Part I: Defining Value
For a growing number of therapies, especially specialty drugs, manufacturers can no longer assume payer coverage and patient access based on regulatory approval alone. Increasingly, manufacturers are being asked to first demonstrate the “value” of the drug – to patients and to the health care system – and thus, justify its price, before being added to a payer’s formulary, which is comprised of those prescription drugs they’ll cover in part or full.
This demonstration of value will ultimately determine who has access to new therapies, but it also determines how patients gain that access. Value determinations can influence whether payers add additional barriers to certain drugs such as requiring prior authorization from physicians or implementing step therapy, which forces patients to fail first on less expensive drugs before trying others. The challenge? There is no objective or shared measure of value.
This whitepaper explores the value equation from the perspectives of the various healthcare stakeholders, drawing from insights from a MassBio advisory group. Its goal is to educate biopharma companies, especially those in early and mid-stages, about the current and expected environment they’re operating in, and considerations these companies must make to ensure patient access when their drug comes to market. It is our belief that the sooner companies start thinking about value and how they will demonstrate it, the fewer hurdles to patient access will exist.
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