cost-effectiveness, current barriers and access to...
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Education
Clinical Care
Research
Cost-effectiveness, current barriers and access to Hepatitis C treatment in Asia
MBBS. PhD, MMed, FAMS(Gastro) Associate Professor Chair, University Medicine Cluster Head, Dept of Medicine, YLL School of Medicine. Adjunct.,Cancer Science Institute National University of Singapore Head /Senior Consultant. Div of Gastro & Hepatology, National University Health System
Dan Yock Young
Disclosure
Consultation/ Advisory Board/ Research Funding
• Gilead
• MSD
• Abbvie
• Sanofi-Aventis
• Novartis
Disease burden of Hepatitis C
EASL guidelines 2015
Regimen HCV Genotype
1a 1b 4 5 or 6
SOF + PR 12 wks 12 wks 12 wks
SMV + PR 12 wks (naive or relapse) 24 wks (partial/null)
12 wks (naive or relapse) 24 wks (partial/null)
Not recommended
LDV/SOF 8-12 wks,† no RBV 12 wks, no RBV 12 wks, no RBV
OBV/PTV/RTV + DSV
12 wks + RBV
12 wks, no RBV
Not recommended Not recommended
OBV/PTV/RTV Not recommended 12 wks + RBV Not recommended
SOF + SMV 12 wks, no RBV 12 wks, no RBV Not recommended
SOF + DCV 12 wks, no RBV 12 wks, no RBV 12 wks, no RBV
Our version of real world…….
• Treatment of Hepatitis C has shifted from a medical limitation to a socio-economic access challenge.
• HCV can be eradicated-screen, treat, track
• Whose duty is it to make treatment accessible?
Who is paying for these drugs?
• Healthpayer
– Single healthpayer- government
– Private Insurance
– Employer
– Co-payment/Government assist
– Self paying
xxx Self-paying
Single health payer
How do payers decide if they should pay for a new treatment
• NICE (UK) NICE accepts as cost-effective if interventions has ICER < than £20,000 per QALY and there should be increasingly strong reasons for accepting as cost-effective interventions if ICER > £30,000 per QALY. NICE guideline manual
• US CEA threshold < USD50000/QALY highly cost-effective < USD100000/QALY – cost-effective >USD100000/QALY
• WHO <1x GDP per capita – highly cost-effective 1-3X GDP per capita – cost-effective >3x GDP – not cost-effective
• Real-life cost-effectiveness ranking It is not about whether a drug is cost-effective or not If there is a fixed budget – which are the treatment which would give me the highest yield for single health dollar- may be better spent on water sanitation, food nutrition etc.
Cost effective vs affordable
BMW
bicycle
motorbike
Chevrolet
$150K $100K $20K $500
Cost/km travelled
US CEA and affordability
• SOF/LDV is cost-effective – ICERs ranged from $9700 to $284 300 per QALY
– Chhatwal et al Ann Int Med 2015
• SOF/LDV cost $12 825 more per QALY than SOC – Najafzade et al Ann Int Med 2015
• Treating all eligible patients in the US compared to SOC would cost an additional USD 65 billion and offset USD 16 billion of costs.
• However, treating half of the
eligible patients in US would cost
$134 billion and is 1/8th of US
health budget 2014 www.usgovernmentspending.com/us
UK EAP
• The NHS (UK) made available 18.7 million pound for treating CHC but this would be sufficient for only 500 people.
Is it affordable in Asia
• Affordability GDP/ capita
Rank Continent GDP per capita (US$)
Year
World Average 18,351 2010
1 Oceania 39,052 2010
2 North America 32,077 2010
3 Europe 25,434 2010
4 South America 9,024 2010
5 Asia 2,941 2010
6 Africa 1,576 2010
7 Antarctica 0 2010
Is it affordable in Asia
• There is still a place for Interferon IL-28B gene favourable for achieving an SVR rs12979860 CC in Caucasian rs8099917 TT in Asians The pooled prevalence of the favourable IL-28B genotype is more common in Asians (73%) than in Caucasians (41%) and African Americans (13%). Among 8 studies on 2,612 Asian HCV patients from Japan, Taiwan and Korea, Asians who have the favourable IL-28B rs8099917 TT gene had an overall Odds Ratio (OR) of SVR 5.66 (95% CI 3.99, 8.02) compared with those without the favourable gene Compared to OR rates 3.88 (95% CI 2.75, 5.49) and 4.63 (95% CI 2.52, 8.50) for Caucasian and Black patients, respectively
• Rangnekar et al. Aliment Pharmacol Ther 2012;36:104-14. • Jimenez-Sousa et al BMC Med 2013;11:6.
