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Page 1: (Guidelines of Methodological Standards for ... › PEguidelines › source › 2006_PE_Guidelines.pdf · 6 œ ß ˝˜34 ° € Ó ły¶ › ƒ g ˜° € Ó łØ r fl‡ fi e¥

���������� � �

(Guidelines of Methodological Standards for Pharmacoeconomic Evaluations)

1.0�� �� ��

95/12/14

� � � � � �� � � � � ���� �� ��� �� � � � ! "

# $ %&� � ' �( ) * + , - . / 0� �1 2 �� �� " # 3 45$

%�6 789 :�� �� 5" # ;�3 45$ %&<� � = > 5? @ A B

C D EF G HI J K L M N �OP QR S T U A B V W XHY Z [ �\]

^ �@ A B _ ` Ha 8b Hc d ( �ef g hi j k l �mn o p q r $

%�s � AMCP $ %�tu h1 2 �$ %� ���vw� x yewz { |X}y~ r � � }� �� h�e� 1 2 �� �� " # 3 45$ %�� e�

�&

�������������������� ����

QR � � � � � � ��� " # �' �8� � H� �y� � v� �� �

� � � � ���h�y�� t�� �&� <�� " # �8� x ��]F  

¡ ¢ �£ ¤¥ ¦§�� �� " # ¨�© ª « �¬¥ ­ � g �� ® ¯ °   �

�¥ ¦± ��   4&² �� " # ³ µ ¦t¶ ·¸ ¹F   º »�� � �¼

½ ¾ ¿ º »�F   À Á  &

e© �� �� " # ´. / Ãe© �� Ä ��Å Æ Ç� È p �ÉÊ�³

£ �yËÌ ¥ ¦�­ � g � � �´ÍÇ� È p �ÎÏ Ð Ñ Ò]/�QR   ÓÐ �ÔÓ �&Õ<Ö × ÃØ Ù�Ú Ø Û F   S T Ü Ý Ö × Þ ß �àá �â

ã ËÌ �� àá ä å �æç è&é 6 ��e© ê ë �ìí î h�Ó Ò´Í

A B QR   Ó Ð }È p �² ¹;³}È p �� �ï ð ñòó�ô Íõ t

¹�QR   Ó ² ¥ ¦� ö �F   ÷ ø &Õ<�È p F   º »�h�Ó Ò´

Í}³´Í¸ }ù ú F   �û��² Û üÐ ´ýtþ Ü Ý û�}����

�QR   Ó � � � &�� �� " # �Ë��Ö × Û Ø (evidence-based) ÷ ��à � ô � ç � . �� ó���È p � ô � � � � HÇ� Ù�÷

� Ú ÃX � �� . �¹;� F   S T ÷ ø Í �ÇÓ ��� � &

1 2 �� �� " # 3 45$ %��� � � �e� 9 :�� �� " # �

3 45 � � &�<� � �9 :�� �� " # �� ��}� F   S T Ü Ý n

0�´Ê� � �� �&��ìç �� Çeß �Ä �� ! 1 2 9 :��

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2

" # ;�� � " ¦�3 45$ %�� � � # $ �\]" # % &� ' u ( ) &

�3 45$ %´¤¦ ! * + , -ì./y9 :ß F   º »��� " #

;�01 " # � �;�\]2 " # � �¤¦t34 ;&Õ<�� � ô H0

1 ô y34 ¤¦ô � 5 ¤ 6 7 �� �� " # �� � 3 45&�3 45$ %

# �89� � �Ö × e : ; . �" # 3 4´× <=�Õ<�2 " # � ��

´� � è> r ?�@2A B C D � � � E �´Íèù t� ú &² � : � �

3 45¸ �� F G � � ô �H I J� �� K � ® L � � : 3 45&�$

%¸ M � N O ß 3 45�Ä ��³ M � F G º 5� � � P �Q&

R S T ÇU � V W y ' X � �e : �� " # 3 45� Y o �² 8��

�� 5� � Ð � Z Ç U � � [\ Ç ] � &¶ ^ Õ�� _ `\ a ß b c �_

`� U � h� d ey�� �ü d e�3 45�Z 8 f g b c O&0ù ú ]

