The Institute for Clinical and Economic Review (ICER) and the U.S. Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office made news recently by announcing a collaboration to evaluate the comparative clinical effectiveness and value of drugs for use by U.S. veterans. In a new blog published by Health Affairs, NPC Chief Science Officer and Executive Vice President Robert W. Dubois, MD, PhD, expands on our initial thoughts on this collaboration and explores why the VA should proceed with caution.
Dubois breaks down four key considerations the VA should address before using ICER’s value assessment framework as part of its formulary development and price negotiations:
- Broaden the clinical evidence beyond randomized controlled trials (RCTs): ICER reviews are typically performed just before or as drugs gain approval from the U.S. Food and Drug Administration (FDA). That means the evidence used in ICER’s analysis is almost exclusively data from randomized controlled trials (RCTs) and misses the real-world insights that come from post-approval analysis and research. How does a drug fare among the VA’s unique population? Unless ICER assessments are routinely updated to incorporate data from the VA’s large, information-rich databases, they will be making coverage decisions for service members and their families without the most relevant information and insights from their own patient databases.
- Consider the perspective of veterans and their families and the health care system: When it comes to weighing the value of a medication, ICER’s assessments incorporate the perspectives and costs that are most relevant to health systems and payers – not the costs and consequences that can impact service members and their families. Particularly for veterans navigating complex conditions like PTSD, loss of limbs or chronic pain, the ability to return to work or reduce reliance on a caregiver can deliver benefits that are not included in ICER’s calculus of value.
- One size can’t fit all– there is a need for a broader set of value inputs: Assessments of value and what is important to patients differ by disease, the stage of that disease and personal determinants of those patients. ICER’s value framework is one of many tools for decision-makers, like those developed by the American Society of Clinical Oncology or the National Comprehensive Cancer Network. The VA should not tie the benefits of their entire population to just a single assessment, but instead incorporate information from a fuller range of approaches to address patient-centered inputs.
- Arbitrary spending limits on individual drugs is an incorrect policy: ICER’s current value framework uses a $915 million budget impact threshold for an individual drug. That static value doesn’t take into account whether the medication treats a large or small patient population. Arbitrary spending limits can put the brakes on using treatments that stand to offer the most benefit for patients, like therapies for Hepatitis C, and potentially reduce other health costs like hospital care.
In the discussion around improving health and health care, few things are more important than upholding our nation’s commitment to veterans and their families. To continue their work to promote quality throughout the system, the VA should proceed with caution before relying on ICER’s assessments.
For more information on value assessment frameworks, see NPC's Guiding Practices for Patient-Centered Value Assessment, our landscape assessment of value frameworks and other related resources.