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Outcome 2 – Access to Pharmaceutical Services

Access to cost-effective medicines, including through the Pharmaceutical Benefits Scheme and related subsidies, and assistance for medication management through industry partnerships

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Outcome Strategy

Outcome 2 aims to provide reliable, timely and affordable access to cost-effective, sustainable and high quality pharmaceutical services and medicines. The department worked to achieve this Outcome by managing initiatives under the programs outlined below.

This chapter reports on the major activities undertaken by the department during the year, reporting against each of the major activities and performance indicators published in the Outcome 2 chapter of the 2010-11 Health and Ageing Portfolio Budget Statements (PB Statements) and the 2010-11 Health and Ageing Portfolio Additional Estimates Statements (PAES). It also includes a table summarising the estimated and actual expenditure for this Outcome.

Outcome 2 was managed in 2010-11 by the Pharmaceutical Benefits Division.

Program Name Program Objectives in 2010-11
Program 2.1: Community Pharmacy and Pharmaceutical Awareness
  • Support timely access to medicines and professional pharmacy services through the implementation of the Fifth Community Pharmacy Agreement.
  • Support quality use of medicines for Aboriginal and Torres Strait Islander peoples, through education and targeted support for consumers and health professionals.
Program 2.2: Pharmaceuticals and Pharmaceutical Services
  • Manage the Pharmaceutical Benefits Scheme (PBS) including gaining better value from competition between brands of medicines listed on the PBS.
  • Improve health outcomes and sustainability of the PBS by improving the evidence base for prescribing decisions and the assessment of effectiveness of listed PBS medicines.
  • List cost-effective new, innovative, clinically effective medicines on the PBS.
  • Improve community access to a range of pharmaceutical benefits when prescribed by appropriately trained and certified nurse practitioners and midwives.
Program 2.3: Targeted Assistance – Pharmaceuticals
  • Improve access to new and existing medicines for patients with life threatening conditions.
Program 2.4: Targeted Assistance – Aids and Appliances
  • Increase the affordability of insulin pumps and associated consumables for children under 18 years of age with type 1 diabetes.
  • Continue to assist people with a stoma by providing free stoma related products.
  • Ensure continued access to necessary and clinically appropriate dressings, and improve the quality of life for people with Epidermolysis Bullosa.

Major Achievements

  • Developed the Community Pharmacy Service Charter and Customer Service Statement. To be displayed in pharmacies from 1 July 2011, they will provide consumers with a better understanding of the types and level of service they can expect to receive at their pharmacy.
  • Implemented Further Pharmaceutical Benefits Scheme Reforms.
  • Listed 142 new PBS medicines or extensions to existing PBS listed medicines, with a total value of $439.9 million over five years. The PBS medicines included azacitidine for the treatment of certain types of Leukaemia and extension of the listing of nicotine patches for smoking cessation. In addition, one medicine was included on the Life Saving Drugs Program (LSDP) with a total value of $135.9 million over five years.
  • Continued access to National Diabetes Services Scheme for more than one million Australians with diabetes following successful negotiations with Diabetes Australia to improve services and information under the scheme for a further five years.

Challenges

  • Monitoring the changing pharmaceutical wholesaling environment to ensure continued timely
    access to PBS medicines by the Australian community.
  • Administering the listing of new items on the PBS and Life Saving Drugs Program within revised
    approval processes.

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Trends

Figure 2.4.2.1: Government PBS expenditure and cost per capita, 2007-08 to 2010-11

Figure 2.4.2.1: Government PBS expenditure and cost per capita, 2007-08 to 2010-11
Text version of this chart

Note: The Australian population figures used to derive the per capita estimates are based on Australian Bureau of Statistics publication 3101.0.

Program 2.1: Community Pharmacy and Pharmaceutical Awareness

Program 2.1 supports the timely access to medicines and professional pharmacy services through the implementation of the Fifth Community Pharmacy Agreement. It also supports quality use of medicines for Aboriginal and Torres Strait Islander peoples through education and targeted support for consumers and health professionals.

Fifth Community Pharmacy Agreement

The Fifth Community Pharmacy Agreement between the Government and the Pharmacy Guild of Australia provides $15.4 billion over the life of the Agreement from 1 July 2010 to 30 June 2015. The Agreement’s programs and initiatives support community pharmacies to deliver quality professional services and provide timely access to medicines through the PBS.

The enhanced governance arrangements, including a new Programs Reference Group, contributed to improved policy and program outcomes for consumers by ensuring program design, implementation, and evaluation was directly informed by consumer interests and broader expertise from the health sector.

Qualitative Deliverable:Implement revisions to professional programs and services under the Fifth Community Pharmacy Agreement.
2010-11 Reference Point:Establish the Programs Reference Group and agreement on revisions for new and existing programs and services.
Result: Deliverable met.
The Programs Reference Group was established and Terms of Reference agreed at its first meeting in December 2010. The Programs Reference Group members, with broad expertise in the health care sector, met three times and provided substantial policy input to the design, operation and evaluation of programs under the Fifth Community Pharmacy Agreement.

Nine existing programs are continuing under the Fifth Community Pharmacy Agreement, with enhancements to improve targeting and accountability. Three of the six new programs started from 1 July 2011 and a further three will start from 1 July 2012.
As part of the Agreement, and in consultation with consumers, carers and other groups, the department and the Pharmacy Guild of Australia have developed a Community Pharmacy Service Charter.25 Based on the Australian Charter of Health Care Rights, the Community Pharmacy Service Charter seeks to empower consumers through providing information on their rights as well as the responsibilities of pharmacists in delivering quality services and professional care. The Charter covers a number of areas such as access and participation and informing consumers of their rights in terms of making decisions around their medicines. The Charter further allows patients, consumers, families, carers and community pharmacies to have a shared understanding of the rights of people receiving health care.

A Customer Service Statement has also been developed in conjunction with the Charter. This Statement is prepared by individual pharmacies to provide consumers with information about the pharmacy and the professional services it offers.

From 1 July 2011, community pharmacies must display and adhere to both the Charter and Customer Service Statement to access new Pharmacy Practice Incentives.
Qualitative Deliverable:Develop and implement a Patient Service Charter framework.
2010-11 Reference Point:In consultation with key stakeholders, develop a Patient Service Charter that is agreed for use by community pharmacies.
Result: Deliverable met.
The department developed a Community Pharmacy Service Charter and Customer Service Statement in consultation with key stakeholders. The Community Pharmacy Service Charter is based on the Australian Charter of Health Care Rights developed by the Australian Commission for Safety and Quality in Health Care in 2008 and was adapted to the community pharmacy setting. The department consulted with consumers, carers and relevant stakeholders between December 2010 and March 2011. The agreed Charter and accompanying information for pharmacies and consumers were distributed in June 2011.

The Pharmacy Practice Incentives Program will improve patient health outcomes in three priority areas and also introduce three new programs formalising existing services such as clinical interventions, aids for administering doses of medicines, and staged supply of medicines when it is in the patient’s best interest. The Program was officially launched in March, and over 4,000 community pharmacies registered to participate by June 2011.

During 2010-11, the department enhanced two existing medication management programs. The Home Medicines Review Program will be more accessible from 1 October 2011 when general practitioners can directly refer patients to accredited pharmacists, in addition to current arrangements which allow referrals to a community pharmacy. Also from 1 October 2011, collaboration will be required between pharmacists and general practitioners when providing Residential Medication Management Reviews to residents of aged care facilities. These programs continued to provide benefits by reducing the risk to the community of medicine misadventure and related hospital admissions.

