Company

Ticker Symbol

Product(s)

Barr Pharmaceutical/ Duramed

BLE.DE

SEASONALE and SEAONSONIQUE

Warner Chilcott

WCRX

Loestrin 24 Fe, Femcon Fe

Name

Hospital

State

Mark Yurchisin

The Medical Center at Bowling Green

KY

John Washington

Central Carolina Gynecology

NC

Viki Forlano

Shannon Medical Center

TX

Paul Coppola

Middlesex Hospital

CT

Heidi McNaney-Flint

Martin Memorial Medical Center

FL

Harold Green

Mount Carmel Health System

OH

Linda Harrell

Private Practice

IN

Frederick Friedman

Maimonides Hospital

NJ

Ian Taras

West Hills Hospital & Medical Center

CA

Ruby Huttner

Hunterton Health Care System

NJ

Fred Duboe

St. Alexius Medical Center

IL

Question

Pages

Q1: Current practices

Please describe your current oral contraceptive prescribing practices, including the mix of products you prescribe (brands and/or generic products) and to what types of patients.

4

Q2: Product decision drivers

What are the main drivers of your choice of oral contraceptive products? Please discuss clinical factors, such as product attributes and patient characteristics, as well as non-clinical factors, such as reimbursement.

8

Q3: Drivers of switch

What drives you to switch a patient from one oral contraceptive product to another? Please explain using examples if possible.

9

Q4: Patient perspective and influence

How much influence does patient request or preference have in your choice of oral contraceptive product prescribed?

11

Q5: Branded versus generic

Please discuss the decision to use branded versus generic oral contraceptive products. When do you choose one versus the other, and why?

13

Q6: Recent product introductions and impact

What new products have been introduced in the past few years that have impacted your oral contraceptive prescribing patterns?

15

Q7: SEASONALE and SEASONIQUE

What do you know about SEASONALE and SEASONIQUE and do you prescribe these products? Prescribers: In what patient types or circumstances do you prescribe SEASONALE and SEASONIQUE? What percentage of your patient population receiving oral contraceptives receives these products? Non-prescribers: Why haven’t you prescribed SEASONALE or SEASONIQUE? What would lead you to prescribe these agents?

16

Q8: Loestrin 24 Fe

What do you know about Loestrin 24 Fe and do you prescribe it? Prescribers: In what patient types or circumstances do you prescribe Loestrin 24 Fe? What percentage of your patient population receiving oral contraceptives receives this product? Non-prescribers: Why haven’t you prescribed Loestrin 24 Fe? What would lead you to prescribe it?

18

Q9: Femcon Fe

What do you know about Femcon Fe and do you prescribe it? Prescribers: In what patient types or circumstances do you prescribe Femcon Fe? What percentage of your patient population receiving oral contraceptives receives this product? Non-prescribers: Why haven’t you prescribed Femcon Fe? What would lead you to prescribe it?

19

Q10: New products in development

What new products, if any, are you aware of that are in development that you are interested in learning more about or using in the near future?

20

Q11: Trends in next 1-3 years

What do you expect the trends in oral contraceptive prescribing patterns in the next 3 years? Please explain.

21

Q12: Other issues

Other than what has been discussed, what is important to know for someone trying to understand the prescribing patterns and likely trends in prescribing in the next few years?

22

Introduction

Welcome to this discussion among obstetrician-gynecologists and primary care physicians. We will focus on oral contraceptive prescribing practices and the impact of new product introductions on these prescribing patterns. MedPanel discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, MedPanel expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your MedPanel home page after you've logged in.

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Q1: Current practices

Please describe your current oral contraceptive prescribing practices, including the mix of products you prescribe (brands and/or generic products) and to what types of patients.

Panelist 11: I generally prefer the lower dose (.5/20 or 1/20) products unless there are other considerations or problems. I usually tell patients how to take them in a continuous fashion rather than cyclic. Recently I have had a lot of Yaz and Loestrin 24 samples and have used them. I prefer the generics however for cost reasons.

