The Supreme Court denied to fast track consideration of ACA constitutionality.

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Jan. 24, 2020

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FEATURED STORY
 

Unequal to the Task (This Year): ACA Denied Fast Track

 
 

On Tuesday, the Supreme Court denied to fast track the consideration of the constitutionality of the Affordable Care Act (ACA), delaying the decision on the fate of the 10-year-old health law until after the 2020 election.

District Court Judge Reed O’Connor originally ruled the ACA’s individual mandate was unconstitutional since it can no longer be considered a tax. A 3-judge panel of the Fifth Circuit Court of Appeals agreed but declined to decide on whether the rest of the law should go down with the mandate. On January 3, Attorneys General from 20 Democratic states filed a motion requesting the Supreme Court to fast track the case challenging the legality of ACA in its entirety. The purpose of the fast track would be to add certainty to the ACA marketplace and to the 2020 election talking points.

Providing no reason for not taking the case, the Supreme Court decided instead that the District Court should decide whether the mandate could be severed from the rest of the health law before the case is heard at the Supreme Court level. Sending the case back to lower courts is expected to add years to the proceedings. For now, the ACA remains in place—which isn’t such a bad thing because there is no replacement plan yet. (See Heard on the Street below.)

 
 

Have Questions on the Impact of AMCP Format v4.1?
Xcenda Has Answers.

 
 

The Academy of Managed Care Pharmacy (AMCP) released its new Format for Formulary Submissions (Version 4.1). The Format provides updated guidance on the evidence and information exchange between industry and payers for unapproved products and for new indications under US Food and Drug Administration (FDA) review for approved products. It is anticipated these changes will impact the content manufacturers can share and the method by which they will provide this kind of preapproval information.

Xcenda and the FormularyDecisions team closely tracked the development of the new Format and are available to address questions and provide additional guidance surrounding these updates.

Turn to us to help align your organization’s information dissemination process with payers according to the new Format.

Contact us today >

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LEGISLATIVE UPDATE
 

Legislative Byte

 
 
  • Bipartisan Energy and Commerce Committee leaders requested information on lagging approvals for complex generic drugs, indicating that, “The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products.”

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THE VALUE CORNER
 

HYT > QALY?

 
 

On Tuesday, the National Pharmaceutical Council (NPC) published an interview with Sarah Wells Kocsis, MBA, Vice President of Public Policy for the Society for Women’s Health Research (SWHR), on the organization’s approach to and involvement in value assessment. Ms. Kocsis shared SWHR’s previous experiences with the Institute for Clinical and Economic Review (ICER) and provided suggestions for improving the value assessment process, such as being open to constructive feedback, accounting for patient diversity, and evaluating the specific factors relevant to women, including the ability to work and function.

In the January issue of Value in Health, an article written by Aleksandra Torbica, PhD, and colleagues describes a conceptual framework for the 36 Organisation for Economic Co-operation and Development (OECD) countries, which suggests that institutional context and, indirectly, social values may play a role in shaping the use of economic evaluation in healthcare decision making. Given these differences among countries, the authors conclude it is unlikely there will ever be a single, harmonious approach to economic evaluation.

Another article from the January issue of Value in Health presented a new metric for analyzing cost-effectiveness, termed “health years in total” (HYT), that overcomes both the specific distributional issue raised by the quality-adjusted life-year (QALY) measure and the efficiency challenges of the equal value of life (EVL) measure. The authors described how the HYT framework separates life expectancy changes and quality of life changes on an additive scale and concluded that HYT may be a viable alternative to the QALY and EVL.

If you need assistance with all things ICER or value-related, please contact Linnea Tennant.

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REGULATORY UPDATES
 

Remember When the TI Calculator Was Cool? AI and Drug Development

 
 

On Tuesday, the National Academy of Medicine (NAM) and the Government Accountability Office (GAO) released a joint report that explores the implication of artificial intelligence and machine learning (AI/ML) in healthcare. ML is a field of AI in which software utilizes data to perform a specific task and can increase the efficiency and effectiveness throughout the drug development process. This report aims to address challenges, such as lack of data and research gaps, through 6 policy options with the hope that these improvements make drugs accessible to patients more quickly.

The first part of the report, prepared by NAM, is titled, Artificial Intelligence in Health Care: the Hope, the Hype, the Promise, the Peril. The second part, prepared by the GAO, is a full presentation of the GAO’s technology assessment and is titled, Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning in Drug Development. According to the 2-part report, “Machine learning holds tremendous potential in drug development”; such technologies could cut down the current time of 10 to 15 years it takes to develop and bring a new drug to market. Moreover, researchers involved in drug discovery said infusion of ML technologies at the early stage of drug development could result in an estimated savings of between $300 million and $400 million per successful drug.

ML is being demonstrated in application to the first 3 steps of the drug development process: drug discovery, preclinical research, and clinical trials. However, some of the challenges that hinder the impact of ML in drug development include gaps in research, a shortage of high-quality data, costs and legal issues surrounding sharing data, a low supply of skilled and interdisciplinary workers, and uncertainty about potential regulation of ML used in drug development. In response to these challenges, the GAO developed the 6 policy options that focus on research, data access, standardization, human capital, regulatory certainty, and the status quo. Overall, the GAO recommends that policymakers should make several changes to the federal law, such as focusing more on funding basic research to obtain more data surrounding AI, creating a mechanism for sharing high-quality data, and having a consistent message regarding ML in drug development.

The report found that application of AI technologies could help identify new treatments, reduce failure rates in hospitals, and result in more efficient and effective drug development. By addressing the legal and policy challenges that surround AI, it may be more feasible to decrease the cost and time required to bring a greater number of new drugs to market.

