On January 6, 2023, the FDA granted accelerated approval and on July 6, 2023 it granted full approval to Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease. It’s the second drug that targets the disease’s cause instead of its symptoms. The drug was developed by Eisai Co Ltd that is partnering with Biogen Inc. for marketing in the United States. Approval was based on study results showing individuals who took Leqembi experienced “moderately less decline on measures of cognition and function.” This page discusses whether insurance companies will cover this expensive drug or simply deny health insurance claims for Leqembi. Insurers like Blue Shield of California, Anthem Blue Cross, 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 Leqembi health insurance denial, contact Law Offices of Scott Glovsky.
What is Alzheimer’s Disease?
More than 6.5 million Americans, or nearly 11 percent of those 65 and older, have Alzheimer’s disease. In fact, 73% are over 75 or older. Alzheimer’s is an incurable disease. Alzheimer’s is the most widespread form of dementia. In Alzheimer’s patients, scientists believe that tau tangles and beta-amyloid plaques harm and kill nerve cells. This harm, together with other damage, affects memory and other cognitive functions and hinders activities of daily living. Other symptoms can include anxiety, insomnia, confusion, disorientation, language issues, mood, and behavior changes, and more. Researchers don’t know exactly what produces Alzheimer’s, but family history, age and chronic health conditions likely play a role.
How is Alzheimer’s Disease Diagnosed?
Physicians rely on various exams to diagnose Alzheimer’s disease including neurological and physical exams, mental status tests, medical and family histories, and diagnostic tests and brain images. Fortunately for potential patients with this disease, on October 13, 2023, the Centers for Medicare & Medicaid Services (CMS) removed the limitation that individuals may only receive one PET scan in their lifetimes. Now, Medicare recipients can receive amyloid PET scans to test for Alzheimer’s disease.
What is the New Drug Leqembi™?
U.S. regulators believe Leqembi™ treats the underlying cause of Alzheimer’s as opposed to simply managing its symptoms. Leqembi works by helping to clear beta-amyloid protein build up in the brain. The drug isn’t a cure for Alzheimer’s and doesn’t reverse its decline. Leqembi was studied in people with mild dementia or mild cognitive impairment who also had amyloid beta pathology. The study showed that participants had a 27% reduction in brain amyloid plaque and slower decline.
Who is Leqembi Approved For?
Leqembi is approved for patients in the mild cognitive impairment or mild dementia stage of Alzheimer’s disease, which is about 1.5 million people.
How is Leqembi Administered?
The drug is administered via an IV infusion every two weeks.
How Much Does Leqembi Cost?
The list price of Leqembi is $26,500 annually.
Do Insurance Companies Cover Leqembi™ as a Treatment for Alzheimer’s?
Medicare and Medicaid (aka Medi-Cal in California) normally cover medications approved by the FDA. Government health insurers like Medicare and Medicaid also depend on national guidelines from third-party organizations such as the American Academy of Neurology. In March 2023, the Veteran’s Health Administration announced it would cover Leqembi for veterans who met its criteria. Medicare’s approval for Leqembi was initially similar to its approval for Aduhelm. In other words, given its accelerated approval, Medicare only covered Leqembi for individuals who participated in clinical trials. However, on July 6, 2023, the FDA granted full standard approval to Leqembi. Shortly afterwards, Medicare revealed it would cover 80% of the cost for eligible participants in traditional Medicare. Medicare Advantage coverage is usually the same as traditional fee-for-service Medicare. And those with Medigap or Medicaid may pay less than 20%.
The Centers for Medicare and Medicaid Services (CMS) defined coverage requirements for Leqembi. Patients must be Medicare recipients and have been diagnosed with either mild Alzheimer’s with evidence of amyloid plaque in the brain or have mild cognitive impairment. In addition, patients’ doctors and clinical teams must share information in a registry. This information includes patient tests, Leqembi side effects, and whether the patient is on blood thinners. Ultimately, the registry helps CMS understand patient outcomes.
Of course, insurance companies like Kaiser, Anthem Blue Cross, Aetna, Blue Shield, and others will likely approach Leqembi differently. This is because they rely on their own internal guidelines. And guidelines are different for different insurers. It is advantageous to know their process for assessing new medications and a potential Leqembi health insurance denial.
How Do Health Insurance Companies Assess New Treatments and Prescription Medications?
