NORD 2015 Rare Diseases & Orphan Products Breakthrough Summit

NORD 2015 Rare Diseases & Orphan Products Breakthrough Summit
October 21-22, 2015 | Arlington, VA

The ONLY Rare Disease Conference Co-Sponsored by the FDA: www.nordsummit.org

Drug Channels readers will save $200 off the standard registration rate when they use code TCC245.*

At NORD’s 2015 Rare Diseases & Orphan Products Breakthrough Summit www.nordsummit.org, benefit from breakthrough conversations in:

• Integrating the patient voice into R&D
• Optimizing clinical trial success
• Precision medicine initiatives
• The legislative path ahead on federal and state levels
• Branding & fundraising strategies for rare diseases
• Expediting early diagnosis
• Perspectives from pediatric patients
• And more!

This is the largest multi-stakeholder event www.nordsummit.org in rare diseases. You won’t want to miss the chance to hear from an unparalleled speaking faculty, including four featured Keynote Addresses:

• Jono Lancaster, Patient Advocate, Treacher Collins Syndrome
• Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER), FDA
• Stephen Ostroff, M.D., Acting Commissioner, FDA
• Christopher P. Austin, M.D., Director, National Center for Advancing Translational Sciences (NCATS), NIH

For more information including the speaker list and session line-up, please visit www.nordsummit.org.

Drug Channels readers will save $200 off the standard registration rate when they use code TCC245.*

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category 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.

What’s Behind Walmart’s Pharmacy Profit Warning?

Last week, Wal-Mart Stores surprised everyone by highlighting reduced profits from its pharmacy business. In corporate-speak, these were called “headwinds from pharmacy reimbursements” on its quarterly and annual earnings. Investors took note, especially since Walmart usually discloses nothing about its pharmacy business.

Walmart didn’t provide many details about what caused the margin reduction, but I believe two factors played a key role: (1) lower margins from newly insured consumers (compared with cash-pay consumers), and (2) Walmart’s aggressive participation in preferred networks.

Does this profit announcement signal that Walmart will start emphasizing its pharmacies’ profits over growth? I’m sure that its competitors hope so. Read on and see if you agree.

The Retail Generic Drug Inflation Slowdown: It’s Real

Looks like stock prices aren't the only things that have stopped rising. As we predicted in April, generic price increases are slowing down.

For the second quarter of 2015, we again found that generic drug price increases were lower than our previous examinations. So far in 2015, no drugs have had with mega-increases that exceed 1,000%. Below, I highlight comments by executives at the large wholesalers that confirm our slowdown analysis.

A separate RBC Capital Markets study (shown below) found an inflection point in the Food and Drug Administration’s (FDA) approval of new generic drugs. If the trend continues, new supply will enter the market and generic prices will decline. Hello, Econ 101!

Meanwhile, the pharmacy industry’s lobbyists may find that faster MAC updates may be quite painful if generic prices start falling. Wheee!

Real-Time Benefit Verification & ePrior Authorization Benchmarking Summit

Real-Time Benefit Verification & ePrior Authorization Benchmarking Summit
October 22-23, 2015 | San Francisco, CA
www.cbinet.com/epriorwest

CBI’s third installment of the Real-Time Benefit Verification (RTBV) & ePrior Authorization (ePA) Benchmarking Summit elevates the conversation on the adoption and implementation of electronic patient services (RTBV, eBV, ePA, EMRs, EHRs) by providing concrete case studies and experiences on systems integration, workflow improvements, and information exchange.

Drug Channels readers will save $400 off the standard registration rate when they use code NMK264.*

Featuring a multi-stakeholder faculty, including manufacturers, payers, PBMs, physicians, specialty and retail pharmacies, EHR/EMR vendors and other leading service providers, this summit presents the latest developments and creates a roadmap for next steps needed to achieve success in RTBV and ePA adoption. Visit www.cbinet.com/epriorwest for more information.

Speakers include representatives from:
Allergan | CVS Health | AssistRx | Athenahealth | Blue Shield of California | CenterX | CoverMyMeds | Fairview Specialty Pharmacy | MedSocket | NewCrop | NextGen Healthcare | OA Systems | Pharmacy HIT Collaborative | Pfizer | Point-of-Care Partners | Providence Health Services | RelayHealth Pharmacy Solutions | SureScripts | UCSF School of Medicine | University of Illinois Hospital and Health System | Walgreens

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category 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.

