Drug Channels News Roundup, July 2019: Amazon/PillPack, Novo Nordisk on the G2N Bubble, Copay Accumulators, and Adam's Favorite Chart

Let’s cut through the steamy summer haze with our refreshing selection of articles and insights. In this issue:

• New details about Amazon’s PillPack deal

• Novo Nordisk’s CEO on the gross-to-net bubble

• Fresh data on adherence problems with copay accumulators

• My all-time favorite chart!

Plus, I am dazed and confused by a Specialty Pharmacy Times article.

P.S. Stay current with my daily links to cool stuff at @DrugChannels on Twitter.

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ON SALE! We are offering our 2018–19 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors at discounts up to 30% off. Sales prices valid thru 9/3/19. The updated 2019-20 edition will be available in early October 2019.

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CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products

CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products
September 12-13, 2019 | Hyatt Regency | Cambridge, MA
www.cbinet.com/SpecialtyCompliance

CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products conference, taking place September 12-13 in Cambridge, MA, is tailored to the distinctive business needs and compliance challenges of specialty biotech and pharmaceutical manufacturers.

Exclusive Offer for Drug Channels Readers: Register Now to SAVE $400* using promo code TXF846

This CCB, CPE, CLE accredited conference provides numerous interactive sessions, panel discussions and networking events, optimizing face-to-face engagement with fellow compliance and legal industry professionals, including:

• Create your own tailored conference experience with 4 comprehensive breakout sessions
• Gain insights into the government perspective with a keynote panel featuring U.S. Attorneys from the District of Massachusetts, District of New Jersey and Southern District of New York
• Deep dive into patient support and assistance with 3 focused afternoon sessions highlighting compliant patient interactions, nurse educator programs and copay assistance
• Hear about the successes and letdowns of building compliance programs from the ground-up during the closing fireside chat with senior thought leaders
• PLUS! This year will include the inaugural, invitation-only Legal & Compliance Leadership Summit, designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing compliance leaders across the industry

Hear valuable content on high-impact issues for breakthrough therapies from 40+ industry leaders including Acceleron Pharma, Sobi, Vertex Pharmaceuticals, EMD Serono, Radius Health, Sanofi Genzyme, Sarepta Therapeutics, Sunovion, Strongbridge BioPharma, TherapeuticsMD, Avanir Pharmaceuticals, TESARO, Servier Pharmaceuticals, Alexion, Akebia Therapeutics, Takeda, Sage Therapeutics, Boehringer Ingelheim, Boston Biomedical, Blueprint Medicines and more!

Visit www.cbinet.com/SpecialtyCompliance to view the complete speaker and in-depth session lineup, then register using promo code TXF846 for this exclusive savings of $400 off!*

*Discount expires 9/11/19; cannot be combined or applied to existing registration. 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.

Improving Medication Access Through Network Connections to Impact More Patients

Today’s guest post comes from David Holladay, President of CoverMyMeds.

David discusses the obstacles and frustrations patients experience as they navigate the patient journey. He describes CoverMyMeds’ technology solutions that have helped solve medication access and adherence challenges for patients.

To learn more about technology-enabled patient support, download this new case study: Comprehensive Prior Authorization Support to Help Impact More Patients.

Read on for David’s insights.

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law

STAT recently published our op-ed: State drug importation laws undermine the process that keeps our supply chain safe.

I co-authored this op-ed with Dirk Rodgers, an independent consultant and author of the excellent RxTrace blog.

As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.

States can't wish away the requirements of a significant federal law. Either we have a secure drug supply chain or we don’t.

Note that our op-ed was published before Canada announced that it would resist drug exportation.

Full text below. Read on and let us know what you think.

CBI’s 13th Hub and SPP Model Optimization

CBI’s 13th Hub and SPP Model Optimization
September 26-27, 2019 | San Diego, CA
www.cbinet.com/hubswest

With mounting cost pressures and increased demands for affordable, value-based treatment options, our industry faces an increasingly competitive market, for both specialty and non-specialty products. Increasingly, companies must strategize to manage the most critical challenges associated with product and patient services. CBI’s 13th Hub and SPP Model Optimization provides executives with strategies for developing and integrating hub programs and other patient-centric services to ensure product access and maximize reimbursement.

