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Major Depression Disorder (MDD) in Europe Health Care | Research & Development - Pharmaceuticals September 2011 Key Treatments · Prescription Criteria · Reimbursement · Pricing · Diagnosis Trends

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Atheneum Partners 2013
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This product (Product) has been produced independently by
Atheneum Partners (AP) for business purposes. The Product is on the
Major Depression Disorder (MDD) treatment market within Europe
with a focus on assessing the entry of a new product into the market.
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are represented by their AP code, but the content of the interviews has not been altered. For more information regarding the expert participants, please contact Atheneum Partners. Introduction This interview with a Psychiatrist with over 15 years of experience in psychotherapy analyses the factors influencing product success in the market for Major Depression Disorder (MDD) treatment. The strengths and weaknesses of existing medications are discussed and the impacts of side- effects, cost, and efficacy on prescription processes are detailed. The investigation evaluates the plausibility of a new drug entering the market in Europe. The objective of this document is to elaborate on the treatment offers and costs related to the Major Depression Disorder. This interview was part of a broader study backed by 20 specialists. 1.1 You mentioned that you see an average of 80 MDD patients per month. Has this number increased over time? Do you expect it to increase in the foreseeable future? Roughly speaking, it will remain the same, as it hasn’t changed in the past. However, socio-economic issues mean that it might increase in future. 1.2 Which factors are considered when making a decision as to whether or not to prescribe anti- depressant medication to a patient with MDD? I start with medication from the beginning. 1.3 You previously rated the need for new therapies for depression as moderate. Could you please explain? What is currently being met well, and what are the key unmet needs? I’m happy with the ones currently offered and there’s a good amount available, but there is always ground to improve. The ideal antidepressant would be one that makes depression better in the first week. Also, a medication with no side effects at all, or at least a very low profile, would be very competitive in the market. 1.4 You also mentioned that a new product with head- to- head data vs. Valdoxan showing comparable or slightly better efficacy, similar tolerability, and better safety would be of interest to you. Why? I would be interested because there is a need for better efficacy and fewer side-effects. 1.5 Finally, you mentioned that a new product with head- to- head data vs. Cymbalta showing comparable or slightly better efficacy, similar tolerability, and better safety would be of interest to you. Why? The sales representatives for Cymbalta come to see me quite often, and I’ve used it for a few years. Again, I would be interested in a more efficient option. 1.6 You mentioned that your top three antidepressant choices for a treatment- naive patient are Escitalopram, Duloxetine, Agomelanina. ii. Has your use increased over the last two to three years, and do you expect it to Escitalopram is the top choice as it is the medication that causes the best improvements in the least amount of time. I am used to certain drugs so I prescribe them sometimes without even thinking. I probably prescribe them more now than in previous years. 1.7 You mentioned that your top 3 antidepressant choices for second- line patients are Venlafaxine, Mirtazapine, and Reboxetina. ii. Has your use increased over the last two to three years, and do you expect it to I don’t prescribe the tricyclics, so I don’t have many other options to choose from. ECT is used sometimes as well if it is available in the area. 1.8 How has your prescribing of Valdoxan (NDDI), Cymbalta (SNRI), and Escitalopram (SSRI) changed over the last few years? How do you expect it to change in the foreseeable future? Valdoxan and Cymbalta increased their market share because of marketing; Escitalopram increased its share because of efficacy. 1.9 Valdoxan (agomelatine) launched recently and has been used despite the large number of generic therapeutic options. In your opinion, what are the key drivers of Valdoxan’s use? I don’t care much about the costs, so the fact that there are generic options available would not influence my use of a certain drug. This may be the cause for Valdoxan’s use. 1.10 Do reimbursement and the cost of drugs influence your prescribing habits? As patients don’t have to pay for the drugs themselves, reimbursement and cost do not affect my prescriptions at all. 1.11 What share of the drugs that you prescribe is generic in comparison to branded? I normally go for a particular brand; around 80% of the drugs I prescribe are brand-name. That being said, branded drugs are not always better than generics. 1.12 How often are you unable to prescribe your preferred drug due to budgetary constraints? How do you determine which patients to give expensive branded drugs to vs. generic drugs? What are the decisive factors for you to prescribe a more expensive drug? In Spain, there is no top-down pressure to prescribe certain drugs. I have never been unable to prescribe a certain drug because of budget constraints, but that depends on the area. I know that in Madrid and Barcelona they have some more problems than I do in the Basque country. It would be very different as a private practitioner –patients then wouldn’t want to pay for their own medications and the insurer wouldn’t cover it. 1.13 When you choose between various similar drugs, what are the key factors Escitalopram has a few less side effects than Citalopram. If both have the exact same side-effects in a particular patient, I would prescribe the one I am most familiar with. 1.14 What is the importance of different promotional activities (rep. visits, samples, It is definitely still very important in Spain and one of the main issues influencing the prescription process. 