1. Introduction

Usually, an insurance provider will require the patient to first try Aripiprazole or Abilify before approving the prescription of Rexulti. If there was previous usage of Aripiprazole and Abilify, and especially if the patient had a great response to Aripiprazole but stopped because of side effects, it makes a strong case to try Rexulti. In this case, it is clearly not just a “strategy to switch patient from Abilify to Rexulti in an effort to enhance patient response and improve symptoms and potentially reduce adverse events,” which would be indicated by a B9732 code. The more severe the condition and symptoms, the more likely the patient can justify a trial of Rexulti. It is imperative that the physician clearly documents in the chart about previous usage and the exact reasons why the patient was not continued on Aripiprazole or why the patient reacted unsatisfactorily to Aripiprazole. A prior authorization will often need to be done in cases such as this, and it may or may not be approved. To avoid rejection of a newer drug, it’s best to check with the insurance as to whether the drug in question would be a “preferable alternative” or “middle tier,” or anything that is not the highest category. Usually, the higher the cost, the more likely it would be rejected without further justification. (Noel & Jackson2020)

Rexulti is a blockbuster drug which is used for many health issues. Its main competitor is Abilify, which is prescribed for schizophrenia and bipolar disorder. Rexulti is also used for depression. Abilify was the number one selling drug of last year, with sales of $7 billion. Since doctors are getting familiar with this class of drugs, it’s no longer just psychiatrists who are prescribing Abilify, but also Rexulti for depression. This is a very important topic for physicians to understand because Rexulti is so similar to its generic cousin, Aripiprazole (the generic form of Abilify), which is available in many countries. It is quite likely that eventually the government/insurance will try to severely limit or prevent the prescription of Rexulti because of its high cost, lack of generic, and similarities to Aripiprazole. In anticipation of future restrictions, it behooves patients and physicians to understand whether or not Rexulti is the right drug to take, how to go about getting it, and what to do if access becomes limited. This article will help you understand how best to use Rexulti for depression, and you can refer here if there are problems with access in the future.

1.1. Overview of Rexulti

Patients living with the conditions Rexulti is meant to treat often live under limited financial means due to the disabling nature of their illnesses. Therefore, many look to Medicare, a federal health insurance program for individuals who are 65 or older, under 65 and disabled, or diagnosed with end-stage renal disease, for help with covering the cost of their medications. So it is no surprise that many of these patients are searching for information about whether or not Medicare helps with paying for Rexulti.

Rexulti is the brand name for brexpiprazole, a prescription drug used to treat psychiatric conditions such as schizophrenia and depressive disorders. It is manufactured by Otsuka America Pharmaceuticals Inc. and is administered orally as a tablet. The drug was approved by the United States Food and Drug Administration (FDA) in 2015 and is said to work by changing levels of certain natural substances in the brain. The substance is used to reduce symptoms of psychiatric conditions, such as visual and auditory delusions or hallucinations, disorganized thinking, and periods of depression and mania. This medication should not be used in place of other antipsychotic drugs and does come with a black box warning about the increased risk of death in elderly patients with dementia-related psychosis.

1.2. Importance of Medicare Coverage

An often unrecognized loophole to Medicare is that many disabled or elderly patients are still rarely underinsured, if not uninsured. This may simply be because the public is unaware that disabled persons under 65 are eligible for Medicare, or because it takes time and documentation to arrange for Medicare for such individuals. Moreover, those who are eligible for both Medicare and Medicaid are referred to as ‘dual eligibles’. Dual eligibles have the highest rates of chronic physical and mental conditions. Unfortunately, they are also the poorest and most vulnerable sector of the population, with high rates of medical service use and yet worse access to care and worse clinical outcomes than Medicare beneficiaries. Dual eligibles often qualify for low-income subsidies to prescription drug coverage. Continued cost sharing exemptions and coverage extensions for these groups is ultimately what will make Rexulti coverage feasible and beneficial for its neediest patients.

The importance of Medicare coverage of Rexulti cannot be overemphasized. There is a very high correlation between severity of mental illnesses and lack of private insurance and high socioeconomic status. What this means for Rexulti patients is that they often cannot afford the medication, may take it intermittently or stop it altogether. Then as mentioned previously, because of the chronic nature of many mental illnesses, the results can be catastrophic. This in turn causes more potentially avoidable psychiatric hospitalizations and emergency room visits. This is an extremely pricey issue. Medicare coverage of Rexulti could help break this self-perpetuating cycle by affording greater access to medication and decreasing psychiatric morbidity, hospitalizations, and healthcare expenditures.

