ᮏ᪥࠾ヰࡋࡓ࠸ෆᐜ〇⸆௻ᴗ㸦ࣂ࢖࢚ࣝ⸆ရ㸧ࡢᡓ␎ࠊQoL࣭PRO◊✲ࡢ⫼ᬒ• ᅜ㝿⮫ᗋヨ㦂ࠊ᪥ᮏ༢⊂ࡢヨ㦂ࠊPSSࠊISSࠊ⮫ᗋヨ㦂௨እ
QOL-PRO㸸࣓࣮࣮࢝࠿ࡽࡢᮇᚅཬࡧࡑࡢྲྀ⤌ࣂ࢖࢚ࣝ⸆ရ ࣐࣮ࢣࢵࢺ࢔ࢡࢭࢫᮏ㒊
Bruno ROSSIQoL࣭PROᡓ␎ࡢᐇ᪋౛㸸୺せ┠ⓗู࡟⤂௓• ࢫࢸ࣮ࢡ࣍ࣝࢲ࣮࡬ࡢ⑌ᝈࡢ㈇ᢸ࡜࢔࣓ࣥࢵࢺࢽ࣮ࢬࢆ⌮ゎࡍࡿØ ║⛉ࠊᚠ⎔ჾࠊ፬ே⛉• ᝈ⪅ࡢQoL࣭PROホ౯ࡢ㔜せᛶࢆఏ࠼ࠊ⮫ᗋ⌧ሙ࡬ࡢᑟධࢆಁࡍØ ║⛉• ᐇ㝿ࡢデ⒪࡟࠾ࡅࡿ〇ရࡢ᭷ຠᛶࢆᝈ⪅ࡢどⅬ࡛ホ౯ࡍࡿ• Post-Marketing Surveillanceᮇᚅ / Challenges➨8ᅇ CSP-HOR ᖺ఍࣭2014ᖺ6᭶21᪥

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QoL࣭PROホ౯ࡢ⫼ᬒ㸸ࠕ࢔࢘ࢺ࣒࢝◊✲ࡢ᪂ࡋ
࠸ὶࢀ㸸PROࡀ 㔜せどࡉࢀࡿࡼ࠺࡟࡞ࡗࡓࠖ•••᝟ሗඹ᭷→་ᖌ࣮ᝈ⪅ࡢ  ࢥ࣑ࣗࢽࢣ࣮ࢩࣙࣥࢆಁ㐍἞⒪㑅ᢥ࡞࡝ࡢពᛮỴᐃ࡜἞⒪ࡢホ౯࡟࠾࠸࡚ࠊ་⒪ࡢཷࡅᡭ࡛࠶ࡿᝈ⪅ࡢどⅬ࡟❧ࡗࡓ࢔࢘ࢺ࣒࢝ࡀ㔜せᝈ⪅୰ᚰࡢ་⒪ࠕ⑌⑓ࢆ἞⒵࣭ඞ᭹ࡍࡿࠖ࡜࠸࠺ព㆑࡛ࡣ࡞ࡃࠊࠕ೺ᗣࢆ⥔ᣢ࣭ቑ㐍ࡍࡿࠖ࡜࠸࠺ព㆑࡬ࢩࣇࢺ೺ᗣ࡟ᑐࡍࡿព㆑••••㧗㱋໬࡜་Ꮫࡢ㐍Ṍᛴᛶ⑌ᝈࡢῶᑡࠊ៏ᛶ⑌ᝈࡢቑຍ἞⒪ࡢ┠ⓗࡢኚ໬㸦QoLࡢྥୖ㸧⑌ᝈศᕸࡢኚ໬

