Transcript ภาพนิ่ง 1 - KANITA DAYALI TIP

HTA in Pharmaceutical regulation
Yot Teerawattananon M.D., Ph.D.
Outline
 Mechanisms for health sector/pharmaceutical
regulation
 Involvement of HTA in pharmaceutical
regulation: examples from Thailand and Korea
 Discussion and conclusions
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Conceptual framework of health sector regulation
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Source: Teerawattananon et al. Health sector regulation in Thailand. Health Policy 2003;63;323-338
Pharmaceutical regulation and regulators
 Market authorization
• FDA
 Price control (direct and indirect methods)
• FDA, Department/Ministry of Health, Ministry of Commerce
 Reimbursement and financial control policy
• Third party payers (national health insurance) with the
support from HTA organizations
 Procurement/diffusion
• Local authorities e.g. hospital drug formulary committee
 Post-marketing monitoring
• FDA
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Evidences and approaches used
Thailand
Market authorization
Korea
Safety and efficacy
submitted by pharmaceutical companies
Price control
Cost structure (direct
price control) for overthe-counter drugs
Collective
information on
purchasing prices of
similar drugs‘reference price’
International price
comparison
Reimbursement and
Safety, efficacy,
Value for money of all
financial control policy availability of
new medications
alternatives, and value (commencing in 2007)
for money for high-cost
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drugs (since 2007)
Evidence used and approaches
Thailand
Procurement
/diffusion
Korea
setting up ‘Positive List System’
No clear monitoring mechanisms and systems
on drug accessibility
Post-marketing
monitoring
Passive (voluntary) surveillance and use of
international evidence on adverse
consequences including social, ethical and
medical problems
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




Safety
Efficacy/Effectiveness
Value for money
Drug accessibility
Adverse consequences
are all HTA information!
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Reasons for decisions not to reimburse new
medicines of Republic of Korea
Orange indicates “Lack of evidence on cost-effectiveness”, blue “Lack of evidence on clinical
effectiveness”, and green “Contradiction to the principle of insurance.”
Source: HIRA
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Cost-effectiveness league table of selected interventions in Thailand
Health Interventions
Baht/QALY (2008)
Coverage
cost-saving
Yes
IFN alpha + Ribavirin vs. palliative care for chronic hepatitis C infection, genotype 3
22,000
Under consideration
Antiretroviral treatment of HIV/AIDS vs. paliative care
26,000
Yes
Prevention of mother-to-child HIV transmission using AZT+NVP vs. null
59,000
Yes
Generic simvastatin for males with CVD risk in 10 years ≥30% vs. null
82,000
Yes
Cholecystectomy: Laparoscopic vs. Open
101,000
No
Peg alpha 2a + Ribavirin vs. palliative care for chronic hepatitis C, genotype 1,4, 5, 6
126,000
Under consideration
Galantamine for treatment of mild to moderate Alzheimer's disease vs. paliative care
157,000
Under consideration
Rivastigmine for treatment of mild to moderate Alzheimer's disease vs. paliative care
177,000
Under consideration
Treatment of cytomegaloviris retinitis using intravitreal gancyclovia vs. paliative care
185,000
Yes
Donepezil for treatment of mild to moderate Alzheimer's disease vs. paliative care
243,000
Under consideration
Anti-diabetic: Pioglitazone vs. Rosiglitazone
211,000
No
HPV vaccination at the age 15 years vs. Pap smear every 5 yrs (35-60 yrs)
247,000
No
Alendronate for osteoporosis vs. calcium + vit D
296,000
No
Residronate for osteoporosis vs. calcium + vit D
328,000
No
Generic simvastatin for males with CVD risk in 10 years <2.5% vs. null
393,000
No
Peritonial dialysis vs. paliative care
435,000
Yes
Hemodialysis vs. paliative care
449,000
Yes
Raloxifene for osteoporosis vs. calcium + vit D
634,000
No
Calcitonin for osteoporosis vs. calcium + vit D
1,024,000
No
HPV vaccination at the age of 25 years vs. Pap q 5 yrs (35-60 yrs)
2,500,000
No
Anemia in cancer patients: EPO vs. blood transfusion
2,700,000
No
Cervical cancer screening every 5 yrs (30-60 yrs) vs. no screening
Example of using HTA in price negotiation
the analysis of pricing threshold of the HPV vaccine against the WTP threshold
Vaccine price in Thai Baht
18,000
HPV price threshold at 1X GDP
HPV price threshold at 3X GDP
15,000
97%
86%
12,000
9,000
74%
61%
6,000
In Fab55%
09 a company
48%
announced a price
reduction of
the vaccine to 7,000 Baht 37%
26%
3,000
0
Vaccination at the
age of 15 years
Source: HITAP 2008
Vaccination at the
age of 20 years
Vaccination at the
age of 25 years
Vaccination at the
age of 30 years
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Utilization of statins in Thailand
number of patients current treated
100,000
90,000
Males
80,000
Females
70,000
60,000
50,000
40,000
30,000
20,000
10,000
0
.
. -
-
-
-
-
10-year risk of developing acute coronary
syndrome
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Problems related to HTA in
Pharmaceutical regulation
 Current attention focuses mainly on
market authorization and reimbursement
and lack of HTA on procurement/diffusion
and post-marketing monitoring
 Although there are many stakeholders
involved in the regulation, lack of
knowledge and skills on HTA among
stakeholders esp. decision makers, health
professionals, the media and the public
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Factors influencing decision making about health technology adoption by Thai
decision makers (N=450)
Chaikledkaew et al. A national survey on human capacity for health technology assessment in Thailand (a draft manuscript for
submission to international journal)
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Knowledge of selected technical terms used in HTA
among Thai decision makers (N=450)
never heard
ever heard
known (understood)
able to use
ICER
Sensitivity analysis
Discounting
QALY
CMA
Marginal cost
CUA
CBA
CEA
Indirect cost
Direct cost
Unit cost
0%
20%
40%
60%
80%
100%
Chaikledkaew et al. A national survey on human capacity for health technology assessment in Thailand (a draft manuscript for
submission to international journal)
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Conclusions
 HTA is a useful tool in every aspect of
pharmaceutical regulation
 Greater attention need to be given to the use of
HTA in other aspects of pharmaceutical
regulation (apart from reimbursement )
extensive consultation and prioritization of HTA
topics are important
 Capacity building on HTA is crucial esp. for
those decision makers, professionals, the media
and the public so that they are aware and/or be
able to use the tool
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Thank you
Who are producers of the HTA evidence?
Thailand
Korea
Industry
Industry
Value for money
The government HTA
agency namely HITAP
Industry’s submission
reviewed by the
government agency
i.e. HIRA
Adverse
consequences
Passive and voluntary
basis, no systematic
approach
Passive and voluntary
basis, no systematic
approach
Safety and efficacy
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