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Market Access and Reimbursement

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Chronic Hepatitis C

Chronic hepatitis C virus (HCV) infection is associated with significant morbidity and mortality. The global prevalence of HCV infection has been estimated at 1.6% (1.3–2.1%), equivalent to 115 (92–149) million individuals. Whereas rates of infection are decreasing in the developed world, HCV related liver disease is expected to increase due to the latent nature of early infection and the significant number of undiagnosed cases.

Interferon-based therapy had been used for HCV treatment for many years but was associated with modest efficacy, long treatment duration and poor tolerability.  Consequently, historic rates of treatment uptake had been relatively low. The arrival of direct acting antivirals (DAAs) dramatically increased the likelihood of eradicating HCV from the blood (sustained virological response) and was associated with significantly fewer tolerability issues and shorter treatment durations.  However, compared to interferon based treatment, the DAAs were deemed expensive.

HEOR Ltd successfully undertook the following programme of research:

  • Initially, we undertook a health economic systematic literature review to inform the conceptual design and implementation of a chronic hepatitis C virus (HCV) cost-effectiveness model (1)
  • Developed and published a chronic HCV model (the MOdelling the NAtural histoRy
    and Cost-effectiveness of Hepatitis [MONARCH]) with an initial application assessing the cost-effectiveness of response guided therapy (2)
  • Published an adapted version of the model capable of estimating the unknown numbers of people infected with HCV (applied to UK and Taiwanese settings)(3, 4)
  • Published public health papers assessing the cost-effectiveness of screening for HCV within the context of assessing the numbers needed to treat(5-7)
  • Developed a chronic HCV disease transmission model and integrated this into the MONARCH model to communicate how increasing the number of HCV patients successfully treated improved the cost-effectiveness of treatment as a function of future infections avoided (8)
  • Successfully developed full health technology assessments dossiers
  • Successfully undertook local cost-effectiveness adaptations (9-13)

The number of treatment permutations, including both choice and timing of competing regimens, rendered the health economic assessment of HCV treatment strategies in clinical practice prohibitively complex. We subsequently developed a number of post HTA publications designed to:

  • Quantify the health economic value of a cure from the clinician and patient perspective(14)
  • Assess the health economic impact of implementing a targeted approach to prioritizing treatment in HCV patients with advanced chronic HCV disease (15)
  • Demonstrate how the value for money of treating chronic HCV with the new Direct Acting Antivirals (DAAs) improves based on treatment uptake – driven by a reduction in disease transmission(8)

References

Townsend R, McEwan P, Kim R, Yuan Y. Structural frameworks and key model parameters in cost-effectiveness analyses for current and future treatments of chronic hepatitis C. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2011;14(8):1068-77.

McEwan P, Kim R, Yuan Y. Assessing the cost utility of response-guided therapy in patients with chronic hepatitis C genotype 1 in the UK using the MONARCH model. Applied health economics and health policy. 2013;11(1):53-63.

Ward T, Gordon J, Bennett H, Webster S, Sugrue D, Jones B, et al. Tackling the burden of the hepatitis C virus in the UK: characterizing and assessing the clinical and economic consequences. Public Health. 2016;141:42-51.

McEwan P, Ward T, Chen C-J, Lee M-H, Yang H-I, Kim R, et al. Estimating the Incidence and Prevalence of Chronic Hepatitis C Infection in Taiwan Using Back Projection. Value in Health Regional Issues. 2014;3(0):5-11.

Selvapatt N, Ward T, Harrison L, Lombardini J, Thursz M, McEwan P, et al. The cost impact of outreach testing and treatment for hepatitis C in an urban Drug Treatment Unit. Liver International. 2017;37(3):345-53.

Kim D, Han K-H, Jun B, Kim T, Park S, Ward T, et al. Estimating the Cost-Effectiveness of One-Time Screening and Treatment for Hepatitis C in Korea. PloS one. 2017;12(1):e016770.

McEwan P, Ward T, Yuan Y, Kim R, L’Italien G. The impact of timing and prioritization on the cost-effectiveness of birth cohort testing and treatment for hepatitis C virus in the United States. Hepatology (Baltimore, Md). 2013;58(1):54-64.

Bennett H, Gordon J, Jones B, Ward T, Webster S, Kalsekar A, et al. Hepatitis C disease transmission and treatment uptake: impact on the cost-effectiveness of new direct-acting antiviral therapies. The European Journal of Health Economics. 2016:1-11.

Ward T, Webster S, Mishina S, McEwan P, Wygant G, Wang F. Assessing the Budget Impact and Economic Outcomes of the Introduction of Daclatasvir+ Asunaprevir and Sofosbuvir/Ledipasvir for the Treatment of Chronic Hepatitis C Virus Infection in Japan. Value in Health Regional Issues. 2017;12:1-6.

McEwan P, Webster S, Ward T, Brenner M, Kalsekar A, Yuan Y. Estimating the cost-effectiveness of daclatasvir+ sofosbuvir versus sofosbuvir+ ribavirin for patients with genotype 3 hepatitis C virus. Cost Effectiveness and Resource Allocation. 2017;15(1):15.

McEwan P, Ward T, Webster S, Yuan Y, Kalsekar A, Kamae I, et al. Estimating the cost‐effectiveness of daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b. Hepatology Research. 2016;46(5):423-33.

McEwan P, Bennett H, Ward T, Webster S, Gordon J, Kalsekar A, et al. The cost-effectiveness of daclatasvir-based regimens for the treatment of hepatitis C virus genotypes 1 and 4 in the UK. European Journal of Gastroenterology and Hepatology. 2016;28(2):173-80.

McEwan P, Ward T, Webster S, Yuan Y, Kalsekar A, Broglio K, et al. Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b. Value in Health Regional Issues. 2014;3(0):136-45.

McEwan P, Selvapatt N, Brown A, Thursz M, Bennett H, Webster S, et al. A clinician’s guide to the cost and health benefits of hepatitis C cure assessed from the individual patient perspective. European Journal of Gastroenterology and Hepatology. 2017;29(2):208-14.

Ward T, Gordon J, Jones B, Bennett H, Webster S, Kalsekar A, et al. Value of Sustained Virologic Response in Patients with Hepatitis C as a Function of Time to Progression of End-Stage Liver Disease. Clinical drug investigation. 2017;37(1):61-70.

Training and Education

Economic evaluations of healthcare interventions routinely focus on population level cost-effectiveness analyses to support reimbursement decisions; the so-called ‘Fourth Hurdle’. Yet what is informative at the policy level does not always translate meaningfully to the local population or individual patient level.Population level analyses consider the ‘average patient’, while local payers and prescribers work with a group of individual patients with specific characteristics and health challenges. Translating the findings of policy level analyses to individual patients requires a full understanding of drivers of economic value and consequent affordability. Demonstrating value to payers and prescribers is increasingly recognised as the ‘Fifth Hurdle’.

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