Each health insurer has its own policies known as “medical” or “pharmacy” policies. These policies include internal clinical rules on the factors and conditions in which drugs and treatments are “medically necessary.” (Approved drugs can be viewed in their formularies.) Health insurance companies track new medications that are FDA approved. Their company pharmacists research the medical literature on these medications. The pharmacists then deliver a recommendation on whether they are medically necessary or experimental/investigational.
Health Insurers frequently take their internal recommended policies to external doctors who determine whether the policies are appropriate. Yet, because the doctors who vote on policies are regularly compensated by the insurance companies, there may be an incentive to approve an overly restrictive policy. Also, some of these doctors may ultimately want to work for the specific insurance company. These physicians have another reason to concur with proposed policies. And insurers have incentives to exclude expensive treatments and drugs because they effect the corporate bottom line.
Too often insurer policies are overly restrictive. The policies may not contain what independent medical specialist organizations consider to be safe and effective for treating medical health conditions. You may have heard of “Generally accepted standards of medical practice.” These standards refer to protocols and guidelines that are usually followed by physicians in a given specialty. They are based on reliable scientific evidence that is published in peer-reviewed medical journals. And they are generally recognized by the applicable medical groups and are accepted by other medical workers in the community. It is not uncommon for an insurance company policy to be different than what a person’s doctor believes is “medically necessary.”
What is The Difference Between Medically Necessary and Medically Beneficial?
These two are not the same. In fact, just because a treatment or prescription drug might treat a given health condition, it may not be medically necessary under the specific health insurance policy. For instance, if a less expensive and less invasive procedure is available to treat a symptom, then according to some insurers a more expensive and advanced treatment procedure for that same symptom may not be medically necessary.
It is common for health insurance companies to use “step therapy.” Here, they deny more costly medications and approve less costly ones first. In California, the patient must remain on an approved medication for 60 days before substituting another medication. It is possible to get exemptions in California, but California exemption laws have many loopholes and lack enforcement procedures. Delaying the right medication may cause harm to patients. Health insurance companies use step therapy often with complex, incapacitating medical conditions such as immune disorders and cancers. The reason, of course, is because these health conditions depend on specialty medications that are quite costly.
Medically Necessary vs. Experimental or Investigational
When a medication or treatment is called “experimental” or investigational,” the health insurer doesn’t consider the drug or treatment to be medically necessary. Interestingly, an experimental or investigational medication may be approved by the FDA. And unfortunately, nearly anything could be considered experimental or investigational for a variety of reasons. Perhaps a drug or treatment helps some people but not others. This fact is true of nearly every medication or treatment. And a medication or treatment may improve certain but not other health conditions. This is how one insurance company might consider a drug medically necessary while a different insurer might consider the same medication experimental or investigational.
Do Insurance Companies Have Duties When They Review Policyholder Claims?
Absolutely insurers have duties. They must thoroughly investigate a request for medical care and fully investigate all possible reasons that could support the request. They must respond to the request in a given prompt timeframe. And they must have qualified medical professionals making utilization review decisions.
What Can You Do if You Receive an Leqembi™ Health Insurance Denial?
Of course, you have the right to appeal a denial. First consider if you have an “ERISA” (Employment Retirement Income Security Act of 1974) or a non-ERISA plan. You can always ask your company’s plan administrator if you don’t know which type of plan you have. If you don’t receive health insurance from your employer, you can call your insurance company and ask.
Most health insurance plans provided by companies are ERISA plans. But there are exceptions as explained below.
ERISA doesn’t apply to the following kinds of plans:
- Plans from government employers (i.e., police, firefighters, public defenders, teachers, public park, public transportation, and public utility employees, etc.) at different levels (township, city, municipality, county, state, federal, and so on)
- Policies from religious organizations
- Business plans in which the health insurance plan only covers the business owner and his or her family
- The majority of individual and family plans purchased through Covered California
- Many plans purchased directly from insurers such as Blue Shield and Anthem Blue Cross
- Most plans for Native American tribes or entities
We suggest that you speak with a special healthcare insurance attorney before you submit an ERISA or non-ERISA appeal. Then, If you have an ERISA policy, file an appeal. Go here to learn more about steps to take if you have an ERISA plan. If you have a non-ERISA plan, you have several options, and you’ll want to know why your claim was denied. Go here to learn more about non-ERISA steps.
Contact Law Offices of Scott Glovsky if You Receive An Leqembi™ Health Insurance Denial
The Law Offices of Scott Glovsky has represented injured consumers and victims of wrongful business practices for over twenty years. Our firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. We get justice for our clients and hold wrongdoers accountable.