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Biotech industry has "implementation gap" around demonstrating the value of products under development
Date:4/22/2013

ate product value.

Key findings include:

  • Near-consensus on strategic importance: 94% or more of the survey respondents agreed that it is "important" or "very important" for biotech companies to have a strategic focus on matters of efficiency and matters of evidence.
  • Implementation gap on matters of evidence: However, among respondents who considered evidence measures to be "important" or "very important", most companies indicated that they are unlikely to undertake specific evidence-focused initiatives. Only 11% of respondents have added payer/reimbursement expertise to their management teams, just 13% have added such expertise to their clinical development teams and a scant 4% have added such expertise to their boards of directors. There was no such implementation gap around initiatives focused on matters of efficiency.
  • New approaches needed: To succeed, companies will need to revisit their approaches to R&D. It will be imperative to monitor evolving standards of care. A model Ernst & Young calls the "value pathway" can help identify the biggest unmet needs or failures that payers will be most focused on. Companies will then need to align their offerings to fill these "value leakages" and design clinical trials to develop evidence that is compelling for payers (e.g., through head-to-head or adaptive trials).
  • "It's time for biotech firms to debunk any myths that may be holding them back," concludes Glen Giovannetti . "The shift to evidence is happening faster than many might have expected, and it affects companies regardless of their size, maturity or disease focus. Many evidence-focused initiatives — engaging stakeholders earlier on issues of value and reimbursement, rethinking trial design or exploring pre-competitive data collaborations — don't cost much and could even avoid of the expense of additional studies. The question is not whether you can afford to do this, bu
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    SOURCE Ernst & Young
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