Novartis’ promise to patients and healthcare providers
When developing medications, it is important to take the patient's view into account from the outset and on a systematic basis.
Hence, in 2018, we adopted company-wide principles to take the needs of patients even more into account in our work.
We impact the lives of millions of people around the world.
We enter into a dialogue with various worldwide patient organisations that represent around 200 million patients all over the world.
We understand and respect patients’ perspectives
We continue to expand access to our drugs
We conduct clinical studies responsibly
We recognise the importance of transparency and disclosure
The patient community is significantly involved in the co-design of study protocols, of targeted product profiles, and in the development of patient-relevant endpoints, so that our innovative drugs meet the patients’ needs.
We recognise the benefits of this early engagement, in the form of better outcomes and better patient-based evidence for regulatory and political players, as well as sponsors.
Solutions / Services / Partnerships
All non-branded offerings – often in the form of stand-alone solutions, platforms and/or strategic partnerships that meet specific needs along the patient journey
Customer engagement (patient-oriented)
Raising awareness and motivating patients via websites, social media and other digital and non-digital channels
Experience with the product
Directly connected to the “physical” product – with or without trademark – such as secondary packaging (e.g. QR codes) or support with introduction (e.g. starter kits)
PSPs (Patient Support Programmes)
An umbrella term for programmes that offer direct services to patients, typically from enrolment to ongoing treatment
Specific examples of patient engagement
Chronic myeloid leukaemia (CML):
Contribution to the paediatric study and study on the preferred first treatment option for CML
WHICH POINTS WERE OBSERVED?
The study concept and protocols were reviewed by a global team of patients and experts. Parents of children living with CML were also included for important insights.
WHAT HAVE WE LEARNED?
The significance for our patients of less frequent bone marrow collections or the elimination of these
HOW DID WE INTEGRATE THIS IN THE PLANS?
Bone marrow collections for exploratory endpoints were scheduled, but these were eliminated from the protocols after feedback from patients.
IMPACT
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The study design, including the endpoints, was reviewed and confirmed by the community.
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In addition, food effects were perceived as significant and were reduced through once-daily medication intake.
Acute myeloid leukaemia (AML):
Contribution to the AML symptom diary for the AML clinical development programme
WHICH POINTS WERE OBSERVED?
A global team of patients and experts contributed to the development of the symptom diary, the participant screener and to the discussion manual for the patient interviews.
WHAT HAVE WE LEARNED?
How important it is to use patient-friendly language, e.g. “first drug for the treatment of AML” vs “first-line treatment”, and “disease has returned” vs “relapsed/refractory”
HOW DID WE INTEGRATE THIS IN THE PLANS?
We revised the symptom diary, the participant screener, and the discussion guide for interviews with adults with AML on evaluating the symptom diary
IMPACT
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Feedback on the participant screener and discussion manual ensured that the questions were understood by the participating patients and that the interviews successfully evaluated the AML Symptom Diary for the clinical development programme
The life experience of patients as the basis for the clinical plan for psoriasis:
Patient-relevant endpoints dictate the treatment regimen
WHICH POINTS WERE OBSERVED?
Through qualitative patient surveys and cognitive tests, the team received information about the patients’ life experience, the clinical programme and their diagnostic procedures.
WHAT HAVE WE LEARNED?
Patient surveys and cognitive tests showed that the patients experience itching, pain and scaling to an extent previously unseen by doctors
HOW DID WE INTEGRATE THIS IN THE PLANS?
• The patient contribution confirmed the need to develop more patient-relevant clinical endpoints with a focus on itch and pain.
• A daily electronic diary for psoriasis patients was developed and included in two phase III studies
IMPACT
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The authority recognised that the clinical studies provided sufficient evidence of an improvement in itching, pain and scaling
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These were included in the summary of product characteristics and recognised as best practice by the authority.
Tracking the learning and the effects of our medication in acne inversa
WHICH POINTS WERE OBSERVED?
Through collaboration with patient organisations and patients, patient feedback was received on the topics of "patient life experience", "clinical programme and laser microdissection", as well as "product objectives designed by patients" and "integrated evidence plan".
WHAT HAVE WE LEARNED?
• Patients were, to varying degrees, willing to accept intravenous administration
• Symptoms described in the literature do not reflect the full impact of living with acne inversa. Therefore, it is important to consistently record in diaries drainage and the mental health state
HOW DID WE INTEGRATE THIS IN THE PLANS?
• Feedback, in particular on the method of administration (syringe or infusion)
• Inclusion of electronic diaries on mental health and treatment preferences for future studies (Phase IV)
IMPACT
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Objectives for the product profile, and clinical study endpoints based on patient preferences
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Inclusion of an electronic diary instrument for mental health in phase III studies