This draft contract is sent by e-mail to the person in charge. The applicant has up to 10 business days to respond. If more time is required, an extension may be requested by email to the Department of Health Contact Officer. The next section should guide the reader through the important steps of concluding the contract. This begins with a request for PBAC followed by the recommendation and pricing that follows, until the negotiation, implementation and expiry of the agreement. Following a positive recommendation from PBAC, the sponsor is invited to contact PBS Pricing and Managed Access to learn more about the fact process and standard agreement. Discussions at this stage are necessarily general, as the nature of the facts is generally not complete and prices have not been agreed in principle. All deeds correspondence should be directed to PBS Pricing and Managed Access, Pricing and Policy Branch (see “Who to contact?”). The guidelines also aim to raise awareness of action development processes among sponsors and to recognize the importance of a rapid opening of negotiations. These guidelines have been developed to reflect experience. It is a living document that will develop to allow for inevitable change.
The department can be advised on an act by the PBAC or on the PBAC of DUSC or ESC. The department will send an e-mail to the applicant and advise them on the results of a possible fact check. If a drug is to adhere to an existing act, the two sponsors (for new and existing drugs) must accept the publication of certain information enabling the completion of the joint act. At this stage, the promoter may propose changes to the facts, but only if they are supported by concrete evidence of a possible infringement of the business, if the existing act is applied. If a drug has been recommended by the PBAC to have a record of agreement, the drug is not mentioned until it has been performed. The typical common action process begins with receiving a positive recommendation from PBAC. The Department then sends a letter to the sponsors of the current list and tells them to disclose to the new sponsor all the necessary confidential information contained in its “acts” with the government. Once published, this detail is used to establish an act with the new sponsor that guarantees justice and fairness between quotes. All offers require the approval of the calculation forecasters.
After approving estimates of use and financial impact between the department and the proponent, other health services and portfolio agencies involved are encouraged to verify costs. A final cost to the government is reviewed by the Ministry of Finance. These agreements are most frequently used to provide PBAC with additional evidence of the cost-effectiveness of a rating. These may vary depending on their requirements, ranging from the use and provision of existing data to the implementation of a completely new procedure. There is a basic action document (annexed to these guidelines) which is then adapted to each specific list to include specific price agreements and risk-sharing agreements. Below is a non-exhaustive list of certain types of general agreements: the department verifies all acts at the end of the period or after a recommendation from the PBAC that affects the functioning of the facts. Acts may be cancelled or renewed after verification. This plan generally implies that the Department recovers a percentage of expenditures as soon as an agreed amount or a ceiling of grants (“ceiling”) has been exceeded.
They focus on the risks associated with the uncertainty of total expenditure and cost-effectiveness and are based on agreed estimates. The cap is generally expressed in dollars and the percentage of repayments varies depending on the level of risk.