Analysis

CBI’s 15th Annual Life Sciences Accounting & Reporting Congress
March 20-22, 2019 | Loews Philadelphia Hotel | Philadelphia, PA
www.cbinet.com/accounting

As product pricing and contracting within the channel continues to tangle in complexity, and the gross-to-net “bubble” swells in size, leaders in Finance and Accounting are often at the front lines, making decisions around strategy and reporting.

CBI’s 15th Annual Life Sciences Accounting & Reporting Congress, the world’s top event for finance, accounting and business leaders within life sciences, provides the in-depth CPE education and networking with nearly 600 professionals.

Visit www.cbinet.com/accounting for further details and to register. Drug Channels readers will save $400 off the standard rate when they use promo code SNQ255 and register prior to February 8th.*

Hot topics include: SEC reporting, R&D financing, product pricing and contracting, critical audit matters, GTN, robotic process automation, valuation, collaborations and licensing, capital creation and allocation, SOX compliance, M&A, corporate tax, new product commercialization, FP&A, cybersecurity and data privacy, carve-outs and divestitures, revenue recognition, forecasting and financial planning, leases, and third-party oversight. You’ll return to the office ready to advance your organization to stay ahead in 2019.

You can sign up to view the agenda here, and see a snapshot of what you can expect:

• CEO Fireside Chat – Candid Conversation on Key Business and Industry Topics
  Featuring Cathy Engelbert, CEO, Deloitte and Heather Bresch, CEO, Mylan
• CFO Keynote Panel – Leading in Finance and Navigating the Course of Change
  Led by Laura Robinette, US Pharmaceutical and Life Sciences Assurance Leader, PwC and Featuring Chief Financial Officers from Endo, Impax/Amneal and Insmed Incorporated
• Women’s Leadership Summit - Stories on Career Development, Leadership and Mentorship
  Featuring PwC, Shire, Covance, Ipsen and Solid Biosciences
• Wall Street and Investment Panel – Impactful Deals Impacting the Life Science Marketplace
  Featuring Achillion Pharmaceuticals, Bain Capital, Bank of America Merrill Lynch and PwC

Additional sessions to be presented by Alnylam Pharmaceuticals, Adamas Pharmaceuticals, Johnson & Johnson, Allergan, BMS, Ironwood Pharmaceuticals, Pfizer, Boston Scientific, Medtronic, AMAG Pharmaceuticals, AnaptysBio, Spero Therapeutics, and many others.

Visit www.cbinet.com/accounting for further details and to register. Drug Channels readers will save $400 off the standard rate when they use code SNQ255 and register prior to February 8th.*
CBI will see you there!

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rate or non-profit rates. 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.

Time for Drug Channels’annual look at independent pharmacy owners’ business economics, drawn from the recently released 2018 National Community Pharmacists Association (NCPA) Digest, Sponsored by Cardinal Health. Here's the press release: NCPA Releases 2017 Digest.

Below, I update our estimates on pharmacy economics and margins. Our analysis reveals that independent pharmacy owners have faced another year of deteriorating finances.

What's more, we estimate that in 2017, the average pharmacy owner’s salary fell to a level comparable to that of an employed pharmacist. Owning a pharmacy, with all of its hassles and additional obligations, now brings the same reward as being an employee. I wonder how many owners will conclude that it’s barely worth the risk and effort.

Read on for our look at pharmacy profits and some comments on the industry’s competitive dynamics, including the financial impact of direct and indirect remuneration (DIR) fees.

The pharmacy consolidation endgame is getting closer. The next time you see a pharmacy owner, offer your condolences.

CBI’s 6th Annual e-Rx and EHR
March 12-13, 2019 | The Inn at Penn | Philadelphia, PA
www.cbinet.com/erx

CBI’s 6th Annual e-Rx and EHR conference, taking place March 12-13 in Philadelphia, provides tangible takeaways and tailored sessions to help you understand how to maximize e-prescribing and EHR technology engagement. Don’t miss the major key insights from industry thought-leaders as they discuss the challenges with streamlining HCP workflow, refined strategies for educating patients and best practices in coordinating channel integration with EHR platforms.


Featured Discussion Topics:

• Discuss the e-prescribing provisions within the SUPPORT for Patients and Communities Act of 2018
• Examine current initiatives within Apple, Amazon and the City of Philadelphia and how they are becoming three key players in the EHR space
• Evaluate early clinical factors and treatment of patients to a specific therapeutic area for quality care
• Hear innovative insights into the efforts of Geisinger and Merck with MedTrue™
• Review what providers are looking for and assess the gaps in using EHRs
• Discuss current patient support tools and resources that truly drive physician and patient engagement in population health management
• Learn to deliver patient-specific drug benefit and cost-information within the e-prescribing workflow at the point of care
• Understand the value of data analytics in regards to prescribing patterns

Expert Multi-Stakeholder Speaking Faculty:

PHYSICIAN PERSPECTIVE:

• David Kaelber, M.D., Chief Medical Informatics Officer, The MetroHealth System

PAYER PERSPECTIVE:

