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We examine the President’s priorities for “innovation” on prescription drug pricing.

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Feb. 23, 2018

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FEATURED STORY
 

White House Hat Trick on Drug Pricing

 
 

On Wednesday, White House economists unveiled their first “Economic Report of the President.” The report presents a highly optimistic view of the economy’s current condition and future course, consistent with the Administration’s tone and tenor over the past year.

The report touches on a number of priorities President Trump has to spur economic growth, including infrastructure and energy, trade and the international sphere, intellectual property, cybersecurity, and innovation.

The “innovation” priority includes prescription drug pricing, which is the third time the Administration has written about the topic this month. In last week’s Health Policy Weekly, we wrote about the Council of Economic Advisers (CEA) white paper and the President’s fiscal year 2019 budget request. The drug pricing sections in the economic report are largely reworked from the CEA white paper, including:

  • Changes to the Medicare and Medicaid programs
  • Pharmacy benefit manager (PBM) market concentration and lack of transparency
  • Free-riding by foreign countries that centralize pricing
  • Lengthy clinical trials and Food and Drug Administration (FDA) review times
  • Faster generic approval processes

What we said last week for the white paper holds true for this week’s economic report: while it contains ideas that could give healthcare stakeholders a panic attack, it is aspirational and not yet in motion. Importantly, however, the drug pricing proposal trifecta gives a sense of potential priorities for the Administration.

 

340B Changes: What Biosimilar Manufacturers Need to Know

 
 

Federal reimbursement is one of many complex topics that surround biosimilars in the US. One reimbursement program—Medicare’s 340B pricing program—will be critical for biosimilar manufacturers.

Xcenda’s Amanda Forys, Senior Director of Reimbursement Policy Insights, speaks with The Center of Biosimilars and discusses what manufacturers need to know under the latest version of the program. Learn more

 

 

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REGULATORY UPDATES
 

Proposed Rule Out of the Gates, Downhill to a Medal or a Crash?

 
 

Prompted by President Trump’s Healthcare for All executive order, the departments of Health and Human Services (HHS), Labor, and Treasury proposed a rule on Tuesday to expand the availability of short-term, limited-duration insurance. These changes would increase the maximum duration of this coverage from less than 3 months to less than 12.

Short-term, limited-duration insurance aims to provide coverage when an individual is transitioning from one plan or coverage to another. As a result of the rule change, the Centers for Medicare & Medicaid Services (CMS) projects that 100,000 to 200,000 individuals will switch to these short-term plans from Affordable Care Act (ACA)-compliant plans in 2019.

This type of coverage is exempt from ACA requirements that apply to individual health insurance—for example, the mandate to cover essential health benefits, the prohibition on charging sick people more than healthy people, and denying people coverage based on their medical history.

The comment period for the proposed rule will remain open for 60 days. While supporters of the change are promoting it as an opportunity to expand access to more affordable options and provide relief from higher premiums, opponents see this as another attempt by the current Administration to deliver a blow to the ACA in light of failed repeal efforts.

 

ICER Delivers CAR-T to the Button

 
 

The Institute for Clinical and Economic Review (ICER) recently published its updated evidence report on the effectiveness and value of chimeric antigen receptor T-cell (CAR-T) therapies for B-cell malignancies. A draft evidence report was published in December 2017; this version incorporated comments received from manufacturers, clinical societies and experts, and patient and patient advocacy organizations. Similar to the December findings, this report found the 2 CAR-T therapies, KYMRIAH™ (tisagenlecleucel) and YESCARTA™ (axicabtagene ciloleucel): 1) improved response rates and survival for patients who have exhausted most other treatment options; and 2) are priced in alignment with their clinical value.

In addition to the rigorous review of clinical benefits and cost evaluation, the report also included insights from patient-centric groups, coverage policies, clinical guidelines, and value-based price benchmarks. The coverage-policy analysis included a public- and private-payer policy search and synopsis of policies found for Aetna, Humana, and UHC, including coverage requirements, exclusions, and that prior authorization is required.

CAR-T therapies voting questions, along with ICER’s response to comments, were also released at the same time. On March 2, there will be an evidence discussion with key stakeholders hosted by the California Technology Assessment Forum in Oakland, CA. To attend the event in person, register here, or register to view the live webcast here.

Even though the report’s findings indicate CAR-T therapies’ prices are aligned with their value, commercial payers still face the reality that they will likely not see the downstream benefit of the therapy; however, given the small patient population, the budgetary impact is likely to be much less than that of cheaper treatments for more common diseases.

