Vipul Dholia Rx To Otc

Analysis of Prescription Drug to Over The Counter (Rx to OTC) Switch Movement: A Strategic Review With Reference To Statins.

Presented by: Vipul Dholia MBA(Pharm) NIPER

Reason for study

ü The trend for seeking advice from a doctor or medical practitioner

ü Approximately 800 over-the-counter (OTC) products currently available use ingredients and dosages available only by prescription 20 years ago. There are a number of possible reasons for this trend, including:

• A growing emphasis on individual autonomy and self-help • Trend toward deregulation in the Health care cost containment efforts

• Pharmaceutical industry self-interest/profit ü ZOCOR heart pro is now a days available in UK as OTC and it is beneficial for patients in primary prevention of disease.

Research Gaps & Objective Gaps: üGiants in UK and USA have entered in market for This OTC statins and now that’s turn for Indian Pharma companies to enter in to this lucrative Market. üAvailability of statins as lower price in USA and in UK can it be in India? üRegulation in India for OTC segment üStill not any availability of OTC statins in India but potential for this segments seems to be high

Objective: ü To identify the market potential for statins in India. ü Concept testing for OTC Statins ü Effect of OTC statins in USA,UK ü Strategies that companies can implement in launching of this OTC version of statins. ü Regulatory aspects of OTC statins

Methodology

Research methodology of the project involves following steps: ü Research design ü Sampling plan ü Data collection ü Analysis ü Conclusion and findings ü Case study method

STATINS Mechanism of Action

ü Based on the inhibition of the hydroxy-methylglutaryl-

coenzymeA (HMG-CoA) reductase resulting in the inhibition of cholesterol synthesis in hepatocytes. The number of LDL receptors on hepatocytes is increased, and the elimination of LDL from the blood is enhanced. Part of the action may be through very low-density lipoprotein (VLDL) or even other mechanisms.

Effectiveness

ü LDL is decreased by 30 to 40%. ü HDL is increased by 5 to 15%. ü Triglycerides are decreased by 10 to 30%. ü Combining statins with resins results in additive effects

Safety profile for STATIN ATORVASTATIN

ü No evidence of teratogenicity was found in rats at doses

up to 300 mg/kg per day or rabbits at doses up to 100 mg/kg per day

FLUVASTATIN

ü No evidence of teratogenicity was found in rats or rabbits given doses of up to 36 mg/kg and 10 mg/kg per day, respectively

CERIVASTATIN

ü No anomalies or malformations were found in rabbits given 0.75 mg/kg

LOVASTATIN

ü Studies in mice and rats at doses producing plasma

concentrations 40 (mouse fetus) and 80 (rat fetus) times the human exposure found an increased incidence of skeletal malformations. No changes occurred in rats or mice at multiples of 8 and 4 times, respectively, or in rabbits at exposures up to 3 times the highest tolerated human exposure.

PRAVASTATIN

ü Studies in rats and rabbits given pravastatin at doses of

1000 mg/kg per day (240 times the human exposure based on surface area) and 50 mg/kg per day (20 times the human exposure based on surface area), respectively, did not reveal teratogenic effects.

SIMVASTATIN

ü No teratogenic effects were observed in rats or rabbits given simvastatin at doses of 25 mg/kg per day (6 times the human exposure based on surface area) and 10 ,mg/kg per day (4 times the human exposure based on surface area), respectively.

Efficacy of Low-Dose STATIN (LOVASTATIN)

ü The statins have a proven track record of safety and

effectiveness in millions of patients around the world. But for OTC use, the safety and efficacy of a low-dose statin must be studied in a patient population that includes those most likely to use the product without consulting a physician. The recent study by Larouche et al. addressed this question directly. ü blinded, placebo-controlled, randomized, parallel-group, Multicenter, clinic-based study included 210 patients with characteristics of the anticipated target population for OTC statins: – Men were 45 years or older. – Women were 55 years or older or naturally postmenopausal. – Patients had no heart disease (myocardial infarction or angina).

