Analysis

eyeforpharma Real World Evidence & Market Access Summit 2015
December 3-4, 2015 | Philadelphia, PA
www.eyeforpharma.com/rwe/

The 4th annual eyeforpharma Real World Evidence & Market Access Summit 2015 provides attendees with 5 strategic events in one, offering a rare 360° view on how big data becomes evidence, and evidence becomes value. For the first time, 15+ major health systems and key payers signed up to talk specifics from data sharing, formulary design to risk-based contracting. Of course, the program will still include government contributions and exclusive pharma industry case studies. That promises a fascinating bundle of unfiltered information from the entire suite of data and market access stakeholders – all under one roof.

Drug Channels readers will save $300 off the standard registration rate when they register with discount code 4318DC300

Speakers Include:

• Usman Iqbal, Senior Director, Medical Affairs Leader, AstraZeneca
• Eugene Kolker, Chief Data Officer, Seattle Children’s Hospital
• Mark Weiner, Chief Medical Information Officer, Temple University Health System
• John Hernandez, Global VP, HEOR, Abbott
• Marilyn Metcalf, Sr. Director, Benefit Risk Evaluation, GlaxoSmithKline
• Faisal Mehmud, VP Medical Affairs, Novartis
• Garrett Ingram, VP & Head, US Market Access, Sanofi
• Julie Locklear, VP, HEOR, EMD Serono
• Eric Newman, Vice-Chair of Clinical Innovations, Chief of Specialty Care Innovation & Integration, Geisinger

Use discount code 4318DC300 to save $300. Register 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.

On Tuesday, AmerisourceBergen announced a new $2.4 billion share repurchase program. Read the press release. This new program brings ABC’s total repurchases to more than $4 billion in less than two years.

Here's why: ABC’s multi-faceted deal with Walgreen Boots Alliance (WBA) is motivating these transactions.

Let’s peer over the hedge and find out what’s going on.

In July, I highlighted how payer and pharmacy consolidation will affect drug wholesalers. As I detail below, two big acquirers—OptumRx and Albertsons—are both switching primary wholesalers and simultaneously migrating their generic purchasing to the wholesale channel.

These latest deals show how generic purchasing consortia are accelerating business alignment between pharmacies and their wholesaler suppliers.

The deals also signal further generic purchasing consolidation. For both brand-name and generic drug manufacturers, a robust channel strategy function is more important than ever.

CBI’s VA DoD PHS Federal Pricing and Contracts
November 18-19, 2015 | Philadelphia, PA
www.cbinet.com/vadod

Now in the seventh year, CBI's VA DoD PHS Federal Pricing and Contracts Forum elevates the conversation and dives deep into the complexity of contracting with the "Big Four" federal programs. This meeting offers bio/pharma manufacturers best practices and timely updates from government officials and industry counterparts on pricing models and processes for complying with complicated rules and regulations. Download the complete agenda here.

BREAKING NEWS! As of August 27th, HRSA has released its proposed “Mega/Omnibus” Guidance, which addresses longstanding questions around manufacturer and covered entity participation in the 340B program. This conference is poised to deliver insight into key program changes and regulatory updates within the rapidly evolving 340B program. Benefit from sessions dissecting the guidance, benchmark with peers on operational challenges, and participate in an interactive discussion during the 340B focus group luncheon.

Visit www.cbinet.com/vadod for more information. Drug Channels readers will save $200 off of the standard registration rate when they use code UAP764.*

*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.

In New CMS Forecast: Drug Spending Grows Along with Impossible Hospital and Doctor Spending, I examined the July 2015 drug spending forecasts from the Centers for Medicare and Medicaid Services (CMS).

Today, I identify new insights about payments in the 2024 drug market. As the charts below show:

• CMS expects the employer-sponsored insurance market to be slightly more resilient than it had previously projected.

• By 2018, however, Medicare, Medicaid, and other public programs will pay more than employers for drugs.

• CMS still projects that individually-purchased private insurance (via exchanges) will account for a small share of drug spending.

As the government’s role grows, don’t tell me you were fooled (again).

eyeforpharma Customer Engagement USA Summit 2015
November 19-20, 2015 | Philadelphia, PA
www.eyeforpharma.com/customer-engagement/

At eyeforpharma’s 3rd annual Customer Engagement Summit, attendees will learn how to engage their key customers through a wide range of channels - from digital to F2F. The speaker faculty selected from both inside and outside the industry will focus on truly intelligent engagement strategies that start with the customer and end with the channel.

Drug Channels readers will save $300 off the standard registration rate when they register with discount code 2772DC300.

