NPC Responds to ICER—VA Collaboration on Drug Coverage for Veterans

Robert Dubois, MD, PhD, chief science officer of the National Pharmaceutical Council (NPC), has advised the Department of Veterans Affairs (VA) to be cautious when using the information provided by the Institute for Clinical and Economic Review (ICER)’s drug assessment reports to inform formulary decisions.

In his Health Affairs blog post, Dubois tags the VA as an organization that receives the steepest discounts in the United States, the result of:

• A restrictive formulary that covers only 59% of the top 200 prescription drugs (Medicare covers 85%)
• A statute that guarantees steep price discounts (24% lower than the average sales price)
• Additional discounts for formulary creation.

Dubois raises questions on whether the agreement between ICER and VA’s Pharmacy Benefits Management (PBM) Services would improve access to care for veterans and whether there would be improvement in their health outcomes.

The agreement, made public in June this year, states that ICER will utilize its drug assessment reports to assist the VA in drug coverage and price negotiations with the pharmaceutical industry. The VA PBM staff will integrate data from the reports into VA’s formulary management process, which includes comparative clinical effectiveness and value of drugs. ICER’s value-based price benchmarks are expected to be the basis of VA’s negotiations with drug developers.

ICER has released several reports over the past 2 years, including:

• A value-based price benchmark report for PCSK9 inhibitors
• Evaluation of diabetes prevention programs
• An evidence report on PARP inhibitors for ovarian cancer
• A health technology assessment report for multiple myeloma drugs.

In his piece, Dubois draws attention to a few key considerations that could ensure successful utilization of ICER’s reports by the VA:

1. Need for broader clinical evidence. Looking beyond randomized clinical trials to evaluate real-world performance of drugs is important, according to Dubois, especially for the VA, “where there are populations of patients with complex clinical problems, such as younger veterans with post-traumatic stress disorder and older veterans (covered by Medicare) with multiple chronic conditions,” he writes.

Since ICER does not routinely update its assessments, the VA should consider conducting periodic assessments by leveraging its electronic health records.

2. Including patient and family caregiver perspectives. ICER’s assessments are based on a health system or payer’s perspectives with respect to cost. Dubois urges the VA to consider societal perspectives, such as the economic consequences of a veteran’s ability to work effectively or reducing the care burden on family caregivers.

3. Need for broader value inputs. Value needs a broader definition, beyond cost and clinical endpoints. It should include personal attributes such as quality of life, complexity of the regimen, and caregiver burden.

Dubois also recommends that the VA inform its decisions by using other frameworks developed by the National Health Council, Avalere/FasterCures, and the American Society of Clinical Oncology, among others.

4. Correcting the budget-impact threshold. ICER uses a blanket $915 million budget-impact threshold for all drugs, irrespective of the size of the patient population. “Arbitrary limits on sector spending or a priori division of the health care spending pie (for example, among hospital care, physician services, imaging, and drugs) would neither be economically efficient nor in patients’ best interest,” Dubois notes.