ü Patients’

low-density lipoprotein (LDL)-cholesterol values, based on the average of two determinations, were between 125 and 165 mg/dL.

Several conclusions can be reached based on the results of the Larouche study

ü Six weeks of dietary therapy and 12 weeks of lovastatin

10 mg/day produced lipid changes from baseline that were all significantly better than those of placebo. ü The magnitude of lipid changes from lovastatin 10 mg/day were comparable with a clinic-based, placebocontrolled study and other open-label studies simulating the nonprescription use of lovastatin in OTC settings. ü The beneficial changes to lipid profiles were obtained in a patient population similar to that likely to use lovastatin in nonprescription settings. ü Lovastatin 10 mg/day was well tolerated, with a side effect profile similar to that of placebo.

Over the Counter Medication (OTC)

ü Over-the-counter (OTC) pharmaceuticals are medicines

•

Increase In Self medication 90% 80% 70%

Percent

•

that are available to the consumer for purchase without a prescription from a physician.OTC pharmaceuticals are subdivided into two segments Those that need to be purchased from a pharmacy under pharmacist supervision, Those that are available freely,

60% 50% 40% 30% 20% 10% 0% Take an OTC

Wait t i ll c ur e

Consul t

Tak e

Take diet r y

medi cat ion

i t sel f

physic ian

pr escr ipt i on

suppl ement s

medi cat i on

Factors

Chang e di et

India OTC Market $BILLION 2000

INRBILLION 1.6

India OTC pharmaceutical market

% GROWTH

10

72.5

8

2001

1.7

77

6.3

2002

1.8

82

6.4

2003

2

88.7

8.2

2004

2.1

96.3

8.6

%GROWTH

YEAR

8.2

8.6

2002

2003

7.4

6.4

6.3

6 4

TOTAL 200-2004 CAGR

2 0

7.4

YEAR 2000

2001

2004

India OTC Market Forecast

INDIA O T C m a r k e t f o r e c a s t

$Billion

INR billion

% Growth

2004

2.1

96.3

8.6

2005

2.3

104.7

8.7

2006

2.5

112.7

7.7

2007

2.7

120.7

7.1

2008

2.8

128.7

6.6

2009

3

136.7

6.2

CAGR 2004-2009

7.3

% Growth

Year

10 9 8 7 6 5 4 3 2 1 0

Source: data monitor 2005

8.6

8.7 7.7

2004

2 0 0 5 Y e a r2 0 0 6

7.1

2007

6.6

2008

6.2

2009

Future drivers of OTC Pharmaceutical Market

Health care cost containment

Dual regulatory status Rx to OTC switch activity Future drivers

Emergence of new indication Increase in self care medication

Impact of technology

What is Rx to OTC switch?

ü This refers only to OTC marketing of a product that was

once a prescription drug product for the same indication, strength, dose, duration of use, dosage form, population, and route of administration.

ü Rx-to-OTC switching increases the number of drugs

available OTC and ensures that the drugs are available for self-medication, without the prescription from a physician or a pharmacist supervision. Rx-to-OTC switching has been the dominant factor in the growth of the OTC market in recent years.

Rational for switches Reasons why pharmaceutical companies decide to pursue switches from prescription (Rx) to over-the-counter (OTC) status for their drugs. ü Extending revenue generated by a drug (life-cycle management) ü Development of a defense strategy against generic competitors ü Expansion and growth of an OTC drug portfolio ü And broadening consumer access to innovative OTC medication

Rxo OTC switch activity in USA

No of switches

10

9

8 6 4 2 0

Year

Rx to OTC switches in US 1976-2004

Cumulative switches world wide

Drivers for Rx-to-OTC switching

Revenue protection

Drivers for Rx to OTC switching

Patent expiry

Extension of PLC

Umbrella branding

List of Rx to OTC Switches

Revenue protection

Patent expiry

ü A primary reason for switching a drug to OTC status is to

maintain the revenue stream of the drug even after it has lost patent protection. Companies incur huge costs in the drug development process and, when the product patent expires, generic companies are likely to introduce cheaper versions of the same molecule and the discoverer is likely to lose market share, as some customers switch to the low cost generics.

