anant kumar _tenecteplase

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Project title- Pharmacoinvasive management of STEMI patients & the perception of the doctors. Project Guide- Mr. Prashant Agrawal (General Manager) Emcure Pharmaceutical Ltd. Project by- Anant Kumar MBA (Hospital & Health Care Management) Symbiosis Institute of Health Sciences Pune

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Page 1: ANANT KUMAR _Tenecteplase

Project title- Pharmacoinvasive management of STEMI patients & the perception of the doctors.

Project Guide- Mr. Prashant Agrawal(General Manager)Emcure Pharmaceutical Ltd.

Project by- Anant Kumar MBA (Hospital & Health Care Management)Symbiosis Institute of Health SciencesPune

Page 2: ANANT KUMAR _Tenecteplase

Executive Summary• The purpose of the study was to get acquainted with the perception

of doctors regarding the treatment of AMI (Acute Myocardial Infraction) & the strategy followed in the treatment of STEMI patient.

• The survey was carried in Delhi particularly south Delhi & was categorized in two category A & B .

• Category A consist of Cardiac hospital where there was 24 hrs CATH lab available & highly experienced doctors available round the clock.

• Category B Consist of General Physician and other hospital where heart patient visit.

• The study identified the awareness of 3rd generation thrombolytic drug among the two categories & also the perception of doctors with regard to the strategy followed in treatment of STEMI patients in Indian Scenario.

• The project further aims in identifying the insight of doctors on the subject of ideal characteristics of thrombolytic drug on rank basis in both the category A & B.

Page 3: ANANT KUMAR _Tenecteplase

Introduction• Potentially carved with attributes like fastest bolus administration,

proven clinical effectiveness, ease of administration, and with best safety profile, tenecteplase (Elaxim) has remarkably poised it presence for its use in ST-Segment Elevation Myocardial Infarction (STEMI).

• It has been observed that timely delivered bolus injection of Elaxim can make a sea face change in outcome of Heart attack victims.

• The project paddles around identifying the awareness of third generation thrombolytic drug among the Cardiologists & General physician & also the perception on Pharmacoinvasive strategy in STEMI cases.

• The project further aims to identify the present trend of use of tenecteplase in AMI cases with regard to Pharmacoinvasive strategy in Indian scenario.

Page 4: ANANT KUMAR _Tenecteplase

Research Methodology

• Number of samples n=92» Number of Cardiologist= 36

» Number of General Physician=56

• Number of days of Survey= 17 days

• Survey Methodology= Interviewing method.

• Survey area covered-» Category A- Cardiologist M.D., D.M (Cardio).

» Category B- General Physician M.D.

Page 5: ANANT KUMAR _Tenecteplase

Doctors Speciality

39%

61%D.M. (Card)

M.D.

Following graph shows categorization of Doctors specialty wise who were surveyed for the Study.

Page 6: ANANT KUMAR _Tenecteplase

Average no. of AMI patients visiting

0%

20%

40%

60%

80%

100%

Category A Category B

3% 11%12%

34%21%

34%68%

21%

Above 20

11 to 15

6 to 10

1 to 5

It is well evident from the bar diagram the AMI patients visiting the category A doctors were more than category B doctors.

Page 7: ANANT KUMAR _Tenecteplase

74%

17%

9% 1%

Category A

P.C.I.

Thrombolysis

Depends on the caseReferred cases

22%

62%

10%6%

Category B

First line of treatment given to STEMI patient

Category A - 74% of doctors preferred P.C.I as first line of treatment rather than opting thrombolysis, if presented within 3 hrs of symptom onset, as there were 24 hrs CATH lab available & also suggested that affordability of the patient is one of the important factor that help them to decide the line of treatment.

Category B- 62% of doctors preferred thrombolysis as the first line of treatment if presented within 3 hrs of symptom onset & 22% preferred PCI on CATH lab availability followed by 10% of doctors who suggested that it depends upon the case .

Page 8: ANANT KUMAR _Tenecteplase

• Both the Category A & B doctors agree for pre-hospital thrombolysis if pain to door time exceed more 3 hours.

• Super speciality cardiac hospital where there is 24 hrs Cath lab availability they prefer PCI than thrombolysis or pre-hospital thrombolysis is done.