QoL࣭PROホ౯ࡀ㔜せ་⒪㈨※ •ࡢ᭷㝈ᛶ་⒪ࡢ㧗㢠໬࡟క࠸ࠊ་⒪㈨※ࡣ᭷㝈࡞ࡶࡢ࡛࠶ࡿ࡜࠸࠺ㄆ㆑ຠ⋡໬ࡢᚲせᛶ࡟ᛂࡌ࡚⛉Ꮫⓗ࡞࢔࢘ࢺ࣒࢝◊✲ࡢά⏝ࣂ࢖࢚ࣝ⸆ရ࡛ࡢ⤒㦂࣭࣭࣭Iฟ඾㸸ụୖ➼ࡢⴭ᭩ࠕ⮫ᗋࡢࡓࡵࡢQOLホ౯ࣁࣥࢻࣈࢵࢡࠖࡼࡾ

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CSP-HOR, Tokyo, June 21, 2014

Page 4〇ရ㛤Ⓨ࣭་⒪⌧ሙ࡟࠾ࡅࡿPROホ౯ࡣᮍࡔᗈࡃࡣཷࡅධࢀࡽࢀ࡚࠾ࡽࡎࠊ⌮ゎࡉࢀ࡚࠸࡞࠸ࡢࡀ⌧≧〇⸆௻ᴗ㸦ࣂ࢖࢚ࣝ⸆ရ㸧ࡢᡓ␎〇⸆௻ᴗ㸦ࣂ࢖࢚ࣝ⸆ရ㸧ࡢᡓ␎PROs㸸Where?
ü ᅜ㝿⮫ᗋヨ㦂࣭Ph III㹼II㸦㹼㸶㸮㸣㸧ü ᪥ᮏ༢⊂ࡢヨ㦂ü ᕷ㈍ᚋㄪᰝ㸦PMS㸧ü ་ᖌ୺ᑟヨ㦂㸦ISS㸧ü ⮫ᗋヨ㦂௨እWho?
§ ᅜ㝿ヨ㦂㸦㹼㸶㸮㸣)⮫ᗋ㛤Ⓨ§ ᪥ᮏ༢⊂ࡢヨ㦂㸦㹼㸰㸮㸣㸧⮫ᗋ㛤Ⓨ§ ᕷ㈍ᚋㄪᰝ㸦PMS)Ᏻ඲ᛶ§ ་ᖌ୺ᑟヨ㦂㸦ISS)
MAF§ ⮫ᗋヨ㦂௨እ§ PRO Validation
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QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 ║⛉᪥ᮏ࡟࠾ࡅࡿⁱฟᆺຍ㱋㯤ᩬኚᛶ࡟క࠺
ᝈ⪅ࡢ㈇ᢸ [┠ⓗ]

PROᡓ␎
㛤Ⓨ୰

HEORHEOR

ᕷ㈍‽ഛᮇ㛫

ᕷ㈍ᚋ
Unmet Needsࡢᢕᥱ⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹

QoLࡢྥୖ࡬㈉⊩〇ရ䛾䝷䜲䝣䝃䜲䜽〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬䝙䞊䝈䜢᫂☜໬

Understand the disease
Identify treatment gaps
Quantify unmet needs
Planning for advocacy------------//////-----------Define end-points ofregulatory studies
Page 7䝬䝛䞊䝆䝯䞁䝖

PMDA label(very few, actually)
Interview forms

Confirmation of productuse and impact inReal-Life setting

Product differentiation
Marketing, Promotion
Access to therapy-----------//////------------NHI price premium(very few)

Product differentiation

CSP-HOR, Tokyo, June 21, 2014-----------/////-----------Possibly, if HTA after2016

་ᖌ࠿ࡽࡢどⅬ(Clinician )• Unmet needsࢆ‶ࡓࡋࡓQoLࢆྥୖࡉࡏࡿ἞⒪• QoLᨵၿࡢ㔜せᛶࡢఏ㐩ᝈ⪅ᵝࡢ
どⅬ(Patient)• ⌧≧࡜㐍ᒎࡢ⌮ゎ
• QoLᨵၿ࡬ࡢព㆑ࢆ㧗ࡵࡿ〇⸆఍♫ࡢ
どⅬ(Pharma)• Unmet needsࢆᨵၿࡍࡿ

