Managing Performance in Patient Centricity

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Managing Performance in Patient Centricity

Transcript Of Managing Performance in Patient Centricity

Managing Performance in Patient Centricity
Making the link between value for patients and value for the pharmaceutical industry

EXECUTIVE SUMMARY
Patient engagement in healthcare has been described as the ‘new blockbuster drug of the century’,1 and patient centricity is a key driving force for change in the pharmaceutical industry at present. However, it is important that progress in this area is considered alongside other key elements of company performance. This is consistent with healthcare as a whole; for instance, the Institute for Healthcare Improvement ‘Triple Aim’ – widely adopted in the US and influential worldwide – is to improve the patient experience of care (including quality and satisfaction), improve the health of populations and reduce the per capita cost of healthcare.
Although it seems taboo to discuss patient centricity and financial considerations in the same breath, pharmaceutical executives are obligated to act in shareholders’ interests to generate profits and increase the value of their companies. Pharmaceutical companies must therefore balance investments to address their own triple aim of driving innovation, gaining a return on investment and addressing unmet need to create value for patients.
Create patient value

Pharma Triple Aim

Drive innovation in science or
ways of working

Generate financial ROI

Figure 1: The ‘Triple Aim’ of the pharmaceutical industry

1 http://www.hl7standards.com/blog/2012/08/28/drug-of-the-century/
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We believe that these aims are complementary, however there is a paucity of data in the pharmaceutical industry to back this hypothesis. This is because pharmaceutical companies lack performance measures on how much patient value they are adding. This is reflected by a recent survey of pharmaceutical industry executives that found the topic of greatest interest in the area of patient centricity to be key performance indicators (KPIs), chosen by 80% of survey respondents.2
In this paper, we propose a performance management approach and framework for patient centricity and, more specifically, patient value creation for pharmaceutical companies. We recommend that companies come together to agree an aligned approach in assessing patient value as far as possible to apply both externally- and internally-orientated KPIs factoring the following key elements:
EXTERNAL IMPACT: • Outcomes: Patient outcomes (e.g. clinical outcomes, patient-centric
outcomes, patient activation) from use of the company’s product and services.
• Access and adherence: Improvements in the healthcare system and/or process influenced or driven by a company’s initiatives, e.g. enabling more patients to be diagnosed, access healthcare and receive treatment as needed.
• Patient experience: Patient and carer feedback on their experience of using company products, services and information, and their involvement in other company-led activities (if relevant).
INTERNAL STRATEGY AND EXECUTION: • Strategy: Assessment of how well patient centricity is understood
as a strategic concept and whether genuine patient needs are being addressed by company investments.
• Process: Assessment of how well the patient voice is incorporated into product and service development processes.
• Capability: Assessment of staff and company core capabilities to deliver patient value.
We present a set of draft KPIs within this document, and offer a vision for the path forward to industry-wide alignment on the measurement of pharmaceutical company patient impact and value.

2 Eyeforpharma survey quoted at: http://www.eyeforpharma.com/barcelona/content33.php?utm_ source=Twitter&utm_medium=Social&utm_content=2532%20Twitter%20Webinar&utm_campaign=2532
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We are in an era where companies are looking to ‘put the patient at the centre’

In their vision and mission statements, pharmaceutical companies state a focus on improving people’s lives and healthcare. Historically, the pharmaceutical industry has in fact been much more strategically focused on financial targets, achieved by maximising the price and volume of medicinal product sales, and reducing its cost base. External interactions have been predominantly focused on regulators for product approval and then physicians and payers as the prescribers and purchasers of the pharmaceutical company’s products. In terms of pharma’s triple aim of financial ROI, scientific innovation and meeting unmet patient need, the patient element was typically considered last, and managed through a proxy, i.e. the physician Key Opinion Leader. Pharmaceutical companies had almost no link with patients except in clinical trials, where patients were subject to a procedure rather than engaged participants. As a former head of R&D put it to us, in the past the pharmaceutical industry and healthcare industry ‘never thought about the patient’. This was not necessarily inappropriate or malign, as physicians took the decisions on medicine administration and many patients accepted being passive recipients of healthcare, directed by their physician. The physician was to a great extent the most appropriate customer for pharmaceutical companies to focus on.

