Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a child

Initial treatment

The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND

The condition must be metastatic disease; or

The condition must be both: (i) locally advanced, (ii) unresectable; or

The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND

Patient must be/have been under 18 years of age (i.e. prior to their 18th birthday) at treatment initiation with this drug.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:

(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Initial treatment

The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND

The condition must be a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date); or

The condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (of any date); AND

The condition must be metastatic disease; or

The condition must be both: (i) locally advanced, (ii) unresectable; or

The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:

(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.

(b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).