The Impact of Patient Engagement in Pharmaceutical Companies

The healthcare system of the future sees the patient at the center of events. It talks to patients and not about patients, involving them in a meaningful way when developing new treatments. Communicat... See moreion is open and transparent, and there is joint decision-making with all stakeholders. In tomorrow’s healthcare system, trust and mutual respect are key elements, while any conflicting interests that may arise are honestly declared See more

admedicum is pleased to announce a blog series on topics in patient engagement relevant to those in the pharmaceutical industry.

This is the first part of the series. Read part two here

Introduction: Patient engagement in pharmaceutical companies: Market requirement and strategic task

The healthcare system of the future sees the patient at the center of events. It talks to patients and not about patients, involving them in a meaningful way when developing new treatments.

Communication is open and transparent, and there is joint decision-making with all stakeholders. In tomorrow’s healthcare system, trust and mutual respect are key elements, while any conflicting interests that may arise are honestly declared.

Patient engagement is the way this healthcare system is created. Patients have already called for more involvement and increasingly, so are physicians, regulatory authorities and Health Technology Assessment authorities (HTA) and thus patient engagement is developing into a market requirement that can no longer be ignored by pharmaceutical companies.

Patient engagement as an opportunity

Digital technology, in particular, enables patients to be more active co-designers of an innovative care system. For pharmaceutical companies, consistent patient engagement offers a great opportunity to offer products and services that have real patient benefits and thus a genuine, unique selling proposition.

A high level of patient satisfaction is not only an opportunity to make companies stand out from the crowd, but it is also becoming a prerequisite for marketing authorization, pricing and reimbursement, and success in the market. This makes it a central strategic task for a pharmaceutical and biotech entrepreneur.

In pharmaceutical companies, patient engagement has an impact on four core areas:

    1. Strategy and organization
    2. Research and portfolio management
    3. Product development
    4. Market access, services, and service design

The systematic inclusion of the patient viewpoint in all these areas represents a paradigm shift that an increasing number of companies are embracing.

Part 1: Opportunities and Risks of Patient Engagement

What are the risks for companies that embark on the path of patient engagement? Is there a risk of being criticized for “buying patients” or perhaps merely “paying lip service” to patient views? Furthermore, could companies face a real risk of being fined for non-compliance?

The relationship of the industry with patients and their representative organizations are always under close observation, which is why it is indispensable to be guided by the principles of mutual respect, transparency, and for the patient, unconditional independence.

Guidelines and Principles

First and most importantly, the direct exchange between patients and companies has already been happening for years. It is officially welcomed and actively supported by large patient representations like the European Patients ForumEURORDISWECAN, and many more. Also, industry and the European Commission are actively engaging in making significant progress in involving patients as equal stakeholders, in industrial R&D processes and beyond to ensure the best patient-relevant innovation and actual patient access.  

For companies in Europe, the relevant codes of conduct for the pharmaceutical industry are the EFPIA “Code of practice on relationships between pharma and patient organizations” and their national specifications (e.g. for Germany: FSAAKG and for the UK the ABPI Code). Additional national legislation may also apply.

Also, for patient organizations there may be written guidelines, at European, national or organizational levels (as e.g. for Europe EURORDIS’ Code of Practice Between Patient Organisations’ and the Healthcare Industry). Companies should ensure they are familiar with these guidelines, as well as internal compliance requirements when interacting with patients’ organizations. Any serious and honest approach to anchoring patient engagement in pharmaceutical companies should be based on the principles laid out in the relevant codes or requirements. Disregarding them may seriously damage both companies and patient organizations, whose greatest asset is a credible mandate.

However, a sustainable, credible and mutually beneficial relationship between pharmaceutical companies, patients and patient organizations requires more than a codification of rules and prohibitions. Guidelines for Good Patient Engagement Practice are required, based on the principles of sustainable, respectful partnership, careful listening, and fair involvement. European efforts are currently underway to produce such guidelines in a multi-stakeholder process. Additionally, guidance from EUPATIPFMDPARADIGM, and the Patient Engagement Guide may be helpful.

Patient engagement as a competitive advantage

Evidence of patient-relevant benefit at EMA and HTA level

Patient involvement in regulatory and HTA processes has become increasingly important. Patient representatives are involved in assessments in the US and in European countries and can move the needle with their contributions to the discussion or even influence the vote in the committees assigned to the matter.

For example, major European HTA authorities with strongly established patient involvement to date are NICE in the UK and GBA in Germany. In France, significant efforts are ongoing to strengthen patient participation in the HTA processes of the French authority, HAS.

A frequently used way to involve patients is by collecting patient-reported outcome data (PROs), such as the Quality of Life measurements (QoL). An analysis of the German GBA in February 2017 has shown that a large part of the submissions (9 out of 11) assessed as having a relevant non-quantified benefit or better, have included QoL data in their studies. At the same time, a large part of the submissions (12 out of 14) that had not collected QoL data was assessed as having no benefit. Involving patients, therefore, appears to be a strategic advantage that should be included at all costs.

A promising project to support regulatory and HTA processes is the PREFER research project under the Innovative Medicines Initiative (IMI). PREFER develops recommendations for guideline development of regulatory agencies, HTA bodies, and industry concerning the involvement and collection of patient preference data in decision making.

Biotech, pharma, and medtech should understand the strategic significance of these initiatives and prepare accordingly. Early dialogue and advice at EMAEUNetHTA and local agencies are highly recommended.

Improvement of treatments

Working with patients from the early beginning of treatment development can have a positive effect on the quality of a product and therefore be beneficial for both, the company and patients. Through the recruitment of the right patients for trials, tailoring treatment procedures to patients’ needs as well as disease management patient engagement can shape the way a product is developed (Source).

Enhancement of reputation

A corporate policy that is consistently geared to the needs of patients, enhances the company’s reputation with patients and their families. In the corporate reputation of pharma in 2018 – patient perspective survey, 1500 patients from 78 countries provided feedback about the core reputation criteria for the pharma industry.

Companies that have an effective patient-centered strategy, provide high-quality patient information, ensure patient safety, develop useful products, act with integrity and work effectively with patient groups have the best reputation among pharmaceutical companies.

Even in price negotiations, corporate reputation can make a difference. However, a successful business reputation will always be subject to a company’s approach to patient engagement not as a mask or image polish, but as an intrinsic component that adds value and credibility when delivering innovative and beneficial therapies to the patient.

This is the first part of the series. Read part two here.