DOWNLOAD THE GUIDING PRACTICES
The National Pharmaceutical Council (NPC) first published guiding practices for value assessment in 2016. That was a time when multiple organizations had created unique value assessment frameworks, each for different purposes.
Since then, the US experience with value assessment has changed substantially, with activities increasingly focused on the value of pharmaceuticals. At the time of publication, the Institute for Clinical and Economic Review (ICER) now issues 6-8 assessments per year, and the Centers for Medicare and Medicaid Services' Drug Price Negotiation Program under the Inflation Reduction Act appears to some observers as a form of value assessment, even though (as of this writing) neither the CMS guidance nor statements from agency officials explain whether the government's goal is to lower drug prices, reduce patient out-of-pocket costs, or get more value for the government's money. In addition, the research methods supporting value assessment - particularly around the inclusion of the patient voice in these evaluations - have continued to evolve.
These have all factored into this update of NPC's guiding practices for US value assessment to help inform the growing importance of this tool to support pricing pharmaceuticals based on the value they provide to patients and society as a whole.
Value encompasses the balance of benefits and costs experienced by patients, their caregivers and families, and society over time. Artificially setting drug prices too low fails to account for the value they provide to patients, caregivers, healthcare systems, and society as a whole.
Value assessment comprises both elements that are science and elements that are judgment, or opinion. With this complexity, there is no single answer to a value assessment and it should be viewed as a tool, not a rule to set prices. Nonetheless, high-quality, comprehensive value assessments can inform both payer coverage policies as well as the price that is negotiated between payers and manufacturers.
NPC's updated guiding practices are aimed at facilitating these market-based, individual payer-manufacturer value-driven negotiations to best account for the diverse needs of payers' enrolled populations, local treatment practices, and stakeholder preferences.
Key tenets of our guiding practices address the full spectrum of value assessment uses and activities:
- Value assessment is a multi-stakeholder deliberative process and value-based prices should not merely be the output of a cost-effectiveness model or based on a single threshold.
- The assessment process should be systematic, objective, and transparent and should involve affected stakeholders throughout the assessment process to represent all perspectives. And, with the rapid pace of medical innovation, assessments should be regularly reviewed and updated to keep pace.
- Scientific methods supporting value assessments should focus broadly on all aspects of patient care and healthcare systems, not just on medications. Methods, models, and assumptions should be transparent and follow scientific best practices so that assessment results will be reproducible.
- Benefits of innovation included in assessments should capture the broad array of benefits important to patients and society. Doing so requires engagement with multiple stakeholders, evidence types, and analytic tools should be incorporated in the assessment to capture all relevant dimensions of value.
- Costs of treatment, all healthcare costs, and cost offsets should be included in assessments. Time horizons for costs should be long enough to incorporate the benefits of the treatment and the lower costs of medications when they face branded and generic competition.
- The evidence used throughout assessments should be identified in a systematic, transparent, and robust manner. The best available evidence should be used for the assessment and the evidence should be appropriate for the outcome evaluated; clinical trials and real-world evidence should be evaluated.
- Finally, assessment results should be disseminated in a manner that is transparent and easy for users to interpret and apply. Communications around value assessments should clearly state the intended use and audience to avoid misuse.