Changewave Research: Cox-II Inhibitors Survey

ChangeWave Research: Cox-II Inhibitors Survey

ChangeWave Research Report:

Cox-II Inhibitors Survey

Overview

During the week of January 11-14, 2005 we surveyed Alliancehealthcare industry members to learn more about their reactionto recently released data on Cox-II inhibitors –particularly Celebrex and Vioxx. A total of 150 healthcare members knowledgeable about Cox-II inhibitors and other painkiller medications participated, including 97 doctors.

Reaction to Vioxx Withdrawal. Forty-two percent (42%) of doctors said most of their patients were initially switched to Celebrex when the painkiller Vioxx was removed from the market. Another 31% said most of their patients were switched to Ibuprofen, and 11% said Bextra.

Reaction to Celebrex News.In the aftermath ofall the negative Celebrex news in the media, only 15%of doctors said they have continued prescribing Celebrex as previously.Another 37% of doctors saidthey have informed their patients of the risks and let them choose whether to continue taking the drug.

Importantly, 15% said they have stopped prescribing Celebrex to new patients but are letting existing users make up their own mind – and 18% said that they have stopped prescribing either Celebrex or any other Cox-II Inhibitors to their patients.

The Result:Better than one-in-five doctors (22%) report that more than half of their patients have switched from Celebrex – whilebetter than two-in-five (41%) report that at least a quarter of their patients have switched from Celebrex.

Top Alternatives Recommended for Arthritis Patients. Doctors say Ibuprofen (43%) is the top alternative recommended for arthritis patients that have switched from Cox-II Inhibitors – with Naprosyn (21%) second, and Mobic (6%) tied with Aspirin (6%) for third.

Ibuprofen Also Top Recommendation for Non-Arthritis Patients. Ibuprofen (37%) is also the top alternative recommended for non-arthritis patients that have switched, with Naprosyn (14%) coming in second.

Impact on Other Drug Prescriptions. Nearly half of the doctors surveyed (47%) believe the problems with Cox-II Inhibitors will act to decrease the overall number of prescriptions written for other drugs – with 9% saying it will significantly decrease and 18% modestly decrease overall prescriptions. This also includes20% who believethat there will be a decrease in prescriptions due to the Cox-II problem, but only for non-critical care drugs.

On a more positive note, 46% of doctors say the Cox-II problem will not act to decrease the overall number of drug prescriptions written.

Which Drug Categories Will Be Most Affected? Other Painkillers (Non Cox-II) (39%) is the category of drugs seen as most negatively affected by the Cox-II problem, with Statins (7%) a distant second and Anti-Depressants (6%) third.

Specific Drugs Most Likely to Lose Sales From Drug Safety Concerns. When asked to name a specific drug most likely to lose sales in 2005 because of a generalized concern about drug safety, Celebrex (60%) topped the list by a wide margin, followed by Bextra (38%), and Crestor (11%).

Drugs Most Likely to Gain Market Share Because of Cox-II Problems.Ibuprofen (35%) received the most mentions when respondents were asked to name a drug they think is most likely to gain market share in 2005 as a result of the problems with Cox-II Inhibitors. Also high on the list: Acetaminophen/Tylenol/Paracetamol (17%), Naprosyn/Aleve (14%), Mobic (12%) and Diclofenac/Voltaren (11%).

Some Insurers/Payors are Limiting Cox-II Prescriptions. Seven percent (7%) of doctors say a “majority” of their payors have issued guidelines to stop prescribing all Cox-II Inhibitors – while 24% say a “few” payors have issued such guidelines. Another 15% of doctors say a “few” of their payors have issued guidelines to specifically limit Celebrex prescriptions.

Impact on Merck and Pfizer – Merck Hurt Most. One-in-five doctors (20%) say the problems with Cox-II Inhibitors will permanently impair Merck’s reputation, and 12% say it will act to limit the market acceptance of future drugs from Merck. In comparison, only 6% say Pfizer’s reputation will be permanently impaired, and 6% sayit will act to limit market acceptance of future drugs from Pfizer.

