Revised Arrangements for the Efficient Funding of Chemotherapy Drugs & Streamlined Authority Data Capture

Page last updated: 11 July 2018

What are the Revised Arrangements for the Efficient Funding of Chemotherapy Drugs (the ‘Revised Arrangements’)?

What are the Revised Arrangements?

The Revised Arrangements for the Efficient Funding of Chemotherapy Drugs (the Revised Arrangements) commenced on 1 December 2011. The arrangements will achieve greater efficiency in the use of injectable and infusible chemotherapy medicines used in the treatment of cancer.

Prescribing and dispensing arrangements for oral chemotherapy medicines remain unchanged.

The changes:

  • require prescribers to write dose specific prescriptions using milligrams (in most situations) without specific reference to forms and strengths; and
  • pay approved suppliers/pharmacies for the combination of vials that most cost efficiently makes up the required patient dose. 

Patients will pay only one PBS co-payment ($6.40 concessional or $39.50 general - as of 1 January 2018) for each original prescription dispensed but not for repeat prescriptions (i.e. a patient will pay either $6.40 or $39.50 for the first injection/infusion on the script).

When did the Revised Arrangements commence?

The Revised Arrangements came into effect for private hospitals and community pharmacies on 1 December 2011 and for public hospital pharmacies by 1 April 2012.

How have the Revised Arrangements been implemented?

The Revised Arrangements have been implemented by a new ‘special arrangement’ under Section 100 of the National Health Act 1953. 

All relevant forms and strengths of chemotherapy drugs, including trastuzumab for treatment of early stage breast cancer, are subject to the Revised Arrangements. This includes those previously supplied through the section 85 general schedule of the Pharmaceutical Benefit Scheme and the section 100 Chemotherapy Pharmaceutical Access Program (CPAP) special arrangements. 

What is a chemotherapy infusion or injection?

An infusion may be reconstituted using one or more vials of a particular drug, not necessarily of the same form and strength, or more than one drug.  Also included are chemotherapy items administered by injection.

Why did the Government introduce the Revised Arrangements?

Medicines used in cancer chemotherapy, dispensed by vials, are expensive. Modifying the way these cancer chemotherapy medicines are prescribed will minimise wastage and reduce costs to patients and to the Commonwealth. The changes will also provide pharmacies with specific remuneration for preparing these chemotherapy medicines for patients.

Which drugs have changed and how?

Which drugs have changed and how?

The listing of PBS chemotherapy drugs has changed under the Revised Arrangements.  This includes changes to forms, brands, restrictions, maximum amounts and numbers of repeats (some of which would have occurred on a monthly basis as a result of usual PBS updates). These changes are published each month in new Schedules. It is recommended that prescribers refer to the most current Schedule when prescribing under the PBS.

The Schedules for chemotherapy medicines are available on the Publications page of the PBS website.

Which drugs are included in the Revised Arrangements and what are the restrictions?

A list of the chemotherapy infusible and injectable medicines and restrictions are available here.

Which drugs are included in the Revised Arrangements and what are the maximum quantities and/or number of repeats?

A list of the chemotherapy infusible and injectable medicines, and the maximum amounts and numbers of repeats are available here. 

How have the Revised Arrangements changed the way that chemotherapy drugs are listed in the Schedule?

Chemotherapy items are listed in a special Supplement to the Schedule (under Section 100 of the National Health Act 1953). 

The listings now include:

  • one item code per medicine (in most circumstances) with brands, forms and strengths listed underneath
  • the maximum amount, replacing maximum quantity, which refers to the upper limit in milligrams or other relevant unit of measure that can be prescribed, and
  • more items available as Authority Required (STREAMLINED) for participating public and private hospitals.

Figure 2: Sample - New presentation of chemotherapy items

Figure 2: Sample - New presentation of chemotherapy items

Why isn’t azacitidine subject to the revised arrangements?

The Pharmaceutical Benefits Advisory Committee recommended that azacitidine be listed as a Pharmaceutical Benefit and supplied through the Highly Specialised Drugs Program.  As such it is not subject to the Revised Arrangements.

Why isn’t thiotepa subject to the Revised Arrangements?

