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ELIGIBILITY CRITERIA FOR TALIGLUCERASE ALFA (ELELYSO) (Pharmaceutical Management Agency)

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ELIGIBILITY CRITERIA FOR TALIGLUCERASE ALFA (ELELYSO)
Contents
Initial application taliglucerase alfa (Elelyso).................2 - 4
Renewal application taliglucerase alfa (Elelyso)...........5 - 6
2
SA1880 Initial application taliglucerase alfa (Elelyso)
Please send applications to:
Facsimile (04) 460 4995
Further Contact Details:
Address
Gaucher Panel Co-ordinator
PHARMAC
P O Box 10-254
WELLINGTON
Phone (04) 460 4990
Email gaucherpanel@pharmac.govt.nz
Patient Details
Last Name
First Name/s
NHI No
Date of birth
Gender
Male: Female:
DHB of domicile
Applying Practitioner
Speciality NZMC Registration Number:
Last Name
First Name
Contact address
Phone
Fax
Email Address
Cell phone
Patient physical examination
Date of examination
Weight (kg)
Height (cm) (if child, please attach height chart)
3
Access criteria
Must be ALL of the following (1- 4)
1
The patient has a diagnosis of symptomatic type 1 or type 3 Gaucher disease confirmed by the
demonstration of specific deficiency of glucocerebrosidase in leukocytes or cultured skin fibroblasts,
and
g
enot
y
pic anal
y
sis; and
2
The patient does not have another life-threatening or severe disease where the prognosis is unlikely to
be influenced by taliglucerase alfa or might be reasonably expected to compromise a response to
therap
y
with tali
g
lucerase alfa; and
3
Taliglucerase alfa is to be administered at a dose no greater than 30 unit/kg every other week rounded
to the nearest whole vial
(
200 units
)
, unless otherwise a
g
reed b
y
PHARMAC; and
4
Supporting clinical information including test reports, MRI whole body STIR,
haematologic
al data, and other relevant investigations, are submitted to the Gaucher Panel for
assessment; and
Have you included the following? Please indicate attachments.
test reports
MRI whole body STIR
haematological data
other relevant investigations. Specify:
Plus ANY of the following (5.1- 5.5)
5.1
Patient has haematological complications such as haemoglobin less than 95 g/l, symptomatic
anaemia, thrombocytopenia; at least two episodes of severely symptomatic splenic infarcts confirmed
with imagery; or massive symptomatic splenomegaly; OR
Date of
blood
test
Hb Platelets AST ALP INR APPT Acid
Phos.
Date Spleen size
Clinical: cm below costal margin
Radiology: spleen volume
(
specif
y
t
y
pe of imaging used
)
OR
5.2
Patient has skeletal complications such as acute bone crisis requiring hospitalisation or major pain
management strategies; radiological MRI evidence of incipient destruction of any major joint (e.g. hips
or shoulder); spontaneous fractures or vertebral collapse; chronic bone pain not controlled by other
pharmaceuticals; OR
Please send imaging, including reports, of hips, femur, lumbo-sacral spine and other bones clinically
affected, as per MRI guidelines
4
OR
5.3
Patient has significant liver dysfunction or hepatomegaly attributable to Gaucher disease; OR
Date
Liver size
Clinical: cm below costal margin
Radiology: liver volume
(specify type of imaging used)
OR
5.4
Patient has reduced vital capacity from clinically significant or progressive pulmonary disease due to
Gaucher disease; OR
Date
Pulse rate / min
Blood pressure
(mm/Hg)
Echo
(RV Pressure)
Lung function
DLCO. Radiology
OR
5.5
Patient is a child and has experienced growth failure with significant decrease in percentile linear
growth over a 6-12 month period
Other comments (include any neurological symptoms) (attach additional information if more space is
needed):
Applicant’s Declaration
I confirm that the above and attached details are correct and that in signing this form I understand that I
may be audited. I recognise the requirements for monitoring and managing treatment with taliglucerase
alfa.
Complete reports are attached, including test reports, MRI whole body STIR, haematological data and
other relevant investigations.
Signature:
_____________________
Date:
5
SA1880 Renewal application taliglucerase alfa (Elelyso)
Please send applications to:
Facsimile (04) 460 4995
Further Contact Details:
Address
Gaucher Panel Co-ordinator
PHARMAC
P O Box 10-254
WELLINGTON
Phone (04) 460 4990
Email gaucherpanel@pharmac.govt.nz
Patient Details
Last Name
First Name/s
NHI No
Date of birth
Gender
Male: Female:
DHB of domicile
Applying Practitioner
Speciality NZMC Registration Number:
Last Name
First Name
Contact address
Phone
Fax
Email Address
Cell phone
Patient physical examination
Date of examination:
Weight (kg):
Height (cm) (if child, please attach height chart):
Current dose taliglucerase (max 30 units/kg every other week)
Transition comments (attach additional information if more space is needed)
Has patient transitioned from imiglucerase to taliglucerase alfa since December 2018? When? Dose? Any issues
with patient acceptance, timing, tolerance, access to treatment?
6
Renewal criteria
Must be ALL of 1-7
1
Patient has demonstrated a symptomatic improvement or no deterioration in the main symptom for
which therap
was initiated; and
2
Patient has demonstrated a clinically objective improvement or no deterioration in haemoglobin levels,
platelet counts and liver and spleen size; and
3
Radiological (MRI) signs of bone activity performed at two years since initiation of treatment, and
three yearly thereafter, demonstrate no deterioration shown by the MRI, compared with MRI taken
immediately prior to commencement of therapy or ad
justed dose; and
4
Patient has not had severe infusion-related adverse reactions
which
were n
o
t pre
ventable by
approp
riate p
r
e-medication and/or ad
justment of infusion rates; and
5
Patient has not developed another medical condition that might reasonably be expected to
compromise a response to ERT; and
6
Patient is compliant with regular treatment and taliglucerase alfa is to be administered at a dose no
greater than 30 unit/kg every other week rounded to the nearest whole vial (200 units), unless
otherwise agreed by PHARMAC; and
7
Supporting clinical information including test reports, MRI whole body STIR, haematological
data, and other relevant investigations are submitted to the Gaucher Panel for assessment as
required.
Have you included the following? Please indicate attachments.
test reports
MRI whole body STIR
haematological data
other relevant investigations. Specify:
Applicant’s Declaration
I confirm that the above and attached details are correct and that in signing this form I understand that I
may be audited. I recognise the requirements for monitoring and managing treatment with taliglucerase
alfa.
Complete reports are attached, including test reports, MRI whole body STIR, haematological data and
other relevant investigations.
Signature:
______________________
Date:
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Completed 7 February 2021

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