Panelist 11: Other considerations

You mention a preference for lower dose products unless other considerations or problems. What are some examples of other considerations or problems that would lead to higher dose products?

Panelist 2: some women have difficulties with low estrogen products, esp with libido and break through bleeding

Panelist 8: history of BTB, need to suppress ovarian cyst, histroy of previous low does pill failure.....although each issue could also be solved with 24 days.

Panelist 11: Breakthrough bleeding, poor cycle control or formulary deficiencies mostly.

Panelist 10: Mostly BTB, dysmenorrhea

Panelist 7: BTB & formulary issues

Panelist 5: break through bleeding problems or those who do not withdraw on low estrogen pills

Panelist 3: Yes, I would agree that some pats need better endometrial support with a 30 or 35 mcg pill, or better suppression of ovularion

Panelist 1: breakthrough bleeding

Panelist 6: BREAK-THROUGH-BLEEDING,ACNE

Panelist 9: persistent breakthrough bleeding or amenorrhea that is problematic for the patient are the most common issues that would increase the dosing.

Panelist 12: Breakthrough bleeding, ovarian cyst suppression, status of endometriosis

Panelist 2: treat all ages from teen to 5O using all available OC products

Panelist 5: I tend to prescribe monophasic OCP's with the lowest estrogen available. I tend to be forced to use the generics b/c of cost and insurance formulary.

Panelist 9: 24 day regimens, low dose 20 mcg. preps, monophasics preferred

Panelist 4: use wide variety of ocp. often initiate with samples give 3 cycles to assess how patient responds if likes, continue, if not consider different formulation

Panelist 1: I TYPICALLY USE OCP IN WOMEN WHO NEED CONTRACEPTION, TX OF OVARIAN CYST, DYSMENORRHEA,IRREGULAR MENSES, MENSTRUAL MIGRAINES. I DONT USE IN WOMEN OVER 30 IF THEY SMOKE. I USE SEASONALLE, YAZ, YASMINE, ORTHO PRODUCT LINE. GENRICS ARE OFTEN SUBSTITUTED.

Panelist 8: Use low dose, 24 day regimen, avoid generics as much as possible. Never like triphasics

Panelist 6: I CURRENTLY USE ORTHOTRICYCLEN-LO,YAZ AND GENERICS IF REQUIRED BY PATIENTS INSURANCE.SENIQUEALSO AT TIMES

Panelist 3: New starts" mostly monophasic 20 or 25 mcg E products, esp the new 24 day pills-Yaz and loestrin 24. Some extended cycling with either seasonale/seasonique or any pills by skipping the off days. Prior pill pts I generally keep on what they are on. I dont hesitate to use generics when cost is an issue. New starts I only start on pills I have a sample pack for.

Panelist 7: 24 day regimens, low dose 20+ mcg. preps, monophasics preferred. Samples & patient ed MOST important!

Panelist 7: Samples & patient ed. most important. Next is if patient had a preference for whatever reason. Else, 24 day regimens, low dose 20 mcg. preps, monophasics preferred.

Panelist 12: I currently encourage patients to take birth control pills continuously and prefer to try 20 mcg estrogen ultralow dose pills. I prescribe by brand name usually Alesse or Miracette however I am tending to support Yaz as we have samples. I never could get insurance to pay for seasonal. I write for Yaz and Disp 4 month and Sig is take one active pill everyday to prevent period

Follow-up: Continuous

Panelist 11 mentions telling patients to take products in a continuous rather than cyclic fashion. Do others advise their patients to do this? Why/why not?

Panelist 2: extended cycle can be tailored to the patient and their desire to avoid monthly patients. This is especiallly true with dysmenorrhea and endometriosis. Also with patients wwnting to avoid a specific date for a period.

