The Cost of Blood Platelets Is About to Surge

Hospitals, including major trauma and cancer centers across the country, could soon experience one of the largest ever price increases for blood platelets. This price increase comes on the heels of one of the most trying times for our nation’s hospitals, which remain financially constrained and have reprioritized budgets to include more personal protective equipment (PPE) and other resources to respond to the COVID-19 pandemic. Curtailing runaway healthcare costs is essential to keeping our healthcare system afloat and protecting patients.

To understand why the cost may soon spike, it’s helpful to review the history of platelet storage for blood transfusion in the U.S.

A Change in Platelet Storage

In addition to being used for trauma patients, transfusions of platelets are critical in treating cancer patients undergoing chemotherapy, which destroys the body’s ability to make its own platelets. While bacterial contamination of transfused blood has been recognized since 1941, bacterial growth in these products was initially not seen as a major problem. This is because the platelets were stored in refrigerators, which inhibited or slowed most bacterial growth.

In 1969, hospitals, clinics, and blood centers began storing platelets at room temperature after it was discovered this would result in longer platelet survival in a patient’s circulatory system after transfusion. However, this warmer storage also creates the optimal condition for bacterial growth. Not surprisingly, in 1971, the first instances of bacterial transmission by platelets were reported. Notwithstanding the risk of bacterial proliferation, platelets are still stored at room temperature since this is best for the patient, despite dozens of published reports of fatalities due to bacterial contamination of room-temperature stored platelets, in addition to extensive research into the types of bacteria responsible and how they enter blood components.

Almost every year, multiple such fatalities are reported to the FDA under its mandatory notification system for transfusion-associated fatalities. Recently published reports have documented patient deaths from bacterially contaminated platelets in North Carolina, California, and Utah. Despite the recognition of this serious risk, the steady drumbeat of deaths, and significant technical advances to detect and eliminate contaminating bacteria, regulatory action to reduce or prevent this risk has been painstakingly slow.

Guidelines to Prevent Bacterial Transmission

After more than 15 years of deliberation, it was not until 2019 that the FDA issued final guidance outlining recommendations to prevent the transmission of bacteria by platelet transfusion. While groundbreaking at first glance, the shortcomings of the detailed guidance quickly overshadowed what should have otherwise been a celebrated milestone. In certain respects, the result of this guidance and some of the subsequent FDA approvals and clearances of products related to the guidance are deeply flawed. And in at least one instance, the FDA approved a method — large volume delayed sampling — with no supporting statistically significant data that proves efficacy compared to the present practice of 24-hour culture testing, which the FDA has repeatedly called inadequate. The agency’s mission of protecting and advancing public health is best served by requiring data-driven proof that new methods are better than the inadequate ones they are permitted to replace.

Notwithstanding these decisions, healthcare providers must comply with the final guidance by October 1. Major blood centers, which are often the sole source of platelets for hospitals in many regions of the country, are already communicating a compliance strategy that would transition to complete reliance on one methodology — pathogen reduction technology, which involves introducing a chemical into the bag of platelets and then exposing them to UV light. This methodology is not only the most expensive option, but also presents a significant price increase over the current average cost per bag of platelets. Further, leading physicians have expressed serious supply chain concerns that come with relying on a single mitigation strategy. Hospitals are not all created equal and have different sets of challenges, patient populations, and community needs. Providing market-dominant suppliers the ability to limit choice is risky and imprudent considering the healthcare supply chain issues our country experienced in responding to COVID-19.

The FDA has a responsibility to get this right. It’s not too late to revisit and amend the final guidance to include only bacterial contamination mitigation methods for which equivalent and sufficient data have provided proof of significant improvements in safety and efficacy compared to the current practice. Our nation’s blood centers also have a responsibility to get this right, by committing to flexibility and choice so hospitals can take greater control over their costs and best meet patient safety and community needs. And if they don’t, Congress must step in and provide greater guidance.

Earl L. “Buddy” Carter, RPh, is a member of the U.S. House of Representatives (R-Ga.) and a trained pharmacist, previously practicing for more than 30 years. He is a member of the GOP Doctors Caucus, and sits on the Energy and Commerce Health Subcommittee.

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