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(Guidelines of Methodological Standards for Pharmacoeconomic Evaluations)

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95/12/14

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18

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19

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20

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24

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³ � � ¨ Ó Q(validity of transferring)&� � ( T8/¦ Ê 9� � ��ô C D �x E �� " # � �;� Ü § ¨ u ä �v7& � ô 82� � � �¤¦t÷

ø � � �� . Ì �³ ¨ W X ¡ e¤¦_ Q�� ¨ Ó Q�v© � [&

�� " # �¤¦_ Q�' �8� # ÇÓ è(efficacy)� Ó �(effectiveness)�v¢Ù&�e78$ % 10 T �x E ñ i &! ! � ¨ Ó Q � [���2·� ��� " # � �m � 1 2 �l§ ¨ µ h�H34 H�� �ü ¹ © �

� þ   &¥ ¦·� �h�" # � �}~ t6 ��� Õ+ � ì 5ì ¹� �

� � , �÷ ø ­ Ü Ý É ( (the relative unit price of resources)}¸ ¹�¥ ¦�F   ÷ ø 9Ë´Í ¹& ì 5� ¨ Ó Q� 6 ��34 Õ+ l¼½ ì ^ L �

� � � �� ( ; è� � � : :�5�Å y1 2 � ó­ ! F   ÷ ø ¥ ¦e

Æ � . è�34 9 Í ÷ È �ó¥ ¦F   ÷ ø �� � �­ F   ( T� p �

�& C E �� � ( T Z �¥ ¦ô �5 C 4¿ . 8 Ê � �� � � �ä å *

" # ÃÚ �( V � �8¸ ¹� � �V ?} ¸ � ã &d e�� �ü�i Æ

§ ¨ V ?Õ Ö �ª Ó (cross-cultural adaptation and validation)�� !   Ó � ��� O�é 6 ��eõ &

�������� 22@@@@b c d e & 'b c d e & 'b c d e & 'b c d e & ' VVVVBudget Impact Analysis�

� 5 - . = w @ ¢ _�������Ø Ù � £ j � � ( ° ¤ ��G � ¥

� z � � � � p q i¥ ß z �K �� �� � �Å � J ç K �� �6 v

y | B � � � + � 5 - . = w �Å æ ó + � _V I ¦ § u ó @ � � _

© + S ª « ) | X

�� �� " # �¶ Oe© Ë��8� . �Å Ê� àá ß ��ì" # �

�} B F ß ���Å í î h�Ó Ò��Å ´\Ç A ËÌ �  4&n ­ F  

� ô n§ � � � ß ���Å ­ F   � � h����� ñòÄ �6 r ì

5��± � 6 ��&Õ< § ¨ Çñò� � � ��� �&ñò � � � ��9

:� § ¨ L Ù | e� $ %�p �&

�� �� " # �ñò � � � �" ô � ¹� � ë y¤¦ì

25

1. \ñò � � � �n§ �w Ǽ � 8F   S T � ³ # �h�9Ë � Æ 6 �èób �8QR � � � ³ �� �h� (\ « }� Qn§ ���é 6 ��) � ü � V � 8� &

2. \�� �� � �n§ �© � �" e�Ü Ý (� ¬ìh�� Ó ��m� (� Q ¡ e)�² ñò � � � ��ms � � Qà b &

3. ñò � � � �� Ã�� �Ü Ý �$ þ ( þ (per member per month,

PMPM)�ï ð ì 5&n�� " # �� �Ü Ý � � �þ � ú � e©   Ó�� û� ö Ï &

26

f g hf g hf g hf g h iiii���������� ������������� ������������� ������������� ��� 1. j � k lj � k lj � k lj � k l (EXECUTIVE SUMMARY) $´ L Ù % &( ) � ^ l�" ¦ r �� ( ) Ú ' u � � � �]% & � ��bottom line result�& $|X<= î x Ç A   4� x �]� � F G �Õ+ & $ � � ç � Ö × � � & 2. m nm nm nm n (INTRODUCTION)

2.1 o p q r s t u v wo p q r s t u v wo p q r s t u v wo p q r s t u v w (General comments on the disease or condition)

$�x /, - $ : :�5÷ ø $ËÌ �34 9 Í à � $ ­ �� Ð � � �

2.2 x = v wx = v wx = v wx = v w (Product Description)

$ °   � r H ¿ �ª ]5ª H � ÷ H¥ ¦ ' ( $ � � �� ¤$ $�9 :�� 5� �� � ¤$&� � �x , -� : :�5� � ­ < �

