EFFICIENT FUNDING OF CHEMOTHERAPY – SECTION 100 ARRANGEMENTS

Explanatory Notes

In addition to the drugs and medicinal preparations listed in the Schedule of Pharmaceutical Benefits, a number of drugs are also available as pharmaceutical benefits but are distributed under alternative arrangements. These alternative arrangements are provided for under section 100 of the National Health Act 1953.

Section 100 cancer chemotherapy drugs

New prescribing and dispensing arrangements for certain chemotherapy drugs subsidised by the Pharmaceutical Benefits Scheme (PBS) came into effect on 1 December 2011 under the Revised Arrangements for the Efficient Funding of Chemotherapy Drugs initiative (Revised Arrangements).

Chemotherapy drugs used for the treatment of cancer and administered through infusion or injection are covered by these Revised Arrangements. The Revised Arrangements operate under a section 100 program which includes certain intravenous chemotherapy drugs, as listed in this Schedule, which were previously supplied through:

• the General Pharmaceutical Benefits Schedule (section 2)
• the Special Authority Program (trastuzumab - Herceptin^®), and
• the Chemotherapy Pharmaceutical Access Program (CPAP).

This Schedule is split into two parts:

1) Chemotherapy items for private hospital/private clinic use

This includes items subject to the revised arrangements, ie. chemotherapy drugs administered through infusion or injection

2a) Chemotherapy items for public hospital use

This includes items subject to the revised arrangements, ie. chemotherapy drugs administered through infusion or injection

2b) Related pharmaceutical benefits (not subject to the revised arrangements) for public hospital use

This includes items such as antiemetics, antinauseants, immunostimulants and detoxifying agents for antineoplastic treatment

Where public hospital prescribers write prescriptions for chemotherapy infusibles, that are to be dispensed outside public hospitals, they will need to prescribe from the list of chemotherapy items for private hospital/private clinic use. In these circumstances any related pharmaceutical benefits will need to be prescribed using the General Schedule listings of these drugs. Any associated authority approvals would also need to be obtained.

Prescribing and Supplying - Information for PBS Prescribers and Pharmacists

NOTE: The following information relates only to chemotherapy items subject to the revised arrangements. The related pharmaceutical benefits listed in this Schedule primarily follow the same rules as those listed in the General Pharmaceutical Benefits Schedule.

Chemotherapy drugs are listed based on the relevant unit of measure. Prescribers of these drugs must write dose specific prescriptions, which specify the amount of active ingredient/s required for a single infusion or injection using milligrams or other relevant units of measure.

• Prescribing will exclude reference to forms and strengths
• Loading and maintenance doses will need to be prescribed separately
• Prescriptions will no longer take the form of an order for a certain number of items, but will instead order an amount of a drug or drugs at the generic (drug) level for a specific infusion/injection
• Prescribers retain the right to prescribe by brand.

This Schedule has been updated to include:

• one item code per drug (in most circumstances) under which brands, forms and strengths are listed
• maximum amount (which replaces maximum quantity) refers to the upper limit in milligrams or other relevant unit of measure

Dispensing software has been upgraded to include an algorithm which will calculate the most cost-efficient combination of vial sizes that make up the required patient dose (one prescription) and calculate the level of remuneration paid.

The algorithm does not determine how the infusion is prepared, however remuneration will be made based on the most cost-efficient combination of vial sizes. Pharmacists will still be able to dispense any subsidised brand or combination of brands.

A dose variation will be allowed by up to 10 percent from the original amount prescribed on the recommendation of the prescriber without requirement for a new prescription.

Same day prescribing will be allowed. Regulations 24 (immediate supply necessary) and 25 (hardship provisions) will not apply for items under this initiative.

To recognise the specialist nature of dispensing chemotherapy drugs the Government has determined new remuneration arrangements. The fee structure for community pharmacies, public hospitals and private hospitals is provided below. 

Authorisation requirements

Authorisation requirements have not been varied by the Revised Arrangements.  Items that require an Authority continue to require an Authority from Medicare.

Prior approval is not needed for Authority Required (STREAMLINED) items (except where increased quantities and/or repeats are required). Instead the authority prescription form must include a four digit streamlined authority code. Under the Revised Arrangements more items are available as Authority Required (STREAMLINED).

Brand equivalence

An 'a' located immediately before brand names of a particular strength of an item indicates that the sponsors of these brands have submitted evidence that they have been demonstrated to be bioequivalent or therapeutically equivalent, or that justification for not needing bioequivalence or therapeutic equivalence data has been provided to and accepted by the Therapeutic Goods Administration. It would thus be expected that these brands may be interchanged without differences in clinical effect.

For other brands of an item, i.e., those not indicated as above, it is unknown whether or not they are equivalent. There may be several reasons for this, such as bioequivalence data not being considered necessary when the products were approved for marketing, or that advice or data have not been forthcoming from sponsors. This does not necessarily suggest a lack of safety or efficacy, but in these circumstances caution should be taken if brands are interchanged.

Remuneration arrangements

Fees payable per item claimed:

Section 90 Community Pharmacy (incl. section 92 approved practitioners)

• Ready Prepared Dispensing Fee ($6.42)
• Preparation fee ($40)
• Distribution fee ($24)
• Diluent fee ($4.75)

Section 94 Approved Public Hospital Authority

• Preparation fee ($40)

Section 94 Approved Private Hospital Authority

• Ready Prepared Dispensing Fee ($6.42)
• Preparation fee ($40)
• Distribution fee ($24) (not payable where the drug is trastuzumab)
• Diluent fee ($4.75)