E �´Íè�� �Æ Ç Y o �3 45�Ê� h :�&

U � T � ��� �� " # 3 45$ %�� � �5 �0i j ke � ´ L

Ù� ^ l�Ú m �� � ô h :� : � � �� �ón ¸ �0 i � �: o 4p

Ú p . �q 9 :�r � � &Õ<�� : ^ l ¸ e. � s �³ t ¸ � u v è&

w �ÍÖ Ãî x y z ��Ç L ÙØ Û ¶ { Û è�" ¦ | � 3 4 5 ´ � } ~ &

ËÌ �� ���e� 1 2 �� �� " # 3 45$ %��e � � � 9 :" #

� p ��� � Í� � � � ¤¦8¸ ¹F   � � �¸ ¹� �y¸ ¹�F   º

»�¼½ ��H�� ^ � HF   ¡ ¢ H¾ ¿ º »�F   À Á  &

� � � � i �� �� " # �� �F   S T Ü Ý ´Í Z � � � � i y �

È p Þ ß ��àá �­ S T Ü Ý �� Q ï ð ñò � � Ç� r &Þ ï ð � �

� �Ç + 8$ %22�² �¸ ��� �� 5" # �e � � �<� �´ P � �he� � ��3 45$ %&

��� �� � � � ! " # $ %¼½ ì�� �� " # 3 45$ %

(methodological guideline)��� �� " # % &' � � � ?' u ( ) (report format)�01 ô " 0 $ %(reviewer guidance)&

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�� ��� ��� ��� ������ � � � � � � � � � � � � � � � �� � � � �� � � � �� � � � � (Guidelines for Pharmacoeconomic Evaluation)

�� �� " # 3 45�$ %� Y Ç 22 © $ % j k! <��A B � ËÌ � � � ¥ ¦�3 45�� � �Ç� � ô H01 ô ]¤¦ô Ú � &$ %

� * �|X�Ö × �� � �y z �¹;$ ÃQR � � o �¤¦_ `&

�������� 1: � � � �� � � �� � � �� � � � (Target Audience)

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

!�" # � $ �� % �& ' ( )

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81 2 �OP QR S T U # � h��� � � g � � " # �� Ä ��@

Ö Ã�Å � � àá �� � &Þ � � Ö × àQS U � �x ���� � x ��

� . �� Ä ��Å � 8À 3 � æ   B + O&ç F G ¥ ¦Þ æ   B + ���

��£ ´\� tQS U �àá &�� �� " # ´\­ �� �h�Ó Ò ¡ [

Ö × � � � x �Þ ÷ �y¢Ù´Ö × ¶ ·­ £ � �\� . �Å � " ¦í

î h�Ó Ò���&¸ ¹Ë� ­ £ �6 ¤ �h�9Ë} e ¥ �� q ��

�� " # /¦ § ¨ © ª �Ë� ­ £ �¹;h�d e§ ¨ í î Ë � ­ £ �6

¤ �h�9Ë&

�������� 2: �� �� �� �� (The Perspective)

* + & ' , - . / 0 �1 2 3 ��4 5 6 7 8 9: ; < = > 6 ? @ A �

�B 1 2 C D EF G)

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� « }�� ¬ �$ " # § ¨ ¼½ �Ç�h�yÑ Ò� ­ �® � Û

