The Department of Health & Human Services (HHS) keeps signaling that it wants to move us toward a world without rebates. Right now, it is evaluating comments on its proposal to remove rebates from federal programs. HHS wants to implement this rule in time for the January 1 start of the 2020 Medicare Part D plan year.

I would like, if I may, to take you on a journey through the 2019 regulatory timeline for both Part D and the proposed rule. As you will see, there is still a viable—but narrow—window for regulatory reform of rebates.

Despite our assessment, you should know that in the Medicare program, there are many implementation and logistical challenges in shifting rapidly toward a world without rebates. I outlined some of these issues in last Friday’s webinar: Preparing for a World Without Rebates. Don’t worry if you missed the live event. You can watch a replay and download the complete slide deck. CLICK HERE TO WATCH THE REPLAY.

In the meantime, read on for our look at the rest of 2019. I can see you shiver with antici…pation.

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Rare Disease Innovation and Partnering Summit

June 13-14, 2019 | Boston, MA

www.raredisease-summit.com

As genomics and advanced diagnostics expand our understanding of rare diseases, so too does the scope of impact expand. More than 30 million Americans live with a rare disease. While the industry has seen growth and heightened focus around the pursuit of orphan products and rare therapies, we’ve only scratched the surface.

CBI and EBD Group, along with support from the Alliance for Regenerative Medicine, Global Genes and MassBio, are pleased to announce the Rare Disease Innovation and Partnering Summit, a platform designed to increase chances of therapeutic success for drug developers, patient groups and investors within the rare disease marketplace. Business brings breakthroughs. Breakthroughs can transform lives.

Visit www.raredisease-summit.com for further details and to register. Drug Channels readers will save $300 off the standard rate when they use discount code SFK676 and register prior to May 10th.*

Take a deep dive into the critical and evolving topics impacting you today and hear from industry thought leaders and patient advocates who have designed and led innovative approaches to complex challenges in driving curative progress.

You can download the complete agenda here. Take a look inside:

Real Life Case Examples:

• Develop New Models for Patient-Centric Registries – Parent Project Muscular Dystrophy
• Leverage Novel Collaborations in Orphan Drug Commercialization – Notable Labs and Cures Within Reach
• Mapping the Patient and Caregiver Journey – An Insights-Driven Approach to Building the Foundation of Patient Identification and Services – Rhythm Pharmaceuticals

PLUS! FDA Perspectives:

• Regulatory and Policy Update – Legislative Updates and New Initiatives within the FDA’s Orphan Drug Program
  
  Featuring: Janet Maynard, MD, MHS, Director, Office of Orphan Products Development, FDA, Samir Shaikh, Deputy Director of Patient Affairs Staff, Office of Medical Products and Tobacco, FDA, Martine Zimmerman, Global Head, Regulatory Affairs, Alexion and John Hallinan, Chief Business Officer, Massachusetts Biotechnology Council

And! Benefit from Four Impactful Tracks:

• Patient-Driven Progress
• Reimbursement & Access
• New Launch & Commercialization
• Partnering & Investment

Additional perspectives and insight from 50+ leaders at companies such as Aegerion Pharmaceuticals, Alliance for Regenerative Medicine, Asklepios BioPharmaceuticals, Athersys, Bexion Pharmaceuticals, BioMarin, bluebird bio, Blueprint Medicines, Boston Children’s Hospital, Cotinga Pharmaceuticals, Cure CMT4J, Cydan II Inc., EveryLife Foundation for Rare Diseases, Geisinger, Global Genes, Horizon Pharma, Intercept Pharmaceuticals, Jackson Lab, Massachusetts General Hospital, MDA, Pfizer, Rare Access Action Project, Recordati Rare Diseases, Recursion Pharmaceutical, Sobi, Syros Pharmaceuticals, Tufts University School of Medicine, Xontogeny and more. Mark this as a must-attend event in 2019. Don’t miss it!

Visit www.raredisease-summit.com for further details and to register. Drug Channels readers will save $300 off the standard rate when they use discount code SFK676 and register prior to May 10th.*

CBI and EBD Group will see you there!

