Medicine Status Website User Guide and Glossary

Submission received for (date) PBAC Meeting

A pharmaceutical company (the applicant) has lodged a submission to the PBAC to list a medicine on the PBS.

The month and year displayed is when the PBAC will consider the submission.

Opportunity for consumer comment

Consumers have the opportunity to provide comments on a medicine submitted for PBAC consideration. All patients, carers, members of the public, health professionals or members of consumer interest groups are welcome to submit comments. The PBAC consider these comments alongside the information submitted by the applicant.

The dates displayed are the dates that the opportunity for consumer comment opens and closes. See the PBS website  to provide comments or for additional information.

PBAC meeting

The PBAC have three main meetings per year. The meetings are three days in length and occur in March, July and November. The PBAC determines if additional meetings are required to progress the work of the committee in a timely manner. These additional meetings may address outstanding matters arising from medicine submissions and/or non-submission related matters.

The MSW contains submissions for the main meetings in March, July and November. The meeting date reflects the first day of the meeting.

PBAC outcome published

Submissions considered by the PBAC result in a one of the following outcomes:

• ‘Recommended’ (also referred to as a positive PBAC recommendation);
• ‘Not recommended’; or
• ‘Deferred’.

PBAC determines the outcome based on consideration of the information within the submission and consumer comments. The PBAC outcomes  are available on the PBS website six (6) weeks after each PBAC meeting. These published outcomes provide a high-level summary of the reasons for the outcome and form the basis of the PBAC’s advice to the Minister for Health. Further explanation of the PBAC outcome is available in the Public Summary Document. Public Summary Documents are available on the PBS website  approximately four (4) months after the PBAC meeting. See the PBAC calendar  for publication dates.

The PBAC outcome field is updated once the ‘PBAC outcomes’ are available on the PBS website

Notice of intent submitted

The Notice of Intent form is mandatory for all submissions that receive a positive PBAC recommendation. Applicants must submit the form to notify the department of their intention to:

• Proceed with the PBS listing process;
• Withdraw from the PBS listing process; or
• Lodge another submission to the PBAC.

The only exception is if the department decides that progressing the listing is necessary to address an urgent public health need. This exception is authorised in the Regulations . If it is applied, the words ‘Exception applied’ will display in this field.

Applicants receive the PBAC Minutes on the Friday three (3) weeks after the PBAC meeting. Applicants then have 60 calendar days to submit their Notice of Intent form before the submission becomes ‘inactive’. A status will display to explain that the process for the medicine is ‘inactive’.

An applicant can choose not to proceed at any point of the process. If this occurs, a status will display to explain that the process for the medicine is ‘ceased’.

Lodgement of required documentation

Applicants who wish to proceed with the PBS listing are required to submit a set of documents to the department. These documents include:

• Administrative forms and supporting information.
• In-principle agreement to any PBAC advice on deed arrangements.
• Confirmation of acceptance of PBAC’s recommended restriction wording.
• TGA approval letter.
• Updated utilisation and cost model.

The MSW displays the date the applicant initially lodged these documents

Acceptance of complete documentation

The department checks that all required documents are included and the information is consistent with the PBAC’s advice. The listing process cannot progress until the applicant submits any missing information or corrects the information provided. The department must accept the documentation as complete before the next step can commence.

This field will display as either accepted, under consideration, or not accepted. If it is not accepted, the applicant is able to resubmit the documentation to address any issues. This would enable the PBS listing process to continue.

Agreement to listing arrangements

The applicant and department work together to reach an agreement on the listing arrangements. The MSW displays the date this step commenced.

The listing arrangements must be consistent with the PBAC’s advice detailed in the PBAC Minutes. The PBAC Minutes are not publicly available however, the key information is summarised in the Public Summary Document. These are available on the PBS website  approximately four (4) months after the meeting.