The manufacturer requested that thiotepa be deleted from the Pharmaceutical Benefit Scheme from 1 December 2011.

How is trastuzumab handled?

Trastuzumab continues to be available through two separate arrangements:

Late stage metastatic cancer

Where trastuzumab is prescribed for the treatment of late stage metastatic breast cancer, it continues to be available through the special Herceptin® Program that is administered by DHS independent of the PBS. In this case, prescribers should continue to use existing arrangements.

Initial or continuing HER2 positive early stage breast cancer

Where trastuzumab is prescribed for initial or continuing HER2 positive early stage breast cancer, through the Pharmaceutical Benefits Scheme, it is available through the Revised Arrangements.  In this case, prescribers should prepare prescriptions for trastuzumab which specify the amount of trastuzumab required in milligrams per infusion.

How is bortezomib handled?

Bortezomib is available through the Revised Arrangements.  In this case, prescribers should prepare prescriptions for bortezomib which specify the amount of bortezomib required in milligrams per infusion.

How are related products handled, such as antinauseants, antiemetics and other chemotherapy drugs (such as interferon)?

Related products such as antinauseants, antiemetics and other chemotherapy drugs (such as interferon)  are listed in the Revised Arrangements schedule, and also remain listed in the general schedule of pharmaceutical benefits.

Related pharmaceutical benefits are not subject to the EFC preparation fee, nor the calculation of reimbursement based on the most cost-efficient vial combination.

Why isn’t drug X available through the EFC, or why is it only available through the EFC? Why are the maximum quantities or maximum repeats as they are?

Drugs listed on the PBS, including for the EFC, must have been recommended to Government by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent, expert advisory body comprising doctors, other health professionals and a consumer representative.

Submissions for PBS listing are usually made by an industry sponsor of a product (for example, a manufacturer) who holds the relevant clinical and other data.  Applications may also be made by other interested parties. Often, the sponsor will indicate in its submission and data the proposed maximum levels for quantities and repeats.

The PBAC considers each submission having regard to the safety, clinical effectiveness and cost-effectiveness (value-for-money) of the medicine for the intended use, in comparison with other available treatments. This includes the cost-effectiveness of the maximum quantities and maximum repeats.

The PBAC would accept a submission for a new drug to be listed through the EFC or general PBS Schedule at any time. The PBAC would also accept a submission for maximum quantities or repeats to be changed. 

Any submission should include applicable data to support the safety, clinical effectiveness and cost-effectiveness (value-for-money) of the medicine for the intended use, in comparison with other available treatments. 

What has changed for patients?

What has changed for patients?

Patients will generally not pay more under the Revised Arrangements – many may pay less. Under the Revised Arrangements patients pay only one PBS co-payment ($6.40 concessional or $39.50 general - as of 1 January 2018) for each original prescription dispensed but not for repeat prescriptions (i.e. a patient will pay either $6.40 or $39.50 for the first injection/infusion on the script).

Prior to 1 December 2011, patients would have paid a PBS co-payment every time a prescription – original or repeat – was dispensed.

Which patients are eligible?

People may access drugs through the Revised Arrangements if they:

  • have a valid Medicare card
  • have a valid Medicare card and Centrelink or Department of Veterans’ Affairs (DVA) concession card (if they have one)
  • have a valid Medicare card and PBS Safety Net entitlement or concession card (if they have one)
  • are eligible under a Reciprocal Health Care Agreement (RHCA)

Medicare special numbers may be used under this measure.

Is the PBS Safety Net affected?

PBS patient co-payments count towards the PBS safety net. Repeat prescription will not appear on the Patient Record Form PRF as no co-payment is payable for repeats.

What has changed for prescribers?

What has changed for prescribers?

Prescribers of chemotherapy medicines must write dose-specific prescriptions. That is, prescriptions must specify the individual patient dose expressed in the appropriate unit of measure (in most cases milligrams), rather than vials. The quantity and number of repeats on the prescription will be clinically appropriate for a single treatment cycle, as set by the Pharmaceutical Benefits Advisory Committee (PBAC). If an increased quantity and/or additional repeats are required an Authority will need to be sought from DHS.

