Have you or a loved one received a Stelara Health Insurance Denial? We Can Help.
Stelara is a prescription biologic drug that impacts the immune system. Doctors prescribe it for Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. In all cases exceptPlaque Psoriasis, it is given to adults but not to children. Unfortunately, health insurance companies may deny this medication from Janssen Immunology due to its high cost. After all, it’s list price over $12,000 for one month. The information below reviews Stelara health insurance coverage claims. It outlines how health insurers evaluate if Stelara is medically necessary. Finally, it shows what you can do if you receive a health insurance denial for this medication. If you receive a Stelara health insurance denial, contact the Law Offices of Scott Glovsky. We understand how insurers operate and have been fighting them for over two decades.
What is Stelara?
Stelara, also known as ustekinumab, is a human interleukin-12 and -23 antagonist. The FDA approved Stelara’s treatment for a variety of conditions between 2009 and 2020. As such, Stelara has been on the market for over ten years. And over 425,000 patients have taken Stelara.
Stelara is a biologic drug. Biologics target a specific part of the immune system. Unlike synthetic drugs, a biologic is developed from a living organism such as a cell, tissue, DNA or protein. It may come from a mammal, insect, plant, bacteria, or bird. Biologic medications can be made from, among other things, blood, proteins, and viruses. They include interleukins (like Stelara), vaccines and antibodies. These drugs are used in the prevention, diagnosis, or treatment of various diseases including cancer.
Biologic medications tend to be expensive. Why? Because these drugs are at the cutting edge in medicine. They are more complex to develop and can be more unstable than synthetic drugs. Perhaps most importantly, cellular and gene-based biologics can treat some diseases that couldn’t be treated in the past.
What Diseases Does Stelara Help?
Stelara is mainly prescribed for four conditions. It is used to treat moderately to severely active Crohn’s disease. Stelara also treats moderately to severely active ulcerative colitis. Finally, it helps moderate to severe plaque psoriasis and active psoriatic arthritis.
What is Crohn’s Disease and How Does Stelara Help?
Crohn’s Disease is a form of inflammatory bowel disease (IBD). Inflammation of the digestive tract can cause abdominal pain and diarrhea. It can also lead to weight loss, malnutrition, and fatigue. Stelara is sometimes prescribed when other drugs, including biologics, didn’t work.
In a clinical trial, Stelara was given to people who didn’t get relief from other drugs. 56% of people who had never taken a biologic drug found symptom relief starting from the first infusion. And 34% of individuals who didn’t get relief from other biologics experienced symptom relief. 53% of study participants were in remission after the first year. And 43% of study participants were in remission after the third year.
What is Ulcerative Colitis and How Does Stelara Help?
Ulcerative colitis is another inflammatory bowel disease. It causes inflammation and ulcers in the digestive tract. It impacts both the colon (the lining of the large intestine) as well as the rectum. Most people have symptoms that increase over time. And the disease, also known as Inflammatory Bowel Disease (IBD), can ultimately be life threatening.
In a clinical trial, 58% of participants had symptom relief after 8 weeks and 19% went into remission. Symptom relief was impressive after both the first and second year on the medication.
What is Plaque Psoriasis and How Does Stelara Help?
Plaque psoriasis is a disease of the skin that causes red, itchy patches. Unfortunately, there is no cure for this chronic disease. The treatments available only manage the symptoms of this disease that flares up and goes into remission.
Over 240,000 patients in the United States have been treated with Stelara for this condition. In a medical study, 7 of 10 participants had at least 75% clearer skin in 12 weeks. And, 6 of 10 people rated their psoriatic arthritis as cleared or minimal after 12 weeks.
What is Psoriatic Arthritis and How Does Stelara Help?
Psoriatic arthritis is a type of arthritis that impacts some people with psoriasis. Symptoms include swelling, stiffness and joint pain anywhere on the body. Like plaque psoriasis, this condition flares up and goes into remission. And this disease has no cure.
According to the company, Stelara may help control joint stiffness and pain. It can also help control swelling along the length of fingers or toes. In addition, Stelara helps with skin thickness, scaling and redness. And finally, it helps with swelling at the elbows, heels or other joints.
How is Stelara Administered?
Administration depends on the disease Stelara treats. For Chron’s Disease, it is first given through an IV infusion and then via injections every 8 weeks. There total of 6 doses in the first year. With Ulcerative Colitis, a one-time IV infusion is followed by 6 injections in the first year. For Plaque Psoriasis, two starter doses are followed by 4 doses a year. And for Psoriatic Arthritis, there are a total of 6 doses.
Do Insurance Companies Cover Stelara?
Health insurance coverage for Stelara varies across insurers and disease types. Medicaid coverage may change across different states. Most Medicare (the federal health insurance program for adults 65+) prescription drug plans cover Stelara. This drug is typically covered via Medicare Part B. In some cases, a Medicare Advantage plan may cover this treatment under Part D. Health care providers must submit claims under Part B or Part D separately.
