%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:20220712110636+02'00')
/Creator <4163726F626174205044464D616B65722031352066FC7220576F7264>
/Keywords <416E6E6578205849492085205265736F6C7574696F6E73206F6E207468652042656E65666974204173736573736D656E74206F66204D65646963696E616C2050726F64756374732077697468204E65772041637469766520496E6772656469656E7473204163636F7264696E6720746F2053656374696F6E20333561205347422056200D0A497661636166746F72>
/ModDate (D:20220826113420+02'00')
/Producer (Adobe PDF Library 15.0)
/SourceModified (D:20220712090625)
/Subject (Pharmaceuticals Directive \(AM RL\))
/Title (Resolution)
/_DocHome (1460877555)
>>
endobj
2 0 obj
<<
/Length 4888
/Subtype /XML
/Type /Metadata
>>
stream
2022-08-26T11:34:20+02:00
2022-07-12T11:06:36+02:00
2022-08-26T11:34:20+02:00
Acrobat PDFMaker 15 für Word
uuid:99618413-232b-495e-a0b8-0879a7975a42
uuid:a90eb429-605e-4247-9206-8d24f69cf81c
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
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
D:20220712090625
1460877555
Arzneimittel-Richtlinie: Anlage XII â•fi Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V
endstream
endobj
3 0 obj
<<
/Count 4
/First 7 0 R
/Last 8 0 R
/Type /Outlines
>>
endobj
4 0 obj
<<
/Count 6
/Kids [9 0 R 10 0 R 11 0 R 12 0 R 13 0 R 14 0 R]
/Type /Pages
>>
endobj
5 0 obj
<<
/K 15 0 R
/ParentTree 16 0 R
/ParentTreeNextKey 10
/RoleMap 17 0 R
/Type /StructTreeRoot
>>
endobj
7 0 obj
<<
/A 18 0 R
/Next 19 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 20 0 R
/Parent 3 0 R
/Prev 21 0 R
/Title (4. Treatment costs)
>>
endobj
9 0 obj
<<
/Contents [22 0 R 23 0 R 24 0 R 25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 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 31 0 R]
/CS1 [/ICCBased 32 0 R]
>>
/Font <<
/TT0 33 0 R
/TT1 34 0 R
/TT2 35 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 0
/Tabs /S
/Type /Page
>>
endobj
10 0 obj
<<
/Annots [37 0 R]
/Contents [38 0 R 39 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 31 0 R]
>>
/Font <<
/C2_0 40 0 R
/C2_1 41 0 R
/TT0 33 0 R
/TT1 34 0 R
/TT2 42 0 R
/TT3 43 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 1
/Tabs /S
/Type /Page
>>
endobj
11 0 obj
<<
/Annots [44 0 R]
/Contents [45 0 R 46 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 31 0 R]
>>
/Font <<
/TT0 33 0 R
/TT1 34 0 R
/TT2 43 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 2
/Tabs /S
/Type /Page
>>
endobj
12 0 obj
<<
/Contents [47 0 R 48 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 31 0 R]
>>
/Font <<
/TT0 33 0 R
/TT1 34 0 R
/TT2 43 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 3
/Tabs /S
/Type /Page
>>
endobj
13 0 obj
<<
/Annots [49 0 R 50 0 R]
/Contents [51 0 R 52 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 31 0 R]
/CS1 [/ICCBased 32 0 R]
>>
/Font <<
/C2_0 40 0 R
/TT0 33 0 R
/TT1 34 0 R
