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CONSULTATION PAPERListing of Medicines on the Pharmaceutical Benefits Scheme (PBS) and designated vaccines on the National Immunisation Program (NIP) – Fees and Charges proposal 2020-21February 2020Contents TOC \o "1-3" \h \z \u Contents PAGEREF _Toc32842903 \h iiIntroduction PAGEREF _Toc32842904 \h 1Purpose of this consultation paper PAGEREF _Toc32842905 \h 1How to submit feedback PAGEREF _Toc32842906 \h 1Timeframes PAGEREF _Toc32842907 \h 1The National Immunisation Program (NIP) PAGEREF _Toc32842908 \h 2The Australian Technical Advisory Group on Immunisations (ATAGI) PAGEREF _Toc32842909 \h 2The Pharmaceutical Benefits Scheme (PBS) PAGEREF _Toc32842910 \h 2The Pharmaceutical Benefits Advisory Committee (PBAC) PAGEREF _Toc32842911 \h 2PBS Process Improvements PAGEREF _Toc32842912 \h 2Update on Delayed Fees PAGEREF _Toc32842913 \h 3Australian Government Cost Recovery Policy PAGEREF _Toc32842914 \h 3Proposed Fees PAGEREF _Toc32842915 \h 4ATAGI Pre-submission advice PAGEREF _Toc32842916 \h 4PBAC Pre-submission services PAGEREF _Toc32842917 \h 5PBAC Submission services PAGEREF _Toc32842918 \h 5Intent to Apply PAGEREF _Toc32842919 \h 5Submission Services PAGEREF _Toc32842920 \h 6Initial submissions PAGEREF _Toc32842921 \h 6Resubmission pathways PAGEREF _Toc32842922 \h 7PBS Pricing Services PAGEREF _Toc32842923 \h 9Notice of Intent PAGEREF _Toc32842924 \h 9Pricing Offer Package lodgement (Pricing applications) PAGEREF _Toc32842925 \h 9PBS List Management Services PAGEREF _Toc32842926 \h 10Costs recovered PAGEREF _Toc32842927 \h 11Cost Recovery Transition Arrangements PAGEREF _Toc32842928 \h 13Stage 1 Cost Recovery Regulation Updates PAGEREF _Toc32842929 \h 14Useful links PAGEREF _Toc32842930 \h 14Attachments PAGEREF _Toc32842931 \h 14IntroductionThe 2018-19 MYEFO measure Improving Access to Medicines — streamlined listings, provided government approval for the first stage of Pharmaceutical Benefits Scheme (PBS) process improvements and the associated cost recovery arrangements. Approval was also provided to update the existing cost recovery arrangements to reflect the true and accurate costs of services provided to industry during the PBS listing process. Stage 1 changes commenced from 1 July 2019. Subject to Government agreement, Stage 2 changes and supporting cost recovery arrangements are expected to commence from 1 July 2020.Purpose of this consultation paperThis consultation paper provides information on the proposed cost recovery arrangements for listing a medicine on the PBS or designated vaccines on the National Immunisation Program (NIP) from 1 July 2020. This proposal includes changes to the Australian Technical Advisory Group on Immunisations (ATAGI) evaluation fees and current PBS fees across pre-submission, submission, pricing and list management services. All proposed fees are subject to Government consideration and approval. If approved by Government, regulation amendments will be required before fee changes are implemented.The Department of Health (the department) is specifically seeking feedback from the pharmaceutical industry on any implementation issues for the following: Proposed fees Transitional arrangementsRevised approach to deed management feesProposed updates to the existing cost recovery regulationsFeedback is also welcome on any aspect of the cost recovery arrangements proposed for implementation from 1 July 2020. All feedback will be reviewed, considered and will inform decisions on the revised arrangements.How to submit feedbackProvide your feedback on the proposed PBS fees and charges for 2020-21 via email to: PBSimprovements@.au. Submissions will be accepted until close of business 16 March 2020.Timeframes These timeframes are subject to change, depending on the feedback received and any subsequent adjustments or other action that may be needed in response to feedback. Event TimeframeConsultation paper publishedFebruary 2020Consultation feedback period closes March 2020Feedback consideredMarch - April 2020Consultation on the 2020-21 CRISpending Government approval Cost Recovery Regulation amendments published pending Government approvalProposed fees and charges schedule comes into effect pending Government approvalThe National Immunisation Program (NIP)The NIP is a population based vaccination program that provides protection to the Australian people against a range of vaccine preventable diseases. Vaccines listed on the NIP are recommended for relatively large population groups. They are promoted by governments to ensure high levels of uptake in order to meet target coverage rates, which can be as high as 95%. Being able to supply a vaccine on the NIP provides a significant market for sponsors, which continue to benefit from the listing process for many