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Ellen Coleman (firstname.lastname@example.org) is President and Chief Executive Officer, MK&A.
Ellen Coleman outlines the highlights of a recent webinar on ensuring that patient advocacy is a key element of a market access strategy.
Accessing the right treatments to manage disease is a challenging aspect for many of patients around the world today. This is especially true among those living with high disease burden and significant additional psychosocial effects. Yet the pharmaceutical industry and academic research community are investing significantly in research, development, reimbursement, and communication for an increasing number of new medicines and devices. Central to these efforts is the role of advocacy linking the patient and patient group to the overall access process. A recent webinar invited speakers to discuss best practice in Europe and the US on ensuring that patient advocacy is a key element of a market access strategy.
This webinar discussed three main areas: compliance, treating patients and patient groups as equal partners, and ensuring internal alignment.
• Successful companies adapted marketing and sales compliance processes for early engagement
• Compliance integrated early and often in advocacy planning
• Starting advocacy at time of pre-launch is no longer an option
• An effective compliance program creates trust
“Effective patient engagement can only exist where there is trust,” said Erik Valera, Program Director from the Latino Commission on AIDS, an advocacy organization from the US. A part of a trusting relationship is built with good internal compliance processes. Successful companies have brought in such processes that combine the rigor of the procedures associated with product launch whilst encompassing the differences when working in early stage development.
Early engagement in some ways poses fewer compliance issues compared to during product launch. As the usual, compliance issues associated with hidden, off label and pre-approval promotion, are irrelevant in early development when no drug exists, so to speak. The aim of engaging patients and patient groups in early development is to minimize later access challenges by making medicines that patients really want; new medicines with health outcomes that matter to patients. This is an increased focus among advocacy groups and industry stakeholders in shaping the discussion about value-based care treatment options and care.
Creating compliant ways for R&D to seek early input from patient groups, patients, regulators, and payers will shift the goal of target product profiles, discovery programs, and clinical trials. Pharma’s role will then shift from developing and bringing products to market, to being vehicles that create understanding about how drugs will change lives in ways that truly matter to patients.
“The compliance focus for patient engagement in early development needs to gain in flexibility to overcome the traditional reflexes due to sales and marketing activities. However, as the product moves towards registration and launch, existing rigor to prevent non-compliant practices must be maintained,” said Nick Hicks of Commutateur.
This is particularly important in smaller companies with limited resources, or those companies who are just beginning to introduce patient engagement where a rigid sales and marketing mindset drives the conversation. A company’s compliance history can also play an important influencing role; previous errors may affect the lens through which new early stage initiatives are viewed.
The best way to shift the risk-benefit concerns to a more flexible approach is to involve the compliance teams as early as possible in the development process. This ensures clear understanding of the goals of the advocacy programmed. Some companies structure compliance teams to be part of the advocacy function to facilitate this process. In disease areas where the company has no historical presence, partnering with a patient group just before launch is no longer a viable compliance option.
In addition, don’t assume patient groups understand the role they can play in Health Technology Assessments (HTA) and access decisions when the time comes, even though it may be years down the road. Many groups are often poorly informed about the national HTA patient group assistance departments. Facilitating the process by which patient groups gain and use HTA knowledge won’t happen overnight; it’s very much an incremental building process. Involvement well before the availability of a drug avoids the perception of a purely commercial interest and shows a commitment to long-term partnering with patients and patient groups.
Treating patients as equal partners
• Create cultures and processes which treat patient groups and patients as equal partners.
• The EURORDIS Position Paper is a framework for a collaborative approach with all stakeholders.
• Driving change requires building strong, long-term relationships and trust.
• Building trust between patient groups and payers is becoming a priority across all markets.
“Problems with access to treatment typically occur in four major areas.” Simone Boselli, Public Affairs Director of EURORDIS explained that patients lack access to appropriate information about their disease and struggle along the diagnosis and treatment journey. “There is a general lack of appropriate evidence to measure the difference between therapies and especially in rare diseases there remains considerable inequalities between marketing authorization and reimbursement among Member States within Europe alone.”
Yet, these problems can be addressed by taking a collaborative approach with patient advocacy groups taking a central role with the many key stakeholders including researchers, biopharma industry, regulators, payers, as well as individual communities.
In January 2018 EURORDIS launched a framework for a comprehensive approach to patient access in Europe, Breaking the Access Deadlock, to Leave No One Behind. The approach is based on four pillars covering:
(i) A blue print to cut costs and reduce R&D.
(ii) Early dialogue and European cooperation between healthcare systems on the determination of value and on patient access.
(iii) European transparent cooperation framework between national healthcare systems for the determination of fair prices.
(iv) Continuum approach to evidence generation linked to healthcare budget spending.
“There is more to gain today in being collaborative between EU Member States to establish themselves as a powerful and responsible partner in negotiations and optimal use of its national healthcare budgets,” said Simone.
