Hospitals play a significant and important role in funding high-cost medicines so patients can access treatments they need. High-cost medicines are often specialty medicines, which contribute to a significant and increasing portion of the hospital budget. It is imperative that these expensive medicines are governed and managed with a fair, standardized evidence-based process. We aim to provide a framework for Drugs and Therapeutics Committees (DTCs).

During 2021, Guiding Principles were developed following a literature review and survey of current practices by DTCs in Australia. An Expert Advisory Group (EAG) was convened, comprising individuals with expertise in quality use of medicines, evidence-based medicine and medicines governance. The guiding principles were drafted by the EAG, in consultation with a range of stakeholders and relevant external organizations. All feedback was collated, reviewed and discussed to refine the content of the final Guiding Principles released in January 2022.

Seven overarching principles provide key recommendations for the governance of high-cost medicines:

1. (i) A definition of high‑cost medicines should be determined and clearly articulated for use by each medicines governance committee.

2. (ii) Review of high-cost medicines requires members with relevant expertize to facilitate good and effective decision-making.

3. (iii) The committee should engage directly with the applicant prior to review to ensure a full understanding of the rationale for the request.

4. (iv) consistent, robust and transparent procedure for the assessment of high-cost medicine applications should be defined and implemented for use by each medicines governance committee to ensure fair process.

5. (v) Ethical considerations fundamentally underpin deliberations around high-cost medicines.

6. (vi) The decisions and outcomes of the decision making should be transparent and appropriately communicated to the various audiences.

7. (vii) The high-quality assessment of high-cost medicines requires appropriate training and resourcing.

These national Guiding Principles promote consistent, evidence-based use of high-cost medicines and provide a framework for DTCs to assess and achieve effective governance for the quality use of high‑cost medicines.

In contrast to high-volume medicines prescribed by general practitioners, low-volume highly specialized medicines have not been supported by national quality use of medicine (QUM) programs in Australia. The first area addressed has focused on optimizing use of biological disease-modifying antirheumatic drugs (bDMARDs).

The program was designed, developed and implemented in partnership with nine consortium member organizations and four affiliate organizations representing consumer and clinical audiences, program development expertize and implementation capability. The common agenda for the collective impact approach was to achieve better health outcomes for people with inflammatory arthritis, inflammatory bowel disease and plaque psoriasis. Multidisciplinary expert working groups reviewed formative QUM research and agreed on objectives, audiences, messages and interventions. Interventions were selected based on identified barriers, enablers and behavioral drivers, informed by the Theoretical Domains Framework. Interventions were co-designed and tested with end-users. Marketing and promotion activity supported implementation of all interventions through consortium channels and networks. Evaluation includes process, impact and outcome measures, and a realist evaluation of the academic detailing.

Program objectives were to optimize: (i) first-line therapy before bDMARD use; (ii) first-choice bDMARDs; (iii) biosimilar prescribing and dispensing; (iv) bDMARD dosage; (v) glucocorticoid and analgesic use. Over 60 interventions supporting key messages for each objective were developed for audiences: consumers; rheumatologists, gastroenterologists, dermatologists; pharmacists; drug and therapeutic committees. Interventions implemented between September 2020 and September 2022 included: consumer decision aids, action plans, fact sheets, lived experience videos; living guidelines and evidence summaries; guidance/position statements for hospitals, podcasts, webinars, online learning; prescribing feedback reports; and academic detailing. Uptake of interventions has largely met targets and surveys have demonstrated shifts in specialist and consumer knowledge and behavior in line with key messages and objectives. Realist and outcome evaluation is ongoing.

Our experience demonstrates the value of a consortium of stakeholder organizations, with different expertise and interests but agreed goals and roles, working together to progress the quality use of highly specialized drugs.

The MedicineWise app is a free consumer health and medicine management app developed by NPS MedicineWise. With 107,000+ downloads and 78,000+ active sessions per month, the MedicineWise app's core functions include: keeping track current medicines lists, medicine dose reminders and recording health conditions, allergies, test results and other health information. Recent enhancements also enabled the app to deliver featured health- and medicine-related content to users based on their medicines and/or health conditions. The goal is to maximise the MedicineWise app's capabilities by personalizing to users’ needs and combining with health professional interventions when needed, to encourage better delivery of health and medicines information and improve medication adherence and health outcomes.