Produced by: CBI and EBD Group

Supported by: Alliance for Regenerative Medicine, Global Genes and MassBio

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates, clinic/hospital rates, non-profit rates other offers. Other restrictions may apply.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

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Today’s guest post comes from Kay Morgan, Vice President of Drug Information Excellence at Elsevier.

Kay discusses her thoughts on the latest developments on rebate reform and drug price transparency reform. Learn more by downloading Elsevier’s white paper: Prescription Drug Transparency Reform: While You Wait.

Read on for Kay’s insights.

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On April 12 at 12:00 p.m. ET, Drug Channels Institute (DCI) will host an exclusive new webinar: Preparing for a World Without Rebates.

Join Dr. Adam J. Fein, CEO of DCI and author of Drug Channels, for this hour long, live event as he helps you understand and get ready for what would be a momentous change to our industry.

The webinar’s benefits include:

• An unlimited number of people may listen on a single phone line. Invite your whole team for an hour of intensive learning and strategic insight. The presentation is sure to spark important internal discussion about the implications for your business.

• Dr. Fein’s slides with marketplace data and analysis. You’ll also receive a downloadable PDF with all of the slides from the webinar.

• An opportunity to ask Dr. Fein questions during the event

• Access via any device with a web browser (computer, iPad, phone)

WHAT YOU WILL LEARN

A serious effort exists to remove or decrease the role of rebates in the drug channel. We will help you and your team master one of the hottest topics in our industry.

Dr. Fein will share his latest thinking on:

• What’s driving the effort to reform the rebate system

• The pros and cons of such alternatives as point-of-sale rebates and negotiated discount models

• The Department of Health & Human Services (HHS) proposed rule to alter the rebate system in federal programs—its timing, implementation, and risks

• Key uncertainties that could affect your scenario planning—including the likelihood of change in commercial markets

• The roles that PBMs, pharmacies, and wholesalers could play in operationalizing a shift to discounts

• What a world without rebates could mean for patients, benefit designs, competition, drug prices, and more

• PLUS: Dr. Fein will take your questions.

HOW TO SIGN UP

The webinar will take place on April 12, 2019, from 12:00 p.m. to 1:00 p.m. ET.

• At least 48 hours before the event, you will receive an email with a toll-free dial-in number and a unique PIN for your location. You will also receive an email on the morning of the event.

• Invite your entire field team to listen from multiple sites around the country. Contact Paula Fein (paula@drugchannelsinstitute.com) to get special pricing for 10 or more locations.

• If you purchase access for multiple sites, we will contact you for the names and email addresses of a contact person at each location.

• Pembroke Consulting clients receive free access to the webinar. Contact Tamra Feldman (admin@drugchannels.net) for details. 

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In Drug Channel Institute's list of the top 15 pharmacies of 2018, we show that many of the largest U.S. pharmacies are now central-fill mail and specialty pharmacies operated by PBMs and insurers. To complement that broader list, below you’ll find the Drug Channels Institute list of the top 15 pharmacies based on specialty drug dispensing revenues.

As you will see, PBMs and insurers dominate specialty drug dispensing channels. The top four companies—all of which are fully or partly owned by a PBM—accounted for more than 70% of prescription revenues from pharmacy-dispensed specialty drugs. Payer- and PBM-owned specialty pharmacies’ market shares grew in 2018, due largely to merger and acquisition transactions.

PBMs are earning an increasing share of their profits from specialty dispensing activities. Don’t be surprised if drug channel reform starts examining the connection between specialty pharmacies’ profits and brand-name list prices.

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Drug Channels Institute will host an exclusive new webinar, Preparing for a World Without Rebates, on Friday, April 12, 2019, from 12 p.m. to 1:00 p.m. ET. Get informed about the hottest topic facing our industry. Registration closes at midnight on Thursday. CLICK HERE TO LEARN MORE AND SIGN UP.

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World Congress’ Integrate 2019

July 22-23, 2019 | Philadelphia, PA

www.worldcongress.com/integrate

Integrate is a three-track event featuring:

• 6th Annual Specialty Network Design and Channel Optimization Summit
• 6th Annual Patient Support Services and Hub Design Summit
• 3rd Annual Patient Services Compliance Summit

Register with promo code DC200 and save an additional $200 on current early bird rate.

