Review and Market Trend - TAIWAN - 17 th Annual IGPA Conference

Transcription

1 Review and Market Trend - TAIWAN - 17 th Annual IGPA Conference Yi-Yun (April) Wang Nov 20, 2014 TAIWAN GENERIC PHARMACEUTICAL ASSOCIATION 1

2 UPDATED REGULATIONS IN TAIWAN TAIWAN GENERIC PHARMACEUTICAL ASSOCIATION 2

3 3 550 Pharma Manufactories in Taiwan Nov 08, 2014 Local Manufactories with PIC/S GMP Approval: 82* ? GMP cgmp PIC/S GMP January 1 st, 2013 official member of the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S) international organization *Source: Approval List of Local Manufactories by PIC/S GMP Inspection, Food and Drug Administration, Ministry of Health and Welfare, TAIWAN

4 4 Updated Regulations PIC/S GMP Jan 01, 2015 Good Distribution Practice Draft GDP Guideline: Oct 24, 2013 Active Pharmaceutical Ingredients GMP: January 01, 2016 DMF: January 01, 2015: 10 items Acetaminophen (=Paracetamol) Cefaclor Cefazolin (Sodium) July 01, 2015: all new applications January 01, 2019 Dextromethorphan HBr Diclofenac Sodium Gliclazide Metformin HCl Risperidone Tamsulosin HCl Valproic acid

5 Patent Linkage 5 US-Taiwan Trade and Investment Framework Agreement Similar system like Orange Book Others?

6 NATIONAL HEALTH INSURANCE (NHI) TAIWAN GENERIC PHARMACEUTICAL ASSOCIATION 6

7 7 Medical points paid by NHIA in million points Inpatient Outpatient Total Hospital Clinic Chinese Medical Dental Outpatient Dialysis Others Source: Analysis Data of National Health Insurance in Taiwan, National Health Insurance Administration (NHIA), TAIWAN

8 8 Drug Price NHI Administration NHI-Listed Price Health Providers Price Difference Actual Transaction Price (negotiable) Drugs Suppliers Source: National Health Insurance in Taiwan Annual Report, National Health Insurance Administration (NHIA), TAIWAN

9 9 Regulations in NHI 2 nd G Listing Pricing Adjusting National Health Insurance Act 41 (II) Drug dispensing and fee schedule should be established jointly by the Insurer and the relevant agencies, experts, beneficiaries, employers, and contracted medical care institutions; drug providers and relevant experts as well as patients, should also be invited to voice their opinions and reported to the Competent Authority for approval. National Health Insurance Act 46 The Insurer should adjust drug prices based on prevailing market conditions; prices for drugs with patents, which have expired for a year, should start being lowered; gradual adjustment to reasonable prices should be done within five years based on prevailing market conditions. The Competent Authority shall determine the operating procedure for the adjustment in the preceding paragraph as well as the relevant rules. NHI Drug Dispensing Items and Fee Schedule Guidelines of Price Adjustment for NHI Reimbursed Drugs

10 10 Reimbursed Price NHI Drug Dispensing Items and Fee Schedule New Drugs New Items of listed ingredients and dosage forms in this Schedule Compounding prescription and special potency drugs Other prescription drugs <Rule 1> Drugs from original R&D pharmaceutical company > > BA/BE generic drugs General generic drugs 100% 90% 80%

11 11 Reimbursed Price <Rule 2> Lowest price by formulations (PIC/S GMP: inspected on site or by documents reviewing) Exchange rate NT : US = 30 : 1 (US$) Tablet / Capsule Oral solution Injection (100~500mL) Injection (>500mL) Injection (others) Lowest price (US$) Suppository Eye drops Oral aluminum small package (granule, powder, suspension) Lowest price <Rule 3> Price raising by classifying the quality conditions Highest price in the Group PIC/S GMP + DMF + user-friendly package PIC/S GMP + DMF PIC/S GMP DMF standard 100% 90% 80% 50%

12 12 Market Price Surveys Guidelines of Price Adjustment for NHI Reimbursed Drugs Subject Survey Period Survey 1 Drugs Suppliers Every Quarter Survey 2 Health Providers Announced by NHIA Survey 3 Certain % of Health Providers Nonscheduled survey (fraud or denied report) 1. Actual price < NHI price x 50% 2. Numbers of products in that group: >3 products 3. Annual amount of the group: > US$ 3.33 million 4. NHI price is NOT the lowest price by formulations

