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Real World Evidence – “In God We Trust, All Others Must Bring Data”

Pharmaco-economic data is to a payer or Value Analysis Committee (VAC) what clinical data is to the FDA.

But here’s the conundrum, while companies spend lots of money and time assembling evidence based arguments supporting the price of their new products, payers and VAC’s often view these with a healthy dose of skepticism. When it comes to the data, you’re damned if you do, but really damned if you don’t.

The challenge comes from the fact that real world evidence cannot be developed while a drug or new device is still in clinical development. Clinical trials are not real world and a company can’t have real world evidence until it’s used in actual practice. It’s a circuitous challenge that companies face at launch: convincing payers that the absence of evidence is not evidence of absence.

While payers and VAC’s tend to be highly rational, their thinking is influenced by intuition and past experience. Are the benefits of the new product intuitively obvious? Is there evidence in the clinical trials and is the trial design credible enough to be believable? Is the period of time short enough to be meaningful? If the answers are yes, they are more likely to give the company the benefit of the doubt as far as access, even if the new product is priced higher. If the benefits are not obvious, or there’s a lack of clinical trial data supporting the potential benefits, access or use is going to be much more difficult to achieve.

Developing New Life Science Products - An Rx for Success

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Harris Kaplan is Managing Partner of Red Team Associates, a boutique life sciences consultancy, and CEO of Healogix, a life sciences marketing research company. His resume includes work on the introduction of more than 100 new products including drug, biotech, device, and diagnostics. He is a commercial strategist who frequently presents and authors pieces on how the shift from a provider to a payer and patient centric world impacts new product innovation. Harris’ understanding of these seismic shifts in the life sciences landscape has made him a leader in the space and much sought after by clients ranging from startups to large multinationals. Harris excels at helping companies develop their commercial and go-to-market plans in support of new products. He has also been an advisor to multiple venture capital and private equity groups relative to assist their portfolio companies.

Harris’ articles have appeared in In Vivo, Medical Marketing and Media, and Product Management. He has presented at Intellus Worldwide Institute, Windhover’s Therapeutic Area Partnerships, IN3 Device Conference, World Orphan Disease Conference, Life Science Alley, the Biotech Conference at UC Berkley, Pharmaceutical Strategy Conference, and the Drug Information Association. He was also nominated as one of Pharma Voice’s most inspiring people in 2011.

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Harris Kaplan, Managing Partner
Red Team Associates
harris.kaplan@redteamassociates.com
410-215-9595