1.4 Proposed PBS listing

Page last updated: September 2016

1.4.1 Essential elements of the requested listing

Complete Table 1.4.1 for the requested listing.

If a sponsor is unwilling to publish the effective price in the PBS schedule, they may request that the Australian Government approve a higher price to be published.

If the government approves the inclusion of a ‘published’ price in the Schedule of Pharmaceutical Benefits, the sponsor will be required to enter into a Deed of Agreement, to define a special pricing arrangement with the government. Special pricing arrangements allow for a rebate to be paid to the government every three months by the sponsor for the difference in government expenditure between the published and the effective price of the medicine. The medicine will be identified as having a special pricing arrangement, but the details of this may be confidential.

Provide details of any proposed special pricing arrangements. Ensure that Table 1.4.1 has been completed to show both the proposed effective price and the published price associated with any special pricing arrangement.

$ SPA = price related to proposed special price arrangement

Where an injectable or infusible chemotherapy medicine is involved, the requested quantities and price should reflect a maximum amount and a dispensed price for maximum amount (DPMA) as in Table 1.4.2.

$ SPA = price related to proposed special price arrangement

Maximum quantities/amounts and number of repeats

Demonstrate consistency between the maximum quantities/amounts and dosage recommendations using the following principles:

• For an acute-use therapy, demonstrate that the requested maximum quantity/amount is consistent with the likely use of the proposed medicine for a normal course of therapy (in accordance with any clinical practice guidelines identified in Subsection 1.2).
• For a chronic-use therapy, demonstrate that the maximum quantity/amount is consistent with the likely use of the proposed medicine for one month of therapy between each dispensing by the pharmacist, and that the number of repeats (usually) permits six months of therapy between each prescription.

Justify proposed deviations from this general approach – for example, to minimise wastage or to facilitate intermittent therapy, as described in Subsection 3A.6.1.

Demonstrate that the requested maximum quantities/amounts and the requested numbers of any repeats are consistent with the TGA-approved dosage recommendations (see also Subsection 1.3).

Interchangeability and brand substitution

Discuss whether the proposed medicine is likely to be interchangeable on an individual patient basis with another medicine listed on the PBS. This is likely to be the case for medicines that belong to a therapeutic class in which already-listed medicines have been regarded as interchangeable. Cross-reference to evidence in the submission that may support or refute a determination of interchangeability.

State whether the proposed medicine may be eligible for brand substitution (also known as ‘a’ flagging). Cross-reference to evidence in the submission that may be relevant for the PBAC when deciding on brand substitution.

Multiple listing scenarios

Where clinical practice or evidence do not clearly inform restriction criteria (eg population characteristics or line of therapy), more than one listing scenario may be presented to the PBAC for consideration. Present alternative listing scenarios and support these with evidence in Sections 2, 3 and 4. For economic evaluations, the preferred approach would be to present a single model that is capable of presenting multiple scenarios rather than separate models with different structures.

1.4.2 Requested restriction(s)

Medicines can be listed on the PBS General Schedule (section 85) as either unrestricted benefits (which have no restrictions on therapeutic use for the purposes of subsidy) or benefits that have restrictions on therapeutic use for the purposes of subsidy. There are different levels of restriction:

• ‘Restricted’ benefits can only be prescribed for specific therapeutic use.
• ‘Authority Required’ and ‘Authority Required (Streamlined)’ benefits seek to limit eligibility for subsidised treatment to specific patient groups in whom treatment is cost-effective. For Authority Required listings, prescribers may need to seek prior approval to prescribe by providing documentation to or telephoning Services Australia (Medicare). For ‘Authority Required (Streamlined)’ listings, prior approval is not required and prescribers declare the use is consistent with the restriction criteria by endorsing the prescription with the appropriate ‘streamlined code’.

Medicines can also be listed for supply with a section 100 arrangement that provides for different distribution arrangements (such as distribution of highly specialised drugs from hospital outpatient departments).

Complete the restriction template from the Australian Government Department of Health and Aged Care. This document provides guidance on how to formulate the restriction wording and justify restriction criteria.

State whether the requested restriction(s) is consistent with the (proposed) TGA-approved indication(s), and the details provided in Subsections 1.1.2 and 1.1.3. Discuss the implications of a requested restriction that are likely to have an effect on the restriction of another PBS-listed medicine (eg its initiation or continuation criteria).