ᝈ⪅ᵝ㈇ᢸࡢ⌮ゎ⫼ᬒ㸸ⁱฟᆺຍ㱋㯤ᩬኚᛶ㸦wet AMD㸧ࡣ᪥ᮏ࡟࠾ࡅࡿどຊ㞀ᐖࡢ୍␒ࡢせᅉ࡛࠶ࡿࠋᮏ⑌ᝈ࡛ࡣどຊࡢపୗ࡟క࠸ࠊQoLࡢపୗࢆྵࡴᝈ⪅࡟࡜ࡗ࡚ࡢ㈇ᢸ
ࡀⴭࡋ࠸࡜⪃࠼ࡽࢀࡿ
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QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 ║⛉᪥ᮏ࡟࠾ࡅࡿⁱฟᆺຍ㱋㯤ᩬኚᛶ࡟క࠺ᝈ⪅ࡢ㈇ᢸ [᪉ἲ]QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 ║⛉Wet AMDࡣᝈ⪅ࡢQoL࡟ᙳ㡪ࢆࡶࡓࡽࡍ
㛤Ⓨ୰ᕷ㈍‽ഛᮇ㛫

ᕷ㈍ᚋ࣮࣓࢟ࢵࢭ࣮ࢪ

㐣ཤ1ᖺ㛫ࡢ࢝ࣝࢸ࣭ࣞࣅ࣮ࣗ

⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹〇ရ䛾䝷䜲䝣䝃䜲䜽〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬䝙䞊䝈䜢᫂☜໬+ᝈ⪅ᵝ࢖ࣥࢱࣅ࣮ࣗ• National Eye Institute Visual Functioning Questionnaire-25
㸦NEI VFQ-25㸧㉁ၥ⚊ࢆ⏝࠸࡚QoLࢆ ᐃ1㸧wAMDᝈ⪅࡛ࡣࠊ୍⯡ⓗぢ࠼᪉ࠊ୍⯡ⓗ೺ᗣឤࠊ㐠㌿ࠊཬࡧ㏆
ぢどຊ࡟ࡼࡿ⾜ື࡟ᑐࡍࡿQoLࢫࢥ࢔ࡀ≉࡟ప࠿ࡗࡓࠋ121ே୰15ྡࡀ࠺ࡘഴྥ࡟࠶ࡗࡓࠋ䝬䝛䞊䝆䝯䞁䝖᪥ᮏ║⛉Ꮫ఍, April 2013
ISPOR, May 2013᪥ᮏ⮫ᗋ║⛉Ꮫ఍, Nov 2013• ⪁ᖺᮇ࠺ࡘᑻᗘࡢ▷⦰∧㸦Geriatric Depression Scale,Short version in Japanese: GDS-S-J㸧ࢆ⏝࠸࡚࠺ࡘഴྥࢆ ᐃ• ἞⒪ࡢ‶㊊ᗘ࡜ேཱྀ⤫ィᏛⓗ᝟ሗ࡟ࡘ࠸࡚⪺ࡁྲྀࡾㄪᰝ

National Eye Institute Visual
Functioning Questionnaire-25 (NEIVFQ-25), Geriatric Depression Scale2㸧඲యࡢ1.2%ࡀどຊ㞀ᐖ࡟ࡼࡾ㌿ಽࡋ࡚࠾ࡾࠊᖺ㛫ࡢ┤᥋་⒪㈝ࡣ୍ேᙜࡓࡾ635,000෇࡜᥎ィࡉࢀࡓ

(Treatment Satisfaction, Demographics)

ฟ඾: ᪥ᮏ║⛉Ꮫ఍㞧ㄅ➨117ᅇ⮫᫬ቑหྕࠊ⸨⏣➼ࠕⁱฟᆺຍ㱋㯤ᩬኚᛶ࡟ࡼࡿᝈ⪅ࡢQOL࡬ࡢᙳ㡪ࠖ2013ࠊp321.
Adachi et al. Patient burden associated with wet age-related maculardegeneration in Japan. Value Health May 2013; 16:A179.

