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

Idiopathic pulmonary fibrosis

Initial treatment 1 - new patient

The condition must be diagnosed through a multidisciplinary team; AND

Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND

Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND

Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND

Patient must not have had an acute respiratory infection at the time of FVC measurement; AND

Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND

Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND

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

Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.

A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.

Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

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

(a) details of the proposed prescription; and

(b) 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

Idiopathic pulmonary fibrosis

Initial treatment 2 - change or recommencement of treatment

Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND

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

Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.

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

Idiopathic pulmonary fibrosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

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

Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.