This is the text extract for SA0473 - Imiglucerase (Cerezyme) therapy - initial application, browse documents here.

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Initial application form for imiglucerase (Cerezyme) therapy

Send completed applications to: Gaucher Panel Co-ordinator PHARMAC P O Box 10-254 WELLINGTON Fax: (04) 460 4995 Phone: (04) 460 4990 Email: gaucherpanel@pharmac.govt.nz

Date of Application:

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Patient Name: NHI number: Date of Birth: Gender:

_________________________________________

_______/_______/_______ Male:

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Female:

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Patient Address:

_________________________________________ (Street no. & name) _________________________________________ (Suburb/City) _________________________________________ (telephone no.)

Prescribing physician /paediatrician:_______________________________ NZMC registration no: _________________________________________ Address: _________________________________________ (Street no. & name) _________________________________________ (Suburb/City) _________________________________________ (Telephone, fax) _________________________________________ (e-mail)

General Practitioner Address:

_________________________________________ (Name) _________________________________________ (Street no. & name) _________________________________________ (Suburb/City) _________________________________________ (Telephone, fax) _________________________________________ (e-mail)

A186860 - qA4277

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Patient History

Current Symptoms (including hospitalisations due to Gaucher disease): _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Past history (including previous hospitalisations due to Gaucher disease): _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Current work / school history (including number of sickness days in past 12 months): _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Other medical conditions: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

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Major symptoms

Please tick those that apply and attach all relevant test reports Haematological complications Haemoglobin <95 g/L, after other causes of anaemia, such as iron deficiency have been treated or ruled out, or sever symptoms from anaemia at a higher level of heamoglobin Thrombocytopenia < 50 x 109 /l on two separate occasions at least one month apart Bleeding complications associated with thrombocytopaenia, irrespective of the platelet count. At least two episodes of severely symptomatic splenic infarcts confirmed by CT or other imaging of the abdomen. Massive symptomatic splenomegaly. Skeletal complications One acute bone crisis severe enough to require hospitalisation and or major pain management strategies. Radiographical MRI evidence of incipient destruction of any major joint, such as the hips or shoulder. Spontaneous fractures or vertebral collapse with evidence from imaging studies that recurrence is likely. Chronic bone pain not controlled by the administration of non-narcotic analgesics or antiinflammatory drugs, or requiring continuous medication or causing a significant loss of time from work or school. Hepatic complications Evidence of significant liver dysfunction, such as incipient portal hypertension, attributable to Gaucher disease (treatment should start before this stage is reached). Significant hepatomegaly e.g., 5 cms below the right costal margin or significant abnormality of the liver function tests. Pulmonary complications Reduced vital capacity from clinically significant or progressive pulmonary disease due to Gaucher disease. Systemic complications Growth failure in children: significant decrease in percentile linear growth over a 6-12 month period.

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Physical examination

__________________________ __________________________ __________________________ (if child, please attach height chart)

Date of examination: Weight (kg): Height (cm):

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Bloods

Hb Platelets AST ALP INR APPT Acid Phos. Chito. / hr Chito. / min

Date

Comments:____________________________________________________________________ ____________________________________________________________________________

Viscera size / volume

Date Clinical: cm below costal margin Spleen Liver Radiology: volume (specify type of imaging used) Spleen Liver

Comments:____________________________________________________________________ ____________________________________________________________________________

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Heart & Lungs

Consider if symptoms Date Pulse rate / min Blood pressure (mm/Hg) Echo (RV Pressure) Lung function DLCO. Radiology

Comments:____________________________________________________________________ ____________________________________________________________________________

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Bones

Please send imaging, including reports, of hips, femur, lumbo-sacral spine and other bones clinically affected, on CD. Date Plain X-ray MRI DEXA Symptoms

Comments:____________________________________________________________________ ____________________________________________________________________________

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Neurological

Comments:____________________________________________________________________ _____________________________________________________________________________ ____________________________________________________________________________

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Current medications

Imiglucerase Bisphosphonates Pain relief Other

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Other comments (including main reason for initiating imiglucerase therapy)

_____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

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10. Checklist

Complete reports are attached Informed consent has been obtained from the patient (patient’s guardian) The patient / guardian has agreed to data being collected on the results of treatment.

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I acknowledge that this application, if approved will be valid for 12 months only and that I will have to reapply for ongoing therapy for this patient.

The patient acknowledges that if there is not sufficient response to therapy that subsidy for ongoing therapy may not be forthcoming.

Signed: ____________________________

Date _____ / _____ / _____

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