Here, we present the results of the qualitative evaluation of the SMC SIP from pharmaceutical company representatives, HTA bodies, and patient groups. Two specific objectives of the project were (1) to collect qualitative data to assess the experience of using the SMC SIP and (2) to develop an international SIP template based on these findings. The Health Technology Assessment international (HTAi) Interest Group for Patient and Citizen Involvement in HTA (PCIG) project was initiated in response to recognition of the value of providing patient groups with clear information, and to help provide tools to support and encourage robust and meaningful involvement of the patient perspective in HTA deliberations. The SIP is made available by the SMC as a resource to support the SMC Patient Group Submission process ( 12). Pharmaceutical companies making an HTA submission to the SMC are asked to provide answers to seven questions, covering the following: the use of the medicine, management of the condition in Scotland, how the medicine works, its effectiveness and safety, and the impact of the medicine on quality of life for patients and carers. However, most other HTA bodies have yet to follow the example of the SMC, and patient input to the HTA process is often in the absence of or with limited information about the intervention (drug, diagnostic, or device) under evaluation. This later became a mandatory part of HTA submissions to the SMC. In 2017, the SMC introduced an update to this template in the form of the Summary Information for Patient Groups (SIP) ( 11). These also include the initiative of the Scottish Medicines Consortium (SMC) to develop a template for pharmaceutical companies to complete that could be provided to patient groups as a plain language summary of the medicine under appraisal ( Reference Single, Macpherson, Fearns, Dickson, Facey, Facey, Ploug Hansen and Single10). These include the use of consultation surveys and consultation documents. Many HTA bodies emphasize the involvement of patient groups and have developed working practices to solicit input to inform these deliberative processes ( Reference Facey, Hansen and Single9). It is, therefore, important that relevant patient audiences have an informed and appropriate understanding of the treatment or technology under review in order to optimize their input into the HTA process. HTA bodies, however, often ask patients or patient groups these questions to inform deliberations in addition to questions about patients’ experience of living with a condition ( Reference Single, Facey, Livingstone and Silva6– Reference Sampietro-Colom and Thomas8). As a result, patients or patient groups may find it difficult to comment on the proposed use of a treatment or discuss trade-offs of the benefits and harms of a treatment. Often, the content of an HTA submission is inaccessible or quite technical. Inclusivity involves creating an environment where stakeholders can meaningfully contribute to the HTA decision-making process, for example by sharing information and/or providing this information in plain language. Patient groups can help provide this information through their engagement with the HTA process, which is illustrative of inclusivity, a core principle of effective deliberative processes in HTA ( Reference Bond, Stiffell and Ollendorf5). Patients, families, and carers can provide unique information about what it is like to live with a condition and give a real-life view of the potential impact of a new medicine ( Reference Perfetto, Oehrlein, Boutin, Reid and Gascho4). Understanding the perspectives of patients and their families and carers is becoming widely recognized as a critical component in any Health Technology Assessment (HTA) for reimbursement purposes ( 1– Reference Weeks, Polisena, Scott, Holtorf, Staniszewska and Face圓).
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