GLG News by Generic Drug Economic Experts

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

Risk/Benefit is the Answer, Even More Now

December 22, 2008

Analysis of:Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died | www.msrc.co.uk

1. In general, the more pharmacologically potent a therapy, the more the possibllity that adverse experiences will be seen. 2. Risk/Beneift is a critical consideration, even for products intented for serious or life-threatening disease. It is incumbent upon both the FDA and the physician community to realistically assess preclnical and clinical data during the review and approval process. 3. Patients must be fully and competently informed of the risks and benefits of such therapies and have the right to decide for themselves whether or not to participate in clinical trials and therapeutic treatment with marketed products. 4. No therapeutic regimen is risk-free and society needs to understand and embrace this fact.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

An Unfortunate Victory for EU Repackagers

December 9, 2008

Analysis of:EU Exec Drops Drug Repackaging Ban Plan | www.reuters.com

Reuters reported on Friday that the EU plans to drop a proposed ban on repackaging of pharmaceuticals. In my opinion, dropping the ban is a very bad decision. Repackaging eliminates the benefit of just about every practical anti-counterfeit tracking technology, including the emerging serialization requirements in some EU countries. Apparently, tablets can even beremoved from blister packs under EU law. It’s hard to see how this will benefit consumers.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

Cardinal Health Rebuilds Reputation with DEA Compliance Efforts

December 8, 2008

Analysis of:Cardinal Health Builds Out its 'Suspicious Order Monitoring Program' | pharmaceuticalcommerce.com

Now that Cardinal Health (CAH) has finally resolved its long-standing DEA issues, the company has quietly launched a series of intriguing Medication Safety web pages. I’m impressed by these initial public efforts at education and greater transparency, although it’s obviously a work-in-progress. Cardinal needs to more clearly describe how a more secure supply chain will translate into sales growth among its now highly monitored pharmacy customers. I’d also like to see the initiative evolve into anti-counterfeit education aimed at changing behavior by pharmacy buyers and consumers.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

Pharmacy Groups Oppose First Databank AWP Settlement

December 3, 2008

Analysis of:NACDS, FMI Urge Court to Oppose Proposed AWP Settlements that Would Penalize Retail Pharmacy and the Patients They Serve | nacds.org

NACDS and FMI filed another brief in opposition to the controversial proposed First Databank settlement, although they overstate their arguments in a few places. I expect this battle to heat up over the next month as we get closer to the late December hearing about First Databank’s settlement. This hearing represents another blow to the use of Average Wholesale Price (AWP) as a reimbursement benchmark for pharmaceuticals.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

McKesson settlement is next step in the demise of AWP

December 2, 2008

Analysis of:McKesson Agrees To Settlement In Pricing Suits | online.wsj.com

McKesson Corp (MCK) settled its pending class action suit for $351 million and set aside a further $143 million reserve for certain future claims. The settlement removes a source of uncertainty for McKesson, but also signals the beginning of the end for the Average Wholesale Price (AWP) benchmark. Average Wholesale Price (AWP) data for pharmaceuticals is still being published, but will continue to lose appeal as a reimbursement benchmark for pharmacies and Pharmacy benefit managers (PBMs).

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

CVS Escalates the Generic Price War

November 13, 2008

Analysis of:CVS joins generic drug price war | www.upi.com

CVS Caremark (CVS) launched its new Health Savings Pass, which allows customers to buy 90 day supplies of over 400 generics for $9.99 (after paying an enrollment fee of $10). The new program sounds like a logical pre-emptive strike against anticipated share losses. Translation: an old-fashioned, race-to-the-bottom price war! A barrier has been breached with CVS’ entry into the discount retail generics game. It seems inevitable that this war will suck a lot of margin from the pharmacy and PBM industry over the next few years. I’m also puzzled by the fit between the new generic program and the legacy Caremark mail order business.

David ZimmermanPresident/OwnerDoctors of Pharmacy, Inc.

Tamper Proof Narcotic Pain pill? YES

November 13, 2008

Analysis of:FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com

This drug will allow patients in severe pain to get the necessary pain relief and not have to worry about the other patients that abuse the drug.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

Crestor's results in the Jupiter Study likely to change medical-economic perspectives in statin choices.

November 13, 2008

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

1:Crestor is the most potent statin in the market,yet is 3d in sales behind Zocor and Lipitor.2:The efficacy supriority together with its capacity to lower CRP levels led to the highest rate of ASCVD prevention in the shortest period of time evr documented in statin trials.3:The trial in near 18,000 patients with otherwise lower risk of ASCVD offered $0% reduction y many ascvd endpoints.4:There were no statistical differences in side effect compared to placebo.5:The dosage was 20 mg /day (an intermediate dose below the approved max dose of 40 mg/day

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

New Details on WMT-CAT Pharmacy Deal

November 6, 2008

Analysis of:Caterpillar/Wal-Mart Rx Drug Pilot Scraps Use of Average Wholesale Price, Uses Drug Cost-Plus Pricing | www.aishealth.com

A just-published article in Drug Benefit News provides new details about the Wal-Mart’s (WMT) $0 generic co-pay program with Caterpillar (CAT). Anyone involved in the pharmacy channel – pharmacies, pharmacy benefit managers (PBMs), insurers, payers, drug wholesalers – should be paying attention to the Wal-Mart/Caterpillar arrangement. Pharmacy channel margins on generic drugs will be increasingly seen as a mechanism to control total drug spending. As a result, I expect even more adoption of cost-plus reimbursement models as Wal-Mart continues to challenge the pharmacy industry's traditional economic model.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

Walgreens buys McKesson Specialty Pharmacy: A Win-Win Deal

November 4, 2008

Analysis of:Walgreen Co. to Acquire Specialty Pharmacy Business from McKesson Corporation | news.walgreens.com

Walgreens (WAG) announced the acquisition of McKesson’s (MCK) specialty pharmacy business in a win-win transaction for both companies. The deal makes sense for both parties as long you understand that specialty distributors sell products to physicians, providers and pharmacies, while specialty pharmacies dispense products to individual patients. It also makes a lot more sense for Walgreens than its now-abandoned plan to buy Longs Drug Stores (LDG).

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