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A CASE STUDY COMPETITION FROM

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Case Study Brief


Pramod Kumar is a bright young management graduate, who joined Novartis and has successfully
completed the two years Graduate Leadership Development Program. The program provided
him with invaluable learning experience about the Industry and the way Novartis functions,
through structured stints in sales, marketing and a cross-functional exposure coupled with an
international experience for six months. Now, he has joined the Dermatology portfolio which is
working on the launch of a new research molecule of Novartis. He has been able to closely
observe what this treatment could bring about to the lives of patients. He is excited to work on
the launch that is going to set a new standard of care (SoC) in the treatment of psoriasis and will
redefine treatment outcome form a physician and patients perspective.

Disease
Psoriasis is a chronic disease that can negatively affect a patients life, both physically and
emotionally. Psoriasis is a common dermatological condition that affects 12% of the population,
2030% of whom have moderate-to-severe chronic plaque psoriasis. Having psoriasis can be
embarrassing, and many people, avoid swimming and other situations where patches can show. It
can severely impact day to day Quality of Life (QoL) of the patients. Psoriasis prevalence
estimated is 12% of the population (~125 Mio suffers worldwide). It is categorized into mild,
moderate and severe.

Patient Experience The Burden of Psoriasis:

https://www.youtube.com/watch?v=QL1X4SaJh_w
https://www.youtube.com/watch?v=tsHq8f9OLCQ

Psoriasis is not only a skin disease but also has a


substantial negative impact on patients health
(i) Psoriatic arthritis - It is estimated that up to 30%
of patients with psoriasis may develop Psoriatic arthritis1
(ii)
Cardiovascular Risk - Hypertension,
hyperlipidemia and coronary heart disease have been
significantly associated with moderate-to-severe psoriasis
(iii)
Depression - Patients with psoriasis
reported significantly higher degrees of depression (67%
vs. 12%) or have a higher risk of developing depression
(20%-25%), are more anxious (45% vs. 18%) and have more
suicidal thoughts than the general population
(iv) Diabetes - Type 2 diabetes and obesity have been significantly associated with
moderate-to-severe psoriasis
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Management of Psoriasis
Psoriasis patients may have to go through a cycle of uncertainty and disappointment following
the appearance of their first symptoms. They are now well aware that it is a chronic condition,
and move from doctor to doctor seeking for a solution and symptomatic relief.
Patients may see doctors at different levels of healthcare, family doctor, and then to
dermatologists, and there are many instances of trying out Ayurveda and Homeopathy.
Typically, the early treatment entails application of creams such as topical corticosteroids,
Moisturizers and Vitamin D analogues.
As the disease progresses, most of the patients dont get relief by topicals (creams) and
they are put on oral first line systemic treatments.
Further, there are Drugs that alter the immune system (biologics). Several immunomodulator drugs are approved for the treatment of moderate to severe psoriasis. They
include etanercept (enbrel from Pfizer), infliximab (Remicade from J&J), Alzumab from
Biocon etc. Their administration varies with remicade and alzumab being given as
intravenous infusion and enbrel being given subcutaneously. Dermatologists use these
injections usually for people who have failed to respond to traditional therapy or who have
associated psoriatic arthritis. Biologics work by blocking interactions between certain
immune system cells and particular inflammatory pathways.

Impact on Daily Life

More than 80% of patients report life impacting problems everyday


Nearly half of psoriasis patients (48%) reported problems sleeping
More than a third of psoriasis patients (36%) report problems using their hands
About 3 out of 10 psoriasis patients (31%) report problems while standing or sitting for
long periods or walking
.and has problems being sexually active (29%)
A PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and
Severity Index). In practice, treatment methods are compared on the basis of improvement in the
PASI score.
Also in India most of the doctors are using the method of calculating the BSA (Body Surface Area)
% for diagnosis of mild, moderate and severe cases of psoriasis.
Additionally, Dermatology Life Quality Index (DLQI) used is a simple self-administered, easy
and user-friendly validated questionnaire used to measure the health-related quality of life of
adult patients suffering from a skin disease. The questionnaire requires the patient to answer
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simple questions that capture various aspects related to his day to day living. (To provide an
illustration, some questions from DLQI questionnaire sample are shown below),

Over the last week, how


itchy, sore painful or
stinging has your skin
been?