 

Biased But Impressive $: MA Costs 40% < FFS Medicare

 
 

According to new research released by UnitedHealth Group, beneficiaries enrolled in Medicare Advantage (MA) plans typically spend nearly 40% less than beneficiaries in Medicare Fee-for-Service (FFS) programs. In addition to covering 6% more of the cost of hospital stays and physician office services than FFS, MA plans also can include Part D prescription drug coverage, caps on annual out-of-pocket costs, and care management programs. Read the report’s press release here.

The research, conducted by Milliman, found that the average annual healthcare costs for a 72-year-old MA beneficiary were $3,632 compared to $5,960 for an FFS beneficiary. Additionally, a typical MA beneficiary who also has Part D prescription drug coverage spends $1,477 less than FFS beneficiaries with Part D coverage. The research included data from the Centers for Medicare & Medicaid Services (CMS) on 2019 MA plan benefit design and premiums and from Milliman’s 2017 Part D consolidated database.

Additionally, the estimated total costs for a 65-year-old on Medicare over a 21-year period would be $214,992 on FFS vs $128,689 on MA. The analysis was based on average healthcare utilization among Medicare-eligible beneficiaries, with the most significant cost savings due in part to the supplemental benefits MA plan holders provide to beneficiaries and greater care coordination to lower unnecessary hospital and emergency department visits.

This research comes as insurers are making significant expansions into MA, allowing Medicare beneficiaries to use their benefit to purchase a private plan. As the healthcare system continues to shift toward value-based care, MA plans are trending to be an important component for reducing costs through the plans’ flexibility and innovation. Manufacturers will need to remain involved in discussions regarding the plan structure and cost savings associated with MA plans and future value-based care initiatives and to continue to push for a measure of outcomes in MA plans.

 

Information Buffet (AKA, Other Stuff That Caught Our Attention)

 
 

We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:

  • International Price Index (IPI) proposed rule release rumors are strong. Refresh your memory with a summary of the rule.
  • Pfizer announced it is introducing 3 new biosimilars, ZIRABEV (bevacizumab-bvzr), RUXIENCE (rituximab-pvvr), and TRAZIMERA (trastuzumab-qyyp), at substantial discounts to the reference products. Fifteen of the 26 FDA-approved biosimilars are now available in the US.
  • The American Society of Clinical Oncology released a policy brief on price transparency, providing an overview of the issues it views as complicating healthcare price transparency, society’s concerns about how the lack of price transparency in the healthcare system is impacting people with cancer, and how drug manufacturers, pharmacy benefit managers, and other stakeholders can be more transparent.
  • The American College of Physicians, the second-largest physician group in the US representing 159,000 internal medicine doctors, recommended that the country achieve universal coverage through 1 of 2 approaches: a single-payer system such as “Medicare for All,” or a publicly financed coverage option combined with regulated private insurance.
  • Kaiser Family Foundation research found that long-term care facility costs are the largest share of annual out-of-pocket spending by Medicare beneficiaries.


 

Embracing Format v4.1 for Early, Effective Exchange of Information With Payers

 
 

AMCP Webinar | Tuesday, January 28, 2020 | 2:00 PM ET

With the recent release of AMCP Format v4.1, what does it mean for the preapproval information exchange between payers and manufacturers?

Join Xcenda’s Evelyn Sarnes, PharmD, MPH, Vice President of Medical Communications, and other key stakeholders for a live webinar on January 28. Moderated by Elizabeth Sampsel, PharmD, MBA, BCPS, Senior Director of Payer, Provider, and Partner Alliances at Xcenda, the expert panel will give perspective and guidance on the early, effective exchange of information in light of these latest changes as well as highlight tools that can help in this endeavor.

Register today >

 
HEARD ON THE STREET
 

“There’s really not a need for a replacement of the Affordable Care Act unless and until there’s a final Supreme Court decision, [which would be] some time away.”

 – Health and Human Services Secretary Alex Azar, when asked about the status of the Administration’s replacement for the ACA

Source: Kevin Wall Radio, January 21

 
POLICY BY NUMBERS
 

52 | 3 | 8

 

Researchers searched the websites of 63 National Cancer Institute-designated cancer centers for the listed cost for simple intensity-modulated radiation therapy (IMRT) for prostate cancer and discovered the information was not consistent, or was missing altogether. While 52 centers, or 83%, published the cost, 3 (5%) did not list a cost for a simple IMRT, and 8 (13%) did not publish costs for any procedure.

Source: “Analysis of Price Transparency via National Cancer Institute-Designated Cancer Centers’ Chargemasters for Prostate Cancer Radiation Therapy,” JAMA Oncology, January 16

 
UPCOMING MEETINGS & CONFERENCES
 

AMCP Webinar: Embracing Format v4.1 for Early, Effective Exchange of Information With Payers

Tuesday, January 28, 2020 | 2:00 PM ET

With the recent release of AMCP Format v4.1, what does it mean for the preapproval information exchange between payers and manufacturers? Join Xcenda’s Evelyn Sarnes, PharmD, MPH, Vice President of Medical Communications, and other key stakeholders for a live webinar on January 28. Moderated by Elizabeth Sampsel, PharmD, MBA, BCPS, Senior Director of Payer, Provider, and Partner Alliances at Xcenda, the expert panel will give perspective and guidance on the early, effective exchange of information in light of these latest changes as well as highlight tools that can help in this endeavor. Learn more

 
 
 

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

 
 
 
 
 
FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Doug Cook
President | Commercialization Services & Animal Health

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda

CONTRIBUTING AUTHORS:

Maureen Holmes | Milda Kaitz | Aishani Patel | Scott Shields | Robin Tan

PRODUCTION:

Laurie Kozbelt | Ellen Olson

 

Jan. 24, 2020

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