Biointelect is pleased to provide the following resources to showcase some of our health policy related work.
Bringing Patient Centricity to Life in Australian Healthcare
The current healthcare environment in Australia offers various opportunities for stakeholders, including patients, to engage with the health system and government in reform efforts. These opportunities arise from factors such as increased awareness of the importance of efficient approval processes for medicines and vaccines due to the Covid-19 pandemic, ongoing reviews of health technology assessment (HTA) policy and processes, and commitments to enhance consumer engagement in listing new medicines on the Pharmaceutical Benefits Scheme (PBS). Undeniably, we are on the precipice of significant healthcare system reform and through this process we can bring patient centricity to life.
Recognising the valuable contributions made by stakeholders in recent reform activites and the importance of what we heard from health consumer organisations during the Bristol Myers Squibb Australia’s (BMS) 2022 Shaping Healthcare Together annual Roundtable discussion, BMS partnered with Biointelect to continue these conversations and explore system reform opportunities that will enhance patient centricity in Australian healthcare. Patient-centric system reform refers to the transformation of healthcare and medicines delivery systems to prioritise the needs, preferences, and outcomes of patients.
This white paper highlights the key concerns and aspirations of participating HCOs for reforming Australia’s HTA system to meet the needs of Australian patients. Across three central themes, it provides ten recommendations, to enhance consumer engagement, incorporate broader value considerations in the evaluation of new medicines and improve the speed of access to innovative medicines.
Bringing Patient Centricity to Life in Australian Healthcare
Submission to the PBAC on the Base Case Discount Rate
This report has been commissioned by Medicines Australia and prepared by Biointelect and Shawview Consulting. The report highlights how Australia must consider the value of the future long-term health of its citizens by considering the inappropriately high current discount rates applied to medicines in the long term. This will be done through investment into health policies that match this need for longer-term health outcomes. This paper recommends a reduction in the base case discount rate based on a review of international Health Technology Assessment (HTA) discount rate practices, the impact of high discount rates on access to medicine and government policies.
Medicines-Australia-submission-to-PBAC-Discount-Rate-Submission-January-2022
Strengthening Australia's Approach to Horizon Scanning for New Therapies
Bristol Myers Squibb (BMS Australia) partnered with Biointelect, to conduct research into the horizon scanning landscape locally and internationally. This research helped to inform BMS Australia’s Shaping Healthcare Together annual roundtable discussion. Shaping Healthcare Together is an annual roundtable series that is convened by BMS Australia, together with patient advocacy groups. The October 2021 Roundtable focused on horizon scanning in Australia.
This report presents findings of the roundtable, combined with desk research and interviews with a range of international experts involved in horizon scanning processes. It makes recommendations for an efficient, effective and inclusive horizon scanning process for the Australian healthcare system.
Horizon Scanning – Strengthening Australia’s approach to horizon scanning for new therapies
Response and resilience of the Australian life sciences sector
As the world emerges from the COVID-19 pandemic, it is critical to reflect on what has been learned and how to make strategic and sustainable investments for the future. Pfizer’s white paper, Response and Resilience: Lessons Learned from Global Life Sciences Ecosystems in the COVID-19 Pandemic, highlights learnings from across the world of the favourable characteristics of the life sciences sector to respond to the COVID-19 challenge. A roundtable was held in Sydney in March 2021 for the local life science sector to discuss aspects of Australia’s response to the pandemic. This white paper identifies priorities areas for future pandemic preparedness, including the need for prioritised and sustainable investments, collaboration across the value chain to achieve commercialisation, technological advances and policies and regulation.
Immunisation Coalition - Enhancing adult vaccination coverage rates in Australia
The COVID-19 pandemic has emphasised the importance of vaccines to Australia and the world, and the roles of the community, healthcare professionals, researchers, biopharmaceutical companies, government, and other stakeholders in safeguarding a return to normal life. This policy white paper, done in partnership with Immunisation Coalition and supported by Pfizer Australia, examines the challenges and barriers to achieving higher rates of vaccination among Australian adults eligible for the National Immunisation Program (NIP), identifies priority areas for action and suggests evidence-based strategies to improve vaccine coverage rates.
