“Value” — especially in the context of healthcare and medicine — is a word that gets used so often these days, and in so many different ways, that it can be difficult to pin down exactly what it means – or should mean. In the debate over the value of prescription medicines, a recent proliferation of what are commonly known as “value assessment frameworks” have used different approaches to quantify anything from a medicine’s efficacy to its launch price in an effort to define its value.  And many healthcare stakeholders – including payors, patients, providers and policymakers – are paying attention to these efforts.  It isn’t clear how and to what extent any of these frameworks are being used to make clinical decisions, but we do know that payors, including Medicare, are watching these efforts closely. We also know that—unless value assessments are patient-centered, methodologically rigorous, and holistic in their approach—any attempt to rely on them to make coverage or care decisions can actually lead to a less efficient, less effective healthcare system by limiting patient access to appropriate medicines.

America’s biotechnology companies are committed to doing our part to ensure that these value frameworks facilitate, rather than hinder, patient access to needed medicines and support the medical innovation ecosystem that is dependent on large, long-term and risky investment to flourish. In particular, BIO has been engaged with the Institute for Clinical and Economic Review (ICER) on its Value Framework and its use for over a year.  Earlier this month, we submitted comments in response to ICER’s call for public input.  Our comments recognize the strides that ICER has made to include opportunities for public comment, but reiterated our grave, persistent concerns that ICER’s methodology does not yet meet the standards of patient-centeredness, methodological rigor, and a holistic assessment of all facets of the value of a medicine over the course of a patient’s life.  

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And we are not alone in these concerns: groups from the research-oriented National Pharmaceutical Council to the National Health Council to Faster Cures are weighing-in on what value means and how it should be assessed.  On this issue, broad participation is needed to ensure that all perspectives are well represented.

Relying on a single voice from a single perspective – like ICER’s, which tries to assess the value of new-to-market medicines based on limited clinical data and incomplete (or nonexistent) pricing data – will not provide the answers to the serious questions that make value assessment an important tool.  Instead, it can lead us down the path of delaying or denying patient access to needed medicines and stifling future, better innovations.  That would be particularly short sighted, given that innovative medicines are one of the best opportunities to reduce total healthcare expenditure over the long term. For example, estimates show that the U.S. stands to save $367 billion in health services by 2050 if biotechnology companies can develop a therapy that simply delays the onset of Alzheimer’s disease by just five years.

Transparency is an important piece of this discussion as well: those organizations that put forward value assessments are not necessarily the same ones that make coverage decisions, which have a real, lasting impact on patients, the healthcare system and society as a whole. This complexity and interconnectedness requires a diverse group of stakeholders to contribute to what is, ultimately, a societal dialogue on how to sustain the innovation that has brought us better and safer treatments, and increasingly cures, while ensuring patients can access the medicines they need without delay.

BIO has been engaged with ICER and other groups because we support value assessment, which we believe is an important input into the goal of getting the right medicine to the right patient at the right time. How these assessments are conducted and how they are used are central in determining whether they facilitate, rather than hinder, improving efficient, effective and individualized patient care.

Done right, value assessments can play a critical role in informing patient/provider decision making and reducing payer-imposed barriers to access, which, in turn, can improve individual patient health outcomes, lead to greater system efficiency, and contribute to decreasing overall healthcare expenditures. But none of us should be satisfied with trading simplicity or speed of assessment for accuracy, thoughtfulness, and holistic assessment.  BIO and our members will continue to be committed partners in moving the healthcare system toward delivering, and paying for, care that is valuable to patients and society.

Greenwood is the president and CEO of the Biotechnology Innovation Organization (BIO) in Washington, DC. He served Pennsylvania's 8th Congressional District from 1993 to 2005.


The views expressed by authors are their own and not the views of The Hill.