° ± ² i h��} ~ tÑ Ò&�A B 8F   S T àá ³ ´ � � _ `�h�

yÑ Ò³5 § ¨ + � µ &� � �OǼ½ F   S T àá ³ ´ �� � ¶ }

�� } h���: 5 § ¨ � · � ��j k� ¸ ¶ /ò�� { h :&Õ<�

2Ç ¹ r �� �� � § ¨ j kÃìF   S T àá ³ ´ # � ¶ } h�(QS U�� ¬ )óp Ð F   S T àá ³ ´ �� � ¶ } h�(F   ³ ´ �� ¬ )ó� ¹º p Ð F   S T àá ³ ´ �� ��} h�(« }�� ¬ )&

�������� 3: �� � � � ��� � � � ��� � � � ��� � � � � (Timing of Studies)

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������� H I J K �L M N O P Q �R S T U V W(X Y H II, III, IVZ))

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�� " # h :�;� » � ! " # � �¥ ¦ô �� K &8ß �� ¼ � �

� b c ½ ¾ �´Í� ^ � � ¿ h :" # Ú m � 34 III, IV � � � � � .\] À ¬ : Á �  p à &8� ¹ � h :�� " # ´8���Ä Å � �

¼ � �­ �É G . yQS àá � . Ð Ç6 ��Æ / &��Ð À �� Ç � �

� " # �´\Ö × � ß �Û ° ¤¦��  Ó ÷ �� ¸ Ö × ��¥ ¦�Èy

L j ¦ b � � ���ÔØ Ù&Ç;�� Ç � �� � ��F   � � �� � �

� � É � ���ì0 b c 34 °   $ %�0 Ê � � °   À 3 � � . ��

��­ Ê r · �� � Ê ; Ë � ( Ì À 3 � � . �� &

�������� 4: � � ��� � ��� � ��� � �� (Disclosure of Relationships)

������� [ R S \ ] ^ _ �& ' ( ` W)* + ` Wa & ' �] b A

c�. d e f g h i ( (X Y j k �l m )B n �o p �qr s t u �(transparency))

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�� �� " # �8 l Ð ´\�Í @ H5@ HÎ Ï � ¡ z Ð H � ��

� � \]� q Ð � ô �� î Ú 9 :&e© í î ÷ ( �� � ô ��$ Æ ÇÞ

� � Ñ Ò y� Ó �( �·/Ô 6 7 Þ � � � Õ Ö ]� K �× Íí î � � � Í� Ø x Ù E p �&� � �/¦ ' 5 § ¨ Íí î � Í Ø x p �y$ %�� K &

� � ÷ Ú ô y" # 8 9 :ô ���8��÷ Ú y E V ' u Ð �! Û�

§ ¨ 8î Ü Ð ÇÝ Þ �! Û� � &8�� " # % &# �� Ç � � �® � �

e© �� © � � k l � � ß �l83 î j ! Û� à á 5 § ¨ Ý Þ |X&Õ

<�8 â î j �ã Ü ' Ð � ä Ç! ï ð H V å Ã�æ H\]¶ · , -y

¹ Æ '  ÷ ��5 § ¨ � X ç ;ß 1 &� � 9 :ô § ¨ 8� � 8½ ¾ �

3 45Ð �Ç � �è æ ó§ ¨ 8� q · é <=� ê ë Ð ÇÃ�æ &�!

Û�z { ´��Ö × Þ (� � )ã Ü ' �ì �n õ h&

�������� 5: ����� � �� � �� � �� � � (Evaluation Techniques)

�� �� " # ¤" ¦�Ííî � � Ë���� ç 3 45�Ç ï � ¸ ¹

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�� �3 4´ " ¦ìh�� �� �(cost-consequences analysis, CCA)�h�� ú � �(cost-minimization analysis, CMA)�h�Ó �� �(cost-effectiveness analysis, CEA)�h�Ó ¦� �(cost utility analysis, CUA)��h�Ñ Ò� �(cost-benefit analysis, CBA)&

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e ð nE �e© �� " # µ ¦ Ç © � � ./ñ _ Ú ò � � � ��÷