/TT2 35 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 4
/Tabs /S
/Type /Page
>>
endobj
14 0 obj
<<
/Contents [53 0 R 54 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 31 0 R]
>>
/Font <<
/TT0 33 0 R
/TT1 34 0 R
/TT2 35 0 R
>>
/XObject <<
/OL1 36 0 R
>>
>>
/Rotate 0
/StructParents 7
/Tabs /S
/Type /Page
>>
endobj
15 0 obj
<<
/K [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 91 0 R 92 0 R 93 0 R 94 0 R
95 0 R 96 0 R 97 0 R 98 0 R 99 0 R 100 0 R 101 0 R 102 0 R 103 0 R 104 0 R
105 0 R 106 0 R]
/P 5 0 R
/S /Sect
>>
endobj
16 0 obj
<<
/Nums [0 [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]
1 [74 0 R 76 0 R 77 0 R 78 0 R null 107 0 R null 108 0 R null null
109 0 R null 110 0 R null 111 0 R null null 112 0 R null 113 0 R
null 114 0 R null 115 0 R null 116 0 R 117 0 R 118 0 R null 119 0 R
null 120 0 R 121 0 R 122 0 R null 123 0 R null 124 0 R 125 0 R 126 0 R
null 127 0 R null 128 0 R 129 0 R 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 null 137 0 R
null 138 0 R null 139 0 R 80 0 R 81 0 R 82 0 R null 140 0 R null
141 0 R null 142 0 R null null 143 0 R null 144 0 R null 145 0 R
null null 146 0 R null 147 0 R null 148 0 R null null 149 0 R
null 150 0 R null 151 0 R null 152 0 R 153 0 R 154 0 R 155 0 R 156 0 R
157 0 R 158 0 R 159 0 R 160 0 R 161 0 R 162 0 R null 163 0 R null 164 0 R
null 165 0 R null 166 0 R null 167 0 R null 168 0 R null 169 0 R
null 170 0 R null 171 0 R null 172 0 R 173 0 R 174 0 R 175 0 R null
176 0 R null 177 0 R 178 0 R 179 0 R 180 0 R 181 0 R 182 0 R null 183 0 R
null 184 0 R 84 0 R null 185 0 R null 186 0 R 74 0 R]
2 [null 187 0 R null null 188 0 R null null 189 0 R null null
190 0 R null null 191 0 R null null 192 0 R null 193 0 R null
194 0 R null 195 0 R 196 0 R 197 0 R 198 0 R 199 0 R 200 0 R null 201 0 R
null 202 0 R 203 0 R 204 0 R 205 0 R 206 0 R 207 0 R null 208 0 R null
209 0 R null 210 0 R null null 211 0 R null 212 0 R null 213 0 R
null null 214 0 R null 215 0 R null 216 0 R null null 217 0 R
null 218 0 R null 219 0 R null null 220 0 R null 221 0 R null
null 222 0 R null 223 0 R null null 224 0 R null 225 0 R null
null 226 0 R null 227 0 R null null 228 0 R null 229 0 R null
null 230 0 R null 231 0 R null null 232 0 R null 233 0 R null
234 0 R null 235 0 R null 236 0 R null 237 0 R null 238 0 R null
239 0 R null 240 0 R null 241 0 R null 242 0 R null 243 0 R 244 0 R
245 0 R 246 0 R 247 0 R 248 0 R 249 0 R 250 0 R 251 0 R 252 0 R 253 0 R 254 0 R
255 0 R 256 0 R null 257 0 R null 258 0 R null 259 0 R null 260 0 R
null 261 0 R null 262 0 R null 263 0 R 264 0 R 265 0 R 266 0 R 267 0 R
268 0 R 269 0 R 270 0 R 271 0 R 272 0 R 273 0 R 274 0 R 275 0 R null 276 0 R
null 277 0 R null 278 0 R null 279 0 R 280 0 R 281 0 R 282 0 R 283 0 R
284 0 R 285 0 R 286 0 R 287 0 R 288 0 R 289 0 R 290 0 R 291 0 R 292 0 R 293 0 R
null 294 0 R null 295 0 R null 296 0 R null 297 0 R null 298 0 R