During 2010-11, the department developed an assessment tool for a pilot of two new in-pharmacy medication review services: MedsCheck and Diabetes MedsCheck. Findings from the pilot will support a national rollout of the MedsCheck and Diabetes MedsCheck services from 1 July 2012.

Qualitative Deliverable:Provide funding to community pharmacies to support the delivery of professional programs and services.
2010-11 Reference Point:Community pharmacies in rural and remote areas access funding to support the delivery of medication management services.
Result: Deliverable met.
In 2010-11, almost 3% of Home Medicines Reviews were conducted in remote areas, indicating that community pharmacies in these areas are accessing funding to support the delivery of medication management services. Pharmacies also continued to access the rural loading payment for travel for the Home Medicines Review Program, indicating that there has been sustained effort towards providing services to people in rural and remote areas.

Under the Rural Pharmacy Workforce Program, pharmacists in rural and remote Australia received assistance to access professional education, locum services, and pharmacist intern placements. The Aboriginal and Torres Strait Islander Workforce Program provided approved Aboriginal and Torres Strait Islander students with access to 23 Pharmacy Assistant traineeships and three undergraduate or postgraduate Pharmacy scholarships. The program strengthened Aboriginal and Torres Strait Islander participation in the pharmacy workforce, which in turn provided improved, culturally appropriate pharmacy services to better meet the needs of their local Indigenous communities and patients.
Quantitative Deliverable:Number of medication management services provided under the Fifth Agreement.
2010-11 Target:60,0002010-11 Actual:61,353
Result: Deliverable met.
The Home Medicines Review Program met and exceeded the target of 60,000 reviews. The increased uptake of the program indicates that more patients could access services to help them better manage their medicines, reducing the risk of a medicine related adverse event occurring. In addition, the Residential Medication Management Review Program resulted in 137,569 reviews provided to residents of Commonwealth funded Residential Aged Care facilities.

The Community Service Obligation arrangements continued under the Fifth Community Pharmacy Agreement ensure all Australians have timely access to PBS medicines, regardless of location. In 2010-11, a new five year agreement for wholesale distribution of PBS medicines was signed with five full-line pharmaceutical wholesalers and enhanced arrangements from the previous agreement. Under these arrangements, Community Service Obligation wholesalers continue to be financially supported to stock and supply PBS medicines within 24 hours to pharmacies nationally. This was done against the background of evolving distribution networks for PBS medicines.

As a result of the severe Queensland floods in January 2011, arrangements were put in place in flood affected areas to assist Queensland residents who had lost their medication and/or prescriptions. The department collaborated with Medicare Australia, the Pharmacy Guild of Australia and Community Service Obligation distributors to ensure that Queensland residents had continued access to PBS medicines. This included extending existing arrangements to facilitate quick approvals for community pharmacies to trade from new temporary premises, where required, and advising pharmacists of arrangements to allow immediately dispensing of medicines to affected patients.

Qualitative Deliverable:Map Pharmacy Accessibility and Remoteness Index to new Australian Standard Geographic Classifications to support shift to new funding model for rural pharmacy programs.
2010-11 Reference Point:Mapping to new geographical classifications completed by 30 June 2011.
Result: Deliverable substantially met.
The Australian Government announced in the 2009-10 Budget that, under the Rural Health Package, the majority of rural health programs which use remoteness classifications would move to the new Australian Standard Geographic Classifications – Remoteness Area.

The department, in consultation with the Pharmacy Guild of Australia, commenced modelling work during 2010‑11 to identify appropriate options for a transition to the Australian Standard Geographic Classification – Remoteness Area. However, the progressive implementation of a new Australian Geography Standard has been scheduled for commencement from July 2011 by the Australian Bureau of Statistics. This development necessitates further modelling to achieve appropriate transition arrangements for Fifth Community Pharmacy Agreement programs.
Quantitative KPI:Percentage of rural community pharmacies accessing targeted programs to ensure accessibility of community pharmacy in rural and remote Australia.
2010-11 Target:60%2010-11 Actual:83%
Result: Indicator met.
During 2010-11, programs supporting community pharmacy in rural and remote Australia were well accessed. The Rural Pharmacy Maintenance Allowance supports 83% (776 of 926) pharmacies in rural and remote areas, based on their geographical classification under the Pharmacy Accessibility and Remoteness Index of Australia. The Rural Pharmacy Maintenance Allowance Program aims to ensure people in rural and remote areas can access PBS medicine through supporting access to Australia’s rural and remote pharmacy network. It provides income support to pharmacies in rural and remote areas. This recognises the additional financial and personal cost of operating in these areas.

A total of 30 Indigenous Pharmacy Assistant traineeship placements (12 continuing from the Fourth Community Pharmacy Agreement) and 10 Indigenous Pharmacy scholarships (seven continuing from the Fourth Community Pharmacy Agreement) are currently active.
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Improve Access to PBS for Aboriginal and Torres Strait Islander Peoples

The department has implemented the Closing the Gap PBS Co-payment Measure to improve access to PBS medicines by Aboriginal and Torres Strait Islander peoples living with, or at risk of, chronic disease. This measure is available to those who attend a participating general practice or Indigenous Health Service. In its first year of operation from July 2010, more than 79,050 eligible Aboriginal and Torres Strait Islander patients received PBS medicines at no cost or at a concessional rate.

During 2010-11, the department continued the Quality Use of Medicines Maximised for Aboriginal and Torres Strait Islander Peoples Program that commenced in November 2008 as a trial. In 2010-11, over 192,000 eligible Aboriginal and Torres Strait Islander patients registered with Aboriginal Community Controlled Health Services and received quality use of medicines support. An independent program evaluation, released in June 2011, found the program was successful in achieving key program objectives of improving access to PBS medicines, and supporting medication compliance and quality use of medicines for Aboriginal and Torres Strait Islander peoples in rural and urban areas of Australia.
Quantitative Deliverable:Number of patients issued a Closing the Gap prescription through the PBS Co‑payment Measure under the Indigenous Chronic Disease Package.
2010-11 Target:20,0002010-11 Actual:79,076
Result: Deliverable met.
Uptake of the PBS Co-payment Measure has been higher than anticipated, significantly exceeding the target of 20,000. In 2010-11, 79,076 patients were issued with a Closing the Gap prescription. The average number of additional patients per month assisted under the measure for the last ten months of 2010-11 was 6,200. This growth rate is expected to continue for at least several more months due to the ongoing promotion of the measure to general practitioners, Aboriginal Health Services and pharmacists. The positive uptake of the measure indicates higher than expected awareness of this measure by prescribers resulting in eligible patients receiving access to more affordable PBS medicines to manage chronic disease.
Qualitative KPI:Successful implementation and uptake of the Subsidising PBS Medicine Co-payments Measure by community pharmacies.
2010-11 Reference Point:Uptake of claims from 1 July 2010, and stakeholder satisfaction with the Measure.
Result: Indicator met.
All dispensing software was upgraded with Closing the Gap processing functionality. This measure has reduced the cost of PBS medications for many Indigenous Australians. Feedback from stakeholders indicates that they recognise the significant benefits resulting from the introduction of the measure. A total of 827,493 PBS prescriptions were dispensed from 3,694 community pharmacies under this measure.
Qualitative KPI:Improved management of medicines for Aboriginal and Torres Strait Islander patients.
2010-11 Reference Point:Overall evaluation of the Indigenous Chronic Disease Package indicates that the Subsidising PBS Medicine Co-payments Measure has contributed to these outcomes.
Result: Indicator met.
The Sentinel Sites Evaluation Report – December 2010 indicates that stakeholders believe access to cheaper PBS medication often translated into medications being taken more readily by Aboriginal and Torres Strait Islander patients.
Quantitative KPI:Percentage of Aboriginal Community Controlled Health Services participating in the Subsidising PBS Medicine Co-payments Measure.
2010-11 Target:80%2010-11 Actual:95.7%
Result: Indicator met.
Uptake of the measure by Indigenous Health Services has been higher than anticipated. This indicates a high level of awareness of this program among Indigenous health services.
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National Prescribing Service

The department has continued its commitment to quality use of medicines through the work of the National Prescribing Service. The National Prescribing Service has expanded the reach of its education programs for health professionals from 12,727 in 2009-10 to 13,149 in 2010-11. Increased participation of general practitioners and specialists in activities such as case studies and clinical audits leads to a reduction in inappropriate prescribing and a saving in PBS expenditure.

