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

Locally advanced or metastatic differentiated thyroid cancer

Initial treatment

The condition must be refractory to radioactive iodine; AND

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

Patient must have symptomatic progressive disease prior to treatment; or

Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND

Patient must have thyroid stimulating hormone adequately suppressed; AND

Patient must be one in whom surgery is inappropriate; AND

Patient must not be a candidate for radiotherapy with curative intent; AND

Patient must have a WHO performance status of 2 or less; AND

Must be treated by a medical practitioner.

Radioactive iodine refractory is defined as:

(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or

(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or

(iii) progression within 12 months of a single RAI treatment; or

(iv) progression after two RAI treatments administered within 12 months of each other.

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

Locally advanced or metastatic differentiated thyroid cancer

Continuing treatment

The condition must be refractory to radioactive iodine; AND

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

Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.