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ISPOR Task Force Grapples with Value Questions


ISPOR's Value Assessment Stakeholder Conference showed its Special Task Force still reaching for clarification around the subject, writes Ansis Helmanis.

The International Society for Pharmacoeconomics and Research’s (ISPOR) Special Task Force has taken on the notable challenge of developing a national umbrella Value Assessment Framework for healthcare. The scope of the challenge facing the Task Force is underscored in a recent National Pharmaceutical Council (NPC) report that notes that existing value assessment frameworks are “challenging for the user to interpret and apply because they utilize different scores with different meanings.”  Moreover, they various frameworks have varying approaches as to how quality, certainty and consistency of evidence are evaluated - and only one uses patient-centered quality metrics.

ISPOR’s September 23 Stakeholder Conference in Washington DC was convened to provide a platform for stakeholder input to help progress the work of the Special Task Force.  Given that the issue of value assessment is of critical importance to the research-based pharmaceutical industry, a question posed by a Pfizer representative at the conference as to how a cure would be assessed as to value was not unexpected.  The question, however, appeared to be unexpected by the Stakeholder Panel, until the co-chair of the ISPOR initiative merely responded that the Task Force was not going to ‘grapple’ with the cures issue.  A surprising response given that Gilead’s cure for hepatitis C was a milestone for the industry and for healthcare, and one would have assumed for the value assessment process as well.

Not surprisingly the cures question is one of importance also to payers, and Aetna’s representative on the Stakeholder Panel did ‘grapple’ with the question.  He noted that the value assessment process could consider the broader context of the savings such a drug would provide to the overall social security system, which might help translate into a way of paying for a cure. The example he gave was the cure for hepatitis C, which not only saves the substantial expense for kidney transplants incurred by the health care system - it also protects others from contracting the virus. 

The payer’s representative also addressed in pragmatic terms what was needed from value assessment frameworks, namely ‘how do we know what’s good and how to use it.’  Noting that at drug launch the least was known about a drug, he proposed incorporating real world experience into the assessment process.  Most of the assessment frameworks that the Task Force will review draw solely on the clinical trial data that was used to support the initial drug approval.  Only the Institute for Clinical and Economic Review (ICER) framework for value incorporates post-marketing experience, if available.

Also noteworthy about the Conference panels was that the medical device industry was conspicuous by its absence.  Personalized medicine is of growing importance to the health care system and it relies on In Vitro Diagnostics (IVDs) to answer the question as to the patients that would benefit from a new drug.  Without IVDs there would be no ‘personalized medicine.’ That may well be the reason why the Conference’s keynote speaker, Dr. McClellan, mentioned the need to incorporate medical devices within the value assessment process. 

Hopefully the work of the Special Task Force was progressed by this Stakeholder Conference, and there may well be a need for another such conference.

Ansis Helmanis is a former FDA official and founder of RegLink Associates.

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