Bottom Line: These survey results do not look promising forCelebrex. A large percentage of doctors report that their patients are stopping Celebrex and/or allother Cox-II Inhibitors. Not surprisingly, Celebrex is the drug respondents see asmost likely to lose out from drug safety concerns.

Ibuprofen is the top doctor recommended alternative for Cox-II Inhibitors,followed by Naprosyn.Mobic,from Abbott Laboratories, is tied with Aspirin as the third most recommended alternative for arthritis patients.Mobic is also fourth on the list of drugs believed likely to gain market share in 2005 because of Cox-II problems – behind Ibuprofen, Acetaminophen and Naprosyn.

Notably, 20% of respondents believed thatMerck’s reputation will be permanently impaired by the Cox-II problem, and 12% said it would act to limit market acceptance of future drugs from the company. Only 6% believed the same aboutPfizer’s reputation and about its future drug acceptance.

The ChangeWave Alliance is a group of 5,000 highly qualified business, technology, and medical professionals in leading companies of select industries—credentialed professionals who spend their everyday lives working on the frontline of technological change. ChangeWave surveys its Alliance members on a range of business and investment research and intelligence topics, collects feedback from them electronically, and converts the information into proprietary quantitative and qualitative reports.

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Table of Contents

Summary of Key Findings...... 4

The Findings...... 5

ChangeWave Research Methodology...... 17

About ChangeWave Research...... 18

I. Summary of Key Findings

Introduction

During the week of January 11-14, 2005 we surveyed Alliance healthcare industry members to learn more about their reaction to recently released data on Cox-II inhibitors – particularly Celebrex and Vioxx. A total of 150 healthcare members knowledgeable about Cox-II inhibitors and other painkiller medications participated, including 97 doctors.

II. The Findings

Total Respondents (n=150)

Doctor Respondents (n=97)

All Other Respondents (n=53)

Part A

The questions in Part A of this survey were exclusively for physicians who treat patients that use painkiller medications, or who are knowledgeable about painkiller medications.

Doctor Respondents (n=97)

(1) Question Asked: In late September, the painkiller Vioxx was removed from the market. Which of the following statements best reflects how your own practice or clinical environment reacted? (Check All That Apply)

Most patients were switched to Celebrex / 42%
Most patients were switched to Ibuprofen / 31%
Most patients were switched to another painkiller / 14%
Most patients were switched to Bextra / 11%
Most patients were switched to Naprosyn / 11%
Most patients were switched to Aspirin / 9%
We do not treat patients that use painkiller medications / 6%
Don’t Know / 4%

Reaction to Vioxx Withdrawal. Forty-two percent (42%) of doctors said most of their patients were initially switched to Celebrex when the painkiller Vioxx was removed from the market. Another 31% said most patients were switched to Ibuprofen, and 11% said Bextra.

(2) Question Asked: In December, the news media reported negative clinical trial results regarding side effects for the painkiller Celebrex. Which of the following statements best reflects how your own practice or clinical environment reacted?

We continued prescribing Celebrex to patients as previously / 15%
We stopped prescribing Celebrex to new patients but let existing users make up their own mind / 15%
We informed all patients of the risks and let them choose whether to continue with Celebrex / 37%
We stopped prescribing Celebrex to all patients / 6%
We stopped prescribing all Cox-II inhibitors to all patients / 12%
We do not treat patients that use painkiller medications / 5%
Don’t Know/No Answer / 3%

Reaction to Celebrex News.In the aftermath ofall the negative Celebrex news in the media, only 15%of doctors said they have continued prescribing Celebrex as previously.Another 37% of doctors said they have informed their patients of the risks and let them choose whether to continue taking the drug.

Importantly,15% said they have stopped prescribing Celebrex to new patients but are letting existing users make up their own mind – and 18% said that they have stopped prescribing either Celebrex or any other Cox-II Inhibitors to their patients.

(3) Question Asked: What percentage of your patients that used Celebrex prior to the negative news have switched to something else?

