Criteria for the Funding of a Drug

The following issues must be addressed in considering a submission to fund a drug through the Life Saving Drugs Program, and in formulating a recommendation to the Minister for Health.

A) The drug must be found to meet each of the following criteria:

1. There is a rare but clinically definable disease for which the drug is regarded as a proven therapeutic modality, ie. approved for that indication by the Therapeutic Goods Administration.

2. The disease is identifiable with reasonable diagnostic precision.

3. Epidemiological and other studies provide evidence that the disease causes a significant reduction in age-specific life expectancy for those suffering from the disease.

4. There is evidence to predict that a patient’s lifespan will be substantially extended as a direct consequence of the use of the drug.

5. The drug must be accepted as clinically effective, but rejected for Pharmaceutical Benefits Scheme (PBS) listing because it fails to meet the required cost effectiveness criteria.

6. There is no alternative drug listed on the PBS or available for public hospital in-patients, which can be used as lifesaving treatment for the disease. However, the availability of an alternative drug under the LSDP does not disqualify the proposed drug from consideration for the LSDP.

7. There is no alternative non-drug therapeutic modality (eg. surgery, radiotherapy) which is recognised by medical authorities as a suitable and cost effective treatment for this condition.

8. The cost of the drug, defined as the cost per dose multiplied by the expected number of doses in a one year period for the patient, would constitute an unreasonable financial burden on the patient or his/her guardian.

B) Consideration and advice will also be sought, if applicable, on:

1. The proposed price of the drug compared with the effective price of the drug in comparable overseas markets.

2. The proposed cost of the drug compared with the cost of comparable drugs, if any, that are already funded through the LSDP.

Pricing Issues

1. Only the cost of the drug will be funded through the LSDP. This may include a factor for importation and transportation of the drug by the manufacturer direct to the place of administration to the patient. No other transport, storage, administration, or any other hospital or medical expenses associated with the use of the drug, or management of the disease or condition, will be funded through the LSDP.

Patient Conditions for Initial and Ongoing Subsidy Through the LSDP

A) Following an Australian Government decision to fund a drug, a patient must meet the following conditions to receive subsidised drugs through the LSDP:

1. Satisfy the relevant criteria for treatment with the drug, as detailed in the relevant drug/condition LSDP Guidelines.

2. Participate in the evaluation of effectiveness of the drug by periodic assessment, as directed by the relevant LSDP drug/condition Guidelines, or have an acceptable reason not to participate.

3. Not be suffering from any other medical condition, including complications or sequelae of the primary condition, that might compromise the effectiveness of the drug treatment.

4. Be a permanent Australian resident who qualifies for Medicare.

B) Patient eligibility will be reviewed in accordance with the frequency set out in the relevant drug/condition LSDP Guidelines, but generally 12 months after commencing therapy and every 12 months thereafter.

Continued eligibility will be subject to the assessment of evidence, as outlined in the relevant drug/condition LSDP Guidelines, which demonstrates:

1. clinical improvement in the patient, or

2. stabilisation of the patient’s condition.

The assessment of eligibility will be made with regard to the natural course and stage of the disease, as described in the relevant drug/condition LSDP Guidelines, and any exceptional circumstances that may apply.