The Department of Health (DOH) is considering funding a new seasonal influenza vaccine for healthy working adults. To evaluate the effectiveness of the new vaccine called "NuvoVax", a double-blinded randomised control trial will be conducted. Trial participants will be recruited from a large company with 2000 employees. Participants in the intervention group will be vaccinated with NuvoVax which is a single injection. For the control arm, the trial investigators are considering using either a placebo injection of saline or alternatively the existing seasonal flu vaccine (called PaleoVax) that does not include the newer influenza strains.

NuvoVax and the control injection will be administered by a nurse. Each participant will be given a thermometer and instructed to record their temperature and symptoms of any respiratory illness/influenza episodes in a diary. This self-reported information will be collected by the research team twice a month for a total period of six months. Other information related to participants' medical history will also be collected. Biological specimens e.g. throat swab and blood samples will be collected from participants who show influenza/flu symptoms.

The DoH wants to know whether the new vaccine, NuvoVax, represents good "value for money". The DoH is also considering investing in a new depression intervention which has a cost effectiveness ratio of $30,000/QALY. Unfortunately the DoH does not have the resources to invest in both the new vaccine and the new depression intervention. You are part of a research team that has been asked to design a protocol for an economic evaluation alongside the clinical trial. Your role in the team is to answer the following:

Question 1

Justify why you believe that an economic evaluation is needed and which control group you think is best to use to help inform the economic evaluation. Briefly provide the reasons why you chose either the placebo (saline) injection or the existing older vaccination (PaleoVax).

Question 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 how health outcomes will be measured. Include a comment on whether you think the time horizon of the RCT is appropriate.

Hint: Natural history, disease progression and how influenza vaccines works can help provide useful information

Question 3

What type of economic evaluation do you think will be the most appropriate for answering your study question? Justify why you have chosen this method for your economic evaluation explaining its strengths over other methods.

NB: Don't forget to include justification based on your chosen health outcomes in your answer.

Question 4

Identify the resources that you will collect under the cost categories from Neumann et al (2017) pages 205-212, 217 (section 8.2 (not including section 8.2.4) and 8.3).

Question 5

Outline the information and data sources that you would use for collecting the resource and cost information for your economic evaluation (focus on the measurement task of costing here).

Question 6:

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

Question 7:

Explain and justify how you will collect and value the health outcomes you have chosen for your economic evaluation.

NOTE:

Please note that this is a hypothetical evaluation and intervention.You may search the literature to see if there are any published papers on similar interventions to guide your answer, but you should treat the exercise as though have been asked to design an economic evaluation alongside a randomised clinical trial.

You are expected to reference appropriate resources that you will use in your protocol, for example source of cost estimates for different types of resources, tools for measuring outcomes, etc.