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QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 ║⛉QoLホ౯ࢆྲྀࡾධࢀࡿ஦࡛ࠊࡼࡾࡼ࠸wAMDデ⒪ࡀᮇᚅࡉࢀࡿ

QoL࣭PROᡓ␎ࡢᐇ᪋౛ 㸸ᚠ⎔ჾᚰᡣ⣽ື(AF)࡟ྜేࡍࡿᾘ໬୙ⰋࡣQoLࢆపୗࡉࡏ⤒῭ⓗ㈇ᢸࢆక࠺㛤Ⓨ୰ᕷ㈍‽ഛᮇ㛫• ຍ㱋㯤ᩬኚᛶ㸦AMD㸧ᝈ⪅ࡢ἞⒪࡟࠾ࡅࡿ
QoLホ౯: ⮫ᗋ◊✲ࡢ⤖ᯝ࡜デ⒪࡟ᑐࡍࡿ᥎ዡ

⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹㛤Ⓨ୰ᕷ㈍ᚋ

These slides are starting〇ရ䛾䝷䜲䝣䝃䜲䜽to get a little boring and䝬䝛䞊䝆䝯䞁䝖
repetitive, need tochange up how topresent each of theseprojects• ᪥ᮏேᝈ⪅࡟࠾ࡅࡿᚰᡣ⣽ື࡟క࠺ྜే

NEI VFQ-25• ┠ⓗ㸸᪥ᮏ࡟࠾ࡅࡿᚰᡣ⣽ື࡜ᾘ໬୙Ⰻᕷ㈍‽ഛᮇ㛫⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬䝙䞊䝈䜢᫂☜໬• ⫼ᬒ㸸ᝈ⪅ࡣAMD࡟ࡼࡿどຊࡢపୗ࡟క
࠸ࠊQoLࡸᚰ⌮≧ែ࡟ࡶ኱ࡁ࡞ᙳ㡪ࢆឤࡌ࡚࠸ࡿࡇ࡜ࡀ⪃࠼ࡽࢀࡿᚑ᮶⏝䛔䜙䜜䛶䛝䛯QoLホ౯ἲ䛻䛴䛔䛶ㄪᰝ䛩䜛䝙䞊䝈䜢᫂☜໬࡞࡝ࡢ⹫⾑ᛶ࢖࣋ࣥࢺࡢࣜࢫࢡࢆቑຍࡉࡏࡿࡇ࡜ࡀ▱ࡽࢀ࡚࠸ࡿࠋ⹫⾑ᛶ࢖࣋ࣥࢺࡢྜేࡢࡳ࡞ࡽࡎࠊAF⮬యࡶᝈ⪅ࡢ⏕ά࡟ᙳ㡪ࢆ୚࠼ࡿྍ⬟ᛶࡀ࠶ࡿ

SF-12, SF-6D, Work Productivity
and Activity Impairment
questionnaire (WPAI)ࡢ㛵ಀᛶࠊཬࡧᚰᡣ⣽ື࡟క࠺ᾘ໬୙Ⰻ࡟㛵㐃ࡋࡓ㈇ᢸࢆ◊✲ࡣࠊ௚ࡢ㔜⠜࡞⑌ᝈ࡜ྠ⛬ᗘ࡛࠶ࡿ• ࣮࣓࢟ࢵࢭ࣮ࢪ㸸ᾘ໬୙Ⰻࡣࠊ⹫⾑ᛶ࢖࣋ࣥࢺ௨እ࡛᭱ࡶ㢖⦾࡟㉳ࡇࡿᚰᡣ⣽ືࡢྜే⑕࡛࠶ࡾࠊᝈ⪅ࡢQoLࡢほⅬࠊཬࡧ⤒῭ⓗ࡞ほⅬ࠿ࡽ㈇ᢸࢆక࠺

ฟ඾: Yuzawa et al. Assessing quality of lifein the treatment of patients with age-related
macular degeneration: clinical researchfindings and recommendations for clinicalpractice. Clin Ophthalmol 2013; 7:1325-32.

