1. Introduction
Medicare administration through government and private insurance (Part C) helps to cover prescription drugs for treating lung cancer. The cost for Part C coverage varies depending on the insurance provider, and there are additional coverage programs available for supplemental coverage of prescription drugs. Tagrisso was approved in 2015 and has shown to double lung cancer progression-free survival in some patients compared to previous chemotherapy. It is important for lung cancer patients to continue to receive modern cancer treatments in order to maintain quality of life and reduce suffering from symptoms. With the high cost of many new age targeted cancer therapies, Medicare coverage is essential in making these treatments accessible to patients. Currently, there are various laws and regulations regarding Medicare funding for new cancer treatments, concerning cancer patients on whether new cancer treatments will be available through Medicare on a long-term basis. This can affect the decisions of cancer patients when considering Medicare as a primary or a secondary option for their healthcare coverage.
Importance of Medicare coverage.
Tagrisso is an oral prescription medication used for treating non-small cell lung cancer. Tagrisso is a kinase inhibitor, a treatment that blocks chemical messengers in the cell. Kinase inhibitors can have serious side effects, including possible harm to the fetus. Most Medicare plans cover Tagrisso, and there are various patient assistance programs which help reduce Tagrisso cost to patients without insurance.
Medicare coverage for patients residing in different states.
1.1. Overview of Tagrisso
Welcome to this article on the Medicare coverage of Tagrisso. Tagrisso is a newly approved treatment for non-small cell lung cancer (NSCLC). It is a tablet that has been shown to help patients live longer before their cancer grows or spreads. This is important because there has been little progress in the treatment of lung cancer over the past 40 years and many patients end up being treated continuously until they become too unwell to benefit from further treatment. Tagrisso works by targeting a specific genetic mutation called T790M. This mutation is present in about 60% of patients whose NSCLC has progressed to the stage of needing second or third line treatment and is often tested using a blood sample or a tissue biopsy. Patients who have this mutation are likely to benefit more from Tagrisso than chemotherapy. Tagrisso’s ability to be taken in tablet form at home also makes it a convenient option when compared to patients having to go into the hospital for intravenous chemotherapy. (Kallas et al.2022)
1.2. Importance of Medicare Coverage
According to the National Cancer Institute, during 2020 about 60% of people diagnosed with lung cancer are older than 65. The American Cancer Society estimates that 13.7% of men and women will be diagnosed with lung and bronchus cancer at some point during their lifetime. The median age at the time of diagnosis is 70. The need for agents that show good efficacy with tolerable side effects, that are covered by insurance is crucial for the patient population with lung cancer. Tagrisso does seem to have changed the standard of care for a specific patient population in the United States. An older population who have smoked or have a history of smoking, with the majority having comorbid conditions and a mutation in their lung cancer. An increase in the options for oral chemotherapy medications has already changed the way oncology care is practiced in the United States. A shift from intravenous to oral medications not only disburdens patients from coming to the medical clinic for treatment, but also can offer better efficacy for patients, which in the long run can be cost saving for insurance companies. Medicare coverage of oral versus intravenous chemotherapy medication and patient access to these medications were studied in a survey involving 400 oncologists and 332 Medicare beneficiaries between 2007 and 2008. According to an ASCO press release there was found to be significantly less patient cost burden, less treatment delays and discontinuation, and fewer access restrictions with Medicare coverage of oral medications. Patients were more likely to have received their medication in a community pharmacy, had lower hospitalization rates and fewer ER visits. These positive trends in outcome for patients and access to oral chemotherapy medications with Medicare coverage suggest the landscape of providing effective cancer treatment may be changing for the better in the United States.
2. Medicare Coverage for Tagrisso
Limitations and Restrictions Certain formulary restrictions may automatically exclude coverage for TAGRISSO in patients with Stage I or II non-small cell lung cancer. Duration of TAGRISSO treatment may also affect coverage as plan benefits in a given contract year may limit coverage for a full year of treatment. Should a Medicare Part D enrollee lose prescription drug coverage at any time, he/she has the right to request an exception to join another Part D plan or to revert back to a Medicare Advantage plan. AstraZeneca staff can provide assistance in appealing plan decisions to deny or restrict coverage for TAGRISSO.
Coverage Details Coverage for TAGRISSO varies by plan. In general, lower tiered formulary drugs will cost less than non-formulary drugs. Tier placement is determined by the plan’s Pharmacy Benefits Manager and may vary by region. Patients, their prescribing health care professional, or an appointed representative have the right to request a coverage determination if they think they are entitled to a different cost-sharing amount. A coverage determination is the first step in the appeals process if coverage is denied. Patients may also qualify for patient assistance to obtain their first fill of TAGRISSO if coverage is expected to be delayed. AstraZeneca staff can assist patients in exploring available options to access TAGRISSO.
Patients with AstraZeneca Medicare Advantage, Medicare Part D plan prescription drug coverage and other Medicare Part D plans can access TAGRISSO. Eligibility for Medicare coverage of TAGRISSO also depends on specific employer-sponsored and retiree drug coverage.