As discussed in the Kinapse White Paper ‘Putting the patient first’3, we are in changing times. We are already in an era where the pharmaceutical industry faces many challenges to profitability and productivity,4,5 with the years of double digit year-on-year revenue growth long gone6. More importantly, we are now in an information age where internet access enables and empowers individuals to engage far more in their own healthcare. Many patients independently read about their conditions and their medicines, building an understanding of the role that they can take in managing their own healthcare and uncovering questions that they need answered. The physician is no longer the sole decision maker, but is becoming more a trusted advisor or personal shopper for their patients’ healthcare, including the medicines and services that they receive. In addition, regulators are actively seeking patient input and beginning to factor patient preferences in their approval decisions7.
Faced with this shifting dynamic, the pharmaceutical industry is now focusing resources much more on the end customer, the patient, in a desire to be more ‘patient centric’. If these efforts are successful we may finally find out whether George Merck’s famous assertion of over 50 years ago ‘put patients first and profits will follow’8 is true.

3 http://www.kinapse.com/media/1112/putting-the-patient-first-how-the-life-sciences-industries-might-look-in-2018.pdf 4 ‘The productivity crisis in pharmaceutical R&D’ Pammolli et al Nat Rev Drug Discov 2011 5 Adams & Brantner. Spending on new drug development, Health Econ. 2010 6 Goodman M. ‘Pharmaceutical industry financial performance’ Nat Rev Drug Discov. 2009 Dec;8(12):927-8 7 FDA approves first-of-kind device to treat obesity http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430223.htm 8 Time (18th August 1952)

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Unfortunately, we do not have common agreement on what patient centricity is, and we are not clear on what the benefits are

There is no common understanding or definition of patient centricity in the pharmaceutical industry. This is true in the literature, across the industry and its representative bodies, and typically within individual companies. This is a problem because a clear definition of ‘patient’ and ‘patient centricity’ is a key prerequisite for organisations to define strategic ‘patient centric’ goals and priorities, and assess progress toward against these goals.
Although there is no single agreed definition in the healthcare sector either, the following expert definitions of ‘patient-centred care’ are well aligned:
• ‘Providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions’9
• ‘The experience (to the extent the informed, individual patient desires it) of transparency, individualisation, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care’10
Aside from references to clinical decisions, many of the healthcare sentiments apply for pharma. As pharmaceutical companies take a more holistic role in healthcare, we propose to apply broad definitions for pharma for the purpose of this paper and the associated performance management framework11:

• Patient refers to people living with, or at risk of living with a disease12. This includes carers and close family members.
• Patient centricity is an attitude and approach that puts patients’ interests central to all decision making and activities.
• Patient value is improvement in the life of the patient as defined from the patient’s perspective.
In other words, patient centricity is the mindset and direction that moves you towards the desired outcome or vision. Patient value is the desired outcome, and ultimately the only thing that matters. As an example of why this division is required, a project team can be told to be patient centric, and might think they are patient centric because they are involving patients in project meetings, or because they are talking to patients. In reality these actions only have a benefit if they lead to outcomes that have a positive impact on patients’ lives, i.e. they create ‘patient value’.
Once we have an agreed set of definitions we then come to the next problem: we are not clear on what the parameters of success are in delivering patient value. This is critical as these parameters will define the performance management framework, which in turn is crucial in building a sustainable approach; business leaders and shareholders will be increasingly resistant to ‘patient centric’ investments in the long term if they cannot see measurable benefits, and cannot correlate patient value creation with business value creation.

