PERCEPTION ANALYSIS OF DOCTORS ABOUT FEBUXOSTAT AS A DRUG FOR

HYPERURICEMIA

PERCEPTION ANALYSIS OF DOCTORS ABOUT FEBUXOSTAT AS A DRUG FOR

HYPERURICEMIA

Guide:

Ms. Nivedita Parulekar

Group Product. Manager

Submitted by:Gagandeep kaur

MBA PHARMANIPER

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FLOW OF PRESENTATION

Sun pharma : Company profile

• Sun Pharma (March 09 Net Sales USD 932 million), Net Profit ( USD 396 million),

• Company with a twenty-five year history of robust profits. The company has doubled revenues and tripled profits every four years since listing on the stock exchanges in India in 1994.

• Forbes listed Sun Pharma among the best companies globally for 2001, 2003, 2004 and 2005 (Category of Companies with turnover less than $1 billion) and in “Forbes Global 2000” in 2008

• Ranked among the top 50 high growth companies in Asia by Business Week.

• Sun Pharma is Number 1 by prescription share with psychiatrists, neurologists, cardiologists, orthopedists and ophthalmologists

• About 8,600 employees, including 2,500 medical detail persons across 18 marketing divisions in India, and over 400 detail persons in international markets.

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• Around 30 branded generics are introduced every year in India. Most of these are based on internally-sourced API

• Present in 30 countries like Brazil, Mexico, Russia and most countries in Southeast Asia, with speciality brands and marketing teams

• Sun has invested over Rs. 15 billion (~ USD 300 million) in R&D so far. Last year, Sun invested 8% of net sales in research. Sun has nearly 575 scientists, a team that has one of the highest R&D efficiencies

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Sun pharma : Company profile

Objective:

Perception analysis of doctors about febuxostat as a drug for hyperuricemia

Sub- Objectives :

To understand the treatment pattern for hyperuricemia across superspeciality such as nephrologists, cardiologists and diabetologists

 To evaluate the efficiency of current treatment options available for hyperuricemia 

To analyse the need for newer options

To evaluate the potential of febuxostat to meet the market requirements

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HYPERURICEMIA

Definition:

Hyperuricemia is a level of uric acid in the blood that is abnormally high. In humans, the upper end of the normal range is 360 µmol/L (6 mg/dL) for women and 400 µmol/L (6.8 mg/dL) for men

Causes:

 increased production of uric acid, decreased excretion of uric acid, and mixed type

• Causes of increased production include high levels of purine in the diet and increased purine metabolism.

• Causes of decreased excretion include kidney disease, certain drugs, and competition for excretion between uric acid and other molecules.

• Mixed causes include high levels of alcohol and/or fructose in the diet, and starvation.

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Febuxostat Mechanism of action

• Febuxostat is a non-purine selective inhibitor of xanthine oxidase

• It works by non-competitively blocking the channel leading to the active site on xanthine oxidase

• Xanthine oxidase is needed to successively oxidate both hypoxanthine and xanthine to uric acid

• Hence, febuxostat inhibits xanthine oxidase, therefore reducing production of uric acid

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Research Methodology

Research design: The research design used in this work was primary research

Sampling design

• Sampling unit: This included doctors- nephrologists, cardiologists and diabetologists.

• Sampling method: This research design required collection of information from nephrologists, cardiologists and diabetologists using a questionnare

• Sample size : The sample size for this study included 151 respondents – 97 nephrologists and a total of 54 cardiologists and diabetologists

• Sampling area: This research study was conducted in various areas of 2 metropolitan cities Mumbai and Delhi.

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Market analysis

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Febuxostat brand evealuation

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Allopurinol brand evealuation

Zyloric: GSKLodoric: SDZCiploric: CPLAlopur: SALogout: IGAZyprinol: ZYCGudloric: MAUritas: INAllgoric: KAMZyric: CPLAloric: INPiloric: PYRSwiloric: I-S

C- MARC DATA EVALAUTION

12Nephro>Diabeto> Cardio>Orhto> Uro> Onco> Cons Physician

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DATA ANALYSIS

NEPHROLOGISTS

Sample Size : 97

Delhi: 49 Mumbai: 48

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How many patients of CKD do you see in a week?

• 43% nephrologists see 50-100 patients per week• 39% nephrologists see 25-50 patients per week•14% nephrologists see >100 patients per week• 5% nephrologists see <25 patients per week

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What percentage of total patients have elevated serum uric acid levels?

• 52% of doctors say that 25-50% of total patients have elevated serum uric acid levels• 28% doctors say that <25% of total patients have elevated serum uric acid levels

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What percentage of CKD patients suffer from GOUT ?