years.Vaccine evaluations support sponsors in seeking pre-submission advice from the ATAGI to inform the development of a vaccine submission to the Pharmaceutical Benefits Advisory Committee (PBAC). The Australian Technical Advisory Group on Immunisations (ATAGI)The ATAGI advises the Minister for Health (the Minister) on the NIP and other immunisation issues. In 2006, amendments to the National Health Act (1953) were made to require a positive recommendation from the PBAC in order to list vaccines on the NIP. The ATAGI has been providing pre-submission advice to sponsors of vaccines and evaluation advice to the PBAC since that time.The Pharmaceutical Benefits Scheme (PBS) The Pharmaceutical Benefits Scheme (PBS) lists medicines available to patients at a Governmentsubsidised price. The Schedule is part of the wider PBS managed by the Department of Health 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: 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; andWhat you can expect to pay for medicines.The PBS has been in existence since 1948 and is governed by the National Health Act (1953).The Pharmaceutical Benefits Advisory Committee (PBAC)The?Pharmaceutical Benefits Advisory Committee (PBAC)?is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists and consumer representatives.The PBAC’s primary role is to consider medicines for listing on the Pharmaceutical Benefits Scheme (PBS) and vaccines for inclusion on the National Immunisation Program (NIP). The Government does not list a medicine or modify a listing on the PBS without a PBAC recommendation to do so.PBS Process Improvements In 2017, the Australian Government signed a five year Strategic Agreement (the Agreement) with Medicines Australia, recognising both parties’ commitment to a viable medicines sector in Australia and a sustainable PBS. Clause 10 of the Agreement details objectives intended to improve the efficiency, transparency and timeliness of the PBS listing processes. In August 2018, the Minister for Health endorsed process improvements designed to meet the objectives of the Agreement. The Minister also endorsed a staged implementation approach. Stage 1 PBS process improvements includes: Changes to pre submission meetings;An Intent to Apply step;Introduction of positive recommendation pathways; andRevised cost recovery arrangements.Stage 1 process improvements and revised cost recovery arrangements to reflect the true cost of providing services were implemented from 1 July 2019. The Government approved a delay to the implementation of ATAGI fees and deed management fees until 1 July 2020 to enable the department to address stakeholder concerns. Subject to Government approval, Stage 2 process improvements will include:Changes to PBAC categories for initial submissions;Introducing resubmission pathways; andRevised cost recovery arrangements, including the commencement of ATAGI fees and the revised approach to deed management fees. Further information about the PBS process changes is available via the PBS process improvements webpage.If Government does not agree to the proposed approach and fees, the Government agreed fees currently published in the 2019-20 CRIS will apply from 1 July 2020.Update on Delayed Fees ATAGI FeesIn 2019, the department conducted a competitive tender process, which has resulted in a significant reduction to ATAGI fees. Pending Government agreement, the proposed fees outlined below and associated process improvements will commence from 1 July 2020. PBS Deed Management feeTo address industry’s request to clarify deed management activities, the annual deed management fee is proposed to be split into three separate fees. This will ensure there is no cross subsidisation across these fees. The revised approach to deed management fees is: Rebate management fee: includes the activities required for all deeds on an annual basis for rebate management services. To reduce administrative burden on the applicant and the department, it is proposed this fee will be included in the Pricing Pathway A, B and C fees and cover the activities for the five-year deed term.Deed variation request fee: includes the activities required in response to applicant’s requests to vary the terms of an existing deed (within the current deed term).Deed renewal request fee: includes activities required at the end of a deed term renew a deed of agreement. This fee will also include the (five-year) rebate management fee. The proposed rebate management fee is outlined in the pricing services section below and the proposed deed variation request and deed renewal request fees are outlined in the PBS list management services section below.Australian Government Cost Recovery PolicyCost recovery involves government entities charging individuals or non-government organisations