2. Medicare Coverage for Prescription Drugs

Medicare is a federal health insurance program that covers a variety of medical expenses, primarily for people age 65 and older. It comes with four parts – Part A (hospital insurance), Part B (medical insurance), Part C (Medicare Advantage), and Part D (prescription drug coverage). Since, like most health insurance programs, Medicare Part D is complex and has many coverage “phases” and out-of-pocket costs, to understand coverage for REXULTI under Part D, it is important to know the coverage “phases”. Medicare Part D helps to lower the cost of prescription drugs. Prices and drugs covered vary by plan and are different in each region. Also, if you have limited income and resources, you might qualify for extra help from Medicare to pay the costs of Medicare Part D drug coverage. This extra help also can provide assistance with other Medicare prescription drug costs. If you are in an employer group health plan, union plan, or other healthcare plan, your membership in that plan might affect your prescription drug coverage. If you are unsure about coverage under the other plan, contact your benefits administrator.

2.1. Medicare Part D

Exclusion criteria: Individuals who are eligible for Medicare benefits but not Part A (usually premium-free) are not eligible to obtain Part D. In these cases, it may be possible for the individual to drop Part B and reapply at a later time in order to defer beginning of Part D (and avoid spending down assets), but this can be risky and should be discussed with a benefits counselor or attorney.

All Medicare drug plans must give at least a standard level of coverage set by Medicare, but plans can vary in cost and drugs covered. To get Part D, a person must be entitled to Medicare Part A or enrolled in Part B. Part D is available to all Medicare beneficiaries eligible for benefits, regardless of income and resources. Due to a coverage gap known as the “donut-hole”, several beneficiaries with high drug costs will still have to bear a significant portion of their prescription drug costs, but all extra help beneficiaries and full benefit dual eligible individuals are exempt from the coverage gap.

Medicare Part D provides prescription drug coverage for individuals entitled to Medicare Part A or Part B, and who are enrolled in a Medicare plan. Medicare plans are run by private insurance companies and provide different ways to get prescription drug coverage. People enter Part D by joining a standalone prescription drug plan (PDP) for an additional premium, or by enrolling in a Medicare Advantage plan with prescription drug coverage. Availability of specific plans may vary by location.

2.2. Formulary Coverage

Access to coverage information can eliminate confusion and frustration about prescription drug coverage. This will be an important factor to consider when comparing options for traditional Medicare and Part D to enrollment in a Medicare Advantage plan. This is because while Medicare Advantage plans are required to provide all Part A and B services and some must also include Part D, benefits and drug formularies can vary and are subject to change in future plan years.

Information provided by the pharmaceutical manufacturer indicates whether the stated drug is on the Medicare Part D formulary. It is the first opportunity for Medicare patients to see if their drug is covered. At this point, patients can have an informed discussion about formulary coverage and explore possibly lower-cost alternatives with their prescriber. If the patient and the prescriber agree that the current drug (or a trial from a different covered drug) is necessary, there are steps that can be taken for an exception. Either the prescriber or the patient can contact the plan requesting an exception, and the prescriber must submit a statement of support for the exception. This process is Title 42, section 1395w-102(e) of the Social Security Act. If a decision at any level of the exceptions process is adverse, there are appeal rights of which the plan must inform the enrollee. Step therapy and prior authorization requirements can also be subject to exceptions and appeals. Step therapy, if a patient has taken a drug and it has failed, requires the patient to try a different, often generic, drug for the same medical condition before coverage is granted.

(Pricing, 2020)Formulary coverage, where a prescription drug is covered for a particular therapeutic class, but is subject to limitations or conditions, is quite common with both public and private insurance. With Part D, plans may cover both generic and brand name drugs. Generally, there are 2 or more cost-sharing tiers for prescription drugs, and formularies must include a mix of drug types and classes to support beneficiaries with a range of medical conditions. Non-limited, formulary, Part D drugs must cover all or substantially all drugs in the following 6 categories: antidepressant, antipsychotic, anticonvulsant, anticancer, immunosuppressant, and HIV/AIDS. If a drug is not on a formulary, Medicare and the plan’s enrollees have different coverage options.

