PMID- 30832967
OWN - NLM
STAT- MEDLINE
DCOM- 20190417
LR  - 20190417
IS  - 1524-4733 (Electronic)
IS  - 1098-3015 (Linking)
VI  - 22
IP  - 3
DP  - 2019 Mar
TI  - Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an 
      Economic Evaluation Approach to Regulatory Decisions.
PG  - 293-302
LID - S1098-3015(18)36155-2 [pii]
LID - 10.1016/j.jval.2018.09.2840 [doi]
AB  - BACKGROUND: Migraine is a common, chronic, disabling headache disorder. Triptans, 
      used as an acute treatment for migraine, are available via prescription in 
      Australia. An Australian Therapeutic Goods Administration (TGA) committee 
      rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to 
      pharmacist-only between 2005 and 2009, largely on the basis of concerns about 
      patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration 
      and free up healthcare resources. OBJECTIVES: To estimate the cost-effectiveness 
      of reclassifying triptans from prescription-only to pharmacist-only in Australia. 
      METHODS: The study design included decision-analytic modeling combining data from 
      various sources. Behavior before and after reclassification was estimated using 
      medical practitioner and patient surveys and also administrative data. Health 
      outcomes included migraine frequency and duration as well as adverse events (AEs) 
      discussed by the TGA committee. Efficacy and AEs were estimated using randomized 
      controlled trials and observational studies. RESULTS: Reclassifying triptans will 
      reduce migraine duration but increase AEs. This will result in 337 
      quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 
      years for all Australian adults older than 15 years (19.6 million). The 
      incremental cost-effectiveness ratio was estimated to be A$17 
      412/quality-adjusted life-year gained. CONCLUSIONS: The incremental 
      cost-effectiveness ratio is likely to be considered cost-effective by Australian 
      decision makers. Serotonin syndrome, a key concern of the TGA committee, had 
      little impact on the results. Further research is needed regarding 
      pharmacist-only triptan use by migraineurs currently using over-the-counter 
      medicines and by nonmigraineurs, the efficacy of triptans, and the risk of 
      cardiovascular and cerebrovascular AEs and chronic headaches with triptans.
CI  - Copyright (c) 2019 ISPOR-The Professional Society for Health Economics and Outcomes 
      Research. Published by Elsevier Inc. All rights reserved.
FAU - Parkinson, Bonny
AU  - Parkinson B
AD  - Centre for the Health Economy, Macquarie University, Sydney, NSW, Australia. 
      Electronic address: bonny.parkinson@mq.edu.au.
FAU - Gumbie, Mutsa
AU  - Gumbie M
AD  - Centre for the Health Economy, Macquarie University, Sydney, NSW, Australia.
FAU - Cutler, Henry
AU  - Cutler H
AD  - Centre for the Health Economy, Macquarie University, Sydney, NSW, Australia.
FAU - Gauld, Natalie
AU  - Gauld N
AD  - School of Pharmacy, University of Auckland, Auckland, New Zealand.
FAU - Mumford, Virginia
AU  - Mumford V
AD  - Australian Institute for Health Innovation, Macquarie University, Sydney, NSW, 
      Australia.
FAU - Haywood, Philip
AU  - Haywood P
AD  - Centre for Health Economics Research and Evaluation, University of Technology 
      Sydney, Sydney, NSW, Australia.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20181224
PL  - United States
TA  - Value Health
JT  - Value in health : the journal of the International Society for Pharmacoeconomics 
      and Outcomes Research
JID - 100883818
RN  - 0 (Nonprescription Drugs)
RN  - 0 (Oxazolidinones)
RN  - 0 (Prescription Drugs)
RN  - 0 (Serotonin 5-HT1 Receptor Agonists)
RN  - 0 (Tryptamines)
RN  - 2FS66TH3YW (zolmitriptan)
RN  - 8R78F6L9VO (Sumatriptan)
SB  - IM
MH  - Australia/epidemiology
MH  - Cost-Benefit Analysis/*methods/trends
MH  - Drug and Narcotic Control/economics/*methods
MH  - General Practitioners/economics
MH  - Humans
MH  - Migraine Disorders/*drug therapy/*economics/epidemiology
MH  - Nonprescription Drugs/classification/economics/therapeutic use
MH  - Oxazolidinones/*classification/economics/therapeutic use
MH  - Pharmacists/economics
MH  - Prescription Drugs/classification/economics/therapeutic use
MH  - Serotonin 5-HT1 Receptor Agonists/classification/economics/therapeutic use
MH  - Sumatriptan/*classification/economics/therapeutic use
MH  - Tryptamines/*classification/economics/therapeutic use
OTO - NOTNLM
OT  - *5-HT receptor agonist
OT  - *behind-the-counter
OT  - *cost-effectiveness
OT  - *economics
OT  - *legislation
OT  - *nonprescription drugs
OT  - *over-the-counter
OT  - *prescription drugs
OT  - *triptan
EDAT- 2019/03/06 06:00
MHDA- 2019/04/18 06:00
CRDT- 2019/03/06 06:00
PHST- 2018/02/27 00:00 [received]
PHST- 2018/09/05 00:00 [revised]
PHST- 2018/09/14 00:00 [accepted]
PHST- 2019/03/06 06:00 [entrez]
PHST- 2019/03/06 06:00 [pubmed]
PHST- 2019/04/18 06:00 [medline]
AID - S1098-3015(18)36155-2 [pii]
AID - 10.1016/j.jval.2018.09.2840 [doi]
PST - ppublish
SO  - Value Health. 2019 Mar;22(3):293-302. doi: 10.1016/j.jval.2018.09.2840. Epub 2018 
      Dec 24.