�ì(1) “Piggyback” � � ���$ 8ó ´ � x ÇÓ èyZ ® è�34 ôÓO�p � �� " # �� d e�h�y�� �üÐ �� �&(2)P S , - � �(Naturalistic trials)��$ 8Û ° F   9 Í õ ö ] , -* �./e© �� " #�� � &(3) s î è� � ��$ m¶ ·� © � � � � s î ¢Ù( ´ î � �)��mr ÷ ÷ ø ù � �Ú ú � � � ��¢Ù&(4) ¥ ¦¢5� ´ /û ) � h:�� � &

� �e© ß �Ä ��34 ôÓ �' �Ë�8 ª . Þ ��°   Z ® èy

ÇÓ è(safety and efficacy)&� y·�� � �Þ ß �Ç� È p �°   ÉÊ�l¥ ¦Þ �°   ��Çh��\]�h�y ü � È p �°   ÉÊ���!

Û�£ �ý �� " # Ú j . / &<;¦Ú °   ��Çþ   �¼½ ��L j

¦\]¶ À x h�� 5 � � 8" # # e&e© �� �� " # § ¨ j kÃ

� È � �(incremental analysis)���$ ¦°   B Ú » A °   A ;�� È p �°   h�� \� È p �°   Ó �&

� e© ��yËÌ � 8�°   � � �8°   ÉÊÐ Ç� È p �Ó Ò�

l " # �3 4�Ô�h�Ó �� �(CEA)]/�h�Ó ¦� �(CUA)�» � !Þ ��ñ� �Ó �� � � �\]�°   � � �� � � &

�� �� " # Ç* + ï � ¸ ¹�� �3 4´ " ¦ì

6 v F G= w (CCA)

h�� �� � � . / 0°   �� ï � °   Ó �$ � ¯ Çs î he© Y

¹$ � �e� � �3 4&�� � �3 4´2�� °   �¶ ·QR � � � �

� � �ÉÊ�\�� s �3 ) j kÃ� � QR   Ó �÷ �&�³�8 � ë

Ð � � Ü �e� � �&e ð nE ��! CCA ´\2 ß °   3 4� � � \� s y � X�3 ) j k��´�o � . ô P : � . �<= � e9 ­ ·

Q�ÇÑ �  Ó � �ó ¸ ´\à·é � |�Ç´ � �¢ÙÚ � �·é

ÃF   ÷ ø � � �� � � . &

6 v , x = w (CMA)

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� ß ��34 °   Ó �y¶ ­ � g �°   Ó �é r � �� ® e ¥ �l

´ µ ¥ ¦h��ú � �&<; w � � vg °   3 4�h�&

6 v y G= w (CEA)

8<� �3 4O�  Ó � �� d e�" ¦� x Ü Ý (physical units)� S �vg °   3 4�°   h�y  Ó � � � � &  Ó � �� d e Ü Ý ´Í

� é r �m � � (mmHg)�ù ú �� � � �( ¢�� È p �� Ä � ¢Â &8h�Ó �� �O�� � �O�� ��� � � d eÊ�¤�ÔÍ � � h�®

� ���� È p �� Ä � ¢&

6 v y z = w (CUA)

h�Ó ¦� �¶ Û �h�Ó �� ��e� ã �� w �  Ó � ��d e

Ü Ý � ã h�ü� æ�� � (quality-adjusted life-years, QALYs)&QALYs � î i � Ä � ¢y�� �ü�â ã (� � �y � ��) ��h � î d eÊ�n8 ^l Ð yQR � � /¦ �� r � � ��h c 5 � ��8Ç8� �&¥ ¦h

�Ó ¦� �;��� �ü�d e� �¥ ¦ d eÓ ¦Ê�i Æ &�: Ó ¦Ê

� �íîà « }�� Ô(preferences of society)�¬m « }�ê 7Ú ý�Ä ��¢y�� �ü&

6 v { | = w (CBA)