null 299 0 R null 300 0 R 301 0 R 302 0 R 303 0 R 304 0 R 305 0 R 306 0 R
307 0 R 308 0 R 309 0 R 310 0 R 311 0 R 312 0 R null 313 0 R null 314 0 R
295 0 R]
3 [null 315 0 R null 316 0 R null 317 0 R null 318 0 R 319 0 R 320 0 R
321 0 R 322 0 R 323 0 R 324 0 R 325 0 R 326 0 R null 327 0 R 328 0 R 329 0 R
330 0 R 331 0 R 332 0 R 333 0 R 334 0 R 335 0 R 336 0 R 337 0 R null 338 0 R
null 339 0 R null 340 0 R null 341 0 R null 342 0 R null 343 0 R
null 344 0 R 345 0 R 346 0 R 347 0 R 348 0 R 349 0 R null 350 0 R null
351 0 R 352 0 R 353 0 R 354 0 R 355 0 R 356 0 R null 357 0 R null 358 0 R
359 0 R 360 0 R 361 0 R 362 0 R 363 0 R null 364 0 R null 365 0 R 366 0 R
367 0 R 368 0 R 369 0 R 370 0 R null 371 0 R null 372 0 R 373 0 R 374 0 R
375 0 R 376 0 R 377 0 R null 378 0 R null 379 0 R 380 0 R 381 0 R 382 0 R
383 0 R 384 0 R null 385 0 R null 386 0 R 387 0 R 388 0 R 389 0 R 390 0 R
391 0 R null 392 0 R null 393 0 R 394 0 R 395 0 R 396 0 R 397 0 R 398 0 R
null 399 0 R null 400 0 R 401 0 R 402 0 R 403 0 R 404 0 R 405 0 R null
406 0 R null 407 0 R null 408 0 R null 409 0 R null 410 0 R 411 0 R
412 0 R 413 0 R 414 0 R 415 0 R null 416 0 R null 417 0 R 418 0 R 419 0 R
420 0 R 421 0 R 422 0 R null 423 0 R null 424 0 R 425 0 R 426 0 R 427 0 R
428 0 R 429 0 R null 430 0 R null 431 0 R null 432 0 R null 433 0 R
null 434 0 R null 435 0 R]
4 [null 436 0 R null 437 0 R null 438 0 R null 439 0 R null 440 0 R
null 441 0 R null 442 0 R null 443 0 R null 444 0 R null 445 0 R
null 446 0 R null 447 0 R null 448 0 R 88 0 R 89 0 R 90 0 R 91 0 R
92 0 R 93 0 R null 449 0 R 94 0 R 95 0 R 96 0 R 97 0 R]
5 449 0 R 6 449 0 R 7 [98 0 R 99 0 R 100 0 R 101 0 R null 450 0 R null 451 0 R null null
452 0 R null 453 0 R null 454 0 R null 455 0 R null 456 0 R null
457 0 R null 458 0 R null 459 0 R 460 0 R null 461 0 R null 462 0 R
463 0 R null 464 0 R null 465 0 R 466 0 R null 467 0 R null 468 0 R
null 469 0 R null 470 0 R null 471 0 R 472 0 R null 473 0 R null
474 0 R 475 0 R null 476 0 R null 477 0 R 478 0 R 103 0 R 104 0 R 105 0 R
106 0 R]
8 186 0 R 9 314 0 R]
>>
endobj
17 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
18 0 obj
<<
/D [9 0 R /XYZ 69 420 0.0]
/S /GoTo
>>
endobj
19 0 obj
<<
/A 479 0 R
/Next 21 0 R
/Parent 3 0 R
/Prev 7 0 R
/Title (2. Number of patients or demarcation of patient groups eligible for treatment)
>>
endobj
20 0 obj
<<
/D [14 0 R /XYZ 69 743 0.0]
/S /GoTo
>>
endobj
21 0 obj
<<
/A 480 0 R
/Next 8 0 R
/Parent 3 0 R
/Prev 19 0 R
/Title (3. Requirements for a quality-assured application)
>>
endobj
22 0 obj
<<
/Length 37
/Filter /FlateDecode
>>
stream
x+*23P0bdBr.KB W
endstream
endobj
23 0 obj
<<
/Length 980
/Filter /FlateDecode
>>
stream
HVˎ[7߯\[[@ .l ]]7N2<4s(<sE#fɋWf n닋ۿ}ZV9Iѭ"URqosVֿn7w~g6.o6y2}07V|7spNWYNo"ߖ)UM+If
1*AkZ0On;}`몤noMWXaS, 9cK\䫨P)ZmRK(0`4W67HLsnIA
aH)dg lS*{ (WӜA
&0jY͐v`܅lyH3NĎg6=}6S0~HHaR9ꈢ@T >s(