Panelist 6: PTS.WHO PREFER NOT TO HAVE MENSES OR HAVE DYSMENORRHEA SHOULD TAKE CONTINUOUS HORMNAL THERAPY ALSO TREATMENT OF ENDOMETRIOSIS

Panelist 8: Depends on the clinical situation. For the women wanting to have no menses but willing to tolerate 6 months or so of irregular spotting, this is a possible choice.

Panelist 10: I believe continuous is acceptable when trying to avoid cyling problems such as PMS, dysmenorhea, migraines, etc.

Panelist 7: I believe continuous is acceptable when trying to avoid cyling problems such as PMS, dysmenorhea, migraines, endometriosis, & certain date avoidance, but beware of the BTB potential. I only rec. 3 months in a row.

Panelist 5: I have pts take on a cyclic basis mostly just for ease of use. All pills can be taken on a continuous cycle but recommend that most pts perform better on the cyclic ones

Panelist 3: Yes, I will do so for both pt interest or indications for patients who have problematic periods, dysmenorrhea, and they would benefit from less periods.

Panelist 1: I USE THESE MONTHLY UNLESS THEY SPECIFICALLY REQUEST CONTINUOUS FASHION. I USE THOSE MEDICATIONS SPECIFICALLY APPROVED FOR THAT PURPOSE.

Panelist 9: improves patient symptoms with dysmenorrhea, menorrhagia and endometriosis. Prevention of ovarian cysts also may improve.

Panelist 6: PTS.WHO PREFER MENSESTAKE PILLS CYCCALLY;THOSE WHO DON'T OR HAVE MEDICAL INDICATIONSTAKE PILLS CONTINUOUSLY

Panelist 12: if they have premendtrual migraines, dysmenorrhea, acne, cysts

Follow-up All: Percentage mix

Some of you mention preferring monophasic versus triphasic products. Do all agree with this preference? Why/ Why not? What percentage of your patients are on monophasic versus triphasic and do you expect any trends in this mix?

Panelist 2: no particular preference unless treating for DUB, then prefer monophasic

Panelist 8: always thought triphasics were a marketing scheme with no added advantage. Seems to have been confirmed with all studies and clincally.Monophasics easier to understand when pt. has btb re. cuase.

Panelist 10: tend to see less BTB with monophasics

Panelist 7: triphasics often with more BTB, but compliance is the most important issue. i'd say that most new pills are monophasics so higher percentage of new starts will be monophasics. about 1/4 are triphasics in my population.

Panelist 5: All of my pts are on monophasic pills just because of less side effects

Panelist 1: USE DEPENDING ON BTB.

Panelist 6: TRIPHASICS=LOWER HORMONE AMOUNTS.80%TRI PHASICS20%MONOPHASICS

Panelist 9: 90% are on monophasic because of the greater predictability of response and consistency as well. Finally, I find more patients developing ovarian cysts on triphasic regimens.

Panelist 6: MOST OF MY PTS. ARE ON TRIPHASIC;IFBTB PRESENTWILLSWITCH TO MONOPHASIC; IF PATIENTS NEED/WANT LONGER CYCLE WILL GIVE MONOPHASIC

Panelist 12: prefer monophasic especially if taking continuous. 90/10 mono to triphasic

Panelist 11: I dont have any absolute preference. For non-cyclic treatment or not traditional use, the monophasic are better.

Follow-up ALL: Product choice

Several specific products were mentioned. Please explain why certain brands are selected for certain patients. a) Yaz b) Loestrin 24 c) Seasonale d) Seasonique e) Ortho Tricyclen-Lo f) Other brands (not including generics)

Panelist 2: Yaz - low dose and less fluid retention Orthotricyclen lo tricyclic low dose acne indication and no generic plenty of samples seasonique for extended cycle

Panelist 8: Often times depends on product availability and most importantly patient specific request. When they ask for it, we usually comply.In general I will use LE 24 for all new start patients absent the above

Panelist 10: I typically use Yaz when the patient has desire for oral contraception and history of PMS. I don't prescribe any Loestrin -- 24 since I have no samples, have abundant samples of low Ortho Tri-Cyclen and use it frequently. I have never been a fan of Seasonale, but now prescribing some Seasonique and observing whether or not this has lessened, the frequency of breakthrough bleeding and increased patient compliance.