• Kimberly Hansen, Director, Network Operations, UnitedHealthcare

HEALTH SYSTEM PERSPECTIVE:

• Julie K. Rockey, MBA, RHIA, Strategic Program Director, Geisinger Health System

MANUFACTURER PERSPECTIVES:

• Eric Wente, Regional Account Executive, Market Access US, Bayer Healthcare Pharmaceuticals, Inc.
• Patricia Cunningham, MSHI, RHIA, CHPS, Associate Director, Health IT, Boehringer Ingelheim
• Mark Monticelli, Associate Director, Health Systems Marketing, Astellas
• Vanessa Menton, Director, Oncology Marketing, Astellas

Don't be left out of the conversation. Download the agenda for complete details and register by Friday, February 8, 2019 and receive $300* off the standard rate with promo code DCX300.

*Offer expires Friday, February 8, 2019; applies to standard rates only and may not be combined with other offers, category rates, and promotions or applied to an existing registration.

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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.

Oral generic drugs keep getting cheaper. The Food & Drug Administration (FDA) has intensified the generic industry’s competitive pressures with record drug approvals. The FDA’s actions, combined with the negotiating leverage of the large generic purchasing organizations, led to 2018’s persistent double-digit deflation in manufacturers’ selling prices for oral generic drugs.

Below, we update our analysis of these generic drug mega-buyers.

We estimate that for 2018, the three largest buyers accounted for more than 90% of total U.S. generic drug purchases from manufacturers. In 2019, acquisitions and contract switches will shift market share among these groups, but not diminish their impact. It's no surprise that manufacturers lose their minds when seeing these monster firms.

There are now fewer therapeutic areas with excess inflation, so future price reductions will be smaller. What’s more, some generic manufacturers have signaled their intention to exit highly competitive generic drug categories in which prices have dropped. Look for oral generic prices to stabilize—and possibly rise—over the next 12 to 18 months. Perhaps the blindfolds will come off?

P.S. Portions of this post have been adapted from our forthcoming 2019 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. We'll be taking this updated and expanded edition out of our bird box on March 5!

CBI’s 20th Annual Patient Assistance & Access Programs – PAP 2019
March 4-6, 2019 | Baltimore, MD
www.cbinet.com/pap

During a time when copay programs and patient support are under intense scrutiny and underinsurance continues to plague many patients, PAP 2019 convenes over 450 leaders from the patient assistance and product access field (manufacturers, copay foundations, non-profits, free clinics, advocacy organization, hospitals) to prepare you for what’s ahead. Join over 50 distinguished speakers who are prepared to address the legal environment, industry best practices and policy watch-outs related to prescription access and financial assistance.


You can download the agenda here and see in-depth coverage on critical issues, such as:

• The Impact of Copay Accumulators on Access and Adherence
• Legal Underpinnings of Patient Assistance and Gain Insight on OIG Oversight
• Technology and Automation Tools that are Improving the Patient Journey and Outcomes
• Advancements in Electronic Benefit Verification
• Strategies for Effectively Managing Patient Data
• Patient-Centric Support Programs to Remove Barriers and Support Adherence
  Navigating Changes and Ensuring Coverage for Medicare Patients
• Trends and Approaches in Nursing Support Programs

Visit www.cbinet.com/pap for further details and to register. Drug Channels readers will save $400 off the standard rate they use discount code REK226 and register prior to January 25th.*

CBI will see you there!

*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.

Let’s kick off 2019 with a quick review of last year’s specialty pharmacy mergers and acquisitions (M&A). Our list (below) includes only deals that were publicly announced in 2018.

Pharmacy benefit managers (PBMs) were especially busy. CVS Health bought five specialty pharmacies. UnitedHealth’s OptumRx bought Avella Specialty Pharmacy, the largest independent specialty pharmacy.

Diplomat Pharmacy was uncharacteristically quiet during 2018, though it had been one of the most active acquirers in previous years.

The specialty pharmacy industry is rapidly maturing, so I expect many more exits in the coming years. Looking to pick up a fast-growing specialty pharmacy? Click here for your post-holiday shopping list.

This week, I’m rerunning some popular posts before the holidays. Click here to see the original post and comments from August 2018.

This has been the most impactful article that I have ever published on Drug Channels. Review it and get ready for 2019.

P.S. You can also find this material at www.WorldWithoutRebates.com. (Yes, we bought that domain!)

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Are you ready for a world without rebates?

In June, Alex Azar, Secretary of the U.S. Department of Health & Human Services (HHS), summarized his long-range vision for a new drug channel system:

“[W]e may need to move toward a system without rebates, where PBMs and drug companies just negotiate fixed-price contracts. Such a system’s incentives, detached from artificial list prices, would likely serve patients far better.” (emphasis added)

No one has yet explained what a system without rebates would look like.

To facilitate the discussion, I have sketched out a possible new drug channel system that would:

• Respond to the HHS vision for a “system without rebates”

• Remove/decrease the reliance on list price as a component of intermediary compensation

• Use negotiated discounts as an alternative to the current system of retrospective rebates

• Require manufacturers to negotiate for desirable market access

You can download The Drug Channels Negotiated Discounts Model below.

