This is the text extract for SA0797 – Alendronate Tab 70 mg - with or without Cholecalciferol, browse documents here.

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Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

Page 1

Form SA0797

February 2009

PATIENT NHI: ...................................................... REFERRER Reg No: ............................................

Reg No: ................................................................ First Names: ......................................................... First Names: ......................................................... Name: ................................................................... Surname: .............................................................. Surname: .............................................................. Address: ............................................................... DOB: ..................................................................... Address: ............................................................... ............................................................................... Address: ............................................................... ............................................................................... ............................................................................... ............................................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: .........................................................

Alendronate Tab 70 mg - with or without Cholecalciferol

INITIAL APPLICATION - Underlying cause -- Osteoporosis Applications only from a relevant specialist or vocationally registered general practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick boxes where appropriate)

or

u u u u

History of one significant osteoporotic fracture demonstrated radiologically and documented bone mass density (BMD) ≥ 2.5 standard deviations below the mean normal value in young adults (i.e. T-Score ≤ -2.5) History of one significant osteoporotic fracture demonstrated radiologically, and either the patient is elderly, or densitometry scanning cannot be performed because of major logistical, technical or pathophysiological reasons. It is unlikely that this provision would apply to many patients under 75 years of age History of two significant osteoporotic fractures demonstrated radiologically Documented T-Score ≤ -3.0

or or

INITIAL APPLICATION - Underlying cause -- glucocorticosteroid therapy Applications only from a relevant specialist or vocationally registered general practitioner. Approvals valid for 1 year. Prerequisites (tick boxes where appropriate)

u

and

The patient is receiving systemic glucocorticosteriod therapy (≥5 mg per day prednisone equivalents) and has already received or is expected to receive therapy for at least three months and has either documented BMD ≥ 1.5 standard deviations below the mean normal value in young adults (i.e. T-Score ≤ -1.5) history of one significant osteoporotic fracture demonstrated radiologically

or

u u

RENEWAL Current approval Number (if known):............................................................... Applications only from a relevant specialist or vocationally registered general practitioner. Approvals valid for 1 year. Prerequisites (tick box where appropriate)

u

The patient is continuing systemic glucocorticosteriod therapy (≥5 mg per day prednisone equivalents)

Note: 1. Evidence used by National institute for Clinical Excellence (NICE) guidance indicates that patients aged 75 years and over who have a history of significant osteoporotic fracture demonstrated radiologically are very likely to have a T-Score ≤ -2.5, and therefore do not require BMD measurement for treatment with bisphosphonates. 2. Osteoporotic fractures are the incident events for severe (established) osteoporosis, and can be defined using the WHO definitions of osteoporosis and fragility fracture. The WHO defines severe (established) osteoporosis as a T-score below -2.5 with one or more associated fragility fractures. Fragility fractures are fractures that occur as a result of mechanical forces that would not ordinarily cause fracture (minimal trauma). The WHO has quantified this as forces equivalent to a fall from a standing height or less. 3. In line with the Australian guidelines for funding alendronate, a vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Ministry of Health, Private Bag 3015, Wanganui – Fax: 0800 100 131