9 Institute of Medicine http://iom.edu/~/media/Files/Report%20Files/2001/Crossing-the-Quality-Chasm/Quality%20Chasm%20 2001%20%20report%20brief.pdf
10 Berwick DM. What ‘Patient-Centered’ Should Mean: Confessions Of An Extremist Health Affairs July/August 2009 vol. 28 no. 4 w555-w565 http://content.healthaffairs.org/content/28/4/w555.full
11 Adapted from definitions formed at the Kinapse Patient Centric Pharma Forum, London May 2013
12 A similar definition is applied by the FDA’s Patient Focused Drug Development initiative, see e.g. http://www.fda.gov/downloads/ AboutFDA/CentersOffices/CDER/UCM310754.pdf and in the paper by Hoos, Anton, et al. “Partnering With Patients in the Development and Lifecycle of Medicines A Call for Action.” Therapeutic Innovation & Regulatory Science (2015)

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Drawing on the symmetry of ‘triple aims’, there is an opportunity to learn from the healthcare sector and how patient value is assessed there. This seems particularly apt as pharmaceutical companies increasingly look to act as integrators in the healthcare system, and to provide more holistic services around their products, rather than just the medicines themselves3. Health quality bodies in the USA – arguably the leading country in the world in the area of healthcare performance measurement – cite four basic categories for assessment: health outcomes, processes, structures and patient experience. Within these, there is a recognised need to shift the balance to place more emphasis on health outcomes and experience and less on process measures, but this is not always possible and so a balance is required13. The Cleveland Clinic is often cited as a best practice example in an institution, as one of the first organisations to collect and publicly disclose a wide variety of metrics for each hospital in its network.14 Their clinical quality metrics are presented in the order of priority: outcomes, process then volume. Outcomes metrics are typically clinical, but there is an intention to use more patientreported outcomes in future. Where outcomes are not possible to report, they focus on reporting process or volume measures that are known to correlate with outcomes.15

Health outcomes measures are widely seen as a step forward from purely process measures but, as with all performance measures, they must still be carefully selected in order to drive the right decisions. Blanket ‘optimal’ clinical outcomes targets applied to all patients can be harmful. For example, blood pressure targets of <130/80 mm Hg are not realistic for the most severely hypertensive patients, and evidence suggests that overmedication of these patients in pursuit of this goal may increase mortality.16
It is also important to note that patient-reported outcomes are often defined from existing tools, or developed by scientists or clinicians, and so they still may not report the outcomes that matter most to patients. The emerging field of patient-centred outcomes research is required to ensure we also identify and study the outcomes that matter most to patients. These priorities can be identified through working with patient focus groups, use of conjoint analyses and so on.
A summary of measures used to monitor patient benefit in healthcare is given in table 1 below. A number of these measures are relevant to the support that pharma companies provide and will be applied to that discussion.

13 http://www.fastercures.org/assets/Uploads/PDF/VC-Brief-EvidenceBasedMeasurement.pdf 14 E.g. http://www.forbes.com/sites/davidwhelan/2012/09/02/what-business-can-learn-from-cleveland-clinic-
how-to-report-quality-to-the-public/ 15 http://my.clevelandclinic.org/about-cleveland-clinic/quality-patient-safety/treatment-outcomes 16 Hayward, R. All or Nothing Treatment Targets Make Bad Performance Measures American Journal of Managed
Care.13.3 (2007): 126-128
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CATEGORY Outcomes

DESCRIPTION
Clinical outcomes i.e. clinically-defined and measured disease or quality of life status
Patient-reported outcomes on their disease status / quality of life (QoL)

Patient-centred outcomes, i.e. health and lifestyle outcomes measures defined by patient themselves

Patient experience

Patient feedback on the healthcare they have received through satisfaction surveys

Patient activation**

Assessment of how engaged and able patients feel in managing their disease

Process

Compliance with or improvement of a process known to contribute to improved health outcomes

Volume

Absolute number of procedures or people involved

EXAMPLES
• Glycaemic control in diabetes (e.g. HbA1c<8%)
• 30-day hospital readmission rates for Myocardial Infarction

CHALLENGES
Outcomes may or may not be of concern to patients

• SF-36 • EQ-5D™ • UPDRS II (Parkinson’s disease)

Outcomes may or may not be of concern to patients

No standards; initiatives to identify disease-specific patient research priorities include the Patient Focused Drug Development (US FDA) initiative and James Lind Alliance (UK)
• HCAHCPS and CAHPS survey results (US)
• Reviews on iWantGreatCare.com (UK)
• Patient Activation Measure (PAM)
• Self Efficacy to Manage Chronic Disease Scale (SEMCD)
• % people aged 60-75 screened for colorectal cancer
• % procedures compliant with an evidence-based clinical guideline
• Number of hip replacements performed by an institution in a year
• Number of patients covered by a health plan

