PMID- 36757567
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230329
IS  - 2509-4254 (Electronic)
IS  - 2509-4262 (Print)
IS  - 2509-4262 (Linking)
VI  - 7
IP  - 2
DP  - 2023 Mar
TI  - A Budget Impact Model of Maintenance Treatment of Chronic Inflammatory 
      Demyelinating Polyneuropathy with IgPro20 (Hizentra) Relative to Intravenous 
      Immunoglobulin in the United States.
PG  - 243-255
LID - 10.1007/s41669-023-00386-2 [doi]
AB  - BACKGROUND: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, 
      progressive autoimmune disease causing peripheral nervous system dysfunction. 
      Guidelines recommend immunoglobulin (IG) therapy as an immunomodulatory agent in 
      CIDP. Drawbacks and unmet needs with intravenous immunoglobulin (IVIG) include 
      adverse effects and wear-off effects, along with the burden of administration 
      based on site of care. Subcutaneous administration of Hizentra, a subcutaneous 
      immunoglobulin (SCIG) reduces patient burden by allowing self-administration 
      outside the hospital setting and has fewer adverse events (AEs). OBJECTIVE: We 
      aimed to compare the expected cost of treatment and the budget impact of Hizentra 
      compared with IVIG for maintenance treatment of CIDP in the United States. 
      METHODS: A decision tree model was developed to estimate the expected budget 
      impact of maintenance treatment with Hizentra for US stakeholders. The model 
      adopts primarily a US integrated delivery network perspective and, secondarily, a 
      commercial perspective over a 1-year time horizon. Pharmacy costs were based on a 
      payment mix of average sales price (73%), wholesale acquisition cost (2%), and 
      average wholesale price (25%). Costs in the model reflect 2022 US dollars. In 
      accordance with the International Society for Pharmacoeconomics and Outcomes 
      Research (ISPOR) guidelines and recommendations for budget impact modeling, no 
      discounting was performed. The PATH clinical study of Hizentra maintenance in 
      CIDP was used to determine clinical inputs for relapse rates at initial 
      assessment (24 weeks) and at 52 weeks for Hizentra. The ICE clinical study of 
      Gamunex maintenance in CIDP was the basis of relapse rates for Gamunex (and other 
      IVIGs). Literature-based estimates were obtained for infusion costs by site of 
      care, costs of IVIG infusion-related complications, and significant IVIG AE 
      rates. Hizentra AE rates from the US Hizentra prescribing information were 
      assessed but were not included in the model as the AEs in CIDP were mild, easily 
      treated, and self-limited. Sensitivity analyses and scenario analyses were 
      conducted to evaluate variations from the base case. RESULTS: The model showed 
      that a Hizentra starting dose of 0.2 g/kg is expected to result in annual cost 
      savings of US$32,447 per patient compared with IVIG. For a hypothetical 
      25-million-member plan, the budget impact of a 10% market share shift from IVIG 
      to Hizentra is expected to result in savings of US$2,296,235. CONCLUSION: This 
      analysis projects that Hizentra is likely associated with favorable economic 
      benefit compared with IVIG in managing CIDP.
CI  - (c) 2023. The Author(s).
FAU - Mallick, Rajiv
AU  - Mallick R
AD  - CSL Behring, King of Prussia, PA, USA.
FAU - Carlton, Rashad
AU  - Carlton R
AD  - Xcenda L.L.C., 5025 Plano Parkway, Carrollton, TX, 75010, USA. 
      rashad.carlton@xcenda.com.
FAU - Van Stiphout, Joris
AU  - Van Stiphout J
AD  - Xcenda Switzerland GmbH, Bern, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20230209
PL  - Switzerland
TA  - Pharmacoecon Open
JT  - PharmacoEconomics - open
JID - 101700780
PMC - PMC9910243
COIS- Rajiv Mallick is an employee of CSL Behring and holds stock options. Rashad 
      Carlton and Joris Van Stiphout are employees of Xcenda, which received funding 
      from CSL Behring for this analysis.
EDAT- 2023/02/10 06:00
MHDA- 2023/02/10 06:01
PMCR- 2023/02/09
CRDT- 2023/02/09 11:20
PHST- 2023/01/03 00:00 [accepted]
PHST- 2023/02/10 06:01 [medline]
PHST- 2023/02/10 06:00 [pubmed]
PHST- 2023/02/09 11:20 [entrez]
PHST- 2023/02/09 00:00 [pmc-release]
AID - 10.1007/s41669-023-00386-2 [pii]
AID - 386 [pii]
AID - 10.1007/s41669-023-00386-2 [doi]
PST - ppublish
SO  - Pharmacoecon Open. 2023 Mar;7(2):243-255. doi: 10.1007/s41669-023-00386-2. Epub 
      2023 Feb 9.