Extension of product life

ü The entry of a more effective product or technology can also lead to a decline in the sales value of a prescription drug, which may also prompt a switch to OTC status as a possible treatment for less serious conditions

Timing consideration for lifecycle management strategies

Umbrella branding

ü Umbrella branding refers to the process of launching an

OTC brand with the same brand name for a drug that was previously available through prescription only. This is also a driver for Rx-to-OTC switches where some drugs are switched to OTC status in order to complement a company’s existing product portfolio.

Steady growth for BEPANTHEN

Differences in Rx to OTC status from country to country?

ü Different traditions ü Different situations for initiating a switch ü Different procedure ü Different political support ü Different level of information / education of the patient Conservative

Moderate

Progressive

Italy

USA

Australia

France

Germany

New Zealand

Japan

China

UK Canada

Regulatory Consideration

ü The decision to make a drug available over the counter

and, in particular, to change the status of a drug from prescription-only to over-the-counter availability raises questions relevant to the quality of health care, patients' access to drugs, patients' autonomy, and the cost of health care. Approval of over-the-counter status for a drug requires an assessment by the Food and Drug Administration (FDA) that the drug is safe and effective.

ü The 1951 Durham–Humphrey Amendment provided a

statutory basis and specific criteria for differentiating prescription from over-the-counter drugs. The amendment includes three explicit considerations.

ü It specifies that habit-forming drugs must be available

only by prescription ü Drugs that can be used safely only under the supervision of a licensed health care practitioner also require a prescription ü If a drug has been approved as the result of a new drug application for use under professional supervision, then its purchase requires a prescription The regulatory requirements for drug approval were further expanded by the Kefauver–Harris Amendments of 1962, which require the FDA to assess the efficacy as well as the safety of new drugs

Switching Procedures in the EU

The European Switching Guideline consists of two parts:

ü Part I: addresses criteria for classifying medicinal product as Rx or Non-Rx (OTC) ü Part II: outlines data requirements for a switch application

Part I: Criteria for Product Classification (Rx or not) Criterion 1: “Medicinal products shall be subject to medical prescription when they are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision." several factors should be taken into consideration: ü ü ü ü ü

The direct danger or safety profile Indirect danger or safety profile self-assessment risk and consequences of incorrect use patient information

Criterion 2: “Medicinal products shall be subject to medical prescription when they are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct danger to human health.”

Criterion 3: “Medicinal products shall be subject to medical prescription when they contain substance or preparations thereof the activity and/or side-effects of which require further investigation.” Criterion 4: “Medicinal products shall be subject to medicinal prescription when they are normally prescribed by a doctor to be administered parenterally (for injection)”. ü ü ü ü ü

Maximum dose Maximum daily dose Strength Pharmaceutical form Certain types of packaging and/or other circumstances of use

Part 2: Data Requirements for Switching Procedures in EU In the EU, the main criteria facilitating a switch are safety and efficacy data. The amount of data needed for an application is related to the nature of the active substance. ü Expert report ü Safety Information ü Efficacy ü Product information ü Other information such as a change in the packaging that might have an effect on the product

Switching Procedures in the US Exception ü OTC status and/or switching criteria in the US are similar to those in the EU. The “switch regulation” in the US was promulgated by FDA in 1956. As in the EU, if public health is not at risk, FDA can exempt an NDA drug from prescription status. Switches can also be achieved via the OTC monograph process. Supplements ü A switch can be made via a NDA or a NDA supplement submitted to CDER’s new drug review divisions and reviewed conjointly with the OTC drug division. Three criteria apply for a switch via a supplement: • The product should have been on the market for at least three years. • The product usage was high enough to enable a fair estimation of any •

adverse effects. Adverse reactions and their frequency have not increased during the assessment period.