Over the last week, how


embarrassed or selfconscious have you been
because of your skin?

Current Scenario (therapies do not sufficiently address needs and lead to a high level of patient
and physician dissatisfaction):
Studies indicate that, Dermatologists are dissatisfied with current treatment outcomes in about a
third of cases and 41% of patients are dissatisfied with their current level of disease control. The
following table summarizes the research findings from different stakeholders
Doctors

Patients

Care giver (family


members)

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Relatively lower usage of Biologics in Psoriasis on account of


perceived side effects, administration challenges and above all
high cost of therapy vs topicals and orals.
PASI score not well established among doctors to effectively
measure therapy benefit
Believes compliance is a major concern and sees value in
bundling schemes offered by pharmaceutical companies as
compliance drivers
Perceived lack of efficacy requires strong reinforcement for
therapy compliance
Typically wanes off from Biologics therapy within 3 months of
1st administration
Low awareness of any structured parameter to assess disease
control
Have dissatisfaction with current treatment options on
account of side effects / perceived lack of efficacy
Frequent doctor visits for administration of injectable is seen
as a hindrance to dosage compliance

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FARETO A new hope for Psoriasis


Fareto is a new Biologic for the treatment of Psoriasis. It is an immunosuppressant that
reduces the effects of a chemical substance in the body that can cause inflammation. It is a
Biologic for Psoriasis that has been developed through one of the biggest development programs
and has a mode of action that is distinct. In the body, at a cellular level, Fareto targets a specific
bio-messenger which is different than earlier biologic treatment options. Due to its high clinically
relevant efficacy and favourable safety profile, Fareto 300mg is the only Biologic indicated as firstline treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic
therapy.
Fareto has shown excellent promise in clinical trials as against current Standard of Care (SOC) in
biologics treatment. With Fareto the patients can achieve clear or almost clear skin. On PASI
scale Fareto will provide significantly better results than current available treatment options.

Meaning of DLQI Scores (0-1 = no effect at all on patient's life I 2-5 = small effect on patient's life I
6-10 = moderate effect on patient's life I 11-20 = very large effect on patient's life I 21-30 = extremely
large effect on patient's life).
The recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed
by 300 mg every 4 weeks thereafter. Each 300 mg dose is given as 2 subcutaneous injections of 150
mg.
Looking at all this, Pramod feels very excited and energized; he believes that it is a very
interesting time wherein the power of research will soon transform the lives of psoriasis patients
and the treating physicians will be empowered with a product that can truly make a difference in
the lives of these patients.

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But at the same time a number of questions are running in Pramods mind, like how does one
goes about designing the launch strategy. So he gathered additional details about the customer
population, as follows:

Over 6000 dermatologists are available across the country.


Approximately 600-700 dermatologists have already used the current available biologics.
There are also a variety of customer segments like some dermatologists attached to
hospitals. While many are prescribing type, few are stocking and dispensing segment.

So here is a great opportunity to prepare a robust launch strategy for Fareto by addressing the
pivotal questions like:

What should be the key strategic drivers for Novartis to keep in mind while preparing to
launch the drug?
How does Novartis establish the higher standard of care being delivered by Fareto, in the
minds of physicians and patients?
What would be the best Go to Market approach for Fareto?
For proper efficacy of Fareto, strict adherence to the required dosage will be required.
How can proper compliance among the patients be ensured?

Pramod has been asked to share his version of launch plan for Fareto with a cross-functional team
in two weeks from now.

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