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Janssen UCL Medicinal Personalization

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User Guide

User guide to valuation tool for the assessment of scenarios involving changes to treatment protocol/care pathway/patient mix

The tool is excel-based and consists of 9 worksheets. The first three sheets provide background information for the users. The last six sheets guides the user through a staged process within which the user can enter data on scenarios for organising Hep C care in the NHS and assess the value and costs associated with these scenarios. This user guide will provide information on each of the worksheets of the tool.

Within the population selection sheet, assumptions input sheet and sensitivity analysis, cells highlighted in light blue are unlocked to allow users to make adjustments to the model.

Worksheet 1: Design

Worksheet 1 provides an outline of the tool’s design process. The development of the costing template for national and local use followed a structured approach, which involved:

  • Conducting background research into the content, current clinical practice, published information and available data in the Hep C field.
  • Gathering expert opinion, in particular from the Royal Free and UCLH, which formed the setting of our initial case study.
  • Developing a costing model to estimate the costs of changes to various Hep C treatment protocols/care pathways/patient mixes.
  • Testing the model, including the assumptions and outcomes.
  • Developing the template based on the costing model.
  • Gathering data from Janssen and comparing the cost-effectiveness of introducing the IDYLLA-based diagnostics pathway in HCV care with current clinical practice across a range of settings.

Worksheet 2: Costing report

The costing sheet summarises the main implications of the NICE guidance and provides some background. It also provides a summary of the financial implications based on the selections made in sheets 4 and 6, summarises the sensitivity analysis and highlights further factors that should be considered when using this template.

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Worksheet 3: References & Data sources

Sheet 3 lists references and sources used in the development of the tool and the costing template. The reference numbers relate to the source numbers listed on sheet 6 and are hyperlinked to the appropriate reference.

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Worksheet 4: Population selection sheet

Worksheet 4 allows the user to select the population a specific treatment centre serves. The sheet allows the user to manually input a population size or select a proportion from a number of different pre-set populations. If the user makes no changes on this sheet, the template will use a default value of a population of 100,000.

Follow the instructions at the top of sheet 4 to select the correct population for your costing calculation.

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Worksheet 5a: Unit costs – telaprevir

Sheet 5a allows users to see how the telaprevir unit costs used in this template have been calculated.

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Worksheet 5b. Unit costs – boceprevir

Sheet 5b allows users to see how the boceprevir unit costs used in this template have been calculated.

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Worksheet 6: Assumptions input sheet

Sheet 6 allows the user to amend the assumptions in the template to take account of local circumstances. Several assumptions are made to produce this costing template, based on national data and the view of clinical experts advising NICE. However, we recognise that these assumptions may not accurately reflect local circumstances. Therefore, users can input their own assumptions in the light blue cells (column E) to be used in the model.

Any number and combination of the assumptions can be changed. To revert to the NICE assumptions, the user needs to delete input and either leave the cell blank or input a ‘-‘. If no data on assumptions are entered by the user, default assumptions will be used. The pathway shows how the assumptions affect the population, and calculates the volume of activity to be used in the costing template. Local assumptions can be amended as many times as required, and the pathway and the costing template will update automatically.

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Worksheet 7: Costing template

Sheet 7 shows the financial impact of the input regarding the served patient population in sheet 4 and the clinic/treatment assumptions made in sheet 6. There is a separate section within the template to estimate the drug costs associated with a specific scenario.

The first column of calculations shows the resource impact using the selected population and the standard NICE assumptions about Hep C treatment. The second column shows the resource impact using the selected population and any local assumptions that have been made. Changes made on sheet 6 update the costing template automatically.

Below the main costing template, a second table shows the effect of VAT on the costing model, and allows users to manually include any discounts they receive.

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Worksheet 8: Sensitivity analysis

Sheet 8 demonstrates the extent to which fluctuations in the variables will affect the overall costs of implementing the guidance. Table 1 considers the impact of fluctuations of individual variables. The sensitivity analysis is independent of the input sheet and the costing template, and should be used to inform users about the sensitivity of the costs to changes in the identified variables.

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Worksheet 9: Introduction of a novel rapid turnaround diagnostics service based on the IDYLLA device

In this sheet, we incorporate data on the number of patients an HCV clinic sees annually, the type of patients that are referred to the clinic, the number of Viral Load tests performed, the costs of drug therapy, and the costs of purchasing and using the IDYLLA device to calculate savings associated with the introduction of IDYLLA vis-à-vis present practice of pathology lab tests.

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