Cases / 2022-06-01-D-824
completed2022-06-01D series

Setmelanotid

Adipositas und Kontrolle von Hunger, POMC-, PCSK1- oder LEPR-Mangel-Adipositas, ≥ 6 Jahre

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Brand
Imcivree
Manufacturer
Rhythm Pharmaceuticals Inc.

G-BA action

final resolution

2022-12-01

Arzneimittel-Richtlinie/Anlage XII: Setmelanotid (Adipositas und Kontrolle von Hunger, POMC-, PCSK1- oder LEPR-Mangel-Adipositas, ≥ 6 Jahre)

Evidence-checked summary

The G-BA found a hint of non-quantifiable added benefit for Erwachsene, Jugendliche und Kinder ab 6 Jahren mit POMC-, PCSK1- oder LEPR-Mangel zur Behandlung von Adipositas und zur Kontrolle des Hungergefühls. The G-BA issued a final resolution on 2022-12-01. The official page states that it took effect as follows: 01.12.2022. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

This is the latest validated public action attached to this case. It is separate from the IQWiG assessment result.

Final benefit result

G-BA result by patient group

Open decision 5753 →

Patient group

Erwachsene, Jugendliche und Kinder ab 6 Jahren mit POMC-, PCSK1- oder LEPR-Mangel zur Behandlung von Adipositas und zur Kontrolle des Hungergefühls

Hint of non quantifiable added benefit

Comparator

Open official result PDF ↗

Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2022-10-10

112 parsed turns

Oral hearing: Setmelanotid (Adipositas und Kontrolle von Hunger, POMC-, PCSK1- oder LEPR-Mangel-Adipositas, ≥ 6 Jahre)

Official Wortprotokoll · 18 pages

IQWiG comparison

Assessment record versus G-BA action

0 reference

IQWiG assessment findings and the later G-BA action are separate records. Open both to compare them.

No IQWiG assessment reference is present on the validated official case page. This is an explicit absence, not a broken graph link.

G-BA decisions

Distinct actions and documents

1 decision

2022-12-01

final resolution

Arzneimittel-Richtlinie/Anlage XII: Setmelanotid (Adipositas und Kontrolle von Hunger, POMC-, PCSK1- oder LEPR-Mangel-Adipositas, ≥ 6 Jahre)

The G-BA found a hint of non-quantifiable added benefit for Erwachsene, Jugendliche und Kinder ab 6 Jahren mit POMC-, PCSK1- oder LEPR-Mangel zur Behandlung von Adipositas und zur Kontrolle des Hungergefühls. The G-BA issued a final resolution on 2022-12-01. The official page states that it took effect as follows: 01.12.2022. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

3 official documents · 4 cited claims

Official sources

Case document package

8 source
Generic graph relations · 5