A budget impact model was developed for Praluent for a hypothetical health plan.

1. A Budget Impact Analysis of Alirocumab in Heterozygous Familial
Hypercholesterolemia Treatment
Background:
Heterozygous familial hypercholesterolemia (HeFH) is a rare genetic disease affecting an
estimated 1:500 people. The disease results in LDL levels far above the recommended
range which results in an increased risk of adverse cardiac events. Current standard of
care treatment options such as high intensity statins and ezetimibe, only achieve
recommended LDL levels, instituted by ATP III guidelines, in 20% of treated
patients.PKSC9 inhibitors are a new class of effective but highly priced drug therapy
recently approved to treat HeFH that have been shown to be safe and more effective in
lowering LDL to guideline recommended levels.
Objective:
The aim of this study was to prepare a budget impact analysis based on pharmacy drug
costs only, as outcomes data was not yet available, to assist a commercial health plan in
evaluating the 1 year financial impact of the introduction of Alirocumab to their
formulary for the approved treatment of Heterozygous Familial Hypercholesterolemia.
Methods:
A budget impact analysis was developed for a hypothetical commercial US health plan
consisting of 1 million members ages 18-64 years old. Data was inputted into a model
created in an excel spreadsheet. Model inputs included disease prevalence reported from
the center for disease control, target population, drug costs obtained from whole sale
acquisition costs from Red Book (accessed June 2015), and estimated drug market shares
based on treatment guidelines and efficacy data. Costs were reported in 2015 US dollars
as total overall costs, price per member per month (PMPM), and price per treated
member per month (PTMPM). A One-Way sensitivity analysis was performed on the
study assumptions which included the costs of the new treatment and the already
established medications for treatment, and the percentage of patients treated.
Results:
An estimated 1,600 of the hypothetical 1,000,000 enrollees were projected to be treated
for heterozygous familial hypercholesterolemia. It was estimated based on current
treatment data, that 70% or 1,120 enrollees would be placed on Alirocumab due to lack
of meeting ATP III LDL goals by current basic standard of care treatments. Statistical
analysis was done on drug costs only. It was found that the addition of Alricoumab as a
treatment option resulted in a total drug spend of $11,712,160 over a 1 year time horizon.
The estimated PMPM for all covered lives was $0.976 while the estimated PTMPM for
all covered lives was $7,320. Based on the sensitivity analysis, the PMPM after the
introduction of Alirocumab had a range $0.883-$1.074 and the range for PTMPM was
$6,954-$7,686.

2. Conclusion:
Alirocumab has been proven by multiple double blind, placebo, controlled clinical trials
to be safe and effective with 94% of patients treated achieving LDL levels less than
100mg/dL. It is an effective treatment option for patients who are not achieving their
LDL goals on a high intensity statin with or without ezetimibe. However, the high
projected cost of $10,000 for a one year of treatment with alirocumab will need to be
heavily weighed when making formulary decisions. A better analysis will be able to be
formed when data from the ODYSSEY OUTCOMES trial is released in 2017.

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