• General physician and the hospital where there is no Cath lab availability prefer going for thrombolysis and refer the patient where the Cath lab is available.

Page 9: ANANT KUMAR _Tenecteplase

Reason for referring the STEMI patients

0% 20% 40% 60% 80%

No CATH lab avalibility

Lack of specialized doctors

Lack of avalibility of thrombolytic drug

Others

78%

11%

6%

5%

78% doctors mentioned the reason for referring the patient was non availability of CATH lab and 11% mentioned lack of specialized doctors.Certain hospitals refer the patient as no thrombolytic drug available.

Page 10: ANANT KUMAR _Tenecteplase

Reason for primary PCI

42%

8%

14%

9%

8%

11%

36%

72%

0% 20% 40% 60% 80%

Category A

Category B Contraindicated patient

Less Mortality

To prevent re-occlusion

To cut down unnecessary cost

42% doctors in Category A prefer going for PCI rather than thrombolysis as to cut down the unnecessary cost as them PCI has to be done to prevent re-occlusion.In Category B the 72% doctors prefer going for PCI if the patient is contraindicated to the thrombolytic drug .

Page 11: ANANT KUMAR _Tenecteplase

0%10%20%30%40%50%60%70%80%90%

100% 91%

4% 5%

51%41%

8%Category A

Category B

Awareness of 3rd generation thrombolytic drug

Category A- 91% of doctors are well known of 3rd generation thrombolytic drug ,Where as in Category B-only 55% are well aware & 41% are partially aware.

Page 12: ANANT KUMAR _Tenecteplase

Preference of thrombolytic Drug

41%

55%

3%

1%

0% 20% 40% 60%

Tenecteplase

Streptokinase

Reteplase

Urokinase

Total (n=92)

A high preference of tenecteplase (71%) is seen in category A , while in category B Streptokinase is more preferred (83%)

A high preference for Streptokinase as Thrombolytic (55%) is seen due to following reasons:1.Widely available2.Cheaper in price3.Cost effective results4.Good past experience5.Affordable by patient.

27%

83%71%

12%2% 4%

0%

20%

40%

60%

80%

100%

Category 1 Category 2

Streptokinase

Tenecteplase

Reteplase

Urokinase

Page 13: ANANT KUMAR _Tenecteplase

Preference of the Tenecteplase brand

88%

4%8%

% of brand preference

Elaxim

Metalyse

Don’t remember

Elaxim is the most preferred brand. 88% of doctors prefer Elaxim than Metalyse.Few of the doctors find difficult to recapitulate the name of brand as the drug is issued by the hospitals pharmacy.

Page 14: ANANT KUMAR _Tenecteplase

Reason for not prescribing Elaxim

56%

18%

21%

5%High price

Affordability of patient

Good past experience of Streptokinase

No information

56% Doctors Don’t Prescribe Elaxim because of its high cost. Whereas 18% Doctors mentioned the affordability of the patient as the limiting factor. And 21% doctors said that streptokinase has shown better result throughout their experience.

Page 15: ANANT KUMAR _Tenecteplase

02468

101214161820

Category A Category B

Rating of the attributes while selecting a thrombolytic for patient with STEMI

It is evident from the above graph that, doctors while selecting a drug for patients with STEMI preferably look for a molecule which is rapid acting with single bolus administration & should possess no re-occlusion.

Page 16: ANANT KUMAR _Tenecteplase

Ranking of the attributes

Attributes Category 1 Category 2 Total

Single dose 2 2 2

Rapid Action 1 1 1

Fibrin Specific 10 5 7

No Re-occlusion 3 4 3

Resist to PAI 1 6 10 8

Longer half life 9 8 9

Reduction in 30 days mortality 4 6 4

Compatibility 5 3 6

No Antigenicity 7 3 5

No effect on B.P. 8 9 10

Page 17: ANANT KUMAR _Tenecteplase

21

7

3

89

4

65

10

0

2

4

6

8

10

12

Rank

ing

Overall rapid action of the drug is ranked as the most important attribute while selecting a drug for STEMI case ,Single dose admin as bolus is the second most important factor ,followed by No Re-occlusion in STEMI cases.