¤$�ËÌ 34 Ð °   à ���� ���¦t� ; Ë �( î Ì &

2.3 � � � �� � � �� � � �� � � � (Objective of the study)

2.4 y z � � { | } ~ { G � � �y z � � { | } ~ { G � � �y z � � { | } ~ { G � � �y z � � { | } ~ { G � � � (Disclosure of relationship)

$) Ú ô y� � % &' u ô ���! Û�î Ü Ð �Z V $ � � ô � P ' èy b B E V � æ Ñ

3. � � �� � �� � �� � � (METHODS)

3.1 ] ^ � & ' � �] ^ � & ' � �] ^ � & ' � �] ^ � & ' � � (Type of analyses)

$ Ì { èH ~ * èH û ) (modelling)H� + î �3 4 $�¥ ¦�� �»� �¶ x �]6 �� O . (�ìh�� ú � �Hh�� �� �Hh�Ó �� �Hh�Ó ¦� �Hh�Ñ Ò� �)

$ � � ./]�" ¦� : _ � ´ /3 4] ª Ó 3 4(validation method)

3.2 � � � �� � � �� � � �� � � � (Target audience)

27

$ý<� � � ��' �­ £ ���ìÀ 3 � � � . ô HF   S T � � H

{ �À 3 ô �

3.3 � 6 �� 6 �� 6 �� 6 � iiii R � & ' R � & ' R � & ' R � & ' (Viewpoint)

$<� ¬ �<=]x ���« }� QH� �� ��¬ �

3.4 ! " � � �! " � � �! " � � �! " � � � (Treatment comparator)

$ � � g �<=]x ���ì¯ Ç°   H�� H ; ? � $ � �� � g 34   Ó �3 4(�ì ç � 34 ôÓ �( , y( , � � ��¸ ¹ôÓ � ´ î � �4 meta-analysis)

3.5 ! " � � ( )! " � � ( )! " � � ( )! " � � ( ) (Time horizon)

3.6 : � � �: � � �: � � �: � � � / � � � s� � � s� � � s� � � s (Related studies/background)

$ ³ ´ è� - . r � à -�°   �\Ì ñ ��� 5� � V W

3.7 S- C DS- C DS- C DS- C D (Outcome measurement)

$Ç � : � �ã ¢ $34   Ó �� �(¦ q 3 4�÷ ��Ú ø ��j � O .) $ ò � t� : 34 ¢Ù $�¼½ �34 � �ã ¢]�q d e��ìL j ¦H�/ �H� � �� $QR ! �� �ü� d ei Æ ��ì � ­ ; . � ��d e B Hs �

QR > �d e B HQR $ � d e B � $ ¶ ·� �ã ¢m �¥ ¦² % " ¦ô (> |X ^ Õ)

3.8 A B G C D �A B G C D �A B G C D �A B G C D � HHHHIIII (Cost measurement and valuation)

$�¼½ �h�9Ë]�q È d e¥ ¦e��ì ¶ } h�H;�� f

�h�H¶ · � 0 � û��h�H¶ ·© ( � û��h�� $ Ü Ý É( �q G . ��ìÇ C ¥ ¦� � �h�� $¢Ù�Ú ø �÷ ø ¥ ¦�¢Ù ò � $�j �O . $h�y� ��ák

3.9 � � � � � ,� � � � � ,� � � � � ,� � � � � , (Uncertainty)

$�Å Çh : � � � c d Q� �18c d Q � �O�" # ã ¢�ã �

�2�� ö 1�Å î x 1 $ + ø ª . è�Ú P ! <¥ � B � Z �8� O .�I h�e© �

28

2& + Ãm ´ /3 4(� � , �)� c d Q � ���h�� �

3.10 � � � & '� � � & '� � � & '� � � & ' (Sub-group analyses)

$�Å Ç © £ ª n Ã�wÌ � }Ç ¹�� ���ìÓ ��w Ì � H

� Ô�wÌ � Hh��w Ì � Hh�Ó ��wÌ � � 3.11 � � � � � �� � � � � �� � � � � �� � � � � � (List of assumptions)

$ ª n Ã� �O�' � O .]¶ F G (�� Ð y34 Ð )�@|X�: O.}�q ì 5 � � �

4. SSSS ---- (RESULTS)

4.1 & ' � S-& ' � S-& ' � S-& ' � S- (Analysis and results)

