%PDF-1.5
%
1 0 obj
<<
/Lang (en)
/MarkInfo <<
/Marked true
>>
/Metadata 2 0 R
/Outlines 3 0 R
/PageLayout /OneColumn
/PageMode /UseOutlines
/Pages 4 0 R
/StructTreeRoot 5 0 R
/Type /Catalog
/ViewerPreferences <<
/DisplayDocTitle true
>>
>>
endobj
6 0 obj
<<
/Author (Gemeinsamer Bundesausschuss/Federal Joint Committee \(g-ba.de\))
/Category ()
/Comments ()
/Company ()
/CreationDate (D:20220712123106+02'00')
/Creator <4163726F626174205044464D616B65722031352066FC7220576F7264>
/Dokumenten-ID (J3YDCFXW1IJE340DKCRA437OHF)
/Keywords <416E6E6578205849492085205265736F6C7574696F6E73206F6E207468652042656E65666974204173736573736D656E74206F66204D65646963696E616C2050726F64756374732077697468204E65772041637469766520496E6772656469656E7473204163636F7264696E6720746F2053656374696F6E20333561205347422056200D0A497661636166746F722F54657A61636166746F722F456C657861636166746F72>
/Klassifizierung (Extern-Vertraulich)
/Klassifizierungs-Datum (11/04/2021 09:03:17)
/Klassifizierungs-Id (9BA217E89CFD49ABA5B02114618634AD)
/ModDate (D:20220826113714+02'00')
/NovaPath-SeverityLevel (3000)
/NovaPath-SeverityName (Hoch)
/NovaPath-Version (5.1.0.13233)
/Producer (Adobe PDF Library 15.0)
/SourceModified (D:20220712103051)
/Subject (Pharmaceuticals Directive \(AM RL\):)
/Title (Resolution)
/_DocHome (1460877555)
>>
endobj
2 0 obj
<<
/Length 5572
/Subtype /XML
/Type /Metadata
>>
stream
2022-08-26T11:37:14+02:00
2022-07-12T12:31:06+02:00
2022-08-26T11:37:14+02:00
Acrobat PDFMaker 15 für Word
uuid:cbc853cb-17de-4b56-8674-df90c97a2a81
uuid:f83afeec-6391-4d36-ad57-266d4e2a7c36
1
application/pdf
Resolution
Pharmaceuticals Directive (AM RL):
Gemeinsamer Bundesausschuss/Federal Joint Committee (g-ba.de)
Annex XII – Resolutions on the Benefit Assessment of Medicinal Products with New Active Ingredients According to Section 35a SGB V
Ivacaftor/Tezacaftor/Elexacaftor
Adobe PDF Library 15.0
Annex XII – Resolutions on the Benefit Assessment of Medicinal Products with New Active Ingredients According to Section 35a SGB V
Ivacaftor/Tezacaftor/Elexacaftor
D:20220712103051
1460877555
Extern-Vertraulich
9BA217E89CFD49ABA5B02114618634AD
11/04/2021 09:03:17
Hoch
3000
J3YDCFXW1IJE340DKCRA437OHF
5.1.0.13233
Arzneimittel-Richtlinie: Anlage XII â•fi Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a des Fünften Buches Sozialgesetzbuch (SGB V)
endstream
endobj
3 0 obj
<<
/Count 4
/First 7 0 R
/Last 8 0 R
/Type /Outlines
>>
endobj
4 0 obj
<<
/Count 3
/Kids [9 0 R 10 0 R 11 0 R]
/Type /Pages
>>
endobj
5 0 obj
<<
/K 12 0 R
/ParentTree 13 0 R
/ParentTreeNextKey 6
/RoleMap 14 0 R
/Type /StructTreeRoot
>>
endobj
7 0 obj
<<
/A 15 0 R
/Next 16 0 R
/Parent 3 0 R
/Title (1. Additional benefit of the medicinal product in relation to the appropriate comparator therapy)
>>
endobj
8 0 obj
<<
/A 17 0 R
/Parent 3 0 R
/Prev 18 0 R
/Title (4. Treatment costs)
>>
endobj
9 0 obj
<<
/Contents [19 0 R 20 0 R 21 0 R 22 0 R 23 0 R 24 0 R 25 0 R 26 0 R 27 0 R]
/CropBox [0.0 0.0 595.32 841.92]
/MediaBox [0.0 0.0 595.32 841.92]
/Parent 4 0 R
/Resources <<
/ColorSpace <<
/CS0 [/ICCBased 28 0 R]
/CS1 [/ICCBased 29 0 R]
>>
/Font <<
/TT0 30 0 R
/TT1 31 0 R
/TT2 32 0 R
/TT3 33 0 R
>>
/XObject <<
/OL1 34 0 R
>>
>>
/Rotate 0
/StructParents 0
/Tabs /S
/Type /Page
>>
endobj
10 0 obj
<<
/Annots [35 0 R]
/Contents [36 0 R 37 0 R]
/CropBox [0.0 0.0 595.32 841.92]
/MediaBox [0.0 0.0 595.32 841.92]
/Parent 4 0 R
/Resources <<
/ColorSpace <<