Prescribers are no longer able to write prescriptions ordering particular forms or strengths of a drug, nor may they order enough drug for a course of treatment in a single prescription.

More information on the prescribing changes is available in the relevant supplement to the Schedule of Pharmaceutical Benefits. 

Why are there changes for prescribers?

The revised approach to writing prescriptions will help reduce wastage by limiting the amount of drug prescribed to the amount required for one infusion/injection.

What if I work in a public hospital that hasn’t yet transitioned to the Revised Arrangements?

All public hospital pharmacies are required to implement the Revised Arrangements from 1 April 2012. Even if your public hospital pharmacy does not yet have the necessary software, you must still write prescriptions based on the Revised Arrangements.

The Chemotherapy Pharmaceutical Access Program ceased on 1 April 2012, and therefore any claims from this date, which are prescribed in this manner, will not be accepted by the Department of Human Services under the Pharmaceutical Benefits Scheme

My prescribing software has not been fully upgraded to reflect the Revised Arrangements, how can I write prescriptions for my patients?

You should contact your software vendor if your prescribing software has not been fully upgraded to reflect the Revised Arrangements.

You can continue to prescribe chemotherapy medicines using your prescribing software, even it if is not fully upgraded. However, you must also specify the dose in milligrams per infusion. This may be done by either using the free text field of your software, or by hand writing on the prescription. 

Below is a sample prescription (with fictitious names and information) which has been produced by prescribing software that has not been updated for the Revised Arrangements. The sample shows the annotation necessary for the Revised Arrangements.

Image 1: Sample prescription with annotation

Sample Chemotherapy prescription

What if I am working in a public hospital, which hasn’t transitioned to the Revised Arrangements, but my patient needs a prescription from a community pharmacy?

All prescribers must use the Revised Arrangements for writing PBS prescriptions from 1 April  2012.

All pharmacies must use the Revised Arrangements for claiming PBS prescriptions through the PBS from 1 April 2012.

If you are working in a public hospital, and you need to prescribe medicines to be dispensed in a community pharmacy, you must prescribe using the Revised Arrangements.  That is, you must use the item numbers from the Schedule for the Revised Arrangements, and you must specify the drug in units of measurement (i.e. usually milligrams).

Some chemotherapy infusion or injection items require prior authority approval – how will this work with an infusion or injection consisting of multiple items?

The Revised Arrangements have not changed the authorisation processes.  Items that require an Authority continue to require an Authority, although many eligible chemotherapy drugs have changed to Authority required (STREAMLINED) arrangements.

What if an infusion or injection ingredient requires more than the maximum amount?

Requests for authority to prescribe increased amounts or increased repeats are still necessary.

Note that under the Revised Arrangements, requests for increased amounts must take the form of a request for an increase in terms of relevant units of measure (i.e., usually milligrams), and not an increase in numbers of vials.

How do I prescribe/dispense/claim where the volume of drug is small (eg micrograms), or where the drug volume is not in integers?

Prescriptions should be written to describe the amount of the drug using the unit of issue in the EFC Schedule (eg, micrograms, milligrams, etc).

Pharmacists may supply the drug using any combination of vials that makes up the prescription, but will only be reimbursed for the most cost-efficient combination.

Claims must be entered in whole numbers and most claiming software will only accept milligrams. If necessary, claims for supply of half one milligram should be rounded up.

Can prescribers prescribe by brand?

Prescribers retain the right to prescribe by brand; however PBS claims will be calculated based on the most cost efficient combination of vial sizes on all available brands.

Do Regulations 24 and 25 apply?

Regulations 24 (supply of original and repeat on same day) and 25 (4 and 20 day rule) do not apply for items under this initiative.

Is same day prescribing allowed?

Same day prescribing may occur.

How have STREAMLINED authority listings changed?

There is less administrative burden for prescribers with more streamlined authority listings for infusible/injectable chemotherapy medicines. 

Since 1 December 2011, more of the existing listings for Authority Required cancer chemotherapy medicines have been streamlined to reduce the need for prescribers to obtain an authority from DHS.

