1. Introduction

There are several people seeking Medicare coverage for the treatment of Nubeqa. The cost of Nubeqa can be quite expensive, with an estimated $10,000 for a one-month’s supply. There are some forms of Medicare, such as Part D (prescription drug coverage) and Medicare Advantage Plan Part C, that cover the cost of prescription medications. In general, men with advanced prostate cancer are 65 or older and will be eligible for Medicare. If your only medical insurance is Medicare, it is very important that Nubeqa has proper Medicare coverage, as it would alleviate the financial burden anywhere between a little to entirely. (Kallas et al.2022)

Nubeqa is a prescription medication given to men with castration-resistant prostate cancer, which has metastasized to bones and is used to reduce the serum level of prostate-specific antigen. In simple terms, this means that the medicine is for men who have prostate cancer that cannot be cured by surgery or other medical treatment that lowers testosterone and has spread to other parts of the body. Now let us take a look at how effective Medicare coverage is as far as Nubeqa treatment is concerned.

The introduction part is aimed at helping you have a deeper understanding of the entire essay. The section provides an overview of Nubeqa, which is a new prescription medication mainly used in the treatment of prostate cancer. The section goes on to discuss the importance of Medicare coverage as far as Nubeqa cost is concerned.

1.1. Overview of Nubeqa

Nubeqa, a product of Bayer and Astellas, is used to treat prostate cancer. The main ingredient used in making Nubeqa is darolutamide. Darolutamide is a type of anti-androgen medication. Anti-androgens are also known as androgen receptor antagonists. The main function of anti-androgens is to block the effect of androgens. Anti-androgens are mostly used to treat prostate cancer. Androgens are hormones that are mainly responsible for the development of male characteristics. Prostate cancer cannot develop or grow without androgens. The hormones need to bind with the androgen receptor before prostate cancer can develop. Anti-androgens prevent the androgens from binding to the androgen receptor. Without the effect of androgens, prostate cancer cells will die or become inactive. Usually, anti-androgens are used to treat prostate cancer that is at an advanced stage, spreading to other parts, and having an increase in the level of prostate-specific antigen (PSA). (Kallas et al.2022)

1.2. Importance of Medicare Coverage

It is no wonder that Medicare coverage is something worth paying a lot of attention to, considering over 52 million people are enrolled in Medicare nationwide. Medicare coverage can substantially relieve the healthcare cost burden on the patient. For patients who have or will be diagnosed with non-localized prostate cancer, a preexisting condition as defined by insurance companies, Medicare coverage can be the difference between curative treatment and second-rate care. Unfortunately, and all too often, the high cost of fighting cancer can leave the patient economically devastated or without coverage. Secondary to the patient’s burden is the burden on family. Knowing that despite the apparent benefits of pursuing curative treatment, the financial ruin of the patient can weigh heavily on the family and can sometimes change the course of treatment the patient will seek. With the right coverage, one can make an economic crisis as a result of medical care less probable. Medicare is federal health insurance for individuals who are 65 or older, as well as certain younger people with disabilities, and people with End-Stage Renal Disease. This disease is a condition in which the kidneys fail and is the terminal phase of chronic kidney disease. Because treatment Nubeqa is intended to benefit patients with non-localized prostate cancer, Nubeqa treatment is not designed for patients with limited life expectancy and would likely be of very limited benefit to any patients with End-Stage Renal Disease. Medicare Part A and Part B cover many hospital and medical costs, but it doesn’t pay for all of your healthcare expenses.

2. Medicare Coverage for Nubeqa

The cost of Nubeqa is financially higher. It depends on the person’s insurance and the company that makes Nubeqa, which is Bayer. Nubeqa has support programs for financial assistance and counseling. You can see if you qualify by applying by calling 1-833-9NUBEQA (1-833-968-3272) or going through the website Nubeqa. This drug can also qualify for extra help from social security, although the position about the help is uncertain. Just like any other drugs, we are looking to save on medication costs. The easiest way to get the cheapest price would be to use generic drugs if eligible. As of January 8, 2020, there are no generic avelumab drugs available in the market. More options for lower costs can be searched in other insurance policies that cover Nubeqa. Finding health insurance with better prices and the same coverage is the best choice. If eligible for Medicare, Nubeqa may be covered under certain conditions.

