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It is easy for those who are not health care professionals to overlook the tremendous potential for innovation in our field today. Similarly, anyone who is not a health policy wonk might not see the important ways policy is evolving to improve the delivery of care for millions of patients. Health care policy isn’t as flashy as cryptocurrency or other topics captivating Washington, but 2023 presents an array of opportunities and challenges that industry and policy makers can leverage to improve the health of our nation.
Susan Cantrell
Innovations in pharmaceutical research offer new, sometimes life-saving, treatments that demand new approaches to coverage and reimbursement. The Academy of Managed Care Pharmacy and its members are leading these discussions, helping facilitate policies and practices that give patients access to the medications they need at a price they can afford.
Here are important developments to consider as we look ahead to 2023:
Implementation of the inflation reduction act
On August 16, President Biden signed the Inflation Reduction Act (IRA) of 2022, a landmark bill with a significant impact on managed care pharmacy. AMCP supports aspects of this wide-ranging act and is reviewing additional components to understand where policy changes may have unintended downstream effects that could increase costs or create barriers to care for patients.
Importantly, IRA will enhance payments for biosimilars and extend expanded Affordable Care Act tax credits to help ensure coverage for millions of individuals and families. It will also delay the Rebate Rule. This last provision may sound like an arcane process point, but it will help ensure that, for the time being, health payers may continue using rebates to keep premiums lower for all patients. While AMCP is encouraged by these steps to preserve access to prescription drug coverage and expand the market for promising biosimilar therapies, more work remains.
Additional IRA provisions focus on drug pricing, namely the creation of a drug price negotiation program, inflationary rebates and a redesign of Medicare Part D. These are significant reforms, and it will take time to understand the impact of implementation. Key components like drug price negotiation will not be in effect until 2026. This may seem like an eternity, but the interim period gives organizations like AMCP a critical window to engage with the Centers for Medicare and Medicaid Services (CMS) to provide input to inform responsible implementation. Lowering seniors’ prescription drug costs is as popular as mom and apple pie, but the technical details of reforms require evidence and analysis to minimize downstream effects that may increase costs in other parts of the health care system or negatively impact innovation.
IRA’s biosimilars provision went into effect on October 1, 2022, and others kicked in on January 1, 2023. AMCP will monitor developments closely and seek opportunities to advance the conversation on key issues. Specifically, we will prioritize advocacy and communications around areas where policy can help overcome historic, systemic disparities to provide more equitable access to care. This is an important, evolving conversation among our membership and other communities in the health care ecosystem, and we are committed to advancing health equity.
PIE legislation
We aren’t talking apples anymore, but PIE (pre-approval information exchange) has been one of AMCP’s top legislative priorities since 2016.
Patient access to medications and treatments approved by the Food and Drug Administration can be delayed when health plans do not have access to critical data on the efficacy and costs surrounding the drug until after FDA approval.
To combat this, Rep. Brett Guthrie (R., Ky.), working with AMCP, introduced and built bipartisan support for the Pre-Approval Information Exchange (PIE) Act. At the time of writing this piece, Guthrie was working to pass the bill in 2022.
In the complex world of health policy, PIE offers a simple solution that would let payers conduct their rigorous review of new treatments alongside the FDA approval process. If enacted, PIE could mean the difference between life and death for many Americans by safely expediting the window in which payers review critical economic and clinical information from pharmaceutical manufacturers to determine how they will cover treatments for patients.
AMCP appreciates PIE’s bipartisan support and is optimistic it can become law to safely speed the delivery of life-saving medications to patients in need.
The promise of prescription digital therapeutics
Prescription digital therapeutics (PDTs) represent promising therapies in the health care product and policy pipelines. These software-based treatments can stand alone or work in combination with medications or other treatments to help patients prevent, treat and/or manage their disease while ensuring optimal health outcomes.
PDTs are unique from other digital health applications because they are prescribed by a health care provider and use software to deliver a clinical mechanism of action. Software applications without their own clinical action are not digital therapeutics. While the creation and adoption of PDTs has grown in recent years, coverage is still not widespread, due to questions about how to appropriately cover and reimburse for PDTs given their novel supply chain.
Help is on the way. Sens. Shelly Moore Capito (R., W.Va.) and Jeanne Shaheen (D., N.H.) along with Reps. Mike Thompson (D., Calif.) and Dave McKinley (R., W.Va.), introduced the bipartisan Access to Prescription Digital Therapeutics (PDTs) Act of 2022. The bill creates a benefit category to cover PDTs authorized by the FDA under Medicare and Medicaid. The legislation does not compel Medicare or Medicaid to cover PDTs but offers flexibility to do so if they are found to be clinically appropriate.
PDTs represent an evolving industry and policy space. AMCP members and others will play a critical role, providing real-world evidence that will help refine approaches to coverage and reimbursement. The Access to PDTs Act will help set us down the path toward developing a comprehensive, responsible strategy for this growing field of health tech. The bill sponsors began building a coalition of support during the last Congress, and AMCP is hopeful that the legislation will be passed during the 118th Congress, which began this month.
Building broader biosimilar adoption
Biosimilar and biologic products represent another innovative and promising field within managed care pharmacy, and 2023 will be an important year for biosimilars. While not a perfect analogy, biosimilars are the biologic equivalent of generic small-molecule drugs. Increased adoption of biosimilars will be critical to our nation’s health as it provides affordable access to life-saving medications and encourages innovation and competition within the industry that can decrease costs. The FDA has approved 39 biosimilars, 22 of which are available to patients today.
This year we expect biosimilars to expand into their own pharmacy benefit category, allowing them to be adopted in more therapeutic classes and increasing the development of more interchangeable biologics. Interchangeable products can be substituted for treatment without new action by the doctor prescribing the reference product. This is like how generic drugs are routinely interchanged for brand-name drugs. This substitution happens at the pharmacy level and is subject to state pharmacy laws.
To realize the promise of biosimilars, we must promote real-world evidence and make a compelling case for the value of interchangeability with regulators. We must simultaneously focus on educating patients and health care providers on the safety and benefit of these new medications. While this work takes time, it’s encouraging to see momentum building for broader adoption, and AMCP members look forward to helping support this effort.
Seizing the opportunity of 2023
As you can see, 2023 has the potential to shift the health care landscape in monumental and beneficial ways. By advancing smart policies with clear purpose, we can help reduce out-of-pocket medication costs, gain swifter access to potentially life-saving treatments, and leverage new digital technologies and advances in biosimilar medicine to manage patient health. Health care policy may not always grab top headlines on news outlets, but there is a steady pipeline of work under way that has the potential to greatly improve access and quality of care across America. AMCP is excited to advocate on behalf of its members to inform this work and help improve the lives of patients everywhere.
Susan Cantrell is the CEO, Academy of Managed Care Pharmacy.