Additionally, the National Prescribing Service has undertaken a mass media campaign, Be Medicine Wise, aimed at making consumers more aware of their medicines. This campaign included the Brand Choice campaign26, which commenced on 3 April 2011 and includes an enhanced media presence and supporting resources (print and web) for health professionals and consumers.

National Return and Disposal of Unwanted Medicines Program

The purpose of the National Return and Disposal of Unwanted Medicines (NatRUM) Program is to collect consumers’ expired and unwanted medicines through the Community Pharmacy network to help avoid, among other things, accidental childhood poisoning and medication misuse. The program contributes to the Quality Use of Medicines through disposing of these medicines in a safe and environmentally friendly manner, predominantly using high temperature incineration. Consumers are able to return their expired and unwanted medicines to all community pharmacies across Australia (approximately 5,000). There is no fee charged either to consumers or pharmacies for this service.

Following the severe flooding in Queensland, New South Wales and Victoria in January 2011, emergency collection and disposal of flood damaged medicines was actioned by the National Return and Disposal of Unwanted Medicines Program. The additional collections increased substantially compared to usual business, adding approximately $50,000 in costs.
This program has been running for 12 years, and was the first service of its kind in the world. Even now, Australia is one of only a few countries who provide for this type of service. During 2010-11, the National Return and Disposal of Unwanted Medicine Program collected 565 tonnes at an average of 47 tonnes per month, increased from 440 tonnes in 2009-10 with an average of around 37 tonnes per month.

Figure 2.4.2.2: NatRUM Collections Between 2000-01 and 2010-11

Figure 2.4.2.2: NatRUM Collections Between 2000-01 and 2010-11
Text version of this chart

Whole of Program Performance Information

Qualitative Deliverable:Produce relevant and timely evidence‑based policy research.
2010-11 Reference Point:Relevant evidence‑based policy research produced in a timely manner.
Result: Deliverable met.
The department entered into funding arrangements to support the Research and Development Program over the life of the Fifth Community Pharmacy Agreement, which aims to contribute to maintaining and improving the health outcomes of Australians through evidence-based best practice in issues related to pharmacy and the provision of quality services to consumers. Commissioned projects will address six identified topic areas: Consumer Needs; Mental Health; Rural Pharmacy Workforce; Health Literacy; Professional Integration and Chronic Illness.
Qualitative Deliverable:Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
Stakeholders were widely consulted across a range of programs and services. A total of 35 submissions were received following the public distribution of consultation papers on 9 March 2011, relating to Electronic Recording and Reporting of Controlled Drugs, Continued Dispensing in Defined Circumstances and Supply and PBS Claiming from a Medication Chart in Residential Aged Care Facilities. These programs have been supported by regular consultative committee meetings. The department has also sought further stakeholder participation through direct discussion with health care providers and their representative organisations and presentations at conferences attended by pharmacists and health care professionals working in the aged care setting.
Quantitative Deliverable:Percentage of variance between actual and budgeted expenses.
2010-11 Target:0.5%2010-11 Actual:0.8%
Result: Deliverable substantially met.
Several large demand driven programs are administered under Program 2.1, some of which have parameters that change throughout the year.
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Program 2.2: Pharmaceuticals and Pharmaceutical services

Program 2.2 aims to improve health outcomes by listing cost effective, new, innovative and clinically effective medicines on the PBS and by improving the community’s access to a range of pharmaceutical benefits when prescribed by appropriately trained and certified health professionals. The department also undertakes a range of activities to increase the sustainability of the PBS to ensure Australians continue to have access to cost effective medicines. This includes improving the evidence base for prescribing decisions and the effectiveness of PBS listed medicines.

Pharmaceutical Benefits Scheme

The PBS aims to provide Australians with timely access to a wide range of affordable and cost effective medicines. In 2010-11, the PBS subsidised more than 760 medicines available in more than 1,960 forms and marketed as more than 3,950 differently branded items.

Stakeholder Engagement

During 2010-11, the National Medicines Policy advisory structure continued to implement the key National Medicines Policy priorities. In relation to the evidence into practice and policy priority, work commenced to develop a revised version of the guidelines for medication management in residential aged care facilities. The 2010 National Medicines Policy Partnerships Forum was attended by more than 125 stakeholders who came together to discuss the important theme of Informed and Active Consumers, another of the key National Medicines Policy priorities. The outcomes from this event were used by the advisory structure to identify five key areas to improve medicines information and resources for consumers, which are continuing to be progressed in collaboration with key stakeholders. The department has continued to work with the pharmaceutical industry to advise the Minister for Health and Ageing on how medicines can be supplied more effectively through the PBS. This includes work through the Access to Medicines Working Group on implementing and monitoring activities under the Memorandum of Understanding with Medicines Australia. The Memorandum of Understanding, announced in the 2010-11 Budget, is estimated to achieve around $1.9 billion in PBS savings over five years.

Qualitative Deliverable:Provide advice to Minister for Health and Ageing on streamlining PBS processes.
2010-11 Reference Point:Advice provided to the Minister in a timely manner.
Result: Deliverable met.
The Minister was advised promptly about the implementation of parallel processing and the managed entry scheme. Advice about the listing of high cost drugs, covered in the Memorandum of Understanding, was provided to the Minister following each meeting of the Pharmaceutical Benefits Advisory Committee.

The department also established the Generic Medicines Working Group in 2010-11. This is a high level strategic generics industry forum with representatives from the department and the Generics Medicines Industry Association, and provides advice on how Australian policy settings both facilitate and make use of generic medicines in meeting the objectives of the National Medicines Policy.

