Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Outcome 2 Access to cost-effective medicines, including through the Pharmaceutical Benefits Scheme and related subsidies, and assistance for medication management through industry partnerships Outcome Strategy The Australian Government, through Outcome 2, provides reliable, timely and affordable access to cost-effective, sustainable and high quality medicines and pharmaceutical services. The Government does this through subsidising the cost of medicines through the Pharmaceutical Benefits Scheme (PBS), by providing free access to expensive and ‘life-saving’ drugs, and by supporting the provision of aids and appliances. The Government also provides advice and support to health professionals and consumers on the quality use of medicines, and works with the pharmaceutical industry to ensure the supply of medicines through the PBS. The National Medicines Policy provides an overarching framework for the activities in Outcome 2. There are four central objectives of the policy: timely access to medicines at an affordable cost to individuals and the community; medicines should meet quality, safety and efficacy standards; quality use of medicines; and maintaining a responsible and viable medicines industry. Under the National Medicines Policy, the Australian Government provides advice and support to health professionals and consumers on the quality use of medicines, along with programs aimed at improving the use of medicines in the community, improving health outcomes for patients and increasing the sustainability of the PBS. Through the Fifth Community Pharmacy Agreement (the Fifth Agreement), the Government will provide funding and support to around 5,000 pharmacies to continue dispensing PBS medicines. The Government collaborates with community pharmacies, peak bodies and consumers to implement the Fifth Agreement. Ensuring the sustainability of this system and access to innovative treatments for Australian consumers is of the utmost importance to the Government. The 2010 PBS reforms and Price Disclosure continue to be a highly effective mechanism for ensuring the sustainability of the PBS and making head room for new medicines. For example the expanded and accelerated price disclosure reforms of 2010 continue to deliver price cuts of between 10% and 87% whilst following the market rather than setting it. These reforms continue to reduce the price of medicines for the consumer as well as Government. In its first year of operation the 2010 reforms delivered $1.9 billion of price cuts to the PBS. The price changes that have occurred or will occur in 2013 73 Outcome I 02 ACCESS TO PHARMACEUTICAL SERVICES Budget Statements – Department of Health and Ageing and beyond will reduce the forward estimates by a further $2 billion, around $4 billion in savings, since these reforms commenced. The Government will continue to implement and monitor pricing reforms and other initiatives agreed to under the Memorandum of Understanding with Medicines Australia, such as the Managed Entry Scheme and Parallel Processing. Consumers and key stakeholder groups such as Medicines Australia, the Generics Medicines Industry Association and the Consumers Health Forum, continue to be consulted through this process. Outcome 2 is the responsibility of Pharmaceutical Benefits Division. Programs Contributing to Outcome 2 Program 2.1: Community pharmacy and pharmaceutical awareness Program 2.2: Pharmaceuticals and pharmaceutical services Program 2.3: Targeted assistance – pharmaceuticals Program 2.4: Targeted assistance – aids and appliances 74 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Outcome 2 Budgeted Expenses and Resources Table 2.1 provides an overview of the total expenses for Outcome 2 by program. Program 2.1: Community pharmacy and pharmaceutical awareness Administered expenses Ordinary annual services (Appropriation Bill No. 1) Departmental expenses Departmental appropriation1 Expenses not requiring appropriation in the budget year2 Total for Program 2.1 Program 2.2: Pharmaceuticals and pharmaceutical services Administered expenses Ordinary annual services (Appropriation Bill No. 1) Special appropriations National Health Act 1953 - pharmaceutical benefits Departmental expenses Departmental appropriation1 Expenses not requiring appropriation in the budget year2 Total for Program 2.2 Program 2.3: Targeted assistance - pharmaceuticals Administered expenses Ordinary annual services (Appropriation Bill No. 1) Departmental expenses Departmental appropriation1 Expenses not requiring appropriation