This is the text extract for SA0788 – Atorvastatin, browse documents here.

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Ministry of Health Phone 0800 243 666

APPLICATION FOR MANUFACTURERS PRICE BY SPECIAL AUTHORITY

Page 1

Form SA0788

August 2010

APPLICANT (stamp or sticker acceptable)

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

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

Atorvastatin

INITIAL APPLICATION Applications only from a relevant specialist, or general practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick boxes, and write the data requested in the space provided where appropriate)

and

u u u

or and

Patient has a calculated absolute risk of cardiovascular disease of at least 15% over 5 years

Patient has severe documented intolerance to simvastatin (blood tests are not required)

Patient has been compliant with a dose of simvastatin of 80 mg per day for at least 2 months

and and

u

Patient has venous CABG

LDL cholesterol test 1: ......................................≥ 2 mmol/litre LDL cholesterol test 2: ......................................≥ 2 mmol/litre (at least 1 week after test 1) or

and and

u

Patient does not have venous CABG

LDL cholesterol test 1: ......................................≥ 2.5 mmol/litre LDL cholesterol test 2: ......................................≥ 2.5 mmol/litre (at least 1 week after test 1)

Note: To confirm that cholesterol levels are not still improving, two lipid tests must be carried out during treatment with simvastatin 80 mg, and have results for LDL cholesterol that have reduced by <10% in the second test. The tests must be carried out while the patient is in a fasted state (with the exception of patients with IDDM). The following indications of intolerance to simvastatin, are known as class effects for all statins, and hence are likely to mean that the patient may also be intolerant of atorvastatin: • Constipation, flatulence (may occur in >1% of patients) • Asthenia, abdominal pain, headache (may occur in >1% of patients) • Myopathy, rhabdomyolysis (may occur in <3% of patients) • Elevated serum transaminase levels (may occur in <1% of patients) Statins have been shown to be generally well tolerated in clinical studies, with the rate of discontinuation due to adverse reactions being less than 5%, and similar to the discontinuation rate for patients taking a placebo.

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