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This document provides clinical guidelines for managing hyperhaemolysis in patients with haemoglobinopathies, focusing on the use of intravenous immunoglobulin (IVIg) in the treatment process.
Version: V3.0
Author: Dr Julia Sikorska, Consultant Haematologist, STSTN Clinical Guidelines Group
Note: 2019
Executive/Divisional sponsor: Via Hospital Transfusion Committee
Applies to: All staff involved in the care of patients with Sickle Cell Disease
Date issued: V3.0 February 2020
Review date: February 2023
Approval person/Committee: Hospital Transfusion Committee
Date: March 2020
Year: 2020
Region / city: St George’s, UK
Topic: Hyperhaemolysis management in Haemoglobinopathies
Document type: Clinical guidelines
Organization / institution: St George’s University Hospitals NHS
Target audience: Healthcare staff involved in the care of Sickle Cell Disease patients
Effective period: February 2020–February 2023
Approval date: March 2020
Price: 8 / 10 USD
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Intravenous immunoglobulin (IVIg) clinical practice guidance, March 2023, Australia
Year: 2023
Country: Australia
Document type: Clinical guidance
Organization: Australian Government Department of Health / Blood Service
Target audience: Healthcare professionals administering IVIg
Scope: IVIg administration, safety, and monitoring
Effective from: April 2023
References: Criteria for the clinical use of intravenous immunoglobulin in Australia, 3rd edition, October 2018; Product information sheets of Privigen®AU, Kiovig®, Flebogamma®, Gammunex®, Octagam®
Appendices: Product comparison, infusion rate guides
Intravenous immunoglobulin (IVIg) clinical practice guidance, March 2023
Date: March 2023
Country: Australia
Subject: Intravenous immunoglobulin administration
Document type: Clinical practice guidance
Healthcare setting: Hospital and health services
Target audience: Healthcare professionals involved in IVIg prescribing and administration
Regulatory context: BloodSTAR authorization and national IVIg criteria
Products referenced: Privigen®, Kiovig®, Flebogamma®, Gammunex®, Octagam®, Intragam®10
Effective period: From April 2023
Clinical scope: Indications, precautions, preparation, infusion, storage, and adverse effects
Source type: Official guidance
Supporting Statement – Part A: Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration (CMS-10518, OMB 0938-1246)
Program: Medicare IVIG Demonstration
Administering Agency: Centers for Medicare & Medicaid Services (CMS)
Country: United States
Legal Basis: Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012
Extended Under: Disaster Tax Relief and Airport and Airway Extension Act of 2017
Further Extension: Consolidated Appropriations Act, 2021
OMB Control Number: 0938-1246
CMS Form Number: CMS-10518
Subject: Application for beneficiary participation in the IVIG Demonstration
Target Population: Medicare Part B beneficiaries with primary immune deficiency disease (PIDD)
Enrollment Cap: 6,500 beneficiaries (originally 4,000)
Funding Limit: $45 million including administrative and evaluation costs
Coverage Scope: Bundled payment for medically necessary supplies and services for in-home IVIG administration
Application Requirement: Mandatory signed application by beneficiary and provider
Submission Methods: Mail or fax
Languages Available: English and Spanish
Period of Demonstration: Through December 31, 2023 or until statutory limits are met
Participation Status: Voluntary; may be terminated by beneficiary at any time
Topics: hyperhaemolysis Haemoglobinopathies IVIg