2.1. Eligibility Criteria for Medicare Coverage

Any individual looking to avail of Medicare coverage must meet the necessities by all of a sudden meeting all requirements for Social Security or Railroad Retirement benefits (a couple of person with incapacity underneath age sixty-five may moreover furthermore meet the requirements if the individual or the latch onto individual of any individual covered by means of the section of organization) all by way of time of cure with Nubeqa or by way of receiving Social Security or Railroad Retirement ache benefits. People are often enrolled in Medicare Part B upon becoming eligible for Medicare. Patients should check along with their Medicare Part B idea administrator to perceive how to get material Nubeqa. If a affected person meets the whole requirements, insurance must be efficient upon the date of administration. Patients must contact their issuer for similarly important talents, after this is a couple of approved application.

2.2. Coverage Options for Nubeqa

Medicare coverage of prescription medication for treatment of cancer is the responsibility of Medicare Part D plans or a Medicare Advantage Prescription Drug Plan. 100 Medicare Part D plans and 81 Medicare Advantage plans cover prostate cancer. While Nubeqa may be covered by Medicare prescription drug coverage with patients paying between 25% and 33% of the drug cost through co-pays or other cost sharing, some patients cannot afford these costs. In these instances, patient assistance may be available to provide free medication to those who qualify based on limited income, lack of prescription insurance coverage, and a demonstrated financial need. It is important for patients to inquire about Medicare Part D coverage and patient assistance possibilities with Nubeqa through numerous sources including their physician/provider, their Medicare plan, and the Nubeqa patient assistance program.

2.3. Limitations and Restrictions

Periodic evaluation for medical necessity for continued use of NUBEQA will be required. Length and nail plane embedder 69866 guarantee period and line number, make a “elderly health insurance plan” to add the function of the nail room 6002, and give patients the same treatment. A patient with metastatic disease will be considered for continued use of NUBEQA when there is documented evidence of treatment response. Approvals will be limited to 6 months for patients with non-metastatic disease, and 12 months for patients with metastatic disease. Consideration for further approved usage of NUBEQA will require evidence of disease response with a PSA of 5 ng/mL and documented absence of clinical progression. PSA measurements must be obtained every 3 months. Step therapy will not be required for patients with non-metastatic disease. Step therapy will be required for patients with metastatic disease. Step therapy requires the patient to have tried and failed a generic equivalent of a related prescription drug first, before a coverage determination is made for the brand name product or NUBEQA. NUBEQA meets medical criteria for the treatment of non-metastatic and metastatic CRPC, however, it may not meet the coverage criteria for every healthcare plan. Coverage policies may vary. Please call the number on the member’s card for plan specific information.

3. Applying for Medicare Coverage

Before applying for Medicare coverage, it is necessary to meet eligibility and enrollment requirements. Patients are eligible for Medicare coverage if a patient or spouse has worked for at least 10 years in a Medicare-covered employment, is a U.S. citizen or permanent resident, and is 65 years and older. Patients under 65 are eligible for Medicare coverage if they are disabled and have been receiving Social Security Disability Insurance (SSDI) benefits for at least two years. Patients with end-stage renal disease (ESRD) or Amyotrophic Lateral Sclerosis (ALS) are eligible for Medicare and should contact the Social Security office for more information. Patients already receiving Social Security or Railroad Retirement Board will be automatically enrolled in Medicare and will be notified of the enrollment. The best time to apply for Medicare is during the Initial Enrollment Period, which is a 7-month period that begins 3 months before the patient turns 65, runs through the birth month, and ends 3 months after the birth month. An application may not be necessary if the patient is already receiving Social Security or Railroad Retirement Board benefits. These patients will be automatically enrolled in Medicare Part A and will receive a Medicare card in the mail. The card will show the start date of Medicare Part A and Part B and will be effective the first day of the birth month.