QoLࢆホ౯ࡍࡿࡇ࡜࡟ࡼࡾࠊどຊ᳨ᰝ࡛ࡣィ ࡛ࡁ࡞࠸ᝈ⪅ࡢどⅬࢆ ᐃ࡛ࡁࡿࡓࡵࠊᝈ⪅ࡢ≧ែ࡜἞⒪ຠ
ᯝࢆࡼࡾࡼࡃ⌮ゎࡍࡿࡇ࡜ࡀ࡛ࡁࡿᐇ㝿ࡢデ⒪࡟QoLホ౯ࢆྲྀࡾධࢀࡿࡇ࡜ࡀ᥎ዡࡉࢀࡿᾘ໬୙Ⰻ⟶⌮ࡢྥୖࡣᚰᡣ⣽ືᝈ⪅ࡢࡼࡾࡼ࠸࢔࢘ࢺ࣒࢝࡟ࡘ࡞ࡀࡿࡶࡢ࡜⪃࠼ࡽࢀࡿ
Page 12

CSP-HOR, Tokyo, June 21, 2014䝬䝛䞊䝆䝯䞁䝖• ⫼ᬒ㸸ᚰᡣ⣽ື㸦AF㸧ࡣࠊ⹫⾑ᛶ⬻༞୰• 䜻䞊䝯䝑䝉䞊䝆䠖 wAMDࡢᝈ⪅QoL࡬ࡢᙳ㡪NEI VFQ-25ࡣ⑓≧ࠊどຊࡢᝏ໬࡟ᑐࡍࡿឤᗘࡀド᫂ࡉࢀ࡚࠾ࡾࠊ⡆༢ୟࡘṇ☜࡟QoLࢆホ౯ࡍࡿࡇ࡜ࡀ࡛ࡁࡿᕷ㈍ᚋ

〇ရ䛾䝷䜲䝣䝃䜲䜽〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬⑕ࡢ㈇ᢸ㸸ᾘ໬୙Ⰻ࡟ࡘ࠸࡚• ┠ⓗ㸸 AMD䛜ᝈ⪅䛾QoL䛻୚䛘䜛ᙳ㡪䚸ཬ䜃

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ฟ඾: Kinoshita et al. Burden of comorbidities among Japanesepatients with atrial fibrillation: a case study of dyspepsia. Clin Exp
Gastroenterol 2013; 6:51-9.

CSP-HOR, Tokyo, June 21, 2014

QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 ፬ே⛉᭶⤒㝶క⑕≧ࡢࡓࡵ࡟㏻㝔ࡍࡿዪᛶࡣ20%࡟
࡜࡝ࡲࡿ㛤Ⓨ୰• ᪥ᮏேዪᛶ࡟࠾ࡅࡿ᭶⤒㝶క⑕≧࡟క࠺㈇ᢸ – ࢧ࣮࣋࢖ㄪᰝ࡟ᇶ࡙ࡃ⤖ᯝሗ࿌
(Journal of Medical Economics࡟࡚
accepted, ᰯṇసᴗ୰)• ⫼ᬒ㸸᭶⤒③࡞࡝ࡢ᭶⤒㝶క⑕≧ࡣࠊẖ᭶཯᚟ࡍࡿࡇ࡜࡛ከࡃࡢዪᛶࡢQoLࢆⴭࡋࡃపୗࡉࡏ࡚ࡿ࡜⪃࠼ࡽࢀࡿᕷ㈍‽ഛᮇ㛫⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹ᕷ㈍ᚋ

〇ရ䛾䝷䜲䝣䝃䜲䜽〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬䝙䞊䝈䜢᫂☜໬䝬䝛䞊䝆䝯䞁䝖ISPOR, June 2012• ┠ⓗ㸸᪥ᮏேዪᛶ࡟࠾ࡅࡿ᭶⤒࡟క࠺㈇ᢸ
ࢆ᪥ᖖ⏕άࡢほⅬࠊཬࡧ⤒῭ⓗ࡞ほⅬ࠿ࡽ◊✲•Page 13