Visit www.cbinet.com/hubswest for further details and to register. Drug Channels readers will save $300 off the standard rate when they use discount code YZN462 and register prior to August 9th.*

Just a few highlights from the program include:

• Current litigation/court rulings that impact Hub and SP Models
• Integration of medical and pharmacy benefits
• AI across patient access programs to improve conversion and adherence
• Key learnings on aligning patient services and market access for rare disease launch success
• Examining EHR data to generate claims data and understand care episodes to see the effectiveness of a therapy
• Evaluating key patient and therapeutic traits that influence hub model design
• Best practices for combining data sources to provide a complete picture of the patient journey
• Tips to prepare for the hubs of the future and designing patient-centric hub models

Download the agenda here and prepare to return to the office armed with critical updates and valuable takeaways.

Visit www.cbinet.com/hubswest for further details and to register. Drug Channels readers will save $300 off the standard rate when they use discount code YZN462 and register prior to August 9th.*

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 or 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.

Expanding Patient Engagement in Commercial Healthcare

Today’s guest post comes from Pritesh Patel, Commercial Segment Director of Clinical Effectiveness at Wolters Kluwer, Health.

Pritesh presents a case study of how technology improved patient engagement, which translated into better patient health outcomes. To learn more, download their complete ebook: Patient Engagement in Commercial Health.

Read on for Pritesh’s insights.

Walgreens, CVS, and Walmart Lead the 25,000 Pharmacies Now Profiting From the 340B Program

It’s time for our annual look at the booming pharmacy component of the 340B Drug Pricing Program. Our latest, exclusive analysis finds that:

• About 25,000 pharmacy locations now act as contract pharmacies for the hospitals and other healthcare providers that participate in the 340B program. Contract pharmacies now account for almost 40% of all pharmacy locations in the United States. Wow.

• The total number of pharmacy locations has grown by 14% over the past 12 months and has almost doubled since 2013.

• Six large retail chains—Walgreens, CVS, Walmart, Rite Aid, Kroger, and Albertsons—account for two-thirds of 340B contract pharmacy locations. CVS added 1,200 locations—as many as the other five chains combined.

Clearly, multi-billion-dollar, for-profit, publicly traded pharmacy chains are benefiting from the 340B discounts intended for covered entities. Below, I offer some policy suggestions so that we can better understand what's going on here.

In upcoming articles, I’ll examine pharmacy benefit manager (PBM) and specialty pharmacy participation in 340B and explain the oversize profits that pharmacies can earn from the program.

For now, you should ponder how and why the 340B program continues its unbridled takeover of the pharmacy industry...and beyond.

JAMA: Withdraw This Flawed and Inaccurate Article About the 340B Program and Drug Prices

The Journal of the American Medical Association (JAMA) recently published Estimated Changes in Manufacturer and Health Care Organization Revenue Following List Price Reductions for Hepatitis C Treatments by Sean Dickson and Ian Reynolds. The paper purports to show that manufacturers’ net revenues increased following a decrease in three drugs’ list prices.

However, the paper contains a significant computational error: The authors do not properly calculate the 340B ceiling price. Consequently, the authors’ calculations are inaccurate and their conclusions are erroneous. As we might expect, a manufacturer’s revenue per-patient doesn’t increase when list prices decline and net prices remain constant.

Below, I explain how to compute a drug’s ceiling price under the 340B Drug Pricing Program. I then illustrate the crucial mathematical error in the JAMA paper. I also briefly highlight a few other errors and omissions in the paper.

The paper’s serious and irredeemable flaws imply that readers will be significantly misinformed about drug prices and the 340B program. You may or may not agree with me about the 340B program. But I hope you will concur that respected academic journals should publish truthful and accurate information.