Resource intensive to scientifically validate new instruments Patient priorities will vary by individual and group
Satisfaction surveys do not always reflect the full experience e.g. whether the patient has been treated personably and compassionately
Patient activation is an emerging research area that is not yet well defined; PAM is the first and dominant index but must be licensed in order to be used in a health system
Provides no/minimal information on quality or patient experience
Provides no/minimal information on quality or patient experience

Table 1: A summary of standard measurement approaches used in healthcare

** Patient activation / patient empowerment is an emerging and not yet well-defined area of measurement. It can be considered a process and an outcome; we have considered it a separate category in this table for the purpose of clarity. McAllister et al.17 argue that patient empowerment should be considered an outcome when it can be measured and therefore managed, as it has been shown to influence the effectiveness of healthcare interventions. Considering patient empowerment separately from Quality of Life (QoL) health outcomes tools is expected to be useful as QoL tools focus on health status and do not clearly differentiate psychosocial aspects. Separate measurement would allow examination of the effect of trade-off decisions that patients make between health status and psychosocial outcomes.

17 McAllister M et al. BMC Health Services Research 2012, 12:157 http://www.biomedcentral.com/content/pdf/1472-6963-12-157

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What would the tangible outcomes of patient centricity for the pharma industry be, and how could we measure them?

In pharma, as in healthcare, it is important to be clear on the patient-centric outcomes that we are trying to achieve. We can then define and measure a set of elements that lead us to those goals, and another set that demonstrate we are achieving them. Some elements will relate to external impact, i.e. the effect that the pharma company has on improving care in the eyes of the patient, and some will relate to internal activities that must be optimised to ensure success.
If the outcome we want is improvement in the quality of patients’ lives in ways that are meaningful to them, our measures should be based around achievement of that aim, using the products and services that a pharmaceutical company can offer. Therefore, health and patient experience outcomes are important external impact measures. To achieve these outcomes, the right operational objectives must be set and met. Common themes in this area will centre on achieving strong mechanisms for insight management, understanding of the patient, and positive patient perceptions and engagement. The critical success factors for the achievement of these objectives then need to be defined. These will include elements such as:

• An ability to understand and stratify the patient population, including genotype, phenotype, epidemiology, psychology and behaviour
• Effective prioritisation and resource allocation
• Robust and compliant means of engagement with patients, carers and other key health system stakeholders
• Transparency in working practices and sharing of data externally
• An ability to develop excellent products and services that meet patient needs.
Based on Kinapse’s view of the critical success factors and informed by the approach used in healthcare, a set of draft Key Performance Indicators has been defined as a starting point for discussion. The key internal and external KPI categories are presented in figure 2 with more detail in table 2 below. External KPIs will be mostly reflective of the impact a company has made up to that point (lagging indicators) while internal KPIs are designed to assess whether the right operational elements are in place to ensure the desired future external impact can be achieved (leading indicators).

EXTERNAL
LAGGING: HAVE WE BEEN SUCCESSFUL?
Outcomes: Patient-centric outcomes including QoL, patient activation, shift in continuum of care

OUTCOMES STRATEGY

INTERNAL
LEADING: ARE WE GIVING OURSELVES THE BEST CHANCE OF BEING SUCCESSFUL IN FUTURE?
Strategy: Patient focused investment review process, staff feedback on corporate strategy

Patient experience: Product, information and initiative experience surveys and discussions; corporate reputation surveys

PATIENT EXPERIENCE

CAPABILITY

Capability: Hiring criteria, competency maturity model, insights management maturity model

Process: Patient adherence, patient access to medicines and services

PROCESS PROCESS

Process: Patient input and review at each key stage of product development and commercialisation

Figure 2: Summary of proposed patient value KPI categories and their key constituent parts

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EXTERNAL

CATEGORY
Outcomes (including patient activation)

DESCRIPTION FROM PHARMA PERSPECTIVE
Patient outcomes from use of company product and services in the real world

Patient experience

Patient and carer feedback on products, services information received and their involvement in company led activities

Access and adherence

Improvements in the patient’s healthcare process influenced or driven by the pharma company’s initiatives