The Agreement to listing arrangements step requires the applicant and the department to:

• Agree on the in-principle subsidised rate for the medicine.
• Agree in-principle to the expected financial impacts.
• Finalise a deed of agreement, if required. A deed of agreement is a commercial agreement between the Australian Government and pharmaceutical company.
• Finalise the restriction wording. The restriction details the circumstances for prescribing that apply for the medicine to be available for subsidy.

The agreed listing arrangements are subject to agreement by the Minister for Health (or an approved delegate) and other relevant Government entities. This occurs during the government processes step.

Displays whether the Agreement to listing arrangements step is in progress or finalised.

Government processes

Once Agreement to listing arrangements step is complete, government processes can commence. The MSW displays the date this step commenced.

Government processes includes:

• The department and pharmaceutical company finalise the expected financial impacts. 
• Approval of the listing arrangements by other Government agencies. For example, the Department of Finance must approve the financial information and Services Australia must approve the wording for the medicine’s restrictions for use.
• Submission of all required listing documents by the applicant, such as assurance of supply. 
• Finalise and distribute the amended PBS schedule. This enables software vendors, Services Australia and others to load data in their systems to give effect to the changes.
• Finalise software requirements for general practitioners, pharmacies, hospitals and allied health professionals.

Government then approves the listing arrangements.

Following the required approvals, the Minister for Health (or an approved delegate) signs a legislative instrument enabling the medicine’s inclusion on the PBS. The signed legislative instrument is then added to the Federal Register of Legislation.

The Government is committed to completing these government processes within 26-weeks. Annual performance against this commitment is available in the Department of Health’s Annual Report .

Medicine listed on the PBS

Once the government processes step is complete, the medicine is available on the PBS schedule. This means that medical professionals can prescribe the medicine to eligible patients. With a valid prescription, pharmacies can dispense the medicine to patients at the Government-subsidised price. The PBS schedule is updated on the first of every month and is available on the PBS website .

The MSW displays the date the medicine was listed on the PBS Schedule.

Applicant

‘Applicant’ refers to the individual or organisation who is responsible for preparing the PBAC submission. The applicant may be a pharmaceutical company responsible for the medicinal product/pharmaceutical item and/or an organisation or individual supporting the preparation of the PBAC submission.

Brand name

‘Brand name’ is the brand which the medicine will eventually be sold under by the Pharmaceutical company.

Comment

This ‘Comments’ field contains information regarding a medicine that has been or is to be considered by the Pharmaceutical Benefits Advisory Committee, and that the Department is able to make publicly available.

The constraints on providing all information associated with applications to the PBAC and other listing documents arise generally from considerations of privacy, commercial sensitivity and, as a consequence, of the operation of relevant Commonwealth Acts and Regulations. For further information, visit the PBS website .

Condition/indication
(therapeutic use)

‘Condition/indication (or therapeutic use)’ is the condition/s which the medicine is designed to treat.

Deed of agreement

Deeds of agreement are commercial agreements between the Australian Government on behalf of the Commonwealth of Australia and Responsible Persons (pharmaceutical companies), and are designed to help maintain the appropriateness and cost-effectiveness of listed medicines. They may also reduce the Government’s exposure to the risks associated when listing particular medicines on the PBS, following a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation.

These agreements are negotiated between officers of the Department of Health and Aged Care, representing the Australian Government, and the Responsible Person of a medicine, and are formalised in a legal document called a ‘deed of agreement’.

Note – While the PBAC may recommend that the Government negotiate a deed, they do not decide on its final content.

Drug/Medicine name

‘Drug/Medicine name’ is the scientific name that the Pharmaceutical company has given to the medicine.

Federal Register of Legislation

The Federal Register of Legislation (Legislation Register) is a database or permanent repository of versions (including authorised versions) of Acts, legislative instruments, notifiable instruments and compilations of Acts and instruments together with associated documents and information including explanatory statements and Gazette notices. It is established under section 15A of the Legislation Act 2003.

