Received a Humira Health Insurance Denial? Contact Us
The Food and Drug Administration (FDA) first approved Humira® for use as a treatment for Rheumatoid Arthritis (RA) in 2002. Humira has since received approval for many other autoimmune diseases including psoriatic arthritis and Crohn’s disease. It is also approved for Ulcerative Colitis, Polyarticular Juvenile Idiopathic Arthritis, and Ankylosing Spondylitis. And for Hidradenitis Suppurativa and Uveitis. Humira comes from American biopharmaceutical company Abbvie and has been the world’s top selling drug since 2012 (annual Humira revenue is $21 billion). Humira, which stands for “human monoclonal antibody in rheumatoid arthritis,” is the brand name drug for the generic adalimumab. This article addresses Humira health insurance coverage claims. In addition, it covers how insurance companies make decisions about medical necessity. It also covers next steps for action after receiving a Humira health insurance denial. If you receive a Humira health insurance denial, contact the Law Offices of Scott Glovsky.
What is Humira?
Humira is a prescription medication and type of immunosuppressive drug. It is administered by injection under the skin either via the injectable Humira Pen or the prefilled Humira Syringe. Patients typically take Humira once every other week. Humira targets an inflammation-causing protein, the tumor necrosis factor-alpha (TNF-alpha) protein. The immune system naturally produces TNF-alpha. Over-production of TNF-alpha, however, can cause inflammation and contribute to autoimmune disease. By binding to the TNF-alpha, Humira helps block interaction between TNF-alpha and other cells.
Humira is approved for use in adults and, for specific autoimmune diseases, in children. Because Humira treats a range of different autoimmune diseases, its effectiveness varies across different contexts. In clinical studies, 63% of patients with moderate to severe Rheumatoid Arthritis who took Humira alongside methotrexate saw improvement in symptoms. Humira works at sign and symptom reduction but does not cure autoimmune disease. You can read more about frequently asked questions on Humira here.
What Does Humira Treat?
Humira is a biologic drug prescribed in cases of autoimmune disease. Humira targets an inflammation-causing protein that contributes to a variety of different autoimmune diseases. As such, it proves effective at symptom and inflammation reduction against a swath of conditions from arthritis to skin disorders.
Physicians prescribe Humira for symptom reduction in the following cases:
- moderate to severe rheumatoid arthritis (RA) in adults
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older
- psoriatic arthritis (PsA) in adults
- ankylosing spondylitis (AS) in adults
- moderate to severe hidradenitis suppurativa (HS) in people 12 years and older
Humira also treats the following cases:
- moderate to severe Crohn’s disease (CD) in adults and children 6 years and older
- also moderate to severe ulcerative colitis (UC) in adults and children 5 years and older
- and moderate to severe chronic plaque psoriasis (Ps) in adults
- non-infectious intermediate, posterior, and panuveitis in adults and children 2 years and older.
More information about Humira as a treatment for specific conditions can be found on the Humira website.
Do Insurance Companies Cover Humira as a Treatment for Autoimmune Disease?
Government health insurance programs like Medicaid can provide coverage for Humira as a treatment for autoimmune disease. However, coverage can vary depending on state of residence. Medicare, the federal health insurance program for people 65 and older, can also provide coverage for Humira. Medicare grants this coverage through Medicare Advantage Plans (Part C) and Supplemental Plans (Part D). Patients must enroll separately for this prescription coverage, however.
Commercial private insurance companies like Anthem, Aetna, UnitedHealthcare, Humana, HCSC, Blue Shield, and Kaiser Permanente hold different coverage standards. Many private insurance plans do cover Humira as a treatment for the aforementioned autoimmune diseases. Coverage requirements for authorization vary across different insurers. It is important to understand the process through which insurers deem a drug like Humira as medically necessary and to speak with an attorney if you receive a Humira health insurance denial.
Is There a Biosimilar (Generic Counterpart) For Humira?
Biosimilars are the generic counterparts of brand biologic drugs. On January 31, 2023, Amgen introduced a biosimilar for Humira called Amjevita. This biologic has two price tiers. The first tier provides Amjevita at a 5% reduction to Humira. The second tier is about half the cost of Humira.
The reason why health insurance companies and PBMs (pharmacy benefit managers) may prefer the more expensive tier is that most policyholders’ coinsurance costs are an established percent of a drug’s retail list price. So it’s likely that most policyholders’ costs will be established off the higher list price that brings more dollars to the insurance company or PBM. UnitedHealthcare and Cigna, with two of the largest PBMs, said they will charge identical out-of-pocket costs for both Humira and its biosimilars. With identical OOP costs, there is less incentive for doctors to prescribe the biosimilar. Of course Humira has been around for longer and patients might already take Humira.
