KPMA Brief Vol. 01 CONTENTS - - refund Vol FAX *KPMA Brief

KPMA Brief 2014. 05. Vol. 01 Contents - refund

KPMA Brief 2014. 05. Vol. 01 CONTENTS - - refund - - - - 2014 5 1 2014. 05. Vol. 01 161 02-581-2103 FAX 02-581-2106 *KPMA Brief www.kpma.or.kr.

.. PICs,,.... 4,.. 2010. R&D. R&D,,. KPMA Brief,,.. KPMA Brief. KPMA Brief. KPMA Brief.

4 KPMA Brief 2014. 05. Vol. 01. R&D. 1 1999 SK 2013 20 LG 3,000 500 FDA. 20 270 500 3 1 13,. 1. 1. 1 SK 99.07 2 0.05 3 1.07 4 1.07 5 LG 2.11 6 3.06

- 5 7 CJ 3.09 8 4.03 9 5.09 10 ST 5.11 11 B 6.11 12 7.04 13 SK 7.07 14 8.1 15 10.09 16 11.08 17 JW 11.08 18 12.01 19 LG 12.06 20 13.07 2013 1. 100 ST, 3 2. R&D R&D.. 2013 7 5 R&D R&D 5 10,, R&D... www.kpma.or.kr

6 KPMA Brief 2014. 05. Vol. 01 2. 2013 2012 YoY SK - - - 9 12-26.20% - - - 19 16 18.90% LG 23 22 1.80% 25 12 103.00% CJ - - - 25 22 10.20% 25 34-26.70% ST 117 170-31.20% 35 57-38.30% 32 34-3.20% SK 13 19-27.90% 77 65 17.70% 105 21 400.0% 209 165 27.00% - - - JW 10 29-65.40% 8 1 1243.10% LG 53 1 4741.20% - - - 785 680 8.60% IMS / 2013.. R&D...

- 7 1. -, 2014,.. A B-B' 53.55%, 1 X" 53.55%.. 1. 53.55%.. 53.55%. 53.55%. 53.55% 2.,.,. www.kpma.or.kr

8 KPMA Brief 2014. 05. Vol. 01...... 30%. ST -. R&D R&D. - 1.. 5 5.. 4.... 3 ST 20%. 1..

- 9... R&D. R&D.. R&D. 2017 10 5 2017 11, 4.. www.kpma.or.kr

10 KPMA Brief 2014. 05. Vol. 01 - Refund. 1. PASLU,,,,,,. PBAC, 1... 11 2 8, 2009 7 2, 3 2. 1, 1., 2013. 9. 17. p.10.

- Refund - 11,,, 3. 2. Conditional treatment continuation + money back guarantee, Expenditure cap, Refund, Utilization cap/fixed cost per patient, 2. Coverage with Evidence development,,. 2006 -. 3.. 2. 1. 3 - - - - - - - - - 2,, 23 2,, 2013, pp. 91-93. 3,, Issue & Focus 21 2010-4,, 2010, p. 7. www.kpma.or.kr

12 KPMA Brief 2014. 05. Vol. 01 - - -, -. 1.,. 2013. 9. 17. -,,.. 2...,,,.,,. -,,

- Refund - 13,.., 2.,..,,.... 1.,. Coverage with Evidence development PMS.. 100%., IRB,,.,, www.kpma.or.kr

14 KPMA Brief 2014. 05. Vol. 01..,. - 13 4 1 3 8 2 1 4 [ 3]. [ 2. - 2] 1 2006 -., - 2 Refund. 4. -., Refund.. 3. -, - 4 [ 3] -,.

- Refund - 15,, -... 4. [ 1], 3 5,, 53.55/80,.. -. 2013. 7. 5 5., -,...,. -, - - 1, 1., 2013. 9. 17. p.10. www.kpma.or.kr

16 KPMA Brief 2014. 05. Vol. 01.,,.. 2009. 1. 2009. 8.,, 2010. 5. 27.,, 2010. 11. 28..,. 2010. 7.,,,,, 2011. 4. 5..,..,.

- 17. 99 2. 2. 1. - 2014. 1. 1. 12176 2014. 7. 2., 47 2 1 1 41 2 1,, 41 2 2., 100 40 가. 요양급여적용정지대상이되는약제 41 1 2 2 31 2 3 42 1 47 2,,,,,,, 76 1 5 2 3 1 47,,,,,,,.,,,,,,. 2 41,,. 2. 3 76,,,,,,,,, 31 4. 77 1,, 1., 4. 5 2. 47 2 www.kpma.or.kr

18 KPMA Brief 2014. 05. Vol. 01 94 2 4, 70 2 [ 8] 1. 70 2 [ 8] 2., 5, 2 70 2 나. 요양급여적용정지기간및적용제외판단기준,,.,. 41 1 2,, [ 8] 3. i 12, ii 12 5, 41 2 2 70 2 [ 8] 4, 70 2 [ 8] 4.. 1. 1 2 3 500 2 500 2,000 1 3 2,000 3,500 2 4 3,500 5,500 4 6 4 94 2 47 2 3 2 3.,.

