Natalizumab (Tysabri®)
Highly Specialised Drugs Program Declaration Form*
| Patient's Name: | ____________________________________ |
| Medical Record Number: | ____________________________________ |
| Medicare Number: | ____________________________________ |
I certify that the above patient meets the Pharmaceutical Benefits Advisory Committee's criteria for funding under Section 100 of the National Health Act, 1953.
Criteria
CAUTION:
Progressive Multifocal leukoencephalopathy (PML) has been reported with this drug
- Initial treatment (maximum 6 infusions), as monotherapy, by neurologists, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older, who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years.
The diagnosis must be confirmed by magnetic resonance imaging of the brain and/or spinal cord unless determined by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
- Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously treated with this drug who does not show continuing progression of disability (confirmed after every 3 infusions) while on treatment with this drug, and who has demonstrated compliance with, and an ability to tolerate, this therapy.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
*To be completed by the specialist or authorised prescriber initiating drug treatment, and retained by the hospital Pharmacy Department.
July 2008