Drug shortages can drive up costs for patients, and a new analysis suggests ways these issues could be avoided.
Take belatacept, for instance, a drug that prevents organ rejection. In October 2016, a spike in demand for the medication generated a shortage that created access problems for many consumers, according to a report (PDF) by the office of the Assistant Secretary for Planning and Evaluation (ASPE) based on data compiled by the RAND Corporation.
The report explores how drug shortages affect consumers, and what occurred with belatacept represents just one case study. After the shortage ended, there was a 46.6% increase in volume for the medication.
“In the 12 months following the shortage, the average price of alternative drugs for belatacept increased more than the price of belatacept," according to the report.
Another example included in the report is asparaginase, a drug for acute lymphoblastic leukemia. Manufacturing and capacity problems in March 2017 resulted in a 73.7% increase in the price of alternative drugs, while the price of asparaginase decreased by 45%.
The authors note that while prior investigations focused on the frequency and duration of drug shortages, this ASPE report explored just how those shortages affect consumers. Drug shortages increase the cost of the drug in question as well as their substitutes, the report concluded.
In addition, the increase in the cost for the substitute drug can be substantially higher than the drug in short supply.
Before a drug enters shortage, 652,100 individuals a month fill prescriptions to meet their medical needs, according to the report. A year after the shortage saw a reduction of 10.8% in those filling prescriptions. The impact by age: 65 to 85 (32%) fewer prescriptions filled, 55 to 64 (24%) and 45 to 54 (17%).
Sales of a drug a year after the shortage ends drop between 28% and 35%; generic drug sales dropped 37.6%, and brand name drug sales dropped 30.4%.
Overall, the study found that the prices of drugs in shortage increased by 16.6%, which was largely backed by an increase in generic drug prices of 14.6%,
“In some cases, the increase in the price of substitute drugs was at least three times higher than the price increase of the drug in shortage," the researchers wrote.
However, the report suggests some policy changes that could remedy the situation. For one, manufacturers should reach out to the Food and Drug Administration (FDA) about manufacturing disruptions that could lead to shortages. In addition, the FDA could expedite the review process for certain drug applications to address demand.
Policymakers could also require drugmakers to produce yearly reports on the amount of each drug that they manufacture, compound, propagate or process for commercial distribution that is in storage, according to the report.
Though the FDA currently gathers information from drug manufacturers that could help the agency spot possible shortages, that information doesn’t provide an extensive review of potential supply chain vulnerabilities, according to the report.
“Collecting additional data such as notifications when a shortage is expected due to an increase in demand, manufacturing volume, and original manufacturer and supply chain information could enhance FDA’s visibility into the supply chain,” the analysts wrote. “These data would also help develop better surveillance and modeling methods or other tools that can help to more quickly identify potential shortages and to help target resources and outreach efforts more efficiently and more proactively.”