We were requested to produce a full evaluation submission document for submission to the Agency of Care Effectiveness (ACE) in Singapore, for one of the first manufacturer submissions under the new HTA process. This was prior to the publication of the ACE process guidance or any appraisal documents, thus requiring us to use our background in UK HTA to best support our client. Complicating the submission further, the evaluation considered two different competing products from the same manufacturer against four competitor products, in a crowded indication with clear standards of care already well-entrenched.
We responded by working with the global, regional, and local medical, HEOR, and commercial teams to develop a strategy based on previous HTA experience and local priorities in Singapore. We attended all meetings with ACE to support the manufacturer and ask appropriate questions in order to advise on a practical approach to the submission, making use of existing materials, and understanding the decision drivers for ACE. We developed a budget impact model and conducted interviews with key opinion leaders to provide inputs for the model, as well as understanding the unmet need and the changes that would occur in local clinical practice with the introduction of these treatments. We also provided support to the commercial team on pricing scenarios, including possible competitor pricing strategies, and completed a thorough write-up of the full evaluation submission document comprising sections on the unmet need, the place in therapy, clinical effectiveness, cost-effectiveness and budget impact of the therapies.
Guidance documents published on the ACE website in July 2018 recommended that both products from our client were to be listed for subsidy on the Standard Drug List, the list of drugs assessed to be cost-effective and essential to the provision of medical care to all Singaporeans.