Fighting Super Bugs
In 2019, Biointelect and MTPConnect convened a multi-disciplinary workshop to bring together key stakeholders in the sector (Regulators, state / territory governments, academia, industry) to discuss the threat of antimicrobial resistance and what could be achieved in collaboration. This workshop led to the creation of the report ‘Fighting Superbugs: A Report on the Inaugural Meeting of Australia’s Antimicrobial Resistance Stakeholders’ which made a series of recommendations for new and improved approaches. The Australian Antimicrobial Resistance network (AAMRNet) has been established in 2020 following recommendations made in this report.
Regenerative Medicines Consortium Programme
Biointelect is a founding member of the Regenerative Medicine Catalyst, a consortium of seven partners, considering how to best strengthen the Australian regenerative medicine value chain of research, development, regulation, advanced manufacturing capabilities, reimbursement, and patient delivery. The comprehensive report highlights that by addressing multiple ‘links’ in the ‘chain’, cumulative value will be delivered.
Accelerating Access to Innovative Medicines
In 2022, Janssen commissioned Biointelect to explore current approaches to reimbursement for new and promising medicines in Australia and internationally. The resulting report, Accelerating Access to Innovative Medicines analyses Australia’s current reimbursement pathways and compares with international policies designed to accelerate access to medicines. Research highlights that Australians are waiting longer for funded access to new medicines following regulatory approval than most OECD countries. This report has a particular focus on access to innovative medicines that receive market authorisation based on early or limited clinical trial data.
Cancer Survivorship in Australia
Over the past few decades, many cancers once thought to be fatal have become curable or amenable to long term control. BMS Australia commissioned Biointelect to conduct research into the Australian cancer survivorship landscape to see available programs and services for ‘cancer survivors’, their challenges, the gaps in services and how to address them. Biointelect found that although there are well defined models for cancer survivorship, the provision of care is fragmented, and inconsistent across different institutions. The issues highlighted above in the coming future will get worse as increased screening and innovative treatments advance, hence addressing the issue now is critical.
Six Months in a Leaky Boat
Six Months in a Leaky Boat featured in 2019 at the ARCS (Association of Regulatory and Clinical Scientists) conference, it explored the reasons for uncertainty contributing to rejections of reimbursement submissions at Australia’s Pharmaceutical Benefit Advisory Committee (the PBAC). Companies spend a considerable amount of time and money developing submissions for the PBAC, the evaluation of these submissions is extensive and focuses on identifying areas of uncertainty in the claims. Uncertainty can ‘sink’ your PBAC submission, Biointelect analysed multiple submissions to identify the common areas of uncertainty and other contributors to rejections and found that many of these ‘leaks’ can be ‘plugged’ with comprehensive and robust new product planning. The six months corresponds to the period it takes for the PBAC to evaluate submissions.
Contemporary issues in valuing new oncology medicines: Do we need a new model?
In 2019 Biointelect hosted its second annual medicines policy symposium, this report summarises the main points of the presentation discussing this topic. The main discussions being the challenges of valuation of new oncology medicines, whether oncology submissions are optimal for assessment of value, what is to be learnt from the international discussion on valuation and the perspective of the patients, the ultimate stakeholder.
White Paper on Precision Medicine in Australia
In 2019 MTPConnect commissioned Biointelect to facilitate a Round Table bringing together stakeholders in the sector to discuss the key issues surrounding technology, regulation and reimbursement, commercialisation, and implementation. This was done so MTPConnect can understand how to better support the sector in implementing precision medicine into the Australian health care system and contribute as a sector to the national strategy.
Download the 2019 Precision Medicine White Paper_MTP Connect report
Broadening the Evidence Report
Over the past 10-15 years there has been an evolution in the way in which consumers can engage and participate in Health Technology Assessment (HTA) processes. BMS Australia commissioned Biointelect to research the perspectives of Australian stakeholders to obtain insights on the experiences of consumers and views on areas for improvement. The report shows there are several areas where patient / consumer engagement and participation could be improved in Australia.
