Asembia 2023: Expectations and Policy Impacts for Specialty Therapies

Asembia 2023: Day 1, Session 1

Presenter: Ray Tancredi, divisional vice president, Walgreens

Summary: What was discussed

This presentation looked at recently approved specialty therapies and medicines currently in development — including oncology, cell and gene and rare and orphan.

Topics discussed included analysis of the drug pipeline, including the growth in biosimilars, as well as pricing expectations and their impact on patient access and affordability.

Key takeaways

Tancredi discussed drugs in the Food & Drug Administration (FDA) review and approval pipeline that could have the biggest impact on the healthcare ecosystem.

Tancredi also addressed themes that are changing the specialty landscape, such as breakthrough, accelerated and fast-track designations from the FDA. He also discussed how cell and gene therapies are emerging as important areas in the pharmaceutical industry, with numerous products in development.

He said these innovative treatments have the potential to revolutionize the way certain diseases are treated and managed.

"We look at what is the innovation that is coming,” Tancredi said. “It is the digital experience.”

The industry call to action

Greater Provider Awareness

Healthcare providers need visibility into the availability of new therapies, reimbursement policies and administration procedures to best help patients start and stay on prescribed therapies, Tancredi said.

Nimble Commercialization Strategies

Tancredi suggested that pharma needs medication access solutions that are highly configurable based on the specific therapeutic area, disease state and patient population. The strongest solutions, he said, will also consider the entire patient, such as relevant socioeconomic factors, education requirements, care team composition and optimal visibility across the care continuum.

“When you think about that many drugs coming to the market, there’s going to be a lot of capabilities required, a lot of education necessary, and frankly, really an intense focus on the cell and gene products,” Tancredi said.

Asembia 2023: Day 1, Session 2

Presenters: Omar Hafez, managing director, Avalere; Matt Kazan, managing director, Avalere; Kelsey Lang, principal, Avalere

Summary: What was discussed

Perhaps the hottest topic of conversation among pharma leaders was the Inflation Reduction Act (IRA). From provisions that impact pricing to stipulations on what patients are expected to pay for their medication, the legislation is packed with changes the industry may need to contend with.

While IRA inflation rebates and drug-price negotiation will impact drug-launch prices in Medicare, there will likely be spillover effects in Medicaid and commercial markets, presenters warned.

The industry’s recent response to the IRA’s limits on Part D cost sharing for insulin of $35 per month is an example of potential impacts beyond government plans.

Presenters called out that while many components of the IRA are prescriptive and clearly defined, there are also many that require clarification and guidance from the Department of Health and Human Services (HHS).

Among them is the list of drugs subject to the IRA’s provisions. That list will be released in September 2023. While the industry awaits instruction, speculation grows over how the provisions will shape the pricing, access and reimbursement landscape — as well as research and development (R&D) and innovation investment.

Key takeaways

The Effects of Negotiation

The IRA’s negotiation program accelerates the lifecycle of Part B and Part D products. This means a pharma brand’s net revenue may decline substantially after negotiation.

The effect could be a condensed timeframe for pharma brands to create ROI and may lead to increased launch prices as brands prepare for eventual price reductions.

Inflation Rebates

The spillover effects of the Medicare inflation rebate provisions into commercial markets will likely depend on the target patient populations for a given drug.

The mechanics at play in negotiations with the government may incentivize manufacturers to raise net prices. Downstream impacts could cause pharma brands, health plans and pharmacy benefit managers to revisit rebate designs.

Part D Redesign

The IRA restructured the Part D benefit to include a $2,000 out-of-pocket spending cap, a new manufacturer discount program across coverage phases and an increase in plan liability.

The Impact on Biosimilars

The IRA raises questions about the value for generic and biosimilar drugs, as Medicare is already negotiating to a lower price and negotiation shortens the lifecycle of branded products.