8h�Ñ Ò� �O�h�yÑ Ò 5 �¦ÎÏ ÉÊÚ j k&Õ<´\ �

­ ¸ ¹�� � � � �\ ¹Ü Ý ($) s � �� � &

�! w Ç8ß ��Ç� È p �°   ÉÊ;�� Ê� �� " # �Õ<�

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o n 0 q d e 3 4�� ç &Õ<� ¦h�Ñ Ò� �ç j ! e�" # 3 4

5�ËÌ � n 0 � � � &e ð � ­ ß ���� " # �� � � 9 :@j k

h�Ó �� ��h�Ó ¦� ��� �% &&

�������� 6: � � � � � � � �� � � � � � � �� � � � � � � �� � � � � � � � (Indications and Population under Evaluation)

������X Y j } ~ � � � � �� � � r � ���� � � � � �

� a �� * ��� !� )� � �� � = w �� � � � � � � � ���

!= � �@ A � � � �� � � ��j � + A �� !�� � � )�

���� H   J & ' !� ¡ ` W�. d H ¢ £ ¤ * � ¥ ��� � ¡ `

W)�� � � ¦ §�y �6 v ¨ © e ª « ¬ ­ B � � ® ¯ °± ¥ )

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8�� �� " # O�� ��Ì � ��û ) � �# ¥ ¦�Ì � � § ¨ Í

A B % Ú Û ° 34 9 Í ;�Þ ���2 ¥ ¦t� Ì � &0 t� ® �Xª

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Ì � � - �|ì ¹� ) þ � . è�/ è�¸ ¹� � �' 6 è��¸ ¹�

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í î h�Ó Ò�&�" # ¸ 8ýÞ �� 1 �Å í î h�Ó Ò�n�ý¶ ¥

¦�Å í î h�Ó Ò&m� Q Ú ý�¶ � �´Í� � Þ ���¥ ¦�2

¤ F G 8Ê � � � ¤$�� � �2&

�������� 7: � � � ! " � �� � � ! " � �� � � ! " � �� � � ! " � � (Choice of Comparative Treatment)

������r a + ² ³ � µ �¶ · ¸ �² ³ ��� � j N O ` ¹ ¸

, + � � º a �� * » ¼ ( �� � j � I J ��I J ½ ¾ ¿ À ¨ Á v @ �

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  3 4�� ç �&

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ÇÓ èyÓ ��v© ¸ ¹�� ë & * + ,* + ,* + ,* + , �$ e© ��8�Q R G �

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Ç b X �y z � ¶ � � § ¨ c d Q � �&

Ó �� � (Effectiveness research) � � � d e°   ��® � �&�® � ���$ QR , È�â ã ��ìÈ p °   $ , � ÔR G �b ���ù ú Ê � �

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¤$�°   3 4ô �³´ j kÃÚ &

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r · Ø Ù � 8;� � ´ÍL Ù� ú r · �Ø Ù&� � Æ w ¸ ´¦Ú » A

º 5è�� �Ø Ù&<= � � �ä å \] ò � · é Æ w �3 4�5 § ¨ 8

" # % &OX ª �� � &� � Æ w 8* + , -�Ç Æ / �ì

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pseudo-randomization) II-1b R G è34 ôÓ ¯ Ç ç � � � (Controlled clinical trial without

randomization)

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II-2c Ì � ~ � è� � ǹ; R G g (Cohort retrospective study with parallel

control) II-3 : :�5~ � � R G � � (Epidemiological case - controlled studies

retrospective) III �Ì y���È � � (Studies of “before and after” type) IV � � Æ w (E�Delphi)3 45� � T}'   % &�� � è� � )

| e�   Ó � �Ø Ù{Û è�� r 3 ) �» � ! * + � � �� r �@m� V tú ì

-- m ³ ´ è01 ú � �Ø Ù (evidence from systematic review)� -- mÌ { èç � � � ú � �Ø Ù (evidence from prospective randomized studies)� -- mr p û Ì { è� � è�± ç � � � ú � �Ø Ù (evidence from large-scale

