Cases / 2021-01-01-D-641
completed2021-01-01D series

Afamelanotid

Neubewertung nach Fristablauf: Erythropoetische Protoporphyrie

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Brand
Scenesse
Manufacturer
Clinuvel (Europe) Limited

G-BA action

final resolution

2021-07-01

Arzneimittel-Richtlinie/Anlage XII: Afamelanotid (Neubewertung nach Fristablauf: Phototoxizität bei erythropoetischer Protoporphyrie)

Evidence-checked summary

The G-BA found a hint of non-quantifiable added benefit for Erwachsene Patienten mit erythropoetischer Protoporphyrie zur Prävention von Phototoxizität. The G-BA issued a final resolution on 2021-07-01. The official page states that it took effect as follows: 01.07.2021. 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

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Patient group

Erwachsene Patienten mit erythropoetischer Protoporphyrie zur Prävention von Phototoxizität

Hint of non quantifiable added benefit

Comparator

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2021-05-10

108 parsed turns

Oral hearing: Afamelanotid (Neubewertung nach Fristablauf: Erythropoetische Protoporphyrie)

Official Wortprotokoll · 19 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

2021-07-01

final resolution

Arzneimittel-Richtlinie/Anlage XII: Afamelanotid (Neubewertung nach Fristablauf: Phototoxizität bei erythropoetischer Protoporphyrie)

The G-BA found a hint of non-quantifiable added benefit for Erwachsene Patienten mit erythropoetischer Protoporphyrie zur Prävention von Phototoxizität. The G-BA issued a final resolution on 2021-07-01. The official page states that it took effect as follows: 01.07.2021. 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

7 source
Generic graph relations · 4