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[G20-18] Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, combination regimen with ivacaftor in patients aged 12 years and older [homozygous for the F508del mutation]) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Last updated 01.12.2020

Project no.:
G20-18

Commission:
Commission awarded on 01.09.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Health Economics

Application field:
Airways and respiratory system

Note:

In accordance with §35a (1) Sentence 11 Social Code Book (SGB) V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. On behalf of the Federal Joint Committee (G-BA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier.

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. The resolution on the extent of added benefit is passed by the G-BA after the hearing. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA Website.

Project no. Title Status
A19-105 Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-69 Ivacaftor (cystic fibrosis, from 12 to < 24 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-68 Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-67 Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-66 Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-71 Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-70 Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-65 Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V Commission completed
G18-21 Ivacaftor (cystic fibrosis) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V Commission completed
G15-13 Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V Commission completed
G14-09 Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment) Commission completed
G12-02 Ivacaftor - Assessment according to § 35a (1), Sentence 10, Social Code Book V (dossier assessment) Commission completed
G20-20 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, combination regimen with ivacaftor in patients aged 12 years and older [heterozygous for F508del and MF mutation]) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V Commission completed
G20-19 Bulevirtide (chronic hepatitis delta virus infection) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V Commission completed
G21-03 Ivacaftor (cystic fibrosis) - Addendum to Commissions G20-18, G20-20, A20-77, A20-83 Commission completed
A23-122 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, MF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book Commission completed
A23-123 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book Commission completed
A22-19 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-124 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, gating mutation, heterozygous) – Benefit assessment according to §35a Commission completed
A23-125 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, RF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book Commission completed
A21-73 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book Commission completed
A21-72 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 12 years and older, residual function mutation) - Benefit assessment according to §35a Social Code Book Commission completed
A21-71 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book Commission completed
A22-16 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-18 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, RF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-15 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, MF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-17 Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-126 Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, other/unknown mutation, heterozygous) – Benefit assessment according to §35a Social Code Book Commission completed

Federal Joint Committee (G-BA)

2021.02.18 A G-BA decision was published.

G-BA documents on this decision

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