The four digit streamlined authority code for applicable listings is available from the Schedule of Pharmaceutical Benefits.  When quantity and/or repeats greater than the listed maximums are required, authority approval is required from DHS.

What has changed for dispensers/suppliers?

What has changed for dispensers/suppliers?

The Revised Arrangements have changed the way that prescriptions are written and how pharmacies are remunerated - pharmacies are now paid for the most cost efficient combination of vials which makes up a patient dose.

To assist approved suppliers with the task of identifying the most cost efficient combination of vials, an algorithm has been included in dispensing software.

Pharmacists are still able to choose how they prepare each injection or infusion. The Revised Arrangements have changed the way pharmacies are remunerated.

Which suppliers are subject to the Revised Arrangements?

  • Section 90 pharmacists
  • Section 92 dispensing doctors
  • Section 94 Approved / Participating Public Hospitals
  • Section 94 Private Hospitals
  • Section 94 non-participating hospitals but only for trastuzumab early stage breast cancer. 

Software upgrades and the dispensing algorithm

Dispensing software has been upgraded to incorporate an algorithm, which determines the most cost efficient combination of vials for chemotherapy medicines that makes up a patient dose. The algorithm determines the Government subsidy and is not designed to instruct how a pharmacist should prepare the infusion/injection.

For more information on system changes, pharmacists should consult their respective software vendors. For further detail about the deployment of software in public hospital pharmacies, pharmacists should consult their respective State or Territory Health Departments.

How do I claim an infusion that could not be administered? What happens to the co payment?

Supplies may be claimed where an infusion has been reconstituted in good faith but is not able to be administered for reasons beyond the control of the approved supplier. 

In these cases, DHS will calculate the amount payable under the PBS as if the infusion has been dispensed. If the prescription is an original or deferred, a patient co-payment will be applied. 

To claim for an infusion that was prepared but not administered, the supplier will need to indicate in the claim the original or repeat number that was supplied. The patient will need to obtain a new prescription to cover any missed infusions that are still required for their treatment cycle and will be charged another co-payment on the original of this new prescription.

What happens to the algorithm if there is a stock shortage?

Stock shortages can be isolated or widespread and can be for a few days or months.  The Department will respond to stock shortages on a case by case basis. Where there is national shortage for a significant period the product will be temporarily removed from the dispensing algorithm

What has changed for private hospitals and community pharmacies?

What has changed for private hospitals and community pharmacies?

The Revised Arrangements commenced in private hospital and community pharmacies on 1 December 2011.

The Revised Arrangements have changed the way that prescriptions are written and how pharmacies are remunerated. Private hospital and community pharmacies are paid for the most cost efficient combination of vials which makes up a patient dose. To assist approved suppliers with the task of identifying the most cost efficient combination of vials, an algorithm has been included in dispensing software.

Pharmacists are still able to choose how they prepare each injection or infusion. The Revised Arrangements have changed the way pharmacies are remunerated.

Why have there been changes for private hospital and community pharmacies?

The Government has identified opportunities to dispense injectable and infusible chemotherapy medicines more cost efficiently, which will help ensure patients have continued access to PBS-subsidised chemotherapy treatment. 

What has changed for public hospital pharmacies?

What has changed for public hospital pharmacies?

All prescribers must use the Revised Arrangements for writing PBS prescriptions from 1 April 2012.

All pharmacies must use the Revised Arrangements for claiming PBS prescriptions through the PBS from 1 April 2012.

From 1 April 2012, public hospital pharmacies are only paid for the dispensing of chemotherapy medicines using the most cost efficient combination of vials which makes up a patient dose.  Pharmacists may still choose how they prepare each injection or infusion. The Revised Arrangements have changed the way pharmacies are remunerated.

It is recommended that pharmacies check that prescriptions are consistent with the Revised Arrangements, and not the previous Chemotherapy Pharmaceutical Access Program.  PBS prescriptions written in the form of the Chemotherapy Pharmaceutical Access Program cannot be claimed from 1 April 2012.