Restricted benefits and Authority Required listings

A submission requesting a Restricted benefit or Authority Required listing is specifically seeking PBAC endorsement of use within the requested restriction and to exclude use beyond that restriction. The PBAC considers the appropriateness of a request for an Authority Required benefit on initial listing against two key principles:

• There is potential for use in a population in which the proposed medicine is not cost-effective or where the PBAC has not yet determined it to be cost-effective.
• There is potential for a high cost per patient or high total opportunity cost to the health system.

Other important factors are quality use of the medicine, safety and administrative burden.

If a Restricted benefit or Authority Required listing is considered appropriate, provide the following information:

• The intention of the requested restriction.
• Alternative options that would be acceptable to the sponsor. Consideration of these options help the PBAC to determine the simplest but most effective restriction to administer.
• Trade-offs between the clinical preference for a simple restriction and a complex restriction to limit the use of the proposed medicine to the target population.
• The justification for the requested restriction level, method of applying the restriction and criteria proposed in the restriction.

Word the restriction to identify the use that should eventuate, and be consistent with TGA-approved indications (and other sections of the product information). Restrictions may increase the administrative burden associated with prescribing and the PBAC would prefer that the complexity of the criteria be weighed against the risk and consequences of use outside the target population.

Grandfathering

An Authority Required restriction might need to include grandfathering provisions for eligible individuals who start therapy before the requested PBS listing is implemented. If so, include the following information in the submission:

• Details of the patients (such as estimated numbers, disease or condition characteristics, and information relevant to the requested restriction) currently receiving the proposed medicine and the scheme(s) through which the medicine is available. Where available, provide the eligibility criteria for provision of the medicine through the scheme. Ensure that you also identify and count the estimated number of patients currently receiving the proposed medicine in Section 4.
• An explanation of why patients currently receiving the proposed medicine would not be able to access the proposed medicine under the requested restriction (where patients would be eligible, no grandfathering clause is required).
• Justification of a grandfathering provision that would enable patients currently receiving the proposed medicine to access it through the PBS. This might include
• evidence that patients cannot cease treatment to ascertain eligibility
• evidence that patients would have been eligible according to the requested restriction at the time of initiating the medicine
• any other relevant factors.

1.4.3 Justification for continuation criteria

Continuation criteria should only be applied when use of a medicine may cease to be cost-effective in specified future circumstances. These circumstances include evidence of response to specified tests, progressive disease or a limited number of doses per patient. The PBAC may specify that the prescriber provides documentation to support continuing therapy (referred to as continuation rules). It is preferable that medicines are cost-effective for the treatment of all patients who continue to receive net benefit from treatment.

Justify the need for continuation criteria and present the proposed wording in a separate restriction for continuing treatment (identified in the ‘Treatment phase’ of the restriction template). Unambiguously justify each element in the continuation criteria on clinical grounds, using objective rather than subjective measures. Explain the thresholds applied with any tests. State whether the continuation criteria are consistent with the clinical evidence presented in Section 2.

Continuation criteria are unlikely to be suitable where recommencement is likely but breaks in therapy are likely to cause rebound, where there is an increased risk of toxicity associated with subsequent recommencement, or where there is reduced likelihood of benefit from subsequent recommencement. Continuation criteria may not be acceptable where the criteria involve subjective assessments or are likely to result in prescribers seeking to maintain subsidy despite the continuation rules.

1.4.4 Assessment and monitoring requirements

Describe any tests or investigations that are required to determine initial patient eligibility or continuing eligibility for the proposed medicine. Where a required test is not currently listed on the MBS, or the MBS item descriptor needs amending to permit use with the proposed medicine, a material codependency may exist (refer to Part B, Product type 4).

Present required tests or investigations in Subsection 1.2. Where the use of tests or investigations differ from those required by the nominated comparator, include the following information:

• In Section 3, the costs associated with testing, the costs and health outcomes associated with adverse events that arise from testing, and an analysis of the applicability of the tests used in the clinical evidence to the Australian setting.
• In Section 4, the costs of testing and of treating any adverse events that arise from testing.

1.4.5   Patient indication(s)

When requesting an unrestricted listing, state the main patient indication. This should be within the (proposed) TGA-approved indications listed in Subsection 1.3, be consistent with the population and treatment details described in Subsection 1.1, and account for the largest proportion of patients treated in Section 4. The patient indication is defined as what would eventuate following listing in the absence of a Restricted benefit.

If there is no clear ‘main’ indication, present Sections 1–4 for each indication (preferably in separate submissions; seek advice from the PEB).