Quantitative KPI:Percentage of prescriptions listed on the Schedule of Pharmaceutical Benefits subsidised under the PBS.
2010-11 Target:80%2010-11 Actual:80%
Result: Indicator met.
The estimate of the proportion of subsidised prescriptions listed on the Schedule of Pharmaceutical Benefits was 80% for the period 1 July 2010 to 30 March 2011. The remaining 20% of prescriptions were priced at or under the co-payment level (currently $34.20) and dispensed to general, non-safety net patients.27
Quantitative KPI:Number of prescriptions subsidised through the PBS.
2010-11 Target:201m2010-11 Actual:188m
Result: Indicator substantially met.
188 million PBS prescriptions were subsidised, representing approximately 8.4 prescriptions per capita.
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Increase Sustainability of the Pharmaceutical Benefits Scheme

Growth of the Pharmaceutical Benefits Scheme

During 2010-11, PBS growth, excluding revenue, was 5.7%. This growth takes into account the impact of PBS reform measures implemented in 2007 and 2010. PBS growth is influenced by a number of factors, including the prices of existing PBS medicines and changes in price over time. The factors also include the number and cost of new medicines added to the PBS, population growth, the level of coverage by concession cards, the number of prescriptions dispensed, and the amount that patients contribute towards the cost of prescriptions.27

Memorandum of Understanding with Medicines Australia

The Memorandum of Understanding with Medicines Australia was announced in the 2010-11 Budget. It contains key deliverables and is estimated to achieve around $1.9 billion in PBS savings over five years in exchange for new policy development in some areas and pricing stability during its operation.
The department has met all critical deliverables contained in the Memorandum of Understanding: the statutory price reductions of 2% and 5% came into effect on 1 February 2011 for all non-exempt medicines on the F2 formulary28: the Expanded and Accelerated Price Disclosure Program commenced on 1 December 2010; and on 1 January 2011 the new Managed Entry Scheme and Parallel Therapeutic Goods Administration and Pharmaceutical Benefits Advisory Committee (PBAC) processes for registration and reimbursement evaluation of major submissions came into effect.

Expanded and Accelerated Price Disclosure Policy

Price disclosure policy, which was introduced in 2007, was accelerated and expanded to include all medicines on the F2 formulary, making the disclosure of pricing information mandatory for all non-exempt pharmaceutical items containing medicines listed on the F2. An external service provider, Australian Healthcare Associates (AHA) was engaged to provide data services relating to the program including receipt of price disclosure data from manufacturers of medicines, reminding manufacturers of deadlines for provision of data, and running calculations to determine the weighted average market price. AHA was selected following an open tender process.
As part of this contract, AHA developed a dedicated data collection tool to assist companies subject to the Expanded and Accelerated Price Disclosure policy. This was delivered to companies on 31 March 2011. Positive feedback on the new processes has been received from industry, including recognising the reduced burden of only having two data collection points instead of four, under the new arrangements.
Qualitative Deliverable:Provide advice to affected sponsors of outcomes from price disclosure, three times a year, based on calculations from data collection.
2010-11 Reference Point:Data collection and calculations completed in a timely manner to allow determination and notification to be made in accordance with regulations.
Result: Deliverable met.
Data collection for the first part of the first main cycle of Expanded and Accelerated Price Disclosure has been completed. 112 out of 115 separate data submissions were received by the deadline on 12 May 2011 and the remaining three have subsequently been received.
Qualitative Deliverable:Put in place a dispute resolution framework for PBS price disclosure by 2010-11.
2010-11 Reference Point:Dispute resolution framework implemented in a timely manner.
Result: Deliverable met.
A dispute resolution process has been developed with and agreed to by industry through the Price Disclosure Working Group in February 2011, and presented to industry at the Price Disclosure Education Workshops in Sydney and Melbourne in March 2011.
Quantitative Deliverable:Percentage of notification to affected sponsors of outcomes from price disclosure calculations.
2010-11 Target:100%2010-11 Actual:100%
Result: Deliverable met.
In 2010-11, all sponsors affected by price disclosure related price reductions were notified prior to the reduction taking place.
Qualitative KPI:Achieve better value from medicines that are subject to price competition by applying price disclosure processes.
2010-11 Reference Point:Accurate and timely price disclosure calculations and notification to affected sponsors.
Result: Indicator met.
In 2010-11, determinations were made for the fifth, sixth and seventh rounds of price disclosure, resulting in price reductions on 1 April 2011 and 1 August 2011. Consistent with the relevant legislative requirements for price disclosure, all affected sponsors were notified more than six months prior to the reduction dates.
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Medicine Price Reductions

By 30 June 2011, as a result of the Expanded and Accelerated Price Disclosure policy, 272 medicines across over 1,600 brands are now subject to price disclosure provisions. To date, calculations have been performed on 45 medicines with price reductions ranging from between 10% and 72%.
These price reductions will contribute to the sustainability of the PBS by ensuring that the Government and Australian taxpayers get value for money for medicines supplied through the PBS. In some cases, these price reductions may also result in direct savings to patients. For example, as a result of price disclosure, the price of some vancomycin items was reduced from $45.80 to $17.96 on 1 April 2010, with a second round of price disclosure reductions to $16.52 on 1 April 2011. This means that a general patient paying the usual co‑payment of $34.20 would now pay $16.52, a saving of $17.68.
Quantitative KPI:Estimated savings to Government from the price disclosure program.
2010-11 Target:$38.0m292010-11 Actual:$42.5m
Result: Indicator met.
Price disclosure saved the Government $42.5m in 2010-11. Price disclosure-related price reductions are an adjustment of the prices the Commonwealth pays for heavily discounted drugs, to more closely reflect the prices at which the drugs are supplied to the pharmacist. Reductions occurring in 2010-11 ranged from 11.9% to 61.4%.
Quantitative KPI:Estimated saving to Government from Further PBS Reform.30
2010-11 Target:$30.7m2010-11 Actual:$30.0m
Result: Indicator met.
Further PBS Reform saved the Government $30.0m in 2010-11. This includes implementation costs, savings from the 2% and 5% reductions on 1 February 2011 in the prices of all medicines listed on the F2A and F2(T) formularies respectively on 11 October 2010; and savings from the 1 February 2011 increase from 12.5% to 16% in the statutory price reduction applied to all medicines when their first generic competitor lists on the PBS.

Streamlined Listing Processes

Two new initiatives that commenced on 1 January 2011 aim to streamline the PBS listing process. These initiatives will benefit patients by speeding up the time taken to list innovative medicines on the PBS.

Under the Parallel Processing Initiative, a submission to PBAC may be lodged at any time from the date of lodgement of the Therapeutic Good Administration registration dossier. The implementation of parallel processes brings greater overlap between the two technical areas and streamlines the regulatory and reimbursements approvals. PBAC considered the first submissions lodged under the new parallel processing arrangements at its July 2011 meeting. Of the 31 submissions considered at this meeting, 12 were submitted under the Parallel Processing Initiative.

The objective of the Managed Entry Scheme is to develop a mechanism under which PBAC may recommend listing of a medicine at a temporary price justified by existing evidence, pending submission of more conclusive evidence of cost effectiveness which may justify a higher future price. This scheme ensures Australians’ access to medicines of high clinical need is not delayed due to price negotiations.
Quantitative Deliverable:Percentage of submissions to the PBAC for PBS listings that are considered within 17 weeks of lodgement.
2010-11 Target:100%2010-11 Actual:100%
Result: Deliverable met.
In 2010-11, all submissions lodged with the secretariat of the PBAC, on or before the advertised cut-off date, were considered by the committee at its next scheduled meeting, within 17 weeks of lodgement.
Qualitative KPI:Develop strategies with consumer groups to encourage consumers to participate in the consideration of PBAC submissions.
2010-11 Reference Point:Strategies developed in a timely manner.
Result: Indicator met.
Throughout 2010-11, the PBAC Secretariat engaged with consumer groups and stakeholders, such as the Consumers Health Forum, CF Australia, to enhance the input of consumers into the consideration of submissions by the PBAC. In 2010-11, there were 288 consumer submissions on matters before the PBAC, which was higher than the 187 received in 2009-10. Consumer comments on medicines under consideration by the PBAC are sumarised and provided to the medicine’s sponsor and are taken into account by the committee in its decision making process.
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PBS Cost Recovery Arrangements

Cost recovery arrangements for the listing of new medicines or vaccines, or to vary the listing of existing products, were introduced from 1 January 2010. Applying for a listing is a commercial decision of the product sponsor.
Revenue from 1 July 2010 to 30 June 2011 was estimated to be $14.0 million based on the anticipated number and types of submissions and the number of granted waivers and exemptions in line with the requirements specified in regulations, which were in draft form at the time.
Quantitative KPI:Revenue received from the cost recovery of the PBS listing process.
2010-11 Target:$14.0m2010-11 Actual:$7.821m
Result: Indicator not met.
PBS Cost Recovery is demand driven. Revenue depends on factors outside the control of the department, such as the type and number of submissions, and the number of waivers and exemptions applicable.

