This is the text extract for Proposal to alter the access criteria to cholesterol lowering pharmaceuticals, browse documents here.

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15 June 2007 To All Hospital Pharmacists, Pharmaceutical Suppliers, Medical Groups and Interested Parties

Consultation on a proposal to alter the access criteria to cholesterol lowering pharmaceuticals

PHARMAC is seeking feedback on the following proposal to alter the access criteria to the cholesterol lowering pharmaceuticals atorvastatin (Lipitor), ezetimibe (Ezetrol) and ezetimibe with simvastatin (Vytorin). The main elements of this proposal are: Treatment algorithm This proposal would enable patients to access statins and ezetimibe according to the following treatment algorithm: 1. If a patient has dyslipidaemia and an absolute 5 year cardiovascular risk of 15% then simvastatin would be available without restriction (this would be up-titrated to 80 mg as required). 2. If a patient is either intolerant to simvastatin or is not reaching their target LDL cholesterol level on 80 mg of simvastatin, then atorvastatin would be available via Special Authority. 3. If a patient is either intolerant to atorvastatin or is not reaching their target LDL cholesterol level on 80 mg of atorvastatin, then ezetimibe would be available via Special Authority. This is different from the current treatment algorithm as it: · enables ezetimibe to be prescribed in combination with atorvastatin or simvastatin if a patient is intolerant of atorvastatin 80 mg or is not reaching their target LDL cholesterol level on atorvastatin 80 mg. removes the ability to prescribe ezetimibe for patients who cannot tolerate a simvastatin dose of 40 mg per day or greater without trialling atorvastatin; and removes the criteria in the ezetimibe Special Authority for patients with familial hypercholesterolemia who are on maximum dose statin therapy and whose LDL cholesterol is greater than 5 mmol/litre (these patients would still qualify for ezetimibe under the proposed criteria);

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A129459 - T07-069

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Other alterations In addition we proposed that: · · · the Specialist restriction for ezetimibe and ezetimibe with simvastatin is removed; Special Authority approvals for ezetimibe and ezetimibe with simvastatin would be interchangeable; and Special Authority restrictions for atorvastatin, ezetimibe and ezetimibe with simvastatin would include a provision for subsidy for patients whose LDL cholesterol are not able to be calculated due to high triglyceride levels.

Please find attached a flow diagram of the proposed treatment algorithm, and the proposed Special Authority forms. It is anticipated that the proposed changes, if approved by PHARMAC’s Board, would take effect from 1 September 2007. If you wish to make comments for the PHARMAC Board to consider when making its decision on whether to accept this proposal, please forward them to Stephen Woodruffe at PHARMAC by 5:00 pm, 11th July 2007. Yours sincerely

Stephen Woodruffe Therapeutic Group Manager

A129459 - T07-069

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Proposed criteria for patient access to HMG CoA Reductase Inhibitors (Statins) and Selective Cholesterol Absorption Inhibitors (Ezetimibe) in the Pharmaceutical Schedule Patient has dyslipidaemia and an absolute 5 year cardiovascular disease risk of 15% or greater

Initiate simvastatin and titrate up to simvastatin 80 mg as required

Patient is intolerant to simvastatin

Patient is not reaching target LDL cholesterol level on simvastatin 80 mg

Initiate atorvastatin and titrate up to atorvastatin 80 mg as required (Special Authority required)

Patient is intolerant to atorvastatin

Patient is not reaching target LDL cholesterol level on atorvastatin 80 mg

Initiate ezetimibe and/or simvastatin (Special Authority required)