Monographs ü The third possibility is via the monograph route. Switches can be made before final monograph publication if the product is recommended for category I and there is no objection from the commissioner, according to the “rush-to-market” regulation. For category III products or in cases where the commissioner raises an objection, OTC status is not allowed.

Rx to OTC switch procedure in us Sponsor contacts DOTCDP and request meeting Initial ,meeting ID issues sponsor will need to address address Sponsor submits NDA to DOTCDP

DOTCDP notifies division responsible for therapeutic/ pharmacological pharmacological class

NDA review team is formed within 14 days, generally includes medical,pharmacotoxilogical,chemistry,biostastical,biopharmacological,project medical,pharmacotoxilogical,chemistry,biostastical,biopharmacological,project management and drug safety.

Meetings between FDA and sponsor continue during review process Advisory committee meetings Labeling content and format

Switch decision Yes Post approval sponsor safety reporting

ü To approve a reclassification to OTC status, FDA • • •

reviewers must find that, A drug is safe and effective in its proposed use(s), The benefits of the drug outweigh its risks, and Consumers will be able to use the drug’s labeling (e.g., its package insert) to safely use the medication in an OTC setting.

NDA drug Monograph Review Process

OTC Drug Monograph Review Process

Potential Benefits & risk

ü Benefits • • • • •

Increased Access to Effective Drugs Decreased Frequency of Visits to Physicians and Lower Health Care Costs Increases in Patients' Autonomy and Education Decrease cost to third party payers Improved education of consumers.

ü Risks • • • • • • •

In accurate diagnosis by patients, based on symptoms Delay in obtaining need therapy Use of sub optimal therapy Increases resistance to anti microbial agents as a result of in appropriate use Increased cost to patient Failure to follow label instruction and warnings Perceived loss of control by physician

Groups Affected By Rx to OTC switch

Consumer who uses it ü Patients may have easy access for the medicine and at affordable prices ü cost savings to consumers result from reduced physician office visits. ü The benefits to consumers from switching drugs from prescription to OTC must be weighed against the very real costs of the switch(es).These costs include • The costs of inappropriate self-medication, over- or under• •

medication, adverse reactions, failure to obtain appropriate medical attention, The increased costs of medication because the drug is no longer covered under a health insurance plan.

Pharmaceutical Companies

ü The impact of the Rx-to-OTC switch movement on

Pharmaceutical companies is almost entirely positive. ü Switch drugs offer greater market opportunities to the manufacturers for a number of reasons • Drugs which reach the end of their patent life usually experience a • • • •

25 - 40 % drop in sales as Generics enter the market (Winters and Freeman; 1990). Moving these drugs to OTC offers Protected market expansion opportunities; Switch drugs often experience significantly expanded markets Switching bypasses the intermediary agents of the physician and pharmacist, removing the “detailing” costs associated with marketing prescription drugs. These detailing costs can exceed $5,000 per physician per year for a single company. Switching may eliminate some of the pricing constraints created by third-party reimbursement Programs

We can see how it can be beneficial to pharmaceutical companies

Source: Data monitor 2004

Physicians ü The increasing presence of OTCs affects physicians both professionally and economically. Professionally, physicians are faced with the challenge of treating patients who are likely to be self-treating with one or more OTC medications. Pharmacist ü The overall impact of the Rx-to-OTC switch movement on pharmacists is unclear. While there is strong potential for the switch movement to enhance the professional role of the pharmacist, there are so potentially negative economic implications as well

ü The Rx-to-OTC switch movement could benefit the pharmacy profession by placing pharmacists in a position of providing more advice and counseling.

ü The presence of more effective (but also more risky)

OTC medications allows pharmacists to assume a greater role in the treatment of patients by counseling them regarding choice of OTC as we be the appropriateness of seeking further medical attention.

