1760 - DPYD genotyping to predict fluoropyrimidine-induced toxicity

Page last updated: 26 June 2024

Application Detail

Description of Medical Service

Fluoropyrimidines (FP) are chemotherapy drugs widely used for the treatment of solid tumours (e.g. colorectal, upper gastrointestinal, breast, head and neck, and pancreatic cancer) and can be toxic at high doses. Four DPYD variants have been studied in-depth and have demonstrated a significant association with an elevated risk of severe toxicity. Targeted testing for these four variants using polymerase chain reaction (PCR) prior to treatment with FP will identify carriers of variants associated with enzyme deficiency, allowing for pre-emptive dose reduction, improving patient tolerance and safety and reducing hospital-related management incidents.

Description of Medical Condition

The DPYD gene codes for an enzyme that is involved in the metabolism of FP treatment administered intravenously or orally for the treatment of solid tumours. Certain variants in the DPYD gene can result in some patients being unable to metabolise FP at normal rates. Some patients with these certain DPYD variants are more sensitive to FP therapy which results in excess exposure when patients are treated with a standard FP dose, potentially leading to life-threatening toxicity and can be fatal.

Reason for Application

New MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Summary and PICO Set

Application Summary (Word 34 KB)
Application Summary (PDF 237 KB)

PICO Set (Word 248 KB)
PICO Set (PDF 661 KB)

Consultation Survey

Consultation Survey

PASC Consultation
PASC Consultation closed

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 11 October 2024 for it to be considered by MSAC at its November 2024 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 1977 KB)
PICO Confirmation (Word 1330 KB)

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

7-8 December 2023

ESC

10-11 October 2024

MSAC

28-29 November 2024