2014 ISPOR 6th Asia-Pacific Conference ISSUE PANELS - SESSION I Sunday, 7 September, 3:45 PM - 4:45 PM The Pricing Challenges faced in Taiwan Yen-Huei (Tony) Tarn, PhD 2014/9/7 Executive Director Center for Pharmaceutical Care Development Taiwan Pharmacist Association 2014~2016, ISPOR Board of Director Chair, ISPOR Asia Consortium, Executive Committee First-term Director of HTA Division Center for Drug Evaluation, Taiwan New Process under 2 nd -NHI (starting 2013) Ministry of Health and Welfare Expert Group Consultation Meeting Recommendation for listing & pricing NHIA Stakeholders Meeting Make coverage decision: Covered / Not covered / Conditionally covered Set the price Drug assessment report in 42 days NHIA National Institute of HTA (NIHTA) New drugs Medical devices Diagnostics Procedures NHIA= National Health Insurance Administration 2 1
26 Members in Stakeholders Meeting (starting 2013) 1 Insurer and the relevant agencies, one of each.(2) 2 Experts(5) 3 Beneficiary representatives(3) Public Representatives 4 Employer representatives(3) 5 Representatives from contracted medical care institutions, including:(13) Provider Organization (1) Taiwan Medical Association, Taiwan Dentist Association, Taiwan Tradition Medicine Asso., Taiwan Pharmacist Asso. (2) Taiwan Hospital Association (one of each) (3) Medical Center, Regional Hospital, Community Hospital, Primary Care. (two of each ) Pricing and Reimbursement Guideline (1) Category 1 new drug: (Breakthrough innovative product) Must meet one of the following criteria: Have new mechanism of action The first drug for a specific disease shown to have good effectiveness Via head-to-head comparison or indirect comparison indicates substantial improvement of the therapeutic value than the current listed comparator Shown to be cost-effectiveness Pricing principle Set at median price of international ten ref. C Have efficacy and safety clinical trial in Taiwan with a reasonable scale, add 10%. * UK, Germany, Japan, Swiss, US, Belgian, Australia, France, Sweden and Canada 4 2
Pricing and Reimbursement Guideline (2) Category 2 new drug: Category 2A:Compare to comparator shown to have moderate improvement of the therapeutic value Category 2B:Compare to comparator shown to have similar therapeutic value Pricing principle: median of International ten is the ceiling price methods: The lowest of the international ten Prices at the original country International price ratio Dosage regimen ratio Combination product: sum of single drug price times 70% or one single drug price 5 Stakeholders Meeting approved 36% of the new drugs (2013/02~2014/04) Revision of reimb. rule Cases for reporting (1) combinati on products (2) Same ATC 5-digit product, similar efficacy * 案件數計算之方式申覆一次的案件於本表中算兩次 Cases for discussion (3) New drugs (4) Drugs for rare diseases (5) Must have products * 資料來源 : 全民健康保險藥物給付項目及支付標準共同擬定會議會議記錄 (1)+(2)+(3) (1)+(2) +(3)+(4)+(5) N % N % N % N % N % N % N % N % approve 32 68% 8 89% 23 88% 9 36% 2 100% 8 89% 40 67% 50 70% pending 9 19% 0 0% 3 12% 3 12% 0 0% 0 0% 6 10% 6 8% disapprove 6 13% 1 11% 0 0% 13 52% 0 0% 1 11% 14 23% 15 21% 總計 47 100% 9 100% 26 100% 25 100% 2 100% 9 100% 60 100% 71 100% 82 36 6 3
Stakeholders Meeting (2013/02~2014/04) approved cancer drug only 13% Drug category Approved Pending Rejected Total Approved % endocrine 1 0 0 1 100% cardiovascular 1 0 1 2 50% new born 1 0 0 1 100% hematology 1 0 1 2 50% immune 0 0 1 1 0% respiratory 0 0 1 1 0% eye 0 0 1 1 0% transplant 1 0 0 1 100% infection 3 1 0 4 75% fatigue in cancer 0 0 3 3 0% Cancer 1 2 5 8 13% Total 9 3 13 25 36% Delayed access! Price in average 53.38% of the median ten in 2013 2014.1.9. data 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 1st 第一屆 term 第二屆第三屆第四屆 5th 第五屆 term 第六屆第七屆第八屆 9th 第九屆 term New 專家 1~12 term New 新藥案 drugs 90.00% 80.00% 73.00% 80.00% 63.00% 60.00% 51.77% 51.69% 48.62% 54.46% Appeal 申覆案 cases 86.00% 59.00% 66.00% 59.00% 62.00% 47.00% 54.74% 49.31% 56.71% 51.11% Total 合計 89.07% 71.63% 70.38% 73.37% 62.72% 55.52% 53.19% 50.61% 51.83% 53.38% New drugs Appeal cases Total 8 New term 8 4
The Pricing Challenges faced From provider representatives Under global budget and fee-for-service scheme Control unit price but will push resources utilization Tend not to approve new expensive products Emphasize budget impact analysis (block cases) From NHIA Did price-volume agreement for about ten years Fear of implement risk sharing or coverage with evidence development. (negotiation unit price) Industry did not propose risk sharing scheme Patient registry may costly 5