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Industry Insights: Takeaways from Asembia's AXS24 Specialty Pharmacy Summit

MAY 23
Asembia’s AXS24 Summit drew representatives from across the value chain, from pharmaceutical manufacturers to pharmacies and specialty pharmacies, to insurers, and a broad array of technology and services companies supporting the specialty drug ecosystem. This must-go conference yields new business opportunities, reveals cutting-edge discoveries, and unveils innovative models that propel the specialty drug delivery market forward. With the impact that specialty drugs has on patient outcomes and overall healthcare costs, this unique conference is one that TripleTree is proud to sponsor.
 
Our team gleaned the latest advancements in specialty medication and contributed to the ongoing dialogue shaping the industry’s future. Reflecting on our time in Las Vegas, we share some of the sentiment and our insights on GLP-1 drugs that are sparking considerable attention and focus across the healthcare ecosystem, the overall state of specialty drugs, and the potential impacts of recent legislation.
 

The Rapid Rise in Popularity and Impact of GLP-1s

Glucagon-like peptide-1 (GLP-1) is a hormone that regulates blood sugar, appetite, and insulin secretion, primarily from the intestine. GLP-1 drugs are not considered specialty drugs, however they dominated discussions and presentations across a conference that traditionally focuses on specialty drugs, rare diseases, and orphan drugs.
 
These GLP-1 drugs, with brand names such as Ozempic, Wegovy, Mounjaro, and Rybelsus, come with considerable costs (though considerably less than many specialty drugs targeting other conditions, such as cancer). GLP-1 drugs have been on a trajectory of rapid growth, given the potential that upward of 50 percent of U.S. adults might qualify to take them for weight loss under current clinical guidelines.
 
GLP-1’s have captured attention because they treat common chronic conditions such as diabetes and obesity, however they come with considerable affordability and access concerns. Their popularity and effectiveness have spurred manufacturers to develop over 100 GLP-1 drugs, primarily to capitalize on the expanding opportunity to support diseases beyond approved uses for diabetes, weight loss, and cardiovascular issues. For example, clinical trials are underway for other indications such as chronic kidney disease, sleep apnea, and non-alcoholic fatty liver disease.
 
The obesity drug market is expected to reach $131 billion by 2023, according to an IQVIA forecast. With broader coverage of GLP-1s to treat more conditions, the near-term financial outlook for this sector is considerable. The potential growth of GLP-1s and their implications for healthcare expenditure will remain newsworthy moving forward.
 
As healthcare payers assess the price tag of treatment options for obesity and chronic conditions, GLP-1 drugs emerge as a focal point. Their analysis extends beyond mere cost. Health insurers and the government are continually scrutinizing efficacy and analyzing where they fit in formularies while payers and employers implement tight prior authorization controls in an attempt to manage the significant financial burden this category of medication represents. Half of the new fill attempts for Wegovy, as an example, are denied according to IQVIA. No doubt anti-obesity drugs will remain a focal topic for the industry for quite some time.
 

The State of Affordability, Access, and Outcomes

 A large part of the specialty drug discussion at the summit focused on increasing affordability and expanding patient access to this drug category. Within the market, a select few high-cost medications significantly drive drug spending, particularly specialty drugs, which saw a substantial increase in expenditure, reaching $301B in 2021, marking a 43% rise since 2016. Specialty drugs accounted for half of total drug spending in 2021. In contrast, generic drugs comprise 80% of prescriptions filled by Americans. Interestingly, the top 10% of drugs, ranked by price, constitute less than 1% of all prescriptions.
 
The industry’s focus on improving specialty drug margins relies on efficiency gains because developing drugs for a limited patient pool incurs significant costs across drug development to delivery stages.
 
Conversations delved into the long-term viability of drug cost support programs from pharmaceutical manufacturers. Currently, the programs temporarily reduce cost burdens for patients, but sustainability doesn’t seem certain, given regulatory changes, market dynamics, and financial considerations.
 
This conference also spotlighted the pivotal role of distributors, specifically pharmacists, in guiding patients through specialty drug regimens. Adherence programs and digital and tangible tools are expanding to address complexities and side effects, amplifying support programs’ importance.
 
The strong showing of technology vendors indicated how specialty drug makers rely on analytics when formulating medications and distributing drugs, wielding insights to drive efficiency.
Attendees were eager to explore how AI and machine learning could accelerate this sector forward, shaping the future of drug delivery.
 

Impact of the Inflation Reduction Act on Specialty Drugs

The discussion on upcoming elections and its potential impact on the pharmaceutical industry and specialty drugs appeared notably light at this year’s summit. However, there were several sessions focused on the potential impact of the already passed Inflation Reduction Act of 2022(IRA).
 
The IRA gives the Department of Health & Human Services the ability to negotiate prices directly with manufacturers for certain high expenditure Medicare Part D and Part B covered drugs without generic or biosimilar competition. Additionally, the IRA caps patient out of pocket costs to $2,000 starting in 2025 and has additional price support features to help address affordability and access issues for these important medications. The first cycle focused on 10 already named drugs but later phases expand to broader categories of small molecule and large molecule drugs, opening price negotiation within 7-11 years after the drug’s first indication is approved by the FDA.
 
Much of the discussion at the summit around the IRA focused on strategies the drug manufacturers might employ during the R&D and commercialization process of the specialty drugs to comply with the legislation while still building the financial case to develop new drugs and target particular therapies and disease stages. Beyond the manufacturers, payers, distributors, and patient advocates all have interest in understanding the IRA and its impacts across the industry.  Clearly the IRA has long term implications to the specialty drug market and we know this will be a ongoing topic of conversation in the industry and future conferences.

For the thousands of decision-makers from the specialty pharmaceutical industry in attendance at Asembia’s AXS24 Summit, it was evident that they are balancing a confluence of factors, such as reimbursement policy cost controls, pricing, market access, competition, and—most importantly—patient needs. Anticipating and navigating these dynamics is crucial for sustained growth in this evolving landscape.
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Scott Donahue
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Colin Aldridge
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Jeff Jones
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Seth Kneller
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