New Medicine Listings

The PBAC is an independent, expert advisory body which makes recommendations to the Government about PBS listings. Each year, an annual report on the processes leading up to the PBAC consideration is prepared and tabled in Parliament. The report for the 2010-11 financial year is at Appendix 2.

PBAC assesses the therapeutic benefits and cost effectiveness of medicines, including comparisons with other treatments. PBAC membership includes medical specialists, general practitioners and other health professionals, and also consumer representation. PBAC meets three times a year in March, July and November, and the agenda is published on the department’s website six weeks prior to each meeting.

A medicine cannot be included on the PBS unless PBAC recommends to the Government that it be listed. Therefore, a positive PBAC recommendation is a very important step in the listing process.

Qualitative Deliverable:The PBAC meets at least three times a year and provides recommendations to the Minister on new listings for the PBS.
2010-11 Reference Point:The PBAC recommendations for listing on the PBS are based on the clinical effectiveness and the cost effectiveness of new medicines, and provided in a timely manner.
Result: Deliverable met.
New listings on the PBS must be clinically effective and cost effective. In 2009-10, PBAC considered 216 submissions, of which 73 were major submissions requiring cost effectiveness analysis, and 143 were minor submissions which did not require a cost effectiveness analysis.

PBAC, when considering the listing of a new medicine on the PBS, must take into account the requirements of the National Health Act 1953, that the treatment be clinically effective, and cost effective.

In 2010-11, PBAC considered 191 submissions, of which 63 were major submissions requiring cost effectiveness analysis, and 128 were minor submissions which did not require a cost effectiveness analysis. PBAC recommendations were provided to product sponsors and the Minister for Health and Ageing and made publicly available in timeframes consistent with long standing arrangements agreed
with industry.

Quantitative Deliverable:Percentage of Public Summary Documents, including recommendations, released 16 weeks after each PBAC meeting.
2010-11 Target:100%2010-11 Actual:100%
Result: Deliverable met.
In 2010-11, all Public Summary Documents, except for those submissions that were rejected for the first time by the PBAC, were released 16 weeks after each meeting of PBAC. All Public Summary Documents for ‘first time rejections’ were released 18 weeks after the relevant meeting, as agreed under the Australian-United States Free Trade Agreement.
Quantitative Deliverable:Percentage of applications for consideration at next Pharmaceutical Benefits Advisory Committee meeting published on the department’s website to allow for public comment.
2010-11 Target:100%2010-11 Actual:100%
Result: Deliverable met.
In 2010-11, all submissions lodged with the secretariat of the PBAC, on or before the advertised cut-off date, were published on the department’s website to allow for public comment.

The Pharmaceutical Benefits Pricing Authority (PBPA) is an independent, non-statutory body established by the Minister for Health and Ageing. As part of its responsibilities, the PBPA reviews prices of all brands of pharmaceutical items listed on the PBS at least once each year. This year, for the first time, the PBPA Annual Report is included as an appendix to the departmental Annual Report (Appendix 3) for consistency with that of the PBAC.

In accordance with the Memorandum of Understanding with Medicines Australia, for those submissions requiring Cabinet approval, the Government has undertaken to use its best endeavours to implement a maximum time frame of six months for consideration and decision by Cabinet. The six months commences from the date of notification by the department to the sponsor that pricing is agreed. This arrangement applies to submissions considered by PBAC from its July 2010 meeting onward. For the high cost medicines31 listed in 2010-11, subject to the provisions of the Memorandum of Understanding, the average time from the date of the pricing agreement to Cabinet consideration was about 3.5 months.32 Two of these medicines, fingolimod and levodopa with carbidopa, were considered by Cabinet within one month of the proposed price being agreed.

Given the current fiscal environment, the Government decided in 2010-11 that all positive recommendations made by PBAC and the PBPA for new or amended PBS listings and price increases which have a financial impact for Government, will be considered by Cabinet. Previously, Cabinet consideration was only required for the listing of high cost medicines with a cost greater than $10 million. Since the introduction of these arrangements, additions and changes to the PBS and Life Savings Drug Program recommended by the PBAC have generally been listed in accordance with established timeframes under the revised approval process.

In 2010-11, the listing of the following high cost medicines was announced.

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Table 2.4.2.1: High cost medicine listings announced in 2010-11

Medicine Indication Listing date Est. no. patients p.a. Est. expenditure – 5 yrs
Azacitidine Certain types of Leukaemia 1 February 2011 670 $124.2 million
Dutasteride Benign prostate enlargement 1 February 2011 84,000 $77.1 million
Extension of the listing of nicotine patches Smoking cessation 1 February 2011 72,000 $54.5 million
Extension to the listing of varenicline Smoking cessation 1 February 2011 11,000 $48.9 million
Romiplostim Rare blood disorder 1 April 2011 300 $73.0 million
Levodopa with carbidopa Parkinson Disease 1 May 2011 190 $49.2 million
Cetuximab Late stage bowel cancer 1 September 2011 2,700 $272.9 million
Fingolimod Multiple Sclerosis 1 September 2011 2,500 $184.8 million

In 2010-11, 142 new medicines or extensions to existing PBS listed medicines were added to the PBS at a net cost of $439.9 million over five years. During the same period, given the current fiscal environment, the listing of seven medicines was deferred until fiscal circumstances permit. One of the deferred medicines, dutasteride with tamsulosin, was listed on the PBS on 1 August 2011.

Qualitative Deliverable:Price negotiations with sponsors and conditions for listing finalised, and quality and availability checks undertaken for new PBS listings.
2010-11 Reference Point:All negotiations and listing activity completed in a timely manner.
Result: Deliverable met.
The listing requirements for the 142 new medicines or extensions to existing PBS listed medicines listed on the PBS (after consideration by PBAC and approval by the Government, against appropriate criteria such as quality, availability and price), were completed in a timely manner, taking into account that the department must negotiate outcomes with sponsors.
Deferred listings will be reconsidered by Government when appropriate to do so, and do not need to be reconsidered by PBAC or the PBPA, unless a sponsor seeks a price change or presents further clinical evidence to support a new price.

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Nurse Practitioners and Midwives

In November 2010, following broad consultation and clinical input from key stakeholders, nurse practitioners and midwives were given access to prescribe certain medicines on the PBS, deemed appropriate by PBAC.

PBS items listed for midwife and nurse practitioner prescribing, were widely consulted through the formation, by the department, of technical advisory groups. The results of these consultations were considered and recommended by PBAC and later approved by the Minister for Health and Ageing for listing on the Schedule of Pharmaceutical Benefits. Medicines are identified in the schedule by the annotation ‘MW’ for midwives and ‘NP’ for nurse practitioners.33

All new submissions to PBAC to consider the listing of medicines (or changes to listings) are considered for all prescriber groups. Therefore the midwife and nurse practitioner prescribing lists are under regular review/update.

