cost-effectiveness of daa- based...

Cost-effectiveness of DAA-

based treatments

Y.Yazdanpanah ([email protected])

Service des Maladies Infectieuses et Tropicales Hôpital Bichat Claude Bernard

Equipe ATIP/Avenir INSERM (U1137) : "Modélisation, Aide à la Décision, et Coût-Efficacité en Maladies Infectieuses"

Université Paris Diderot: site Bichat

How best to utilize the resources that are available ?

-In low-income countries -In high-income countries

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The Big Question?

Resource constraints In particular in the time of crisis

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Economic evaluation

To assist decision makers in choosing from among competing alternatives, in situations of uncertainty and limited resources.

“Quantitative analysis for qualitative insight.”

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Two questions for any strategy: • Is it effective? • Is it cost-effective?*

(*If it’s not effective, it’s not cost-effective…)

Public health evaluation

+

−

+ −

Incremental Health Effect

Incremental Cost

Yes

No Evaluate C/E Ratio

Evaluate C/E Ratio

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Cost-effectiveness analysis

• Cost-effectiveness has two outcomes* – Cost ($, Euros, rand) – Effectiveness (YLS or QALY or DALY)

• Cost-effectiveness ratio – $/YLS or $/QALY gained

• The value of resources spent

*A cost analysis that has only one outcome ($ or rand)

Cost-effectiveness Analysis

• Cost-effective ≠ cost-saving • More effective intervention:

often more expensive • Is the additional benefit worth

the additional cost?

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• What are we willing to pay?

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Intervention $/ QALY Streptokinase in acute myocardial infarction, age 60 1,300 Neonatal intensive care, 1000-1499g 5,500 Coronary artery bypass, three vessel 7,200 Long-term beta-blockers post myocardial infarction 7,300 Treatment of severe diastolic hypertension (>105 mmHg) 11,400 Implantable defibrillator 17,400 Treatment of mild diastolic hypertension (95-104 mmHg) 23,200 Heart transplant 26,900 Estrogen replacement therapy post-menopause 33,700 Percutaneous coronary angioplasty, two vessel 49,000 Hospital hemodialysis 59,500 HMG-CoA reductase inhibitor for high cholesterol 93,000 Annual mammography, age 40-49 94,500 Prophylactic IV immune globulin in chronic leukemia 6,000,000

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Cost-effectiveness of specific clinical interventions adopted in sub-Saharan Africa

Intervention US$/DALY Malaria control 1-121 Mother-to-child HIV transmission 1-731 Oral rehydration therapy 58-580 Preventive therapy for tuberculosis 169-288 Onchocerciasis vector control 171-327

The Commission on Macroeconomics and Health

• CE ratios < GDP/capita = “very cost-effective” • CE ratios < 3 x GDP/capita = “cost-effective”

Cost-effectiveness analysis: Understanding, prioritizing and optimizing the use of health care services Decision science – decision-oriented and not truth oriented Informing standards and guidelines for care, not individual patient care 13

Published Studies in Cost-effectiveness

Slide, R. Walensky; https://research.tufts-nemc.org/cear4/AbouttheCEARegistry/WhatistheCEARegistry.aspx

“Cost-effective doesn’t mean cheap”

16 In the next years

Background

• Therapeutic progress accompanied by an increase in health-related costs

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0

1000

2000

3000

4000

5000

Peg-Riba Telaprevir Boceprevir Sofosbuvir

unit price €/week

• Is the additional benefit worth the additional cost?

Strategy SVR (%) $/QALY Mild fibrosis PegInf-Riba 38

IL28-Guided 57 62 900 Triple Therapy 61 102 600 Advanced fibrosis PegInf-Riba 32 IL28-Guided 48 32 800 Triple Therapy 51 51 500

Bocéprevir Mild = F0, 30%; F1, 41%; and F2, 29%.

Advanced : F2, 29%; F3, 23%; and F4, 48%.

Intervention $/ QALY Streptokinase in acute myocardial infarction, age 60 1,300 Neonatal intensive care, 1000-1499g 5,500 Coronary artery bypass, three vessel 7,200 Long-term beta-blockers post myocardial infarction 7,300 Treatment of severe diastolic hypertension (>105 mmHg) 11,400 Implantable defibrillator 17,400 Treatment of mild diastolic hypertension (95-104 mmHg) 23,200 Heart transplant 26,900 Estrogen replacement therapy post-menopause 33,700 Percutaneous coronary angioplasty, two vessel 49,000 Hospital hemodialysis 59,500 HMG-CoA reductase inhibitor for high cholesterol 93,000 Annual mammography, age 40-49 94,500

Stratégie SVR (%) $/QALY Mild fibrosis PegInf-Riba 38

IL28-Guided 57 62 900 Triple Therapy 61 102 600 Advanced fibrosis PegInf-Riba 32 IL28-Guided 48 32 800 Triple Therapy 51 51 500

Bocéprevir Telaprevir Mild = F0, 30%; F1, 41%; and F2, 29%.

Advanced : F2, 29%; F3, 23%; and F4, 48%.