0%-10% / 18%
11%-25% / 23%
26%-50% / 19%
51%-75% / 3%
Over 75% / 20%
Don’t Know / 17%

The Result: Better than one-in-five doctors (22%) report that more than half of their patients have switched from Celebrex – while better than two-in-five (41%) report that at least a quarter of their patients have switched from Celebrex.

(4) Question Asked: For arthritis patients that have switched from Cox-II inhibitors, what is your own practice or clinical environment recommending?

Ibuprofen / 43%
Naprosyn / 21%
Aspirin / 6%
Mobic* / 6%
Don't Know / 1%
Not Applicable / 8%
Other / 13%
No Answer / 2%

*Note: Mobic was not provided as a choice, but 6%of respondentsnamed Mobic in their “Other” response.

Top Alternatives Recommended for Arthritis Patients. Doctors say Ibuprofen (43%) is the top alternative recommended for arthritis patients that have switched from Cox-II Inhibitors – with Naprosyn (21%) second, and Mobic (6%) tied with Aspirin (6%) for third.

(5) Question Asked: For non-arthritis patients that have switched from Cox-II inhibitors, what is your own practice or clinical environment recommending?

Ibuprofen / 37%
Naprosyn / 14%
Aspirin / 11%
Tylenol (Acetaminophen)* / 7%
Don't Know / 3%
Not Applicable / 9%
Other / 11%
No Answer / 7%

*Note:Tylenol (Acetaminophen) was not provided as a choice, but 7% ofrespondents named Tylenol or Acetaminophen in their “Other” response.

Ibuprofen Also Top Recommendation for Non-Arthritis Patients. Ibuprofen (37%) is also the top alternative recommended for non-arthritis patients that have switched, with Naprosyn (14%) coming in second.

Part B

The questions in Part B were answered by all of the respondents to this survey, including physicians, healthcare workers, and individuals who work for payors, research institutions or other organizations that provide first hand knowledge of painkiller medications. The results have been segmented into two overall groups: Doctors (n=97) and All Other Respondents (n=53).

(6) Question Asked: For patients switching to NSAIDs, how concerned are you about gastric side effects?

Doctors / All Other
Respondents
Very concerned for a majority of patients / 15% / 13%
Very concerned - but only for a small percentage of patients / 21% / 11%
Somewhat concerned for a majority of patients / 28% / 21%
Somewhat concerned - but only for a small percentage of patients / 30% / 32%
Not Concerned / 2% / 2%
Don't Know / 0% / 6%
Not Applicable / 2% / 13%
Other / 2% / 0%
No Answer / 0% / 2%

Concern Over Gastric Side Effects For Patients Switching to NSAIDs. Fifteen percent (15%) of doctors say they are “Very concerned” for a majority of patients” about gastric side effects for “a majority” of patientsfor patients switching to NSAIDs. Another 21% are also “Very concerned” but only for a “small percentage” of patients. Twenty-eight percent (28%) are “Somewhat concerned for a majority of patients” and 30% are “Somewhat concerned – but only for a small percentage of patients.” Only 2% of doctors are not concerned about gastric side effects.

(7) Question Asked: What measures - if any - do you recommend for monitoring patients that switch to NSAIDs?(n=83)

General Monitoring / 21%
Adherence to Recommended Dosage Limits/Take With Meals / 16%
Monitor Stool Samples / 15%
Gastro Intestinal Precautions/Monitoring / 15%
Proton Pump Inhibitors (PPI) / 8%
Monitor Kidney and Liver / 5%
Patient Education on Symptoms and Side Effects / 5%
Monitor Blood / 4%
Other / 10%
None / 4%

Among all respondents, General Monitoring (21%) is the top measure recommended for monitoring patients that switch to NSAIDs. Advising patients to adhere to recommended dosage limits and take the drug with meals (16%) is next, closely followed by Monitoring Stool Samples (15%) and Gastro Intestinal Precautions/Monitoring (15%).

A Sample of Alliance Member Responses can be found in Appendix A on page 13.

(8) Question Asked: Do you believe the problems with Cox-II Inhibitors will act to decrease the number of prescriptions written for other drugs?