some or all of the efficient costs of a specific government activity. This may include goods, services or regulation, or a combination of these. In 2015, the Australian Government implemented revisions to the Cost Recovery Guidelines that set out the overarching framework under which government entities design, implement and review cost-recovered activities.The Australian Government’s cost recovery policy is that, where appropriate, non-government recipients of specific government activities should be charged some or all of the efficient cost of those activities. The Australian Government Charging Framework applies to non-corporate and corporate Commonwealth entities as defined in the Public Governance, Performance and Accountability Act 2013 (PGPA Act).The Department of Health is a non-corporate Commonwealth entity.The National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 (the Regulations) provides authority for cost recovery charges for processes associated with the services provided to list and manage items on the PBS and NIP. Effective 1 July 2019, the cost-recoverable services for PBS/ NIP listing and management are:Pre-submission meetings; Intent to Apply (‘prior notice’) and applications for submission services;Notice of Intent for Pricing (‘prior notice’) and positive recommendation (pricing) pathways;List management services – price increase requests and ministerial discretion requests; and Independent reviews.The PBS cost recovery fee categories are defined in the Regulations.The current schedule of fees and charges for PBS listings and the CRIS are available via the PBS website. The CRIS provides information on how the department implements cost recovery arrangements and the PBS/NIP Cost Recovery Administrative Guidelines provides information for applicants on administrative processes of cost recovery. Proposed Fees The proposed schedule of fees has been developed to meet the requirements of the Australian Government Charging Framework. The tables in this section both outline the fees that the government has approved will apply from 1 July 2020 (as set out in the 2019-20 CRIS) and the proposed fees that would apply from 1 July 2020, subject to Government agreement.Stage 2 PBS process improvements affect the submission services component of the PBS listing process. However, fees have otherwise changed due to parameter changes that include: IT and depreciation costs, and changes to departmental salary and wages in line with Government requirements.ATAGI Pre-submission adviceATAGI pre-submission advice (evaluations) are an existing service, and are a mandatory component of the NIP listing process. From July 2020, the department will introduce process improvements and associated fees for ATAGI services. Table 1: Agreed and proposed fees for ATAGI pre-submission advice from 1 July 2020.Fee CategoryProposed DescriptionGovernment agreed fee from 1 July 2020Proposed fee from 1 July 2020ATAGI evaluation – Complex submission (new fee, mandatory)For applications that require extensive, or complex, data analysis and review.$300,440$180,960ATAGI evaluation – Simple submission (new fee, mandatory)For applications that are not in the complex category.$178,550$103,270The proposed ATAGI fees will decrease as a result of the 2019 ATAGI panel tender process.PBAC Pre-submission servicesPBAC pre-submission meetings are an existing cost recovered service and are an optional component of the PBS listing process.Pre-submission meetings are an applicant-driven service for the department to provide pre-submission advice on the preparation of major submissions to the PBAC by applicants. From July 2019, Stage 1 PBS process improvements introduced improved processes to support the delivery of pre-submission meetings. This included establishment of a dedicated pre-submission meeting team; a formal pre-submission meeting request form; briefing paper; and introduction of a meeting outcomes record. There are no changes to these processes for 2020-21.Table 2: Agreed and proposed fees for PBAC pre-submission meetings from 1 July 2020.Fee CategoryGovernment agreed fee from 1 July 2020Proposed fee from 1 July 2020PBAC Pre-submission – First meeting (existing fee, optional)$16,290$15,580PBAC Pre-submission – Second meeting (existing fee, optional)$21,360$21,180Proposed pre-submission meeting fees will decrease slightly as a result of parameter changes.Consistent with current process – fee waivers and or exemptions will not apply to these fees.PBAC Submission servicesPBAC submission services include all the activities conducted once an Intent to Apply form has been lodged until the PBAC makes a decision regarding a submission (including publishing committee outcomes and public summary documents). Stage 2 PBS process improvements will introduce revised