Graph Showing the preference of Ideal thrombolytic drug

Page 18: ANANT KUMAR _Tenecteplase

Average effective time for thrombolytic to be administered

77%

20%

0% 0%

61%

34%

0% 0%0%20%40%60%80%

100%120%140%160%

0-1 hrs 2-4 hrs 4-6 hrs More than 6 hrs

Category A Category B

Approximately 77% of doctors in Category A said that 0-1 hr. (golden hour) is the most effective time for Thrombolytic to be effective & 61% in case of Category B.Where as many suggested that if thrombolytic can’t be administered in golden hours then it can be administered up to 3 hrs. Both Category suggested that thrombolysis should not be preferred after 3 hours & alternative therapy should be adopted.

Page 19: ANANT KUMAR _Tenecteplase

79%

18%

3%

42%

53%

5%

0% 20% 40% 60% 80% 100%

Yes

Partial Knowledge

Don’t No

Category B

Category A

Awareness of Pharmacoinvasive Management of STEMI patient

79% of the doctors are well aware of Pharmacoinvasive management of STEMI patient in Category A. Where as only 42% of doctors are aware in Category B.18% of doctors have partial knowledge in category A & 53% in case of category B.

Page 20: ANANT KUMAR _Tenecteplase

Information of Pharmacoinvasive management received from

0% 10% 20% 30% 40% 50%

Company representative

Conference

Medical Journal

Others

42%

33%

18%

7%

Medical Representatives (42%) and Conference (33%) were referred as major source of Information through which doctors got familiar about the Pharmacoinvasive management in STEMI patient.

Page 21: ANANT KUMAR _Tenecteplase

Pharmacoinvasive approach in Indian scenario

In category A 68% of the doctors agree to the Pharmacoinvasive approach in Indian scenario & 24% strongly agree. Where as 58 % of doctors in category B agree to it & 39% strongly agree to pharmco-invasive strategy .

0%20%40%60%80%

100%120%140%

Strongly Agree

Agree Disagree Strongly disagree

24%68%

6% 2%

39%

58%

3% 0%

Category A Category B

Page 22: ANANT KUMAR _Tenecteplase

Ideal time for P.C.I after thrombolysis

0% 20% 40% 60% 80%

3-6 hrs

6-9 hrs

9-12 hrs

More than 12 hrs

59%

22%

11%

8%

9%

13%

64%

14%

Category A Category B

In category A 59% of doctors preferred the ideal time for PCI after thrombolysis is between 3 to 6 hrs. Where as in category B 64% prefer between 9-12 hrs .

Page 23: ANANT KUMAR _Tenecteplase

Management of the patient during off time (6 PM to 8AM)

41% 49%

10%

89%

0%

11%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Thrombolysing P.C.I Depends on case

Category A

Category B

49% of doctors prefer for the PCI in category A as there is 24 hrs CATH lab available & 41% suggested to go for thrombolysis as availability of specialized doctor is a major problem during off time.Where as in Category B 89% prefer for thrombolysis & 11% suggested that it may depend upon the case.

Page 24: ANANT KUMAR _Tenecteplase

Overall Tenecteplase rating

0

0.2

0.4

0.6

1 2 3 4 5 67

0 0 0 7% 14%

56%

23%

56% of doctors rated the tenecteplase as 6 out of 7 rest 23% rated it 7 out of 7.

Page 25: ANANT KUMAR _Tenecteplase

Findings• Though the tenecteplase is potentially carved with attributes like fastest

bolus administration, proven clinical effective, ease of administration, and with best safety profile etc, the tenecteplase is still do not hold a good market share in Indian scenario.

First Line of Treatment Given to STEMI Patients-• 74% of Category A doctors DM (Cardio) prefer PCI rather than

thrombolysis if presented within 3 hrs of onset of action as there is 24 hrs Cath lab availability or they prefer pre hospital thrombolysis rather than in hospital thrombolysis

• 62% of Category B prefer for thrombolysis during first 3 hrs of symptom onset to start timely reperfusion and further refer the patient where Cath lab is available.

Reason for Referring the STEMI Patients-• 78% doctors mentioned the reason for referring the patient was non

availability of CATH lab and 11% mentioned lack of specialized doctors.