in the budget year2 Total for Program 2.3 Program 2.4: Targeted assistance - aids and appliances Administered expenses Ordinary annual services (Appropriation Bill No. 1) Special appropriations National Health Act 1953 - aids and appliances Departmental expenses Departmental appropriation1 Expenses not requiring appropriation in the budget year2 Total for Program 2.4 75 2012-13 Estimated actual $'000 2013-14 Estimated expenses $'000 333,854 367,130 6,784 157 340,795 6,274 212 373,616 190,182 193,135 9,466,358 9,878,169 36,521 1,191 9,694,252 35,730 1,482 10,108,516 151,016 153,336 3,292 76 154,384 3,045 103 156,484 745 681 284,592 304,915 3,292 76 288,705 3,045 103 308,744 Outcome I 02 Table 2.1: Budgeted Expenses and Resources for Outcome 2 Budget Statements – Department of Health and Ageing Table 2.1: Budgeted Expenses and Resources for Outcome 2 (cont.) 2012-13 Estimated actual1 $'000 2013-14 Estimated expenses1 $'000 675,797 9,750,950 714,282 10,183,084 49,889 1,500 48,094 1,900 10,478,136 10,947,360 2012-13 230 2013-14 214 Outcome 2 totals by appropriation type Administered expenses Ordinary annual services (Appropriation Bill No. 1) Special appropriations Departmental expenses Departmental appropriation1 Expenses not requiring appropriation in the budget year2 Total expenses for Outcome 2 Average staffing level (number) 1 2 Departmental appropriation combines “Ordinary annual services (Appropriation Bill No 1)” and “Revenue from independent sources (s31)’. “Expenses not requiring appropriation in the Budget year” is made up of depreciation expense amortisation expense, makegood expense and audit fees. Program 2.1: Community pharmacy and pharmaceutical awareness Program Objectives Support timely access to medicines and pharmacy services through the Fifth Community Pharmacy Agreement The Australian Government will ensure all eligible Australians continue to have timely access to PBS medicines and other professional services through the Fifth Agreement. The Fifth Agreement provides funding over five years, from 2010-11 to 2014-15, to remunerate pharmacists for dispensing PBS medicines and provide a range of professional programs and services that aim to improve consumer health outcomes. These include services to support medication management, programs to assist the pharmacy workforce, activities to support improved service quality, and ongoing research and development work to inform future service delivery models. In 2013-14, the Department will continue over 20 programs to support the delivery of pharmaceutical services and quality use of medicines through community pharmacies. These initiatives include the Electronic Recording and Reporting of Controlled Drugs Supply (which aims to collect and report real time data relating to controlled drugs to help address problems of forgery, abuse and prescription shopping), and PBS Claiming from a Medication Chart in Residential Aged Care Facilities (which aims to improve medication safety for residents, and decrease the duplication of paperwork and administrative burden) and Continued Dispensing of PBS Medicines in Defined Circumstances (which aims to maintain patient adherence to therapy by preventing treatment interruption due to the inability to obtain a timely prescription renewal). The Department will support the sustainability of community pharmacies in rural and remote Australia through a range of targeted programs. These programs will 76 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services The Department will continue to support the Medication Management Review (MMR) programs which aim to improve the quality use of medicines and reduce medication misadventure among people using multiple medicines. The MMR programs will be supported by the ongoing roll out of the MedsCheck and Diabetes MedsCheck program which assists services that focus on improving consumer education and management of their medicines. The Department will continue to work with the Pharmacy Guild of Australia to ensure all Fifth Agreement programs are sustainable within the available Fifth Agreement allocation by re-prioritising funding between programs to ensure that services continue to meet consumer expectations and needs and overall expenditure is not exceeded. The effectiveness of these programs will be reviewed in the context of the Fifth Agreement Evaluation Framework. Programs with a medication management focus will be specifically reviewed under the Combined Review of Fifth Agreement Medication Management Programs. The progress and reports of all the reviews will be made available on the