Financial impacts

The utilisation and cost model workbook is used as part of the PBAC submission process to quantify the use and financial impacts of the new medicine. Departmental officers check that each component of the estimates of use and costs would be correct at the expected time of listing and reflect the PBAC recommendation to the Minister. These officers also review the financial model structure and inputs to ensure this is accurate and complete.

The finalised model of use through the PBS and the Repatriation Pharmaceutical Benefits Scheme (RPBS) is provided to each applicant for review, comment and clarification. The applicant is required to agree to the estimates of use and costs. Where an applicant is unable to agree to the estimates of use and cost, the listing process will stop and a further submission to the PBAC may be required.

Legislative instrument

Legislative instruments (LIs) are laws on matters of detail made by a person or body authorised to do so by the relevant enabling legislation. Examples of LIs include regulations, rules and determinations. Under the Legislation Act 2003, all legislative instruments require registration on the Legislation Register.

The Legislation Register contains authorised versions of every legislative instrument made since 1 January 2005 and every instrument made before then but still in force on 1 January 2008.

Page [content] last updated

‘Page last updated’ date is that date that the page content was last updated.

PBAC Application type

‘PBAC Application type’ is how the medicine application is classified by the Department of Health and Aged Care in order for it to be processed accordingly by the Pharmaceutical Benefits Advisory Committee.

PBAC outcome

‘PBAC outcome’ is the recommendation made by the Pharmaceutical Benefits Advisory Committee, in respect of the medicine they considered for listing/changing on the Pharmaceutical Benefits Scheme.

PBAC submission / application

The dossier provided by an applicant in support of its request to have a medicine listed on the PBS and vaccines on the National Immunisation Program  (NIP).

From 1 January 2021, Category 1 and Category 2 will replace major submissions, and Category 3 and Category 4 will replace minor submissions. There is no change to the existing categories of committee secretariat and new brand of an existing pharmaceutical item (generic). For further information, visit the PBS website .

Vaccines or generic submissions are not included on the Medicine Status Website. 

PBS

The Pharmaceutical Benefits Scheme (PBS) Schedule lists all of the medicines available to be dispensed to patients at a Government-subsidised price. The Schedule is part of the wider Pharmaceutical Benefits Scheme managed by the Department of Health and Aged Care and administered by Department of Human Services.

This schedule is now on-line and updated on a monthly basis. This on-line searchable version contains:

• All of the drugs listed on the PBS
• Information on the conditions of use for the prescribing of PBS medicines
• Detailed consumer information for medicines that have been prescribed by your doctor or dentist;
• What you can expect to pay for medicines.

The PBS has been in existence since 1948 and is governed by the National Health Act 1953 (Commonwealth).

Pharmaceutical company

The ‘Pharmaceutical company’, is the company that ‘sponsors’ the medicine for listing on the Pharmaceutical Benefits Schedule (PBS).

Public Summary Document

The purpose of ‘Public Summary Documents’ is to provide to the public, information pertaining to PBAC recommendations, so that stakeholders (such as doctors, health professionals and patients) are aware of the rationale for specific PBAC recommendations, and gain an improved understanding of the overall PBS listing process.

Related medicines

‘Related medicines’ are those medicines which relate to the medicine being viewed. For example, it might take a combination of two medicines to treat a single condition/indication. These two medicines would be considered ‘related medicines’ and therefore links between the two medicines are provided for the user.

The related 'Related medicines' field also links deferred outcomes and resubmissions. 

There may be more than one related medicine.

Restriction

The general intention of a restriction is to identify the population of individuals who would be eligible for PBS-subsidised use of the proposed medicine, usually by reference to certain diagnostic criteria of a medical condition, disease or disorder.  

Resubmission Pathway

From March 2021, applicants with a ‘not recommended’ PBAC outcome are able to seek PBAC reconsideration via a ‘Resubmission Pathway’. 

Resubmission pathways include: Early Resolution, Early Re-entry, Facilitated Resolution and Standard Re-entry. For further information, visit the PBS website .
 
Vaccines or generic submissions are not included on the Medicine Status Website.