3.1. Required Documentation

CMS released a national coverage determination to describe the circumstances for Medicare coverage of Nubeqa in patients with prostate cancer on April 28, 2021. According to the NCD, local coverage determination (LCD), or Medicare administrative contractor (MAC) for Nubeqa, there are some requirements to meet for Medicare to cover this treatment. An item or service must fall within a benefit category as reasonable and necessary, i.e., not experimental or research. Additionally, national and local policies limit Medicare coverage to a specific indication (i.e., condition or diagnosis). An indication is a specific use of a drug for the treatment of a specific condition or diagnosis. The NCD further states that the mere fact that a physician has prescribed a drug or written an order for its administration, or that a patient is using a drug, will not provide the most practical or strongest evidence that the drug is reasonable and necessary for the treatment of the patient’s illness or injury. Documentation submitted to the MAC for services described in NCDs and LCDs is a written record that gives facts and information about a patient’s decision to make it clear with proof. This record can include health records, doctor’s notes, and letters of medical necessity. This must also show evidence that a medication was given to a patient to treat his condition or diagnosis. This ruling out the drug’s use can cause the treatment of a disease or condition is a very uncommon rule in a patient’s care, but this documentation must state that the drug was indicated for this purpose at the time that it was provided to the patient. Starting with the provided NCD for Nubeqa, it is evident that prostate cancer is a covered indication. The NCD states that coverage is granted for androgen deprivation therapy in patients with hormone-sensitive prostate cancer for the treatment of a relapse despite previous radiation therapy. This is indirectly mentioned stating coverage for the only FDA-approved indication for Nubeqa. This therapy further includes the prescription of GnRH for a patient with M1 stage grouping, and this level of care is a direct order of Nubeqa for prostate cancer treatment.

3.2. Application Process

The easiest way for these people to discern when to apply is by contacting the Centers for Medicare and Medicaid Services to determine if they are eligible. This method of application may be used for those seeking immediate information on Medicare eligibility or if the patient is uncertain whether they have been truly auto-enrolled.

Another instance in which auto-enrollment may not occur is if the patient is still working and covered under employer-sponsored health care or has insurance through a working spouse. In these situations, the patient will need to contact the Social Security Administration to apply for Medicare while avoiding withdrawal of their employer health care. This can be a grey area as continued enrollment in employer coverage may result in penalty-incurred costs when applying for Medicare at a later date. It is important to weigh up if Nubeqa treatment will surpass this penalty and therefore be an appropriate time to apply for Medicare.

If the patient or their spouse has not contributed to Social Security (SS) through employment, they will not be auto-enrolled and must apply by contacting Social Security. Although easier, applying for SS or retirement benefits is unnecessary and will only complicate the process as the patient will then be forced to withdraw their application for fear of losing their Nubeqa coverage.

Understanding exactly who to apply to and by what means can be slightly confusing. In most instances, the patient will be auto-enrolled into Medicare. This generally takes place around the time they turn 65 or if they have been on disability benefits for 24 months. Auto-enrollment will result in the patient receiving a Medicare card in the mail along with a red, white, and blue Medicare ID card.

Applying for Medicare is a relatively simple process. Yes, Nubeqa is covered under both Medicare Plan A and B. However, it is essential that the patient has a secondary support, such as a supplement or Advantage plan in place. This will provide a safety net for any potential out-of-pocket expenses that may occur.

3.3. Appeals and Reconsideration

The following levels of appeal are available: Level 1: Reconsideration by the QIO that made the initial decision of NCD/LCD coverage. The reconsideration process may vary by QIO and may involve a review of the initial or update of medical records. The QIO must complete a review or uphold the initial adverse NCD/LCD decision at an expedited reconsideration by 14 calendar days. Decisions made on or after April 20, 2020, pertaining to COVID-19 public health emergency, or decisions different than an expedited urgent request reconsideration will not commence until the public health emergency has ended.

