Specialty Pharmacy Is Ready for Its Close Up

Our team recently attended the annual Asembia Specialty Pharmacy Summit, and one thing became abundantly clear: therapies delivered via injectable, infusible, or inhalable means are dominating the pharmaceutical and patient care landscapes. These types of prescriptions or orders tend to be high-cost, require special handling, and are distributed outside of typical pharmaceutical fill processes. However, continuing to refer to these treatments as "specialty" is starting to feel like a bit of a misnomer.

Today, 80 percent of therapies being reviewed by the FDA for approval are classified as specialty in nature. Additionally, there is greater spending than ever on these products. According to a recent report by IQVIA, spending in the specialty class now represents over half of all medication spending, double what it was in 2011.

A New Type of Blockbuster

Once upon a time, blockbuster drugs were dominated by tablet formulations available for pickup in brick-and-mortar pharmacies. Household names like Zoloft, Lipitor, and Prilosec have been replaced in recent years by specialty medicines, including Humira, Ozempic, and Keytruda, thanks to impressive outcomes coupled with high consumer advertising spending. Other factors have fueled the tremendous growth of the specialty pharma market. For example, the promise of personalized medicine is finally coming to fruition. A better understanding of genetics and genomics, along with advances in molecular science and drug delivery systems, has helped move breakthrough discoveries from the lab to the patient's bedside. Moreover, direct-to-patient distribution has emerged as a viable, convenient, and safe way to get these therapies into patients' hands.

Given the expense of specialty medicines coupled with the sizable market demand, there are many issues to be worked out in terms of payment and reimbursement. The topic of prescription drug pricing has always commanded significant legislative, advocacy, and payer attention. Certainly, 2023 is not looking any different. Putting that ongoing debate aside, the Asembia Summit featured a lot of dialogue around several key trends fueling specialty market growth in 2023 and beyond.

Specialty Market Drivers

  1. Increased competition in the biosimilars market: This will be largely driven by one event—the expiration of Humira's patent, which protected market share for this top-selling drug for over 20 years. With the loss of exclusivity in 2023, eight competitive agents are attempting to enter the market as treatments for common autoimmune disorders, including psoriasis and rheumatoid arthritis. Patients and advocacy groups alike are eagerly awaiting the commercial availability of new options, which could happen as soon as July.

  2. Novel treatment approaches for challenging cancers: Despite many advances in the early detection of cancer, overall, cancer is still widespread. Spending in the oncology space is expected to grow in the coming years, as more than 100 new treatments sit in manufacturer pipelines. mRNA therapies, such as vaccines and new immunotherapies, are advancing through trials for some of the most difficult-to-treat cancers, such as melanoma, pancreatic cancer, lung cancer, and metastatic breast cancer.

  3. Maturation of cell and gene therapy treatments: Cell and gene therapy (CGT) continues to excite researchers and physicians. Approaches such as CAR-T command headlines for demonstrated success in limiting or eradicating disease. As 2023 unfolds, more than ten treatments could become FDA-approved for illnesses such as sickle cell disease, hemophilia, and blood cancers, including multiple myeloma. Beyond these promising developments, there are 200 Phase III CGT clinical trials underway for myriad other disease states.

  4. Rare diseases get a boost from AI: Conditions affecting less than 200,000 individuals are considered rare. Estimates put the number of rare diseases anywhere from 7,000 to 10,000. Diagnosing patients with a rare disease can often be a challenge due to the lack of real-world information about the clinical presentation, leaving physicians stymied. The common quote, "When physicians hear hoofs, they think horses, not zebras," illustrates this challenge. However, AI applications are providing help by scanning medical records and journal data to surface symptomology or patterns suggestive of a rare condition. Identifying patients enables data sharing and clinical trial participation in a timelier manner, fueling drug development. In 2022, more than 50% of FDA approvals were for rare diseases, and this trend is expected to continue throughout 2023.

  5. Monoclonal antibodies offer hope to chronic patients: Patients managing lifelong conditions are also benefiting from expanded care options in the form of monoclonal antibodies. Towards the end of 2022, the FDA approved Tzield, a therapy shown to delay the onset of type 1 diabetes in children deemed at risk. Only a few months later, the agency issued another antibody approval when Tezspire was approved for self-administration by patients dealing with severe asthma. Previously, this treatment was only available in physician offices. More than 20 antibody treatments are currently under review for approval in 2023.

The specialty pharmaceutical market is showing no signs of slowing down. It is plausible that these therapies will become the norm in the coming years, with traditional pharmacies playing a supporting role. As distribution and storage requirements change in line with this evolution, AeroSafe will continue to support patient and supplier needs with our reusable thermal packaging solutions designed to protect temperature-sensitive specialty products. Our innovative and personalized solutions received rave reviews at Asembia. Our ability to deliver confidence in the product, patient, provider, and the planet is our reason for being and resonated with attendees. Contact us today if you want to learn more about our cold chain and direct-to-patient solutions for the specialty market.

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