Dalbavancin (2) – Xydalba®

Acute bacterial skin and soft tissue infections (ABSSSI), ≥ 3 months

Characteristics

Start date 01.08.2023 – Marketing authorisation: 05.12.2022
Resolution 01.02.2024
INN Dalbavancin
Brand name Xydalba®
Pharm. company Dossier: Advanz Pharma Germany GmbH
New distributor: Advanz Pharma GmbH
G-BA Procedure ID D-971
ATC code J01XA04 Glycopeptide antibacterials (J01XA)
ICD-10 codes (AIS) A26.0Erythema migrans, A46Erysipelas, A49.0Staphylococcal infection, unspecified site, A49.1Streptococcal infection, unspecified site, H00.0Hordeolum (externum) (internum) of eyelid, H05.0Acute inflammation of orbit, H60.0Boil of external ear, J34.0Cellulitis of nose, K12.20, K61.0Anal abscess, K61.1Rectal abscess, K61.3, K61.4Intersphincteric abscess, L01.0Impetigo contagiosa, L02.0Cutaneous abscess, furuncle and carbuncle of face, L02.1Cutaneous abscess, furuncle and carbuncle of neck, L02.2Cutaneous abscess, furuncle and carbuncle of trunk, L02.3Cutaneous abscess, furuncle and carbuncle of buttock, L02.4Cutaneous abscess, furuncle and carbuncle of limb, L02.8Cutaneous abscess, furuncle and carbuncle of other sites, L02.9Cutaneous abscess, furuncle and carbuncle, unspecified, L03.01Cellulitis of right finger, L03.02Acute lymphangitis of right finger, L03.10, L03.11Cellulitis of right axilla, L03.2Cellulitis and acute lymphangitis of face and neck, L03.3Cellulitis and acute lymphangitis of trunk, L03.8Cellulitis and acute lymphangitis of other sites, L03.9Cellulitis and acute lymphangitis, unspecified, L08.0Pyoderma, L08.1Erythrasma, L08.8Other specified local infections of the skin and subcutaneous tissue, L08.9Local infection of the skin and subcutaneous tissue, unspecified, N48.2Other inflammatory disorders of penis, N61Inflammatory disorders of breast, N76.4Furuncle of vulva
Alpha-ID codes (AIS) I110434Anal abscess, I11157Scalp abscess, I11160Nasal abscess, I11372Orbital abscess, I11393Eyelid phlegmon, I12312Foot phlegmon, I12313Arm phlegmon, I12332Finger phlegmon, I12333Toe phlegmon, I13884Erysipelas, I17529Erythrasma, I21012Penile abscess, I21898Ischiorectal abscess, I21901Rectal abscess, I24574Buttock abscess, I24764Breast abscess, I25230Infection due to streptococci n.e.c, I27519Skin erysipeloid, I27544Infection due to staphylococci n.e.c, I28516Anal sphincter abscess, I28527Skin abscess, I31181Cellulite, I571Pyoderma n.e.c, I5849Impetigo contagiosa due to staphylococci, I5854Skin abscess of the face, I5861Neck abscess, I5869Torso abscess, I5873Facial phlegmon, I5877Trunk phlegmon, I5895Local skin and subcutaneous infection, I67422Abscess of the upper extremity, I78896Head phlegmon n.c, I78954Oral phlegmon, I90106Abscess of the outer ear, I91021Abscess of the external genital organs in women, I95329Infection of a skin sinus n.c
Therapeutic area Infectious diseases Soft tissue infections (ABSSSI)
Reason for procedure Initial assessment – Reserve antibiotic
Regulatory status Reserve antibiotic

Therapeutic indication of the resolution

Xydalba is indicated for the treatment of acute bacterial skin and soft tissue infections (ABSSSI) in adults and paediatric patients from 3 months of age.
Subpopulation Indication Comparator
Adults and children aged 3 months and over with acute bacterial skin and soft tissue infections (ABSSSI)

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted

Adults and children aged 3 months and over with acute bacterial skin and soft tissue infections (ABSSSI)

  • The additional benefit is deemed proven.
  • For the medicinal product Xydalba, containing the active ingredient dalbavancin, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 20 April 2023, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
  • Requirements for a quality-assured application
    • Dalbavancin may only be used if there is evidence, or in exceptional cases a strong suspicion, that the infection is caused by methicillin-resistant Staphylococcus aureus (MRSA) and only limited treatment options are available.
    • Qualified consultation shall take place, in accordance with the relevant specialist expertise, with a specialist with additional qualification in infectious diseases, a specialist in internal medicine and infectious diseases, or a specialist in microbiology, virology and infectious disease epidemiology.
    • As a general rule, dalbavancin should not be used as part of a calculated (empirical) treatment regimen. Its strict indication as a reserve antibiotic requires knowledge of the pathogen.
    • Should pathogen testing reveal that the pathogen is susceptible to other antibiotics (without reserve status), treatment must be de-escalated accordingly to avoid unnecessary use of the reserve antibiotic.
    • For the appropriate management of MRSA infections and the relevant requirements in clinical practice, please refer to the current recommendations of the RKI.
    • With a view to the future assessment of the resistance situation, the use of a standardised system is necessary. The RKI’s ARS system aggregates data on antibiotic resistance across Germany and also forms the basis for Germany’s participation in international surveillance systems. For this reason, efforts should be made to ensure that the laboratory serving the practice participates in this system.
    • To implement the requirements for a quality-assured application, it is necessary that these be incorporated into the clinic’s internal regulations and processes.
    • The reporting of consumption and resistance data on dalbavancin to the aforementioned systems must be ensured within six months of this resolution coming into force.

Courtesy translation only, please refer to the German original.

Associated procedures



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