• Certain hospitals refer the patient as no thrombolytic drug available.

Page 26: ANANT KUMAR _Tenecteplase

Reason for Primary PCI-• 42% doctors in Category A prefer going for PCI rather than thrombolysis as

to cut down the unnecessary cost as them PCI has to be done to prevent re-occlusion.

• In Category B the 72% doctors prefer going for PCI if the patient is contraindicated to the thrombolytic drug .

Awareness of 3rd generation thrombolytic drug-• Category A- 91% of doctors are well known of 3rd generation thrombolytic

drug

• Where as in Category B-only 55% are well aware & 41% were having partial knowledge of the it.

Page 27: ANANT KUMAR _Tenecteplase

Preference of Thrombolytic Drug-• 71% Category A doctors prefer tenecteplase while 83% in Category B Streptokinase is preferred.•Most of the doctors (55%) prefer Streptokinase as because of –

1.Widely available2.Cheaper in price3.Cost effective results4.Good past experience5.Affordable by patient.

Preference of the Tenecteplase Brand-

•Elaxim is the most preferred brand, 88% of doctors prefer Elaxim than Metalyse.•Few of the doctors find difficult to recapitulate the name of brand as the drug is issued by the hospitals pharmacy.

Page 28: ANANT KUMAR _Tenecteplase

Reason for not prescribing Elaxim• 56% Doctors Don’t Prescribe Elaxim because of its high cost. • Whereas 21% doctors said that streptokinase has shown better result

throughout their experience followed by 18% doctors who mentioned the affordability of the patient as the limiting factor.

Ranking of Ideal Thrombolytic Drug-• While ranking the attribute of ideal thrombolytic drug, doctors while

selecting a drug for Patients with STEMI preferably look for a molecule which is rapid acting with single bolus administration & should possess good safety profile at affordable price with no re-occlusion.

Average effective time for thrombolytic to be administered

• Approximately 77% of doctors in Category A said that 0-1 hr. (golden hour) is the most effective time for Thrombolytic to be effective & 61% in case of Category B.

• Where as many suggested that if thrombolytic can’t be administered in golden hours then it can be administered up to 3 hrs.

• Both Category suggested that thrombolytic should not be preferred after 3 hours & alternative therapy should be adopted.

Page 29: ANANT KUMAR _Tenecteplase

Awareness of Pharmacoinvasive Management of STEMI patient

• 79% of the doctors are well aware of Pharmacoinvasive management of STEMI patient in Category A. Where as only 42% of doctors are aware in Category B.

• 18% of doctors have partial knowledge in category A & 53% in case of category B.

Information of Pharmacoinvasive management received from-

• Medical Representatives (42%) and Conference (33%) were referred as major source of Information through which doctors got familiar about the Pharmacoinvasive management in STEMI patient.

Pharmacoinvasive approach in Indian scenario-• In category A 68% of the doctors agree to the Pharmacoinvasive approach

in Indian scenario & 24% strongly agree. Where as 58 % of doctors in category B agree to it & 39% strongly agree to pharmco-invasive strategy .

Page 30: ANANT KUMAR _Tenecteplase

Management of the patient during off time (6 PM to 8AM)• 49% of doctors prefer for the PCI in category A as there is 24 hrs CATH lab

available & 41% suggested to go for thrombolysis as availability of specialized doctor is a major problem during off time.

• Where as in Category B 89% prefer for thrombolysis & 11% suggested that it may depend upon the case.

Overall Tenecteplase rating-• Most of the doctors who had used the Tenecteplase in their clinical

practice have rated the Tenecteplase as an ideal thrombolytic drug.• Doctors who have not used the Tenecteplase in their clinical practice &

have the knowledge about the drug have rated above 5 out of seven.

Cost of Tenecteplase in Indian Scenario-• Though most of the doctors could not answer as they only know the cost

of tenecteplase is much more than any other thrombolytic drug and is not affordable by patient in Indian scenario.

• Rest of doctors who answered suggested the price should be between 12000 to 15000 on an average.

Page 31: ANANT KUMAR _Tenecteplase

SWOT AnalysisStrengths

• Attributes of Elaxim such as rapidity of action, single dose administration, no re-occlusion etc.