Doctors / All Other
Respondents
Yes, it will significantly decrease the number of overall prescriptions / 9% / 6%
Yes, it will modestly decrease the number of overall prescriptions / 18% / 15%
Yes, it will significantly decrease the number of prescriptions, but for non critical-care drugs only / 4% / 0%
Yes, it will modestly decrease the number of prescriptions, but for non critical-care drugs only / 16% / 15%
No, it will not decrease the number of prescriptions of other drugs / 46% / 53%
Don't Know / 2% / 11%

Impact on Other Drug Prescriptions. Nearly half of the doctors surveyed (47%) believe the problems with Cox-II Inhibitors will act to decrease the overall number of prescriptions written for other drugs – with 9% saying it will significantly decrease and 18% modestly decrease overall prescriptions. This also includes 20% who believethat there will be a decrease in prescriptions due to the Cox-II problem, but only for non-critical care drugs.

On a more positive note, 46% of doctors say the Cox-II problem will not act to decrease the overall number of drug prescriptions written.

(8A) Question Asked: What category of drugs do you believe will be most negatively affected?

Doctors / All Other
Respondents
Other Painkillers (Non Cox-II) / 39% / 26%
Statins / 7% / 13%
Anti-Depressants / 6% / 9%
No Drugs will be Negatively Affected / 29% / 26%
Don't Know / 9% / 21%
Other / 5% / 4%
No Answer / 4% / 0%

Which Drug Categories Will Be Most Affected? Other Painkillers (Non Cox-II) (39%) is the category of drugs seen as most negatively affected by the Cox-II problem, with Statins (7%) a distant second and Anti-Depressants (6%) third.

(8B) Question Asked: What specific drug(s) do you believe is most likely to lose sales in 2005 because of a generalized concern about drug safety? (n=53)

Celebrex / 60%
Bextra / 38%
Crestor / 11%
Aleve / 8%
Naprosyn / 8%
Serevent / 6%
Lipitor / 6%
Mobic / 4%
Accutane / 4%
Meridia / 4%
Prozac / 4%
Other / 17%

Specific Drugs Most Likely to Lose Sales From Drug Safety Concerns.When asked to name a specific drug most likely to lose sales in 2005 because of a generalized concern about drug safety, Celebrex (60%) topped the list by a wide margin, followed by Bextra (38%), and Crestor (11%).
(9) Question Asked: What instructions - if any - has your practice or clinical environment received from insurers/payors?

Doctors / All Other
Respondents
A majority of payors have issued instructions to stop prescribing Celebrex / 1% / 0%
A majority of payors have issued instructions to stop prescribing all Cox-II Inhibitors / 7% / 6%
A few payors have issued guidelines to limit prescriptions of Celebrex / 15% / 8%
A few payors have issued guidelines to limit prescriptions of all Cox-II Inhibitors / 24% / 15%
Don't Know / 34% / 55%
Other / 13% / 6%
No Answer / 5% / 11%

Some Insurers/Payors are Limiting Cox-II Prescriptions. Seven percent (7%) of doctors say a “majority” of their payors have issued guidelines to stop prescribing all Cox-II Inhibitors – while 24% say a “few” payors have issued such guidelines. Another 15% say a “few” of their payors have issued guidelines to specifically limit Celebrex prescriptions.

(10) Question Asked: What overall effect - if any - will the Cox-II Inhibitor problem have on Merck and Pfizer? (Check All That Apply)

Doctors / All Other
Respondents
Little overall effect on either company / 16% / 11%
Merck's reputation will be slightly impaired / 66% / 57%
Merck's reputation will be permanently impaired / 20% / 15%
It will act to limit the market acceptance of future drugs from Merck / 12% / 17%
Pfizer's reputation will be slightly impaired / 62% / 60%
Pfizer's reputation will be permanently impaired / 6% / 2%
It will act to limit the market acceptance of future drugs from Pfizer / 6% / 9%
Don't Know / 5% / 11%

Impact on Merck and Pfizer – Merck Hurt Most. One-in-five doctors (20%) say the problems with Cox-II Inhibitors will permanently impair Merck’s reputation, and 12% say it will act to limit the market acceptance of future drugs from Merck. In comparison, only 6% say Pfizer’s reputation will be permanently impaired, and 6% sayit will act to limit market acceptance of future drugs from Pfizer.