• 90% nephrologosts say <25% of CKD patients suffer from gout• 10% nephrologists say 25-50% of CKD patients suffer from gout

What percentage of hyperuricemic patient require treatment ?

• According to 11% of Nephrologists >75% of total hyperuricemics require treatment• According to 19% of Nephrologists 50-75% of total hyperuricemics require treatment• According to 45% of Nephrologists only 25-50% of total hyperuricemics require treatment• According to 24% of Nephrologists say only <25% of total hyperuricemics require treatment

Thus taking an average value, according to Nephrologists, around 45% hyperuricemic patients require treatment for hyperuricemia

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Do you treat asymptomatic hyperuricemia?

• 71% nephrologists responded positively and said they treat patients with asymptomatic hyperuricemia, if not treated, may lead to rapid progression of CKD( also clinical trials have indicated that high serum uric acid levels are associated with cvs and nervous damage)• Most of the nephrologists said they treated hyperuricemia only if serum uric acid level was > 10mg/dl

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Which drug do you prefer most for the treatment of hyperuricemia?

• According to 99% doctors, allopurinol is the highest prescribed drug for treatment of hyperuricemia. • And 59% doctors have started prescribing Febuxostat, especially in patients who show allopurinol intolerance

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What is the duration of therapy for the treatment of hyperuricemia ?

• According to 30% doctors, the duration of therapy depend on serum uric acid levels• 50% say the treatment is longterm or lifelong• 20% doctors say treatment is short term term ranging from 2 to 6 months

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What dose of allopurinol do you prescribe ?

Dose ranges from 100mg/day to 300mg/day

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What are the various side effects &/or limitations seen with allopurinol ?

• 65% of Nephrologists say hypersenstivity is the major side effect of allopurinol• Also 10% (9 out of 97) of nephrologists say patients complain of G.I. problems (gastritis and vomiting)• 10% nephrologists say problem with allopurinol is dose adjustments/modifications in different patients according to renal function or their tolerance• 10% nephrologists say other side effects like steven Johnson syndrome, AIN (allergic interstitial nephritis), leucopenia and WBC & other interactions

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Do you continue treatment of hyperuricemia even after serum uric acid levels have normalized?

• 68% nephrologists continue treatment of hyperuricemia even after serum uric acid levels normalize• 27% of doctors do not continue treatment

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What percentage of patients require >300mg of allopurinol ?

90% of nephrologists say that <25% of patients require >300mg dose of allopurinol per day

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To how many of your patient have you prescribed febuxostat and in what dose?

• 55% Of doctors are prescribing febuxostat to <25% of their total hyperuricemia patients• 20% of doctors are prescribing febuxostat to 25-50% of their total hyperuricemia patients• 5% doctors are prescribing febuxostat to all new patients of hyperuricemia• 20% doctors are not prescribing febuxostat(reason: they do not find any limitation with allopurinol )•Implies that most doctors have started presecribing febuxostat All those doctors who are prescribing febuxostat are using 40mg OD/BD

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What are the advantages of febuxostat ?

• The various advantages of febuxostat listed by doctors are OD dosing schedule, free from side effects like hypersensitivity, gastritis, vomiting, renal friendly and that the drug is safe and effectively controls uric acid levels• Conclusively it can be said that febuxostat is a safe and effective drug

Cardiologists Diabetologists

Sample Size : 54

Delhi: 24 Mumbai: 30

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How many patients do you see in a week?

• Around 50% doctors see greater than 100 patients per week• 40% doctors see 50-100 patients per week

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What percentage of total patients have elevated serum uric acid levels?

• 91% of cardiologists and diabetologists say that <25% of total patients are suffering from elevated levels of serum uric acid level• Although no. of patents are less, with the strong link between uric acid metabolic syndrome & CV risk, diabetologists & cardiologists are potential customers to target along with nephrologists

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What percentage of hyperuricemic patient require treatment ?

• 52% of Cardiologists and Diabetologists say that 20-40% of total hyperuricemics require treatment• 27% of Cardiologists and Diabetologists say that 40-60%% of total hyperuricemics require treatment• Thus there is good scope for febuxostat in cardiology and diabetology

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Which drug do you prefer most for the treatment of hyperuricemia?

• All doctors prescribe allopurinol for treatment of hyperuricemia.• 26% doctors have started prescribing febuxostat, particularly in patients who show allopurinol intolerance • 20% doctors use colchicines as well as diet modification, hydration as initial therapy • Implies that curently allopurinol is the highest prescribed drug

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What is the duration of therapy for the treatment of hyperuricemia ?

• 40% doctors say treatment ranges from 2 -6 months• 50% doctors say treatment is longterm lifetime• 10% say it depends on serum uric acid levels

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What dose of allopurinol do you prescribe ?

