Government of Ontario: Ministry of Health and Long-Term Care

Ontario Public Drug Programs (OPDP)
Drug Programs Delivery Branch
5700 Yonge St., 3^rd floor
Toronto ON M2M 4K5

Request for Myozyme®

Please fax completed form and/or any additional relevant information to 416 327–7526 or toll-free 1 866 811–9908; or send to the Exceptional Access Program (EAP), 5700 Yonge Street, 3rd floor, Toronto ON M2M 4K5.
For copies of this and other EAP forms, please visit http://www.health.gov.on.ca/en/pro/programs/drugs/eap_mn.aspx

The Executive Officer (EO) of Ontario Public Drug Programs considers requests for coverage of drug products not listed in the Ontario Drug Benefit Formulary under the Exceptional Access Program (EAP). This form is intended to facilitate requests for drugs considered under the EAP. The EO may request additional documentation to support the request. Please ensure that all appropriate information for each section is provided to avoid delays.

Section 1 – Prescriber Information

First name
Initial
Last name

Type of Prescriber
Physician
Nurse practitioner
Other (specify)

Mailing address Street no.
Street name
City
Postal code

Treatment Centre

Fax no.

Telephone no.

Section 2 – Patient Information

First name
Initial
Last name

Ontario Health Insurance Number

Enter the first four digits - Enter the next three digits - Enter the next three digits

Gender

Male Female

Body Weight (kg)
Date of Birth (yyyy/mm/dd)

New request Renewal of existing EAP Approval (specify EAP #)

Section 3 – Drug, Dosage and Regimen

Myozyme® (alglucosidase-alfa) 50 mg/ml
Regimen and Dosage

Section 4 – Clinical Information – New Request

Confirmed Diagnosis of Pompe Disease
Age at Diagnosis:
Please provide enzymology testing report AND/OR mutation analysis report

Infantile / Early Onset Pompe Disease:
(require all 3 clinical features below to be eligible for reimbursement):

Onset of generalized weakness before 12 months of age
Feeding difficulties resulting in failure to thrive
Presence of significant cardiomyopathy
Ventilator Status:

Adult / Late Onset Pompe Disease:

Provide myometric confirmation or Medical Research Council (MRC) confirmation for proximal and distal muscle;
AND/OR
Provide Spirometry Report and details of respiratory function:

Provide details on current functional status

Ambulatory
Ambulatory with assistance
Wheelchair outside the home
Wheelchair inside the home
Bedbound
Ventilator Status (include status of c-pap or bi-pap use):

Adult / Late Onset Pompe Disease Provide Eastern Cooperative Oncology Group (ECOG) Performance Status:

Section 5 – Clinical Information –Renewal Request

Infantile / Early Onset Pompe Disease:

Ventilator Status: (if patient on ventilator, please confirm if patient has been deteriorating after initiation of ventilatory support)

Provide Chest Radiograph, ECG, and Echocardiogram Reports (to determine cardiac function)

Adult / Late Onset Pompe Disease:

Provide Spirometry Report and details of respiratory function

Ventilator Status (include status of c-pap or bi-pap use):

Provide details on current functional status

Ambulatory
Ambulatory with assistance
Wheelchair outside the home
Wheelchair inside the home
Bedbound
Provide Eastern Cooperative Oncology Group (ECOG) Performance Status:

Section 6 – Current Medication Use and Co-Morbid Conditions

List of current medication use and document serious co-morbid conditions, if any

The information on this form is collected under the authority of the Personal Health Information Protection Act, 2004, S.O. 2004, c.3, Sched. A (PHIPA) and Section 13 of the Ontario Drug Benefit Act, R.S.O. 1990c.O.10 and will be used in accordance with PHIPA, as set out in the Ministry of Health and Long-Term Care “Statement of Information Practices”, which may be accessed at www.health.gov.on.ca. If you have any questions about the collection or use of this information, call the Ontario Drug Programs Help Desk at 1 800 668–6641 or contact the Director, Drug Programs Delivery Branch, 5700 Yonge St., 3^rd Floor, Toronto ON M2M 4K5.

Authorized prescriber (print name)
Authorized prescriber signature (mandatory)

Registration number
Date (yyyy/mm/dd)