Bridging Innovation and Access

Asembia’s Specialty Pharmacy Summit is one of the premier events in the specialty pharmaceutical industry, attracting more than 8,000 attendees each year from across all facets of the industry. For McKesson, Asembia’s AXS25 Summit, held in Las Vegas April 28-30, was an opportunity to engage with customers, biopharma partners and other industry stakeholders. Additionally, we were able to showcase our expertise surrounding critical topics including the future of the specialty therapy pipeline, continued challenges arising for access, distribution and dispensing of specialty products, innovation around the future needs of the patient journey, the commercialization of emerging cell and gene therapies, as well as the evolving regulatory landscape and the Inflation Reduction Act (IRA).

Below are a few of the key highlights and takeaways from these sessions. 

Exploring the impact of the Inflation Reduction Act (IRA) on patient access and reimbursement

John Beardsley, senior vice president of Corporate Business Development at CoverMyMeds, led a discussion on whether the changes necessitated by the IRA’s Drug Price Negotiation Program will improve access to needed medications, and the anticipated impacts for pharma companies, payers, pharmacies, providers and patients. Joining Beardsley on the panel were Fauzea Hussain, vice president of public policy for McKesson, and Ashwin Singhania, partner and principal of Life Sciences Strategy at EY-Parthenon, Ernst & Young LLP. 

The session explored the potential unintended consequences of the IRA, and panelists debated whether the cost savings driven by the policy would be passed through to patients. The speakers also discussed the potential impact of the IRA on pharmacies, which may be overburdened by the need to track new data streams and manage a unique reimbursement process for a handful of drugs selected for the program.  

The IRA was also the focus of a session led by Avalere Health, which included Ramesh Srinivasan, senior vice president and chief strategy and transformation officer for U.S. Pharmaceuticals, McKesson. This session explored how the inclusion of Medicare Part B drugs in the initial price applicability year (IPAY) program will affect buy-and-bill dynamics, contracting and distribution strategies, prescribing incentives and site of care selection. 

The session outlined the implications of applying Maximum Fair Price (MFP) – the highest price Medicare beneficiaries can pay for a selected drug as negotiated by the Centers for Medicare & Medicaid Services (CMS) – to medical benefit drugs typically reimbursed through a buy-and-bill model. 

Supporting the commercial adoption of cell and gene therapies 

In addition to exploring policy issues like the IRA, Asembia also featured discussions around how the evolving treatment landscape is affecting the specialty pharmacy industry. Joe DePinto, head of Cell, Gene and Advanced Therapies (CGT) at McKesson, moderated a session that explored the barriers that are slowing the commercial uptake of some cell and gene therapies, and strategies for accelerating adoption. DePinto was joined by two panelists with extensive experience in the CGT industry: Rocky Billups, vice president of Operations at HCA Healthcare/Sarah Cannon Cancer Network, and Dan Kirby, chief commercial officer of Iovance. 

Panelists discussed the barriers that have delayed commercial adoption of some cell and gene therapies, including hurdles among both government and commercial payers, lack of CGT familiarity among physicians, and challenges among sites of care in managing the complex processes needed to administer these novel therapies. 

While the panelists were aligned that no single solution can address all of these barriers, they discussed several potential strategies that could accelerate commercial uptake. Kirby talked about the importance of starting with a strong commercialization plan that is designed around the needs of patients and healthcare providers. Billups said it is critical to create agreements that help mitigate risk for the hospitals and medical oncology practices administering the therapies. The panel agreed that specialty pharmacy is poised to play an increasingly vital role in reducing financial risk and enabling more hospitals to access CGTs. They also emphasized the need for expanded education for both providers and patients as a critical step in broadening access to these therapies in the future. 

Understanding the strategic advantages of specialty distributors 

Asembia also provided an opportunity to examine the strategic role distributors can play in driving access to critical specialty medicines. Natalie Bedford, senior vice president of U.S. Pharmaceutical Distribution Services, McKesson, led a discussion on this topic with Colin Russi, principal of ZS Associates; John Vernon, senior director of National Channel Accounts at AstraZeneca; and PJ Agarwal, vice president of Channel Management at Pfizer. 

The discussion looked at how manufacturers and distributors are partnering together in innovative ways to support patient needs. 

The panel also spoke at length about the role that specialty distributors can play in managing complexity across the value chain by creating connectivity between healthcare providers, pharmacies and manufacturers. Russi remarked that as the industry shifts toward value-based care models for higher-cost specialty therapies, distributors will serve an important role in collecting and integrating data because of their scale and touchpoints across multiple stakeholders. 

As stakeholders continue to navigate head winds revolving around patient access, reimbursement, commercial adoption complexities, regulatory shifts and more, it’s clear that the supply chain of the future is dependent on enhanced enterprise collaboration and connectivity. 

“Specialty distributors are more than just delivery agents,” said Bedford. “They are vital partners in navigating complex regulatory landscapes, enhancing digital connectivity, and ultimately ensuring that every stakeholder – from manufacturers to patients – benefits from a streamlined and effective healthcare supply chain.” 

Asembia’s AXS25 Summit provided valuable insights into navigating the evolving landscape of specialty medicine, particularly in the context of policy changes and innovative therapies. These discussions will continue to play a crucial role in shaping the future of patient care and industry practices.