HSH719 - Economic Evaluation of Health Australia Assignment

Assignment Task

The Australian Department of Health (DOH) is considering funding a new medication to treat refractory/relapsed Chronic Lymphocytic Leukemia (CLL) in Australian adults (aged 18 years and over). The medication is called 'fenubrutinib' and has been approved by the Therapeutic Goods Administration (TGA) in Australia to be administered to adult patients with refractory/relapsed CLL.

The TGA-approved dosage of fenubrutinib is a 160 mg twice daily administered as a subcutaneous (SC) injection. A Phase II randomised controlled trial designed to assess the safety of fenubrutinib, which recruited a small group of patients. They found that there was a risk of experiencing cardiac disorders immediately after taking a fenubrutinib injection.
For this reason, the TGA requires patients who receive a fenubrutinib injection in Australia to remain in the presence of a registered nurse who can monitor them for 15 minutes after receiving the medication.

A Phase III randomised-controlled trial (RCT) to evaluate the effectiveness of fenubrutini in treating refractory/relapsed CLL is due to begin in January 2024. The RCT will be conducted in Australia and will enrol patients aged 18 years and over with a diagnosis of refractory/relapsed CLL.

Participants in the RCT will be randomised to the intervention group where they will receive a 160mg fenubrutinib injection in the presence of a registered nurse, or they will be randomised to the control group where they will receive ibrutinib at a dose of 420 mg once daily.
The RCT will last for 12 months. After this, patients will be followed-up for an additional 18 months in order to collect further cost and outcome data.

The DoH wants to know whether fenubrutinib would represent value for money in treating in adults diagnosed with refractory/relapsed CLL in Australia. You are part of a research team who has been asked to design a protocol for an economic evaluation alongside the RCT for fenubrutinib. Your role in the team will be to answer the questions bel

Question

1. Justify why you believe an economic evaluation is needed and what comparator you think is best to help inform the economic evaluation. Note - please assume your chosen comparator for your economic evaluation is also the same as the control arm of the RCT.

2. Form a well-defined study question to help guide your economic evaluation. Make sure you include all the elements of a good study question, including what health outcome(s) will be measured. Include a comment on whether you think the time horizon of the RCT and follow-up is appropriate and why or why not.

3. What type of economic evaluation is the most appropriate for answering your study question? Justify the use of your chosen method and explain its strengths over other types of economic evaluations. Note - Don't forget to include justification based on your chosen health outcome(s)

4. Identify the resources you will collect under the cost categories from Neuman et al.

5. Outline the information and data sources that you would use for collecting the resources and cost information for your economic evaluation. Note - focus on the measurement task of costing here.

6. Explain how you will value each of your resource inputs in your economic evaluation.

7. Explain and justify how you will collect and value the health outcome(s) you have chosen for your economic evaluation.

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