/CS0 [/ICCBased 28 0 R]
/CS1 [/ICCBased 29 0 R]
>>
/Font <<
/C2_0 38 0 R
/C2_1 39 0 R
/TT0 30 0 R
/TT1 31 0 R
/TT2 33 0 R
/TT3 32 0 R
>>
/XObject <<
/OL1 34 0 R
>>
>>
/Rotate 0
/StructParents 1
/Tabs /S
/Type /Page
>>
endobj
11 0 obj
<<
/Annots [40 0 R 41 0 R]
/Contents [42 0 R 43 0 R]
/CropBox [0.0 0.0 595.32 841.92]
/MediaBox [0.0 0.0 595.32 841.92]
/Parent 4 0 R
/Resources <<
/ColorSpace <<
/CS0 [/ICCBased 28 0 R]
/CS1 [/ICCBased 29 0 R]
>>
/Font <<
/C2_0 39 0 R
/TT0 30 0 R
/TT1 31 0 R
/TT2 32 0 R
/TT3 33 0 R
>>
/XObject <<
/OL1 34 0 R
>>
>>
/Rotate 0
/StructParents 2
/Tabs /S
/Type /Page
>>
endobj
12 0 obj
<<
/K [44 0 R 45 0 R 46 0 R 47 0 R 48 0 R 49 0 R 50 0 R 51 0 R 52 0 R 53 0 R
54 0 R 55 0 R 56 0 R 57 0 R 58 0 R 59 0 R 60 0 R 61 0 R 62 0 R 63 0 R
64 0 R 65 0 R 66 0 R 67 0 R 68 0 R 69 0 R 70 0 R 71 0 R 72 0 R 73 0 R
74 0 R 75 0 R 76 0 R 77 0 R 78 0 R 79 0 R 80 0 R 81 0 R 82 0 R 83 0 R
84 0 R 85 0 R 86 0 R 87 0 R 88 0 R 89 0 R 90 0 R]
/P 5 0 R
/S /Sect
>>
endobj
13 0 obj
<<
/Nums [0 [44 0 R 45 0 R 46 0 R 47 0 R 48 0 R 49 0 R 50 0 R 51 0 R 52 0 R 53 0 R
54 0 R 55 0 R 56 0 R 57 0 R 58 0 R 59 0 R 60 0 R 61 0 R 62 0 R]
1 [63 0 R 64 0 R 66 0 R 67 0 R 68 0 R 69 0 R 70 0 R null 91 0 R null
92 0 R null null 93 0 R null 94 0 R null 95 0 R null null
96 0 R null 97 0 R null 98 0 R null 99 0 R null 100 0 R 101 0 R
102 0 R null 103 0 R null 104 0 R 105 0 R 106 0 R null 107 0 R null
108 0 R 109 0 R 110 0 R null 111 0 R null 112 0 R 113 0 R 114 0 R null
115 0 R null 116 0 R null 117 0 R null 118 0 R null 119 0 R null
120 0 R null 121 0 R null 122 0 R null 123 0 R 72 0 R 73 0 R 74 0 R
75 0 R 76 0 R 77 0 R null 124 0 R null 125 0 R 64 0 R]
2 [78 0 R 79 0 R null 126 0 R 80 0 R 81 0 R 82 0 R 83 0 R 84 0 R 85 0 R
null 127 0 R null 128 0 R null null 129 0 R null 130 0 R null
131 0 R null 132 0 R null 133 0 R null 134 0 R null 135 0 R null
136 0 R 137 0 R null 138 0 R null 139 0 R 140 0 R null 141 0 R null
142 0 R 143 0 R null 144 0 R null 145 0 R 146 0 R null 147 0 R null
148 0 R null 149 0 R null 150 0 R null 151 0 R 152 0 R 87 0 R 88 0 R
89 0 R 90 0 R]
3 126 0 R 4 126 0 R
5 125 0 R]
>>
endobj
14 0 obj
<<
/Annotation /Span
/Artifact /P
/Bibliography /BibEntry
/Chart /Figure
/Diagram /Figure
/DropCap /Figure
/Endnote /Note
/Footnote /Note
/InlineShape /Figure
/Outline /Span
/Strikeout /Span
/Subscript /Span
/Superscript /Span
/TextBox /Art
/Underline /Span
>>
endobj
15 0 obj
<<
/D [9 0 R /XYZ 69 419 0.0]
/S /GoTo
>>
endobj
16 0 obj
<<
/A 153 0 R
/Next 18 0 R
/Parent 3 0 R
/Prev 7 0 R
/Title (2. Number of patients or demarcation of patient groups eligible for treatment)
>>
endobj
17 0 obj
<<
/D [11 0 R /XYZ 69 585 0.0]
/S /GoTo
>>
endobj
18 0 obj
<<
/A 154 0 R
/Next 8 0 R
/Parent 3 0 R
/Prev 16 0 R
/Title (3. Requirements for a quality-assured application)
>>
endobj
19 0 obj
<<
/Length 37
/Filter /FlateDecode
>>
stream
x+*23P0bdBr.KB W
endstream
endobj
20 0 obj
<<
/Length 1083
/Filter /FlateDecode
>>
stream
HVnGW,9=s1
`䠬X %2ɐ%XftW?oן/{jf\\}rw%ZK*K?z?_]~w[Oom{
yDK▛iww'}_n$e7KL1Bu'I*>OpELmUٛ. liKkXK x!JI`T(_7ܜ`s 4ע=;pGmPCxV'ԧL
|+jri~/Ad} 4DiVW&[LQ4j8D2
8S
p*msMԆxLd!@j(&C,Y{Hˍ:`r%)X"ՑEĭ >2HE9'D! @ED!
WB3sy>E8Gg*uGgN<2Lx',?=gfS
#$T
v* {Z3
2=.0w*c =tM@&ha>Į9foM
8A BW^P5'k;[Y?AuJg-oH~ƥA-Uko
k+>(;]UL:<8;{踻h'>l'>>u7Sxh;=gT>kzA4iNEbbӑh]i]e,+!i:
ӿ#=싹y[-E}N
(|Qmd8O<Ƣ\ijCHQn1y;1pMBD`?0zM%yB&.ڞL#I/0Cr|eTl80h^E9%f.5!tj#Б" s֏ u8 /$ٲ*e1*אegR4E7Ę
S$`jʗU
`XU_U@9/PL$\BF(?g