CBI’s 3rd Annual Finance & Account for Bioscience Companies

CBI’s 3rd Annual Finance & Account for Bioscience Companies
September 24-25, 2019 | Boston Marriott | Cambridge, MA
www.cbinet.com/BioFinance

Exclusive Offer for Drug Channels Readers:

Register Now to SAVE $400* using promo code ACC400

CBI’s Finance & Accounting for Bioscience Companies conference, taking place September 24-25 in Cambridge, MA, is tailored to the distinctive business needs and technical accounting challenges of small-middle market biotech, pharmaceutical and device companies.

During this CPE, CLE accredited conference, Finance and Accounting executives gain commercialization and product launch strategies, frameworks for managing gross-to-net estimates and mitigating risk, models to scale and grow a best-in-class finance function, timely updates on tax and legal matters, systems implementation case studies and industry expertise for communications and investor relations.

Hear valuable content on high-impact issues from CFOs, chief accountants, corporate controllers and more from a broad range of life sciences companies, including those representing Neon Therapeutics, Alnylam, Akcea Therapeutics, Karyopharm, Ironwood Pharmaceuticals, RSM US LLP, Spring Bank Pharmaceuticals, Shire, Karuna Therapeutics, Novapeutics, Sunovion Pharmaceuticals, Bluerock Therapeutics, Merck and more! Plus, attendees choose from two tracks of sessions, one tailored for Clinical-Stage Companies and one tailored for Commercial-Stage Companies.

Visit cbinet.com/BioFinance to view the complete speaker and in-depth session lineup, then register using promo code ACC400 for this exclusive savings of $400 off!

*Discount expires 9/23/19; cannot be combined or applied to existing registration. 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.

Six Reasons Why the Rebate Rule Failed—And What’s Next

Yesterday, we all awoke to the unexpected news that the Department of Health & Human Services (HHS) withdrew its plans to reform rebates in federal programs. The world without rebates has been delayed—perhaps indefinitely.

Below, I highlight six key policy and political factors behind this decision. I also discuss winners and losers among drug channel participants.

The underlying problems of the the gross-to-net bubble remain. As H.L. Mencken observed: “There is always a well-known solution to every human problem—neat, plausible, and wrong.” Get ready for a slew of drug pricing policy proposals that perfectly fit these criteria.

The Gross-to-Net Bubble Reached a Record $166 Billion in 2018 (rerun)

This morning, the White House withdrew its proposed rule to reform the rebate system in federal programs. I am surprised by the timing, which likely has more to do with politics than policy. Tomorrow, I'll post some reflections on this unexpected news. 

In the meantime, today's rerun is a reminder of what's still at stake in reforming rebates within the U.S. drug channel
. 
Click here to see the original post and comments from April 2019. You can also reach this post at www.GrossToNetBubble.com. ;)

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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.

How Health Plans Profit—and Patients Lose—From Highly Rebated Brand-Name Drugs (rerun)

This week, I’m rerunning some popular posts during the holiday week. Click here to see the original post and comments from February 2019.

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My Wall Street Journal op-ed (Don’t Blame Drug Prices on ‘Big Pharma’) has received a lot of attention.

Especially notable was a letter to the editor from American Health Insurance Plans (AHIP). It claims that “the savings that insurance providers negotiate are returned directly to consumers through lower premiums and out-of-pocket costs."

Don’t believe this misleading half-truth. It distorts the primary argument of my WSJ op-ed: Patients often pay full price for drugs that are sold to insurers at deep discounts.

Below, to show you why, I follow the dollar for an expensive, highly rebated brand-name drug used by a consumer with a high-deductible health plan. As you will see, the consumer pays more than twice the true discounted price of the drug. Meanwhile, the health plan pockets a large rebate.

That's the uncomfortable reality of the gross-to-net bubble that AHIP wants to hide. Insurers may not use rebates to lower the out-of-pocket costs for the patient whose prescription generated the rebate. And at the same time, AHIP indignantly blames "the prices drugmakers set." We all deserve better.