Panelist 7: Not sure what part of the studies are marketing and which parts are not, so I am back to my old formula. New starts = sample supply, patient desire, patient education & pharm rep "nice to doc."

Panelist 5: yaz is good for poly cystic ovarian disease pts. Some pts request ortho tri cyclen b/c of acne concerns

Panelist 1: USE YAZ, TRICYCLEN LO FOR ACNE. SEASONALLE FOR CONTINUOUS MEDS

Panelist 6: MOST ON ORTH TRI CYCLEN-LO;2ND IS YAZNEXT SEASONIQUE AND LOESTRIN 24--BETTER RESULTSWITH THESE

Panelist 9: Ortho triycyclen lo primarily to patients who request this pill. Ortho is generous at sampling and I will not change a patient off a regimen that is working well for her. Seasonale and Seasonique for those who want 4 cycles annually, though the btb complications can drive many patients away by 3-4 months. Yaz for those with poor response to traditional progestins or who respond well to the diuretic effects of DRSP. Lo estrin 24 is used for those who request it by name or who desire a lesser flow and dysmenorrhea patients will improve with 24 day regimens.

Panelist 3: Most of the ones listed are the only ones still samples. It is difficult to start a pt who is NOT alreay on the pill without samples.

Panelist 6: YAZ=YOUNGER PTS WORRIED ABOUT WEIGHT;LOESTRI-4=PTS WITH DEPRESSION,HEADACHE DURING MENSES;SEASONALE=PTS. WITH DYSMENORRHEA OR DON'T WANT MENSES;SEASONIQUE=SAME AS SEASONALEBUT WTH PROBLEMS OFF HORMONES;ORTHOTRICYCLEN-LO=BEST ALL-AROUND PILL

Panelist 12: orthotricyclenlo usually samples available- use in smokers. Seasonale great for menses suppression if insurance pays

Panelist 11: Yas: may be a little better for pms/fluid retention. Loestrin24: lots of samples, well tolerated. Seasonalle and seasonique: expensive version of the extended cycle monophasic. OrthoTricyclin Lo: pretty well toleerated, lots of samples.

Follow-up: Oral contraceptives versus other types of contraception

Do you see any trends towards using products OTHER THAN oral contraceptives, such as patches or the NuvaRing or IUDs? What are the trends you are seeing or expect to see, and why?

Panelist 2: nice to have as alternative but still see majority of patients prefer oral products

Panelist 8: Trend up with ring and down with patch

Panelist 10: I to am seeing the trend of increasing usage of Nuva ring and lessening the patch

Panelist 7: I hope there will be NuvaRing competitors & lower dose patches.

Panelist 5: people like the convenience of shots but Depo Provera causes weight gain and mood swings, not to mention irregular bleeding. Lots of people like the nuvaring b/c of convenience

Panelist 3: Most patients just prefer oral. Nuvaring is catching on, but still too many patients won't give it a try. After the reports of possible increased risk with patch due to a high circulating blood level of estrogen in patch users, combined with a decrease in effectiveness at higher weights/obese patients, its use is trending down. I'd like to see a lower patch.

Panelist 1: SOME INCREASE IN IUDS. DECLINE IN PATCH USE DUE TO CONCERNS OF SIDE EFFECTS

Panelist 6: PATCHES ARE GOOD ALTERNATIVE;NUVARING=POOR ACCEPTANCE; IMPLANTS NOT FOR MY PATIENTS

Panelist 9: Am not seeing any specific trends in the other direction.