Department’s website. Program 2.1 is linked as follows: The Department of Human Services (Services to the Community – Program 1.1) administer payments under various professional programs and services contained within the Fifth Community Pharmacy Agreement. This includes payments to claiming pharmacists for Medication Management Programs, and payments to pharmacies that participate in the Pharmacy Practice Incentive Program. Program 2.1: Expenses Table 2.2: Program Expenses Annual administered expenses Ordinary annual services Program support Total Program 2.1 expenses 2012-13 Estimated actual $'000 2013-14 Budget 333,854 6,941 340,795 77 $'000 2014-15 Forward year 1 $'000 2015-16 Forward year 2 $'000 2016-17 Forward year 3 $'000 367,130 6,486 373,616 400,900 6,440 407,340 400,920 6,479 407,399 400,942 6,586 407,528 Outcome I 02 address challenges specific to rural pharmacists including continuing professional education, locum services and undergraduate support. Budget Statements – Department of Health and Ageing Program 2.1: Deliverables Qualitative Deliverables for Program 2.1 Support timely access to medicines and pharmacy services through the Fifth Community Pharmacy Agreement Qualitative Deliverables 2013-14 Reference Point or Target Phased roll out of measure: Electronic Recording and Reporting of Controlled Drugs Continue measure phase in, for completion during the first half of 2013-14, including working with jurisdictions to facilitate the delivery of this measure1 Phased roll out of measure: Supply and PBS Claiming from a Medication Chart in Residential Aged Care Facilities Continue measure phase in, for completion during 2013-14, including evaluation of the National Residential Medication Chart in pilot sites prior to consideration of a national rollout Phased roll out of measure: Continued Dispensing of PBS Medicines in Defined Circumstances Continue measure phase in, for completion during 2013-14, dependent on state and territory enabling legislation being introduced to facilitate the delivery of this measure Quantitative Deliverable for Program 2.1 Support timely access to medicines and pharmacy services through the Fifth Community Pharmacy Agreement Quantitative Deliverable Number of medication management services provided under the Fifth Agreement 1 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 63,000 64,500 66,000 67,500 69,000 Implementation of the system will vary across the jurisdictions as states and territories need to make necessary legislative changes to ensure the system can migrate with existing technologies and processes. 78 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Program 2.1: Key Performance Indicators Quantitative Key Performance Indicators for Program 2.1 Quantitative Indicators 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Percentage of rural community pharmacies accessing targeted rural programs to support the sustainability of community pharmacy in rural and remote Australia2 70% 75% 80% 80% 81% Percentage of community pharmacies participating in the Pharmacy Practice Incentives Program3 45% 90% 91% 91% 92% Program 2.2: Pharmaceuticals and pharmaceutical services Program Objectives List cost-effective, innovative, clinically effective medicines on the PBS The PBS is the primary means through which the Australian Government ensures Australians have timely and affordable access to pharmaceuticals. In 2012-13, the PBS is expected to cost $9.5 billion, increasing to $9.9 billion in 2013-14. The listing of medicines on the PBS is based on the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body comprising doctors, other health professionals and a consumer representative. The PBAC assesses the safety, therapeutic benefits and cost-effectiveness of the medicine for the intended use, in comparison with other available treatments. Since the Mid Year Economic and Fiscal Outlook in October 2012, the Government has approved a number of new or amended PBS listings, at an overall net cost of $692 million over five years, including the listing of pregabalin (Lyrica®) for the treatment of chronic pain on 1 March 2013, and the listing of two new innovative medicines, boceprevir (Victrelis®) and telaprevir (Incivo®), to treat Hepatitis C. Increase the sustainability of the PBS The Government ensures that the PBS is managed in a fiscally responsible and sustainable way, so that the Australian community will continue to have access to affordable medicines into the future. 2 Targets have been revised as uptake of the program has been greater than expected. 