Speakers include:

• Jim De Lash, Director Multi-Channel Marketing Execution, GlaxoSmithKline
• Tom Wagner, Leader, Global Digital Governance, AstraZeneca
• Jorge Herrera, LatAm Head of Digital, Pfizer
• Sandra Velez, Content Strategy Leader, Customer Engagement COE, Merck
• John Kane, Director of Commercial Training & Leadership Development, Eisai
• Laurent Flouret, Director Digital Launch Readiness, Sanofi
• Andrew Schwartz, Director NA IT Strategy & Ops, Ipsen
• Greg Cohen, Global Associate Director, Multichannel Marketing, UCB
• Rachel Sosalski, Director, Pharmacy Marketing, GlaxoSmithKline

Download the brochure now to find out who else is on the agenda.

Use discount code 2772DC300 to save $300. Register 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.

In Manufacturers: The Government Wants to Use 340B to Oversee and Publish Your Specialty Channel Strategy, I highlight one area of significant concern in the Omnibus Guidance for the 340B Drug Pricing Program from the Health Resources and Services Administration (HRSA).

To provide perspective on other elements, below I provide links to more comprehensive reviews from four major law firms. Each provides a different spin on key topics in the proposed guidance—patient definition, duplicate discounts, covered entity requirements, contract pharmacy oversight, manufacturer responsibilities, and more.

Hope these analyses temporarily satiate your 340B desires.

Attention, proles! The Health Resources and Services Administration (HRSA) has released its long-awaited Omnibus Guidance for the 340B Drug Pricing Program.

The guidance brings some much-needed clarity to the definition of an eligible patient. Its focus on duplicate discounts and diversion is welcome, as is the requirement that covered entities audit and monitor contract pharmacies.

Unfortunately, HRSA has granted itself intrusive oversight for what it calls “limited distribution plans.” Under the guise of auditing manufacturer compliance, HRSA is asserting novel and impractical review and approval authority over manufacturers' channel strategies.

And as I describe below, every manufacturer is expected to have its channel strategies reviewed and then published by the U.S. Department of Health and Human Services (HHS). Watch out!

CBI’s Final Rule Forum
November 20, 2015 | Philadelphia, PA

Attention, AMP fans! CMS’ long-awaited Final Rule on Covered Outpatient Drugs is officially under final review at the OMB, with an anticipated completion date of October 2015. Mark your calendar for November 20, 2015 and plan to attend CBI’s Final Rule Forum. Here, bio/pharma manufacturers will gain exclusive insight into policy changes and best practices to put learnings into action within their organizations.

Practical Approaches and Positions on:

• Rule dissection, top ten high impact areas and considerations for implementation
• Next steps for changes to the wholesaler ‘build-up’ provision
• Definition of RCPs and impact on 5i products/methodology
• Impact of changes on class or trade and AMP calculations
• Considerations and best practices for system changes/updates
• Bona fide service fees, fair market valuations, and bundling
• Documentation and contracting process changes
• Calculation and implementation of line extensions

PLUS! There will be an exclusive Manufacturer Town Hall led by Biogen, Bristol-Myers Squibb, Celgene, Chiesi USA, Purdue, Sandoz and West-Ward Pharmaceuticals.

Visit www.cbinet.com/finelrule for more information. Drug Channels readers will save $300 off of the standard registration rate when they use code CAP779.*

*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.

This week, I’m rerunning some popular 2015 posts. Click here to see the original post and comments from February 2015

Today’s rerun is especially timely. Yesterday, Zarxio launched at a reported 15% discount to Amgen’s Neupogen, the innovator reference product.

Since my original article, CMS has proposed that multiple biosimilars for the same reference product be grouped into the same J-code. See Payment for Biosimilar Biological Products Under Section 1847A in its July 2015 proposed rule (CMS-1631-P). However, my general math below still applies.

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In Zarxio: How Channel Dynamics Will Limit the First U.S. Biosimilar, I argue that reimbursement and channel dynamics will slow adoption for Zarxio. Zarxio, a provider-administered specialty drug, is a non-interchangeable biosimilar of Amgen’s Neupogen.

Today, let’s catch up on two important items regarding reimbursement for biosimilars:

• In my original article, I didn’t mention the Affordable Care Act’s special reimbursement formula, which provides additional reimbursement for the biosimilar. Below, I explain this methodology and provide a mathematical example using Neupogen and Zarxio.

• Last week, the Centers for Medicare & Medicaid Services (CMS) released a brief Q&A with new details on biosimilars. Highlights below.

Taken together, this information still supports my original conjectures about a moderate pace for adoption for biosimilars paid under the medical benefit—and implies some manufacturer pricing strategies that could influence adoption.