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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


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 immuno-

modulator 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


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),

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 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

Patients

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

Care giver (family

members)

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

Over the last week, how

itchy, sore painful or

stinging has your skin

been?

Over the last week, how

embarrassed or self-

conscious have you been

because of your skin?


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 first-

line 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.


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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