Immunoglobulin Review Pilot Process

Page last updated: 06 September 2019

Health Technology Assessment Reviews of Immunoglobulin funded under the National Blood Agreement for specific medical conditions.

Background


Immunoglobulin is a plasma-derived product used as a treatment for a range of medical conditions. It may be infused intravenously or subcutaneously. Access to government-funded immunoglobulin is through the national blood arrangements and determined by the National Blood Authority’s (NBA) National Policy: access to government-funded immunoglobulin products in Australia and the Criteria for the clinical use of immunoglobulin in Australia (the Criteria).

All Australian Governments, through the Jurisdictional Blood Committee (JBC), have agreed to conduct robust Health Technology Assessments (HTAs) of immunoglobulin use (Ig Reviews) funded under the National Blood Agreement. The Ig Reviews will consider immunoglobulin use in the context of both intravenous and subcutaneous infusion where relevant. Outcomes of Ig Reviews will ensure government-funded use within Australia for specific medical conditions based on evidence of clinical safety, effectiveness and cost-effectiveness. This is consistent with how other pharmaceutical and medical technologies are assessed for government funding.

The Ig Reviews will complement the NBA Immunoglobulin Governance Program. The process for conducting the Ig Reviews has been based on the framework for conducting Post Market Reviews of medicines subsidised via the Pharmaceutical Benefits Scheme, with modification to allow evaluation of the evidence for each immunoglobulin indication by the Medical Services Advisory Committee (MSAC). The initial Ig Reviews are considered a pilot. Feedback during and after the pilot will be incorporated to improve the process for future reviews.

Reference Group


The Ig Reviews are supported by a reference group. The Ig Review Reference Group membership consists of clinical experts in the fields of haematology, immunology, neurology, and pharmacy, a health economist, and a consumer representative.

Outline of the Immunoglobulin Review Process (pilot)

DescriptionProcess
Referral SubmittedThe applicant (National Blood Authority) submits the HTA application Referral to the MSAC Ig Secretariat in the Department of Health. Once accepted, a summary is published on the MSAC website.
Targeted ConsultationStakeholder groups nominated by the applicant are provided the Referral and a questionnaire for each Ig condition. Stakeholder responses are provided to the Ig Review Reference Group for consideration.
Development of the PICOThe Referral is provided to contracted HTA groups to inform the development of a draft PICO for the Contracted Assessments. The Ig Review Reference Group ratifies the PICO. The PICO is published on the MSAC website.
Development of the Contracted AssessmentGuided by the PICO, contracted HTA groups prepare a draft Contracted Assessment. Sponsor companies of Ig are invited to provide input to the Contracted Assessment. The Ig Review Reference Group considers the draft Contracted Assessment before it is progressed to MSAC.
Public ConsultationThe Contracted Assessment is made available via the MSAC website for public consultation. Comments and feedback are provided to the ESC.
Ig Review Outcomes Considered by the ESCThe ESC considers all Ig Review documents, including the public consultation submissions. The ESC formulate advice for the MSAC on the quality, validity and relevance of the Contracted Assessment.
Ig Review Outcomes Considered by the MSAC The MSAC considers all Ig Review documents provided and the ESC advice.
Outcomes Reported The MSAC advice is provided to the applicant, the Jurisdictional Blood Committee and the Commonwealth Government. A public summary document is published on the MSAC website.

Legend: Ig: immunoglobulin; HTA: health technology assessment; PICO: population, intervention, comparator, outcome; MSAC: Medical Services Advisory Committee; ESC: Evaluation Sub-Committee of MSAC


Current Conditions under review

The following links will direct you to the MSAC webpage where the Ig Review documents are available:


  • MSAC – 1564 – Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
    Condition 1564
  • MSAC - 1565 - Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation
    Condition 1565
  • MSAC - 1566 - Myasthenia Gravis
    Condition 1566
  • MSAC – 1590 – Multifocal motor neuropathy (MMN)
    Condition 1590
  • MSAC – 1591 – Secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haematopoietic stem cell transplantation (HSCT)
    Condition 1591
  • MSAC – 1592 – Primary Immunodeficiency diseases (PID) with antibody deficiency
    Condition 1592

To receive news alerts and information related to the Ig Review from the MSAC Website, you can sign up to the MSAC home page under the heading MSAC email bulletin - MSAC - Subscribe. You may also email any queries to the MSAC Ig Review Secretariat: MSACIg_Secretariat@health.gov.au.