’s policy to differ from what a patient’s physician believes is “medically necessary.”
What is Medically Necessary vs. Medically Beneficial?
It is important to note that medically necessary is not synonymous with medically beneficial. Just because a procedure or drug might treat a condition, it may not be medically necessary under the insurance contract. For example, if a less invasive and less expensive procedure which can treat a symptom is available, then according to some insurance companies a more costly and advanced procedure for treatment of that same symptom may not be medically necessary.
Insurers often attempt to utilize “step therapy” where they deny more expensive drugs and approve less expensive ones first. In California, the patient must remain on the approved drug for 60 days before switching to another drug. It is possible to get step therapy exemptions in California, but exemption laws have many loopholes and lack enforcement systems. Unfortunately step therapy can cause harm to patients by delaying access to drugs that are most beneficial for them. Insurers use step therapy a lot with complicated, incapacitating medical conditions like cancers and autoimmune disorders. Often the reason is that these conditions rely on specialty drugs that are quite expensive.
Medically Necessary vs. Experimental or Investigational
A drug or treatment is considered “experimental” or investigational” if an insurer deems a medicine or treatment not medically necessary. An experimental or investigational drug may be approved by the FDA. As you can see from one health insurer’s definition below, just about anything can be considered experimental or investigational.
The use of any treatment, service, procedure, facility, equipment, prescription drug, device or supply (intervention) which is not determined (by this insurer) to be medically effective for the condition being treated. Insurer will consider an intervention to be Experimental/Investigational if: the intervention does not have Food and Drug Administration (FDA) approval to be marketed for the specific relevant indication(s). Or if available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes. And/or if the intervention is not proven to be as safe and as effective in achieving an outcome equal to or exceeding the outcome of alternative therapies. Or if the intervention does not improve health outcomes; or, the intervention is not proven to be applicable outside the research setting.
In the above definition, for example, “does not improve health outcomes” can be subjective based on clinical studies. There may be a pharmaceutical or treatment that helps some people but not others. This fact is likely true with nearly every drug or treatment on the market. It helps explain why the same drug may be considered medically necessary by one insurer and investigational by another.
In other words, insurance company policies can deem anything as experimental or investigational. A great hypothetical example is aspirin. Even though it has been around for years, aspirin may not be considered medically necessary. The reason is that science doesn’t necessarily understand how aspirin works.
What Is the Duty of Insurance Companies when Members Submit Claims?
When a member submits a claim, insurers review the claim against company policies and approve or deny the claim. Of course, health insurers have several duties. They have a duty to thoroughly investigate a request for care. Another duty is to fully inquire into all possible bases that might support the request for care. They have a duty to promptly respond to the request for care. And they have a duty to ensure that qualified health professionals make utilization review decisions.
What Can You Do if You Receive an Aduhelm Health Insurance Denial?
You have the right to appeal a denial. You should first consider whether you have an “ERISA” (Employment Retirement Income Security Act of 1974) or non-ERISA plan. If you aren’t sure of which plan you have, you can ask your plan administrator.
ERISA applies to most health insurance plans that employers provide to employees. But there are exceptions as noted below.
ERISA does not apply to the following types of plans:
- Government employee plans (i.e., police, firefighters, public defenders, etc.) at all levels (city, county, state, federal, and so on)
- Religious organization plans
- Business plans in which the policy only covers the business owners
- Most individual and family plans purchased through Covered California
- Most plans purchased directly from insurance companies like Anthem Blue Cross or Blue Shield of California
If you have an ERISA plan, you should file an appeal. We suggest you speak with an ERISA attorney before you submit the appeal. You can learn more about what to do if you have an ERISA plan here. If you don’t have an ERISA plan, you have many options and it is best to understand why your claim was denied. You can learn more here.
Contact Law Offices of Scott Glovsky if You Receive An Aduhelm™ Health Insurance Denial
The Law Offices of Scott Glovsky has represented injured consumers and victims of wrongful business practices for more than the past two decades. The firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse and consumer-related litigation. We get justice for our clients and hold the wrongdoers accountable.