Join your peers across specialty distribution, patient support services and hub design, and patient services compliance to break down silos and strategize best practices for improving support and access from manufacturer to patient, provider and networks.

Our mission is to break down silos between internal colleagues and key stakeholders to help streamline business practices and provide better support and access to patients.

How will you benefit from attending?

• Three Master Classes: Choose from three master classes focused on specialty data strategies, Nurse Educator Programs, and Compliance and Auditing strategies for Patient Support Services
• Legal Roundtable: Hear from the DOJ and industry C-Suite Compliance executives on current and future trends in litigation and regulations around patient support services and foundational partnerships
• Multi-Stakeholder Insights: Hear directly from specialty pharmacies, payers, PBMs, Hubs, government agencies, health systems, and industry leaders to ensure specialty product success
• Access to Three Tracks: Customize your learning experience through free movement between sessions- All for 1 ticket price!

Shouldn’t you be there?

Register with promo code DC200 and save an additional $200 on current early bird rate.

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The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees.

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Today’s guest post comes from Bill Nolan, VP/GM of Access and Adherence at RxCrossroads by McKesson.

Bill discusses the proliferation of co-pay accumulators and the negative effects they can have on patients, particularly those with high-deductible health plans. He offers solutions that biopharma companies can embrace to mitigate the impact, including the adoption of patient-centric support.

To learn more, download McKesson’s white paper: The Impact of Accumulators on Co-pay Programs.

Read on for Bill’s insights.

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The gross-to-net bubble—the ever-growing pile of money that sits between a manufacturer’s list price for a drug and the net price after rebates and other reductions—reached another high last year.

Drug Channels Institute developed the term gross-to-net bubble to describe the speed and size of growth in the total value of manufacturers’ gross-to-net reductions.

We estimate that in 2018, the total value of gross-to-net reductions for brand-name drugs was $166 billion. As you will see below, that figure doubled over the preceding six years. Below, I also highlight the various elements that fill the bubble. About two-thirds of total gross-to-net reductions come from rebates paid to third-party payers.

The gross-to-net bubble reflects—and drives—many of the problems with U.S. drug pricing. However, recent movement toward a world without rebates suggests that we may soon hear this bubble pop…

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Drug Channels Institute will host an exclusive new webinar, Preparing for a World Without Rebates, on April 12, 2019, from 12 p.m. to 1:00 p.m. ET. CLICK HERE TO LEARN MORE AND SIGN UP.

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Spring has finally reached our worldwide headquarters here in lovely downtown Philadelphia. (See photo at right.) Before your allergies kick in, please inhale this month’s selection of noteworthy news stories:

• Eli Lilly discloses the bonkers gross-to-net economics for Humalog insulin

• John O’Brien of HHS blasts the current drug pricing system

• The Community Access National Network’s 340B Commission releases an excellent new report—and you can read my testimony, too!

Plus, a compelling new HBO documentary delves further into the sordid tale of Elizabeth Holmes and Theranos.

P.S. Join the more than 7,200 people who follow my comments and links at @DrugChannels on Twitter.

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SAVE THE DATE: Drug Channels Institute will hold a special live, interactive webinar titled Preparing for a World Without Rebates on April 12, 2019, at 12 PM ET. Details and registration information will be announced on Monday.

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The econowonks at the Centers for Medicare & Medicaid Services (CMS) have recently published new projections for U.S. National Health Expenditures (NHE). You’ll find links and my data analysis below.

As you will see, total U.S. spending on healthcare is projected to grow, from $3.5 trillion in 2017 to $4.8 trillion in 2023. Spending on hospitals and professional services is expected to grow by a combined $750 billion—about 59% of CMS’s projected $1.3 trillion increase in U.S. healthcare spending.

CMS also projects that spending on outpatient prescription drugs will account for only 9% of the total increase in U.S. healthcare spending. What’s more, total growth in spending on healthcare administration by the government and insurance companies is roughly equivalent to the growth in total spending on outpatient prescription drugs. Guess which of these categories will contribute more to patients’ well-being!

These sobering figures put the debate about drug spending in context. To say that slashing drug spending would solve the healthcare spending problem is like saying you can afford a New York City penthouse by making fewer trips to Starbucks.

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