SVR (%) $/QALY

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61 86 800 70 102 400

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54 45 300 60 54 100

“For patients with mild fibrosis, universal triple therapy at a cost of $1100 per week is not cost-effective, even at $100 000 per QALY”

Should we await Interferon-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 95141)

Sylvie Deuffic-Burban (Inserm, IAME, UMR1137, Univ Paris Diderot, Paris & Inserm, U995, Univ Lille 2, Lille), Michaël Schwarzinger, Dorothée

Obach, Vincent Mallet, Stanislas Pol, Georges-Philippe Pageaux, Valérie Canva-Delcambre, Pierre Deltenre, Françoise Roudot-Thoraval, Dominique

Larrey, Daniel Dhumeaux, Philippe Mathurin, Yazdan Yazdanpanah

Objectives

• To assess the cost-effectiveness of IFN-based new DAAs compared to TVR/BOC-based triple therapy

• To compare different IFN-based new DAAs initiation strategies, given that IFN-free regimens will soon be available

ILC 2014 - London 24

Decision analysis model

25 ILC 2014 - London

Therapeutic interventions up until age 70

Persistence in the stage of infection Transition to another stage Transition to death

F1 F2 F3 F4 F0

Background mortality

HCC First decompensation

Stable decompensation

Progressive decompensation

HCV-related death

Liver transplantation

Data on SVR


Stage F0-2 Stage F3-4 TVR/BOC* 73% 54% IFN-based new DAAs 89% 71% IFN-free regimens 95% 85%

Jacobson et al, NEJM 2011; Sherman et al, NEJM 2011; Poordad et al, NEJM 2011; Poordad et al, Gastroenterology 2012

*Response-guided therapy and stopping rules were taken into account

Costs regarding treatment


Unit price Unit price of molecules, €/week Peg-Riba 312 TVR 2,210 BOC 796 IFN-based new DAAs (Sofosbuvir)* 4,750 IFN-free regimens** 9,500 (assumption)

French Red Book, 2012; Agence Technique de l'Information sur l'Hospitalisation (ATIH) *Based on current sofosbuvir expanded assess costs in France **Assumption = two times higher than IFN-based new DAAs

Baseline analysis: Diagnosis at F0-1


Strategies Lifetime cost (€)

LE (years)

QALY (years)

ICER (€/QALY)

Treat with TVR/BOC-based triple therapy when ≥ F2

25,700 20.80 19.32

Treat with IFN-based new DAAs when ≥ F2

40,500 21.10 19.71 37,900

Treat with IFN-based new DAAs regardless of fibrosis

64,300 21.13 19.94 103,500

Await IFN-free regimens; then treat when ≥ F2 (≥2015)

69,100 21.22 19.84 Dominated

Await IFN-free regimens; then treat regardless of fibrosis (≥2015)

112,500 21.25 20.09 321,300




LE (years)

QALY (years)

ICER (€/QALY)


25,700 20.80 19.32


40,500 21.10 19.71 37,900


64,300 21.13 19.94 103,500


69,100 21.22 19.84 Dominated


112,500 21.25 20.09 321,300

ICER < 3 times the French GDP/capita




LE (years)

QALY (years)

ICER (€/QALY)


25,700 20.80 19.32


40,500 21.10 19.71 37,900


64,300 21.13 19.94 103,500


69,100 21.22 19.84 Dominated


112,500 21.25 20.09 321,300

ICER > 3 times the French GDP/capita




LE (years)

QALY (years)

ICER (€/QALY)


25,700 20.80 19.32


40,500 21.10 19.71 37,900


64,300 21.13 19.94 103,500


69,100 21.22 19.84 Dominated


112,500 21.25 20.09 321,300 More expensive and less effective




LE (years)

QALY (years)

ICER (€/QALY)


25,700 20.80 19.32


40,500 21.10 19.71 37,900


64,300 21.13 19.94 103,500


69,100 21.22 19.84 Dominated


112,500 21.25 20.09 321,300

ICER > 3 times the French GDP/capita

50% reduction in costs of IFN-based and IFN-free regimens


Diagnosis at F0-1 Strategies

Lifetime cost (€)

LE (years)

QALY (years)

ICER (€/QALY)


23,600 21.10 19.71

Treat with TVR/BOC triple therapy when ≥ F2

25,700 20.80 19.32 Dominated


34,000 21.13 19.94 45,200


37,400 21.22 19.86 Dominated


57,600 21.25 20.09 157,300

ICER < 3 times the French GDP/capita

Impact of new DAA-containing regimens on HCV transmission among people who inject drugs (PWID): a model-based analysis (ANRS 95146)

Anthony Cousien, Viet Chi Tran, Marie Jauffret-Roustide, Sylvie Deuffic-Burban,

Jean-Stéphane Dhersin, Yazdan Yazdanpanah

J Hepatol 2013

• “Cost of oral therapy was unavailable since these treatments are currently unapproved.

• The baseline cost of oral therapy was calibrated such that the average total treatment cost of oral therapy was equal to the average total treatment cost of triple therapy = $5800 per week.

Unit price Unit price of molecules, €/week Peg-Riba 312 TVR 2,210 BOC 796 IFN-based new DAAs (Sofosbuvir)* 4,750 IFN-free regimens** 9,500 (assumption)

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Budget impact analysis

The financial consequences of introducing a new technology in a specific setting over the short to medium term : affordability

Budget impact

“With the present estimates of costs, treating even half the HCV-infected persons in the United States would add billions of dollars to an already overburdened medical care system. Costs alone cast a pall over the stunning success in achieving the long-hoped-for goal of a safe and effective therapy for hepatitis C”

Hoofnagle JH, and Sherker AH. N Engl J Med 2014; 370:1552–53.

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Conclusions

• What economic evaluation is: – a means for evaluating the economic

impact of clinical decisions – quantitative analysis for qualitative insight

• What Economic Evaluation is Not: “The answer”

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One component useful for clinical policy development alongside with other issues including fairness, ethics, and political concerns

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Economic evaluation

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Inserm, Avenir team « Decision Sciences in Infectious Disease Prevention, Control and Care »

cost-effectiveness of daa- based...

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