initial submission categories and formal pathways for resubmissions to the PBAC.Intent to ApplyThe Intent to Apply step is an existing cost recovered activity and is a mandatory component of the PBS listing process that occurs four weeks before the relevant submission lodgement deadline.From July 2019, Stage 1 PBS process improvements introduced the Intent to Apply step to assist the department to plan and resource for submissions coming forward for PBAC consideration. This process will remain unchanged, however, from 1 July 2020 all PBAC submissions will require this step (refer Stage 1 Regulation Updates section for further details). Table 3: Agreed and proposed fees for Intent to Apply step from 1 July 2020.Fee CategoryGovernment agreed fee from 1 July 2020Proposed fee from 1 July 2020PBAC Evaluation – Intent to Apply (existing fee, mandatory)$400$430Proposed Intent to Apply fees will increase slightly as a result of the parameter changes. Consistent with current processes, fee waivers and exemptions apply to this fee. The Intent to Apply fee is a non-refundable deposit unless the delegate authorises an exception based on urgent public health need. Further details are outlined in the PBS/NIP Cost Recovery Administrative Guidelines.Submission ServicesSubmission services include existing cost recovered activities that are a mandatory part of the PBS listing process. Existing submission fee categories include:Major submission;Minor submission;Committee Secretariat; andNew Brand of an existing pharmaceutical item.From July 2020, Stage 2 PBS process improvements will introduce revised categories for initial submissions and formal pathways for resubmissions to the PBAC. Initial submissionsInitial submission categories have been established to reflect the activities required to process the varying submission types coming forward for PBAC consideration. In addition, changes to initial submission categories aim to further reduce cross subsidisation within fees between submission types.From July 2020, the existing evaluation fee types of ‘Major’ and ‘Minor’ will be split into the following four new categories for initial submissions. New fees will be introduced as a result of these changes. Existing Committee Secretariat and New Brand (Generic) submission categories remain unchanged.Fee CategoryProposed Description Category 1For all applications that meet one or more of the following criteria:A novel medicine or vaccine.A new medicine for a currently untreated medical condition OR a new vaccine for a medical condition for which there is currently no vaccine.A TGA provisional determination related to the proposed population.A medicine or vaccine with a codependent technology or service that requires an integrated codependent submission to the Medical Services Advisory Committee and PBAC.Note: Revised Procedure Guidance will include definitions.Category 2The application is not a Category 1 submission and seeks to list new drugs or medicinal preparations for PBS subsidy or to make substantial changes to current listings.An application for a variation to an existing listing may also be a Category 2 submission if it requires the PBAC to apply a health advantage test.Category 3The application is not a Category 4 submission and involves changes to existing items that do not have significant cost implications but do require consideration by PBAC for clinical effectiveness and/or potential impact on the PBS.Category 4For applications that meet one or more of the following criteria:A new pharmaceutical item of a listed medicine or designated vaccine that has a bioequivalence or equivalence statement from the TGA.Consideration as an exempt item.Including a listed medicine on the prescriber bag or varying an existing prescriber bag listing. A change/new manner of administration of a listed medicine.A change to the maximum quantity and/or number of repeats of a listed medicine.A change or addition to the prescriber type(s) of a listed mittee SecretariatSecretariat listings must demonstrate that the risk to a patient, associated with using a drug, medicinal preparation or vaccine, is not greater than the risk of using a listed drug, medicinal preparation or a designated vaccine.New Brand (Generic Submission)For applications that are bioequivalent or biosimilar and the price is already determined by an existing item. Table 4: Agreed and proposed fees for initial submissions from 1 July 2020Existing fee CategoryGovernment agreed fee from 1 July 2020Proposed fee categoryExpected volumes(per annum)Proposed fee from 1 July 2020PBAC Evaluation – Major submission(existing fee, mandatory)PBAC Evaluation – Category 1 (new fee, mandatory)16$222,910$224,780PBAC Evaluation – Category 2 (new fee, mandatory)51$168,270PBAC Evaluation – Minor submission(existing