Resolution
by the Federal Joint Committee
on an amendment to the Pharmaceutical Directive (AM-RL):
Appendix XII – Resolutions on the benefit assessment of pharmaceuticals
with new active ingredients, in accordance with the German Social Code,
Book Five (SGB V), section 35a
Living larvae of Lucilia sericata
From 20 November 2014
In its session on 20 November 2014, the Federal Joint Committee resolved to amend the Pharmaceutical Directive
(AM-RL), version published 18 December 2008/22 January 2009 (Federal Gazette, number 49a of 31 March 2009), last
amended on 20 November 2014 (Federal Gazette, AT 2 December 2014 B1) as follows:
I.
Appendix XII shall be amended in alphabetical order to include the active ingredient living larvae of Lucilia sericata:
Living larvae of Lucilia sericata
Therapeutic indication:
Living larvae of Lucilia sericata (BioBag® and BioMonde® free larvae):
Debridement of coated chronic or slowly healing wounds when instrumental/surgical treatment is not desired.
1. Additional benefit of the pharmaceutical over appropriate comparator
Appropriate comparator:
The appropriate comparator for the debridement of coated chronic or slowly healing wounds is a suitable, patientindividualized debridement technique as determined by the physician. Criteria for selecting the debridement technique
include the type, location, and size of the wound.
Extent and probability of additional benefit over a debridement technique as determined by the physician.
An additional benefit is not considered proved.
2. Number of patients and criteria for defining patients groups eligible for treatment
Approx. 500,000 to 1,000,000 patients
3. Requirements for quality-assured administration
The specifications outlined in the product information are to be followed.
Living larvae of Lucilia sericata may be applied only by healthcare professionals experienced in therapy with fly larvae.
4. Costs of treatment
Duration of treatment:
Designation of therapy
Mode of treatment
Number of
treatments per
patient
per wound
Duration per
treatment (days)
Number of
treatment days
per patient per
wound
Maximum 51
3–4
20
7 – 21
7 – 21
Pharmaceutical evaluated: living larvae of Lucilia sericata
Living larvae of Lucilia sericata
as needed
every 3 – 4
days
Appropriate comparator: debridement technique as determined by the physician2
Enzymatic debridement:
Clostridiopeptidase A with other
proteases, e.g. Iruxol®
1
2
ongoing,
1 – 2 x daily
Maximum 5 treatment cycles if no success is apparent.
Selection of possible debridement techniques.
1
Number of
treatments per
patient
per wound
Duration per
treatment (days)
as needed
n.d.3
n.d.
n.d.
TegadermTM 3MTM
hydrocolloid 10 x 10 cm
as needed
n.d.
maximum 7
n.d.
Dracohydro hydrocoll.
dressing 10 x 10 cm
as needed
n.d.
maximum 7
n.d.
Neoheal® hydrogel
dressing 6 x 12 cm
every 2 days
n.d.
n.d.
n.d.
Askina® gel
as needed
n.d.
n.d.
n.d.
Surgical debridement
as needed
n.d.
1
n.d.
Designation of therapy
Mode of treatment
Mechanical debridement
Number of
treatment days
per patient per
wound
Autolytic
debridement4:
Consumption:
Designation of therapy
Strength
Number/amount per pack
Average consumption for
treatment defined
Pharmaceutical evaluated: living larvae of Lucilia sericata
Living larvae of Lucilia sericata n.d.
100 – 200 larvae
625 – 1250 larvae
Appropriate comparator: debridement technique as determined by the physician
Enzymatic debridement:
90 – 180 g ointment5
Clostridiopeptidase A
with other proteases,
e.g. Iruxol®
Clostridiopeptidase A:
1.2 IU/g ointment
other proteases: 0.24
IU/g ointment
Mechanical debridement
n.d.
n.d.
n.d.
TegadermTM 3MTM
hydrocolloid 10 x 10 cm
n.d.
5 count
5
Dracohydro hydrocoll.
dressing 10 x 10 cm
n.d.
10 count
5
Neoheal® hydrogel
dressing 6 x 12 cm
n.d.
5 count
10
Askina® gel
n.d.
5 × 15 g
5 × 15 g
Surgical debridement
n.d.
n.d.
1
100 g ointment
Autolytic
debridement4:
Costs:
Cost of pharmaceutical:
Designation of therapy
Cost per pack
(pharmacy retail price)
or treatment
rebates
Cost after legally mandated
Pharmaceutical evaluated: living larvae of Lucilia sericata
Living larvae of Lucilia sericata
3
4
5
6
7
200 free larvae
€168.24
€106.40 [€1.806; €60.047]
100 free larvae
€144.95
€92.25 [€1.806; €50.907]
n.d. = not defined.
Sample listing.
According to product information, 5 cm3 are to be applied for a 5 cm x 5 cm wound. This corresponds to 4.5 g. at an assumed density of 0.9 g/cm3.
Rebate in accordance with SGB V, section 130.
Rebate in accordance with SGB V, section 130a.
Designation of therapy
Cost per pack
(pharmacy retail price)
or treatment
rebates
Cost after legally mandated
Appropriate comparator: debridement technique as determined by the physician
Enzymatic debridement:
Clostridiopeptidase A
with other proteases, e.g. Iruxol®
€51.24 [€1.806; €2.477]
€55.51
100 g ointment
Mechanical debridement
n.d.
not quantifiable
TegadermTM 3MTM
hydrocolloid 10 x 10 cm
€42.518
Not quantifiable9
Dracohydro hydrocoll.
dressing 10 x 10 cm
€63.20
Not quantifiable9
Neoheal® hydrogel
dressing 6 x 12 cm
€17.558
Not quantifiable9
Askina® gel
€50.28
Not quantifiable9
Autolytic debridement4:
Surgical debridement10:
GOP 3110-1
(Dermatosurgical intervention, category A1)
€89.25
(881 EBM points)
n.d.
GOP 3110-2
(Dermatosurgical intervention, category A2)
€145.67
(1438 EBM points)
n.d.
“Lauer-Taxe”, effective 1 October 2014
Costs for additional, necessary SHI benefits: none
Annual treatment costs:
Designation of therapy
Treatment costs per patient11
Pharmaceutical evaluated: living larvae of Lucilia sericata
Living larvae of Lucilia sericata,
€411.45 – €730.65
Appropriate comparator: debridement technique as determined by the physician
Enzymatic debridement:
Clostridiopeptidase A
with other proteases, e.g. Iruxol®
Mechanical debridement
€51.24 – €102.48
not quantifiable
Autolytic debridement:
TegadermTM 3MTM
hydrocolloid 10 x 10 cm
€42.51
Dracohydro hydrocoll.
dressing 10 x 10 cm
€63.20
Neoheal® hydrogel
dressing 6 x 12 cm
€35.10
Askina® gel
€50.28
Surgical debridement
8
not quantifiable
Taxe purchase price including VAT.
Contract prices.
10
Examples of GOPs in which surgical wound debridement can be billed; additional billable GOPs (e.g. post-operative monitoring and treatment,
anaesthesia) are not included in the costs shown.
11
Calculation based on entire packs; treatment costs reflect the sum of the prices for the lowest-cost packs needed to cover the standard case defined.
9
II.
This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee
on 20 November 2014.
The justification for this resolution will be published on the websites of the Federal Joint Committee at www.g-ba.de.
Berlin, 20 November 2014
The Federal Joint Committee in
accordance with SGB V,
section 91
The Chair
Hecken