The industry call to action

Balancing Innovation, Access and Cost

Data collection and evidence generation requirements for negotiation may also affect launch-price decision-making. When a product is selected for negotiation, CMS could require several data points about pricing throughout a product’s lifecycle.

“Currently, there is no single supplier in the supply chain that has all the data elements needed for that to happen, and that is going to be a bit of a challenge,” said Omar Hafez, managing director, Avalere.

Protecting Patient Access

Kazan said that the IRA, when fully implemented, is likely to impact drug pricing — although to what extent remains to be seen. This could have implications for patient access, with measures to help ensure affordability, particularly for commercially insured patients, a key consideration for pharma.

While patients may be less in the weeds on IRA policy, pricing is still top of mind. In a recent survey conducted by CoverMyMeds, patients selected cost as the second most important factor when it comes to their prescription — only behind treatment effectiveness.^[2]CoverMyMeds Patient Survey, 2022

“If this is something that is going to help patients in terms of how they pay for their drugs, you might see an increase in adherence and utilization,” Hafez said. “But the other thing (for plans) is that this is going to cause an operational burden that did not exist before.”

Asembia 2023: Day 1, Session 3

Presenter: Luke Greenwalt, vice president, market access, IQVIA

Summary: What was discussed

When it comes to the dynamics between patients, payers and pharma, all are in constant tango. Decisions from one entity impact the other and could put a squeeze on patients seeking to access life-changing medication.

Greenwalt analyzed trends in the pharmaceutical industry, outlined how policy changes are altering the cost of medication access and discussed the importance of continued innovation.

Greenwalt also discussed key industry issues driving change and strategies to help manage through the complexities.

Key takeaways

Accelerated Margin Compression

Greenwalt said the pharmaceutical industry is experiencing significant margin compression, with discounts increasing in the last decade.

As some manufacturers may struggle to adapt, they are reducing their spending on sales, general and administrative expenses (SG&A) and profits, while maintaining their R&D investments.

Despite these challenges, Greenwalt remained optimistic about the industry’s ability to innovate and adapt moving forward, highlighting the importance of understanding these trends and preparing for future changes.

Rapidly Changing Launch Dynamics

The dynamics of pharmaceutical product launches are changing rapidly, with day one evidence and strategic finance becoming more critical than ever before.

Greenwalt highlighted the increasing difficulty of successful product launches, noting that recent launch brands are five times as likely to fail to hit $10 million in the first year of sales.

Greenwalt reminded the audience that “launch is no longer 12 to 18 months. It is now 18 to 36 months. That means that that access and uptake is taking longer.” He also emphasized the importance of updating payer control and patient behavior analytics to ensure success in the changing launch environment.

“The No. 1 reason we see brands miss today is because they have been incorrect in their market sizing because of payer control,” Greenwalt said.

Accelerated Policy Changes are Impacting Patient Access

As policy changes in the pharmaceutical industry accelerate, they are having a significant impact on patient access to medications. Key policy changes such as the IRA, Part D redesign and inflation rebates represent new margin challenges for the industry.

“What is going to happen over the next decade is going to make this past decade look very, very different,” Greenwalt said. “We have to be prepared for that.”

The industry call to action

Strategic Investments in Support for Patients

Patients will need increasing levels of help to access and stay on their prescribed medication, Greenwalt said. Affordability options, like copay savings cards, and hub programs that guide patients through the complicated access environment may play a more paramount role following diagnosis and treatment decision.

Planning for Outcomes-based Measurement

Greenwalt suggested that patient engagement and adherence solutions, especially those that can provide outcomes-based measurement, will also be critical for pharma to prove and defend the value of a therapy.

“Patient service programs are so critically important,” Greenwalt said. “Intervention early in that journey has a significant impact on the patient’s ability to get and stay on prescription treatment.”

CoverMyMeds looks forward to sharing another update Wednesday with a recap of select sessions from Tuesday. Sign up to stay up to date on the next AXS23 recap.