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February marks an important time for health care professionals and caregivers alike — it's American Heart Month. As a former neurology and emergency room nurse who treated patients suffering from heart conditions and strokes, my advocacy became personal last December when my 88-year-old father, a former Dallas police officer, lifelong tennis player and athlete suddenly suffered a stroke due to undetected atrial fibrillation. While I worked with his providers who were looking for the cause of the stroke to determine the treatment plan, I found myself standing at the critical intersection of patient care and innovation and personal awareness. Heart disease remains the leading cause of death in the United States, underscoring the urgency to raise awareness and education, promote prevention and advocate for access to treatment and care for those affected by cardiovascular conditions.
In my policy role at PhRMA, I'm privileged to witness the dedication of researchers, scientists and clinicians who work tirelessly to develop innovative treatments for cardiovascular diseases. These advancements can not only save patients’ lives but can also improve their quality of life, allowing them to live fuller, healthier and more productive lives.
By developing groundbreaking new medications that either prevent or treat heart disease and reduce existing burdens of care, the biopharmaceutical industry plays a pivotal role in driving progress in cardiovascular care. In fact, my father is a beneficiary of this innovation because he is now taking an anticoagulant medication that lowers the risk of stroke in patients with atrial fibrillation, the heart rhythm disorder that initially caused his stroke over a year ago. Today, there are nearly 100 medicines in development for cardiovascular diseases like congestive heart failure, coronary artery disease, high cholesterol, hypertension and stroke.
If one thing is certain, there has never been a more promising time given the tremendous progress researchers have made in treating cardiovascular disease. It is imperative that we not only celebrate the progress we've made but also advocate for policies at both the state and federal levels that safeguard the future of medical innovation, including the importance of investing in research and development to continue bringing forward lifesaving treatments for those with cardiovascular conditions.
That’s why I am so concerned about the Inflation Reduction Act’s price setting provisions and the anticipated impact the law may have on treatment choices for patients with cardiovascular conditions. The price setting provisions of IRA, coupled with other major benefit design changes to Medicare Part D’s structure, could result in health plans restricting access to certain medicines to manage cost and plan liability. For example, Part D plans may use more utilization management restrictions, impose higher cost-sharing, or they may stop covering some medicines altogether since they are only required to cover a minimum of two drugs in most therapeutic classes.
This year, two anticoagulant medications used to treat and prevent blood clots and stroke from the same class were selected for government price-setting. By selecting these medicines for price setting, the government has put access to medicines in this class at risk for those who rely on these selected medications or the therapeutic competitors in the class. Co-occurring cardiovascular conditions are common among those who rely on anticoagulants, making the choice of treatment within the class important as prescriber decisions are often guided by an effort to mitigate against certain risk and adverse health outcomes from other cardiovascular comorbidities. More than 3.5 million Medicare beneficiaries rely on the two medicines selected for price setting, and more than 4.5 million beneficiaries in total rely on a medicine in this class of treatments. Unfortunately, government price setting puts choice within this class at risk, potentially jeopardizing patient health outcomes.
Lack of access to needed medicines is dangerous to patients’ health because we know one size doesn’t fit all. Patients respond differently to medications depending on their medical history, genetics, current medication regimen, comorbidities and other important factors that come into play.
As a nurse who witnesses the impact of innovative therapies on patient care, I am deeply troubled by the potential repercussions of such short-sighted policies like those in the IRA that restrict access. So, as we observe this month dedicated to matters of the heart, let's commit ourselves to support federal and state policies that promote broad clinical treatment choices, nurture innovation and empower researchers to push the boundaries of medical science. And let’s urge our policymakers to do the same.
Sharon Lamberton, MS, RN
Sharon Lamberton is a registered nurse by training and serves as a Deputy Vice President of State Policy and External Outreach at PhRMA, focusing on state and federal healthcare policy issues related to access and affordability. She works closely with patient and provider groups, and frequently presents to third party groups, including National Governors Association, National Foundation of Women Legislators and Women in Government. Previously, Sharon worked for a senior’s association of more than 5 million members, as well as at the Government Accountability Office (GAO) on rural health issues and GMU Center for Health Policy, Research and Ethics. Her clinical experience includes working as an Emergency Room nurse and at National Institutes of Health Clinical Center, where she performed direct patient care on clinical trial patients, focusing on brain cancer, multiple sclerosis, epilepsy, stroke and more.
Sharon Lamberton
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