3 Targets have been revised as uptake of the program has been greater than expected. 79 Outcome I 02 Support timely access to medicines and pharmacy services through the Fifth Community Pharmacy Agreement Budget Statements – Department of Health and Ageing Further PBS reforms not only deliver savings to taxpayers but also deliver savings direct to consumers’ pockets. For example by the end of 2013 treatments for gastrointestinal conditions, blood pressure, depression and cholesterol are expected to be up to almost $16 a packet cheaper for consumers compared to what they were paying in 2011, as a result of the price cuts under the 2010 PBS reforms. Price Disclosure is expected to achieve a further saving of $2 billion through price reductions occurring in 2013 and beyond. These reforms use market prices to achieve ongoing savings to the PBS providing the Government the ability to list new and innovative medicines as they become available. Price disclosure is one of the primary means through which the Government will continue to reduce the costs of PBS subsidised drugs. It requires suppliers of medicines to disclose the prices they charge to pharmacies, allowing prices paid under the PBS to be revised to reflect the weighted average prices actually charged in the market. Price disclosure now applies to more than 300 drugs. Further reductions are scheduled for 1 August 2013, 1 December 2013 and 1 April 2014. The Department will also work with the pharmaceutical industry to balance the need to promote competition in the industry through the use of generic medicines without discouraging investment in pharmaceutical research and innovation. Post Market Surveillance In 2013-14, the Government will continue to progress several reviews of medicines in use, focusing on the appropriate and quality use of medicines to help improve health outcomes for patients and ensure continued value for money for taxpayers. Quality Use of Medicines In 2013-14, the Department will continue to apply the National Medicines Policy through collaboration with National Medicines Policy partners to improve the quality use of medicines in the community, including considering issues such as antimicrobial resistance and health literacy. Increased funding for chemotherapy services In 2013-14, the Department will undertake a comprehensive review of funding arrangements for chemotherapy services. From 1 July 2013 to 31 December 2013, additional funding of $60 per infusion will ensure the ongoing viability of chemotherapy services. The review of chemotherapy arrangements will report to the Minister for Health by October 2013 with recommendations on a longer-term sustainable approach to funding chemotherapy services. Program 2.2 is linked as follows: The Department of Human Services (Services to the Community – Program 1.1) to administer the PBS, including payment of script benefits, authority approvals, new and other PBS items. 80 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Program 2.2: Expenses Annual administered expenses Ordinary annual services Special appropriations National Health Act 1953 pharmaceutical benefits Program support Total Program 2.2 expenses 2012-13 Estimated actual $'000 2013-14 Budget $'000 2014-15 Forward year 1 $'000 2015-16 Forward year 2 $'000 2016-17 Forward year 3 $'000 190,182 193,135 196,316 199,528 199,468 9,466,358 9,878,169 10,374,106 10,811,795 11,284,504 37,712 37,212 36,478 35,365 35,845 9,694,252 10,108,516 10,606,900 11,046,688 11,519,817 Program 2.2: Deliverables Qualitative Deliverables for Program 2.2 List cost-effective, innovative, clinically effective medicines on the PBS Qualitative Deliverables 2013-14 Reference Point or Target The PBAC meets at least three times a year and provides recommendations to the Minister on new listings for the PBS The PBAC recommendations for listing on the PBS are based on the clinical effectiveness and cost-effectiveness of new medicines, and provided in a timely manner Price negotiations with sponsors and conditions for listing finalised, and quality and availability checks undertaken for new PBS listings All negotiations and listing activity completed in a timely manner Post Market Surveillance Qualitative Deliverable 2013-14 Reference Point or Target Undertake reviews of medicines in use, focussing on the appropriate and quality use of medicines Complete two reviews in 2013-14: medicines used to treat asthma in children and medicines and products used to manage diabetes 81 Outcome I 02 Table 2.3: Program Expenses Budget Statements – Department of Health and Ageing Quantitative Deliverable for Program 