Asia PR News

SYDNEY, March 30 /Medianet International-AsiaNet/ –

Changes to Special Authority criteria extend the patient group eligible
for subsidy and reduce wait for treatment

(Auckland, New Zealand)- Eli Lilly New Zealand announced today that it had
reached an agreement with Pharmaceutical Management Agency of New Zealand
(PHARMAC) regarding changes to the special authority criteria for the diabetes
medicine, Actos.

A key improvement is that general practitioners can now write the initial
prescription for Actos, under Special Authority. Previously only specialists
(of which there are limited numbers) were able to initiate a patient on ACTOS,
leading to long waits for many people to secure funding approval for the
medicine.

"This is a key change that will significantly improve patients’ ability to
be quickly assessed and, if appropriate, approved for funded Actos treatment by
a GP" said Wei Li Shao, General Manager of Eli Lilly New Zealand.

Shao said the company was pleased to work closely with PHARMAC to deliver
the funding changes. "Lilly has a proud heritage in innovation in diabetes care
and these amendments allow much broader access to an important diabetes
treatment."

Access to Actos for patients taking a combination of diabetes medications
is also expanded under the changes. Where previously an HbA1c value (which
reflects the average blood glucose level over several months) of 8 per cent or
more was required to qualify for funding, this has been reduced to 7.5 per cent.

In addition to allowing GPs to initiate treatment, the rules around
renewing treatment have been relaxed. Now, if the treating GP feels a patient
is benefiting from ACTOS, he or she can choose to continue to prescribe this
treatment without the need for tests showing HbA1c values greater than 8 per
cent.

Actos is a tablet, taken once daily, that lowers blood glucose levels.
Actos works by decreasing insulin resistance, an important underlying defect in
type 2 diabetes. Treatment with Actos results in lower blood glucose
concentrations, lower insulin levels and lower HbA1c values.

About Actos (pioglitazone):
Pioglitazone is indicated for the treatment of type 2 diabetes mellitus
inadequately controlled by diet. Pioglitazone is effective as a single agent
and may also be used in combination with sulfonylureas, metformin or insulin
when diet plus the single agent does not result in adequate glycaemic control.
It is contraindicated in patients with known hypersensitivity or allergy to
Pioglitazone or any of its excipients. Approved Product Information is
available on request.

Pioglitazone received its first regulatory approval in July 1999 in the
United States. Pioglitazone was approved by Medsafe in June 2002.
Pioglitazone is reimbursed for use in dual combination with metformin or a
sulfonylurea, when either metformin or sulfonylurea cannot be used due to a
contraindication or intolerance. It is also reimbursed for use in combination
with insulin.

Precautions: Not for treatment of patients with type 1 diabetes, diabetic
ketoacidosis, NYHA Class III or IV cardiac status or clinical evidence of
active liver disease or increased transaminase levels (ALT > 2.5 times the
upper limit of normal). A reduction in the dose of concomitant insulin or oral
hypoglycaemic agents may be necessary to prevent hypoglycaemia, dose reduction
may be required when co-administered with CYP2C8 inhibitors, an increased dose
may be required when co-administered with CYC2C8 inducers. May result in
resumption of ovulation and risk of pregnancy; use with caution in patients
with oedema; can cause fluid retention when used alone or in combination with
other anti-diabetic agents and may lead to or exacerbate heart failure; dose
related weight gain may occur.

Adverse Reactions: Very common (>10%): Oedema, hypoglycaemia in combination
with anti-diabetic agents. Common (>1% and <10%): Cardiac failure, upper
respiratory tract infection, headache, sinusitis, myalgia, back pain, urinary
tract infection, pharyngitis, tooth disorder, fatigue, accidental injury, leg
cramps, abnormal vision. Rare (<0.1%): macular oedema.

SOURCE: Eli Lilly

Media contact:
Barbara Critchlow
Eli Lilly New Zealand
+649-523-9308
critchlow_barbara@lilly.com