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Am J Manage Care. 2022:28(9): in press
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Pick up points
- Good policy requires good research.
- Lack of reproducibility in research results raises questions about the quality of evidence.
- We need to hold studies to make policy as high as possible. Failure to do so means that our policy arguments are, to say the least, ill-informed. At worst, blindly accepting misleading information can lead to policies that harm patients, consumers, and employers.
- The National Pharmaceutical Council recently released the Guiding Principles for Healthcare Costing to promote rigorous, evidence-based evaluation and discussion of healthcare cost estimates and policies.
- Our goal should be to improve the efficiency of healthcare spending and maximize patient health. Using these principles to determine the true rigor of any study provides policymakers, journalists, and others with better evaluation tools in this endeavor.
- Good research, placed in the proper context and fully understanding the inherent risk, uncertainty and potential trade-off of any recommendations is incredibly valuable.
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Health spending continues to grow, with total spending exceeding $4.1 trillion in 2020, or 19.7% of US GDP.1 Concerns are mounting about the sustainability of further increases, and details of a recent proposal to allow the federal government to “negotiate” drug prices have just been released.2 At this critical juncture in the health spending debate, what policymakers desperately need is an honest, objective, and evidence-based discussion. That’s not happening, mainly because policymakers are inundated with poorly designed studies, drawing conclusions based on unrealistic assumptions that aren’t supported by evidence.
With the right tools, policymakers and other decision makers can better evaluate these studies to ensure that policy discussions are properly based on evidence. Qualitative research allows them to identify deficiencies in rigor and operational methods; It can also foster greater confidence in empirical research that is transparent in methodology and assumptions.
That places a special burden on health policy researchers, who must design studies using data, assumptions, and methods that are appropriate for the case and be clear about which questions are intended to provide relevant insight.
Unfortunately, many studies in the public arena fall far short of this. Reproducibility, the ability of an independent researcher to replicate the results of a study, is one criterion for evaluating the quality of evidence. Three studies assessing reproducibility met this criterion in only 40% to 62% of cases, raising questions about the quality of evidence.3-5
Challenges are not limited to the quality of the results but also to the interpretation of these results. An oft-cited 2015 study , for example, notes that “many of the key insights” that led to transformational medicine began with publicly funded basic research.6 Proponents of government price controls argue that the findings of this study suggest that as long as government investment is high, the rate of innovation will remain unchanged.7
However, policymakers should be aware that the research shows that the pharmaceutical industry can invest more than $1 billion per treatment, compared to government investment of tens of millions of dollars. If private investment declines, what causes the gap? The study is silent on this question.
The point here is that we need to hold policy-informed studies to a higher standard. Failure to do so means that our policy arguments are, to say the least, ill-informed. At worst, blindly accepting misleading information can lead to policies that harm patients, consumers, and employers.
As part of our commitment to robust and quality research, the National Pharmaceutical Council recently issued guidelines for the Health Care Costing Guidelines to encourage rigorous, evidence-based evaluation and health care costing estimates and policies.8
These principles can help decision makers assess methodological rigor, limitations, and consistency with patient-centered care and provide a framework to guide the evaluation of policy proposals by identifying trade-offs, uncertainties, and unintended consequences. These thoughts.
Our goal should be to improve the efficiency of healthcare spending and maximize patient health. Using these principles to determine the true rigor of any study provides policymakers, journalists, and others with better evaluation tools in this endeavor.
Good research, placed in the proper context and fully understanding the inherent risk, uncertainty and potential trade-off of any recommendations is incredibly valuable. Anyone involved in the drug pricing debate, regardless of their views, should accept the standard of good research.
Doing so allows stakeholders in the health care system to have an honest conversation about how to best address rising health care costs and promote patient-centered care.
That talk is worth having.
Author contact: National Pharmaceutical Council (MC, JMO), Washington, DC.
Funding Source: nothing else.
Author Disclosures: Mr. Ciarametaro is a former employee of the National Pharmaceutical Council, a health policy research organization supported by the biopharmaceutical industry. Dr. O’Brien is an employee of the National Pharmaceutical Council.
Author information: Concept and Design (MC, JMO); Access to information (MC); Data analysis and interpretation (MC, JMO); Drafting of the manuscript (MC, JMO); critical revision of the manuscript for important intellectual content (MC, JMO); Access to financial support (MC, JMO); administrative, technical or logistical support (MC, JMO); and supervision (MC, JMO).
Address relevance for: John Michael O’Brien, PharmD, MPH, National Pharmaceutical Council, 1717 Pennsylvania Ave NW, Ste 800, Washington, DC 20006. Email: jmob@npcnow.org.
References
1. Kourani N, Ortaliza J, Wager E, Fox L, Amin K. How has US health care spending changed over time? Peterson-KFF Health System Tracker. In the year 20 billion, %201970-2020
2. Subtitle I–Prescription Drug Price Modification. Senate Finance Committee. Accessed August 1, 2022. https://www.finance.senate.gov/imo/media/doc/070622%20Prescription%20Drug%20Pricing%20Reform%20Leg%20Text.pdf
3. Open science collaboration. Psychology. Presuming the rebirth of psychological science. Science. 2015;349(6251):aac4716. doi: 10.1126/science.aac4716
4. Klein RA, Vianello M, Hasselman F, et al. Multiple Labs 2: Examining Repetitive Variance Across Samples and Settings. Practice adv methods psychol psychology. 2018; 1 (4): 443-490. doi:10.1177/2515245918810225
5. Camerar CF, Dreber A, Holzmeister F, et al. Assessing the frequency of social science experiments in Nature And Science Between 2010 and 2015. Nath Hum behavior. 2018; 2 (9): 637-644. doi:10.1038/s41562-018-0399-z
6. Kesselheim AS, Tan YT, Avorn J. Roles of academia, rare diseases and rehabilitation in developing highly transformative drugs. Oral Health (Millwood). 2015;34(2):286-293. doi:10.1377/hlthaff.2014.1038
7. Kesselheim AS, Avorn J. Allowing government to negotiate drug prices does not hurt innovation. The Washington Post. September 22, 2021. Accessed June 13, 2022. https://www.washingtonpost.com/outlook/2021/09/22/drug-pricing-negotiation-biden-bill/
8. Principles of health care cost guidance. National Drug Council. May 12, 2022 Accessed on May 12, 2022. https://www.npcnow.org/hcsgp
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