(11) Question Asked: Finally, which drug(s) do you think is most likely to gain market share in 2005 due to the problems with Cox-II Inhibitors? Why?(n=65)

Ibuprofen (Advil/Motrin) / 35%
Acetaminophen (Tylenol/Paracetamol) / 17%
Naprosyn/Naproxen/Aleve / 14%
Mobic / 12%
Diclofenac (Voltaren) / 11%
Celebrex / 6%
Bextra / 6%
Lodine (etodoloc) / 5%
Arcoxia / 3%
Tramadol (Ultram) / 3%
Relafen (Nabumetone) / 3%
Darvon/Darvocett (propoxyphene) / 3%
Other / 17%

Drugs Most Likely to Gain Market Share Because of Cox-II Problems.Ibuprofen (35%) received the most mentions when respondents were asked to name a drug they think is most likely to gain market share in 2005 as a result of the problems with Cox-II Inhibitors. Also high on the list: Acetaminophen/Tylenol/Paracetamol (17%), Naprosyn/Naproxen/Aleve (14%), Mobic (12%) and Diclofenac/Voltaren (11%).

As Doctor WPW6938 writes, "Generic nonsteroidals like Ibuprofen and Naproxen, because people that have arthritic pain will continue to get the most relief from anti-inflammatories -- and because these meds can be purchased easily OTC (without a prescription) they are readily obtained and also are perceived to be less dangerous by most people." WIL1338 adds, "Diclofenac, Ibuprofen, Naprozine - relatively long known products with manageable side effects.” P2P3810 says, "Abbott's Mobic … has the most COXII nature but it is not considered a COXII. I have a source claiming Mobic market share went up 24% since Vioxx withdrawal.”

Appendix A

(7) Question Asked: What measures - if any - do you recommend for monitoring patients that switch to NSAIDs?(n=83)

Sample of Alliance Member Responses:

(a)General Monitoring (21%)

Doctor DJA1158 writes, "Monitor clinically and with labs if necessary."

Doctor MES5884 writes, "None for short term use. Long term use is monitored with more frequent physical exams & routine tests/labs."

Doctor PET4075 writes, "Let us know if symptoms."

DOW8381 writes, "Use minimum dosage and watch for problem symptoms."

Doctor TRU7599 writes, "No routine monitoring although all patients are advised of GI risk and gastro protection prescribed in appropriate cases. Monitoring is then done at routine clinical follow up."

GUE6131 writes, "Usual battery of tests every 6 months."

Doctor DRD2304 writes, "Monitor symptoms...avoid use in high risk patients."

Doctor ECR4086 writes, "For some it is a clinical issue- ‘How do you feel? Any evidence of bleeding etc.’ For others, kidney function needs to be followed and then you have to see if it is effective for what you are using it in the first place."

Doctor JRJ9829 writes, "We monitor symptoms since our patient population tends not to be on these meds long-term."

Doctor LKB3320 writes, "Annual follow up."

Doctor DRJ5952 writes, "Frequent follow up."
Doctor JAM8235 writes, "Follow-up office visits."

Doctor JIN7221 writes, "Effectiveness of NSAIDs for symptom control. Report for significant side effects, especially GI."

Doctor DR.8915 writes, "Ask patient questions regarding symptoms of ulcers or bleeding and check BP at each follow up visit. Patients are to call if symptoms occur between visits."

Doctor STE3218 writes, "Watch for specific symptoms: stomach pain, change in stools, fluid retention. Notify immediately. Cox-II over prescribed previously to groups of patients that would not have seen any additional benefit over traditional NSAIDs like ibuprofen or Naproxsen."

Doctor ALA7205 writes, "Report new symptoms immediately."

Doctor SIL8037 writes, “More frequent office visits to check up on them; most patient takes antacids and Zantac with NSAIDs now.”

(b)Adherence to Recommended Dosage Limits/Take With Meals (16%)