Costs for Medicare Patients Significantly Higher during Leucovorin Shortage

San Diego—The cost of care has significantly increased for Medicare patients taking leucovorin and/or Fusilev® (levoleucovorin) since the first leucovorin shortage in 2008, according to findings from a recent retrospective analysis presented during a poster session at the AMCP meeting. The poster was titled Impact of Leucovorin Shortage on Treatment Costs in Medicare Members.

Beginning in 2008, manufacturers of leucovorin, a drug used in several chemotherapy regimens, have been unable to produce sufficient supplies. This shortage, which was attributed in the poster to manufacturing delays, corresponded with the launch of Fusilev, an alternative branded drug option with a higher cost. According to the poster, studies have not shown any superiority of treatment with Fusilev; however, sales of the drug have significantly increased as a result of the leucovorin shortage.

This latest retrospective analysis used data from a large national health plan to study the impact the drug shortage had on per member per month (PMPM) costs for patients in a Medicare Advantage Prescription Drug (MAPD) plan who were receiving leucovorin and/or Fusilev therapies.

To be included in the study, MAPD members between 19 and 89 years of age were required to have ≥1 pharmacy claim for leucovorin or Fusilev during the first 3 months of the respective plan year and have continuous enrollment for the entire plan year.

Participants were excluded if they had ≥1 inpatient medical claim for either drug where the cost of the drug was not itemized.

The primary outcome was the average PMPM costs for treatment using leucovorin and/or Fusilev. Additional outcomes were defined as the average member out-of-pocket costs and the proportion of claims for each product during each plan year.

The researchers found the impact of the leucovorin shortage did not become significant until 2011, several years after the onset of the initial shortage. Fusilev usage saw a 400% increase starting in 2011.

The PMPM costs also rose significantly between 2010 and 2012. Researchers found that in 2010, the PMPM cost was $32.60, compared with a PMPM cost of $432.50 in 2012. During this time, the average sales price (ASP) for the 2 drugs differed significantly and ranged from $0.81 to $2.41 for leucovorin and from $99 to $180 for Fusilev.

Those patients who were either only taking Fusilev or those who were taking a mixed treatment regimen saw higher out-of-pocket costs compared with those taking leucovorin. Researchers reported that the total cost per claim for leucovorin was $27.10 with an average member out-of-pocket cost per claim of $2.40. Comparatively, the total cost per claim for Fusilev was $1049.90 with an average member out-of-pocket cost per claim of $162.40. This meant that members taking Fusilev had as high as 6600% higher cost shares than members who were taking leucovorin.

According to the researchers, there were several limitations to the study including its retrospective design, which relied on medical and pharmacy claims data. Other limitations were that researchers were unable to identify a specific time of the leucovorin shortage, the continuous eligibility requirement may have led to a healthier study population, and there was an assumption that members who switched to Fusilev were impacted by the leucovorin shortage.

They concluded by saying that continuous monitoring of the shortage is necessary for cost management.