NPC Asks CMS to Consider Patients’ Individual Treatment Effects In Part D Rulemaking
The National Pharmaceutical Council (NPC) today asked the Centers for Medicare and Medicaid Services (CMS) to consider maintaining “protected classes” designations under its prescription drug benefit program (Medicare Part D) to ensure that patients will have access to the treatment options they need.
The National Pharmaceutical Council (NPC) today asked the Centers for Medicare and Medicaid Services (CMS) to consider maintaining “protected classes” designations under its prescription drug benefit program (Medicare Part D) to ensure that patients will have access to the treatment options they need.
Under CMS’ proposal, Medicare Program; Contract Year 2015 and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs, Part D plans would no longer be required to carry “substantially all” of the chemically distinct drugs in three of the original six “protected” drug categories: Antidepressants and Immunosuppressants (to lose protected status in 2015) and Antipsychotics (to lose protected status in 2016). Instead, those plans would only be required to carry one brand name drug and one generic drug for these drug classes. These original protected category designations were intended to protect patients who face potentially severe health consequences that may result from restrictive policies by ensuring broad access to unique medicines and treatment options.
In a letter submitted during CMS’ public comment period on its notice of proposed rulemaking, NPC explained that significantly limiting the drugs covered by Part D ignores the challenges faced by individual patients for whom the “average” treatment does not work.
NPC wrote:
“This limitation can lead to the unintended consequence of restricting treatment options to what may work best for the ‘average’ patient. For healthcare to be patient-centered, it is necessary to consider patient heterogeneity of treatment effects (HTE). Different patients can have very different responses when it comes to different treatment options. The treatment that is best for most patients may not be the one that is right for an individual. Healthcare coverage and benefit design that is focused on ‘average’ treatment response can result in restricting a patient from access to the particular treatment option that is most effective for him or her.
“When patients don't receive the medications best matched for them, worsening of symptoms, avoidable hospitalizations, and impaired quality of life would likely result. For some health conditions, policies that delay optimal treatment even for a few months while patients are required to try ineffective treatment options may cause irreversible damage. This is the case for immunosuppressant therapy for patients with autoimmune conditions or organ transplant. In the absence of optimal treatment, these patients can experience substantial tissue degradation. Furthermore, medications are often not interchangeable. A patient who is taking a medication that works well in treating his or her chronic illness could experience vastly different effects and side effects if forced to switch to another treatment that is not suited for his or her individual use.
“Restricted access greatly impacts individual patient health, but also could have a substantial impact on downstream healthcare costs as patients’ conditions progress in the absence of the most effective treatment and/or they suffer from increased adverse events. Policies designed to save upstream costs by restricting access to expensive drugs can actually have a net negative economic impact mainly because of reduced health among patients who do not receive timely effective treatment due to these restrictive policies. Thus, consideration of HTE can contribute to more individualized and more efficient healthcare.”