• Dose ranges from 100mg/day to 300mg/day.

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What are the various side effects &/or limitations seen with allopurinol ?

• 32% of doctors reported hypersenstivity (allergiy/skin rash)as the major side effect of allopurinol• 5% indicate G.I. problems (gastritis and vomiting)• 10% say other side effects like steven Johnson syndrome, AIN (allergic interstitial nephritis), leucopenia and WBC & other interactions• 10% doctors say problem with allopurinol is dose adjustments in different patients according to renal function or their tolerance• 30% doctors say they have not seen any side effects with allopurinol

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Do you continue treatment of hyperuricemia even after serum uric acid levels have normalized?

• 52% of cardiologists and diabetologists continue treatment of hyperuricemia even after serum uric acid• 48% of cardiologists and diabetologists do not continue treatment of hyperuricemia after serum uric acid

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What percentage of patients require >300mg of allopurinol?

• Almost100% doctors say <20% patients require >300mg/day dose of allopurinol• Lesser patients can tolerate high dose of allopurinol, so there is good opportunity for newer option with better efficacy & tolerability profile

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To how many of your patient have you prescribed febuxostat and in what dose?

• 38% Of doctors are prescribing febuxostat to < 25% of their total hyperuricemia patients• 13% of doctors are prescribing febuxostat to 25-50% of their total hyperuricemia patients• All those doctors who are prescribing febuxostat are using 40mg OD/BD

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What are the advantages of febuxostat ?

• 25% doctors say that febuxostat is safe and ensures effective control of serum uric acid levels• The various advantages of febuxostat listed by doctors are OD dosing schedule, free from side effects like hypersensitivity, gastritis, vomiting, renal friendly and that the drug is safe and effectively controls uric acid level

Key findings1. 60-70% doctors treat asymptomatic hyperuricemia but in

patients with very high levels of uric acid and allopurinol intolerance

2. Allopurinol is the most preferred drug for treatment of hyeruricemia

3. Allopurinol has a number of side effects, and is not safe in patients of CKD and renal impairment, so a section of doctors have started prescribing febuxostat

4. There is need and scope for a better drug to control hyperuricemia

5. A considerable number of patients are allopurinol intolerant, and show various side effects with allopurinol. Thus there is scope for introduction of newer xanthine oxidase inhibitor which is safe and more effective

6. Around 20% doctors restrict the dosage up to 200 mg/day due to side effects like allergy, with higher dosage regimen

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5. The major side effects of allopurinol as listed by doctors are allergic rash/ hypersensitivity reactions, gastritis, vomiting, steven Johnson syndrome, dosage modifications in patients of renal impairment, WBC interactions, drug interactions such as with azathioprine, theophylline, mercaptopurine and rarely allergic interstitial nephritis etc

6. The advantages of febuxostat as listed  

• Once daily dosing schedule

• no hypersensitivity

• no serious side effects- like SJS, AIN etc

• safe and effective drug

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Key findings

Conclusions

• There is high prevalence of hyperuricemia among CKD patients

• In this survey it was found that amongst the superspeciality nephrologists see maximum number of hyperuricemia patients followed by cardiologists and diabetologists

• Many CKD patients are intolerant to side effects of allopurinol like hypersensitivity, gastritis, vomiting, drug interactions with azathioprine, mercaptopurine, theophylline

• Doctor’s first choice for treatment of hyperuricemia is allopurinol

• As allopurinol is the only available option, but many patients are intolerant to its side effects, there is need for a new drug with better efficacy and lesser side effects

• As per clinical studies and doctors observation febuxostat has low side effects and high efficacy, Thus febuxostat can be a better option for treatment of hyperuricemia than allopurinol

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Recommendations• As Febuxostat has much higher potential than allopurinol there

need to highlight the benefits of febuxostat 

• Febuxostat can be launched in both nephrology and cardio- diabeto segments

• The pricing strategy of febuxostat should be such that it matches the cost of treatment with that of allopurinol. As doctors have pin pointed the fact that cost of treatment with febuxostat is high.

• Heavy promotion highlighting better efficacy & safety of febuxostat over allopurinol is required

• Product should be promoted more to nephrologists, as they see maximum number of hyperuricemic patients, followed by cardiologists as well as diabetologists as lot of patients from these segments suffer from elevated serum uric acid levels

• The drug can also find some usage in the oncology segment, as in most of cancer patients, uric acid levels are raised due to cell lysis

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Recommendations

• The suggested Brand name for febuxostat :

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Thus representing a drug which brings a quick fall in elevated serum uric acid levels

This name is easy to remember, easily gets positioned into the mind of customer and helps in clear understanding of the indication for which the drug is intended

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