 

Express Scripts and Walgreens Twizzle Into New Partnership

 
 

On Tuesday, Walgreens Boots Alliance and Express Scripts announced their intention to expand their procurement of specialty pharmaceuticals through a group-purchasing arrangement which, they believe, could result in lower medication costs and enhanced patient access to lifesaving therapies. The products will be sourced by ValoremRx Specialty Solutions to simplify the global supply chain.

Pointedly, Express Scripts mentioned that biosimilars would be included in the new purchasing agreement. The PBM has long been extolling the savings potential of biosimilars and stated the US could save $250 billion over 10 years if biosimilars were more available.

As consolidation continues across the healthcare sector, the deeper Walgreens-Express Scripts alliance may provide a business blueprint for other pharmaceutical conglomerates to follow as projections for specialty drug spending continue to increase exponentially over the next decade and beyond.

 

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:

 

CBI 10th HUB and SPP Model Optimization Conference

 
 

February 27–28 l Philadelphia, PA

Join Lash Group at CBI’s 10th Annual HUB and SPP Model Optimization Conference in Philadelphia on February 27–28.

Mark Spykerman, Senior Vice President at Lash Group, will present a session titled, “Implement New Technology Innovations to Improve Speed, Scale, and Patient and Provider Experience for Electronic Benefit Verification and Prior Authorization” on February 28 at 11:45 AM ET.  Learn more

 

 

 
HEARD ON THE STREET
 

“It doesn’t make any sense to spend any energy right now at the federal level. There is a logjam that’s not going to get broken before 2020.

 

– Andy Slavitt, Board Chair of United States of Care and former CMS Acting Administrator, commenting on how he had no illusions about overcoming the political or ideological barriers to universal coverage in Congress or the White House

Source: “Why the Nation’s Premier Health Care Wonk Has Given Up On Congress,” Huffington Post, February 19

 
POLICY BY NUMBERS
 

64.1%

 

The top 6 dispensing pharmacies—CVS Health, Walgreens Boots Alliance, Express Scripts, OptumRx (UnitedHealth), Walmart, and Rite Aid—accounted for nearly two-thirds of US prescription dispensing revenues in 2017.

Source: “The Top 15 US Pharmacies of 2017: Market Shares and Key Developments for the Biggest Companies,” Drug Channels, February 21

 
UPCOMING MEETINGS & CONFERENCES
 

CBI 10th HUB and SPP Model Optimization Conference

February 27–28 l Philadelphia, PA
Join AmerisourceBergen sister company Lash Group at CBI’s 10th Annual HUB and SPP Model Optimization Conference in Philadelphia. Mark Spykerman, Senior Vice President, Lash Group, will present a session titled, “Implement New Technology Innovations to Improve Speed, Scale, and Patient and Provider Experience for Electronic Benefit Verification and Prior Authorization.” Learn more

 

CBI 19th Patient Assistance and Access Programs Conference

March 6–7 l Baltimore, MD
Join leaders from Xcenda and Lash Group at the 19th PAP Conference in Baltimore. Ana Stojanovska, Vice President, Reimbursement & Policy Insights, and Teri’ Burnell, PharmD, Senior Vice President, Field Support at Xcenda, will host the Opening Luminary Address on “The Changing Landscape of Healthcare Coverage and Access.” Tommy Bramley, PhD, President of Lash Group, will present the Keynote Address on “Pioneering to New Grounds in Patient Access—Rewriting the Playbook for Patient Programs.” Learn more

 

AMCP Managed Care & Specialty Pharmacy Annual Meeting

April 23–26 l Boston, MA
Join AmerisourceBergen companies, US Bioservices and Xcenda, at AMCP’s Annual Meeting at the Boston Convention and Exhibition Center April 23–26. Meet with our specialty pharmacy and commercialization experts at the largest gathering of managed care professionals who work, lead, and innovate in the ever-changing world of pharmaceutical management. Visit AmerisourceBergen at booths 316 and 321. Learn more

 

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

 
 
 
 

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FEATURED CONTRIBUTORS
 

EDITOR-IN-CHIEF:
Jennifer Snow
Senior Director,
Health Policy
Xcenda

MANAGING EDITOR:
Scott Shields
Associate Director,
Health Policy
Xcenda

 

ADVISORY BOARD:

Peyton Howell, MHA
Executive Vice President & President, Health Systems & Specialty Care Solutions | AmerisourceBergen Corporation

Amy Grogg, PharmD
Senior Vice President | Strategy & Commercialization | AmerisourceBergen Corporation

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 | Reimbursement & Policy Insights | Xcenda

CONTRIBUTING AUTHORS:

Andrew Gaiser | Darren Jensen | Scott Shields | Diane Smith

PRODUCTION:

Laurie Kozbelt | Ellen Olson

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Feb. 23, 2018

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