2.1. Eligibility Criteria
Private Insurance and Individual Health Care Plans. There are also other possibilities if you do not have Medicaid and Medicare. At first glance, the cost of a Tagrisso prescription may seem frightfully expensive. However, many Tagrisso patients are eligible for coverage of their Tagrisso prescription under an individual insurance plan with a cost much lower than initially thought. This is because the cost for the insurance is a shared cost between your employer and the insurance company, which often gives the patient access to better benefits than they would otherwise receive, due to the fact the insurance company is seeking to keep the patient’s business.
Medicare. In order to be eligible for AstraZeneca’s Tagrisso prescription, you must be taking it for an off-label use of Iressa (targeted therapy for lung cancer) as the Medicare coverage issues will be discussed in this situation. Then be eligible for financial assistance from the Extra Help program, which is a cost-sharing program designed to assist in payment for prescription drugs and lower the cost of Part D for Part D eligible individuals. Usually, you are automatically approved for Extra Help each year when you apply for Medicare, or if you receive Medicaid benefits. Tagrisso currently is covered under Medicare Part D. If so, then you will be eligible for financial assistance to help the coverage of prescription drugs in which Tagrisso has the availability to receive payment. This also depends on the type of plan that you have.
Your doctor may be able to help you find something to do with the high expense of Tagrisso, since it was prescribed by him/her. There are programs designed to help pay for the cost of Tagrisso when it is prescribed for a serious medical condition for which the patients cannot be treated effectively by using other treatments. You can find more details for a cost-sharing program provided by Tagrisso’s manufacturer to assist in payment located here. Also, there may be available medical and social resources for patients who meet the program’s financial and medical criteria. This assistance may help patients to find medical insurance with the ability to provide coverage.
2.2. Coverage Details
For Tagrisso that is provided outside of the states (foreign or unapproved use), there are specific criteria that must be met and pre-authorization will be required. The prescriber must be enrolled in the Medicare program and request for it is to be administered under Medicare Part B. This essentially means that the patient will have to pay out-of-pocket for the medication then submit a claim to Medicare. If the prescriber is not enrolled or a claim is not submitted, the patient is responsible for the total cost of the drug. This process is unlikely to occur and may not be successful. (Kallas et al.2022)
Coverage for Tagrisso by Medicare Advantage plans and stand-alone Part D plans are subject to national and local formulary decisions. If the patient lives in an area in which Tagrisso is not on the formulary, or is on the formulary but with utilization management restrictions that are not conducive to individual medication, the patient and prescriber may request a formulary exception.
Tagrisso will typically be covered by Medicare if criteria are met. The coverage will depend on the individual’s circumstances and the specific Part D plan or Medicare Advantage plan. The patient may encounter cost-sharing in the form of co-insurance, and there is no fixed dollar amount for out-of-pocket expenses; it will depend on yearly drug expenses. Patients should be encouraged to contact the specific plan or the Social Security Administration at 1-800-772-1213 for more information.
2.3. Limitations and Restrictions
The limitations and restrictions are as follows: 1. Enrollees of prescription drug plans or other health plans who are receiving coverage for Tagirsso are not eligible for this program. Tagirsso patients receiving prescription drug coverage through Medicaid, Medicaid HMO, TRICARE, or any other government-funded program (except for Medicare) are not eligible. 2. Offer not valid for prescriptions reimbursed under Medicare, Medicaid, or any other federal or state program. Subject to change at any time without notice. This program is not health insurance. 3. Patients who move from a commercial prescription benefit plan to a Medicare Part D plan will no longer be eligible. This includes changes during the coverage year and changes in plan level or formulary tier. 4. Patients who are eligible for Tagirsso and have already completed their Initial Coverage Period (patients’ initial 4 months of Medicare Part D coverage) are not eligible to apply for Extra Help. This program deems patients who are receiving low-income subsidy through Medicaid, Medicare Savings Programs, or patients who are receiving full Medicaid ineligible. 5. Patients receiving Medicare Part D coverage using a late enrollment penalty are not eligible until the Part D late enrollment penalty is paid off and the patient is no longer suspended from their Medicare Part D coverage. 6. Patients residing in the states of Massachusetts, Minnesota, and Wisconsin do not qualify as they have their own State Pharmaceutical Assistance Programs.
3. Alternatives to Medicare Coverage
During the process of learning if Tagrisso is covered by Medicare, the outcome is unknown. In this instance, there are no alternative ways of getting Tagrisso at a lower cost. When privately insured, individual and group health policies that provide prescription drugs cover some of the costs of a targeted cancer therapy. Free samples of medications can no longer be given to patients due to the Medicare Modernization Act of 2003 that went into effect in 2009. With the help of oncology providers and patient assistance programs, patients may be able to obtain the targeted cancer therapy at a low cost. It is ideal to have the Tagrisso you’re obtaining purchased through the Medicare Part D program or Medicaid. If no other alternatives are available, negotiating with the pharmaceutical company of the drug is an option, but the success rate of this is low and pharmaceutical companies do not give away medications free of charge.