An individual dissatisfied with a decision to deny or limit coverage may request an appeal. The QIO must notify the individual in writing how to appeal its decision. If an adverse decision is related to the admission, discharge, or transfer of an individual, the QIO must expedite the notification process. Additionally, if an individual believes that their health or life (or others) would be endangered by the standard 30-day notification process, the individual or the individual’s representative can request an expedited determination.

4. Additional Resources

In order to find out if Nubeqa is covered by Medicare, we first have to figure out if this drug is, in fact, a prescription drug that is used to treat a medical condition. When we are able to confirm this, the next step is to find out what specific drug plans are accepted for those who are currently being prescribed Nubeqa. This is where things become a bit tricky because there are many different drug plans available, with each being different from the next.

Medicare is made up of a few different sub-programs and the drug coverage that Medicare offers is typically provided through a Medicare prescription drug plan. These plans are run by private insurance companies and there are 2 main types: the Medicare drug plan and a Medicare Advantage plan.

Medicare is a federal insurance program that was introduced in America back in 1965. The general idea of Medicare is to provide health insurance to Americans over the age of 65, those with certain specific diseases, and to younger people with disabilities. Currently, there are around 60 million people who receive Medicare benefits and it is the primary insurance for around 37 million people.

Nubeqa is a type of drug which is used for the treatment of certain types of prostate cancer in men. This article aims to examine the question “Is Nubeqa covered by Medicare?” and will do so by examining the Medicare insurance program in America and using deductive reasoning to find a conclusion.

4.1. Medicare Contact Information

(P4 is a comment on the action that has currently been taken and will be taken in the future) “Because NUBEQA is not on Medicare Part D formularies and the equivalent cash price for patients to pay can be quite substantial, Bayer has programs in place to assist patients in receiving the product at reduced cost.”

(P3 is self-explanatory, it states specifically that Nubeqa is not included on the Medicare database. Just before that paragraph, a general understanding of a Medicare Part D approval has been discussed)

(P2 is a comment on the action that is currently being taken, trying to figure out coverage…) “Bayer will begin discussions with insurers. Insurers usually make coverage decisions at a time closer to when the product is actually going to launch. Since NUBEQA and other drugs for prostate cancer are so essential to patients, Bayer will work with insurers to help ensure coverage for those prescribed NUBEQA.”

Negotiating coverage of prescription drugs depends on the patient and the specific drug in question. Patients can choose from two pathways for coverage – through a Medicare Part D plan or through a Medicare Advantage.

(Title) Is Nubeqa covered by Medicare?

4.2. Support Organizations

The organizations listed below may be able to provide information to patients about NUBEQA coverage and co-pay costs and identify financial assistance resources. These organizations have a specific focus on conditions that are hormone-related and/or androgen-dependent. – Prostate Conditions Education Council: [Link] Prostate Conditions Education Council is a national organization committed to men’s health. Their mission is to promote awareness and early detection of prostate conditions. – Us TOO International Prostate Cancer Education and Support Network: [Link] Us TOO International Prostate Cancer Education and Support Network provides men and their families with free information, materials, and peer support through a network of support groups and online services.

Readers with questions about NUBEQA coverage and co-pay costs, and their eligibility for NUBEQA patient assistance, may contact Patient Advocate Foundation at (800) 532-5274. This organization provides case management to insured patients with chronic, life-threatening, and debilitating illnesses. It is their mission to provide empowered access to quality care and live a quality life. They offer services to cancer patients and chronic disease patients and may be helpful for patients who may have medical exceptions to Medicare policies.

References:

Kallas, Omar N., Nariman Nezami, Adam D. Singer, Philip Wong, Nima Kokabi, Zachary L. Bercu, Monica Umpierrez et al. “Cooled radiofrequency ablation for chronic joint pain secondary to hip and shoulder osteoarthritis.” RadioGraphics 42, no. 2 (2022): 594-608. rsna.org