1.15 What is the role of the patient in the decision? Sometimes patients already have certain ideas from the internet or friends about what kind of drug that they want and they’ll ask me to prescribe it. 2.1 Please name the three most important factors when selecting a therapy for 2.2 Is there a difference between the types of patients to whom you would prescribe a certain MDD drug type for first- line treatment? i. When would you choose to prescribe Valdoxan (Agomelatine) and Cymbalta ii. When would you choose to prescribe Escitalopram (leading SSRI drug in Of course, doctors look at a patient’s profile and unique medical situtaion as there are some drugs that suit different kinds of patients. I wouldn’t prescribe Valdoxan or Cymbalta to a patient with sleeping problems. I would prescribe Escitalopram for a young patient with no medical problems because it is the one with the least side effects. Gender is not important; the symptoms of their disorder would be the first consideration. Thirdly, I consider their medical history. 3.1 What is the importance of certain side- effects in the decision to switch Sleeping problems is the biggest issue. Weight gain is not really an issue, nor is sexual dysfunction. 3.2 Are there differences in side- effects between Valdoxan (NDDI), Cymbalta (SNRI), The main side effect of both Valdoxan and Cymbalta is sleeping problems and sometimes gastric and stomach complaints. 3.3 Would you consider this an acceptable trade- off: Less sexual side effects, no weight gain, but 28% mild to moderate diarrhea lasting for a median of 8 days? If not, what would be acceptable? Yes, this would be an acceptable trade-off. 3.4 Are you familiar with the term “emotional blunting” (“flattened affect”)? In your clinical experience, is there an unmet need for a drug which is less likely to cause emotional blunting in your depressed patients? For what percentage of your antidepressant patients is this an issue? I would perhaps consider emotional blunting to be one of the symptoms of the original depression rather than from the drugs. Sometimes they stop taking medication without telling me, so it’s hard to say where the effect came from. In Spain, the compliance rate is 60-70%. 4.1 Are you aware of any new regulations (EU and national) regarding the acceptance There are some differences between laws in Barcelona/Madrid and other parts of Spain. 4.2 In addition to regulatory and reimbursement barriers, do you foresee any barriers to physician acceptance and the use of new antidepressant medications? In Spain, there is a bit of cost-cutting recently, so that is an increasing concern. I think that it’s fairly easy for a new drug to enter the market in Spain. There are no problems in my area. 5.1 Please discuss the advantages/disadvantages of Product X for the treatment of I like trying new drugs. The disadvantages are the diarrhea and the titration (although the titration is not that bad). 5.2 What differentiates this product from other antidepressant options? At the moment, the only comparison is against a placebo rather than against other drugs; I’d like to see it compared against Escitalopram or Cymbalta, for example. The speed of action is average. When Cymbalta first came out, doctors were told that it would work in the first week, and that is just not true. The fact that Product X needs to be taken with food is not a big issue. 5.3 Please describe how you would expect to use this therapy (e.g. which types of patients, which line of therapy, and with which combination of other antidepressant medications?) I might use it with any depression patient, but probably not a patient with gastric problems. I would also administer it to patients with anxiety. 5.4 What is your reaction to the mechanism of action of Product X? I find the new combination with SSRI interesting, but it is yet to be determined if the combination is efficient. 5.5 I would like you to think forward to a time in the future when Product X will have been on the market for 3 full years and continues to demonstrate a clinical profile consistent with the profile you reviewed. i. Which types of patient or patient profiles come to mind as being the most likely to benefit from receiving Product X in your practice? Please be as specific as possible and give the reason(s) for your choices. It would be used as much as the usual and would be used as standard. The main issue is the efficacy in the short-term. ii. What percentage of your MDD patients fall into these patient groups? iii. Of the patients you described by this profile, what percentage would you expect to receive Product X, given all of the other choices available to you? iv. Would you tend to use Product X as a 1st, 2nd, or 3rd line for this type of patient? If a later line, which therapies would you use first? I like trying new medications and testing for efficacy, so I would start it out as a 1st-line treatment. v. Would you tend to use Product X in combination with other therapies? If so, with which other therapies would you expect to use it? I would start by not combining it with anything, but if the patient suffers from anxiety, I might combine it with others. vi. On average, how many patients per month would you expect to prescribe 5.6 In general, would you use Product X in patients with depression and anxiety? Why 5.7 Would you expect to prescribe Product X more, less, or the same as you do the following products? What attributes of Product X would make you prefer it or not prefer it to each drug below? ii. Wellbutrin and other buproprion products? More, because I have prescribed buproprion and it is not effective. 5.8 Overall, which antidepressant product would you expect Product X to most likely displace in your practice? In other words, which drug(s) would you be most apt to use less of as a result of prescribing Product X? If it continues to show efficacy, then it might even replace every first-line drug I prescribe; my use of it will depend on how it works after trying it out for a short period of time.

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