Under the Revised Arrangements, prescribers must write dose specific prescriptions for a treatment cycle with the individual patient dose expressed in the appropriate unit of measure (in most cases milligrams), rather than vials. The number of repeats on the prescription will be clinically appropriate and within the parameters set by the Pharmaceutical Benefits Advisory Committee (PBAC). If additional repeats are required an authority will need to be sought from DHS.

Why have there been changes for public hospital pharmacies?

The Government has identified opportunities to dispense injected and infused chemotherapy medicines more cost efficiently, which will help ensure patients have continued access to PBS-subsidised chemotherapy treatment.

What has happened to the Authority Notification System (ANS)?

The Authority Notification System (ANS) enabled pharmacies to seek approvals under the Chemotherapy Pharmaceuticals Access Program (CPAP).  The CPAP ceased on 1 April 2012, and therefore the ANS has also ceased from this date.

New remuneration arrangements

The Revised Arrangements include new dispensing fees per injection/infusion to recognise the specialist nature of preparing chemotherapy medicines. These are in addition to the Ready Prepared Dispensing Fee of $7.29, and include:

  • Preparation fee ($84.44);
  • Distribution fee ($26.65), which replaces the wholesale mark-up; and
  • Diluent fee ($5.28)

Public hospital pharmacies which are authorised to supply PBS-subsidised chemotherapy medicines are only eligible for the preparation fee (ie, not the distribution or diluent fees).

Table 1: Applicable fees by approved supplier type

Fee

s 90 Community Pharmacy
(incl s 92 approved  practitioners)

s 94 Approved Public Hospital Authority

s 94 Approved Private Hospital Authority

Distribution Fee ($26.65)

YES

NO

YES (not payable where drug is trastuzumab)

Diluent Fee ($5.28)

YES

NO

YES

Preparation Fee ($84.44)

YES

YES

YES

Ready Prepared Dispensing Fee ($7.29)

YES

NO

YES

Premium Free Dispensing Incentive (PFDI) (see exceptions)

YES NO YES
  • Fees commenced on 1 December 2011 (or 1 April 2012 for public hospital pharmacies which had not otherwise transitioned to the Revised Arrangements).
  • Fees are indexed annually on 1 July.
  • Any combination of vials may be dispensed but an algorithm determines the remuneration pharmacies will receive based on the most cost efficient combination of vials that makes up a patient dose.
  • The Premium Free Dispensing Incentive (PFDI) continues to be payable to eligible pharmacies for supply of an original prescription where the algorithm selects at least one ‘a’ flagged, premium-free brand. That is, a PFDI is paid if at least one of the vials in the most cost efficient vial combination, which is identified by the algorithm, attracts a PFDI. Only one PFDI will be paid regardless of the number of vials or number of strengths of the brand supplied.
  • A PFDI is not payable on repeats.  PFDIs are only paid on the original script.  

What about other supply and remuneration issues?

What is involved in the 10 per cent variation to prescriptions?

The prescribed dose may be varied by 10 per cent at dispensing without requiring re-authorisation.  This allows for clinically appropriate adjustments from the original prescription dose, due to factors such as patient tolerance or weight change while the prescription is current. Variations may also be made to non-authority prescriptions.

A 10 per cent variation may only be applied to the dose of the original prescription (i.e. the dose dispensed as a repeat is not to vary by any more than 10 per cent of the dose authorised on the original prescription).  If a dose is varied, it is the varied dose that must be submitted to, and dispensed in accordance with, the algorithm. For example, if the patient dose on an original prescription is 100 mg, and this is varied without a new prescription to 110 mg – either in respect of the original or a repeat, 110mg must be entered into the dispense record.

The dose dispensed is permitted to exceed the maximum amount as long as the dose prescribed is not in excess of 110 per cent of the maximum amount.

To endorse a prescription or medication chart for a variation, the pharmacist needs to record the name of the authorised prescriber who gave the direction, the means by which the pharmacist was notified of the direction (eg by phone or by fax), the date and time the pharmacist was notified by to vary the prescription, the dose the EFC prescription was varied to, the name of the pharmacist making the endorsement; and the signature of the pharmacist making the endorsement.

Can an approved supplier specify a brand in a claim? 

