No one has ever described the pharma market access landscape as simple or easy to understand, and the passage of the Inflation Reduction Act (IRA) is not likely to change that.
“Quantifying the Impact of the IRA is a challenge. Most immediately, it will add confusion in the healthcare space,” explains Daniel Sontupe, Associate Partner, Managing Director, The Bloc Value Builders. “Pharma, formulary decision-makers, and contracting specialists must now track exact dates when drugs became available, then track the difference between average sales price (ASP) and Maximum Fair Price (MFP) to ensure provider reimbursement is correct.”
One of the big changes under the IRA is it will grant Medicare the ability to negotiate the cost for a selection of drugs covered under Medicare Part D and Part B. The reason that tracking dates will become important is small-molecule drugs that are less than 9 years from their approval date and biological products that are less than 13 years from their approval date will be excluded from the negotiation process. However, Medicare will only be able to negotiate prices for 10 Part D drugs in 2026, another 15 Part D drugs in 2027, another 15 Part D and Part B drugs in 2028, and another 20 Part D and Part B drugs for 2029 and subsequent years.
Considering Medicare Part B covers drugs that are administered by physicians, Jon Bambalas, SVP, Business Development & Client Management, Precision Value & Health, predicts this could impact doctors’ perceptions of certain drugs.
“This will create confusion in the marketplace and may possibly lead to delivery of misinformation to healthcare providers (HCPs) regarding a brand’s drug coverage,” Bambalas says. “Pharma manufacturers of brands that are selected for negotiation will absolutely want to ‘pull through’ their coveted, newfound formulary position with HCPs. Additionally, manufacturers of brands not selected for negotiation in the same therapeutic area will still want to promote their patient accessibility on Medicare and commercial plans. As a result, it will be more important than ever to deliver specific market access formulary information that is representative of what plans the HCP’s patients have.”
Impact Beyond Medicare
The IRA won’t just impact negotiation with the government either. Wyatt Gotbetter, SVP and Worldwide Head, Access Consulting, Parexel, believes pharma will also need to shift their strategies with commercial payers as a result.
“Aggressive rebate contracting with commercial payers is expected to increase in order to reduce exposure to Medicare sales and offset potential Medicare discounts,” Gotbetter explains. “However, in anticipation of this, near-term rebating practices are also attracting more legislative activity. And as scrutiny on any price increase beyond inflation continues to intensify, the ability to raise prices that is not supported by underlying evidence will become increasingly challenging.”
Pharma market access teams will also need to prepare as payers in general may look to reevaluate their priorities and tactics, according to Christine Lenthe, President, Evoke Navience.
“Payers will be looking more critically at their budgets and assessing strategies that maximize value and minimize cost,” Lenthe says. “The pressure to deliver a meaningful value proposition inclusive of cost effectiveness or cost offset analyses will be more important than ever. Additionally, payers are likely to exhibit more aggressive utilization management tactics such as generic or biosimilar first, drug exclusions, or sites of care policies. Understanding and interpreting access restrictions and the true downstream impact will inform manufacturer market access and contracting teams in negotiations.”
Looking more long-term, Sontupe hopes the IRA will lead to some “long overdue change” in how this country perceives healthcare.
“It’s amazing we still separate the drug costs from overall healthcare costs,” Sontupe says. “Our hope is the IRA and any future healthcare cost provisions force organizations to look at overall healthcare costs and the impact to Quality Adjusted Life Years—not simply getting cheaper drugs. If all society wants is less expensive drugs, what we’ll achieve is less healthcare value.”
A Greater Focus on Health Equity
The IRA is not the only change that market access teams will need to deal with. Centers for Medicare & Medicaid Services (CMS) is also asking payers to start gathering data on social determinants of health (SDoH) to identify better ways to address healthcare disparities. For 2023, payers are required to report on the Social Need Screening and Intervention (SNS-E) HEDIS measure.
“Although pharma companies are developing revolutionary therapies to address chronic disease, access to those products as well as the desired outcomes are not equitably distributed among the U.S. population,” explains Cynthia Miller, MD, MPH, FACP, VP – Access Experience Team, Precision Value & Health. “For example, in patients with diabetes, we now realize that GLP-1 and SGLT-2 medications have cardiovascular and renal benefits; however, utilization of these potentially life-changing medications remains low. A recent VA study showed that disparities in prescribing existed at the facility level and that non-Hispanic whites are more likely to receive GLP-1 and SGLT-2s than other groups.1 Therefore, SDoH, such as location and race, may play a role in clinical inertia.”
This means that payers will need innovative programs to address these disparities and help to improve outcomes in vulnerable populations while also lowering costs. That is where pharma companies come in.
“Pharma manufacturers must consider market access from a whole new perspective, addressing the key SDoH such as socioeconomic status, where you live, education, and access to nutrition and healthcare,” says Casey McCann, Executive Director, Value, Access, and Reimbursement Strategy, Klick Health. “Patient support programs (PSPs) that used to be simple logistical hubs have now morphed into full ‘CRM’ programs that prioritize the patient and HCP experience—part of the face of the brand. Pharma manufacturers now need to consider how to adjust marketing budgets and PSP offerings to support the whole patient on their entire treatment journey, rather than only factoring for their product.”
Overall, McCann says manufacturers and payers will have to work more closely together to achieve their shared goals of driving costs down and improving outcomes.
“With these changes (and many more to come), we believe that life sciences companies must be laser-focused on truly meaningful engagements with key stakeholders, understanding how each views value,” McCann adds. “Pharma has the unique opportunity to become a guiding partner through the patient journey, especially for patient populations, which have been historically underserved.”
1. Mahtta D, Ramsey DJ, Lee MT, et al. “Utilization Rates of SGLT2 Inhibitors and GLP-1 Receptor Agonists and Their Facility-level Variation Among Patients with Atherosclerotic Cardiovascular Disease and Type 2 Diabetes: Insights from the Department of Veterans Affairs.” Diabetes Care. 2022;45(2):372-380.