Qualitative Deliverable:Implement PBS Prescribing for nurse practitioners and midwives.
2010-11 Reference Point:Implementation from 1 November 2010.
Result: Deliverable met.
PBS prescribing for nurse practitioners was implemented from 1 November 2010. Eligible nurse practitioners and eligible midwives were able to apply to Medicare Australia from 1 July 2010 to become authorised to prescribe PBS medicines. Authorised nurse practitioners and authorised midwives were able to prescribe PBS listed medicines, from their respective medicine lists from 1 November 2011.
Qualitative Deliverable:PBS medicines list for nurse practitioners and midwives in place by November 2010.
2010-11 Reference Point:Medicines list in place by November 2010.
Result: Deliverable met.
The PBS medicines list for both nurse practitioners and midwives was published in the Schedule of Pharmaceutical Benefits on 1 November 2010.
Quantitative KPI:Number of PBS prescriptions written by midwives.
2010-11 Target:9,5352010-11 Actual:Nil
Result: Indicator not met.
A midwife must be an authorised midwife to prescribe PBS medicines. To be an authorised midwife, a midwife must meet registration standards for eligible midwives (including education) as developed by the Nursing and Midwifery Board of Australia and determined in the National Health (Eligible Midwives) Determination 2010.

The Nursing and Midwifery Board of Australia requires midwives to complete approved, accredited prescribing courses, to be endorsed to prescribe as an authorised midwife.

In 2010-11, there were no courses for prescribing by authorised midwives accredited by the Nursing and Midwifery Board of Australia. The department has been working with the National Prescribing Service to address the issue of developing prescribing courses. A number of institutions are in the process of developing courses in the next 6-12 months. The department will provide scholarships to eligible midwives to enrol in these courses, once the courses are accredited.
Quantitative KPI:Number of PBS prescriptions written by nurse practitioners.
2010-11 Target:133,7422010-11 Actual:7,541
Result: Indicator not met.
The number of prescriptions written and dispensed is driven by the number of authorised nurse practitioners practising in the private sector, their ability to write prescriptions under state and territory law and patient acceptance of nurse practitioners as treating health professionals.
While take-up has been slower than predicted, the number of prescriptions dispensed per month has been growing toward the end of 2010-11.
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Whole of Program Performance Information

Qualitative Deliverable:Produce relevant and timely evidence-based policy research.
2010-11 Reference Point:Relevant evidence‑based policy research produced in a timely manner.
Result: Deliverable met.
One of the current priorities for the National Medicines Policy is evidence into practice and policy. During 2010-11, the National Medicines Policy advisory structure has undertaken preliminary work to inform advice being prepared for the Government regarding the quality use of medicines in relation to opioid analgesics and the use of antipsychotic medicines by older people.

The department and Medicines Australia have commenced the joint monitoring of PBS growth trends and drivers under the Memorandum of Understanding with Medicines Australia to better inform both the department and industry of the factors influencing PBS expenditure growth and to provide a firmer evidence base for future PBS policy initiatives.

The department has conducted a review of the practice of applying copyright protection as a barrier to entry for bio‑equivalent generic medicines. The copyright protection concerns product information and the review concluded that recent reforms to the Copyright Act 1968 will have a significant impact in reducing the occurrence of this practice.

Qualitative Deliverable:Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
Regular meetings, both formal (including the Access to Medicines Working Group, the Generic Medicines Working Group and the Pharmaceutical Industry Working Group) and informal, have provided industry with an opportunity to discuss medicines and industry issues, including the uptake of generic medicines. Issues around the National Medicines Policy, particularly those relating to medicines packaging, labelling and the availability of quality medicines information for consumers, are part of an open and ongoing dialogue with stakeholders at regular meetings of the National Medicines Policy advisory structure.

The department has established the Similar Biological Medicinal Products Working Group with representatives from all sectors of the medicines industry to provide a consultative forum for the consideration of regulatory and reimbursement issues associated with these products, also known as follow-on biologics. Options developed by the working group will be presented to the Minister for Health and Ageing and the Australian Government for consideration.

The department has made improvements to the PBS website34 in consultation with key consumer stakeholders to better meet the needs of consumers. These include the addition of answers to Frequently Asked Questions, automated notification of updates to the website and improved access to the PBAC agenda. The department incorporated a consumer focus to the Joint Medicines Policy Conference to be held in August 2011.

Quantitative Deliverable:Percentage of variance between actual and budgeted expenses.
2010-11 Target:0.5%2010-11 Actual:2.9%
Result: Deliverable not met.
Several large demand driven programs are administered under Program 2.2, some of which have parameters that change throughout the year.

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Program 2.3: Targeted Assistance - Pharmaceuticals

Program 2.3 aims to improve access to new and existing medicines for patients with life threatening conditions.

Life Saving Drugs Program

The Life Saving Drugs Program provides subsidised access, for eligible patients, to expensive life saving drugs for very rare life-threatening conditions. During 2010-11, nine drugs were funded through the program for the treatment of 210 patients with seven separate disorders including: imiglucerase (Cerezyme®) and miglustat (Zavesca®) to treat Gaucher disease; agalsidase alfa (Replagal®) and algalsidase beta (Fabrazyme®) for Fabry disease; laronidase (Aldurazyme®) for Mucopolysaccharidosis (MPS) Type I; idursulfase (Elaprase®) for MPS Type II; galsulfase (Naglazyme®) for MPS Type VI; alglucosidase alfa (Myozyme®) for infantile-onset Pompe disease; and eculizumab (Soliris®) for Paroxysmal Nocturnal Haemoglobinuria.

Each condition has separate eligibility guidelines, developed and administered with the advice of an expert disease advisory committee, and any amendments are submitted to PBAC for consideration.
The department continued to implement Government decisions arising from the 2009 review of the Life Saving Drugs Program to improve the listing process and rigour of the program. This included submission of the first annual report to PBAC in April 2011, which provided information such as the number of patients receiving treatment, patient indication for treatment, patient response to treatment, and a description of any significant events that took place in 2010.

The department implemented alternative access arrangements for Fabrazyme®, following a review and recommendation by PBAC of the comparative efficacy and safety of Replagal® and Fabrazyme®.
The global shortage of Fabrazyme® and Cerezyme®, due to manufacturing issues, significantly impacted on the availability of these drugs through the Life Saving Drugs Program for treating Fabry and Gaucher diseases. The department worked with industry and clinical advisory committees to minimise the impact of the supply shortage.

Qualitative Deliverable:Provide funding to facilitate the treatment of eligible patients through the Life Saving Drugs Program.
2010-11 Reference Point:Timely allocation and expenditure of funding.
Result: Deliverable met.
All applications were assessed, and all patients were reviewed every six months against the relevant eligibility criteria for the respective disease. Drug orders were placed in a timely manner and risk share arrangements were in place for the majority of suppliers to cap Commonwealth expenditure.
Quantitative Deliverable:Number of patients assisted through the Life Saving Drugs Program.
2010-11 Target:1912010-11 Actual:210
Result: Deliverable met.
The department provided assistance to 210 patients through the Life Saving Drugs Program. All eligible patients who met the criteria for access to the program were assisted in 2010-11. The higher than forecast number is a result of the demand‑driven nature of the program and patient access to a new drug listed during this period.
Qualitative KPI:Eligible patients have timely access to the Life Saving Drugs Program.
2010-11 Reference Point:Patient applications processed within 30 calendar days of receipt.
Result: Indicator met.
All applications were processed and fully subsidised medicines provided within 30 calendar days of receipt of complete applications.
Quantitative KPI:Percentage of eligible patients with access to fully subsidised medicines through the Life Saving Drugs Program.
2010-11 Target:100%2010-11 Actual:100%
Result: Indicator met.
The department provided fully subsidised medicines to eligible patients, however, due to global supply shortages of Fabrazyme® and Cerezyme®, the dose for some patients was reduced. This was managed in consultation with relevant clinical advisory committees and the doctors of affected patients.