A number of personalized medicines management service offerings were created by combining a technology solution using the MedicineWise app (including the app's core functions as well as added targeted content delivery capability) with a humanistic solution (a health professional-mediated phone-based coaching service). MedicineWise app features were developed iteratively using a human-centred design approach. Consumers were involved in the design, prototyping and testing stages before the features moved to technical-build stage.

Three use-cases will be presented to demonstrate how the MedicineWise app was used to provide personalized medicines management service offerings. These include: (1) curating relevant content and delivering push notifications to users for health conditions including asthma, rheumatoid arthritis and osteoporosis; (2) providing a triaged medication adherence support program with escalating levels of intervention for heart failure patients; and (3) collecting user-reported medication usage data and data monitoring by health professionals to provide support for heart failure patients.

The utility of MedicineWise app can be extended to provide personalized medicines management service offerings in the consumer health care space.

Australia has had high rates of antibiotic use in primary care. Consumer and health professional knowledge and practices in the community vary. In 2012, NPS MedicineWise implemented a five-year national educational program for consumers, general practitioners (GPs) and pharmacies to reduce antibiotic use in Australia.

For consumers, a social marketing approach was used focusing on the winter months. Strategies leveraged collectivism, nudge theory, celebrity endorsement and co-creation and used multiple communication channels. For health professionals, interventions were most intense in 2012 with additional activities implemented each year including face-to-face educational visiting, audits, comparative prescribing feedback, case studies and point-of-care materials. Surveys were conducted periodically to evaluate changes in knowledge and awareness. Pharmaceutical Benefits Scheme (PBS) claims data were analyzed. Organization for Economic Co-operation and Development data was used to compare Australian antibiotic per capita consumption to other countries. Time series analyses were used to estimate the cumulative program effect comparing observed and expected monthly dispensing volumes of antibiotics commonly prescribed for upper respiratory tract infections (URTIs), had interventions not occurred.

Between 2012 and 2017, GP antibiotic PBS prescriptions reduced by 18.4 percent. Antibiotic defined daily doses per 1000 inhabitants reduced from 23.7 in 2012 to 18.4 in 2016, similar to Norway (18.6 in 2016) and the UK (18.7). Time series modelling estimated 24.8 percent fewer GP antibiotic URTI prescriptions by 2017 versus no program. Consumer survey results indicated increased awareness of antibiotic resistance (50 percent in 2011, 74 percent in 2017) and the minority expect/request antibiotics for URTIs (22 percent in 2017).

A five-year national educational program with multiple and repeated interventions for health professionals and consumers has resulted in ongoing reductions in antibiotic use in primary care.

Optimal rheumatoid arthritis (RA) management requires coordinated management and consistent communication by health practitioners with patients. Suboptimal methotrexate use is a factor leading to increased use of biological disease modifying antirheumatic drugs (bDMARDs), which account for significant government drug expenditure. A multidisciplinary co-design approach was used to develop and implement a program aiming to improve early management and quality use of medicines (QUM) for people with RA in Australia.

Literature review and key informant interviews identified broad potential QUM issues in RA management. An initial exploratory multidisciplinary meeting prioritized QUM issues, identified audiences and perspectives, and scoped focus areas to address with education. Iteratively through co-design meetings and activities, program objectives were agreed, barriers and enablers for change explored, characteristics of intervention activities considered and rated, and program products developed and reviewed. Program evaluation included participation and distribution data, surveys and interviews, and analyses of general practice and Pharmaceutical Benefits Scheme (PBS) data.