2.3. Prior Authorization and Step Therapy

After coverage has been approved or two fill/refills have been received, the plan can no longer require a member to try the same or another drug first with step therapy. An enrollee can also request an extension of a step therapy requirements determination to decide if he/she will remain on the current plan. As with any decision on a formulary exception or other Part D benefit, decisions about whether to cover a drug and what the cost sharing will be are reconsiderations of Medicare coverage. If a drug is covered or the cost sharing results in a higher tier or lower cost sharing for a drug at the time of reconsideration, this is considered a change in the drug’s category or class and requires a new formulary exception request.

During the first 90 days in a plan, a prescription for a Part D-covered drug for treatment of a condition that the plan doesn’t normally cover (but can get a “prior authorization” for) must be filled or refilled at least twice with the doctor and patient following the plan’s rules before the plan is required to cover the prescription. If the doctor provides a rationale to expedite an exceptions request, and waiting 72 hours for a decision could seriously harm the enrollee’s health or the enrollee is requesting a formulary exception for a drug he/she has been using, and the enrollee is in the process of disenrolling from a Medicare Advantage plan and has requested a coverage redetermination to facilitate a smooth transition to original Medicare, the plan must cover the request within 24 hours. This is called an “Expedited Exceptions Process.”

3. Coverage of Rexulti under Medicare

Under Medicare guidelines, coverage of specific drugs varies by plan. Medicare drug coverage will generally cover any drug that a doctor prescribes and is deemed medically necessary for treating a health condition. Whether a drug is considered medically necessary is determined by the new interpretive guidances to be of the Social Security Act the Centers for Medicare & Medicaid Services (CMS), and is at the discretion of plan providers. Many Medicare drug plans place drugs into different “tiers” on their formularies. Plans can choose which drugs to place in which tier, as long as they cover at least two drugs in each drug class. Step therapy: You must first try step therapy more cost-effective to reduce medical therapy drugs before moving on to costlier ones. This is very problematic for people who have a stable condition will medication that is effective but expensive. Prior to your decision regarding how to get coverage for Rexulti, you should contact plan providers to confirm if the drug is covered under their formulary and what your expected cost-sharing will be.

Rexulti may be covered by Medicare, though your access to coverage will depend on the type of Medicare plan you have. Medicare prescription drug benefit plans, which are also known as Part D, cover medically necessary drugs. The coverage of these drugs and how much you will have to pay out-of-pocket can vary depending on many factors. If you have original Medicare, you can get prescription drug coverage by joining a stand-alone Part D plan to work alongside it. If you have a Medicare Advantage plan, you will need to enroll in an that includes Part D to get drug coverage. If you are unsure what type of Medicare plan you have, it is important to consult your plan provider.

3.1. Determining Coverage for Rexulti

If the question is whether Rexulti is covered by Medicare “Part D” (the prescription drug benefit), “Medicare Advantage” plan, the original Medicare or the root, the answer of all is yes. For those who are already enrolling “Part D” or “Medicare Advantage” plan, the initial coverage rule requires most beneficiaries to pay the full cost of the drug until they reach the plan’s deductible. The cost for a drug like Rexulti can vary around the nation and from plan to plan, but the average cost of Rexulti is usually the cost of a second-tier drug. From the previous explanation, it can be concluded that it is easier for beneficiaries to get the drug with lower cost because the drug is categorized as the second-tier. This will be beneficial for the next stage of coverage, which is the coverage gap/Medicare donut hole, where the beneficiary will still pay a lower cost for the drug. In the catastrophic phase, the beneficiary only needs to pay a small amount of the drug cost. The rest will be paid by the plan. This clearly gives an advantage to most beneficiaries to get a drug with lower cost, and this applies to Rexulti. For the Original Medicare, it works the same way too. But usually, the cost incurred by the beneficiary would be higher compared to when the beneficiary is under the “Part D” or “Medicare Advantage” plan. This is because most of the time the beneficiary would need to purchase a Medicare supplement insurance (Medigap) policy to cover some or all of the out-of-pocket costs, and this will be an extra cost to the beneficiary. But for those who already signed up for a Medigap policy sold before January 1, 2006, it was possible to keep the drug coverage on the old Medicare “Part D” and D plans were directly sponsored by an employer or union (and employer/union). This may apply to Express Scripts Medicare. But due to recent changes on the access of Medigap policy (see here for the changes), the details on how the drug cost is going to be paid through the Medigap policy is still unclear. But regarding the changes of the Medigap policy, this would not affect Rexulti coverage. (Pricing, 2020)

