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Mayzent
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Mayzent Health Insurance Denial 

 

Mayzent (Siponimod) is a medication used to treat relapsing forms of multiple sclerosis. Mazyent is considered especially significant as it was the first oral drug to treat secondary progressive multiple sclerosis (SPMS). On October 8, 2018, Novartis announced that the FDA had accepted the New Drug application for secondary progressive multiple sclerosis (SPMS), clinically isolated syndrome, and relapsing-remitting MS.   

 In March 2019, the FDA approved Mayzent for the treatment of relapsing forms of MS, and the approval was announced the next day. The FDA approved an additional strength of Mayzent tablets on August 24, 2021. Mayzent approval was based on the Phase III EXPAND trial, which demonstrated that Mayzent significantly reduced the risk of disability progression in patients with active SPMS. If your physician prescribed Mayzent for your MS, and your claim for the drug was denied by your insurer, contact the Law Offices of Scott Glovsky

This page reviews Mayzent, whether there is a generic version available, how health insurance companies review claims for Mayzent, what to do it you receive a Mayzent health insurance denial, and more. 

What is Mayzent? 

Mayzent is an oral tablet taken once daily for relapsing forms of multiple sclerosis. Treatment with Mazyent typically begins with a titration phase, during which the dosage is gradually increased over several days to minimize potential side effects. Following the titration, the maintenance dosage is administered once daily. The specific Mayzent dosage depends on the CYP2C9 genotype of the specific patient.  

 This genotype influences how a person’s body processes Mayzent.  While the cost of Mayzent will vary, it is typically considered a high-cost medication. Novartis initially priced Mayzent at $88,500 per year, which is in line with the prices of other similar MS medications. The actual cost of Mayzent depends on the individual patient’s insurance, deductibles, co-pays, and other out-of-pocket expenses.  

 Most Medicare Part D plans cover Mayzent; however, patients should check with their specific plan for details. Novartis offers a program called Alongside Mayzent Pharmacy, which includes a $0 co-pay card for eligible patients, as well as other programs that may depend on income. For more information, you can find additional information about Mayzent here.   

How Does Mayzent Work? 

Mayzent belongs to a class of drugs known as S1P receptor modulators. The drug binds to S1P receptors 1 and 5 on lymphocytes, which are a type of white blood cell. Once Mayzent binds to these receptors, lymphocytes are prevented from leaving the lymph nodes and entering the bloodstream, effectively reducing the number of circulating lymphocytes.  

 The mechanism by which Mayzent works is not fully understood, but it is believed to reduce central nervous system inflammation and inhibit the migration of lymphocytes into the brain and spinal cord, thereby limiting nerve damage caused by MS. Mayzent has been shown to cross the blood-brain barrier.  

Is There a Generic for Mayzent? 

 While Mayzent does not yet have a generic version, certain other MS drugs, like Ampyra, Tecfidera, Gilenya, Aubagio, and Copaxone , do. Mayzent is protected by several patents, with the latest expiring in April 2036. The estimated date for the generic entry is August 27, 2028, although this date may change due to patent challenges.  

Do Insurance Companies Cover Mayzent As a Treatment for Multiple Sclerosis? 

Commercial private insurers like Kaiser Permanente, Aetna, Anthem, Blue Shield, Aetna, HCSC, and UnitedHealthcare could cover Mayzent, but they have different coverage standards. Coverage will likely be determined based on whether the insurer believes the drug is medically necessary.  

Government health insurance programs like Medicaid and Medicare may provide drug coverage for Mayzent to treat multiple sclerosis. Coverage for both programs may vary depending on the state. Medicaid is for low-income people who cannot afford health insurance. Medicare is for those 65 and older. Medicare drug coverage is either through a Medicare Advantage Plan (Part C) or a Supplemental Plan (Part D). Patients are required to enroll in one of these programs separately from Medicare.  

What Can You Do if You Receive a Mayzent Health Insurance Denial? 

If you have received a Mayzent health insurance denial, you have the right to appeal. How you appeal will depend on whether you have an ERISA health insurance plan (provided by most private employers) or a non-ERISA plan.  

There can be exceptions to ERISA coverage in the form of 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, religious organization plans, business plans that only cover business owners, and government employee plans.  

Those with ERISA plans must exhaust all administrative remedies and should consult an attorney before submitting an appeal. Those with non-ERISA plans need to have a firm understanding of why the claim was denied and an experienced attorney can help with that.  

Terms You Should Know: Medically Necessary, Medically Beneficial, Experimental, and Investigational 

Most health insurance companies have some form of necessary prior authorization, particularly before paying for an expensive drug or treatment. Medically necessary means the drug is necessary to treat the signs or symptoms of a disease. Medically beneficial means that while a drug might offer positive benefits, alternative (less expensive) drugs could offer similar benefits.  Along with prior authorization comes step therapy.  

Step therapy often requires a patient prescribed an expensive drug to try two other less expensive drugs, usually for 60 days each. If the less expensive or generic alternative proves ineffective, then the insurer may re-evaluate the claim and approve the more expensive brand-name drug. While California does have some exemptions for step therapy cases, the process is typically complicated. Step therapy can prevent patients from getting the medication their doctors believe will best treat their symptoms.  

In addition to deeming a drug not medically necessary, an insurer may also label it as experimental or investigational. In some instances, a doctor may prescribe a drug off-label for a disease or condition that the FDA did not include in the approval. Prescribing drugs off-label is a common practice, but it may give an insurance company a reason to deem the drug experimental or investigational.  

When evidence does not result in clear conclusions regarding the health outcomes of a certain drug, insurers may deem it experimental or investigational. Finally, if a drug does not specifically include health outcomes, it could be called experimental or investigational by the insurer. Insurers have an exceptional degree of power over their designations of “investigational” or “experimental.”  

How Do Insurance Companies Evaluate Mayzent Coverage Requests? 

Health insurers evaluate requests for coverage based on internal medical or pharmacy policies. The insurers' own pharmacists research the drugs and develop internal policies, which are then brought before a group of external physicians who will vote on the policies. 

In some cases, the votes of these practitioners are at least partially motivated by financial gain or the potential to work for the insurance company, which can lead to overly restrictive policies. Policyholders bear the brunt of these decisions, as what their doctor deems medically necessary may be overruled by the process in place at insurance companies.  

What Duty Do Insurance Companies Have to Members Submitting Claims? 

Insurance companies have certain duties when asked to approve or deny a medical claim by a member. The insurer must thoroughly evaluate every claim request and fully investigate all reasons that might support the claim. The insurer also has a duty to promptly respond to claim requests and appoint and employ qualified medical professionals to make determinations regarding claim reviews.  

Contact the Law Offices of Scott Glovsky if You Receive a Mayzent Health Insurance Denial 

It can feel like you are all alone as you try to fight a large insurance company that has unlimited money and time, since these are things you probably do not have. Your doctor feels that your medical condition will benefit from the prescribed drug or treatment, yet your insurance company is thwarting you at every turn. Having a strong legal advocate by your side can make all the difference. 

The Law Offices of Scott Glovsky has represented injured consumers and victims of wrongful business practices for almost three decades. The firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. Our firm fights for justice for our clients while holding the wrongdoers accountable.

   

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