What is Medically Necessary vs. Medically Beneficial?
Most health insurance companies require prior authorization before covering this type of drug. Prior authorization requires a decision from your health insurance company that a drug is medically necessary. Insurers deem a drug medically necessary if it is needed to treat the signs or symptoms of a disease.
However, there can be a few catches in the prior authorization process. Oftentimes a drug can be medically beneficial for a patient, yet insurers will deem the drug not medically necessary. A variety of drugs and procedures can treat the same conditions. An insurer may deem a drug not medically necessary because an alternative exists. Not surprisingly, insurance companies often favor less expensive treatment options.
Step therapy is a form of prior authorization. It requires patients to try a less expensive or invasive drug for their symptoms. If the cheaper or generic alternative proves ineffective for the patient, the insurer may then re-evaluate a claim. Through this process, a more expensive or preferred drug can then be deemed medically necessary. Certain insurers require patients to try approved step therapy drugs for 60 days before re-evaluating other drug options. Exemptions can be made for step therapy cases in California, but the process can be complicated. Step therapy can prevent patients from getting coverage approval for expensive or name-brand drugs. It can also harm patients in its pursuit of pushing second-choice drug options. Conditions that require expensive specialty drugs, like cancers and autoimmune disorders, often require patients to complete step therapy. Because Humira is a relatively expensive biologic, the process of receiving prior authorization can be difficult.
How do Insurance Companies Evaluate Humira Coverage Requests?
Health insurance companies evaluate coverage requests based on internal “medical” or “pharmacy” policies. When the FDA approves new drugs, insurance company teams have their pharmacists research these drugs and develop internal clinical policies. These internal policies help the insurers decide which drugs are medically necessary for different circumstances. These guidelines help insurers make recommendations as to whether drugs are medically necessary or experimental/investigational. Once insurance companies develop their policies, they bring them before a group of external doctors who vote on them. Unfortunately, insurers sometimes motivate these doctors with financial gains or the potential to work for said insurers. This can lead external doctors to deem overly restrictive policies appropriate.
Because of restrictive policies, there can be a rift between what a patient’s physician and an insurer deem medically necessary. Physicians and healthcare workers make distinctions about medical necessity based on peer-reviewed medical literature. The scientific evidence in literature helps the medical community decide which drugs are safe and effective for different circumstances.
What is Medically Necessary vs. Experimental or Investigational?
If an insurer deems a drug not medically necessary, then the insurer may also consider the drug to be experimental or investigational. There are several reasons why an insurance company will decide a drug is experimental or investigational. The policy definitions of experimental and investigational will determine whether the insurer is correct. When the FDA does not approve a drug for a specific use, insurers often deem it experimental. If evidence does not make conclusions about the health outcomes of a certain drug, insurers may deem it experimental. If scientific evidence suggests that alternative drugs could be more safe or effective, insurers may deem it experimental. And finally, if a drug is not proven applicable or does not improve health outcomes, insurers may deem it experimental.
These guidelines for deeming a drug medically necessary or experimental/investigational are subjective. Different insurers will make different designations for what is medically necessary. Insurers have a great degree of power over what they deem experimental or investigational – and often get it wrong. Nearly every drug option will have different effects for different patients, which makes these designations slippery. In fact, insurers may even deem a drug like Aspirin to be not medically necessary. Insurance companies often have the authority to deny coverage for drugs like Aspirin if their contract language allows it.
What is the Duty of Insurance Companies When Members Submit Claims?
If a member submits a claim, the insurer will review it and make a decision to approve or deny it. In this process, the insurance company has several duties. Firstly, the insurer has a duty to thoroughly investigate a claim request. Secondly, the insurer has a duty to fully inquire into all possible reasons that might support requests for care. Thirdly, the insurer has a duty to promptly respond to claim requests. And finally, the insurer has a duty to appoint and employ qualified medical professionals to make claim review decisions.
What Can You Do if You Receive a Humira Health Insurance Denial?
If you receive a Humira health insurance denial, you have the right to appeal that denial. Before you appeal the denial, you should determine whether you have an ERISA (Employment Retirement Income Security Act of 1974) or non-ERISA plan. If you are unsure about your plan type, contact your plan administrator.
Most private employers provide employees with ERISA plans. However, there can be exceptions for the following cases:
- government employee plans
- religious organization plans
- business plans that only cover business owners
- individual and family plans through Covered California
- Individual and family plans purchased through private insurance companies like Anthem Blue Cross or Blue Shield of California
If you have an ERISA plan, you should file an appeal as you must exhaust your administrative remedies. We suggest you speak with an 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 A Humira™ 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.