• Less 30 days mortality reported in cases of facilitated PCI using adjunctive Elaxim.• Lesser complication of hemorrhage ,as it is fibrin specific drug.

Weakness• High cost of drug in the market.• Partial or less knowledge about the trials & research models relating with the

Tenecteplase especially in Category B.• No clinical experience with Elaxim.• Affordability of the patients in Indian scenario.

Opportunities• As there is bigger cardiac market in India ,Elaxim can be promoted to doctors in both

the categories who do not have a clinical experience of Elaxim.• As possessing the ideal characteristics of thrombolytic drug, trials & research model

can be well adopted in explaining the advantages over the other thrombolytic drugs especially the use of drugs in pre hospital thrombolysis & reduction in thirty days mortality in Pharmacoinvasive management.

Threats• Preference of Streptokinase, as widely available & affordability by patients in India.• Good past clinical experience of doctors using Streptokinase.• Preference of doctors for PCI in category A rather than thrombolysis if specialized

doctors are available & there is 24 hrs Cath lab available.

Page 32: ANANT KUMAR _Tenecteplase

Recommendations • Aggressive field forces-

– Building good field members with the update knowledge of recent trials & research models in explaining the benefits of benefits of Tenecteplase & make doctors help to decide the strategies (Pharmacoinvasive) to be followed in treatment of STEMI cases which had shown reduction in 30 days mortality in Indian population.

– Regular follow ups to be maintained especially for the doctors not prescribing Tenecteplase.

– Regular SMS reminders to be sent to the doctors for updates in research.

– CME’s to be established on regular basis.

Page 33: ANANT KUMAR _Tenecteplase

• Identifying key opinion leaders (KOL’s)– The doctors who have used the tenecteplase in their

practice can be the KOL’s in promoting the drug.

– Dr. Pramod Joshi, Dr. Vivek Tondon, Dr. SanjeevBharadwaj

(Fortis Escort Heart Institute, New Delhi )

– Dr. Harkrishan Lal Kher, Dr. Ashwani Metha(Sir Ganga Ram Hospital,New Delhi)

– Dr. Sumit Khenderwal (Bhatra Hospital,New Delhi )

– Dr. Anupam Goel (MAX Super Speciality Hospital, Saket , New Delhi )

Page 34: ANANT KUMAR _Tenecteplase

Other recommendations-

• Providing free subscription of National & International Journals to the doctors and providing the updates regarding the trials & benefits of drug.

• Publishing the product monograph in leading medical journals.

• Organizing seminars & conferences, and briefing the doctors about various strategies followed in treatment of STEMI and to persuade them to adopt the strategy (pharmacoinvasive) on the basis of recent trials which has shown less mortality with Tenecteplase as compared to other drugs.

Page 35: ANANT KUMAR _Tenecteplase

• To increase awareness among the doctors about additional benefits conferred by Tenecteplase as compared to its completive products.

• Providing free post diagnostic tests to the patients who had used Tenecteplase, would reassure the doctors and patients of the high clinical efficacy of the drug.

• Tie ups could be made with the leading corporate & public hospitals were STEMI patients visits regularly, so as to focus strategies for increased penetration in the selected target population segment.

• Reviewing the price of elaxim-– The current price of the Elaxim could be reviewed with the

view to decrease the costs incurred in value addition process that extends from development of the molecule to the point at which it is made available to the customers and finally the customers.

Page 36: ANANT KUMAR _Tenecteplase

Conclusion

• Even though tenecteplase is potentially carved with attributes like fastest bolus administration, proven clinical effective, ease of administration & best safety profile etc, it still does not hold a good market share in Indian scenario due to various reasons like high price, lack of awareness among doctors, and lack of clinical experience of Tenecteplase among the doctors and last but not the least its competitor Streptokinase which has got a well established market due to its affordability and good experience with this drug.

• Lack of awareness about the Pharmacoinvasive management of STEMI mainly among primary physicians. And to overcome this problem various strategies should be followed like aggressive field force, regular reminders to the doctors, increasing the visibility of drug in print media and CMEs with the update trials & research model explaining the benefits & mortality ratio.

Page 37: ANANT KUMAR _Tenecteplase

Thank you