Process & Methods

ACE Clinical Guidance (ACG) process and methods

ACGs (also known as Appropriate Care Guides) provide concise, evidence-based recommendations to inform specific areas of clinical practice, and serve as a common starting point nationally for clinical decision-making. ACGs are underpinned by a wide array of considerations contextualised to Singapore, based on best available evidence at the time of development. Each ACG is developed in collaboration with a multidisciplinary group of local experts representing relevant specialties and practice settings. ACGs are not exhaustive of the subject matter and do not replace clinical judgement.

Key steps involved in the development of an ACG are outlined below:

  1. Topic prioritisation
    ACG topics are identified from several sources, including national health statistics and relevant stakeholders, such as professional bodies. Topics are shortlisted through a rigorous prioritisation process with predetermined criteria, including alignment with national health priorities, disease burden, and potential impact on patient outcomes. Shortlisted topics are put forth to MOH for approval to be developed into ACGs.

  2. From evidence to recommendations
    A stepwise approach is taken to identify and review pertinent existing high-quality guidelines as well as published literature. ACG recommendations are formulated based on appraisal of the evidence as a whole, and a balanced assessment of a comprehensive set of considerations, including applicability to local practice.

  3. Role of the expert group
    A multidisciplinary expert group is appointed for each ACG to ensure that clinical content is accurate, current, and relevant for local practice and intended users. Each expert group consists of practising healthcare professionals who are subject matter experts, including specialists, general practitioners, pharmacists and nurses, as appropriate. A structured method is used to capture the expert group’s assessment and deliberation.

  4. Endorsement
    Prior to the publication of each ACG, professional bodies such as the Academy of Medicine, Singapore and the College of Family Physicians Singapore are invited to provide comments and endorse the ACG.

  5. Update of ACGs
    The full development of an ACG takes approximately 8 to 12 months. ACGs are usually reviewed around 5 years after publication, or earlier, if new evidence emerges that requires substantive changes to the recommendations.

 

Health technology evaluation processes and methods


What is health technology assessment (HTA)?

HTA is an established scientific research methodology to inform policy and clinical decision-making on the relative value of new health technologies, such as drugs, devices and medical services, compared to existing standards of care. It is conducted using analytical frameworks, drawing on clinical, epidemiological and health economic information to determine how best to allocate limited healthcare resources.

HTA helps to answer the following questions:

  1. Does the health technology work?
  2. What benefit does it provide and for whom?
  3. What does it cost (to the healthcare service, to the patient, etc.), including opportunity costs?
  4. How does it compare with the available alternatives?

The goal of HTA is to inform the development of effective health policies about the use of health technologies in a manner that is patient-focused and achieves best value. ACE conducts HTAs to support subsidy decisions by the respective MOH advisory committees for two main technology streams:

  1. Drugs: Drug Advisory Committee (DAC)
  2. Medical technologies (including devices, diagnostics and medical services): Medical Technology Advisory Committee (MTAC).

There are currently 3 main process steps which ACE follows when evaluating health technologies to inform decision-making:

  1. Topic submission and selection
    A call for applications is put out annually to the public healthcare institutions to submit requests for subsidy consideration. ACE works with the DAC and MTAC to select the topics for evaluation.

  2. Technical evaluation
    Once a topic is selected, technical evaluations are conducted at 2 levels – expedited or full – depending on the estimated budget impact and uncertainty around the clinical and cost parameters for each technology. In the case of medical technologies, the complexity of the care pathway incorporating the use of the technology is also taken into consideration when deciding the type of evaluation. Most of the evaluations are conducted internally by the technical teams in ACE, with supporting evidence provided by local clinical experts and manufacturers. Value-based pricing is conducted in parallel with technology evaluations, if required, to ensure that the price of the technology recommended for subsidy represents a cost-effective use of healthcare resources and is commensurate with the technology's value in Singapore's context. Under this process, manufacturers are invited to submit their best cost prices for their technologies, which will inform ACE's cost-effectiveness analyses and budget impact assessments.

    1. Higher cost technologies (estimated budget impact >$2 million a year) are typically subject to full evaluation which includes a systematic review of the clinical evidence, and economic modelling to estimate the cost-effectiveness of the technologies in the local context (where feasible);

    2. Technologies with lower budget impact are subject to expedited evaluations (without modelling), which are usually informed by published clinical evidence and international cost-effectiveness studies.

  3. Decision-making
    The evidence in ACE's technical evaluations informs the committees' subsidy deliberations around 4 core decision-making criteria:

    1. Clinical need of patients and nature of the condition
    2. Clinical effectiveness and safety of the technology
    3. Cost-effectiveness (value for money) – the incremental benefit and cost of the technology compared to existing alternatives
    4. Estimated annual cost of the technology and the number of patients likely to benefit from the technology

    5. A 5th criterion is also considered for medical technologies:
    6. Organisational feasibility – the potential impact of adopting the technology to the healthcare system

    Other factors, including social, ethical and value judgments, may also inform the committees' considerations.

    On the basis of the available evidence, the committees recommend whether government subsidy should be given for a health technology through the respective financing scheme.
ACE's Drug and Vaccine Evaluation Methods and Process Guide (Version 3) and Medical Technologies Methods and Process Guide (Version 1) outline the core processes and methods underpinning ACE's assessment of clinical and economic evidence, and any other important factors impacting the adoption of the technologies, which are being considered for government subsidy. The guides also document value-based pricing processes and the committees' decision-making frameworks.

 

Company Submissions to ACE

From 1 January 2021, under a new company-led process, pharmaceutical companies will be able to request for their products to be evaluated for funding consideration and will be responsible for providing an evidence submission to ACE, to support the MOH Drug Advisory Committee’s deliberations.

The aim of the new process is to enable medicines to be evaluated close to the anticipated date of regulatory approval by the Health Sciences Authority (HSA), and expedite funding considerations to improve patient access to clinically necessary treatments. Initially, only evidence submissions for new cancer treatments (or new indications of existing cancer treatments) will be eligible for evaluation through this route. Over time, ACE may accept submissions for other medicines.

Companies are expected to follow the Procedures and Guidelines for Company Submissions to the Agency for Care Effectiveness for Funding Consideration and its accompanying resources when preparing an evidence submission. Information on the fees for company submissions can be found in the Cost Recovery Charging Procedure for Independent Review of Company Evidence Submissions to the Agency for Care Effectiveness.

Video Resource


Take a look at how ACE conducts HTA!