prospective comparative nonrandomized studies)� -- mr p û ~ � è� � è� � ú � �Ø Ù (evidence from large-scale

retrospective comparative studies)� -- mö ¢Ì � � ( �± � � è� � ú � �Ø Ù (evidence from noncomparative

studies of a limited group of patients)� -- m � n ê H è� � ú � �Ø Ù (evidence from occasional observations)� -- mæ ) g h�� � Æ w ú � �¢Ù (data from formalized expert opinion)&

�������� 11: 8 9 : � ; < = >8 9 : � ; < = >8 9 : � ; < = >8 9 : � ; < = > (Health-Related Quality of Life, HRQoL)

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" # �d $ - % & B � ' ( C b � )R S �� ) � g © * � ² ³ �

+ D E³ - �y G�ä !B � � � o � � � µ + + , - . ( �, - �

� z ó / � ' ( C b �y F G���)

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ñ ´ � Q�� d ey" # &n Ã�Å ¤p � �ã 9� � . � § ¨ �Çx

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� " # � ¥ � " # �d y z Ê � ' ( )��

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� : ¡ � ¼ � Ç�� �ü � ë �¸ ¹þ   �@� hÞ d e�e© >

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Ì � �QR © � �� ¢ � � &�! < r ¡ � B [Ë�¡ � � � � s �  

�QR , -�¶ d e � �y; . � �d e i Æ �� �� � ;�c d Q � ú �

¬�à Ô� ;¸ � B kÃ� ¢ ã ?&� d es � > ��� �ü�� � ¥ ¦

MOS 36- item Short Form Health Survey (SF-36)]WHOQOL ¡ � B &

´ ¥ � " # (Disease-specific questionnaires)

� : ¡ � # �[Ë5 � ­ QR ! �� �ü�8þ   Ú b c � ¸ } �

; . � �H� ) �� Íã ?n ' 6 ì 5&Õ<� ; . � �¡ � 5 ­ QR

! �� �ü�â ã é c d &² £ �Õ0�± � ; . (� �� ; ü� e)�èü� I h ¹ � ����� � ï � ¸ ´Í&

y z Ê � ' ( (Utilities measures)

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ü�ÉÊ(the valuation of the HRQoL)&ye ð è ¡ � r � �� : d e͵ ¦t8r ¸ ¹� � �y© ( �Õ<Ç�Q� a E è&² ·³�Ì � ¹ r d ei

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life-year, DALY) ç j QALY� � � | e<=&

$ % 13ì ª n h��9Ë(Cost Identification)

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ß z L ö ^ v 3 4 (human capital approach) ¢ 5 )

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Ë��<� Í h�" # &

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� �m « } QÚ � �� ü � ! �h�£ �s � h�(¶ } F   h

��¶ } ± F   h��º p �} h�)ó� § ��h��« }þ Ý hT Y ¹� ² &8�� à �* � ò � � ¨ � (����f Í © ª ) ¸ ¤ ¤ 0 Ê : ©� � ú Ñ � � f ó« é w �� ñ 6 � � �@ % ¥ ¦ � q ÷ ø &���m¶

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� à $ ��°   �� � � � �(life-years)´ÍÄ ��F   h�& Ä Ú Ä� ( � � ����: h�é X B � �� � � � Ç! �£ ¤Þ m « } s � �

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�� " # § ¨ � � |X2�} h�¼� 8 # �î x ��¶ j 4�2T

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e I f �� � É _ �. Ñ g @ A & ' F G� � ³ �McomparabilityNh �i�MextrapolatabilityN)

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1. û ) ¤Þ Ä � Ü Ä Ô� § ¨ ��Ç�¥ ¦ô 5 Í x y &

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w C �y F Gr ß z g 6 v � A �xE² � C ¢ 5 © EH �É Ê )ó J x