Whole of Program Performance Information

Qualitative Deliverable:Produce relevant and timely evidence‑based policy research.
2010-11 Reference Point:Relevant evidence‑based policy research produced in a timely manner.
Result: Deliverable met.
The department submitted the first Life Saving Drugs Program Annual Report to PBAC, including patients’ responses to treatment and an analysis of significant events that impacted on the administration of the Life Saving Drugs Program. Analysis on proposals for new drugs to be subsidised through the Life Saving Drugs Program were provided to Government in a timely manner.
Qualitative Deliverable:Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
The department held 20 Disease Advisory Committee meetings in 2010-11, which provided advice on clinical management issues. The department also consulted with external stakeholders on draft guidelines for PBAC submissions, where sponsors seek to list a drug on the Life Saving Drugs Program.
Quantitative Deliverable:Percentage of variance between actual and budgeted expenses.
2010-11 Target:0.5%2010-11 Actual:24.7%
Result: Deliverable not met.
Several large demand driven programs are administered under Program 2.3, some of which have parameters that change throughout the year.
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Program 2.4: Targeted Assistance – Aids and Appliances

Program 2.4 aims to increase the affordability of diabetes products and services for people of all ages with type 1, type 2, gestational and other diabetes and provides subsided insulin pumps and associated consumables for children under 18 years of age with type 1 diabetes. Program 2.4 also aims to assist people with stomas by providing free stoma related products; and ensure access to clinically appropriate dressings to improve quality of life for people with Epidermolysis Bullosa.

National Diabetes Services Scheme

The department completed successful negotiations for a new five year agreement with Diabetes Australia to continue the administration of the National Diabetes Services Scheme. The scheme aims to ensure that people with diabetes have access to subsidised products and services needed for the self management of diabetes. To inform the negotiation process, and look for scheme growth and improvement opportunities, the department consulted with 38 scheme stakeholders including state and territory diabetes organisations, the Pharmacy Guild of Australia, the Juvenile Diabetes Research Foundation and manufacturers of diabetes products. At 30 June 2011 more than one million people were registered on the scheme.

Type 1 Diabetes Insulin Pump Program

The department continued to monitor the delivery of the program to ensure it provides appropriate assistance to children with type 1 diabetes.

The department, in conjunction with the Juvenile Diabetes Research Foundation which administers the program, will conduct a review of the program in 2011-12 to ensure that it continues to meet its objective of subsidising the cost of insulin pumps for eligible families who have children with type 1 diabetes. In 2010-11, 117 people received subsidised insulin pumps through the program.

Qualitative Deliverable:Information about the type 1 Diabetes Insulin Pump Program is communicated to healthcare professionals and families of children with type 1 diabetes.
2010-11 Reference Point:Program communications activities are delivered in a timely and effective manner.
Result: Deliverable met.
The Juvenile Diabetes Research Foundation conducted a communication campaign during March 2011, which provided relevant health professionals and families of children with type 1 diabetes with information about the program.

This campaign included a direct mail out through the National Diabetes Service Scheme and provision of a support package for health professionals.

Quantitative Deliverable:Number of people under 18 years of age with type 1 diabetes receiving a subsidised insulin pump.
2010-11 Target:2332010-11 Actual:117
Result: Deliverable not met.
This is a demand driven program. While this number is lower than the target, the increase to subsidy levels in March 2010 and the communication activities conducted by the Juvenile Diabetes Research Foundation in 2011 are influencing growth in subsidy applications. The department will review the program in 2011-12 to ensure that it meets its intended aim of providing subsidised insulin pumps to eligible children under 18 with type 1 diabetes.
Qualitative KPI:Monitor the impact of changes to the type 1 Diabetes Insulin Pump Program.
2010-11 Reference Point:Monitoring concludes that the program meets its intended aim of assisting families with children under 18 with type 1 diabetes with the cost of purchasing insulin pumps.
Result: Indicator met.
The department has analysed program participation rates and clinical information provided by the Juvenile Diabetes Research Foundation. Although the number of insulin pump subsidies provided in 2010-11 grew largely due to the changes made to the program in 2010 and the communication activities conducted in 2011, only 50% of the target was achieved.

The department will continue to monitor the impact of these changes and will conduct a comprehensive review of the program in 2011-12 to ensure that it fully meets its objective of subsidising the cost of insulin pumps for eligible families who have children with type 1 diabetes.
Quantitative KPI:Percentage of eligible applicants receiving subsidised insulin pumps.
2010-11 Target:100%2010-11 Actual:100%
Result: Indicator met.
All applicants who satisfied the eligibility criteria and proceeded with their application to participate in the program received subsidised insulin pumps.
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Stoma Appliance Scheme

The department implemented a revised program framework for the Stoma Appliance Scheme, including a new method of pricing products and a new application and assessment process for listing new products on the Scheme. The revised program framework will ensure that Scheme participants have access to new and innovative stoma products and will also improve the Scheme’s sustainability. In 2010-11, almost 40,000 participants accessed subsidised stoma related products through the Scheme.

During 2011-12, the department will monitor the operation of the Scheme’s new program framework and continue to review products which are provided under the Scheme to ensure that they are consistently priced.

Qualitative Deliverable:Eligible people with stomas are provided access to new and innovative stoma products appropriate for their conditions.
2010-11 Reference Point:New stoma products are approved and listed in a timely and effective manner.
Result: Deliverable not met.
Although no new products were listed on the scheme during 2010-11, there are more than 420 products available to assist eligible people effectively manage their condition. A new application and assessment process will ensure that new and innovative products are considered by the Government for future listing.

The department reopened the application process to assess new products in June 2011. The first products to be assessed under the new arrangements will be considered for potential listing during 2011-12.

Quantitative Deliverable:Number of people receiving stoma related products.
2010-11 Target:38,5002010-11 Actual:39,023
Result: Deliverable met.
The Stoma Appliance Scheme is a demand driven program and the number of people assisted varies throughout the year. The number of people who accessed the program in 2010-11 was higher than anticipated. This is directly related to the number of ostomy surgeries performed during the year.
Qualitative KPI:Evaluate the implementation of a sustainable listing and pricing process for the Stoma Appliance Scheme.
2010-11 Reference Point:Evaluation concludes that approved new listings have been added to the Stoma Appliance Scheme’s Schedule in a sustainable manner.
Result: Indicator not met.
The department opened the revised application process to list new products on the Stoma Appliance Scheme in June 2011 and implemented a revised pricing structure for the scheme which came into effect on 1 July 2011. The department’s assessment panel is expected to consider applications to list new products during 2011-12.