CSP-HOR, Tokyo, June 21, 2014࣮࣓࢟ࢵࢭ࣮ࢪ㸸᭶⤒ࢆ᭷ࡍࡿዪᛶࡢ኱༙ࡣ᭶⤒㝶క⑕≧ࡀ࠶ࡿ࡜ᅇ⟅ࠋ᪥ᖖ⏕ά࡬ࡢᙳ㡪ࠊཬࡧປാᦆኻ࡞࡝࡟ᇶ࡙ࡁ኱ࡁ࡞♫఍࡬ࡢ⤒῭ⓗ㈇ᢸࢆక࠺
⑕≧ࡀ㔜ᗘ࡛࠶ࡾࠊ᪥ᖖ⏕άࡸປാ࡬ࡢᙳ㡪ࢆక࠺ࡶࡢ࡛࠶ࡿ࡟ࡶ㛵ࢃࡽࡎࠊ⑕≧ࡢࡓࡵ࡟፬ே⛉ࢆཷデࡍࡿዪᛶࡣ඲యࡢ࠾ࡼࡑ20%
࡟࡜࡝ࡲࡿPage 14

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QoL࣭PROᡓ␎ࡢᐇ᪋౛㸸 PMSPROホ౯ࡣ᭷⏝࡞࢚ࣅࢹࣥࢫࢆぢฟࡏࡿࡀࠊ
ᐇ᪋࡟ࡣchallengeࡀక࠺㛤Ⓨ୰ᕷ㈍‽ഛᮇ㛫ᕷ㈍ᚋ

• ᕷ㈍ᚋㄪᰝ㸦Post-Marketing Surveillance,PMS㸧࡟࠾ࡅࡿPROホ౯㸸᪥ᮏཬࡧࢢ
࣮ࣟࣂࣝࡢࣉࣛࣥࢽࣥࢢ⑌ᝈ䛾㈇ᢸ䛸䜰䞁䝯䝑䝖䝯䝕䜱䜹䝹〇ရ䛾䝷䜲䝣䝃䜲䜽〇ရ䛾౯್䚸఩⨨䛵䛡䛾᫂☜໬䝙䞊䝈䜢᫂☜໬䝬䝛䞊䝆䝯䞁䝖• ⫼ᬒ:PMSࡣࠊ⮫ᗋヨ㦂࡛ࡣ࡞࠸ᐇែㄪᰝ
㸦ࠕreal-lifeࠖ㸧࡟࠾ࡅࡿPROホ౯ࡀ࡛ࡁࡿᶵ఍࡛࠶ࡿ• ┠ⓗ㸸࢔࢘ࢺ࣒࢝◊✲ཬࡧࣇ࢓࣮࣐ࢥࣅࢪࣛࣥࢫࡢほⅬ࠿ࡽࠊPMS࡟࠾ࡅࡿPROホ౯ࡢྍ⬟ᛶ࡜challenge࡟ࡘ࠸࡚⪃ᐹISPOR, May 2013• ࣮࣓࢟ࢵࢭ࣮ࢪ㸸PMS࡟࠾ࡅࡿPROホ౯ࡣࠊᵝࠎ࡞ሙ㠃࡛ά⏝࡛ࡁࡿᝈ⪅どⅬࡢ⛉Ꮫⓗ࡞࢚ࣅࢹࣥࢫࢆぢฟࡏࡿࡋ࠿ࡋ࡞ࡀࡽࠊᝈ⪅ເ㞟ࡀᅔ㞴࡛࠶ࡿ஦ࠊཬࡧ♫ෆ࡟࠾ࡅࡿࠕPROࠖࡢㄆ㆑ࡀ
ప࠸ሙྜࡀ࠶ࡿ࡞࡝ࠊᐇ᪋࡟ᑐࡍࡿ
challengeࡀ࠶ࡿ

