2012 CHANGES TO PBS PRICING ARRANGEMENTS
Page last updated: 4 March 2014
2012 Changes to PBS Pricing Arrangements – National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 4) – made on 12 July 2012
Amendments to the National Health (Pharmaceutical Benefits) Regulations 1960 will commence on 1 October 2012, to make flow-on changes for price disclosure, ex-manufacturer pricing and prescriber bag arrangements in accordance with changes to the National Health Act 1953. The National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 received royal assent on 28 June 2012 and will commence on 1 October 2012. An explanation of the changes to the Act is available below.
Schedule 7 of the amended Regulations sets out the fall-back approved ex-manufacturer prices for 16 brands of pharmaceutical items. These prices form part of the transition from 'approved price to pharmacists' to 'approved ex-manufacturer price’ which applies for all medicines from 1 October 2012. However, any price agreement or determination made separately for 1 October 2012 will override the price in the Regulations, and future prices may be set out in other agreements or determinations.
The amending Regulation and its Explanatory Statement are available at http://www.comlaw.gov.au/Details/F2012L01552/Download
Information sessions explaining the 2012 PBS pricing arrangements were held in Sydney and Melbourne in June 2012. Interested parties are welcome to download the presentation slides (PDF 409KB).
Request for Approved Ex-Manufacturer Price (PB11a)
The PB11a is a form that sponsors need to submit to reflect the listing price sought for their product on the Pharmaceutical Benefits Scheme (PBS) or when requesting a price or related alteration for a product already listed on the PBS.
The PB11a form has been updated to reflect the new legislation changes commencing 1 October 2012. All price agreements, new listings, changes to pack sizes and brand premiums must use the new PB11a form for all price agreements from 1 October 2012.
For any questions relating to completion of the PB11a form, please email the Pricing Section, Pharmaceutical Evaluation Branch, (firstname.lastname@example.org).
- Request for Approved Ex-Manufacturer PB11a - Instructions (PDF 50KB)
- Request for Approved Ex-Manufacturer PB11a - Form (RTF 194KB)
2012 changes to PBS pricing arrangements
The National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 (the Bill) was introduced in Parliament on 23 May 2012.
The Proposed Ex-Manufacturer Pricing for the PBS (PDF 129KB) document contains important information about these amendments to the National Health Act 1953.
- For the vast majority of medicines on the PBS an approved ex-manufacturer price that is the same as the existing price at the ex-manufacturer level will come into force under transitional provisions in the Bill without any action by, or impact on, responsible persons on 1 October 2012. These medicines are identified by there being nothing written in the ‘DoHA Contact’ column of the spreadsheets attached below. However, the prices in these spreadsheets need to be checked by responsible persons.
- For a small number of pharmaceutical items, existing ex-manufacturer level prices require adjustment under the transitional provisions in the Bill to arrive at a new single approved ex-manufacturer price as required for the new pricing arrangements. For these medicines, the word ‘YES’ is written in the ‘DoHA Contact’ column of the spreadsheets attached. Affected companies will be contacted by 8 June 2012 with further information.
Important next steps for responsible persons are set out at pages 11 to 13 of the Proposed Ex-Manufacturer Pricing for the PBS (PDF 129KB) document.
Spreadsheets for default 1 October 2012 PBS prices
Unless otherwise noted, the spreadsheets below give:
- indicative outcomes for default 1 October 2012 prices calculated in accordance with the provisions in the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012;
- the 1 October 2012 price intended to be prescribed in the National Health (Pharmaceutical Benefits) Amendment Regulations 2012 (the amending Regulations). Currently, only 11 pharmaceutical items (16 brands) are intended to have prescribed prices. The reasons for this are referred to at page 9 of the Proposed Ex-Manufacturer Pricing for the PBS (PDF 129KB) document, and an explanation for prescribing these prices will be sent to affected responsible persons by 8 June 2012.
The prices have been calculated from the prices current at 1 April 2012, and use mark-up and fee schedules applicable in April 2012. Price changes and new listings between May and October may necessitate a recalculation of the prices for 1 October 2012.
The spreadsheets will only be understood if they are viewed in the context of the Proposed Ex-Manufacturer Pricing for the PBS (PDF 129KB) document.
Key for Spreadsheets
Definitions of terms used in the spreadsheets.
