by Kate Morgan and Martin Coombes

Supporting the patient voice in HTA - launching a standard template for information

Kate Morgan, Head of Policy and Access

Myeloma Patients Europe and Martin Coombes, Director, Policy Advocacy and Government Affairs

Bristol Myers Squibb

Patient involvement in HTA Health technology assessment (HTA) is a critical part of securing access to new treatments for patients in many countries . It is an evidence-based process that is used by healthcare systems to determine the value of a new medical treatment or device .

It is increasingly recognised that HTA bodies should seek direct input from patients, their families and carers, although this does not always happen consistently . The views and experiences of patients and carers of what it is like to live with a condition, and the potential impact of a new treatment, is unique and provides a realworld perspective otherwise missing from HTA assessment . Engaging with patients, carers and patient advocacy organisations (“patient experts”) to seek these insights should be a core part of an effective HTA process and there are many best practice examples of how this should be done effectively . For example, HTA bodies like the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) in the UK provide systematic written and verbal opportunities for patient experts to provide evidence .

To be involved in the HTA process, patient experts need clear and accessible information on the treatment and decisionmaking problem they are being asked to comment on . For example, it is useful to receive lay language information on the relevant clinical trial, treatment side-effects and how the treatment will be used in clinical practice . However, this information is not often available or accessible to patient experts . In addition, where information is provided by the HTA body it is often complex and technical in nature . Patient experts often have varying knowledge and experience of HTA, and the medical information being assessed . Taken all together, these factors mean participation is often difficult, which can impact on patient expert HTA submissions .

HTAi PCIG Health Technology Assessment International (HTAi) is a global professional society for stakeholders who produce, use, or are involved in HTA . HTAi have an Interest Group for Patient and Citizen Involvement (PCIG) who share best practice, run projects, and develop tools that encourage robust engagement of patient experts in HTA .

To improve the quality of information provision to patient experts during assessments, the PCIG developed a tool called the International Summary of Information for Patient Groups (SIP) template, alongside detailed guidance to support implementation by HTA bodies and the pharmaceutical industry . The idea is that this can be adapted and used by any HTA body in the world to support patient expert involvement .

What is the International SIP? The International SIP is a plain language summary of an industry submission on a treatment that can be used by patient experts to inform their contribution to the HTA process . The submitting manufacturer completes the template, as part of their normal HTA submission, which is then reviewed by the HTA body before being shared with patient groups .

HTAi PCIG SIP working group co-chair Kate Morgan, Head of Policy and Access, Myeloma Patients Europe HTAi PCIG SIP working group co-chair Martin Coombes, Director, Policy Advocacy and Government Affairs, Bristol Myers Squibb

Figure 1: The four core sections of the SIP

The information contained in the SIP (see Figure 1) is intended to help patient experts to make informed contributions at the appropriate points in the HTA assessment process . This could be to support written submissions or in-person engagement and evidence sessions . The hope is that having a standard template and approach will ensure that patient experts have a baseline level of information and knowledge and that ultimately, this will lead to better informed patient expert contributions . Experience of the SIP so far The SIP approach was initially developed by the SMC and has become a standard part of their HTA submission process . A survey with 17 SMC patient experts who had received and read a SIP found the information helpful to formulating their response (see Figure 2 and Figure 3) . This highlights the utility of the approach to some patient and carer experts, although others stated they preferred to conduct their own research .

Figure 3: All of the SMC patient experts surveyed found the SIP to be either “useful” or “very useful”

Alongside other patient involvement initiatives, the SIP approach can be credited with improving the number and quality of submissions to the SMC from patient experts .

To create the international SIP and guidance, the PCIG project group used the SMC SIP template as a baseline and adapted it using the feedback of SMC users, European and international patient organisations, HTA representatives and the pharmaceutical industry . The template and guidance created has since been piloted by NICE and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia . The results of these pilots are currently being analysed to identify clear recommendations for other stakeholders wishing to adapt the approach .

Where next with the International SIP? Given the obvious benefits, HTAi PCIG has created a further project group tasked with dissemination and communication of the International SIP . This multistakeholder group is working to identify and collaborate with select HTA bodies to assess whether the International SIP could work as part of their HTA process and, if so, how . Issues the group will be considering include the current patient involvement process, local context and resourcing requirements . It will also consider patient group perspectives in these countries and how the template and guidance could be further adapted to support implementation . ➤

Across countries, there are sometimes barriers, or perceived barriers, in place impacting on the dissemination of the SIP approach, such as the perception of bias of industry providing information to patient experts – which can be overcome by the HTA body reviewing the SIP before distibution . In addition, there are concerns about the capacity and resources of HTA bodies to review completed SIPs . These are issues that have been addressed both by the SMC and in the pilots, so we aim to disseminate best practice in this regard and work to develop further solutions to highlighted barriers .

Finally, as well as focusing on specific countries, the project group will also engage international, European and national patient organisations (and other stakeholders) in the work, informing them about the approach and seeking their insights and perspectives . n More information about the International Summary of Information for Patient Groups (SIP)

If you would like further information about the project or to get involved please contact the HTAi PCIG SIP working group co-chairs Kate Morgan, Head of Policy and Access, Myeloma Patients Europe on morgan@mpeurope.org or Martin Coombes, Director, Policy Advocacy and Government Affairs, Bristol Myers Squibb on martin.coombes@bms.com.

The IBTA maintains a list of key online clinical trials portals to help patients and caregivers locate clinical trial centres and understand criteria for joining a brain tumour trial. For more information, visit www.theibta.org

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