Please note that I am not advocating for this approach. I am merely exploring one way that a system without rebates could be implemented. I hope you find it helpful for your strategic planning.

As always, I welcome feedback on how to improve and refine this model. Either leave comments below or email me. Enjoy!

This week, I’m rerunning some popular posts before the holidays. Click here to see the original post and comments from August 2018.

This rerun explains how and why PBMs are shifting responsibility and blame toward third-party payers. In 2019, we'll hear much more about how payers' use of rebates affect patients' out-of-pocket costs and distort the drug channel. Addressing the problems will require a major rethink of commercial and Medicare Part D pharmacy benefit designs. For my related $0.02 on the politics of "drug prices," see also Drug Prices After the Midterms: Five Crucial Implications of Pharmacy Benefit Design.

P.S. Drug Channels was sad to hear about the passing of Stephen Hillenburg, creator of SpongeBob Squarepants.

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Last week, the two largest pharmacy benefit managers (PBMs)—CVS Health and Express Scripts—both stated that rebates now account for a small part of their profits. The companies therefore strongly implied that they could survive in a world in which PBMs did not participate in the flow of funds from a brand-name manufacturer to a plan sponsor. Below, I unpack the new disclosures, which move us materially closer to a new model.

Hmm. The two biggest PBMs and at least one major manufacturer (Pfizer) have now implied a willingness to change. So what’s to stop massive drug channel disruption?

CVS Health perhaps inadvertently identified the real barrier to a system without rebates: employers and health plans. As you will see below, CVS Health disclosed for the first time the massive gross-to-net bubble within its commercial book of business. The new information confirms that plan sponsors are hoarding rebates rather than sharing the savings with the employees whose prescriptions generated the rebate funds.

If we really do migrate to a system without rebates, PBMs’ reportedly minimal profits from rebates mean they could escape drug channel disruption unscathed. The focus will now turn to the plan sponsors that are absorbing rebate dollars. Whether plan sponsors realize it or not, they are the next target.

This week, I’m rerunning some popular posts before the holidays. Click here to see the original post and comments from July 2018.

The challenges facing wholesalers have intensified since this article was originally published, in July. Brand-name drug inflation will likely reach historical lows in 2019, and the prospects for a gross-to-net bubble reset are greater than ever. Have executives at the Big Three companies fully grasped the changes coming to the drug wholesaling business model?

For more on the industry, see our 2018–19 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

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Today, drug wholesalers make money from distribution in a straightforward manner: Buy low, sell high, collect early, and pay late. They also profit as brand-name list prices increase. Like other drug channel intermediaries, wholesalers have warped incentives to prefer ever-higher list prices.

But what happens to their business model if list prices don’t rise—or even if they decrease?

This question is no longer theoretical. Many drug makers—Pfizer, Roche, Novartis, Novo Nordisk, Sanofi, and others—have announced an intention not to raise list prices for 2018 or have rescinded planned increases. Merck has gone further and become the first major manufacturer to reduce the list price of a brand-name, patent protected product, albeit for a product with minimal sales. And for the first time, there is a serious attempt to pop the gross-to-net bubble and build a system without rebates.

Below, I analyze what this could mean for the Big Three drug wholesalers—AmerisourceBergen, Cardinal Health, and McKesson. I explain some of the problems that arise when wholesalers are compensated based on a brand-name drug’s list price. I then suggest an alternative approach that would reshape wholesalers’ economics. It appears that even the wholesalers’ trade association supports some sort of new model.

Given what’s happening, it’s clearly time for some ch-ch-ch-ch-changes.

This week, I’m rerunning some popular posts before the holidays. Click here to see the original post and comments from July 2018.

Expect 340B to stay in the news during 2019. Unfortunately, a sensible, bipartisan legislative fix still seems unlikely.

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The United States Government Accountability Office (GAO) has just issued a must-read report on the 340B Drug Pricing Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement.

Some of the report’s most startling revelations confirm our worst fears about how hospitals and pharmacies are abusing the 340B program.

Here are two especially dispiriting findings from the GAO’s analysis:

• 16 out of 28 hospitals (57%!) did not provide discounted drug prices to low-income, uninsured patients who filled prescriptions at the hospital’s 340B contract pharmacy. Seriously?!?

• Many 340B contract pharmacies can earn excessive profit margins of 15% to 20% from brand-name 340B prescriptions. As I have long suspected, large, publicly-traded pharmacies are sharing in the 340B discounts generated for covered entities.

Bottom line: Hospitals and pharmacies are making money from poor people. Are you kidding me?!? For shame!

The 340B program’s apologists will have a hard time rebutting the uncomfortable facts from this GAO report. Calling something a “drug discount program” apparently doesn’t mean that the neediest patients get access to those discounts. Read on, and prepare to be outraged.

P.S. In two upcoming articles about 340B, I’ll review the pharmacies participating in the program and then examine the role of specialty pharmacies and pharmacy benefit managers.