Arthritis Foundation of Australia.htm/Enbrel in Australia

[Guest guest]

Arthritis Foundation of AustraliaI have been following with great interest the

experiences of members of the group in the US on the drug Enbrel. In the web

site of the Arthritis Foundation of Australia, I found this Q and A page on

Enbrel and its status in Australia which may be of interest to fellow PAs in

Australia and possibly for PAs elsewhere. I intend to ask my rheumatologist

about it at my next visit. The Pharmaceutical Benefit Scheme referred to is

where approved prescription drugs are provided at a fixed subsidized price,

funded from taxation revenue. Currently this is $AUD 21.50 or $AUD 3.50 for

pensioners (as I am).

Regards, Gordon

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Enbrel (otherwise known as Etanercept)

Q: What is Enbrel (Etanercept)?

A: Enbrel is an exciting biotechnology that brings a completely new

approach to treating advanced rheumatoid arthritis.

Q: When should Enbrel be used?

A: Enbrel is intended for use by people who have advanced rheumatoid

arthritis and who are not responding to the currently available therapies.

Q: Who should use Enbrel?

A: People who have been under the care of a rheumatologist and who

are not responding, or who have failed all other treatments including

methotrexate, may benefit from Enbrel.

Q: How does it work?

A: Enbrel works by specifically attaching to and switching off some

of the body's naturally-produced proteins that cause the inflammation within the

joints. In doing so it helps reduce the signs and symptoms of the illness.

Q: What causes this inflammation in Rheumatoid Arthritis?

A: The causes of RA remain unknown. However over recent years,

scientists have learned a lot about the way the inflammation occurs in the

joints. One of the key proteins in this process is called Tumor Necrosis Factor

or TNF. It is this protein towards which Enbrel is targeted.

Q: What are the most common side effects of Enbrel?

A: Based on wide experience in clinical trials and more recently the

use in patients in over 36 countries around the world, the most commonly

experienced side effects are: · A rash that may occur at the site of the

injection. This rash is usually short lived and goes away fairly quickly. ·

Other side effects are rare but may include feeling tired, pain or a dry mouth.

Q:Are there circumstances where Enbrel should not be used?

A: There are some medical conditions, which might occur incidentally

in someone with arthritis, that would constitute a contra-indication to its use.

These conditions include certain chronic diseases, infections and severe heart

failure.

Q:Is Enbrel available in Australia?

A: The Australian Government health authorities have approved Enbrel

as safe and effective, so it can now be prescribed by your rheumatologist.

Q: Is it on the Pharmaceutical Benefit Scheme?

A: Not at the moment. Due to the complexity of producing the drug,

it is more expensive that many of the other drugs on the PBS that are used for

rheumatoid arthritis. This has resulted in some concerns expressed by the

Pharmaceutical Benefits Advisory Committee about how much the taxpayer will pay

if it were to be put on the PBS.

Q: So, will it be on the PBS?

A: The Arthritis Foundation is hopeful that it will be given

approval for prescription under the PBS section 100. But this is likely to be

only for people who have tried all other forms of treatment for their rheumatoid

arthritis and have still not brought it under control.

Q: Why did the PBAC not put Enbrel on the PBS recently?

A: The PBAC were concerned that the due to the effectiveness of the

drug it would be very widely used. Given the cost of the treatment, the PBAC was

concerned that it would blow out to the PBS budget.

Q: Does this mean there are doubts about the effectiveness of

Enbrel?

A: This is a question best directed to the PBAC. However, our

understanding is that the PBAC accepted the excellent results achieved by Enbrel

in the treatment of severe rheumatoid arthritis. Our understanding is that the

rejection of subsidy was purely on the basis of the total cost and the PBACs

assessment of its cost-effectiveness.

Q: Will Enbrel be used widely?

A: Current estimates suggest that there are approximately 4,000

Australians who currently qualify for treatment and who would gain benefit from

access to the treatment. Thereafter, approximately 1,300 new patients each year

would be in line for the treatment.

Q: Will Enbrel work in everyone?

A: Clinical trials suggest that the majority of people who have

advanced and uncontrolled disease will get some benefit from Enbrel. However,

for reasons as yet unknown, a small percentage of people do not respond to

treatment with Enbrel.

Q: How much does Enbrel cost?

A: Because it is not PBS listed, the cost of treating a patient with

Enbrel is approximately $AUD18,000. This compares with $AUD60,000 for Herceptin

a drug recently PBS listed for treatment of Breast Cancer and $AUD43,000 for

Glivec, also recently listed for treatment of leukaemia. Enbrel is one of an

evolving class of treatments that are based on the exciting new science of

biotechnology. It is a protein that very specifically targets the inflammation

that causes arthritis yet does not affect other parts of the body. It is

therefore more effective and has far fewer side effects than the treatments

traditionally used for RA.

Q: Why doesn't the manufacturer reduce its price so it can go onto

the PBS?

A: That is a question best answered by the manufacturer. Our

understanding is that due to the very high costs of development and

manufacturing, along with the adverse exchange rate, the cost of bringing Enbrel

to Australia is very high.

Q: Who can I talk to about getting Enbrel on the PBS?

A: You can write to your local Member of Parliament or to the

various candidates in your electorate. In addition you can write to your local

Arthritis Foundation.

Q: What can be done by doctors to make sure the drug is only used in

the right people with RA?

A: The Australian Rheumatology Association and the Arthritis

Foundation of Australia are proposing to develop an evaluation and registry

process designed to ensure that only the people with arthritis who most need the

drug are given access to it. This will involve collecting information about how

ill the person is with RA, as well as what treatments have been used to that

point. This information is then coded so that only the person's doctor knows who

that person is. The information will then be matched to see if it meets all the

Government's criteria. If it does, the patient is given an authority to use

Enbrel and thus get reimbursement from the PBS. It is proposed that there be a

follow up assessment to ensure that Enbrel is only continued when there has been

benefit.

Q: Is Enbrel reimbursed in other countries?

A: Yes. Enbrel is available in over 36 countries around the world.

It is now recognised, as the best treatment for severe arthritis in the USA, UK

and many European countries such as Italy and Scandinavia. In many of these

companies it is reimbursed for specific groups of people.

Q: What can be done now?

A: You and your medical professionals can help raise the profile of

this issues by writing to candidates in the upcoming election, the Federal

Department of Health And Aged Care in Canberra, the Minister for Health And Aged

Care, and also if you have private insurance, to the manager of your health

fund.

Q: Will Enbrel cost $2.2billion as has been suggested in the papers?

A: No. That figure is based on the incorrect assumption that

everyone with arthritis will be treated with Enbrel. Apart from the fact that

there is not enough Enbrel to treat everyone, it is not how Enbrel is best used.

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