Introduction

Hospitalized patients with inherited or acquired disorders of afibrinogenemia or hypofibrinogenemia need fibrinogen replacement to prevent bleeding or stop hemorrhage. Guidelines recommend using cryoprecipitate (CP) or fibrinogen concentrates (FC) for replacement. While both options are plasma derived, they vary in hospital acquisition cost, purity and fibrinogen concentration (FCo). CP is made by thawing leuko-depleted fresh frozen donor plasma (not pathogen reduced), then centrifuged and resuspended in plasma and kept below freezing (shelf-life ~1 yr) and has a FCo of 3-30 g/L per unit. In contrast FC is highly purified, virus inactivated, lyophilized permitting storage at room temperature shelf-life ~3 yrs) with a FCo of 200mg/dl. For easier dosing comparison of CP and FC, 50 to 200 ml of CP requires 50 to 200 mL (5 to 10 units) of CP to obtain at least 750 mg to 1500 mg of fibrinogen. In contrast, with FC, 50 mL of FC contains 900 mg to 1300 mg of fibrinogen. There are 2 namely RiaSTAP® (CSL Behring, King of Prussia) (RiA) and FIBRYGA® (Octapharma, Lachen, Switzerland) (FiB) which were approved by the Food and Drug Administration in 2021 and 2017 respectively.

Background:

The efficacy and safety of each FC to each other and to CP is well established. FORMA-01 established FiB as non-inferior to RiA. FORMA-02 and FORMA-04 confirmed the efficacy of FiA in treating on-demand bleeding and surgical prophylaxis in adults and children, respectively. FIBRES demonstrated the efficacy of FiB in adult cardiac surgery requiring the use of cardiopulmonary bypass. Both FC products require a 17-micron filter. This is included with each supply of FiB and a part of the charge. It is not included with the purchased separately for RiA and must be acquired separately. The RiA filter is not only difficult to acquire but is institutionally cost-prohibitive at $15,000 per pack of 50 filters. Evidence of the relative cost-effectiveness of these three therapies in the United States is limited. As both FC have similar efficacy and safety, we performed a retrospective inpatient utilization assessment at our institution, the Medical University of South Carolina in Charleston, SC. We then performed a cost comparison between RiA and FiB to determine if switching our inpatient using of RiA to FiB would provide cost savings.

Methods

We reviewed institutional pediatric and adult utilization of FC from 2019-2023. Then, determined the dose and cost of RiA administered to the top 3 utilizers and overall and compared this to the estimated cost if FiB were used. The published average wholesale price (AWP) for a 700-1300mg vial of FiB = $1.32/mg and a 900-1300mg vial of RiA was $1.55/mg. The AWP for the RiA filter (FLT) was $15,000. Finally, we compared the estimated cost of both FC with single- and multi-donor CP assuming therapeutic dose of CP is 5-10 kg of bodyweight per Unit, to increase the FCo by 0.5-1.0 g/L making a typical adult dose 10 units. The AWP for a single-donor CP (SCP)=$45.00 and pooled-donor CP (PCP)= $330.00.

Results

We identified 6 patients throughout our hospital who utilized 30 vials/doses of FC over the 5-year period: n=4 were 0 -18 yrs and n=2 were older than 18 yrs. The three highest utilizers were: a 1mth old (2.63kg), a 13 yr old (41.1kg), and a 29 yr old (68.9 kg), considered as Patients A, B, and C respectively.

Both Patient A and Patient B required 1 vial of RiA to treat a major and minor bleed respectively. The estimated cost was RiA= $1550, FiB=$1320.

To treat Patient C major bleed, the cost of RiA was estimated to total $7750 compared to $6600 if FiB were used.

The total cost spent over 5 years for 30 vials and 30 of the 50 filters: RiA= ($46,500+15,000=) $61,500 compared to FIB=$39,600 (36% cost-saving).

If CP were used for each patient, then the cost for Patient A, SCP=$45, PCP=$330. If at least 10 Units of CP were provided to Patient B and C: SCP=$450, and PCP=$3,300.

Conclusions

The most cost-saving option of FC and CP was CP. But, as CP is not virus inactivated/removed the risk of viral infections, and contains and exposure to unnecessary proteins, and thawing required prior to administration made it less desirable in the setting of hemorrhage. Of the two FC with equal efficacy, using FiB instead of RiA is more cost-saving (36%) to our institution. It highlights the need for a larger study of healthcare utilization and cost-effectiveness analysis paired with measurable outcomes of both FC.

Disclosures

Youkhana:HEMA Biologics: Honoraria.

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2024
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