- 19 1 2 3 5,500 7,500 6 8 7,500 1 9 11 1 12 다. 과징금부과 징수 1 99 2,. i, ii, iii 8 2,,, iv 70 2 [ 8] 5. 2 99 2 100 40.., i 1, ii, 70 2 [ 8] 5., 40%.. 2. - 500 500 ~ 2,000 2,000 ~ 3,500 3,500 ~ 5,500 5,500 ~ 7,500 7,500 ~ 1 1 1 2 4 6 9 12 - - 15% 20% 25% 30% 35% 40% 40% www.kpma.or.kr

20 KPMA Brief 2014. 05. Vol. 01.. 1. 2.,,,.,. 80% 5.,,,,. 5., R&D 가. 제재내용및정도와관련된문제점 1,,,.,.,,,. 5,, 2014. 3. 20.

- 21,,.,,,,. 2.,.,, 1992. 8. 18. 92 1395, 1,000, A 15% 150.,.,,,. 2 A, B 6,000, A 100, A 30% 30, B 10 B 30% 3., 10,.. 3.,.. 1 A 500, A.,.,, www.kpma.or.kr

22 KPMA Brief 2014. 05. Vol. 01.,,., 1 11 1 5,,...,.,.

- 23. 2007 4 FTA., FTA. FTA Hatch-Waxman 1984.,,.,..,,,,.. 180, www.kpma.or.kr

24 KPMA Brief 2014. 05. Vol. 01. 1996 9.5 Teva, 2012 203 10 1. Teva 70% 1.1%, 129 11.4%, 28., 1,418 477, 385 80.7%,.., 2012, 2015 3,.,,.,,....,. 1. 2. FTA 2012,, 13.12 1,132, 962 85.0%, 13 FTA.,,

- 25.,,,,., 3.,,,,..,. 2015,.,, FTA,.,,.,.,,,,, R&D,.,., 3. 3.,.,,.,,,, 3,,. www.kpma.or.kr

26 KPMA Brief 2014. 05. Vol. 01,..,,,.,.,,.,, 1. 4.,, 2015 3.,,.,., 2014,,,.,,.,.,,.,. 12..,.,,

- 27.,..,,.,...,.. H FDA, 2.,..,,.,,.,.,,,.,. R&D.,,. 1986,. 2000, 2006 DERP, 2015 www.kpma.or.kr

28 KPMA Brief 2014. 05. Vol. 01.. WTO,...,,.,, 2015.

- 29. 1st.,,.,,,,,. First-in-class., me too 2 4., 2 4.,. cash cow,. FDA NDA 505 b 2,,. 2012 FDA. www.kpma.or.kr

30 KPMA Brief 2014. 05. Vol. 01?,? 2000,,,.,? FDA 50, 100,.,? 10,., cgmp? cgmp, cgmp,.,?,.,... FTA - Hatch-Waxmann Act. 1st Filer 180 Market Exclusivity.,, 1990, 2000 - Hatch- Waxmann Act 2000, M&A,.,,.,. 1st Business Model.. 10

- 31,.,., FDA,., cgmp.,., FDA,,.,,,, CMO. FDA CMO., FDA ANDA Paragraph IV, FDCA 505 j, CSO., 180 70 80%, 70%, 30%. 1st Filer,,. - Hatch-Waxmann Act, - Hatch-Waxmann Act ' first-to-file 180. FDA OrangeBook.,,. NDA 30 OrangeBook. www.kpma.or.kr

32 KPMA Brief 2014. 05. Vol. 01 ANDA Patent Certification. - Paragraph Certification - Paragraph Certification - Paragraph Certification - Paragraph Certification. Paragraph FDA. 180. Paragraph 45 FDA, 180. 45 30 FDA. FDA ANDA. Paragraph FDA ANDA FDA ANDA 180 1. 1 2007

- 33. - -, - 2007 FTA 2015 3 15. 2014 3 1, 12. 2014...,, 1... -.,,..,. www.kpma.or.kr

www.kpma.or.kr KPMA Brief 2014. 05. Vol. 01 02.2272.7097..

*KPMA Brief www.kpma.or.kr. 16 02-581-2103 www.kpma.or.kr