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

3.2 .2 St Study of

• f liv

liver f func unctio ion n monit

• nitorin

ing in in patient nts r receiv ivin ing agome

• melatin

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?

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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)

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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 )

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HOW?

• EHIF Information Sys tem - all liver function tes ts
• f 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
• r +/-30 days from each purchas e;

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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

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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

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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.

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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)

• f 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

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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

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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

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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)

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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

• ver 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

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