The Future of Infusion Therapies Is in the Ambulatory Center | PBMI 2024

Mike Baldzicki

Mike Baldzicki envisions a time when cell and gene therapies will be administered at ambulatory infusion centers instead of hospital centers of excellence. Aided by newer technology — such as smart infusion pumps, technology that delivers precise medication and remote monitoring — infusion centers of excellence will be able to provide a more cost-efficient solution for delivering these and other infusion therapies.

“The rare disease pipeline and the gene cell therapy markets are growing, and there are nuances around having to customize patient care that will impact the medical benefit,” said Baldzicki, who is chief commercial officer at Polaris Specialty Pharmacy. “How do we adjust to the next phase of healthcare, looking at how do we quickly work with consumers but also looking at how do we manage cost?”

During a session at the Pharmacy Benefit Management Institute’s Annual National Conference in Orlando, Baldzicki discussed how infusion centers will be able to meet the needs of the growing number of patients who will be eligible for infusion and cell and gene therapies.

“I'm a big believer that, based on the pipeline we’re seeing in gene and cell therapy, ambulatory infusion centers will become an appropriate site of care,” he said. “Digital technology and AI and adaptive tools will allow for a holistic approach and allow for us to customize programs based on the appropriate site of care.”

The cell and gene therapy market is growing. There are more than 30 cell and gene therapies approved by the FDA, according to the regulatory agency. And many more are in development. There are currently more than 600 gene and therapy programs in development, and the FDA expects to approval between 10 and 20 news cell and gene therapies by 2025.

All of this development will lead to increased costs to payers. In 2023, spending on cell and gene therapies increased 38% over 2022 to $5.9 billion in 2023, according to a recent report from IQVIA Institute for Human Data Science.

Spending on next generation therapies is expected to grow three and half times to $18 billion in four years.

By 2032, there could be almost 50,000 patients a year that could be treated with gene therapies, predicts a white paper by the Institute for Clinical and Economic Review (ICER) and NEWDIGS, Tufts Center for Biomedical System Design.

Over the past two years, gene therapies have been approved by the FDA with list prices that are higher and higher. The most recent, Lenmeldy, has the highest ever price for a new treatment: $4.25 million.

But the costs of treatment are not the only costs involve in gene therapy, which is a process. Some require that bone marrow be removed to manufacture the therapy, and the therapy is then reinfused into the patient. Some require the administration of chemotherapy prior to the gene therapy.

The FDA is also approving novel therapies for diseases with larger patient populations, Baldzicki said. “The definition of rare disease is changing. It usually means a population of 20,000 or less, but what we’re seeing in newer launches, especially therapies with a first-of-kind mechanism, is that they are hitting larger populations. This means we’re going to see population eligibility for a product launch in the hundreds of thousands. With price tags increasing, especially in rare disease, there will be hundreds of thousands of dollars of costs beyond the therapy…One claim could bankrupt a teachers’ union or school district overnight.”

Baldzicki said there is an opportunity for employers and payers to consider carving out the infusion services and provide care through ambulatory infusion centers. This, he said, is a growing area that has attracted the attention of private equity. One report estimates that global the ambulatory infusion center market to be at $47.1 billion in 2024, with 10.6% compound annual growth rate.

“We’re already seeing some innovative programs with the Blues plans working with provider groups to provide options outside of the hospital, whether buy-and-bill and treating the patient in the office, partnering with a specialty pharmacy or treating the patient at home,” he said. “We’re seeing new models and it’s just not for TPN and hydration product. It’s IVIG products. It’s rheumatology. Payers are getting more robust with their product selection because of the way they’re working with local provider groups.”

Baldzicki stressed that the provider is key for developing these programs. “We have to have a patient and provider focus. Larger groups are being more collaborative with providers so there is less disruption for the patients, and we are seeing more demand from patients.”