• Asian tolerate side effects better ?
Option A- Utopian world
– everyone is entitled to the best treatment.
-- Whoever needs to pay just has to pay.
Option B- Stratify treatment based on need
- Those who need DAA gets DAA
- Those who don’t need DAA gets cheaper but still efficacious Rx and those that fail gets retreated.
Cost-effectivenss of HCV Rx in Singapore. GT1 naïve
BOC (RGT) 29,500 19.56
BOC 36,555 7,055 19.53 -0.03 -235,167 -176,375
IL-28B (PEG/RBV+BOC, RGT) 37,748 8,248 19.13 -0.43 -19,181 -14,386
PEG/RBV 37,916 8,416 18.87 -0.69 -12,197 -9,148
IL-28B (PEG/RBV+BOC) 40,328 10,828 19.16 -0.4 -27,070 -20,303
RVR guided therapy 41,759 12,259 20.13 0.57 21,507 16,130
IL-28B (PEG/RBV+SOF) 52,977 11,218 19.39 -0.74 -15,159 -11,370
Viekira pak 72,416 30,657 20.39 0.26 117,912 88,434
Viekira pak + ribavirin 12 weeks 74,925 2,509 20.39 0 Nil Nil
SOF+ PEG/RBV 87,696 15,280 20.32 -0.07 -218,286 -163,714
SOF + LDV 101,333 28,917 20.42 0.03 963,900 722,925
Viekira pak + ribavirin 24 weeks 148,000 46,667 20.36 -0.06 -777,783 -583,337
SOF + RBV 178,319 76,986 19.83 -0.59 -130,485 -97,864
SOF + SMV 204,019 102,686 20.35 -0.07 -1,466,943 -1,100,207
Compared to no treatment
• When compared to no treatment, all strategies including the all-oral DAA were highy cost-effective with ICER<USD50000.
• Using response guided boceprevir (BOC/RGT, least costly treatment over life-time period) as a base case, peginterferon and ribavirin (PR), 48-week boceprevir, IL-28 guided boceprevir and sofosbuvir were economically dominated by BOC/RGT as they are more costly and less effective.
Oral DAA in Non-cirrhotic HCV
• The all-oral therapies such as Ombitasvir/paritaprevir/ritonavir-dasabuvir and sofosbuvir/ledipasvir had ICER of USD38,780 to USD62,645 relative to BOC/RGT and would be considered to be within cost-effective range given willingness to pay threshold at USD 52,500 (one GDP per capita in Singapore in 2015).
Non-cirrhotic HCV
• But if retreatment is taken into account , i.e. reserving DAA as second line therapy, the oral DAA are not cost-effective as first line therapy
• Oral regimens are only cost-effective compared to Boc/RGT if they are less than SGD47,997 for treatment course
• If cirrhotic , oral DAA are more cost-effective
• the ICER of Viekira Pak and SOF+LDV relative to BOC/RGT was USD 4,505 and USD 10,649 respectively.
Roadmap strategy for naïve non-cirrhotic patients
(ICER, USD 14,336) Is this ethical?
Generic licensing of HCV drugs
• USD 900 for 12 weeks == > extremely cost-effective
• Caveats: -- Pakistan average lifespan 65 years old. No difference in treating HCV. -- The need for universal health coverage for access -- Trained health personnel to reach patients -- Ability to identify patients with disease -anti HCV, HCV RNA, HCV genotyping, fibroscan - convincing patients they need treatment - worry of DAA resistance if not supervised
Is screening cost-effective
• Yes.
• In target population where the prevalence is >1.7%
• Point of care blood test with minimal call back and tracking
• High take up rate for screening
• High adherence rate to treatment
• Successful targeting of 35% of population will reduce end stage disease and HCC by 10%
Conclusion
• HCV treatment is no longer a medical problem but a socioeconomic political issue.
• In countries where patient is direct payer, access to new generation DAA will be limited by cost and healthcare infrastructure.
• Lobbying governments, employer and companies to provide co-payment based on targeted customised treatment algorithm provide a practical strategy to allow access to those who need it rather than those who can afford it.
• HCV in theory, can be eradicated. We need to make it happen.
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