Panelist 12: slight trend toward mirena IUD because of less bleeding and cramping

Panelist 11: Patch has bad press, Ring is great for the patients who will try it. Pills are still the default choice for most people. The implanon sounds interesting.

Panelist 10: I typically prescribed oral contraceptive pills that I have stocked in samples such as Yasmin, Yaz, low Ortho Tri-Cyclen.

Panelist 10: I typically prescribed what is available in my cabinet as samples such as Yazz, Yasmin, lo Ortho Tri-Cyclen and I do not like generics

Q2: Product decision drivers

What are the main drivers of your choice of oral contraceptive products? Please discuss clinical factors, such as product attributes and patient characteristics, as well as non-clinical factors, such as reimbursement.

Panelist 10: The main issues in my choice of contraception would-be efficacy, patient compliance, and side effect profile.

Panelist 11: Dose and cost. I prefer the lower dose products and prefer generics because of price. I usually tell patients to ignore the day labels and take them as a continuous regimine.

Panelist 2: dose, cost and side effect profile. also availability of samples

Panelist 5: The main drivers are efficacy, my familiarity and comfort level of the OCP's, side effects and cost. I avoid all estrogen containing OCP's in women with hypertension. I also do not use in any smoker over the age of 35.

Panelist 9: patient type, requests, specific cycle control needs, again prefer monophasic regimens

Panelist 4: often ask patient if they have a birth control they were interested in trying or particular side effects they wish to avoid or benefits they hope to have on ttheir therapy.

Panelist 1: PT'S MAY COME IN REQUESTING SPECIFIC DRUGS. OFTEN THEY HAVE SEEN ON TV OR IN MAGZINE ADS. THEY MAY HAVE FRIENDS WHO RECOMMEND. I OFTEN WILL GIVE RX FOR NAME BRAND BUT WHEN RX FILLED THEY END UP WITH GENERIC.I PREFER TO USE SOMETHING I HAVE SAMPLES TO START FOR 1ST TIME. SOMETIMES I WILL USE SEASONALLE BUT FORMULARY WILL NOT PAY FOR CONTINUOUS TX

Panelist 8: Efficacy, safety, tolerability Braod patient selection.......clinical trial results in overwight individuals

Panelist 6: TREAT ALL AGES ~15-55 IF WORRIED ABOUT WEIGHT /FLUID RETENTION,I USE YAZ. I LIKE EXTRA DAYS OF EST. TO DECREASE DEPRESSION/PMDD;SEASONIQUEHELPS THIS ALSO

Panelist 3: Samples are key. I favor the lower dose estrogens. I don't tend to start new starts on generics unless pts cannot afford otherwise.

Panelist 7: Samples & patient ed. most important. Next is if patient had a preference for whatever reason. Else, 24 day regimens, low dose 20 mcg. preps, monophasics preferred.

Panelist 12: my main driver is to match type of pill on feminizing to androgenic scale to problems the patient may have other then need for birth control such as acne or premenstrual migraine or pain or heavy bleeding.

Panelist 1: FORMULARY STATUS , PT REQUESTS SIDE EFFECTS

Q3: Drivers of switch

What drives you to switch a patient from one oral contraceptive product to another? Please explain using examples if possible.

Panelist 11: 1.Cost 2. Perceived lack of effect. Ie: no cycle control. 3. Side effects like migrane, acne, mood changes. Usually there is not much difference between one product and another except in the patients mind. I am not sure about the newer progestins though.

Panelist 2: symptoms experienced by a patient such as bloating, nausea or BTB are the most common reasons to switch

Panelist 5: Lack of efficacy in control of cycles, this includes BTB, continued dysmenorrhea. Unfortunately insurance formulary and cost also seem to drive pt's request to be changed

Panelist 9: given side effects, btb symptoms, specific androgenic side effects of a certain progestin, drives me to another choice

Panelist 9

You mention “… specific androgenic side effects of a certain progestin drives me to another choice.” What side effect and product are you talking about?