|AEMP||Approved ex-manufacturer price (price from 1 October 2012 onward)|
|APP/Exman||Approved price to pharmacists or related ex-manufacturer price – whichever is appropriate for the listing. This depends on whether the wholesale mark-up is included in the subsidy for the particular listing. The subsidy for most s100 programs is based on ex-manufacturer price. (price up to 30 September 2012)|
|Claimed APP||The responsible persons claimed price as at 1 April 2012. Used to calculate a special patient contribution / premium for the pack|
|Claimed DPMQ||The responsible persons claimed price with mark-ups and fees added, and calculated for the maximum quantity|
|Claimed exman (1 October 2012 onward)||The responsible person’s claimed price, which will be used to calculate an SPC/premium for the pack|
|Claimed exman (at 1 April 2012)||The responsible persons claimed price at 1 April 2012 with wholesaler mark-up removed|
|DPMA||Dispensed price for maximum amount (applicable for efficient funding of chemotherapy)|
|DPMQ||Dispensed price for maximum quantity|
|DQ||Determined quantity (where there is no formally determined maximum quantity, a quantity may be determined for use when working out price mark-ups)|
|Drug Type||See table below for the different PBS programs that the codes refer to|
|Exman level price||Generally this is the approved price to pharmacists (APP) less wholesale mark-up. For a very small number of pharmaceutical items with a price prescribed in the Regulations, it is the current ex-manufacturer price on which s100 subsidy is based - see page 9 of the Proposed Ex-Manufacturer Pricing for the PBS (PDF 129KB) document.|
|Item Code||PBS Item Code used in the Schedule of Pharmaceutical Benefits|
|MA||Maximum amount (applicable for efficient funding of chemotherapy)|
|MQ||Maximum quantity (ie: determined for prescription of the medicine)|
|Pack Quantity||Manufacturer pack size that will be determined for PBS pricing|
|PEMP||Proportional ex-manufacturer price – only required for pack sizes different to the pricing quantity|
|Premium||Brand premium, therapeutic group premium or other special patient contribution|
|Pricing Quantity||Pricing quantity will be the quantity in the lowest PBS priced pack size across a pharmaceutical item|
|PTP for pack quantity||AEMP or PEMP with wholesaler mark-up added where applicable|
|SPC||Special patient contribution (including brand premium, therapeutic group premium or other special patient contribution)|
Drug Type Codes for Spreadsheets
|Drug type code||Program|
|CT||Section 100 (Chemotherapy - Related Benefits)|
|DB||Emergency Drug (Doctors’ Bag) Items|
|DS||Dental (Special Pharmaceutical Benefits)|
|GH||Section 100 (Growth Hormone)|
|HB||Section 100 (Highly Specialised Drugs) – Public Hospitals|
|HS||Section 100 (Highly Specialised Drugs) –Private Hospitals|
|IF||Section 100 (IVF/GIFT Treatment)|
|IN||Section 100 (Chemotherapy Scheme – Efficient Funding) - Private Hospitals & Approved Pharmacies|
|IP||Section 100 (Chemotherapy - Efficient Funding) - Public Hospitals|
|MD||Section 100 (Opiate Addiction Treatment)|
|MF||Section 100 (Botulinum Toxin Program)|
|PQ||Paraplegic and Quadriplegic Associations|
|R1||Repatriation Pharmaceutical Benefits|
|SA||Section 100 (Special Access Scheme)|
|SB||Special Pharmaceutical Benefits|
|SY||Section 100 (Special Authority Items) – Private Hospitals|
|SZ||Section 100 (Special Authority Items) – Public Hospitals|
|TY||Section 100 (Chemotherapy - Trastuzumab) – Private Hospital|
|TZ||Section 100 (Chemotherapy - Trastuzumab) – Public Hospital|
Default prices where the manufacturer does not have a premium/special patient contribution – Agreed Prices
This spreadsheet sets out all item code/manufacturer code listings where the current approved price to pharmacists for a pack size is agreed with the manufacturer.
Most listings on the PBS will appear on this Agreed prices spreadsheet (XLS 1.3MB).
Default prices for efficient funding of chemotherapy
This spreadsheet includes all item code/manufacturer code listings for items subject to the efficient funding of chemotherapy and where the current approved price to pharmacists for a pack size is agreed with the manufacturer.
These chemotherapy listings are in a separate spreadsheet so that the different dispensed price concepts that apply to the efficient funding of chemotherapy medicines could be reflected more readily. All chemotherapy medicines continue to require an approved price for each brand of pharmaceutical item, and will have a 1 October 2012 default price if a new AEMP is not agreed or determined.
Default prices for efficient funding of chemotherapy, where the manufacturer has a special patient contribution
This spreadsheet includes all item code/manufacturer code listings for items subject to the efficient funding of chemotherapy, but where the current approved price to pharmacists for a pack size is not agreed and the manufacturer has claimed a different price.
These listings have a special patient contribution, which is paid by the patient.
Default prices where the manufacturer has a premium/special patient contribution
This spreadsheet sets out all item code/manufacturer code listings (except efficient funding of chemotherapy medicines) where the current approved price to pharmacists for a pack size is not agreed, and the manufacturer has claimed a different price.
These listings have a brand premium, therapeutic group premium or other special patient contribution, which is paid by the patient.
Default prices where the manufacturer has a premium/special patient contribution, when paid by the Commonwealth
This spreadsheet sets out all item code/manufacturer code listings where the current approved price to pharmacists for a pack size is not agreed and the manufacturer has claimed a different price.
The “Claimed” prices in this spreadsheet are paid by the Commonwealth where provision has been made for the Commonwealth to pay the resulting premium / special patient contribution.
This includes listings:
- with a therapeutic group premium where an authority is obtained for Commonwealth payment of the premium; and
- where there is a premium for a brand listed for supply under a program where patients are not charged a premium (such as repatriation).
- Special patient contribution, when paid by the Commonwealth spreadsheet (XLS 24KB)
Ex-manufacturer prices for single brand combination items
Single brand combination items do not have a default price under the provisions in the Bill for transition to 1 October 2012 ex-manufacturer level pricing; all single brand combination item AEMPs for 1 October 2012 must be agreed or determined. The prices in this spreadsheet are indicative, based on simply removing the wholesale mark-up from the current approved price to pharmacist. Letters will be sent to all responsible persons concerning AEMPs for these medicines.