$�Ç�� �\Ý Þ He Ý Ý �3 ) j k&�¥ Ç 2 3 � D ô ´\6

� /ò�ñ _ $2�¥ ¦� û ) ]8 � O .Ý Þ �j + ÃÚ $4 © 2� �� r b X � j k(�ì� � Ì � �« }( â ´ / ÷ ø �34 ¢Ù�÷ ø ¥ ¦à �  )�S �º 2s î �� �]¥ ¦ÉÊ C ¿ �� ���ì � Ô_ Q� j kÃÚ

$ µ �Ç´Í�Ç A °   3 ���C D ��� � $ ´ /�� � , �] c d Q� � $\ � X3 ) + Ã� �O�6 � F G , -(�ìq � [F G i � �]¶¤¦t¶ · Ì � )

$ F   ² ��9 Í �È�Å } ì 5t" # � ��> àÆ w $¤ � ­ ; Ë 34 � ¤$ñ# � È h�/Ó Ò� Ê(incremental C/E ratio)

4.2 W X ) & ' S-W X ) & ' S-W X ) & ' S-W X ) & ' S- (Sensitivity analysis results)

4.3 � � � & ' S-� � � & ' S-� � � & ' S-� � � & ' S- (Subgroup analysis results)

4.4 �Z ,�Z ,�Z ,�Z , (Equity)

$ z Ê è� O .��ì�Ç( �e© �ü � æ��� � 5 � ¹�� $ � * � e��ì ¯ ú � � ¯ � f �

5. ���� ����

$ # $ ¤x E <� � � F G �� ��¸ ã è(robustness, c d Q � �­ ���â ã à �)� C ¿ �Å í î h�Ó Ò� % & �� � 3 45��

29

[�]ÍÅ ¤¦t¶ · , -�¶ ·� � �� [& $ � ��Ƕ ·� ¤$�l¤� � ¶ · � ¤$�Å ³}r e ¥ ¦<

��n ¶ � Ê}Çé r �¸ ¹1 $¤ñ � Ð À �81 2 �¥ ¦e�\]ñ# Ö × <Ä �� s � �È û

$"% & "� � � ��Çe?�� �&´¦ * + ï � 3 ) B õ 5(1)¥ ¦�Ä �y| eÄ �� � �þ È p e© �ü � æ��� � ¨ û $X����û $Y~$Z���2&(2)y Ç A 3 �� � �¥ ¦<Ä �°   eÝ � ( �}ñ � È p $X 6 ° û��² ¹;ù ú Y © ' ��L j ¦] Z © ¶ ·�L j ¦&

6. SSSS ���� # $ ¤­ * + � [ � E ì% & � �(bottom line result)�z Ê è O .(equity)� s � � � (aggregate impact)�­ � �� E � � &

7. ���� ���� 8. ���� ����

$¢Ù�b X ê B $e Ý eÝ � b X � � Ý Þ $O��� �(intermediate results) $¢Ù ò � �B ( H ¡ � Hd e B   � ì 7 �

30

�������������������������������������������������� � ��� � ��� � ��� � �

< å L Ù� ¹ å �� � ?' u ( ) Ö Ãe : 01 è ¡ [���� � h

� % &' �01 ô �8 h :�� " # 01 ;�� ¡ �6 7�8&� : ¡ [

´ ¤ 0e� Ö 8 �� " # % &' u ô Z Ù ��: � [8% &O § ¨ X ª u

ä ÃÚ &¹;³Ö 8 ¥ ¦ô �8 ~ � �� �;§ ¨ µ � : 6 ��� [&

1. j � k lj � k lj � k lj � k l (EXECUTIVE SUMMARY) � �� �� �� � 1: <� ��"% & "� �� � � ��Çe?�� �&� ¡ [�9 �´¦

* + ï � 3 ) B õ 5(1)¥ ¦�Ä �y| eÄ �� � �þ È p e©�ü � æ��� � ¨ û $X����û $Y~$Z���2&(2)y ÇA 3 �� � �¥ ¦<Ä �°   eÝ �( �}ñ� È p $X 6 ° û��² ¹;ù ú Y © ' ��L j ¦] Z © ¶ ·�L j ¦&

2. m nm nm nm n (INTRODUCTION)

2.1 o p q r s t u v wo p q r s t u v wo p q r s t u v wo p q r s t u v w (General comments on the disease or condition) 2.2 x = v wx = v wx = v wx = v w (Product Description) 2.3 � � � �� � � �� � � �� � � � (Objective of the study) 2.4 y z � � { | } ~ { G � � �y z � � { | } ~ { G � � �y z � � { | } ~ { G � � �y z � � { | } ~ { G � � � (Disclosure of relationship)