2.2 List cost-effective, innovative, clinically effective medicines on the PBS Quantitative Deliverable Percentage of the community’s (public) comments included for consideration at each Pharmaceutical Benefits Advisory Committee meeting 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 100% 100% 100% 100% 100% Program 2.2: Key Performance Indicators Quantitative Key Performance Indicators for Program 2.2 List cost-effective, innovative, clinically effective medicines on the PBS Quantitative Indicators 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Number of prescriptions subsidised through the PBS4 199m 212m 219m 227m 235m $14.1m $14.1m $14.1m $14.1m $14.1m 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 $121.0m $296.0m $578.0m $855.0m $1,117.0m Revenue received from the cost recovery of the PBS listing process Increase the sustainability of the PBS Quantitative Indicator Estimated savings to Government from the price disclosure program per annum 4 This is a demand driven program. Targets have been revised to reflect current medicine usage. 82 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Program 2.3: Targeted assistance – pharmaceuticals Program Objectives The Australian Government will continue to provide fully subsidised access for eligible patients to expensive and life-saving drugs for rare and life threatening medical conditions through the Life Saving Drugs Program. Ten drugs are currently funded through the program to treat seven serious and very rare medical conditions. These conditions are: Fabry, Gaucher, Mucopolysaccharidosis Types I, II and VI, Infantile Pompe disease and Paroxysmal Nocturnal Haemoglobinuria. Each condition has separate treatment guidelines, developed and administered using the advice of an expert disease advisory committee. In 2013-14, the Department will continue to facilitate and monitor access for new and continuing patients to these medicines. Program 2.3: Expenses Table 2.4: Program Expenses 2012-13 Estimated actual $'000 2013-14 Budget $'000 2014-15 Forward year 1 $'000 2015-16 Forward year 2 $'000 2016-17 Forward year 3 $'000 Annual administered expenses Ordinary annual services Program support 151,016 3,368 153,336 3,148 158,692 3,127 160,277 3,146 161,887 3,198 Total Program 2.3 expenses 154,384 156,484 161,819 163,423 165,085 Program 2.3: Deliverables Qualitative Deliverable for Program 2.3 Improve access to new and existing medicines for patients with life threatening conditions Qualitative Deliverable 2013-14 Reference Point or Target Review program guidelines to ensure they remain current and relevant Program guidelines reviewed within agreed timeframes 83 Outcome I 02 Improve access to new and existing medicines for patients with life threatening conditions Budget Statements – Department of Health and Ageing Quantitative Deliverable for Program 2.3 Improve access to new and existing medicines for patients with life threatening conditions Quantitative Deliverable 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Number of patients assisted through the Life Saving Drugs Program 230 245 260 275 290 Program 2.3: Key Performance Indicators Qualitative Key Performance Indicator for Program 2.3 Improve access to new and existing medicines for patients with life threatening conditions Qualitative Indicator 2013-14 Reference Point or Target Eligible patients have timely access to the Life Saving Drugs Program Patient applications are processed within 30 calendar days of receipt Quantitative Key Performance Indicator for Program 2.3 Improve access to new and existing medicines for patients with life threatening conditions Quantitative Indicator Percentage of eligible patients with access to fully subsidised medicines through the Life Saving Drugs Program 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 100% 100% 100% 100% 100% Program 2.4: Targeted assistance – aids and appliances Program Objectives Provide support for people with diabetes The Australian Government, through the National Diabetes Services Scheme (NDSS), aims to ensure that people with diabetes have timely, reliable and affordable access to products and services that help them effectively self-manage their condition. The NDSS is administered by Diabetes Australia through a funding agreement. In 2013-14, the Department, in conjunction with Diabetes Australia, will continue to analyse and implement the outcomes of an integrated review undertaken in 2012-13. The integrated review draws together a number of independent reviews commissioned by Diabetes Australia to determine the future 84 