Outcomes Research

Gap Analysis

Scope of service:

• Assessment of the current situation: The collection and analysis of current data and existing materials related to the product will be carried out.

• Defining the target state: We will set out the objectives and standards that the evaluated product should ultimately meet. Our approach will consider regulatory requirements, clinical expectations and the unmet medical needs of patients.

• Identifying areas requiring attention: The existing materials and data will be compared with what is ultimately required to achieve the product's strategic objective.

• Identification of barriers and a plan for their elimination: We will establish the reasons why data gaps or other issues requiring action have emerged in certain areas and then develop an action plan to eliminate these issues and ensure the effective implementation and use of the product.

Benefits:

• Process and portfolio optimisation: By identifying areas that require attention and the extent to which they necessitate action, the focus will be precisely on the areas that require attention and address needs accurately.

• Organization of activities: Implementing a precise plan ensures that subsequent activities are undertaken in an organised and pragmatic manner, thereby increasing the chances of success while saving time and resources.

Systematic literature review (SLR)

Scope of service:

• Database reviews: In accordance with the PICOS scheme, we will conduct a thorough review of the databases defined in the review protocol.

• Protocol: The development of a systematic review protocol will be carried out in accordance with the guidelines that are in force.

• Critical assessment: We will evaluate the quality and reliability of the studies identified.

• Evidence synthesis and conclusion preparation: The research results will be extracted and synthesised, with the conclusions to be presented in a clear and comprehensible form.

• Report: A comprehensive report will be compiled to facilitate informed decision-making on the part of the client, with particular regard to clinical, regulatory, and strategic considerations.

Benefits:

• The most significant studies will be identified: The key studies that may have the greatest impact on the product being evaluated will be indicated.

• The organisation of knowledge regarding available data: The systematic review will result in a document that presents, in a clear and comprehensive manner, the full range of available scientific studies that meet the eligibility criteria established a priori in the review protocol.

Rapid Reviews

Scope of service:

• Rapid Systematic Literature Review: A pragmatic literature review will be conducted, encompassing the most relevant literature for the product under analysis. This approach will facilitate a streamlined process of selection, quality assessment, data extraction and synthesis when compared to a traditional systematic literature review.

• Timeframe and scope: The delivery of a high-quality report is to be undertaken, the purpose of which is to summarise the clinical evidence for the product under review. The narrow research question and simplified work plan will enable a faster preparation time than that required for a traditional systematic literature review.

Benefits:

• Efficiency: By delimiting the extent of the project and concentrating on its fundamental elements, the report can be compiled with considerably reduced effort, time, and resources.

• Usefulness: The report provided will be of significant value to the relevant decision-makers and stakeholders involved in processes related to the reimbursement of the evaluated product and the creation of health policy.

Real World Evidence (RWE)

Scope of service:

• Comprehensive literature review: Our reviews are designed to encompass all available data from clinical practice, giving due attention to considerations of efficacy, safety, and resource use.

• Data synthesis: The data is extracted and meta-analyses of the results from the identified publications are conducted, thereby facilitating the acquisition of a comprehensive and consistent overview of Real World Evidence.

• Reports and presentations: The preparation of concise text and communication summaries of the results obtained, and their potential use in developing a reimbursement strategy and strengthening the value of the evaluated product, is a key element of the process.

Benefits:

• A complete picture of a drug's value: The utilisation of clinical practice data serves to address the deficiencies in extant scientific evidence derived from clinical trials (Bridging the Data Gap).

• Strengthening the message: The data obtained from real-world clinical practice serves to reinforce the reimbursement portfolio and the potency of the Value Story messages.

• Credibility: Confirmation of the high value of the product in real clinical practice.

Burden of Disease and Unmet need

Scope of service:

• Description of the disease: The development of a description of the health problem will be undertaken, with consideration given to epidemiological data, the course and symptoms of the disease, and its complications.

• The impact of the disease on patients and their caregivers: A review of the extant literature will be conducted with the objective of ascertaining the impact of the disease on the life of the patient and their family members. The review considers various factors, including the impact of the disease on life expectancy and quality of life, professional activity, ability to perform household duties, and social exclusion.

• Economic and social costs: Drawing upon extant literature in the relevant field, we undertake the preparation of studies which present the financial burden associated with the disease. The following costs are taken into account: direct costs, medical and non-medical costs, and categories of indirect costs. The financial implications of patient care are delineated, both in terms of the costs incurred for the treatment of a single patient and the aggregate costs associated with the entire patient population of the country. The identification of factors that influence the increase or reduction of costs is a key aspect of the study. These factors include, but are not limited to, monitoring of the patient's condition and remission.

• Description of clinical practice and unmet medical needs: The current therapeutic pathway for a given disease is presented, and unmet patient needs in terms of access to therapy are identified.

Benefits:

• Clear indication of therapeutic need: The description of symptoms and complications of the disease in the context of lack of access to the latest treatment methods highlights an unmet therapeutic need that can be addressed by the new therapy.

• A comprehensive understanding of the health problem: A detailed description of the disease and its impact on the patient's environment is the fundamental starting point for all activities related to HTA and Market Access.

Horizon Scanning

Scope of service:

• Data identification, selection and prioritisation: The identification of new and emerging technologies with the potential to impact public health, clinical practice, costs, and health policy will be undertaken, followed by the selection of those that are most likely to have the greatest impact.

• Expected impact: Preliminary data will be analysed in order to provide an assessment of the potential impact of the technologies identified on the healthcare system or a pre-agreed area thereof. The assessment of such cases may necessitate the involvement of clinical experts.

• Report: The preparation of a factual and transparent report is to be undertaken, with the intention of including all the elements necessary to enable proactive and rational decisions to be made.

Benefits:

• Data-driven planning: The identification of new technologies and the anticipation of imminent changes in the market environment facilitate the formulation of an action plan in a timely manner, thereby enabling the implementation of appropriate measures prior to the actualisation of the aforementioned changes.

• Increasing the chances of success: Implementing data-driven measures helps to prepare effectively for the introduction of new technologies, thereby reducing potential risks and maximising benefits systematically.