1760 - DPYD genotyping to predict fluoropyrimidine-induced toxicity

Page last updated: 07 March 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 (Word 74 KB)
Consultation Survey (PDF 321 KB)

PASC Consultation
PASC Consultation closed

MSAC Consultation
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PICO Confirmation

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

Assessment Report


Public Summary Document


Meetings for this Application


7-8 December 2023