comments on hta in japan regarding uk and france
TRANSCRIPT
Comments on HTA in Japan Regarding UK and France
Isao Kamae, MD, DrPH Professor of Health Technology Assessment and Public Policy
Graduate School of Public PolicyThe University of Tokyo, Japan
HTA Seminar, GraSPP, University of Tokyo9th May, 2012
Pricing and reimbursement in Japan
Pricing for new technology (drugs and devices) is controlled and determined based on rules in MHLW.
The equations for official pricing have been developed in political and experience-based manners.
Once the price is determined, the new technology is also listed on the National Formulary for reimbursement.
Re-pricing is biennially conducted and the discounting rate is politically determined by MHLW.
Constant reimbursement rate (70%) is applied automatically for all technologies after being listed.
Key features for HTA in Japan
in early 90’s, MHLW introduced a recommendation for PE data submission which justifies the balance between clinical benefit and cost for new drugs.
So far, the recommendation not working. HTA agency regulating the 4th hurdle does not exist, but
comprehensive approach to HTA exists for both levels of micro- and macro-technology.
The comprehensive HTA in Japan is characterized with quasi-VBP.
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Quasi-VBP in Japan
Quasi-VBP: Pricing mechanism reflecting value for money by adding a premium to the control price with taking clinical benefit into account in experience-based manners, considering price-volume impact on the budget constraints in two years.
Reimbursement decision based on Cost/QALY in UK, and what about VBP in 2014?
Reimbursement rate by SMR and pricing decisions by ASMR in France
Japan does not take variable reimbursement rates; constant for all (70%) without any reimbursement decisions quite differnt from UK or French SMR
Q-VBP is performed by premiums - similar to the French ASMR, but the premium rates are subjectively adjusted and politically increased over time.
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Quasi-VBP: different from UK or France?
Approval
Reimbursement
Pricing
Where to use PE?
UK NICEFrance
Japan
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Change of the premium rates
Type of premium Before FY2002 FY2002 FY2006 FY2008
Innovation (%) 40 40 - 100 50 - 100 70 - 120
Usefulness I (%) 10 15 - 30 25 - 40 35 - 60
Usefulness II (%) 3 5 - 10 5 - 20 5 - 30
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Evaluation of innovation
Q-VBP in Japan has a process to evaluate the degree of innovation. Operating income ratio (cost accounting method) Premiums (similar efficacy comparison method)
However..... Conditions to acquire premiums are not clear. Conditions for the premium rates are not described.
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Limitations
Rates without scientific grounds and evidence Subjective/political adjustments Adjustments for cost-containment Lack of science
MHLW wants to:
Have continuing efforts for financial improvement
Attain to make the total costs contained in an affordable range without a decline of quality care
Conduct long-term & sustainable reforms by a new approach using HTA
Potentially apply pharmacoeconomics for pricing of innovative new technology in 2014 --- announced last year.
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The Hukuda Report：How could we apply PE for: ?
Reimbursement /range of reimbursement
Pricing of new drugs
A condition for larger premium
Estimate a premium rate
Determine the official price
Re-pricing for drugs in the market
Constitute a practice guidance for physicians
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However ...
What’s next to the recent sounds towards a potential introduction of pharmacoeoconomics for pricing? ---Any lessons learned from UK or France?
Concerns at both levels: methodological challenges mission of HTA ---beyond the scope of MHLW?
How to overcome the lack of personnel, data and training in a long-term of 5 or 10 years?
Substantial impact will be coming on business.
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Affinity: Japanese premiums vs. ICER
Quasi-VBP has affinity with the PE methodology: ICER
New cost = Control cost + ICER × E JP Premium
New price = Control price + Premium
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However ...
What’s next to the recent sounds towards a potential introduction of pharmacoeoconomics for pricing? ---Any lessons learned from UK or France?
Concerns at both levels: methodological challenges mission of HTA ---beyond the scope of MHLW?
How to overcome the lack of personnel, data and training in a long-term of 5 or 10 years?
Substantial impact will be coming on business. Big challenges for HTA in Japan
