The drug pricing reforms introduced by the Inflation Reduction Act of 2022 (IRA) are expected to significantly impact pharmaceutical companies’ revenues and profitability. The IRA requires the US Department of Health and Human Services to negotiate drug prices, introduces penalties for drug price increases greater than inflation, and makes manufacturers responsible for 20% of catastrophic care costs for Part D patients whose spending exceeds the $2,000 out-of-pocket (OOP) cap.
The USC Schaeffer Center for Health Policy and Economics reports that “taken together, these provisions have been estimated to lead to an approximately 31% decrease in US pharmaceutical revenues through 2039 and result in 135 fewer new drug approvals.” Similarly, an analysis from 5POINT10 predicts a more than 20% hit to the operating income of global biopharma (even more in the US).
Despite the challenges created by the IRA, brand leaders must keep their focus on the day-to-day work of helping patients access—and pay for—their medications. So, what does the IRA mean for patient access leaders, pharma brand managers, and patient service owners? I recently moderated a panel on the topic with three industry experts whose insights I’m sharing here.
Commercial perspective on IRA impact
According to Sarah Butler, chief commercial officer at ADVI Health, four key areas will be affected, and manufacturers will need to adjust their strategies going forward.
1. Indication sequencing
Pre-IRA, the market incentivized biopharma companies to launch a drug first in a smaller population, such as rare disease, because they could continue to earn revenue on the drug while conducting ongoing R&D to expand to additional indications. Now, companies have to make difficult decisions to choose which indication is launched first because once the molecule is on the market, the clock starts ticking to be selected for IRA negotiation.
2. Launch price planning
Because manufacturers need to consider how to delay getting on the list as much as possible, looking at volume projections is more important than ever. Even with a medium- or lower-priced drug, if the volume is high, the drug can appear on the IRA negotiation list sooner than you might think. Market dynamics and the competitive environment also play a crucial role. For example, GLP-1s launched this year in weight loss and have completely impacted the order of drugs on the IRA negotiation list. Paying attention to those market dynamics while preparing for launch is critical.
3. Where to launch first?
Manufacturers are likely to launch new drugs in Europe or Asia first in order to develop the drug, conduct additional studies, and prepare to file for the indication that will have the greatest impact in the US. Restricting drug access in the US to potentially groundbreaking drugs is likely to cause a backlash among patient advocacy groups and other healthcare stakeholders.
In addition to changes in launch strategy that are likely to happen as a result of the IRA, brands are likely to face hard decisions around adjustments to copay assistance programs, hub eligibility criteria, the amount of free product they’re able to offer and where they go overall with the brand in order to continue providing support to patients who need it.
4. R&D investments
Data points to a potential reduction of as much as 40% in the number of FDA-approved drugs over the next 10 years—up to 139 therapies—as a result of the IRA. Some manufacturers may consolidate resources around fewer products and lower investments, while others could pursue assets they might not otherwise approve, and some may discontinue trials. Alexion, for example, has gone on the record and publicly discussed delaying some investments in R&D.
Manufacturers are also beginning to change their organizational structures and adjust engagement strategies to respond to IRA negotiation and create more alignment with their global pricing colleagues. Teams focused on government are getting larger.
Once the negotiated prices are announced in September before taking effect in 2025, the spillover effect on the commercial market will be significant, particularly with Part D, where pricing designs will likely become even more complex. It is important for manufacturers to know their places on the list and use projections to avoid any surprises in terms of submitting evidence packages to the Centers for Medicare & Medicaid Services.
Patient education is key
When new laws directly impact patients, it is critical to educate them about how these regulations will affect their medication journey.
“It’s all about getting the information out to the patient, explaining it to them in ways they can understand it, and meeting them where they are—and not just the patient, but of course, caregivers as well,” said Richard Fahrer, oncology marketing director, patient solutions, at Pfizer.
Copay smoothing is one area Part D patients are likely to need help understanding. Designed to put a $2,000 OOP cap on medications and spread patient costs evenly over the course of the year to make monthly costs more predictable, guidance on this is evolving and still being released.
“For patients to be able to take advantage of the program, they need to understand how it works, how to enroll, and how to smooth out that copay,” noted Fahrer. “They’re also going to need to make sure they make their payments on time, because if they opt-in to copay smoothing and then miss payments, they risk being dropped from the program and expected to pay a lump sum.” Interestingly, in a post-webinar conversation with an attendee, Fahrer learned that at least one independent patient assistance charity is suggesting that patients who expect to gain charitable support should not sign up for smoothing as it could disrupt the charity’s qualification and approval processes.
Making that information available to both patients and caregivers, in multiple languages wherever possible, and also educating prescribing physicians, practice managers, reimbursement specialists, and other patient advocates—as well as internally within the pharma manufacturer—is also critical.
In addition, hub services vendors have an opportunity to act as an intermediary to enroll patients in the copay smoothing program “because that’s going to be a little bit tricky in 2025,” explains Butler. Since patients aren’t able to enroll at the pharmacy counter and need to do so via paper, phone, or online application, the process needs to be as easy as possible.
How will payers react?
Payers are poised to buckle down and do all they can to shrink their risk around the IRA impact. According to Don Sawyer, senior vice president of market access at Stemline Therapeutics, “The negotiations are going to get much more extreme and they’re going to leverage everything they possibly can do.
In the absence of information, payers “are going to backstop themselves, and who’s going to be there to backstop them is who has always been there to backstop them, the manufacturers,” added Sawyer. Payers are also likely to raise premiums, potentially reduce the number of Part D options, and use a more restrictive benefit design with existing plans.
In anticipation of the IRA and expected reduction in hub, patient assistance programs, and affordability program budgets, manufacturers should be looking to streamline their patient support operations. Leveraging artificial intelligence, electronic benefit verifications, more sophisticated benefits support, and blended staffing models all can help brands do more with less without shortchanging patients.
About the Author
Chris Dowd is Senior Vice President, Market Development, at ConnectiveRx.