� �� �� �� � 2: <� ��� � h�1 � � % &� ï Ý j ô �Å Ç : e¹Æ �

;�B F r � 5 ¹ Æ % &O��Ç # $ 1 % &O�Å $ Ãj ô Ç �

� P ' æ <¦� �3 4� ¸ ¸ E � ��q �Çæ Ñ b B �� ��

�1 3. � � �� � �� � �� � � (METHODS)

3.1 ] ^ � & ' � �] ^ � & ' � �] ^ � & ' � �] ^ � & ' � � (Type of analyses) � �� �� �� � 3: <� � % &8 ¡ � � ¡ [1<�� ¡ [�Å ! 1� " ¦� � �

� 5� �3 4Ú ~ 9 � ¡ [1(i.e. Cost comparison, CMA, CCA, CEA, CUA, CBA)

� �� �� �� � 4: <� ��Å " ¦� È � �4(incremental analysis)1

3.2 � �� �� �� � � �� �� �� � (Target audience)

31

3.3 � 6 �� 6 �� 6 �� 6 � iiii R � & ' R � & ' R � & ' R � & ' (Viewpoint) � �� �� �� � 5: <� ��Å X ª |X� < 8 �� ¬ Ú = 1@|X <<=� x

�&�\ « }�HF   S T z Ð �HZ �� ( �� ¬ Ú ý1<� �

�Å \� { �3 ) j kÃ8ê 7�� �1

3.4 ! " � � �! " � � �! " � � �! " � � � (Treatment comparator) � �� �� �� � 6: <� � �Å � ­ ¹à -��( �Ú � � °   g y­ � g � �1

8 � Ç A °   3 ��Å ÇXª �� � 1�<=�­ � g �Å � ç

î x 1

3.5 ! " � � ( )! " � � ( )! " � � ( )! " � � ( ) (Time horizon) 3.6 : � � �: � � �: � � �: � � � / � � � s� � � s� � � s� � � s (Related studies/background) 3.7 S- C DS- C DS- C DS- C D (Outcome measurement)

� �� �� �� � 7: �� Ä �°   ÇÓ è(efficacy)�Ø Ù�Å � ñ ç � 34 ôÓ Ú �

�1 °   ÇÓ è�Ø Ù��Å > Ç' �� ( Ì �w��( Ì �°  

Ó �Ø Ù(effectiveness)Ú � �1 °   Ó ��Ø Ù�Å ��� p 349 Í Ð �l × �� � r s x ÃÚ �18 ¹w Ì � O�Ç ! ] B

� �°   Ó � ���Å Ç� ª n ]% �ÃÚ 1 � �� �� �� � 8: �µ ¦�� �3 4�Å \ Ý Þ ¸ � X�3 ) j kÃ1h��¼ �

�9Ëy8r   Ó � ��9Ë�Å Ý Þ j k134 � ��Å © \

P S Ü Ý Ú j k�S � � � h| e� Ü Ý �� Ñ Ò]Ó ¦�Ü Ý Ú

j k1 � �� �� �� � 9: �Å �Ç6 � ¸ ! �h�]� ��¼½ 8© °   3 4�L j ¦�

5 Ç ª n ÃÚ �@|X Ý Þ 1 � �� �� �� � 10: QR �ü��q d e�1 � �� �� �� � 11: <�� 5� �O�QR �ü� d e�Å 06 ��  Ó � �ã ¢1

h�-Ó ¦� ��� E ­ QR �ü�â ã �Å é c d 1

3.8 A B G C D �A B G C D �A B G C D �A B G C D � HHHHIIII (Cost measurement and valuation) � �� �� �� � 12: 8 � ë û ) O�h�]� �÷ ø ��� ¸ ¹� V W Ú ø ú � 1

Z � ¶ } �; . �( Ì ñ# n Ú �1

32

� �� �� �� � 13: �Å ¶ } F   h��¶ } ± F   h��.ß á? ] » å  ­ x h

� 5 Ǽ½ 8 # 1« é ��q d e�1 � �� �� �� � 14: � } h�(�ì�Ä Jh��;� � f �h�)��q ª n \]#