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services The Government also provides support to the families of children with type 1 diabetes through the Type 1 Diabetes Insulin Pump Program. This program subsidises the cost of insulin pump therapy for those families with children under the age of 18 who have type 1 diabetes and who meet the income limits. Assist people with a stoma by providing stoma related products The Australian Government assists eligible people with stomas 5 by providing them with stoma related appliances (such as pouches, products to assist irrigation, protective films and seals) through the Stoma Appliance Scheme. An ongoing review of the clinical and cost effectiveness of all products listed on the scheme will continue in 2013-14, and the outcomes will be implemented. The outcomes of this review will help ensure that participants of this scheme continue to have access to the most clinically suitable appliances to effectively manage their condition and will also assist in improving the sustainability of the scheme. Improve the quality of life for people with Epidermolysis Bullosa The Australian Government aims to improve the quality of life for people with Epidermolysis Bullosa6 through the National Epidermolysis Bullosa Dressing Scheme. The scheme subsidises clinically appropriate and necessary dressings. The Department works with clinical experts to ensure dressing treatment methods are consistent with best-practice. Program 2.4 is linked as follows: The Department of Human Services (Services to the Community – Program 1.1) to administer payment of claims from Stoma Associations for stoma related appliances. Program 2.4: Expenses Table 2.5: Program Expenses 2012-13 Estimated actual $'000 2013-14 Budget $'000 2014-15 Forward year 1 $'000 2015-16 Forward year 2 $'000 2016-17 Forward year 3 $'000 Annual administered expenses Ordinary annual services Special appropriations National Health Act 1953 aids and appliances Program support 745 681 596 596 596 284,592 3,368 304,915 3,148 326,649 3,126 350,204 3,145 353,111 3,197 Total Program 2.4 expenses 288,705 308,744 330,371 353,945 356,904 5 An opening in the abdomen for evacuation of products from the bowel or bladder. 6 A genetic disease characterised by extremely fragile and blister prone skin. 85 Outcome I 02 arrangements for product supply and delivery, the product schedule and registrant support services. Budget Statements – Department of Health and Ageing Program 2.4: Deliverables Qualitative Deliverable for Program 2.4 Provide support for people with diabetes Qualitative Deliverable 2013-14 Reference Point or Target Provide access to insulin pumps and associated consumables for children under 18 years of age with type 1 diabetes Work with the scheme administrator to ensure efficient insulin pump subsidies are provided Quantitative Deliverables for Program 2.4 Provide support for people with diabetes 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Number of people with diabetes receiving benefit from the NDSS 1,180,000 1,280,000 1,400,000 1,526,000 1,656,000 Number of people under 18 years of age with type 1 diabetes receiving a subsidised insulin pump 62 68 68 68 68 Quantitative Deliverables Assist people with a stoma by providing stoma related products Quantitative Deliverable 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Number of people receiving stoma related products 41,000 41,750 42,5007 43,250 44,000 Improve the quality of life for people with Epidermolysis Bullosa Quantitative Deliverable Number of people with Epidermolysis Bullosa receiving subsidised dressings 7 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 79 83 87 91 95 Figures for 2014-15 and subsequent years have been reduced following identification of an error in estimates. 86 Section 2 – Department Outcomes – 2 Access to Pharmaceutical Services Program 2.4: Key Performance Indicators Quantitative Key Performance Indicators for Program 2.4 Quantitative Indicator 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Percentage of eligible people with diabetes who are able to access clinically appropriate products 100% 100% 100% 100% 100% Assist people with a stoma by providing stoma related products Quantitative Indicator 2012-13 Revised Budget 2013-14 Budget Target 2014-15 Forward Year 1 2015-16 Forward Year 2 2016-17 Forward Year 3 Percentage of eligible people with stomas who are able to access clinically appropriate products 100% 100% 100% 100% 100% 87 Outcome I 02 Provide support for people with diabetes Budget Statements – Department of Health and Ageing 88