No. An algorithm imbedded in the software calculates the most cost efficient combination of vials that makes up the required patient dose, irrespective of brand. 

Even if a claim specifies a brand, the algorithm will select all available brands and not just the brand specified. This does not determine what brand is supplied; it does however determine the remuneration paid per infusion.

What if an infusion or injection is prepared and not administered to the patient?

Supplies under the Revised Arrangements continue to be claimable where an infusion has been reconstituted in good faith but is not able to be administered for reasons beyond the control of the approved supplier.  In these cases, DHS will calculate the amount payable under the PBS as if the infusion has been dispensed and if the prescription is an original or deferred, a patient co-payment applied. 

Do wastage, container or dangerous drug fees apply?

No wastage, container, or dangerous drug fees are payable to any approved supplier under the Revised Arrangements.

What if infusions are prepared by third parties?

Approved suppliers are free to enter into arrangements with third parties for the reconstitution of infusions.  The relevant PBS subsidies flow to the approved supplier, irrespective of whether they reconstituted the infusion themselves or use third parties offering this service. 

How does an approved supplier claim a chemotherapy infusion or injection from DHS?   

The claiming arrangements for public and private hospitals, community pharmacy, friendly societies and dispensing doctors generally remains unchanged.   

The maximum amount of the drug being claimed must be specified as an exact measurement, for example in milligrams or other appropriate unit of measure. The PBS claim form allows for six digits to be entered into the ‘quantity’ field in order to record smaller units of measurement.

Intravenous chemotherapy reconstitutions should be claimed as individual prescriptions (as per prior arrangements) that is, one prescription record per item. If a reconstitution contains multiple items then multiple individual prescription records will be transmitted.

Claiming via the online channel

Claiming via the online channel remains as per prior arrangements, that is, each individual item claimed as a single prescription.

Claiming via the CTS channel

Claiming via the CTS channel remains as per prior arrangements, that is, each individual item is claimed as a single prescription.

Claiming via the manual channel

Although the submission of claims for manual processing is not encouraged, it is supported and the bureau keying fee is applied to each prescription record as per prior procedures.

Claiming trastuzumab for early stage breast cancer via the off-line channel

Trastuzumab continues to be able to be claimed off-line through DHS for those public hospitals that are not approved to supply Pharmaceutical Benefits. 

How are approved suppliers informed of the payment of an infusion or injection and its ingredient items?  

The algorithm in the DHS claiming system calculates, for any given patient dose, the aggregate ex-manufacturer price plus any applicable mark-up of the most cost-efficient combination of vial sizes, and returns to the approved supplier via the online system both the aggregate dispensed price and a text description of the vial-size combination upon which the dispensed price was calculated.  

Scenario for prescribing and dispensing under the Revised Arrangements

An oncologist prescribes 150mg of a medicine that is available in vial sizes of 80mg and 200mg. The most cost-efficient combination of vial sizes is calculated by determining the vial combination. If the most cost efficient combination is the 2 x 80mg vial option, then the pharmacist would be remunerated for two 80mg vials.

 Figure 1: Typical sequence of events incorporating Revised Arrangements and Streamlined Authority Data Capture

 * Medication chart prescribing is currently limited to public hospitals participating in reform arrangements under the National Healthcare Agreements.

Prescriptions written prior to 1 December 2011

From 1 April 2012 the Revised Arrangements apply to all prescriptions. New prescriptions will need to be obtained if a prescription written prior to 1 December 2011 is presented for supply after 31 March 2012.

What has changed for drug manufacturers?

There have been changes to PBS remuneration for infusible/injectable chemotherapy medicines. These changes will need to be considered by sponsors when preparing submissions to the PBAC.

Streamlined Authority Data Capture (for all PBS Authority Required (STREAMLINED) drugs)

Click here for information about streamlined authority items and changes that require the streamlined authority code to be included on the PBS claim (as applicable).

Further information

For more information about the prescribing, dispensing or claiming of chemotherapy drugs, please call DHS on 132 290 or visit the Medicare website.

General questions about the PBS should be directed to the PBS general enquiry line on: 1800 020 613 or email to: pbs@health.gov.au