Mental illness significantly impacts the Medicare populations. Eliminating robust Part D coverage for this population will leave some of the most vulnerable Medicare beneficiaries, who may already have difficulty managing their disease, without adequate protections to ensure timely access to these therapies. It is clear from the data that CMS relied upon that their formulary review process is ineffective in providing access to needed medications for complicated diseases. As demonstrated by their data highlighted in the proposed regulation, for persons with mental illness, their standard formulary review process would only require coverage of 9 generic antidepressant and 6 generic antipsychotic medications, for a total of only 15 medications and no brand drugs. In comparison, the current six protected classes policy entitles Medicare beneficiaries to access to 57 medications: 23 generic antidepressants, 7 brand antidepressants, 18 generic antipsychotics and 9 brand antipsychotics.
Why does this matter? Consider depression. Of the 9 symptoms for major depressive disorder (MDD) in the DSM-V, an individual needs a combination of five symptoms to be diagnosed with major depression. That’s well over 200 different possible ways someone could have MDD and one variant would not look like another. Having only one or two drugs to treat the wide-ranging way someone could present with depression is simply inadequate, especially among an older population where depression is a significant predictor of suicide.
The proposed policy also failed to recognize the interrelatedness among complicated illnesses and diseases. Studies have shown that close to 50 percent of individuals with HIV also have a mental illness. According to the American Cancer Society, 1 in 4 individuals with cancer has clinical depression. Further, studies have shown that persons with epilepsy have higher rates of depression and suicide. It is important that doctors have the ability to choose the right mix of medications for patients with such complicated health needs.
Mechanisms to contain costs and steer patients toward lower cost options already exist in the program. Part D Plans are allowed to tier the cost of medications, which has proven effective. Research by the Medicare Payment Advisory Committee (MedPAC) has shown that generic utilization among the Low Income Subsidy (LIS) population, particularly for antidepressants, is comparable to rates among non-LIS populations. Though importantly, individuals requiring more expensive or brand name medications are ensured access without appeal under six protected classes.
Epilepsy and Parkinson's Disease
Patients with epilepsy who have their medications switched (from brand name to generic or from generic to generic) may be at risk for developing breakthrough seizures, especially when the change happens without a physician's oversight and monitoring. About two-thirds of people diagnosed with epilepsy will become seizure free on the first or second anti-epilepsy drug administered. For elderly epilepsy patients with multiple chronic conditions, it is critical that they have access to a wide range of treatment options. Proposals that would eliminate 'protected class' status for anticonvulsants often rely on the current exceptions, appeals and grievance processes to provide timely access to life-saving and life-enhancing medications when a formulary restricts access. The patient community has long expressed concerns with this process, and called on CMS to provide timely, accessible, and consumer-oriented standard appeals policies to ensure patient safety and appropriate access to medically necessary treatments.
Access to oncology drugs (antineoplastics) is crucial for cancer patients because dugs in these classes cannot necessarily be substituted for each other: for instance, oncology patients may respond differently to different treatments, need to switch between treatments based on changes in their condition, or have fewer or more tolerable side-effects if they use one therapy instead of another. The protected class policy helps keep these treatment decisions between a patient and his or her provider.
The law under which the protected class policy was first codified — the Medicare Improvements for Patients and Providers Act of 2008 — specifically identifies “drugs used in the treatment of cancer” as an example of a drug class that clearly met the criteria that defined a “protected class” at the time. Even with the current protected class policy in place, patients have trouble accessing the drugs that are most appropriate for them because of discriminatory coinsurance policies: antineoplastics are disproportionately included on plan formulary’s specialty tiers, which require patients to pay a certain percentage of the cost of the drug (coinsurance) rather than a set dollar amount (copay). Further, the two criteria by which CMS had proposed to judge whether a drug class should be “protected” were overly restrictive and gave CMS leave to eliminate any of the remaining protected classes in the future. Although the proposed rule recommended maintaining protected class status for antineoplastics, there is nothing inherent about the criteria for future assessment that CMS proposed which would limit the agency from excluding antineoplastics as a protected class in the future, thus putting cancer patients in jeopardy of losing access to their preferred treatment.
For people living with HIV and so many others, new drug therapies have saved millions of lives and prolonged millions more. The advent of antiretroviral medications in the late ‘90s turned HIV from a near certain death to a manageable disease if patients have access to quality care and medications. Not all medications are the same, and each person may react differently to a particular medication. Together, doctors and patients make careful treatment decisions about which therapies are most appropriate on a case by case basis. Some individuals may develop side-effects to a particular drug, while another person may need a certain therapy to avoid a harmful interaction with a drug being taken for another health condition. For people living with HIV drug resistance can occur, and they must have the ability to switch to another drug without interruption.
It was for these reasons that when Medicare Part D was first implemented, CMS determined that a minimum of only two drugs in a class was simply not enough for certain patients, including those with HIV, mental illness, cancer, epilepsy, and those undergoing organ transplantation. The six protected classes was created so that patients could have broad access to all the drugs in these classes. For more than a decade, Medicare Part D has been working for millions of seniors and people with disabilities, including over 120,000 people with HIV. As part of the Affordable Care Act (ACA), Congress took the step to even codified the six protected classes. We see no reason why the protected classes should be changed.
Organ Transplants and Autoimmune Disorders
The CMS proposal in 2014 to eliminate immunosuppressants for the list of protected classes would place persons who received any transplant at risk for severe medical complications, as well as individuals who take these same medications to manage their autoimmune disorders – including lupus, psoriasis, rheumatoid arthritis, Crohn’s disease, and multiple sclerosis.
Immunosuppressive medications are not interchangeable. Even with the same generic name, versions of a medication from different manufacturers react in very different ways. And there is nothing more important to an organ recipient that the stability of action of the prescription drug formulary. If prescription drugs are filled without regard to consistency from one month to the next, the recipient is subject to increased risk of rejection, along with additional clinic visits, lab costs, and potential hospitalization. These are all huge drains on the medical system. No barriers or additional administrative or financial challenges should be placed between patients and access to these life and organ transplant sustaining drugs.
Immunosuppressive are prescribed in combinations tailored to meet the unique needs of the individual recipient and these needs and drug combinations can change over time. This is to achieve sufficient immunosuppression while minimizing the toxicity associated with individual agents. Restricting formularies by eliminating these drugs from the protected classes will limit the physician’s ability to prescribe the right combination of medications and to prescribe them in a consistent month-to-month, year-to-year manner. This crucial balance was recognized in the original decision to include immunsuppressants in the protected classes.