1.2 Clinical management

Page last updated: September 2016

1.2.1 Clinical management algorithms

Present a flowchart that depicts current management of the disease or condition in the target Australian population in the absence of the proposed listing of the new medicine. Present a second flowchart that depicts the eligible patients and the circumstances of use of the proposed medicine if the listing is implemented as requested. The two algorithms may be captured on a single flowchart, if appropriate.

Ensure that the population and the use of the proposed medicine and main comparator(s) in the clinical management algorithm are consistent with those described in Subsection 1.1.

Use the following sources to inform the flowchart(s):

• a literature review of relevant published clinical management guidelines (preferred). The PBAC prefers independent, up-to-date evidence-based clinical practice guidelines developed for Australia or relevant to the Australian setting. Include a copy of the literature review and guidelines as an attachment to the submission
• an expert panel and/or a well-designed survey (if current clinical management guidelines are not available). Present details of who the survey was sent to, who responded, and the survey questions and responses in an attachment to the submission. See Appendix 1 for further advice on expert panels and surveys.

Identify the following criteria and characteristics in the flowchart(s):

• all relevant diagnostic criteria and/or tests to determine the target population (including tests to exclude patients, or inform continuation criteria or stopping rules); reference Medicare Benefits Schedule (MBS) items, where appropriate, and state clearly when a test is not currently reimbursed through Medicare
• important characteristics of patients (eg risk factors, severity of disease or condition) and circumstances of use of the medicine
• who is managing clinical care, who will be prescribing the medicine and whether any special training or specialised facilities are required for prescribing or administration; provide a justification for these below the algorithm
• all treatments, including any required previous therapies or required co-administered therapies, and any consequences for subsequent therapy options; give particular consideration to whether a proposed medicine is likely to replace a currently available option, or whether it is likely to displace that option to a later line of therapy
• all streams of health care resource provision, both before and after the point in the algorithm that the proposed medicine is introduced.

Use the clinical management algorithm to capture the steps (diagnostic and therapeutic) that define the population that would be eligible for treatment, as well as all relevant downstream changes to patient management (eg changes to the use of other medicines). Extend the clinical algorithm to the expected end of the disease or condition process, capturing all the treatment options. If the clinical algorithms for the proposed medicine and the comparator are clearly indicated to be the same after a particular time point in the algorithm, the algorithms may be truncated.

If it is not appropriate to capture all relevant details within the flowchart(s), provide a text description of the details excluded from the clinical management algorithm.

Justify the positioning of the proposed medicine in the clinical management algorithm, and explain why alternative positions for the proposed medicine in the clinical management algorithm are inappropriate.

Variation of a current PBS restriction

If seeking a variation of the current PBS listing of a proposed medicine, restrict the clinical management algorithm to patients whose management will change. Exclude patients from the algorithm who receive the same treatment, regardless of the proposed change to the listing.

Treat a request for a new clinical indication the same way as a request for listing of a new medicine but represent only patients with the new indication in the clinical management algorithm.

For other variations to the PBS restriction, use the proposed clinical management algorithm to reflect the change in practice that would occur if the restriction were to change – for example:

• relaxation or removal of one or more restriction criteria
• relaxation or removal of one or more continuation criteria
• request to change the listing to permit patients to access treatment earlier in the management algorithm (ie moving from a last line to an earlier line of therapy).

1.2.2 Comparison of the two algorithms

Summarise the differences between the current and proposed clinical management, as depicted in the algorithm(s).

1.2.3 Other relevant therapies

Identify those medicines and other health care interventions that would be prescribed less or more often as a consequence of listing the proposed medicine.

If relevant therapies are identified as being prescribed more or less often but are excluded from the economic evaluation or financial analyses, provide justification for this exclusion.