3.2. Medicare Advantage Plans and Rexulti

There are many reasons individuals opt for Medicare Advantage plans rather than Original Medicare. Medicare Advantage plans often include more services as well as reduced costs for aspects such as glasses or hearing aids. Medicare Advantage plans prescription medication coverage (Part D) is usually included as part of the plan, thus eliminating the need for a separate (and often more costly) Part D plan. Coverage for drugs like Rexulti is likely to be found within Medicare Advantage Part D plans. If you are someone with severe mental illness thinking of switching to Medicare Advantage who has been doing well on Rexulti, a thorough examination of different plans’ Rx formularies and cost/coverage of Rexulti is essential before making a decision to leave Original Medicare. If you are someone considering a switch from Original Medicare to a Medicare Advantage plan, also carefully weigh the decision and contact your physicians. While Medicare Advantage plans are required to cover everything that is covered by Original Medicare, some mental health services and medications may be more difficult to find and still subject to prior authorization and utilization management techniques. While using in-network providers will generally still result in much lower cost sharing through Medicare Advantage plans/Part D for those using expensive prescription medications like Rexulti.

3.3. Cost-sharing and Out-of-Pocket Expenses

Because Rexulti is only available in brand form, those with a stand-alone Part D plan with little or no gap coverage, who have not applied for extra help and have a low income, may find it difficult to cover the cost. For many, the quest for coverage may seem fruitless. Ultimately, the decision to take on the full cost of Rexulti will depend on the severity of an individual’s mental illness and financial circumstances.

By now it ought to be clear that getting any medication covered under Medicare Part D, particularly those that fall under the category of not medically necessary, can be a difficult task. Rexulti undoubtedly falls into the category of not medically necessary. Applying the strategies listed above for a medication falling into this category will maximize the chance for coverage. There is, however, no guarantee of success.

3.4. Exceptions and Appeals Process

If your request for covering Rexulti or similar psychiatric drugs under Medicare Part D is denied, you have the right to appeal. The appeals process has 5 levels. You must go through each level within 60 days of receiving the decision. The plan may have a second decision before the first level of appeal. Check your denial notice to ensure an accurate understanding of the talks level required. The levels are: 1. Redetermination – This is the 1st step. You must ask your drug plan to reconsider its decision. If your plan denies your request in whole or part, your case will be automatically sent on to the 2nd level. 2. Reconsideration – This level is conducted by the independent review entity (IRE). Your case is reviewed without input from the 1st level and you will receive a decision within 7 days. If the amount of the drug in question is determined to adversely affect your health, there is also a fast decision process with 72-hour turnaround. 3. ALJ Hearing – If the IRE still denies coverage, the case will be forwarded to the Office of Medicare Hearings and Appeals. You must be requesting a minimum of $160 in redirected coverage to continue if the decision is for the standard amount. Any decision on an amount greater than the standard amount is considered to meet the minimum. This level of appeal will require a written request and you to explain why you disagree with the IRE decision. The drug plan will also prepare a statement on its decision. You may also request an in-person hearing but must meet certain requirements to do so. 4. Council Review – If the decision at the IRE level is not entirely in your favor, you may decide to state your case at the council review. This level is only available if the ALJ hearing level was completed. During the council review, a decision may be made to change the amount and/or type of review the drugs in question. Your decision will be reviewed for legal errors as well as the facts of the case. You will be notified of the council’s decision and if it does not fully overturn the IRE decision, the next and final level is open to you. 5. Federal Court – You have the right to bring a case against the Commissioner of Social Security at the US district court. This waiver of further administrative proceedings is not recommended. It is slow and expensive. You will likely need a lawyer and must feel strongly about your case to go this far.