QUM issues addressed include: (i) timely initiation of conventional synthetic (cs) DMARDs; (ii) appropriate use and persistence with csDMARD therapy, especially methotrexate; and (iii) clarity around professional roles and best practice for prescribing, dispensing, and monitoring DMARDs, and managing lifestyle factors and other risks associated with RA. The educational program (October 2017 to June 2018) included: an article promoting key messages (email to ~115,000 health practitioners), prescriber feedback report based on PBS data (to all Australian rheumatologists), an RA action plan (completed by health practitioners for consumers), an interactive case study (553 participants), visits to 1200 pharmacies promoting key messages, a multidisciplinary webinar (431 live and 366 on-demand), fact sheets for consumers available through MedicineWise app (medicine management app for consumers), and social media activity.

A multidisciplinary co-design process has provided a model for developing a multifaceted QUM program incorporating and addressing multiple perspectives.

Many countries have a national antimicrobial resistance strategy. In Australia, primary care is especially important because this setting encompasses a high proportion of antibiotic use. While antibiotic use decreased during the 1990s, it began to increase again in the mid-2000s. In response to this, in 2009 NPS MedicineWise implemented a series of nationwide educational interventions for consumers, family physicians (general practitioners), and community pharmacies that aimed to reduce excessive antibiotic use.

For consumers a social marketing approach was used, including strategies that leveraged collectivism, nudge theory, celebrity endorsement, and co-creation. Channels included social, print, radio, and other media as well as practice waiting rooms and pharmacies. For health professionals, interventions included face-to-face education, audits, comparative prescribing feedback, case studies, and point-of-care materials. Surveys of consumers and family physicians were conducted periodically to evaluate changes in knowledge and behavior. National Pharmaceutical Benefits Scheme claims data were analyzed using a Bayesian structural time-series model to estimate the cumulative effect of interventions by comparing the observed and expected monthly dispensing volumes if the interventions had not occurred.

The consumer survey results indicated that more people were aware of antibiotic resistance (seventy-four percent in 2017 versus seventy percent in 2014), with the minority requesting or expecting antibiotics for upper respiratory tract infections (URTIs) (twenty-two percent in 2017). People underestimated the usual duration of symptoms for URTIs and were more inclined to expect antibiotics beyond that timeframe. Compared with non-participants, family physicians who participated in the program reported more frequent discussions about hand hygiene (ninety percent versus eighty-two percent) and proper use of antibiotics with patients (ninety-five percent versus eighty-eight percent). Between 2009 and 2015 there was an estimated fourteen percent reduction in prescriptions dispensed to concessional patients for antibiotics commonly prescribed for URTIs.

Family physicians and consumers have responded positively to national programs. Sustaining and building on these improvements will require continued education and further innovation.

While medicines and medical tests are developed in a controlled clinical trial environment, postmarketing surveillance in the real world can be challenging. MedicineInsight—a database of longitudinal patient-level clinical information from primary care practices in Australia—is a novel program that collects primary care data to improve postmarketing surveillance at a national level.

MedicineInsight collects de-identified clinical information from primary care practice information systems using data extraction tools. MedicineInsight currently includes 3.6 million regular patients of 3,300 family physicians (general practitioners) from 650 primary care practices across Australia. MedicineInsight data include longitudinal clinical information on diagnosis and medicines (dose, strength, route of administration, medication switches over time, adverse events, and allergies), and pathology testing data. A series of observational studies was developed for postmarketing surveillance of management of a range of health priorities including type 2 diabetes mellitus (T2DM), chronic obstructive pulmonary disease (COPD), depression, and antibiotics use.

Forty-four percent of patients with T2DM in the MedicineInsight database did not have a recorded hemoglobin A1c result and thirty-one percent did not have a recorded blood pressure reading in the previous 6 months. While guidelines recommend a stepwise approach to the initiation of COPD therapy, forty-nine percent of patients with COPD (with or without asthma) were prescribed dual therapy at initiation and a small number (4.5 percent) were prescribed triple therapy. Between 2011 and 2015, the annual rate of antidepressant prescribing per 1,000 family physician encounters increased by eight percent. High volumes of antibiotics were prescribed for respiratory tract infections in Australian primary care, notwithstanding guideline recommendations that antibiotics are not recommended in most cases.

Large scale, real-world clinical data from primary care practices can play an important role in postmarketing surveillance at a national level.