Application Detail

Status

Closed

Description of Medical Service

C1 Esterase Inhibitor (C1-INH) concentrate is proposed for inclusion on the National Products and Services List (NPSL) for the management of patients with a confirmed diagnosis of Hereditary angioedema (HAE) Type I or II. Administration of human C1-INH to patients with HAE Type I or II replaces the missing or malfunctioning C1-INH protein resulting in relief from the symptoms of HAE.

Description of Medical Condition

Hereditary angioedema (HAE) is an autosomal dominant disorder characterised by recurrent subcutaneous and submucosal oedema without urticaria. One or more of various peripheral or central areas can be affected during an acute HAE attack, with laryngeal swelling the most serious as it may be fatal.

Reason for Application

New non-MBS item

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

PDF Version Unratified Draft Protocol for Consultation (PDF 978 KB)
Word Version Unratified Draft Protocol for Consultation (Word 1094 KB)

PDF Version Feedback and Survey Form (PDF 31 KB)
Word Version Feedback and Survey Form (Word 48 KB)

Final Protocol (PDF 1029 KB)
Final Protocol (Word 1101 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 942 KB)
Public Summary Document (Word 191 KB)

Consumer Friendly Public Summary Document (PSD)

Consumer Friendly PSD (PDF 249 KB)
Consumer Friendly PSD (Word 17 KB)

Consumer Friendly PSDs - The Basics

The Basics (PDF 190 KB)
The Basics (Word 29 KB)

Meetings for this Application

PASC

11 - 12 December 2014

ESC

11 - 12 June 2015

MSAC

30 - 31 July 2015