Assignment Task

The Australian Department of Health (DOH) is contemplating funding a new medication, `fenubrutinib,` for treating refractory/relapsed Chronic Lymphocytic Leukemia (CLL) in Australian adults aged 18 years and over. Fenubrutinib, approved by the Therapeutic Goods Administration (TGA), poses potential cardiac risks post-injection, necessitating patient monitoring by registered nurses. A Phase III RCT comparing fenubrutinib to ibrutinib will commence in January 2024, aiming to evaluate efficacy and safety over 12 months with an additional 18-month follow-up.

Question

1. An economic evaluation is crucial to assess the cost-effectiveness of fenubrutinib compared to ibrutinib, aligning with the RCT`s control arm. Given the potential healthcare budget implications, understanding value for money is imperative for informed decision-making.
2. Study Question: "Is fenubrutinib a cost-effective intervention compared to ibrutinib for treating refractory/relapsed CLL in Australian adults over a 30-month time horizon?" This encompasses direct healthcare costs and health outcomes, ensuring a comprehensive evaluation period that captures potential long-term benefits or adverse effects.
3. Cost-effectiveness analysis (CEA) is most appropriate for this study question. It allows for the comparison of costs and health outcomes, vital for assessing the relative value of fenubrutinib over ibrutinib. CEA`s strength lies in its ability to quantify both costs and outcomes, facilitating informed resource allocation decisions.
4. Cost Categories: Direct medical costs (e.g., medication, healthcare utilization), direct non-medical costs (e.g., transportation), and indirect costs (e.g., productivity loss).
5. Data Sources: Healthcare facility records, patient surveys, government databases, and pharmaceutical company reports. These sources provide comprehensive information on resource utilization and associated costs.
6. Resource Valuation: Direct medical costs will be valued using market prices or reimbursement rates. Direct non-medical and indirect costs will be assessed using relevant valuation methods, such as the human capital approach.
7. Health Outcome Valuation: Health outcomes, including survival rates and quality-adjusted life years (QALYs), will be collected through patient-reported outcomes, clinical assessments, and disease registries. These will be valued based on established utility scores and societal preferences, ensuring a comprehensive evaluation of fenubrutinib`s impact on patient health.