Blue Shield, Kaiser, Anthem Blue Cross, Aetna, UnitedHealthcare, Humana, and HCSC have different coverage policies. Varying autoimmune diseases and patient histories often result in different approval processes. Commercial private health insurance companies typically approve Stelara claims when they deem them medically necessary.
Is Stelara Considered Medically Necessary or Medically Beneficial?
Before covering Stelara, typically insurance companies need prior authorization. Prior authorization indicates that the health insurance company deems this drug to be medically necessary. Medical necessity accepts that a drug is necessary to treat the condition. Depending on insurer requirements, prior authorization is sometimes hard to get.
A health insurance company might deny treatment for Stelara if it deems the drug not medically necessary. Although Stelara may be medically beneficial for a patient, this does not equate to medically necessary. Many treatments and therapies can treat autoimmune disorders. An insurer may prefer these alternatives to Stelara if they are less expensive. Keep in mind that at a list price of $12,000 per month, Stelara is expensive. An insurer may determine that Stelara is not medically necessary because of these alternatives.
Health insurance companies might require step therapy when alternative drugs exist. Step therapy is a type of prior authorization. In step therapy, an insurer requires a patient to try an alternative drug over a doctor prescribed drug. Here, patients may try generic or less expensive drugs or even treatments until they prove ineffective. Most insurance companies require a 60-day trial. If the less expensive drug is ineffective, then the insurer may re-evaluate the necessity of the preferred drug. Unfortunately, autoimmune diseases often require expensive drugs like biologics. In fact, sometimes a combination of biologic or specialty drugs is needed. Because Stelara is expensive, insurers may require step therapy to obtain claim approval. And step therapy may be harmful to patient health. The process of testing alternative drugs can prolong the symptoms being treated to begin with. Without prior authorization, patients often cannot obtain doctor prescribed drugs.
How Do Insurance Companies Evaluate Stelara Coverage Requests?
Internal insurer pharmacy or medical policies set the guidelines to evaluate coverage requests. When the FDA approves a drug such as Stelara, health insurers then research the therapy to develop clinical policies. These internal clinical policies guide medical necessity decisions. Then, a team of external doctors votes on these internal policies to determine their merit. But there are some exterior motives. The promise of financial gain or the potential to work for the insurer can sway these doctors. For these reasons, the external doctors may approve overly restrictive internal policies.
When evaluating a claim, health insurance companies determine whether a drug is medically necessary or experimental or investigational. And overly restrictive policies may create a difference between what the practitioner versus a health insurer deems medically necessary. Doctors rely on peer-reviewed medical literature and prior experience to make treatment decisions. Literature shows safe and effective treatment options for different patient situations. Peer-reviewed literature is based on scientific evidence and research.
What is the Difference between “Medically Necessary” and “Experimental or Investigational?”
Health insurance companies determine if a drug like Stelara is medically necessary. If it is not, then it is called experimental or investigational. Insurers may call a drug experimental or investigational for various reasons. Of course, as explained above, internal policy definitions guide these decisions. If there is inconclusive evidence about the effectiveness of a drug, it could be called experimental or investigational. A lack of FDA approval can also make a treatment experimental or investigational. Alternate drugs that are safe and effective may deem a lesser-known drug experimental or investigational. Finally, if a drug is not applicable or doesn’t improve health outcomes, it may be experimental or investigational.
One health insurer may call a drug medically necessary while another may deem the same drug experimental or investigational. The internal guidelines for classifying drugs can vary and are open for interpretation. Patients also experience different health outcomes using the same drug. These factors contribute to rifts in the claim approval process. Decisions depend on contract language. The language of these guidelines is subjective, making the process complex.
What Duties Do Insurance Companies Have When They Receive Member Claims?
Insurance companies must review submitted claims and approve or deny them. In making this determination, the insurer must thoroughly investigate the claim. It must investigate all possible reasons why the drug or treatment may be medically necessary. It must respond to each claim promptly. And it must have qualified medical professionals review the claim.
What Can You Do If You Receive a Stelara Health Insurance Denial?
You can appeal the Stelara health insurance denial. But the path you take is based on if your health insurance is an ERISA or non-ERISA plan. ERISA stands for the Employment Retirement Income Security Act of 1974. If you don’t know which your plan is, then contact your plan administrator.
Private employers most often have ERISA plans. But there are exemptions in the following cases:
- government employers of course are not private
- religious organizations like churches and synagogues
- business plans only covering business owners
- individual and family plans purchased through Covered California
- Individual and family plans that are purchased through private insurance companies like Anthem Blue Cross or Blue Shield of California
You should file an appeal if you have an ERISA plan. However, it is best to speak with an attorney before filing this appeal. Learn more about the appeals process for ERISA policies here. If you have a non-ERISA plan, you have many options. It is important to first understand why your claim was denied. Non-ERISA plan members can learn more here.
Contact Law Offices of Scott Glovsky if You Receive A Stelara 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.