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 non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); or

The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); or

The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND

The condition must be metastatic disease; or

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

The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND

Patient must have received prior systemic treatment for this disease; or

Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND

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

Patient must not receive more than 3 months of treatment under this restriction; 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 (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.

(c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies.

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).