Strategic Perspective by Cases

REVITAL the Re-Vitalizing OTC:

ü Ranbaxy's Revital successfully shifted from prescription

to OTC and became a market leader. There is more to Revital than just a combination of vitamins, minerals and ginseng. This is one of the top brands from the Ranbaxy that made a successful transition from prescription to OTC markets in India. ü Ranbaxy chose Grey Worldwide to work on the brand during the transition of Revital from prescription to OTC. The challenge was to craft an appeal, which would successfully launch Revital in the OTC segment, by moving from a relatively serious image of Revital, without alienating the already huge base of loyal user and at the same time energising the sales curve with new regular users.

ü Grey Worldwide came up with a series of ads for Revital.

First phase of communication had 3 television commercials called the Wake up ad, the bhangra ad and the Govind ad. Each sought to demonstrate the pre & post usage and benefit scenario of Revital, where in intake of Revital helped reduced all signs of fatigue and weakness. ü The second phase of television ad the Husmukhbhai campaign, wherein the puppet portrayal of an everyday man named Husmukhbhai is seen able to make the most out of life even after a hectic day of work which his friends and colleagues are unable to because Husmukhbhai is a revital user unlike others

U.K switch study of ZOCOR Heart pro (SIMVASTATIN) Back ground ü Third class of BTC drugs exists in UK known as P “Pharmacy”class ü Patent expired in 2003 on Zocor in the U.K. ü Cardiovascular disease represents a significant expenditure for the ü ü ü ü ü

National Health Service (NHS) in U.K. NHS issues Strategic Plan in 2002 where it seeks more products to be made available without a prescription to improve patients acc ess to medicines and decrease spending on Rx drugs Merck Sharp & Dohme(MSD) was granted approval for switch of 10 mg ZOCOR HEART PRO from POM to P status in May 2004 First statin in the world available without a prescription The joint venture Johnson & Johnson-MSD launched ZOCOR HEART PRO in July 2004 All doses of ZOCOR higher than 10mg remain POM.

Indication and usage ü For patients at moderate risk of a major coronary event (those between ü ü ü ü

10% and 15% in 10 years) Risk factors include age, weight, family history, smoking, lifestyle, etc. For men aged 45 and over and women aged 55 and over The drug is intended to prevent a major coronary event (such as a heart attack) and coronary heart disease (CHD)deaths in patients at moderate risk It is positioned as a drug to help reduce risk of CHD and should be used preventively.

Factors that led to switch ü UK NHS committed to the switch to increase public awareness about ü ü ü

elevated cholesterol risks and reduce Rx drug expenditures The P class of medicines allows for patient and pharmacist interaction/consultation MSD had sufficient evidence to support its switch application Cardiovascular drugs one of the most costly Rx drug classes in the U.K.

Not all stakeholders convinced of ZOCORHEART PRO’s suitability as an OTC. ü ü ü ü ü

Physicians are concerned about efficacy at such a low dose Price point is relatively high for British consumers (₤15 to ₤10) Rx statins remain reimbursed so there is incentive for patients to seek an Rx P status requires patients to complete a risk factor questionnaire with a pharmacist before medication is dispensed Some sentiment among British consumers that the switch was driven by purely financial reasons and not necessarily in the interest of public health.

Conclusion ü Opportunities for switches in UK fueled by NHS Strategic plan to make more medications available without a prescription

ü Cost savings for NHS may not be realized in this case since many patients will continue to seek the advice of physicians and use Rx medications

ü Actual use data on Zocor Heart Pro and its effects on public cardio health are anticipated

ü P class of medications creates a “middle ground” for drugs and makes more switches feasible $900 $800 $700 $600 $500 $400 $300 $200 $100 $0

Annual cost of cholesterol control

prescription suggested mevacor list price

likely discount price

eventual generic price

Annual cost of cholesterol control

Data Analysis

Secondary data analysis COMPONENTS OF TREND Cost per Prescription Inflation Units per Prescription Brand/Generic Mix Therapeutic Mix Utilization Prevalence Intensity New Drugs TOTAL KEY FACTS PMPY Rx PMPY Prevalence of Use Average Cost/Rx Rx/User/Year