The department will continue to evaluate the implementation of the revised program framework in 2011-12.
Quantitative KPI:Percentage of new product listings completed in accordance with the new pricing and listing process.
2010-11 Target:100%2010-11 Actual:Not applicable
Result: Not applicable.
No new listings were added to the Stoma Appliance Scheme’s Schedule in 2010-11 as the revised program framework was implemented in June 2011. However, the first products to be assessed under the new arrangements are to be considered for potential listing during 2011-12.
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National Epidermolysis Bullosa Dressing Scheme

The department has improved access to clinically appropriate dressings for people with epidermolysis bullosa through the National Epidermolysis Bullosa Dressing Scheme. The Scheme continues to improve the quality of life for people with Epidermolysis Bullosa by reducing the financial burden associated with the purchase of necessary dressings. The Scheme provided clinically necessary dressings for more than 70 eligible people with Epidermolysis Bullosa in 2010-11.
During 2010-11, the department published the Resource Tool for Epidermolysis Bullosa Wound Care and Dressings Application for the National Epidermolysis Bullosa Dressing Scheme. The first of its kind, the resource tool35 is designed to assist health care professionals and people with Epidermolysis Bullosa in appropriate treatment practices and dressing application. Online video sessions, developed from the resource tool, are also available for educational purposes.
Quantitative Deliverable:Number of people with Epidermolysis Bullosa receiving subsidised dressings.
2010-11 Target:1642010-11 Actual:71
Result: Deliverable not met.
This is a demand driven program. A total of 71 people were assisted under the National Epidermolysis Bullosa Dressing Scheme in 2010-11. This number continues to be less than anticipated, however, applications to the Scheme continue to increase as awareness of the Scheme also increases.
In 2011-12, the department will consider outcomes of a review of the Scheme to ensure it continues to meet the needs of consumers.
Qualitative KPI:Evaluate the National Epidermolysis Bullosa Dressing Scheme.
2010-11 Reference Point:The financial burden of eligible people with Epidermolysis Bullosa accessing dressings is reduced.
Result: Indicator met.
The department continues to reduce the financial burden of eligible people with Epidermolysis Bullosa by providing subsidised access to clinically necessary dressings.

During 2010-11, the department completed a formal review of the scheme to evaluate the program’s effectiveness in the first 18 months. The department will consider the outcomes of the review to ensure it continues to meet the needs of consumers.
Quantitative KPIPercentage of eligible applicants receiving subsidised dressings.
2010-11 Target:100%2010-11 Actual:100%
Result: Indicator met.
In 2010-11, the department has assisted 71 eligible people with Epidermolysis Bullosa to receive access to subsidised clinically necessary dressings.
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Whole of Program Performance Information

Qualitative Deliverable:Produce relevant and timely evidence‑based policy research.
2010-11 Reference Point:Relevant evidence‑based policy research produced in a timely manner.
Result: Deliverable met.
Policy advice provided in 2010-11, on the changes to the Stoma Appliance Scheme program framework and National Diabetes Services Scheme, was based on research, consultation and expert opinion.
Qualitative Deliverable:Stakeholders participate in program development through a range of avenues.
2010-11 Reference Point:Stakeholders participated in program development through avenues such as regular consultative committees, conferences, stakeholder engagement forums, surveys, submissions on departmental discussion papers and meetings.
Result: Deliverable met.
Thirty-eight stakeholders including state and territory diabetes organisations, the Pharmacy Guild of Australia, the Juvenile Diabetes Research Foundation and manufacturers of diabetes products were consulted during the development of the 2011-16 National Diabetes Services Scheme Agreement.
In addition, the department held three stakeholder engagement forums and welcomed feedback and submissions on the new Stoma Appliance Scheme operating framework during its implementation process.
Quantitative Deliverable:Percentage of variance between actual and budgeted expenses.
2010-11 Target:0.5%2010-11 Actual:0.6%
Result: Deliverable substantially met.
Several large demand driven programs are administered under Program 2.4, some of which have parameters that change throughout the year.

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Outcome 2 – Financial Resources Summary

(A) Budget
Estimate1
2010-11
$’000
(B) Actual
2010-11
$’000
Variation
(Column B
minus
Column A)
$’000
Program 2.1: Community Pharmacy and Pharmaceutical Awareness
Administered Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
285,697
283,572
(2,125)
Departmental Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
15,197
15,149
(48)
    Revenues from other sources (s31)
261
234
(27)
    Unfunded depreciation expense
453
376
(77)
    Operating loss / (surplus)
-
1
1
Total for Program 2.1
301,608
299,332
(2,276)
Program 2.2: Pharmaceuticals and Pharmaceutical Services
Administered Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
192,974
192,870
(104)
Special appropriations
    National Health Act 1953 - Pharmaceutical Benefits
9,041,971
8,774,856
(267,115)
Departmental Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
35,120
35,008
(112)
    Revenues from other sources (s31)
603
541
(62)
    Unfunded depreciation expense
1,047
868
(179)
    Operating loss / (surplus)
-
2
2
Total for Program 2.2
9,271,715
9,004,145
(267,570)
Program 2.3: Targeted Assistance - Pharmaceuticals
Administered Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
137,648
103,198
(34,450)
Departmental Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
1,800
1,794
(6)
    Revenues from other sources (s31)
31
28
(3)
    Unfunded depreciation expense
54
45
(9)
    Operating loss / (surplus)
-
-
-
Total for Program 2.3
139,533
105,065
(34,468)
Program 2.4: Targeted Assistance - Aids and Appliances
Administered Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
621
610
(11)
    Special appropriations
    National Health Act 1953 - Aids and Appliances
246,113
244,738
(1,375)
Departmental Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
1,901
1,895
(6)
    Revenues from other sources (s31)
33
29
(4)
    Unfunded depreciation expense
57
47
(10)
    Operating loss / (surplus)
-
-
-
Total for Program 2.4
248,725
247,319
(1,406)
Outcome 2 Totals by appropriation type
Administered Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
616,940
580,250
(36,690)
    Special appropriations
9,288,084
9,019,594
(268,490)
Departmental Expenses
    Ordinary Annual Services (Annual Appropriation Bill 1)
54,018
53,846
(172)
    Revenues from other sources (s31)
928
832
(96)
    Unfunded depreciation expense
1,611
1,336
(275)
    Operating loss/(surplus)
-
3
3
Total expenses for Outcome 2
9,961,581
9,655,861
(305,720)
Average Staffing Level (Number)
280
281
1

1 Budgeted appropriations taken from the 2011-12 Health and Ageing Portfolio Budget Statements and re-aligned to the 2010-11 outcome
structure.

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25 Available at: www.health.gov.au/pharmacy
26 Available at: www.nps.org.au/bemedicinewise/brand_choices
27 Information on the number of non-subsidised prescriptions supplied, that is, those under the patient co-payment amount, is generally not available. Information from a sample of pharmacies is only available after the end of a reporting period. This is due to the nature of the survey used as a source of data, and the length of time pharmacies take to submit prescriptions. The latest prescription supply data available for 2010-11 is to end of March 2011.
28Formulary Two (F2) consists of drugs where there is brand competition on the PBS.
29 The target of $9m was printed in error. The correct figure for 2010-11 is $38m, as reported by PricewaterhouseCoopers, 2010 The Impacts of Pharmaceutical Benefits Scheme Reform, report for the Department of Health and Ageing, page 91, Appendix A Table 3; Savings to Government by year.
30 Includes savings to both the Pharmaceutical Benefits Scheme and the Repatriation Pharmaceutical Benefits Scheme.
31 Changes to the PBS that result in an increase in outlays of more than $10 million in any of the first four years of listing.
32 Includes the drugs fingolimod (Gilenya®), levodopa with carbidopa (Duodopa®) and romiplostim (Nplate®).
33 Available at: www.pbs.gov.au by browsing under ‘Midwife items’ & ‘Nurse Practitioner items’.
34 Available at: www.pbs.gov.au
35 Available at: www.ebdressings.com.au

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