Navigating U.S. and Global Reimbursement Requirements

Here's a conference that should interest Drug Channels readers: CBI’s Reimbursement and Access 2013—A Master Class for Navigating U.S. and Global Requirements. It will be held in Philadelphia, PA on August 13-14, 2013.

Judging by the agenda, the conference will cover many key U.S. drug reimbursement and market access issues. There's also an global market access track, with discussions of the big EU countries: UK, Germany, and France.

Through June 28, Drug Channels readers can register with discount code REIMDC and save $400.* Thanks, CBI!

With a Top Secret Letter, HRSA Blesses Amgen’s New 340B Distribution Plan

Here’s some crucial 340B news—along with a perfect illustration of why the 340B drug discount program urgently needs fundamental reform and oversight.

Amgen just announced that Neulasta purchases by 340B covered entities must be made exclusively from such specialty distributors as AmerisourceBergen’s ASD Healthcare business. Despite loud protests from the Safety Net Hospitals for Pharmaceutical Access (SNHPA), the Health Resources and Services Administration (HRSA) has reportedly decided that Amgen’s distribution plan “will not violate the 340B statute.”

This is a major decision for all pharmaceutical manufacturers that provide discounts to 340B entities. Want to know about HRSA’s guidance? Too bad.

Following in the sad footsteps of other barely-accountable government bureaucracies (IRS, NSA, Justice Department), HRSA has labeled its decision “top secret” and won't release any regulations or public rulemaking about manufacturer distribution strategies. Instead, HRSA continues to operate the 340B program through a tangle of sub-regulatory guidance that is not readily available for public comment or review.

Read on to learn more about Amgen's plan, SNHPA's complaints, and HRSA's "decision."

Listen to My Podcast on the Cigna-Catamaran Deal

This week, I did a podcast interview with Daniel S. Levine, editor of life sciences publisher The Burrill Report. Our topic: Cigna Deal Bulks up Catamaran's Muscle.

In addition to comments on the Cigna-Catamaran deal, we also cover:

• How PBMs influence the healthcare system
• Why the current PBM business model will needs to evolve
• How drugmakers will need to work with payers and PBMs

You can listen to the podcast below or at Cigna Deal Bulks up Catamaran's Muscle. For background on the transaction, see my article Catamaran Sails Away with Cigna’s PBM: Deal Analysis.

Enjoy!

NADAC Momentum: California Abandons Average Acquisition Cost for Pharmacy Reimbursement

You may recall that California was in the process of transitioning Medi-Cal pharmacy reimbursement from the Average Wholesale Price (AWP) benchmark to an Average Acquisition Cost (AAC) benchmark. Would it be Heaven or would it be Hell? Alas, we’ll never know if a CA AAC is a lovely place, because California’s Department of Health Care Services (DHCS) just announced that the its plan is being put on hold. Click here to read the official DHCS statement.

Does this change mean slowing momentum for acquisition cost pharmaceutical benchmarks? I don’t think so. Instead, California actions implicitly endorse the National Average Drug Acquisition Cost (NADAC) data now being collected and published by the Center for Medicare and Medicaid Services (CMS). California wants CMS to take the political hits (and spend the money) to build a new U.S. pharmaceutical pricing benchmark.

The pharmacy industry may want to stab CMS’s efforts with their steely knives, but they shouldn't want to kill this beast. As I see it, they should actually be breaking out the pink champagne (on ice) for cost-based reimbursement, which essentially guarantees pharmacy profits. Read on and let me know if you agree.

Catamaran Sails Away with Cigna’s PBM: Deal Analysis

Last night, Cigna (NYSE: CI) ended months of speculation by announcing a 10-year PBM partnership with Catamaran (NASDAQ: CTRX). Check out the oddly-titled press release, which somehow omits Catamaran’s name from the headline: Cigna Retains and Builds On Success of Pharmacy Business Delivering Market-Leading Value to Customers. Or, click here to listen to the Catamaran conference call.

Catamaran wins big from the deal, because it (1) gains at least $5 billion in incremental revenues, (2) removes a major uncertainty about its business, and (3) can now credibly be called one of the Big PBMs. Cigna’s business will transition to Catamaran over the next 24-36 months.

By structuring the deal as an outsourcing arrangement, Cigna is showing confidence in the independent PBM model. The Catamaran-Cigna relationship looks more like CVS Caremark-Aetna outsourcing deal than the Express Scripts-Wellspring quasi-acquisition. Notably, Cigna did not follow UnitedHealth’s OptumRx strategy of insourcing the entire PBM.

Read on for my perspective on the deal.

Medicaid Drug Rebate Program

I want to remind you about IIR’s 18th Annual Summit on the Medicaid Drug Rebate Program (MDRP), being held in Chicago, Illinois on September 9-11, 2013.

New for 2013 are four never-before-heard pharma case studies from AstraZeneca, GlaxoSmithKline, Acorda Therapeutics, and Janssen Pharmaceuticals. The 2012 MDRP Summit sold out so you should register soon. The 2013 agenda looks very strong, so I expect this year's event to be extremely popular, too. IIR is already projecting more than 500 attendees.

Drug Channels readers can register with promo code XP1858DRC and save $400 off the standard registrations rates. Thanks, IIR!

Profits in the 2013 Fortune 500: Wholesalers, PBMs, and Pharmacies vs. Manufacturers

Time once again for my annual review of the latest Fortune 500 list. Here, I explore the relative profitability of the largest drug wholesalers, chain pharmacies, pharmacy benefit managers (PBMs), and pharmaceutical manufacturers. I also compare these groups with independent pharmacies. These data will help you understand how drug channel intermediaries make money.

Key observations from the new Fortune list:

• Drug channel companies have higher revenues than pharmaceutical manufacturers, so they rank higher on the Fortune 500. This results from quadruple-counting of prescription revenues within the channel. See my explanation below.

• Drug channels companies are profitable. When their profits are measured by Return on Sales, profits of wholesalers, PBMs, and pharmacies are only one-tenth of manufacturer profits. But when these profits are measured by Return on Assets, channel company profitability is about half that of pharmaceutical manufacturers.

• For the second straight year, investors earned higher returns from drugmakers than from the drug channels group. However, the drug channels group has still outperformed manufacturers over the past 10 years.

• The profitability of a typical independent pharmacy is higher than the profitability of the eight largest drug channels companies, including PBMs. Sorry to be the bearer of...good news?

You’ll find the the technical notes are at the bottom. Add a comment or opinion. Enjoy!