fee, mandatory)$40,070PBAC Evaluation – Category 3 (new fee, mandatory)40$42,590PBAC Evaluation – Category 4 (new fee, mandatory)37$33,280PBAC Evaluation – Committee Secretariat(existing fee, mandatory)$10,880PBAC Evaluation – Committee Secretariat(existing fee, mandatory)$12,300PBAC Evaluation – New Brand (existing fee, mandatory)$5,320PBAC Evaluation – New Brand (existing fee, mandatory)$6,450If approved by Government, revised categories for initial PBAC submissions will decrease submission services fees for most application types. This is a direct result of increased granularity and a reduction in cross subsidisation of fees. The proposed Category 1 fee is $1,870 lower than the July 2020 Government approved fee for Major submissions.The proposed Category 2 fee is $56,510 lower than the July 2020 Government approved fee for Major submissions. The proposed Category 3 fee is $2,520 higher than the July 2020 Government approved fee for Minor submissions. The proposed Category 4 fee is $6,790 lower July 2020 Government approved fee for Minor submissions. Proposed fees for Committee Secretariat and New Brand (Generic) submissions will increase slightly as a result of parameter changes.The proposed Committee Secretariat fee is $1,420 higher than the July 2020 Government approved fee.The proposed New Brand (Generic) submission fee is $1,130 higher than the July 2020 Government approved fee. Consistent with current process – fee waivers and exemptions will apply for these fees as per Part 5 of the Regulations.Resubmission pathwaysStage 2 PBS process improvements will introduce solution-focused resubmission pathways for resubmission to the PBAC. Following PBAC consideration, the Committee will nominate a resubmission pathway for all submissions with a ‘not recommended’ PBAC outcome. Pathway nominations will be based on the Committee’s independent assessment of the issues to be addressed and whether a medicine or vaccine represents ‘High Added Therapeutic Value’ (HATV). From July 2020, the existing evaluation fee types of ‘Major’ and ‘Minor’ will no longer apply to resubmissions and the following four resubmission pathways will apply. Resubmission pathways will have fees that reflect the activities required for these submissions (compared to activities for an initial submission).Fee CategoryProposed Description Standard Re-Entry PathwayFor applications where the PBAC has nominated this pathway based on their independent assessment of the submission and considers a new or updated economic model is necessary to support the claims made in the submission, or if there are other changes to the submission that require evaluation. Facilitated Resolution PathwayFor applications where the PBAC has nominated this pathway based on their independent assessment of the submission and considers the issues identified could be resolved through a workshop; and the medicine or vaccine represents HATV.Early Re-entry PathwayFor applications where the PBAC has nominated this pathway based on their independent assessment of the submission and considers the issues identified can be easily resolved. Early Resolution PathwayFor applications where the PBAC has nominated this pathway based on their independent assessment of the submission and considers the issues identified can be easily resolved; and the medicine or vaccine represents HATV.Existing fee CategoryGovernment agreed fee from 1 July 2020Proposed fee categoryExpected volumes (per annum)Proposed fee from 1 July 2020PBAC Evaluation – Major submission(existing fee, mandatory)$224,780PBAC Evaluation – Standard Re-entry Pathway (new fee, mandatory)26$166,220PBAC Evaluation – Facilitated Resolution Pathway (new fee, optional)2$238,230PBAC Evaluation – Minor submission(existing fee, mandatory)$40,070PBAC Evaluation – Early Re-entry Pathway (new fee, mandatory)21$41,250PBAC Evaluation – Early Resolution Pathway(new fee, mandatory)6$41,400Table 5: Agreed and proposed fees for resubmissions from 1 July 2020If approved by Government, the introduction of formal resubmission pathways will decrease submission services fees for the majority of applicants who would currently lodge a Major resubmission. Standard Re-entry Pathway: the proposed fee is $58,560 lower compared to a major submission fee. Facilitated Resolution Pathway: The proposed fee is $13,450 higher than the currently approved fee for Major submissions. This is due to the costs associated with the proposed workshop with members of the PBAC.Proposed changes will slightly increase submission services fees for applicants who would currently lodge a Minor resubmission as a result of parameter changes.Early Re-entry Pathway: the proposed fee is $1,180 higher than the July 2020 Government approved fee for Minor submissions.Early Resolution Pathway: the proposed fee is $1,330 