13 NHI Price Adjustment 13 <Rule 1> (Regular) Guidelines of Price Adjustment for NHI Reimbursed Drugs Frequency Patent expiration day 5 years 1 2 Every 2 years Every year Calculation Method WAP (1-R) Pold No adjustment WAP (1-R) Pold Pnew=WAP+PoldxR 1st year after the expired date 2nd ~ 5th 3 Every 2 years Original R&D The lowest one as below: 1. Lowest price in the 10 reference countries 2. Pnew=GWAP x (1+R) 3. NHI price x 70% Generic in the same group By the decreasing % of the original Original Pnew=GWAP x (1+R) Generic in the same group By the decreasing % of the original Period since 1st product got into the market: < 15 years Pnew=GWAP x (1+R) > 15 years Pnew=GWAP Same API Same quality Same price R=15% Max = 40% R=15% R=15%

14 14 NHI Price Adjustment <Rule 2> Lowest price by formulations (PIC/S GMP: inspected on site or by documents reviewing) (US$) Lowest price Tablet / Capsule (PIC/S) Oral solution Injection (100~500mL) Injection (>500mL) Injection (others) (US$) Suppository Eye drops Oral aluminum small package (granule, powder, suspension) Lowest price

15 15 NHI Price Adjustment <Rule 3> Drug Expenditure Target (DET) A 2-year trial period started on Jan 01, 2013 Category 1 & 3 Category 1 Category 3 Pnew=Pold-[(Pold-Ptemp)x(%)] Amount of adjustment Amount beyond the DET x (price difference in Category 1 / price difference in Category 1 & 3) Amount beyond the DET x (price difference in Category 3 / price difference in Category 1 & 3) (US$ million) DET (growth rate) 4.528% 3.309% Target 4,600 4,752 Actual Spending 4, Exceeding Amount 189 (3.9%) -- Source: Price Adjustment in the 2 nd Generation of NHI, Shang-Ping Chen (Senior Executive Officer, NHIA), Oct 16, 2014, Impact and Future of the Industries from the 2 nd Generation NHI Conference held by TGPA, TAIWAN

16 16 Price cut (US$ million) 1,800 6,000 1,600 5,333 1,400 4,667 1,200 4,000 1,000 3,333 NHI Drug Expenditures 800 2, , , % 24.8% 2, , % 24.4% 3, % 24.6% 24.9% 24.8% 25.0% 24.8% 25.2% 25.4% 25.0% 25.8% 3, % 1,094 1,115 1,130 3,767 3,717 3, % 4.4% 3,853 1, % 1.4% 4,120 1, % 4,337 1,301 1,313 4, % 5.3% 1,424 4,747 1,420 4, % 8.4% 1,541 5, % -0.3% 26.1% 2, Jan- Jun 藥品費用 89 年 90 年 91 年 92 年 93 年 94 年 95 年 96 年 97 年 98 年 99 年 100 年 101 年 102 年 103 年 Drugs Expenditure Drugs Expenditure over Total Health Care Expenditure Growth Rate 藥費占率 成長率 Exchange rate NT$ : US$ = 30 : 1 8.6% 月 Source: Price Adjustment in the 2 nd Generation of NHI, Shang-Ping Chen (Senior Executive Officer, NHIA), Oct 16, 2014, Impact and Future of the Industries from the 2 nd Generation NHI Conference held by TGPA, TAIWAN 26.5% 6.6% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% -5.0%

17 TAIWAN PHARMA MARKET REVIEW TAIWAN GENERIC PHARMACEUTICAL ASSOCIATION 17

18 18 Licenses in Taiwan Total: 27,740 [ Generic Drugs ] 23, % (20,734/2,397) [ New Drugs ] 1, % (523/1,323) [ Orphan Drugs ] % (9/36) [ Biologicals ] % (21/329) [ API ] 2, % (607/2,086) [ Types of Drugs ] Licenses Percentage/27,740 (total licenses) (Local Manufacturing Products/Import Products) Source: Management Strategy of International Drug Quality, Li-Ling Liu (Director, TFDA), Jun 23, 2014, TAIWAN

19 19 Total Market Sales Trend in Taiwan Exchange rate NT$ : US$ = 30 : 1 US$ Million 5,333 4,667 4,000 3,333 2,667 2,000 1, , , , , , , , , , ,

20 20 Branded v. Generics 23% 67%

21 21 Leading Pharmaceutical Manufacturers Exchange rate NT$ : US$ = 30 : 1 Ranking 1 to 10 (US$ Million)

22 22 Leading Pharmaceutical Manufacturers Exchange rate NT$ : US$ = 30 : 1 Ranking 11 to 20 (US$ Million)

23 Leading Products 23 Exchange rate NT$ : US$ = 30 : 1 (US$ Million)

24 THANKS FOR YOUR ATTENTION! Yi-Yun (April) Wang Website: TAIWAN GENERIC PHARMACEUTICAL ASSOCIATION 24