4. Alternatives and Additional Resources

The best way to determine this is to find the prescribing information for the medication. This may be done on sites like the FDA’s webpage and more recently Medicare.gov, which actually has a new feature where people can look up which Part D and Part B in Medicare cover various prescription drugs and therapies. It is currently working to improve the tool so that it’s more specific and accurate with the information it provides. This has the potential to be very helpful with patients who are changing from one medication to the next. If a more effective tool is set in place, people may, with great accuracy, determine whether the new medication they are seeking is covered by Medicare and whether or not there are alternative treatments with equal therapeutic effects.

Patients are advised to consult a prescriber before changing course from the medication they are seeking coverage for. Discussions should be had in which weigh the potential positive and negative effects of the change in medication on the patient’s condition, as well as whether or not the medication is expected to effectively treat the condition which it is meant to treat. If it is agreed that the patient should seek a different medication for his or her condition, there may be a medication similar to the one being changed which has equal therapeutic effects and is covered by Medicare to some extent.

A. Other medications for mental health: Those who were looking into whether or not Rexulti was covered by Medicare may likely struggle with mental health. Many of these individuals seek to optimize the quality of mental health care they receive. This may come with looking for alternate medications to treat the same condition the original medication was made to treat. When it comes to mental health, diagnoses and effective treatment plans vary significantly from one patient to the next. This means that certain alternative medications may or may not be effective for treating the same diagnosis in different patients.

4.1. Other Medications for Mental Health

There are many other medications out there that aren’t on the Medicare formulary that a person can get. This can be a complicated, risky and potentially costly endeavor. Diving into this subject matter is outside the scope of this article, but if you want to explore your options know that there may be patient assistance programs available from the drug manufacturer, many other government and state resources to explore, and some drugs can be procured through using Formulary Exceptions. Also, there are other prescription drug insurance plans aside from Medicare Part D that a person can get. That said, if you are on Rexulti and considering other options it would be prudent to consult your doctors to see if there are other similar medications that are less costly and that may be better covered by Medicare and similar programs.

4.2. Non-Medicare Prescription Assistance Programs

Pharmaceutical companies are known to on occasion have patient assistance programs for their medications. These programs are designed to help those who cannot afford their medication or do not have insurance to cover it. Eligibility and application requirements can vary from program to program. The Partnership for Prescription Assistance (PPARx) is a location that can connect patients to the assistance programs for which they may be eligible. PPARx also has a directory for free or low-cost clinics for both medical and mental health needs. Other alternatives to cover medication costs may be available within one’s community, and contacting the manufacturer of the medication can provide useful information on how to obtain these resources. There is currently no specific request for the makers of Rexulti to create a patient assistance program for Rexulti as far as the author is aware. You should ask the manufacturer and keep an eye out for any news regarding such a program. Note that manufacturers do not always update resources like PPARx with new medication assistance programs, so it may be necessary to contact the manufacturer directly.

4.3. Seeking Guidance from Healthcare Professionals

For a patient or someone seeking coverage information on behalf of someone else, it does not hurt to call your Medicare administrator for personal assistance. In some cases, speaking to a representative who can outline benefits and even initiate conversations with healthcare professionals may be the most effective way to shore up coverage information with regards to Medicare approved medications like Rexulti. A Medicare administrator may also have necessary information about Medicare Part D and pay for prescription drug plans that the patient would not have otherwise identified.

Healthcare professionals are the best source of advice for patients looking into prescription medication coverage. Because healthcare administrators and government policies are constantly updating and changing prescription coverage options for medications like Rexulti, information found online and elsewhere might have a hard time keeping up. Psychiatrists, general practitioners, and pharmacists have their finger on the pulse of these changes and understand what limitations Medicare might place on prescription medications. These professionals can often predict coverage changes for specific medications and offer good advice whether or not a patient should seek other forms of assistance. Also, if a patient is particularly interested in a newly-prescribed medication and is not confident that it will be covered, a healthcare professional may be able to begin a prior authorization to lock in coverage for the medication.

References:

Noel, J.M. and Jackson, C.W., 2020. ASHP therapeutic position statement on the use of antipsychotic medications in the treatment of adults with schizophrenia and schizoaffective disorder. American Journal of Health-System Pharmacy, 77(24), pp.2114-2132. meditool.cn

Pricing, P. D., 2020. REPORT TO CONGRESS. hhs.gov