higher than the July 2020 Government approved fee for Minor submissions.Consistent with current process – fee waivers and exemptions will apply for these fees as per Part 5 of the Regulations. PBS Pricing ServicesPBS pricing services include all the activities conducted following a ‘recommended’ PBAC outcome. From July 2019, Stage 1 PBS process improvements introduced the Notice of Intent step and formal pricing pathways. PBS Pricing services apply from lodgement of a Notice of Intent for Pricing form to PBS listing. This process will remain unchanged. Notice of IntentThe Notice of Intent step is an existing cost recovered activity and is a mandatory component of the PBS listing process. Table 6: Agreed and proposed fees for Notice of Intent from 1 July 2020Fee CategoryGovernment agreed fee from 1 July 2020Proposed fee from 1 July 2020Post-PBAC Pricing Services – Notice of Intent (existing fee, mandatory)$400$430Proposed Notice of Intent fees will increase slightly as a result of parameter changes.Consistent with current processes, fee waivers and exemptions apply to this fee. The Notice of Intent fee is a non-refundable deposit unless the delegate authorises an exception based on urgent public health need. Further details are in the PBS/NIP Cost Recovery Administrative Guidelines.Pricing Offer Package lodgement (Pricing applications)PBS pricing services include existing cost recovered activities that are a mandatory part of the PBS listing process. The pricing offer package is lodged 7-42 days after the notice of intent for pricing form is lodged. This process remains unchanged. From July 2020, the revised approach to deed management fees would apply as outlined in the table below. Table 7: Agreed and proposed fees for Post-PBAC pricing pathways (including the proposed rebate management fee) from 1 July 2020Fee CategoryGovernment agreed fee from 1 July 2020Proposed fee from 1 July 2020Proposed fee from 1 July 2020 – incl the rebate management feePricing Pathway A – Facilitated *(existing fee, optional)$120,410$132,705$140,980Pricing Pathway B - New deed *(existing fee, mandatory)$93,300$103,215$111,490Pricing Pathway C - Existing deed *(existing fee, mandatory)$58,520$65,385$73,660Pricing Pathway D - Standard listing (existing fee, mandatory)$19,510$19,870Pricing Secretariat(existing fee, mandatory)$10,490$12,740* Rebate management fee(new fee, mandatory) – covers the 5 year deed term$8,275Proposed pricing pathway fees will increase as a result of parameter changes. In addition, Pricing Pathway A, B and C fees will increase based on the proposal to include the rebate management fee.Consistent with current process – fee waivers and or exemptions apply for these fees as per Part 5 of the Regulations.PBS List Management ServicesPBS list management services are provided to an applicant in order to manage a PBS listing. From 2019, list management fees for price increase and ministerial discretion requests commenced. List management services are invoiced and charged for each specific listing item (e.g. drug X, 20mg, oral), not per drug. There are no process changes for these services. From July 2020, the revised approach to deed management fees are expected to commence. This includes the introduction of deed variation and deed renewal requests. Table 8: Agreed and proposed fees for list management services from 1 July 2020Fee CategoryGovernment agreed fee from 1 July 2020Proposed fee from1 July 2020Price increase request (per request – existing fee, mandatory)$2,370$5,040Ministerial discretion request (per request – existing fee, mandatory)$3,540$7,040Deed variation request (per request – new fee, mandatory)$1,970Deed renewal request (per request – new fee, mandatory – includes the five year rebate management fee)$10,330Proposed list management fees will increase as a result of parameter changes and, specifically, the inclusion of IT costs due to system improvements and which have not been included in these fees previously.Consistent with current process – fee waivers and exemptions apply for these fees as per Part 5 of the Regulations.Costs recoveredThe proposed fees outlined above include the following costs:Direct costs: include staff salaries (including on-costs for superannuation and leave) for those directly involved in the activity, committee costs and supplier costs (e.g. contractors, consultants and legal).Indirect costs: include staff training and development, workers compensation premium, human resources support, organisational services, desktop ICT services and property operating expenses.Other costs: IT system maintenance and depreciation costs associated with the PBS/NIP listing processes – the Health Products Portal and PharmCIS.Table 9 - Unit cost per activity with breakdownUnit Cost per Activity 2020-21Direct CostsIndirect