E² � Mdiscount rateN� H � � � = w ¡ + * � G )�Gß z © e �xE² � �· � Ñ � ] í u v )

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¹;�¬è�Ó Ò(immediate benefits) � % Ú �Ó Ò(future benefits)�ÇÉÊ&�� � �°   � �P ñ e� \Ð �ák £ ã � ; · 6 �&

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�������� 18@@@@W X ) & 'W X ) & 'W X ) & 'W X ) & ' VVVVSensitivity AnalysisYYYY

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& ' F Gh � � �o p )� I � ë � � � = w Munivariate sensitivity analysisN j | } Ê �� � ~ H � )�Gó � � @ Û �· � � ë = wMmultivariate techniquesN� � K F )ß z �# Ï �� ë �Ã Ä �� ë �Ø Ù �ó c q� ( �  � ð ñ )

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�������� 19@@@@�Z ,�Z ,�Z ,�Z , (Equity)

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# O­ o é ��(base case)�z Ê è O .��|34 ôÓ y�� � �# ��Ç� ( �5 Çz Ê ��y � }\]ú � � � � �  Ó � �&

z Ê è�$ e© � � � � �ì 5t��Ç� Ä H�� � ��ü � æ�

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/¦ z Ê è� O .� i ¶ 8�� " # �34 Û Ó ¹;h :�; � &�� 5

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¸ ­ � 30 � �� � ( Z � 80 � � � ( � È p e© �� � � 5 �¹¥ �6�(equally preferable)&� �( T§ ¨ u ä · é � �;¥ ¦�p æ Ê� ¹�&

�������� 20@@@@[ \ ] ^ �� S-_ U[ \ ] ^ �� S-_ U[ \ ] ^ �� S-_ U[ \ ] ^ �� S-_ U VVVVPresentation of Results of Pharmacoeconomic EvaluationYYYY

* + �F GI t R � � = t MdisaggregateN6 . � Õ Â � �: ; < Â �q ] ; (aggregated)�F G)7 8 ¤ � � � � � e _ Ë ) | X

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�� " # � ��% &' § ¨ b X HÝ Þ ¸ � X&���h��QR �

��' �9˼½ ¶ } h�H� } h�Hú � ��� � (life years gained)H�� �üâ h��: r 9Ë8p � h0© · ã ¢Ê�� �Ê�Ì �¤Þ © \

% p � �÷ ) j k�\íî8� 9Ëã ¢�¢Ê&<� � � h��QR �

� § ¨ � { j k�\ Ö � ê ýð   �� � h��QR � �& % & % p �

�¢Ù(disaggregated data)Ç Ú ! D ô Ý Þ /òy x y " # �X á y � ç è&

� � � �� % &3 ) » � ! " ¦ q � � �4&h�Ó �� �4(CEA)�h�Ó ¦� �4(CUA)� ! % & � � � �; 5 ¤ j k� h�H � Ó ��Ó ¦ÊHh�Ó ��Ó ¦� �H\]� È h�Ó �� Ê (incremental

cost-effectiveness ratio, ICER) �� È h�Ó ¦� Ê(incremental cost-utility ratio,

ICUR)&nh�Ñ Ò� �4(CBA)�� �§ ¨ ¦ � Ñ ÒÊ(net benefit)�3 )j k&

� �� # $ § ¨ ¼½ ¢ÙH� �3 4]� ��x E &� Ç m ¦·� h

:�34 ôÓ �� ��l¤x E Þ V W ¢Ù�´ ¨ � è� � a è�³£ �

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5 § ¨ B F ¶ � �y�� � � �� �è��ô � e: � [Ç ~ tü ý &

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Ã|X&x E ;�� § ¨ |X� � O .�¸ ª . �¢�Å T ! c d Q � �

ñ d ô& | � �� ¨ " # � 2 ß   4 m � 1 2 ��­ « }´ÍÄ ��ì

5&� � % &��� § ¨ b + � ÷ ø � � �4� O .&� Ç¥ ¦t�(

�¢Ù�§ ¨ Æ Æ t� ( ÷ ø � � è�\]34 � � > ��S ! è&�

� �� " # % &' � ' u �§ ¨ L � � � � ( ) Ú j k��´� � ¹ á

÷ ø &

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������ i�� � � Å � ���& ' F Gj � � r z (applicability)_© e � � 9 y I J ] � ¨ � �� p ���F G(6 v �N O d � � � µ FG)� � � (transfer)z Ý © e ] � ¨ © e � �� p �â ã �À � (y � ))�G& ' F G�r z � � j � ] ¨ � ¡ � P Q �· Ð �   ¡ à _ � � � ) | X

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x E � a è;�� � J ]v© þ   ì(e)m ^ L � � �õ ö �� � Ì� � ú � �°   Ó ��ͤ¦t | eÛ ° 34 õ ö �Ì � �_ Qó(")2" # � �m Ê e� � � Ê eQR � � � ³ �¤¦t¶ ·� � �¶ ·F   �

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

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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 &

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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)

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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© �

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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��

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[�]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 �

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

< 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)

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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<� �

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

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4. SSSS ---- (RESULTS)

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

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

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æ � s î 5 � � � % &� D ô P � È &

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A B + -& 'A B + -& 'A B + -& 'A B + -& ' VVVVCEAY@Y@Y@Y@e� � �3 4�8 � °   3 4\ ¹�  Ó � �$ � �� � � ù ú �� � � È p �Ú � � � : °   3 4��� �

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A BA BA BA B « ¬« ¬« ¬« ¬ & '& '& '& ' VVVVCMAY@Y@Y@Y@ = � � � ï � °   3 4�� � B F � O .Ç ¹

�  Ó � ��l� � q °   3 4�û�h��ú & A B + 3 & 'A B + 3 & 'A B + 3 & 'A B + 3 & ' VVVVCUAY@Y@Y@Y@e� � �3 4�¶   Ó � ��\Ó ¦Ü Ý ��ü

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­ ® & '­ ® & '­ ® & '­ ® & ' (Decision analysis)@@@@8 X ª , -* �µ ¦Xª �e? 3 ) Ú I

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����Z ,Z ,Z ,Z , (Equity)@@@@ ­ ¸ ¹© ( �k � �� � °   3 4�÷ ø ;�z Ê è& » � ¼» � ¼» � ¼» � ¼ (Formulary)@@@@8QR S T /¦ * � ­ x èF   � � # �} ~ tàá

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³ ´ � s x H" # ]î e he© � ��� �3 4& Ì © ªÌ © ªÌ © ªÌ © ª (Net benefit)@@@@Ñ Ò�ÎÏ Ü Ý � � Ó � h�&<0 CBA� o ��

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, È��­ � ( Ú |�é Ç! n¸ é 6 ��& = > ¦ § ; < ¨= > ¦ § ; < ¨= > ¦ § ; < ¨= > ¦ § ; < ¨ VVVVQALYY@Y@Y@Y@8 CUA � �O � ¦�  Ó � �ã ¢�î e i

� � � ¢]� ú � �QR �ü�  Ó � ��� � � �� ¢¦�ü

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�_ Q&

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Û Ü Ý �Û Ü Ý �Û Ü Ý �Û Ü Ý � VVVVWillingness to pay, WTPY@Y@Y@Y@e© ( � Æ È á �� r �¦�§ ¨ µ * + v75(1)0 i õ te ; . Ô�QR , È�� ����Èp ¶ b ��´Íè&�(2)È _ ` e; . f �QR , È�� ���ù ú ¶ b ��´Íè&

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� V W 1. Bootman JL, et al. Principles of Pharmacoeconomics 2nd.Ed. 1996

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