AMR Industry Position Paper
Biointelect identified a need to coordinate an industry position on antimicrobial resistance. In partnership with Medicines Australia, AusBiotech, CSIRO, Pfizer and MSD we convened a workshop and developed the following AMR industry position paper. This work was also showcased at Parliament House at PharmAus2019 to raise awareness on this critical public health issue and the role that industry plays as an essential stakeholder.
As a follow-on event to these activities, Biointelect was engaged by MTP Connect to convene a multi-disciplinary workshop to bring key stakeholders together from the medical and research sector, industry and government on this important topic. The report from this workshop is expected to be available in March 2020. For more information contact amr@biointelect.com
Download the AMR Industry Position Paper 2019 report
Biointelect ARCS Webinar Considerations and strategies for running trials during the pandemic
Jennifer Herz talks about some of the development and manufacturing challenges that need to be overcome to produce a vaccine against COVID19. Whilst the progress in vaccine development is evolving daily through the pandemic, the key messages from this presentation remain the same. Australia needs to invest more to bridge the gap between early stage research and commercial scale manufacturing so we can secure a strategic place in the global supply chain.
Shot In The Arm: The Numbers Behind a Vaccine
The Value of Vaccines: A Tale of Two Parts
Since the mid-20th century, vaccination has globally been an integral component of strategies to prevent and eradicate infectious diseases. Australia, like many countries, uses health technology assessment (HTA) processes to evaluate the clinical, cost-effectiveness and budget impact of medicines, including vaccines, to determine whether they get funded.
Critically, HTA typically only measures patient health and healthcare system cost impacts (i.e., the ‘healthcare system perspective’). However, this excludes vaccines’ broader societal impacts, reducing their perceived value. Consequently, this makes timely vaccine funding challenging.
Vaccines’ broader societal benefit has never been more clearly demonstrated than during the COVID-19 pandemic. In Australia, while comprehensive social restrictions (including ‘lockdowns’) helped reduce negative health outcomes, economic activity severely contracted, with large-scale budget measures required to support the economy and healthcare system. Australia’s subsequent vaccination rollout forwent usual HTA processes, facilitating restrictions removal and societal and economic recovery. However, in ‘normal’ circumstances HTA would not consider these societal impacts.
In this published work, Biointelect in conjunction with Victoria University developed detailed modelling comparing the economic impacts between January 2020 and June 2023 of continued lockdowns versus vaccination rollout and examined global HTA vaccine evaluation methodologies.
Modelling demonstrates vaccination rollout’s positive incremental impact on gross domestic product (GDP) to be upwards of AUD 181bn, with tourism (AUD 28bn) and education (AUD 26bn) exports, employment (142,000 jobs) and government finances (AUD 259bn) similarly positively impacted. Conversely, HTA methods, including Australia’s, generally only consider direct patient health outcomes and healthcare system-related costs. However, there are growing calls for broader valuation frameworks to be developed.
With infectious diseases now more than ever at the forefront and ongoing reviews of HTA policy and processes, this published work demonstrates the importance of HTA valuation frameworks capturing the true value of vaccines. Further, these considerations are broadly applicable, becoming increasingly important as we move into a future with a changing population disease profile and a new generation of therapeutic interventions.
National Cell and Gene Manufacturing Blueprint
With the rapid and ongoing global growth of cell and gene (C&G) products there is an opportunity for Australia to be a regional C&G hub. This report was commissioned by AusBiotech and delivered by Biointelect to build on 2021’s Regenerative Medicines Consortium Programme and produce a National Blueprint for the strategic growth and development of an Australian C&G manufacturing ecosystem. Key recommendations from this project include fostering a skilled local workforce, streamlining market access and patient delivery, and strategically expanding our translational and commercial capabilities to meet the increasing demands of the global market.