CostsOtherTotal CostATAGI Pre-submission Evaluation????Complex Submission$121,200$1,720$58,030$180,960Simple Submission$72,640$1,170$29,460$103,270Pre-Submission Meetings1st Pre-Submission Meeting$13,100$1,920$560$15,5802nd Pre-Submission Meeting$17,840$2,590$750$21,180Intent to Apply SubmissionsIntent to Apply/Notice of Intent$360$60$20$430PBAC EvaluationCategory 1$204,230$14,410$4,280$222,910Category 2$157,110$8,580$2,570$168,270Category 3$37,190$4,160$1,250$42,590Category 4$28,120$3,970$1,190$33,280Resubmission - Standard re-entry$154,990$8,640$2,590$166,220Resubmission - Facilitated resolution pathway$225,070$10,160$3,000$238,230Resubmission - Early resolution$35,780$4,330$1,290$41,400Resubmission - Early re-entry$35,660$4,310$1,290$41,250Secretariat Submission$10,190$1,570$540$12,300Generic Submission$5,350$860$250$6,450Positive Recommendation pathwaysPricing Pathway A*$117,590$18,420$4,960$140,980Pricing Pathway B*$93,060$14,600$3,820$111,490Pricing Pathway C*$61,480$9,780$2,400$73,660Pricing Pathway D$16,530$2,570$770$19,870Pricing Secretariat$10,620$1,580$540$12,740Other Chargeable activitiesDeed Variation Request$60$10$1,890$1,970Deed Renewal Request*$6,750$1,780$1,800$10,330Price Increases$4,190$660$200$5,040Ministerial Discretion Request$5,930$860$250$7,040* Includes Rebate management fee - for the five year deed termThe estimates in Table 10 below outlines the annual total expenses and estimated revenue with the proposed fee changes from 2020-21. Government agreed to a partial cost recovery approach in 2018-19 and as a result there is under recovery estimated between 2020-21 to 2023-24 due to:The listing levy not being applied to all PBS listed medicines (approx. $5 million per year); andExpected fee waivers and exemptions (approx. $2 million per year).The balance shows a net loss of revenue (and the need for Government appropriation to the department to cover the shortfall in costs and to support the activities) of $7.27 million in 2020-21. This increases each year with a cumulative loss over the next four years of $29.66 million. Table 10 – Proposed financial estimates for the cost recovery activities from 2020-21 and three forward yearsForecast Financial Estimates2020-21 ($ million)2021-22 ($ million)2022-23 ($ million)2023-24 ($ million)Combined Expenses = X$35.61$36.16$36.81$37.42Combined Revenue = Y$28.34$28.78$29.37$29.85Balance = Y - X($7.27)($7.38)($7.44)($7.57)Cumulative Balance($7.27)($14.65)($22.09)($29.66)Cost Recovery Transition ArrangementsThe implementation of Stage 2 process improvements and associated cost recovery arrangements require transition arrangements to fit within the PBAC timeframes and requirements.Changes will affect submissions seeking PBAC consideration at the November 2020 meeting and those seeking PBAC consideration at the March 2021 meeting. Table 11 below outlines the key dates for these arrangements. Table 11 – Proposed cost recovery transition arrangementsProposed changeTimelinesGovernment agreed introduction of ATAGI fees 1 July 2020Proposed fee changes apply - includes revised ATAGI fees, the introduction of deed management fees and fees to support the implementation of Stage 2 PBS process improvements.(subject to Government approval)1 July 2020November 2020 PBAC meeting(July 2020 lodgement)Current Major and Minor submission categories apply for initial submissions and resubmissions. Major Submission deadlines and fees:10 June 2020 – Intent to Apply due8 July 2020 – Lodgement deadline * Currently approved 2019-20 CRIS fees apply.Minor Submission deadline and fees:24 July 2020 – Intent to Apply due21 August 2020 – Lodgement deadline* Currently published 2020-21 CRIS fees apply.For submissions ‘not recommended’ at the July 2020 meeting, (submissions must go to the next PBAC meeting)Proposed Early Resolution and Early Re-entry resubmission pathways and fees apply+ (subject to Government approval)Early Re-entry is the default pathway for ‘Minor’ resubmissions considered prior to July 2020.Early Resolution and Early Re-entry deadlines and fees:31 July 2020 – Intent to Apply exception process deadline28 August 2020 – Lodgement deadlineProposed 2020-21 Early Resolution or Early Re-entry Pathway fees apply. March 2021 PBAC meeting(November 2020 lodgement)Proposed pre-submission meeting changes apply.(subject to Government approval)+9 September 2020 – last date for pre-submission meetings for eligible submissions.Proposed initial submission category changes and introduction of a single submission date apply. (subject to Government approval)Initial submissions - Category 1, Category 2, Category 3, Category 4 and Committee Secretariat: 7 October 2020 – Intent to Apply deadline 4 November 2020 – Lodgement deadlineProposed 2020-21 initial submission category fees apply.Proposed resubmission pathways apply.