Companies with successful market access strategies treat patients and patient groups as equal partners. Such companies use deep dive engagement with patient groups to address their unmet needs and not just toe in the water engagement. These deep dive strategies have built trust and uncover common, transparent aims to collaborate. Over time of the relationship, the goals are progressively amended in line with the groups’ unmet needs and changing healthcare environment.
Stakeholder engagement occurs across the entire drug development continuum. Engagement supports patient centricity in clinical design and corresponding value measures. A company’s advocacy relations is based around these value measures for example, specific grants for advocacy projects and identifying and involving patient preferences in clinical studies. Other examples include increasing the collection of data types to gain in flexibility of evidence and aligning evidence required for parallel authorization in different countries and member states in both the US and Europe.
“Working together, we can strengthen patients’ access to medicines by enabling earlier diagnoses, providing faster, more efficient regulatory approvals, ensuring access to a range of treatment options and providing more medicines in developing countries. We seek to price our products according to the value they bring to the patients and the health care system,” said Dennis Jackman, SVP Global Healthcare and External Affairs, CSL Behring.
The Latino AIDS Commission Community Engagement programmed is an example of a community engagement programmed which European pharma could use as a framework for a capacity building approach when engaging with patient groups in the context of market access. Based on a five-step model, the Engagement Programmed takes a previously identified goal and successively leads a patient group to shared leadership.
First step is outreach, which focuses on building communication messages and channels with the particular community. Next, is to consult with the community to strengthen existing connections from the first step, often getting information and feedback from the community. Third, is involvement, where the details of the particular challenge are discussed in detail and a group position is identified. The fourth step is collaboration through bi-directional engagement on a project, building trust. The final component of the Programmed is shared leadership whereby patient group activity is directed to improving overall health outcomes.
Achieving leadership and driving change requires building strong, long-term relationships and trust. This can be achieved in a stepwise manner. “Starting by reaching out, then consult and involve, which leads to collaborative projects and leading change,” said Erik Valera.
• Align internally and set appropriate expectations.
• Advocacy focuses on optimal use of treatment according to unmet need not just access.
• Deep dive rather than toe in the water engagement strategies based around patient group capacity building.
• Involve patient preferences in clinical studies and increase collection of data types to gain flexibility of evidence.
Though the value of engaging patient advocates and patient organizations is well accepted because of the unique perspectives they can bring, there has been a lack of advocacy integration during either end of the drug development process: at early stage development and commercialization.
Traditionally, advocacy within a market access context was all about achieving maximum uptake. Across companies who use advocacy well, the definition is shifting to one whereby advocacy with patient groups should not be targeted at just “uptake” but at, for example, optimal use of treatment according to unmet medical need, including input into health outcome research.
“Within CSL we have a definition of Patient Access that goes beyond purely product accessibility and includes diagnosis and treatment across the continuum of the rare disease,” said Dennis Jackman.
Getting internal alignment on a shared definition of access between advocacy and market access teams is important. In a 2016 study market access teams identified working with patient groups in HTA as the biggest compliance challenge for the coming five years whereas advocacy teams identified appropriate patient funding of patient groups as the major compliance concern (N=48).
Greatest compliance challenge in the coming 5 years
14/48 Market access responses: Patient group involvement in HTA
8/48 Advocacy responses: Appropriate level of patient group funding
Journal of Market Access and Health Policy 2016 4 33177
The market access executives saw the patient groups as having mainly an HTA role, whereas sustainable partnering is likely to involve working on common aims which may or may not be related to access. This was also recognized by the advocacy responders.
The difference between the two groups’ views on the most significant compliance challenge illustrates an important consideration when planning an advocacy strategy; the need to think beyond partnering just for access and instead addressing unmet needs of the patient group.
The team’s enthusiasm to impact access hurdles will resonate with patient groups, however, in different ways and for contrary reasons. Internally, advocacy must align with other members of the global access team to scope out priorities. How this is done depends on the way the advocacy function is built into the company infrastructure and the corporate compliance culture. Regardless, there must be a transparent, legitimate and responsible communication with patient groups, which acknowledge the sources of funding.
“One role of advocacy relations is to ensure colleagues appreciate that with collaboration comes respect for the pace and process with which collaborators act. Another role is ensuring the space for respectful disagreement. No one expects 100 percent alignment” said Nick Hicks.
Is patient advocacy an overlooked strategy for achieving equitable market success? was a webinar held on March 20 2018 by MK&A, a global stakeholder relations firm. Panelists were: Nick Hicks, Commutateur Advocacy Communications, Simone Boselli, Public Affairs Director, EURORDIS, Erik Valera, Deep South Program Director, Latino Commission on AIDS and Dennis Jackman, SVP Global Healthcare and External Affairs, CSL Behring. The webinar can be downloaded from http://mkanda.com/webinar/
Ellen Coleman is Senior Vice President, MKA.