Chronic lymphocytic leukaemia (CLL)

Treatment Phase: Dose titration for relapsed/refractory disease

Clinical criteria:

  • The condition must have relapsed or be refractory to at least one prior therapy,

AND

  • The treatment must be the sole PBS-subsidised therapy for this condition,

AND

  • The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.

Treatment criteria:

  • Patient must not be undergoing retreatment with this drug where any of: (i) prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; (ii) 24 months of PBS-subsidised treatment has been administered with this drug for this condition.

Note

The latest International Workshop on CLL (iwCLL) provides guidance on various aspects of management of CLL/SLL. Notably, two of these are:

(1) when to treat versus when to monitor the patient without therapy - see 'Indications for treatment' section; and

(2) recognising progressive disease - see 'Definition of response, relapse, and refractory disease' section.

See the following literature reference for details:

Hallek, M et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood vol. 131, 25 (2018): 2745-2760.

Note

Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.

Note

No increase in the maximum quantity or number of units may be authorised.

Note

No increase in the maximum number of repeats may be authorised.

Note

Special Pricing Arrangements apply.