É1

3.9 � � � � � ,� � � � � ,� � � � � ,� � � � � , (Uncertainty) 3.10 � � � & '� � � & '� � � & '� � � & ' (Sub-group analyses) 3.11 � � � � � �� � � � � �� � � � � �� � � � � � (List of assumptions)

4. SSSS ---- (RESULTS)

4.1 & ' � S-& ' � S-& ' � S-& ' � S- (Analysis and results) � �� �� �� � 15: �� Ê : ã ¢ é ø È d e�� " ¦ q 3 4Ú À x < @ ø 1� " ¦

�3 4�Å 2 � �5 � S ! e� °   3 4�n¥ � � w Ä � Ø S

! ñ � �� �1 � �� �� �� � 16: � : � �ÍÅ µ ¦tñ � �� ( Ð 1­ <� �� � a è(external

validity)\]¢Ùµ ¦t � ô �{Û è�> àÆ w &­ * + ã ¢� , `è�� ° è ��> à Æ w ì� �� : :�5�F G �°

  �È�  Ó ]h� &� � ª Û � 8�þ eã ¢­ � �� �

� Ç� r 1A � e3 S â ã 1�Çã ¢ef µ �l­ � �Ç B

� ¥ � � � 1 � � Ç� r 18� : ´Í �� 8 * �8ËÌ õ ö

}­ � E Ç B � ¥ â ã 1ÍÅ e?ÃÚ 1

4.2 W X ) & ' S-W X ) & ' S-W X ) & ' S-W X ) & ' S- (Sensitivity analysis results) 4.3 � � � & ' S-� � � & ' S-� � � & ' S-� � � & ' S- (Subgroup analysis results) 4.4 �Z ,�Z ,�Z ,�Z , (Equity)

� �� �� �� � 17: � �O i � � ¥ �z Ê èO .1��ì� q ( � ú � ��ü�

æ�� � (QALY)�Å ¤Þ 5 e ¥ 1 � �� �� �� � 18: �Å � ­ ; Ë 34 � ¤$ñ# � È h�/Ó Ò� Ê(incremental C/E

ratio)1�ñ# Ê�Å A B i �Ä �8QS U àá ��Ç¥ ¦ � ¤$1�ŠǶ ·� ¤$³r e ¥ ¦<��n ¶ � Ê}Çé r �¸

¹1 � �� �� �� � 19: �Å Çñ# Ö × <Ä ��s � � È û�(QS U }È p � ö �

33

Ã)1 s � � È h��� ö (¥ ¦<�n ¦ | e�� s � Ú |}

È p � ö h�)1�ñ# Ê�Å ¼ � i �Ä ���Ç � ¤$1 5. ���� ���� 6. SSSS ���� 7. ���� ���� 8. ���� ����

34

�� ��� ��� ��� ������ � � �� � � �� � � �� � � �   ¡ A B  ¡ A B  ¡ A B  ¡ A B (Acquisition cost)@@@@ F   � � HF ² �© ( " C <�� �h�& & ' 6 �& ' 6 �& ' 6 �& ' 6 � (Analytic perspective)@@@@< 8 ¯ �� ¬ � ���« }Ho ´ HQ

S U Há �ô �& Z ¢ A BZ ¢ A BZ ¢ A BZ ¢ A B (Average cost)@@@@e© °   �/¦ � � h� � \} ~ °   �� e(�

6 ° h�)& S-S-S-S-(Consequences)@@@@ye© � ��� � � � Ç! �  Ó � �(outcomes)�

�ìO � H � � HL j ¦H_ ` �¤ D & � � , £ ��� � , £ ��� � , £ ��� � , £ �� (Contingent valuation)@@@@\ä 1 3 4(survey) " # © ( ­ !

°   �Ñ Ò�ÉÊ�n . �- �|� Æ û� ö Ï È ú � Ñ Ò& A BA BA BA B (Cost)@@@@e© ÷ ø �¥ ¦e(Q)yÜ Ý É ( (P)� ¿ E & A B C DA B C DA B C DA B C D (Cost measurement)@@@@ d e÷ ø ¥ ¦e(Q)� ñ _ �0� � � � �

e � � & ¤ ¥ � � A B¤ ¥ � � A B¤ ¥ � � A B¤ ¥ � � A B (Cost of lost time)@@@@ > � � } h�& # $ A B# $ A B# $ A B# $ A B / = > ¦ § ; < ¨= > ¦ § ; < ¨= > ¦ § ; < ¨= > ¦ § ; < ¨ (Cost/QALY gained)@@@@8h�-Ó ¦� �O " ¦

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40

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