3.9% 5.6% -0.5% 0 -1.1% 16.0% 13.0% 2.6% 0.4% 20.9% $81.76 0.97 10.3% $84.62 9.38

project trend

Anti hyperlepidemic market share trend 25

60 50

lipitor

40

paravachol

30

zetia

20

generics

10

crestor

zocor

% growth projected

% prescription

70

20 15 10 5 0

0 2000

2001

2002

2003

2004

year

Market share trend Source: Drug trend report 2004

2002 2003 2004 2005 5006 2007 2008 2009 2010 year

projected trend Source: drug trend report 2004

FIBRATES 9% OTHERS 2%

STATIN 89% FIBRATES

OTHERS

STATIN

Total market for cholesterol reducers Source: ORG –Ims 2005 12

Lipitor (Pfizer)

Zocor (MSD) Plavix (BMS) Zyprexa (Lilly) Norvasc (Pfizer)

Nexium (AstraZeneca Seretide (GSK)

4 3.8 3.7 3.7 3.5 3.3 3.2 3

Erypo (J&J) Ogastro (Abbott) Zoloft (Pfizer) Efexor (Wyeth) Risperdal (J&J) Celebrex (Pfizer) Fosamax (MSD) Neurontin (Pfizer)

5 4.8 4.8 4.8 4.7

5.9

0

sale of STATIN Source: IMSHealth, 2004

15

35.82

31.7-

LOCHOL

23.63

27-

LOVAMEG

4.54

61-

LOVAMEG

4.45

LOVACARD

1.53

55.1-

LIPISTAT

0.85

71.0-

SATIN

0.08

17.8-

128.49

100 36.72 35.82

50

2.3

0

BRAND

SATIN

RECOL

150

LIPISTAT

29.7-

LOVACARD

36.72

LOVAMEG

AZTATIN

LOVAMEG

41.6-

LOCHOL

128.49

200.81 200

RECOL

ROVACOR

18.0-

AZTATIN

200.81

TOB BRAND BY VAL OF LOVASTATIN

250

ROVACOR

LOSTATIN

Gr%(A)

LOSTATIN

Val(L)

VALUE(L)

Brand

LOVASTATIN brands by value and growth

TOB BRAND BY VAL OF SIMVASTATIN 1274.43 1200 1281.18 952.59 1400

SIMVOTIN

1281.18

0.1

ZOSTA

1274.43

60.5

SIMCARD

952.59

11.4

SIMVAS

489.85

20.3

SIMLO

274.67

6.3

SIMVOFIX

155.01

150.1

400 200

SIM

103.54

59.8

0

98.9

0.6

SIMVASTOL

89.39

18.9-

SIMSTAT

63.71

32.8-

VALUE(L)

SIMVASTAIN brands by value and growth

AT ST

L M SI

TO

IN

VA S

SI

M

AT

VA ST

BRAND

SI M

IX VO F M

LO

SI

SI M

VA S M

SI

CA RD

A

M

M

VO T

IN

800 600

SI

VASTATIN

1000

SI

Gr%(A)

ST

Val(L)

ZO

Brand

Val(L)

TOB BRAND BY VAL OF ATROVASTATIN

Gr%(A) 2360.01

52.5

2500

ATROVA

2012.92

42.8

2000

ATOCOR

1186.08

54.6

AZTOR

1144.41

22.2

TONACT

1063.83

56

TG-TOR

965.52

34.1

ATORLIP

909.07

32.3

LIPICOR

766.95

37.3

AVAS

675.26

22

ATOREC

281.48

52.7

1500 1000 500 0 RO ST

VALUE(L)

STROVAS

VA S AT RO VA AT OC OR AZ TO TO R NA C TG T -T OR AT OR LI P LI PI CO R AV AS AT OR EC

Brand

ATROVASTATIN brands by value and growth

BRAND

Primary data analysis

1 According to you what is the age when risk to increase in cholesterol level is greater?

0-20

Age when risk to increase in cholesterol level is greater

% response

80

20-40

7.5

40-60

70

60-80

22.5

80-100

0

70

70

0

% RESPONSE

Age group

60 50 40 30 20 10

22.5 7.5 0

0 >100

0

0-20

0

0

AGE 20-40 40-60 60-80 80-100 >100

2. What do you generally prescribe them at first time of visit?

PREFERENCE

DOCTOR

Total

statin s

Fibrates

Others

Cardiologist

16

5

6

27

GP

5

5

3

13

21

10

9

40

Total

Chi square test:

Value Pearson Chi-Square Likelihood Ratio Linear-by-Linear Association N of Valid Cases

Asymp. Sig. (2sided)

df

2.122(a)

2

.346

2.074

2

.355

.608

1

.436

40

Findings and conclusion ü There is no any significance difference between the two class of

doctors that is cardiologist and general physician for preference of statin. So we can say that although statin is most important class of drug for treatment of hyperlipidemia but their preference is same in both class of doctors. So for launching OTC statin company should give emphasize on both general physician as well as cardiologist PREFERENC E FOR ST A T IN

16 14 12 10 C OUNT 8 6 4 2 0

16

5

6

5

C ardiologis t T YPE OF DO C T ORS

5 3 GP

Prefernce for statin

GENERIC NAME

35

% RESPONSE

29.03

ROSUVASTATIN

14.05

LOVASTATIN

12.41

SIMVASTATIN

17.33

%Response

30 25 17.33

20 15

16.62

10 5

PARAVASTATIN

16.62

FLUVASTATIN

10.53

ATROVASTATIN

29.03

0 1 m olecule ROSUVA STA TIN

LOVASTATIN

SIM VASTATIN

PARAVASTATIN

FLUVA STA TIN

ATROVASTATIN

Prefernce for statins in percentage : SAMPLE SIZE: 40 % Response

30

ROSUVASTATIN

13.66

LOVASTATIN

13.04

SIMVASTATIN

17.7

PARAVASTATIN

16.45

FLUVASTATIN

10.55

ATROVASTATIN

28.57

Pre fe rnce in cardiologist

28.57

25 % Doctor

Generic Name

17.70

20 15 10 5 0

M ole cule ROSUV A STA TIN

LOV A STA TIN

SIM V A STA TIN

PA RA V A STA TIN

FLUV A STA TIN

A TROV A STA TIN

Preference for Statins in Cardiologist: Sample Size: 27

40 % Response

29.25

ROSUVASTATIN

14.96

LOVASTATIN

11.56

SIMVASTATIN

16.32

PARAVASTATIN

17.68

FLUVASTATIN ATROVASTATIN

30 % Doctor

Generic Name

Prefernce in general practioner

20

14.96

10 0

Molecule

10.2 29.25

17.68

ROSUVASTATIN

LOVASTATIN

SIMVASTATIN

PARAVASTATIN

FLUVASTATIN

ATROVASTATIN

Preference for Statins in General practioner: Sample Size: 13

4. Are you aware of Rx to OTC switches?

Respondents General practioner s

Cardiologist Awareness

Total

yes

19

8

27

no

7

6

13

26

14

40

Value

df

Total

Pearson Chi-Square

Asymp. Sig. (2sided)

1.053(b)

1

.305

Continuity Correction(a)

.452

1

.501

Likelihood Ratio

1.035

1

.309

Exact Sig. (2sided)

Exact Sig. (1sided)

.480

.249

Fisher's Exact Test

Linear-by-Linear Association N of Valid Cases

1.027

1

.311

40

Chi-Square Tests result for Awareness of Rx to OTC switches

Aw are ne s s for Rx to OTC sw itches

20

19

15 Coun t

10

8

7

6

5 0 Cardiologist

GP

There is not any significance difference between the two variables cardiologist and general practioner about the awareness of Rx to OTC switch so we can say that both class of doctor are same aware from Rx to OTC switches. so again for implementing marketing strategies for Rx to OTC Statin, company should go for more awareness to both class of respondents; cardiologist as well as general practioners.

