Summary
Korea has recently implemented an innovative reimbursement pathway for IVDs whilst Australia and Singapore have come up with regulatory guidelines for digital solutions.
Midtier segments are booming in Asia, which is a challenge for companies that deal with high-end premium customers. China sees growth, especially in lower-tier cities post-Covid.
Covid-19 has accelerated telehealth and innovation as the health industry bands together with a common of purpose.
Regulatory uncertainty is seen as a major challenge in Asia. Given more experience with the Emergency Use of products in Covid-19, regulatory flexibility may become a more permanent feature.
On 24 September, Centivis attended the inaugural APACMed conference held in a virtual setting. Here are some highlights from the conference, mostly focused on diagnostics and digital technologies.
New entry-first assessment-later IVD pathway in Korea
As introduced by Senior Research Fellow and International Cooperation Advisor of National. Evidence-based Healthcare Collaborating Agency (NECA) Dr Sukyeong Kim
Korea has a national healthcare insurance system with a single Payer, the National Health Insurance Service (NHIS). In 2017, NHIS covered 62.7% of healthcare spending in Korea and aims to expand coverage to 70% by 2023.
In 2007-18, more than 50% of products that applied for health technology assessment were in-vitro diagnostics or genetic tests.
To prevent a market entry delays (also bearing in mind that most IVDs are not inherently harmful to the human body), Korea has implemented an Entry-First-Assessment-Later (EFAL) scheme for IVDs in 2020, after a successful pilot in 2019. Instead of HTA, IVDs will be assessed by systematic reviews and real-world evidence.
Key steps for the Entry First Assessment Later (EFAL) IVD pathways are below. IVDs will be allowed preliminary market entry and coverage, then be assessed by systematic literature reviews and real-world evidence.
Abbreviations: MFDS- Ministry of Food and Drug Safety, NHI- National Health Insurance, HIRA- Health Insurance Review and Assessment Service, nHTA- new Health Technology Assessment, NECA- National Evidence-based Healthcare Collaboration Agency
Already a leader in risk-sharing agreements in the region, Korea has also started a separate assessment program for innovative technologies. This program is for medical products where evidence may be hard to accumulate but the unmet need is high. Technologies will be assessed based on safety, disease burden, unmet need (e.g. rare disease), quality of life, outcome improvement, the possibility of abuse, and presence of alternatives.
2 cases including a stomach cancer prognosis prediction algorithm and a robot-assisted device for rehabilitation have been approved under the scheme, while another 4 are under review.
How is Covid 19 reshaping the Chinese MedTech industry?
Interview with Chairman of the Advanced Medical Technology Association (AdvaMed) China and Senior Vice President Becton Dickinson China James Deng
Hospitals from lower-tier cities are experiencing greater patient flows due to travel restrictions (to higher-tier cities) and better technology, service availability. This trend is likely to last and companies could reallocate resources to support these new dynamics.
China is focusing on innovation with several fast-track approval pathways. These include the Priority Evaluation Appeal (for technologies which show obvious clinical improvements for a disease with high unmet needs) and the Emergency Use Approval (used in case of a pandemic e.g. for Covid technologies). The hope is that the Covid experience results in a more flexible mindset for innovative technology approvals in the long run.
Bo'oa in Hainan is designated as an International Medical Tourism Pilot Zone where innovative devices can be used without any approval from Chinese national authorities. Instead, the Hainan province can provide this approval for use in patients who require these devices urgently.
Generally, China is also investing in county hospitals in Tier 2 and 3 cities where there are limited budgets. Digital technologies may help these cities reach their healthcare goals, whilst reducing costs. This is another opportunity for multi-national companies.
Despite trade wars between the US and China, President Xi Jinping has shown openness to multinational healthcare companies, even inviting them for conversations when this has previously been restricted to state-owned companies.
Future of Regulatory Policies for Digital Health in APAC
Panel with First Assistant Secretary from Australia's Therapeutic Goods Administration (Medical Devices and Product Quality) Tracey Duffy, Director of Singapore's Health Sciences Authority (Medical Devices Branch) Rama Sethuraman, Executive Director of the Centre of Regulatory Excellence Prof John CW Lim, International Regulatory Policy Lead Genetech Lesley Maloney, Regional Manager Regulatory Affairs & Policy Roche Diagnostics Asia Pacific Varun Veigas
Digitally forward countries Singapore and Australia have come up with guidelines for the regulation of software as a medical device (SaMD).
Singapore's guidelines published by the Health Sciences Authority identifies regulatory requirements for products from start to end of a life cycle. The guidelines also cover AI and broad concerns for AI with continuous learning capabilities.
So far, no products using AI with continuous learning capabilities have been assessed. But this does not mean such software is not allowed. Regulators are open to refining guidelines in this aspect when there is an opportunity to assess such technology.
Australia aims to take a light-touch approach to the regulation of software as a medical device. The level of scrutiny will depend on the level of risk the product represents to the patient or healthcare professional using it. Companies can be audited to ensure that they have quality systems in place for change management. Changes to software are mostly on a notification basis and only major changes (e.g. change of intended use) require re-assessment.
Digital is a novel field and capacity-building is needed for all parts of the ecosystem from software developers to Payers and regulators. Software developers might not be used to a regulatory mindset whilst Payers and regulators are adapting to the agility of digital. Co-creation, convergence and collaboration are needed, both within and across jurisdictions.
Policy fora (e.g. those organised by International Medical Device Regulators Forum and private companies) are essential for translating conversation into policies, so as to bring solutions to patients in a safe way.