3.1. Other Insurance Options
If you are not Medicare-eligible or if you have applied to Medicare instantly upon turning into Medicare-eligible age at sixty-five and are receiving Social Security Disability Benefits, you might decide to explore insurance choices through a private insurer. Medigap insurance policies are not available to complement with Medicare Advantage plans. However, for those eligible but not enrolled in premium-free Medicare Part A, there is an option to enroll in Nondiscrimination Package and take Supplement 1. Nondiscrimination Package is a similar plan that covers expenses not covered by Part A and B. If the individual is Nondiscrimination Package-eligible, Supplement 1 acts as a Medigap policy, providing insurance coverage to cover expenses not covered by Package services. However, those with Medicare Advantage plans cannot apply for Medigap insurance policies and are discouraged from applying for Supplemental 1 since this removes them from their Medicare Advantage and/or Medicaid enrollment.
3.2. Patient Assistance Programs
Patient assistance programs (PAPs) are sponsored by pharmaceutical companies and provide free or discounted prescription drugs to low-to-moderate income, uninsured and under-insured patients. Although having insurance coverage, many patients may not have coverage for the drug they need, or they may not have insurance at all. It is important to note that each program has its own set of financial criteria patients must meet in order to qualify. Tagrisso and many brand name drugs may have a bypass for people not meeting financial criteria through providing a free drug to physicians who apply on behalf of their patients that may not meet the financial criteria. This trial drug can be for a set amount of time and often renews if the free drug application is completed again. With limited duration due to funding set by each program, finding when a free drug spot may open for Tagrisso can be viable for a patient in the future. Free samples of drugs can be acquired through physicians’ offices and are sometimes an option when a free drug spot is not available. Since the sample drugs are limited in supply, this can still be used sparingly in conjunction with a free drug spot and a patient’s original Medicare Part D plan, allowing for flexibility between free drug, sample drug, and insurance drug usage. Drug discount cards are another resource offered from PAPs and are usually available without any stringent financial criteria. These cards can be applied for in minutes on a pharmaceutical company’s website and can be used at a pharmacy to acquire a specific brand name drug at a discounted rate.
3.3. Negotiating with Pharmaceutical Companies
Negotiating with pharmaceutical companies can be an effective way for individuals with limited financial resources to receive medication either free or at reduced costs. A physician may be able to aid their patients in this process by contacting the pharmaceutical representative or the company directly. Most pharmaceutical companies have specific programs in place to provide their medications to patients falling within certain income and asset guidelines. These qualifications are specific to each company and may or may not include individuals who do not qualify for Medicaid but are still in need. Tagrisso, its manufacturer AstraZeneca, has a program in place called AZ and Me which provides Tagrisso at no cost to qualifying patients. AZ and Me have a specific income limit based on the Federal Poverty Level. Depending on the company and the individual’s situation, they may still be unable to receive the medication even if a physician has directly contacted the pharmaceutical company. In this case, it’s important to weigh other options and the anticipated timing of their effectiveness in the patient’s health against current Tagrisso treatment, which is the only option providing immediate benefit.
4. Conclusion
Tagrisso is an example of a recently developed drug that has a transformative impact. Priced at over $11,000 per month, it is a remarkably effective treatment for a specific type of lung cancer. Offering an OS (survival) advantage of approximately 20 months relative to the prior standard of chemotherapy and significant improvement in patient reported outcomes and symptom control. Unfortunately, especially in the current Covid era, the drug is often viewed as prohibitively expensive, and there can be a substantial variability in terms of coverage and copays in different health insurance plans. One would anticipate that a drug priced in this manner would generate a great deal of controversy regarding cost and value and Tagrisso is no exception.
A pervasive too-common theme throughout all this frenzy has been excessive emphasis on what drugs cost rather than on what they are worth. This emphasis often leads to short-sighted or sometimes even outright irrational policies and practices. Principle among these are all too frequent efforts by payers, most often health insurance companies, to drive prescription of cheaper older drugs or newer drugs designed to be minor improvements within a drug class. This effort is frequently pursued to the exclusion of new drugs that are truly transformative for patients.
Today, the pace of health care has become somewhat frenetic. Drugs come to market rapidly after truncated FDA approval cycles. The media often demands instant non-expert opinion as to whether new drugs offer truly transformative benefits or are just marginal improvements over alternatives. Myriad other stakeholders, ranging from government agencies to health care payers to advocates for specific patient populations, often seek to gain favorable coverage, access or price terms for their respective constituencies.
References:
Kallas, O.N., Nezami, N., Singer, A.D., Wong, P., Kokabi, N., Bercu, Z.L., Umpierrez, M., Tran, A., Reimer, N.B., Oskouei, S.V. and Gonzalez, F.M., 2022. Cooled radiofrequency ablation for chronic joint pain secondary to hip and shoulder osteoarthritis. RadioGraphics, 42(2), pp.594-608. rsna.org