Catching Up With Cardinal Health China

Pharma distribution nerds, rejoice! Cardinal Health has just released its 10-K annual report for its 2015 fiscal year, which ended on June 30. Unfortunately, Cardinal continues to reduce the amount of information it discloses to investors and others. This year, working capital stats and associated chargeback adjustments have mysteriously vanished from Cardinal's SEC reports and earnings presentations. (When I asked, Cardinal would only say that "it's not a required disclosure." Hmmm...)

Despite the troubling opacity, let's review Cardinal’s China position. As the chart below shows, FY15 revenues at Cardinal Health China were $3.0 billion and accounted for 3% of the company’s total corporate revenues. I include a recent interview with CEO George Barrett, who provides useful insights into China’s political and economic climate.

P.S. Our updated 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors will be released in early October. In the meantime, the 2014-15 edition is on sale until September 9.

2014’s Fastest-Growing, Private Specialty Pharmacies (From the Inc. 5000 List)

Time for our annual review of the Inc. 5000 list, the magazine’s annual ranking of the fastest-growing private companies in the United States. While the list includes only those firms that submitted data to Inc. magazine, it offers a useful snapshot of the dynamic world that lies beyond the top 10 specialty pharmacies.

We have identified 10 specialty pharmacies on the 2015 list, which is based upon revenue growth through 2014. Annual revenues range from $11 to $800 million. The pharmacies and key stats are listed below.

Given specialty drugs’ growth prospects, there is an active market for the buying and selling of specialty pharmacy companies. Diplomat Specialty Pharmacy, now that it has gone public, no longer appears on the list. Below, I review the fate of other companies from recent lists that have been acquired. Given Diplomat’s sky-high valuation, consider this year’s ranking to be a shopping list.

Influence the AMP Final Rule at IIR’s MDRP 2015

IIR’s MDRP 2015
September 30 - October 2, 2015 | Chicago, IL

IIR’s MDRP 2015 is a platform to impact the Final Rule during the comment period and directly influence its outcome. Connect with 550+ MDRP executives and 100+ industry experts to dissect the proposed rule and submit feedback to CMS. Get a head start on your compliance operations for the impending Final Rule implementation.

Get a Front Row Seat Today and Participate LIVE at the Event!

Register Now to SAVE $100 off the Current Rate—Use Code XP2058DRUG

• September 30th: The AMP Rule Full-Day Pre-Conference-Understand the Application, Implementation and Impact of the Final Rule
• Brace Yourself: The AMP Final Rule is Here! What To Do, What Not To Do & What To Do First
• PANEL: Deconstructing the AMP Final Rule: A Step by Step Analysis of the Key Implications of the Final Rule
• Identify Line Extensions & Implement Alternate Rebate Formula
• Clarification to the Re-definition of Bundled Sales & Its Implications
• How to Categorize & Calculate the 5i's
• Implications of the Expansion of RCP
• Impact of the Final Rule on Class of Trade & Innovator Products
• PANEL: Implementation: Constructing a Final Rule Application Checklist

• October 2nd:
• CMS Pharmacy Updates from John Coster, Director, Division of Pharmacy, CMS
• The AMP Final Rule: Operationalizing for MDRP
• Track One: Impact of AMP on Government Pricing
• Track Two: Post AMP Panel Navigating the Regulatory Framework
• Track Three: Financial Implications of the AMP Final Rule on GP Calculations
• Track Four: Re-assessing GP Methodology post AMP

• October 3rd:
• Keynote Fireside Chat with External Counsel focusing on the legal implications of the AMP Final Rule and how to remain compliant
• Townhall to answer all your AMP related questions

Download the Brochure Here for Full Agenda and Speaker Details

PLUS! Get 340B Updates directly from HRSA on October 1st during the main conference from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA, and during the full-day 340B Mega Guidance Compliance pre-conference summit on September 30th.

Register Now to SAVE $100 off the Current Rate!

Use Code XP2058DRUG

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs.

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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.

New CMS Forecast: Drug Spending Grows Along with Impossible Hospital and Doctor Spending

The Centers for Medicare & Medicaid Services (CMS) recently released its latest forecasts for national health expenditures. They are summarized in a new Health Affairs article: National Health Expenditure Projections, 2014–24: Spending Growth Faster Than Recent Trends (Available to Health Affairs subscribers or for purchase).

I crunch the underlying prescription drug data below. In 2014, prescription drug spending growth was higher than the growth in total U.S. healthcare spending. Over the next 10 years, however, drug spending is projected to closely track overall healthcare spending.

