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

Metastatic or locally advanced basal cell carcinoma (BCC)

Initial treatment

The condition must be inappropriate for surgery; AND

The condition must be inappropriate for curative radiotherapy; AND

Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or

Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

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 (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and

(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and

(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.

The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.

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).

Inappropriate for surgery is defined as:

(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or

(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or

(iii) Medical contraindication to surgery.

Inappropriate for curative radiotherapy is defined as:

(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or

(ii) Limitations due to location of tumour; or

(iii) Limitations due to cumulative prior radiotherapy dose; or

(iv) Progressive disease despite prior irradiation of locally advanced BCC.

For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.

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

Metastatic or locally advanced basal cell carcinoma (BCC)

Continuing treatment

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

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

The condition must remain inappropriate for surgery; AND

The condition must remain inappropriate for curative radiotherapy; AND

Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.

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) Confirmation from the treating doctor that the disease has not progressed; and

(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.

The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.

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).

Inappropriate for surgery is defined as:

(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or

(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or

(iii) Medical contraindication to surgery.

Inappropriate for curative radiotherapy is defined as:

(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or

(ii) Limitations due to location of tumour; or

(iii) Limitations due to cumulative prior radiotherapy dose; or

(iv) Progressive disease despite prior irradiation of locally advanced BCC.

For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.

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

Metastatic or locally advanced basal cell carcinoma (BCC)

Initial treatment or Continuing treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; or

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.