Note: • Atorvastatin, ezetimibe, and ezetimibe with simvastatin all require a Special Authority • All of the Special Authorities can be prescribed by a relevant practitioner • For a patient with a venous CABG the LDL cholesterol target is ≥ 2 mmol/litre (two tests are required) • For a patient without a venous CABG the LDL cholesterol target is ≥ 2.5 mmol/litre (two tests are required) • To confirm that cholesterol levels are not still improving, two lipid tests must be carried out and the LDL cholesterol results must not have reduced by 10% or more in the second test • The two lipid tests are required to be at least 1 week apart and in a fasted state except for patients with IDDM • If the triglyceride level is too high to enable a LDL cholesterol value to be determined, then it can be considered that the LDL value for that test would be greater than required • 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 • The following are indications of intolerance to statins: • 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)

Initiate ezetimibe in combination with atorvastatin or in combination with simvastatin (Special Authority required)

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

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 1

Form SA####

DRAFT

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

Atorvastatin

INITIAL APPLICATION - Intolerant to simvastatin Applications from any relevant practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

Patient has a calculated absolute risk of cardiovascular disease >15% over 5 years Patient has severe documented intolerance to simvastatin therapy (blood tests are not required) The patient has venous CABG and has had two LDL cholesterol tests ≥ 2 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM) The patient does not have venous CABG and has had two LDL cholesterol tests ≥ 2.5 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM)

Note: 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. The following are indications of intolerance to simvastatin, 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) If the triglyceride level is too high to enable a LDL cholesterol value to be determined, then it can be considered that the LDL cholesterol value for that test would be greater than required.

INITIAL APPLICATION - LDL treatment targets have not been attained on maximal dose of atorvastatin Applications from any relevant practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

Patient has a calculated absolute risk of cardiovascular disease >15% over 5 years Patient is being treated with 80 mg of simvastatin per day The patient has venous CABG and has had two LDL cholesterol tests ≥ 2 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM) The patient does not have venous CABG and has had two LDL cholesterol tests ≥ 2.5 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM)

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). If the triglyceride level is too high to enable a LDL cholesterol value to be determined, then it can be considered that the LDL cholesterol value for that test would be greater than required.

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

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

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

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 1

Form SA####

DRAFT

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

Ezetimibe or Ezetimibe with Simvastatin

INITIAL APPLICATION - Intolerant to atorvastatin Applications from any relevant practitioner. Approvals valid for 2 years. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

Patient has a calculated absolute risk of cardiovascular disease >15% over 5 years Patient has severe documented intolerance to atorvastatin therapy (blood tests are not required) The patient has venous CABG and has had two LDL cholesterol tests ≥ 2 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM) The patient does not have venous CABG and has had two LDL cholesterol tests ≥ 2.5 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM)

Note: 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. The following are indications of intolerance to 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) If the triglyceride level is too high to enable a LDL cholesterol value to be determined, then it can be considered that the LDL cholesterol value for that test would be greater than required.

INITIAL APPLICATION - LDL treatment targets have not been attained on maximal dose of atorvastatin Applications from any relevant practitioner. Approvals valid for 2 years. Prerequisites (tick boxes where appropriate)

and and

u u u u

or

Patient has a calculated absolute risk of cardiovascular disease >15% over 5 years Patient is being treated with 80 mg of atorvastatin per day The patient has venous CABG and has had two LDL cholesterol tests ≥ 2 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM) The patient does not have venous CABG and has had two LDL cholesterol tests ≥ 2.5 mmol/litre (the tests are at least 1 week apart in a fasted state other than for patients with IDDM)

Note: To confirm that cholesterol levels are not still improving, two lipid tests must be carried out during treatment with atorvastatin 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). If the triglyceride level is too high to enable a LDL cholesterol value to be determined, then it can be considered that the LDL cholesterol value for that test would be greater than required.

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

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131

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

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

PATIENT NHI: ...................................................... REFERRER

Page 2

Form SA####

DRAFT

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

Ezetimibe or Ezetimibe with Simvastatin - continued

RENEWAL Current approval Number:............................................................... Applications from any relevant practitioner. Approvals valid for 2 years. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

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

Post application to Health Payments, Agreements and Compliance (HealthPAC), Private Bag 3015, Wanganui - Fax: 0800 100 131