3.2 .2 St Study of of liv liver f func unctio ion n monit - PowerPoint PPT Presentation

3.2 .2 St Study of of liv liver f func unctio ion n monit onitorin ing in in patient nts r receiv ivin ing agome omelatin ine us using ing the he E Estoni nian H n Healt lth Ins nsur urance Fund und (EHIF) F) dat atabase Maia ia U Uusküla la Katrin in K Kurvit its State Agency of Medicines, Estonia 6.12.2016

WHY? HOW? WHAT? SO? 6.12.2016 Agomelatine aRMM 2

WHY? - CAP, authoris ed in 2009 for the treatment of major depres s ive epis odes in adults - Ris k of liver injury known from the s tart - Warning in the SPC – liver function monitoring before the treatment, after 3, 6, 12 and 24 weeks and thereafter when clinically needed – DHPC in October 2012 – DHPC in September 2013 – aRMM in November 2014 (Phys ician’s guide to pres cribing, including a liver monitoring s cheme, and the Patient’s Booklet) 6.12.2016 Agomelatine aRMM 3

HOW? • Pres cription Centre of EHIF - all agomelatine pres criptions of new us ers during 01.01.2012-31.05.2016 New us ers - patients who had not been pres cribed agomelatine during 2011 Only purchas ed pres criptions were included Patients without health ins urance were excluded (non-ins ured patients are charged for tes ts ) 6.12.2016 Agomelatine aRMM 4

HOW? • EHIF Information Sys tem - all liver function tes ts of thes e patients The code field contains AST, ALT, plus ALP, LDH, CPK, GGT, CPK-Mba, Alpha-amylas e Cons equently the res ult may be s lightly more pos itive of the actual s ituation Whether tes ts were performed initiating and during treatment: • compared the tes t date with period of 15 days or 30 days before firs t purchas e; • compared the tes t date with period of +/-15 days or +/-30 days from each purchas e; 6.12.2016 Agomelatine aRMM 5

WHAT? • 5 630 new us ers s tarted with agomelatine (17 377 pres criptions ) • Mainly pres cribed by ps ychiatris ts (55%) and by GP’s (39%) • Mos t commonly pres cribed for depres s ion (31%), anxiety dis orders (21%) and recurrent depres s ive dis orders (17%) • Patients age range - 4-96 years (! Indicated 18-75 years ) – 0.6% (35 ) were children and adoles cent <18 years – 6.4% (363 ) were ≥75 years 6.12.2016 Agomelatine aRMM 6

WHAT? • An average of 3,1 pres criptions per patient and 1,3 packages per pres cription - average of 4 months treatment (median 2 months ) • During the s tudy period the patients had been tes ted 19 026 times, an average 3.8 tes ts per patient 6.12.2016 Agomelatine aRMM 7

WHAT? • Monitoring of LF at the initiation of tre atme nt – In 17% (984) the te s t wa s pe rforme d 15 days be fore s ta rting the tre atme nt, • 23% in childre n a nd a dole s c e nt • 12% in e lde rly (≥75 ye a rs ). – Exte nding the pe riod to 30 days be fore tre atme nt in 23% (1 267) of patie nts the te s t wa s pe rforme d, • 23% in childre n a nd a dole s c e nt • 17% in e lde rly (≥75 ye a rs ). – 54% of the c a s e s the te s ts we re ordinate d by ge ne ra l pra c titione r, 35% by ps ychiatris t. 6.12.2016 Agomelatine aRMM 8

WHAT? • Monitoring of LF during the tre atme nt: – In 37% (2 094) of patie nts at le a s t one te s t wa s pe rforme d during tre atme nt in +/- 15 days of pre s c ription purcha s e. – Exte nding the pe riod to +/- 30 days - in 45% (2 560) of patie nts at le a s t one te s t wa s pe rforme d during tre atme nt. – 1 029 (18%) patie nts re c e ive d agome latine at le a s t for 6 months, • In 66% (684) at le a s t one te s t wa s pe rforme d during tre atme nt • In 4% (42) te s ts we re pe rforme d a c c ording to the live r monitoring s che me 6.12.2016 Agomelatine aRMM 9

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SO? As rega rds s tudy re s ults : • Adhe re nc e to the live r monitoring s che me is poor. • Furthe r regulatory a c tion / c ommunic ation is e s s e ntia l 6.12.2016 Agomelatine aRMM 12

SO? As regards s tudy methods - CONS - data it is not always marker s pecific (billing data is bas ed on health care s ervices - many markers may be coded in one code field) - it is not pos s ible to inquire tes t res ults - defining the feas ibility of s tudy characteris tics with EHIF is challenging 6.12.2016 Agomelatine aRMM 13

SO? As regards s tudy methods – PROS EHIF databas e contains data of pres criptions and reimburs ed Hcare s ervices (us ing patient’s ID-code lab tes ts, procedures, diagnos is can be linked) EHIF data can be us ed to inves tigate • what medicines are us ed together • what tes ts /procedures are done prior/during/after T • in which indication and population the medicine is us ed (contraindication, off-label us e) • are pres cribing and dis pens ing res trictions followed (limited amount of medicine per pres cription, dis pens ing time) 6.12.2016 Agomelatine aRMM 14

SO? As regards s tudy methods – when can be us ed? Examples of future inves tigations may be: • Valproate us e and switching to an alternative treatment when patient becomes pregnant • Combined us e of medicines affecting the RAS - us e of alis kiren, AKE inhibitors and ARBs (trends over time) • Is otretinoin and medically s upervis ed pregnancy tes ting prior treatment /before every pres cription, length of the pres cription (1 month) in fertile women 6.12.2016 Agomelatine aRMM 15

Thank you! Any que s tions ? pha rma c ovig@ravimia me t.e e