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Case Study 1

Assessing the impact of the implementation of rapid turnaround testing in Hep C care at the Royal Free
Download (Tool 1 – London Royal Free)

In the development of new personalized models of care, the value of instantaneous access to advanced molecular diagnostics information in patient stratification decisions is significant. Currently, turnaround times for such tests are 24 hours for larger hospitals and up to 1-2 weeks for smaller regional hospitals that send out samples for testing to external labs. However, new diagnostics devices will soon be able to turn around tests within much shorter timeframes, providing clinicians with almost instantaneous results. This project examines the challenges of introducing such devices in current care and on quantifying their economic benefits.

We focus on the case of chronic Hepatitis C care following the introduction of new direct acting antiviral drugs, in which advanced molecular diagnostics information, in particular viral load counts have become critical in patient stratification. New antiviral drugs are very costly (around £27,000/treatment at list prices for the UK National Health Service) and have potentially serious side effects. Therefore, potential economic and clinical benefits of earlier access to diagnostics test results that identify non-responders to treatment are significant.

This case study of Hep C care at the Royal Free highlights that the new pathway results in higher pathology laboratory costs for hospitals, which currently carry out viral load tests in-house. However, these costs are offset by significant drug cost savings because non-responding patients can be identified and taken off treatment in a timelier manner.

The modeling template can be utilized by health economists or marketing support groups at pharmaceutical companies, as well as by nurses, clinicians, administrators and other professionals involved in healthcare delivery

Our template can be used to estimate the total costs to the HCV centre/clinic of the present trajectory in which viral load test results are not available until 1-2 days after the consultation or up to 2 weeks in some instances. Should the HCV centre/clinic consider implementing a new POC diagnostics device that would allow results to be available within the time of the patient’s appointment, our template could be used to highlight under what conditions it would be cost-effective to do so.

1.  Selecting patient base

We start with the population selection sheet outlined in the user guide by specifying that Royal Free sees approximately 1,000 patients annually in its HCV clinic.

2.1  Clinic assumptions input sheet

This case study is based on Hep C care at the Royal Free hospital. Most clinic assumptions we used in this case study, are based on the expert input from the teamsof Deenan Pillay (UCL Pathology) and William Rosenberg (Hep C care). Assumptions regarding the following other key parameters were obtained from NICE averages: Hep C prevalence rates according to geographic location, the proportion of the total patient population that is diagnosed and ends up in secondary care, the proportion of patients that develop chronic Hep C, the proportion of Hep C patients with genotype 1 Hep C, those patients entering treatment who have had treatment before for Hep C and those who are treatment naïve. Any user may override NICE estimates with clinic-specific parameters.

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2.2  Clinic assumptions input sheet

 We further stratify the population by accounting for annual transition rates: those who are referred to a new treatment, those who achieve a sustained virological response within the different timeframes, and the various drug therapies that can be prescribed. We also account for different stages of the liver disease (mild, moderate and cirrhosis)

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For each treatment pathway, the tool infers outcomes about the number of patients for whom sustained virological response is achieved while on the drug therapy, and hence quantifies numbers for the different subsets of patients that are taken off their therapies due to adverse effects for instance.

Furthermore, the tool infers how many patients develop complications and progress to a more advanced liver disease state once they start therapy (i.e. decompensated cirrhosis, hepatocellular carcinoma, receive a liver transplant).

2.3  Clinic assumptions input sheet

The next step is to incorporate the drug costs of different therapies and the lengths thereof. The costing template for our example highlights that the total annual non-recurring costs are £1,803,452 for previously treated patients.

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The template allows to account for the potential changes to drug costs and discounts received by the HCV centre.

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3.  Sensitivity analysis

The template allows for the individual variables of the model to be subjected to a sensitivity analysis both for overall parameters and for the recurring costs

For Royal Free, this is 10% and costs are adjusted to reflect this.

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3.  IDYLLA value

In the final step, the tool provides a cost-effectiveness analysis of the introduction of a novel POC diagnostic device in the based on the costs and valuations of the existing treatment trajectory. In this case, the template provides the overall summary of the steps undertaken in (1)-(5):

Out of 974 people that Royal Free annually sees in its HCV clinic, 803 develop chronic HCV and 361 are of genotype 1. 14 Patients will discontinue treatment due to adverse effects. 18 patients on treatment with mild or moderate liver disease will achieve extended sustained virological response by week 10, with further 5 patients in mild/moderate group will achieve SVR between weeks 10 and 11. 5 patients will stop treatment in week 36, while 8 patients will continue to week 48.

A similar breakdown is presented for patients with cirrhosis.

At the Royal Free, patients will undergo in total 2500 viral load (VL) tests at a cost of £27.88 each. Note: these costs are much lower than the national average of £67 or NICE guideline about these costs @ £152 because the Royal Free has a major pathology lab that conducts these tests in-house. Various scenarios comparing different cost scenarios are pursued in Case study 2.

Accounting for various cost components for implementing a rapid turn-around diagnostics service for Hep C patients at the Royal Free, the Royal Free will incur an estimated additional £62,783 of pathology costs; yet, it would benefit of a total of £186,088 of savings on unnecessary drug costs. Thus, the overall annual savings of implementing the service are £123,305.

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