(subject to Government approval)+Early Re-entry is the default pathway for ‘Minor’ resubmissions considered prior to July 2020.Standard Re-entry is the default pathway for ‘Major’ resubmissions considered prior to July 2020.Facilitated Resolution and Standard Re-entry Pathway deadlines and fees:7 October 2020 – Intent to Apply deadline. 4 November 2020 – Lodgement deadlineProposed 2020-21 Facilitated Resolution of Standard Re-entry Pathway fees apply dependent on PBAC’s nominated pathway.Early Resolution and Early Re-entry deadlines and fees:27 November 2020 – Intent to Apply exception process deadline.28 December 2020 (TBC) – Lodgement deadlineProposed 2020-21 Early Resolution or Early Re-entry Pathway fee would apply dependent on PBAC’s nominated pathway.* Refer to the 2019-20 Cost Recovery Implementation Statement (CRIS) for Government agreed fees for 2019-20 and 2020-21.+ Procedure Guidance will be revised to support implementation of Stage 2 to provide additional process information for applicants.Stage 1 Cost Recovery Regulation Updates Following implementation of Stage 1 PBS process improvements and revised cost recovery arrangements, the department has received feedback on further improvements to support cost recovery administration. Proposed amendments to the National Health (Pharmaceutical and Vaccines – Cost Recovery) Regulations 2009 would apply from 1 July 2020 and are outlined in Attachment A.Useful links2019-20 Cost Recovery Implementation Statement (CRIS)Cost Recovery Administrative GuidelinesNational Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009National Health (Pharmaceuticals and Vaccines – Cost Recovery) Amendments 2019 – Explanatory StatementPBAC Procedure Guidance for listing medicines on the Pharmaceutical Benefits Scheme.AttachmentsA: Stage 1 Cost Recovery Regulation Updates. Table 12: Stage 1 Cost Recovery Regulation UpdatesFeedbackProposed Solution Pre-submission meetingsMeetings cannot be confirmed until the Briefing paper is lodged 2 weeks prior to the requested meeting date. This isn’t always sufficient time for the applicant to arrange travel etc. Amend the regulations to allow the department to approve a pre-submission meeting request based on the information provided in the request form (where possible). Department would maintain the ability to not accept/cancel the meeting on the basis of the briefing template where the required information has not been provided. Currently there isn’t flexibility to change the purpose of a scheduled pre-submission meeting. This may be required due to various reasons such as data not being available for the drug therapy and the applicant choosing to discuss a different drug therapy. Allow applicants to withdraw a pre-submission meeting request and submit a new request and briefing paper without having to amend the scheduled meeting date. Briefing papers will continue to be due two weeks prior to the scheduled meeting date. Intent to ApplyCurrently an Intent to Apply form is not required for Committee Secretariat submissions.Amend the regulations to require an Intent to Apply for all submissions considered by the PBAC – this will include Committee Secretariat. Current fee waiver and exemption processes do not allow applicants to withdraw their submission if a fee waiver or exemption application is not approved.Amend the regulations to require: Fee waiver or exemption applications (including required evidence) to be provided with the intent to apply form, upon acceptance of the intent to apply exception (minor resubmission or urgent public health need). Where this occurs, the department will make a waiver or exemption decision prior to issuing an invoice. This enables the applicant to have a 14-day withdrawal period once they are advised of the delegate’s decision. Invoices will have a 28-day payment term.Pricing PathwaysLack of transparency regarding the timing from PBAC meeting outcomes to in-principle price agreement. Lack of certainty regarding when pricing application services become ‘inactive’ and the administration consequences. Amend the regulations to clarify pricing application services become inactive if there has been more than 26 weeks from the date department accepted a complete pricing offer package to the date the department is able to provide the Government with a recommendation to list a medicine.Where pricing application services become inactive, these services are considered complete. If a company chooses to recommence discussions to list a medicine, a new notice of intent and pricing offer package is required to be submitted and the pricing pathway fee will be payable for this service. .auAll information in this publication is correct as at February 2020. ................
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