EXAMPLE METRIC
• Effect of pharma information or service initiative on patient activation score
• User (patient) satisfaction - covering R&D activities in addition to marketed product
• Patient adherence to medicines or services provided (including before and after an intervention)

EXAMPLE ASSESSMENT METHOD
• Patient Activation Measure (PAM) improvement
• Linear customer satisfaction scale (1-5 or 1-7) / Net Promoter Score supplemented with qualitative patient interviews
• Medicines Possession Ratio (MPR) / Proportion of Days Covered (PDC)

Strategy
Capability Process (internal)

Assessment of how well patient centricity is understood as a strategic concept and whether genuine patient needs are being addressed by company investments
Assessment of staff and company core capabilities to deliver on commitments to patients
Assessment of patient influence on core company product service development process

• Expected patient value for investments (low - high)

• % of investments (number and $) with high / very high expected patient value

• Qualitative assessment of organisational ability to manage insights

• Score on an insight capability maturity model

• Measures to ensure patient input to a core process

• % of protocols designed based on patient input

Table 2: A proposed set of patient centric KPIs for a pharma company. Not all KPIs would be required at each level of the organisation.

INTERNAL

This list is not a comprehensive view of all possible measures, but an indication of where the priorities might lie in building a suite of performance metrics. Each of these metrics will benefit from discussion and iteration, and further work is required to identify all implementation challenges and risks. However there are a few aspects of implementation worth highlighting at this stage.
Recognise hierarchy within organisations: Not all KPIs need to be measured and reported at each level in the organisation. Different KPIs

will be relevant to different stakeholder groups: executive leaders are likely to want to focus on portfolio-level impact and portfolio-level measures and will delegate accountability for process excellence; R&D and Medical Affairs managers are likely to focus more on specific initiatives – the impact of specific studies or patient and healthcare professional (HCP) education programmes, for example. This practical application of metrics ensures that the effort and costs of measuring do not exceed the benefits in having the measurement, and that metrics inform decisions and actions.

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Measuring impact on gaps in the implementation of care: To become more patient centric and reduce the risk of becoming commodity suppliers, pharmaceutical companies are increasingly seeking to operate in the healthcare ecosystem in a more holistic manner than before, to integrate and deliver services around the medicine. A disease-specific ‘cascade of care’ is therefore an excellent foundation on which to identify gaps that new or improved services can address and the impact on these gaps such as timely diagnosis or patient retention in care. The HIV therapy area has a well-respected and validated tool for this purpose (see figure 3 below)18, and a similar tool has recently been proposed for diabetes19. Many chronic conditions are amenable to this approach; epidemiology and outcomes data in addition to company insights from external engagement activities can be used to identify where quantifiable gaps in care exist.

There are of course challenges of confounding variables in a broad framework such as this. A pharmaceutical company’s contribution to some outcomes may be hard to differentiate from changes instigated by broader health system initiatives, so the KPI should be made as specific as possible. For example, a company may wish to impact the patient journey by bringing healthcare providers, non-governmental organisations (NGOs) and their own patientfocused information services together as a ‘community of interest’ to increase the proportion of patients diagnosed and linked to healthcare. In this case, the scope of the KPI should be the area where the initiative is focused and expected to have the most impact, i.e. the specific geographic location, patient subgroup and/or point on the patient journey. Control groups where the initiative is not yet implemented will add to the validity of the data and conclusions.

100%

80%

60%

40%

20%

HIV Infected

HIV diagnosed

Linked to HIV care

Retained in HIV care

On ART Suppressed viral load
(≤200 copies/ml)

Figure 3: Visualising a quantifiable impact on the implementation of care, illustrated using the ‘cascade of care’ concept of Gardner et al. in HIV17

18 Gardner EM et al. The Spectrum of Engagement in HIV Care and its Relevance to Test-and-Treat Strategies for Prevention of HIV Infection Clin Infect Dis. (2011) 52 (6):793-800
19 Ali MK et al. A Cascade of Care for Diabetes in the United States: Visualizing the Gaps Ann Intern Med. (2014) 161(10):681-689

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PatientsPatient CentricityPatientHealthcareOutcomes