DUTOPROL: a unique approach

Darshan Kulkarni

Kulkarni law firm

Introduction

I am in favor of companies looking at new and non-traditional ways of putting their product forward. AstraZeneca launched DUTOPROLTM (metoprolol succinate extended release / hydrochlorothiazide) on Apr 12, 2012 as a once a day drug, at a wholesale acquisition price of $15.90. In order to sell DUTOPROL at this competitive price, AstraZeneca decided to “eliminate the middleman”, which are often the wholesalers and distributors. However, AstraZeneca also took the unusual step of eliminating the need for a pharmacy. According to their press release AstraZeneca decided to offer to directly mail the product to patients.

Unique Approach

Instead of a traditional payer contracting strategy, AstraZeneca has taken a novel approach in launching DUTOPROL at a wholesale acquisition price ($15.90) that’s competitive to the generics of TOPROL-XL ®  and hydrochlorothiazide tablets, with or without insurance coverage.

Definitions

The State of Pennsylvania defines pharmacy as “The place licensed by the Board where the practice of pharmacy is conducted.” And the practice of pharmacy is defined as “The provision of healthcare services by a pharmacist and includes the delivery, dispensing, or distribution of prescription drugs.”

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“AstraZeneca also took the unusual step of eliminating the need for a pharmacy…”

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Concerns

So, is AZ not only replacing the “middleman” (i.e. wholesalers, distributors) but also pharmacists?

States require pharmacies to register. I assume AZ has somehow opened up and registered its own internal pharmacy, which is an unusual approach.

Larger implications

What does it mean for pharmacy as a career? If more and more pharmaceutical and life sciences companies decide that they want to eliminate the middleman and adopt a more patient-centric model, which doesn’t require the usual interaction with a pharmacist, is the necessity of the pharmacy minimized? And what does that mean in terms of the career of a pharmacist?

Conclusion

On the other hand, the ingredients of this drug are available in products already available in the market. So is this just a way for AZ to experiment with a new model, and is this new model not expected to be applied to other products? Would this be an appropriate model to use in the case of specialty products, which have unique dispensing and / or educational needs?

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“So is this just a way for AZ to experiment with a new model…”

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These answers can only be discovered in the coming weeks, and I look forward to hearing from AZ about what they intend to do.

Open Questions

1. Is AZ changing its model to have its own pharmacy? (Are they a new payer, new wholesaler, or new pharmacy?)

2. Is this an opportunity for new jobs for pharmacists or fewer jobs for pharmacists?

3. This drug is clinically comparable to several pharmaceuticals and / or combinations of pharmaceuticals already on the market. So, will this lower costs or is this a one off situation?

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European-CME-Forum-15-16-November-2012

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DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.

About the author:

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance / Regulatory Affairs, and a Juris Doctorate degree. He works with and / or for research sites, clinical research organizations and a variety of small and large Life Sciences companies to assist them in meeting their clinical, legal, regulatory and / or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.

You can follow him on twitter at @FDALawyers or visit him at the Kulkarni Law Firm.

Is AZ changing its model to have its own pharmacy?