In EU: Post-Authorization Safety Study
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CSP-HOR, Tokyo, June 21, 2014

ฟᒎ: Adachi et al. Implementation of patient-reported outcomes
assessment in a post marketing safety surveillance: parallels inJapan and global planning. Value Health May 2013; 16:A53.
Heads of Medicines Agencies, European Medicines Agency .
Guideline on good pharmacovigilance practices (GVP) Module VIII –post-authorization safety studies (Rev 1). April 2013
EMA/813938/2011 Rev 1. Accessed at:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf

Menstrual Distress
Questionnaire (MDQ)
Publications
Q4 2013
ฟᒎ: Wang et al. Clinical, humanistic, and economic burden ofmenstrual symptoms in Japanese women. Value Health 2013;
15:A205.
Tanaka et al. Burden of menstrual symptoms in Japanesewomen – Results from a survey-based study. J Med Econ. Inpress 2013.

♫ෆ㛵ಀ㒊⨫PRO㛤Ⓨ㸸᪥ᮏ―ࢻ࢖ࢶᮏ♫་⒪᪋タHTAi

Ꮫ఍࣭࢞࢖ࢻࣛ࢖ࣥ
PMDA୰་༠

ᝈ⪅ᵝPage 17

Take Home Messages• ་⒪ࡢኚ໬࡟ᛂࡌࡿࢫࢸ࣮ࢡ࣍ࣝࢲ࣮ࡢከᵝ໬ࠊ་⒪ᢏ⾡ࡢホ౯࡟࠶ࡓࡾࠕᝈ⪅ࡢኌࠖࡢ㔜せᛶࡀ㏆ᖺㄆ㆑ࡉࢀ࡚ࡁࡓ• PROホ౯ἲࢆ⏝࠸ࡿࡇ࡜࡟ࡼࡾࠊᚑ᮶ࡢ᭷ຠᛶ࡜Ᏻ඲ᛶࡔࡅ࡛ࡣ࡞࠸ࠊᝈ⪅どⅬࡢ࢚ࣅࢹࣥࢫࢆぢฟࡏࡿ• ᘢ♫࡛ࡣࠊPROホ౯ࢆ⏝࠸࡚⑌ᝈࡢ㈇ᢸ࡜࢔࣓ࣥࢵࢺࢽ࣮ࢬࢆ⌮ゎࡍࡿࡇ࡜ࠊ〇ရࡢ౯್ࢆ⌮ゎࡋ఩⨨࡙ࡅࢆࡍࡿࡇ࡜ࠊཬࡧࣛ࢖ࣇࢧ࢖ࢡ࣐ࣝࢿ࣮ࢪ࣓ࣥࢺ࡟ᙺ❧࡚ࡿྲྀࡾ⤌ࡳࢆ⾜ࡗ࡚࠸ࡿ• ࠕᝈ⪅୰ᚰࡢ་⒪ࠖࡀ㏆ᖺㄆ㆑ࡉࢀ࡚ࡁࡓࡀࠊ PROホ౯ࡣᮍࡔᗈࡃࡣཷࡅධࢀࡽࢀ࡚࠾ࡽࡎ⌮ゎࡉࢀ࡚࠸࡞࠸ࡢࡀ⌧≧• ᪂ࡋ࠸PROࡢ㛤Ⓨ࡟࠾࠸࡚ࡣࠊ㛤Ⓨࣉࣟࢭࢫ㸦౛:Validation, samplesize, etc.㸧ཬࡧᮇ㛫 vs. ヨ㦂ࡢ‽ഛ࣭ࢫࢣࢪ࣮ࣗࣝ• PROࡢᴫᛕࠊ౯್ࠊཬࡧ⏝㏵࡟㛵ࡍࡿၨⓎࡀồࡵࡽࢀࡿ

Page 19

CSP-HOR, Tokyo, June 21, 2014

11th Annual Meeting, Washington DC, June 14-18

Challenges