The Big Three Generic Drug Mega-Buyers Drove Double-Digit Deflation in 2018. Stability ahead? (rerun)

This week, I’m rerunning some popular posts. Click here to see the original post and comments from January 2019—complete with now-dated Bird Box references!

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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!

PBMI’s 2019 Specialty Rx Forum

PBMI’s 2019 Specialty Rx Forum
September 10, 2019 | JW Marriott Minneapolis Mall of America | Minneapolis, MN
www.pbmi.com/srx19

In 2021 specialty pharmacy is expected to grow to $500 billion. Specialty drug spend is also expected to reach upwards to 60% of total drug spend. Healthcare stakeholders are not only challenged by the costs and increased utilization of specialty medications, but also by the uncertainty and complexity of specialty pharmacy.

Join PBMI and other healthcare stakeholders for a dynamic and interactive one-day event at PBMI’s 2019 Specialty Rx Forum on September 10, 2019.

The agenda covers a wide variety of topics such as:

• New drugs in the specialty pipeline
• Managing hemophilia
• Cost savings through specialty generics and biosimilars
• Lower net-cost drugs
• Enhancing the patient experience through technology and data devices
• Getting the most out of specialty contracts
• And more.

Check out the full program here.

Early bird rates for this event end July 12, 2019.

Exclusive Offer for Drug Channels readers:

Drug Channels readers can use discount code SRX19 to extend the early bird rate through August 23, 2019! Do you have colleagues who would also like to attend? Feel free to extend this offer to them too.

Click here to register. If you register after July 12th, use discount code SRX19 at checkout to get the early bird rate.

Do you have questions, or are you interested in sponsoring this event? Contact Linda DeChant at ldechant@pbmi.com.

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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.

National Association of Specialty Pharmacy 7th Annual Meeting and Expo

National Association of Specialty Pharmacy 7th Annual Meeting and Expo
September 9-12, 2019 | Washington, D.C.
www.naspmeeting.com

Join the National Association of Specialty Pharmacy (NASP) at its 7th Annual Meeting and Expo September 9-12 at the Marriott Wardman Park in Washington, D.C.

The Annual Meeting and Expo hosts over 1,200 specialty pharmacy stakeholders including senior executives, pharmacy directors, staff pharmacists, consultants and other management-level personnel from specialty pharmacy providers, infusion pharmacies, pharma/biotech manufacturers, institutional pharmacies, managed care organizations, data management and analytic organizations, group purchasing organizations, distributors and suppliers to the industry.

Benefits of Attending:

• Network with industry stakeholders and exhibitors
• Earn continuing education credits
• Share best practices in specialty pharmacy
• Participate in wellness initiatives and fundraisers
• Interact with thought leaders and industry experts
• Extend clinical and practical pharmacy knowledge
• Attend the Women in Specialty Pharmacy Luncheon
• Present original or encore research

In addition to the activities listed above, the following workshops will be offered on September 12:

• The 4th annual Specialty Pharmacy Law Conference delivers valuable insight into the current legal and regulatory requirements, and complexities associated with operating today’s specialty pharmacy. Attendees can receive continuing legal education credits as well as pharmacist continuing education (CE) credits.
• The 3rd annual Certification in Specialty Pharmacy Exam Preparatory Course covers all essential topics to prepare pharmacists interested in taking the CSP exam. CE credit is available for completing the course.
• NASP hosts the 2nd annual Home Infusion Workshop, in partnership with National Home Infusion Association, to provide attendees with a unique opportunity to learn more about the regulatory, legal, operational and clinical complexities of the home infusion industry.

The NASP Education Committee welcomes submission of original or encore research relevant to specialty pharmacy, outcomes related to specialty pharmacy products or services provided by specialty pharmacies. Accepted abstracts will be presented at the NASP Annual Meeting and Expo and published online in the PubMed-indexed Journal of Drug Assessment. Submit your research today.

Secure your spot at the NASP 2019 Annual Meeting and Expo by registering today!

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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.