5. Do you think Rx to OTC switch for STATIN will be ..

Advantage of OTC statin

25

22.37

% Doctor

Company

18.18

Consumer

18.18

Availability

22.37

Product life cycle

21.67

Safe and effective

19.58

21.67

19.58

20 % Doctor

Factors

15 10 5 0 company

consumer

availability

product lif e cycle

saf e and ef f ecit ve

Advantage of OTC statin: for general practioners Sample size: 6 20.6

Company

% Doctor 20.52

Consumer

19.73

Availability

20

Product life cycle

20

Safe and effective

19.73

20.52

Advantage of OTC statin

20.4 20.2

% Doctor

Factors

20

20

20 19.73

19.8 19.6 19.4 19.2 company

Advantage of OTC Statin: for cardiologist Sample size: 19

consumer

availability

product life cycle

safe and effecit ve

6. What do you think for OTC STATIN in the lowlow-toto-moderate risk group? ANOVA TABLE

O T C s t a t in in lo w t o m o d e r a t e r is k

4 .5 4 3 .5

Mean value

3 2 .5 2 1.5 1 0 .5 0

1

2

3

4

5 R e s 6p o n d 7 e n ts 8

9

10

11

12

13

ü From applied statistical tool one way ANOVA and on the

bases of the results obtained there can be seen significance difference in the opinion of two class of doctor for the factor like, ü Risk of inadequate treatment with OTC statins could lead to accidents ü The generic versions be better priced than an OTC statin ü For them significance difference is like .040 and .028 respectively which is less than probability significance value .05.

Conclusion& Recommendation

ü The benefits of OTC statins must be weighed against the

potential side effects. The patient might experience statin side effects due to taking more than the recommended dose, their health condition, or because of drug interactions. These side effects can include headache, nausea, vomiting, constipation, diarrhea, rash, muscle pain, and weakness. Statins are commonly related to muscle problems such as Myopathy, Myalgia, and Rhabdomyolysis. ü Patient education is crucial as prescription statins such as Simvastatin go OTC. The patient should be adequately educated and informed about the possible side effects and risks of the medications. Regular monitoring of lipid levels, avoiding under- or overuse of statins, correct dosing, monitoring drug interactions, and health conditions are key factors that can help minimize the adverse effects of statins.

ü If the company has consumer marketing expertise

(either internally or through a marketing partner), has adequately built the drug’s brand name among healthcare professionals and consumers, has and will continue to invest in significant levels of advertising and promotional campaigns, and has adequate arrangements with retailers for widespread distribution and promotion, the switch is most likely to be carried out and sustained successfully. ü Consumer trends will also continue to shape the future of Rx-to-OTC switches as the baby boomer generation ages and demands more self-medication options. Furthermore, some of the financial incentives recently presented to consumers, such as the use of flexible spending accounts to pay for OTCs, could increase the demand for new, innovative OTCs.

ü The success of an Rx-to-OTC switch is dependent on

several factors, the most important of which are timing of market entry; providing a safe, effective, easy-to use product that consumers need; having a brand name that is recognizable; gaining market exclusivity; and providing a clear, consistent marketing message that communicates product advantages and sustains repeat purchases of the product. ü What will be success ratio in Indian pharma for Rx to OTC switches? ü Good for patient in primary prevention. OTC statin will both increase public awareness about high cholesterol and encourage people with moderately-elevated cholesterol levels (who don’t often seek treatment) to do something about it.

Product Efficacy ·Safety ·Ease of use ·Advantages/claims ·Brand awareness

Regulatory Sufficient clinical evidence to ·Support approval ·Lack of political or moral issues to Impede approval ·Clinical evidence to support 3year Hatch–Waxman market Exclusivity

Company

Rx-toOTC Switch success

·Defines clear strategy for brand ·Communicates consistent marketing message ·Ability to sustain large-scale advertising and promotion campaign ·Retail relationships adequate for smooth launch and widespread distribution ·Consumer marketing expertis

Market ·First to market/early to market ·Reasonable price point ·Consumer need and demand ·Repeat purchases likely

Rx-to-OTC Switch success

Model for OTC Questionnaire

References: ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü

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