By 2024, the U.S. will spend about $560 billion annually on outpatient prescription drugs. Despite this growth and the perceptions that drugs prices are “too high,” outpatient prescription drugs will only account for about one of every 10 U.S. healthcare dollars. Hospitals and physicians will still account for nearly 60% of U.S. healthcare spending—or about six times as much as spending on pharmaceuticals.

Being part the CMS forecasting team is not easy. If any members of the Office of the Actuary are caught with bad projections, the Secretary of Health and Human Services will disavow all knowledge of their actions.

Specialty Product Distribution and Dispensing Optimization

CBI’s Specialty Product Distribution and Dispensing Optimization
October 13-14, 2015 | Philadelphia, PA

CBI’s Specialty Product Distribution and Dispensing Optimization Conference specifically addresses the need for innovative, highly-evolved distribution models as the specialty marketplace continues to grow. Join us for the only event where key stakeholders discuss strategies for creating an optimal distribution network in order to reach patients in need.

Hear perspectives from BIND Therapeutics, Biogen, Biologics, Blue Fin Group, Cardinal Health Specialty Pharmacy, Carolinas HealthCare System, CSL Behring, Diplomat Specialty Pharmacy, Genzyme, Incyte Corporation, Independent Health, Intercept Pharmaceuticals, King & Spalding, McKesson, Omnicare, Onco360, Orsini Healthcare, Prime Therapeutics, UBC: An Express Scripts Company, VHA-UHC Alliance, Walgreens, and more!

Visit www.cbinet.com/specialtydistribution for more information.

Drug Channels readers will save $300 off of the standard registration rate when they register with code GZR984.* Join the hundreds who have benefited from this conference to date!

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category 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.

OMG! AMP Final Rule is at OMB!

You gotta strike when the moment is right without thinking. And its looks like the Centers for Medicare & Medicaid Services (CMS) might finally be doing so.

Apparently, the oft-delayed Federal Upper Limits (FUL) and the Final Rule on Covered Outpatient Drugs, a.k.a., the Average Manufacturer Price (AMP) Final Rule, is now officially under final review at the Office of Management and Budget (OMB). The announcement is pasted below, because you probably don't believe it either.

Does this mean that CMS will finally accomplish this policy goal? How quickly will the pharmacy industry sue to stop implementation? Are you wondering which of the buggars to blame for the delay?

Read on for the proof and some background.

Here Come the 2016 PBM Formulary Exclusion Lists!

The two largest pharmacy benefit managers (PBMs)—Express Scripts and CVS Caremark—have just released their 2016 formulary exclusion lists.

CVS Caremark’s 2016 list has 124 products, including 31 new additions. Express Scripts, which is much more public about its strategy, has only 80 products and fewer additions to its list.

Below, I share some observations on each company’s strategy, differences in each PBM’s approach to specialty drugs and the hepatitis C category, and other related topics. I also provide links, so you can download and review the complete 2016 lists yourself. Enjoy!

Coupon and Co-Pay Off-Set Strategies

Coupon and Co-Pay Off-Set Strategies
October 6-7, 2015 | Philadelphia, PA

Exclusive Offer – Register by 8/14/2015 and save $400* (mention promo code COUPDC) 

Think you know everything there is to know about coupon and co-pay programs? Think again!

With the release of the OIG report, dramatic shifts in formulary coverage and the rising prices of branded medications, manufacturer-driven discount programs are facing new challenges with providing patient affordability options while remaining effective and compliant.

CBI's Coupon and Co-Pay meeting returns to the East Coast in October for its third installment — The first and leading event that brings together the best minds in the industry to provide manufacturers with cutting-edge strategies to maximize products throughout the lifecycle by continuing to leverage these essential discount opportunities. The 2015 agenda boasts a diverse, senior-level faculty from Actavis, Allergan, Bayer, Bristol-Myers Squibb, Churchill Pharma, Pfizer and many more!

Key 2015 Highlights:

• An in-conference workshop on navigating the changing managed care ecosystem, including NDC blocks, step therapy programs and high-deductible plan effects
• A patient advocate panel exploring how to overcome patient affordability concerns to limit patient out-of-pocket costs
• An update from members of NCPDP’s Working Group Number 9 on potential processes to enhance safeguards against anti-kickback
• Specialty Round-Robin Roundtables on three of the biggest challenges facing co-pay programs for specialty products
• A stakeholder panel on how to improve patient adherence through a reduction of behavioral barriers

Register Today! 

*Discount offer valid through 8/14/2015; applies to standard rates only and may not be combined with other offers, categories, 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.