보험인정기준 상세내용

■ 고시 개정 전체내용



1. 허가사항 범위(골관절염) 내에서 투여 시 요양급여를 인정함



2. 동 약제 투여 시 소화기관용 약제를 위염 등의 증상 예방 목적으로 병용 투여하여서는 안됨.



※ 동 약제는 관상동맥 우회로술(CABG) 전후에 발생하는 통증의 치료에는 투여하지 않는 등 허가사항 중 주의사항(금기사항 등)과 용법용량 등을 반드시 참고하여 처방(조제)하여야 함.





■ 고시 개정 고시번호(시행일자)

고시 제2022-250호(2022.11.1.)



■ 고시 개정 사유

국내ㆍ외 허가사항, 교과서, 임상진료지침, 임상연구문헌, 관련 학회의견 등을 고려하여 골관절염에 타 COX-2 억제제인 Celecoxib 경구제, Etoricoxib 경구제와 동일 급여기준으로 급여 확대함.



■ 관련문헌 등

1. Harrison's Principles of Internal Medicine, 21e, 2022, Chapter 371. Osteoarthritis

2. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 13e, 2018, Chapter 38: Pharmacotherapy of Inflammation, Fever, Pain, and Gout

3. Goldman-Cecil Medicine, 26e, 2020, Chapter 246. Osteoarthritis

4, 정형외과학, 대한정형외과학회, 2013

5. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), 2019

6, Guideline for the management of knee and hip osteoarthritis, Royal Australian College of General Practitioners, 2nd ed, 2018

7. BMC Medicine Guideline. Safe prescribing of non-steroidal anti-inflammatory drugs in patients with osteoarthritis ？ an expert consensus addressing benefits as well as gastrointestinal and cardiovascular risks. BMC Medicine (2015) 13:55.

8. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage 22 (2014) 363-388.

9. EULAR recommendations for the health professional’s approach to pain management in inflammatory arthritis and osteoarthritis, 2018

10. American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee

11. NICE guideline. Osteoarthritis: care and management(CG177). 12 Feb 2014. Last Updated: 20.12.11.

12. 골관절염의 약물치료 (Pharmacological treatment of osteoarthritis), 2018

13. 슬관절 골관절염 치료 지침. 대한슬관절학회. 2010

14. Lee M et al. A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis. Clin Orthop Surg. 2017 Dec;9(4):439-457.

15. Stewart M et al. Efficacy of commonly prescribed analgesics in the management of osteoarthritis: a systematic review and meta-analysis. Rheumatol Int. 2018 Nov;38(11):1985-1997.

16. Puljak L et al. Celecoxib for osteoarthritis. Cochrane Database Syst Rev. 2017 May 22;5:CD009865.

17. Gordo AC et al. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74.

18. Curtis E et, al. Safety of Cyclooxygenase-2 Inhibitors in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis. Drugs Aging. 2019 Apr;36(Suppl 1):25-44.

19. Nissen SE et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29.

20. Bally M et al. Risk of acute myocardial infarction with real-world NSAIDs depends on dose and timing of exposure. Pharmacoepidemiol Drug Saf. 2018 Jan;27(1):69-77.



■ 변경 전 고시번호(시행일자)

고시 제2015-118호(2015.7.1.)