Prescription for Better Access

Podcast: Prescription for Better Access
Episode #1: 2023: Looking Ahead in Patient Access

In this inaugural episode of Prescription for Better Access, co-hosts Mark Hansan and Dr. Scott Howell interview Dave Moules who previously served as Pfizer’s SVP, U.S. Payer and Channel Access.  Dave joins the episode today to discuss 2023 and his perspectives on patient access, drug pricing, rebates, manufacturers and more.

The episode starts with Dave describing his career journey. Dave has worked in healthcare for over 30 years which included time in the health insurance sector with Cigna Healthcare and the pharmacy benefit manager (PBM) industry with Diversified Pharmaceutical Services as well as over two decades in the pharmaceutical sector with GlaxoSmithKline and Pfizer where he recently retired after 10 years with the company. He is now at a new firm called EntityRisk which was co-founded by three PhD economists with a focus on helping biopharmaceutical companies predict and prove the value of new medicines. 

Dave starts the conversation by saying the most common theme that he has seen throughout his career is that the system works best when patients have affordable access to the best medical treatments.  In this country, we are fortunate to have access to the best innovation in the world. However, the availability of clinically important medicines is meaningless if they’re not affordable.  

In discussing the state of play in 2023, Dave notes some positives for patients including provisions in the 2022 Inflation Reduction Act (IRA) that make insulin more affordable by capping patient out-of-pocket costs at $35/month and that provide access to recommended vaccines at zero out-of-pocket costs for Medicare beneficiaries. But for many, especially for those with Commercial insurance, benefit designs continue to increase the financial burden for patients. There are obstacles to affording and accessing clinically important medicines including exclusion programs for a growing number of medicines and a proliferation of copay accumulator and copay maximizer programs that take advantage of the pharma manufacturers sponsored financial assistance programs. 

January 1st is a busy time for patients and medication access. When there are changes to formularies, and non-medical switches in prescription drug treatments are required, it creates challenges where patients could go untreated which could lead to negative consequences for the patients. Dave says the transition from one drug to another needs to be as smooth as possible, and we need to keep the patient in the center and do everything we can to make sure there is continuity of care. 

Next, they discuss the perspective on drug pricing related to patient access. Dave highlighted the fact that the Affordable Care Act contained provisions that had a significant financial impact to manufacturers which had the unintended consequence of driving pharmaceutical prices up. If policy changes reduce net prices without an offsetting volume gain, companies either need to reset financial expectations or increase prices to make up for the net revenue loss.  The impact of price inflation is more important today because so many patients have benefit designs where their portion of the cost is determined based on the list price of the drug (e.g., deductibles and coinsurance). 
Dave shared that another unintended consequence of ACA was the luxury tax. Payers started making benefit programs less generous to avoid the tax, so even though the luxury tax was appealed in 2019, this provision still impacted benefit designs as employers offered less generous plans to mitigate their tax expense exposure.  

Over time, as patients have been asked to shoulder a larger financial burden, manufacturers have stepped up to provide financial assistance through their copay support programs. This is important for patients and the system as a whole because ultimately, treating patients with the right medicines is often the most cost-effective way to improve or avoid disease. 

Dave discussed another consequence of the ACA which is the significant growth with the 340B program due to the expansion of Contract Pharmacies. There was a time when the 340B program was smaller than the Medicaid program, but for some manufacturers, the 340B program is much larger than the Medicaid program with volume as high as four times (or greater) as big as the Medicaid program.  Unfortunately, despite the growth in the 340B program, we are not seeing patients that need help with affordable access to medicines benefitting from the significant manufacturer discounts being paid to 340B Eligible Entities. Instead, for-profit entities like the Contract Pharmacies and intermediaries who facilitate the Contract Pharmacy program are profiting from 340B discounts. We need legislators and/or regulators to put the program back on track to what it was intended to provide – which is affordable access to medicines for uninsured, lower income people.  

If we are going to implement wide scale change to address patient access to medicines, this will likely need to happen based on changes in policy. The private sector play a critical role in our health care system and have great ideas to improve access to high quality treatments, but it is difficult to implement some changes unless there is a level playing field for those entities that compete with one another.  Policy actions can establish the ground rules to reset the system so it works for all patients. The system has evolved to one that favors high prices and rebates that don't go directly back to patients using the medicines, instead of one that provides value-based access based on value-based prices.  

Dave says he continues to believe that the system will evolve to improve affordable access to medicines that provide and are priced based on value. He sees a critical role for EntityRisk since they have developed industry-leading capabilities and methods to help companies assess the value of their medicines and to provide the necessary support to companies who decide to take risk based on the clinical or financial outcomes of their medicines. 

The episode wraps up with additional thoughts about what is ahead for patient access and Dave shares his “prescription for better access.” 

Timestamps: 

1:14 - Introduction to this new podcast co-hosted by Dr. Scott Howell and Mark Hansan. 
2:07 - David Moules introduces himself and gives an overview of his background. 
5:51 - Major challenges and positive changes in patient access. 
8:41 - Dave’s experience with the renewal season. 
10:38 - Dave’s perspective on drug pricing in relation to patient access. 
14:43 - Rebates that stand out. 
18:00 - Tipping point for manufacturers. 
21:01- Role of the private market. 
26:04- How a tradeoff could play out this next year. 
36:56- Feedback from payers. 
34:54- Dave compares and contrasts his experience to the marketplace. 
41:16- What do you see ahead for patient access? 
42:28- What’s your prescription for better access? 
46:52- Closing remarks. 

Links: 

Learn more about our special guest, David Moules.
Contact email: dave@entityrisk.com. 
Learn more about Entity Risk. 
IRA Impact On Prescription Drugs
2021 Health Affairs Study
American Patients First Report from HHS.gov
ICER Study on Gene Therapy for Hemophilia A and B

Learn more about your hosts Dr. Scott Howell and Mark Hansan. 

Comments or suggestions for Mark or Scott: comments@prescriptionforbetteraccess.com