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H. LUNDBECK A/S Schizophrenia Treatment Landscape Study Final country report – Germany Q1 2013 (Fieldwork August – October 2012) Prepared by: InforMed Insight Tel: +44 1625 509280 [email protected] Overview of Schizophrenia Treatment Landscape Study Business objective: To gain a real-world snapshot into the management of patients with schizophrenia through the collection and analysis of customised patient report forms Specific focus on patient receiving LAI medication Methodology: retrospective real-world study where physicians retrieved existing patient medical records for 6 patients meeting the screening criteria and entered information into an online survey Target physicians: Psychiatrists (and Nervenärzte in Germany) Scope: 13 markets (5EU, Poland, Australia, Brazil, Canada, Nordics) Total sample: 964 physicians and 5469 patient records Included an over-sample on patients receiving LAI medication Country Physicians (n) PRFs (n) Germany 102 587 Representative LAI oversample sample PRFs (n) PRFs (n) 393 194 2 Sample size: patients receiving oral vs. LAI Representative sample: Country This excludes the additional LAI patients (oversample) and will give a reflective view of the market Germany LAI oversample: We collected additional patient record forms for patient receiving LAI medications to boost the sample size for patients receiving LAIs and permit sub-group analysis Representative sample Oral (n) – Atypicals Oral (n) Typicals LAI (n) – Atypicals LAI (n) Typicals 329 (88%) 32 (9%) 31 (8%) 17 (5%) Country Germany LAI oversample* Oral (n) – Atypicals Oral (n) - Typicals 29 (15%) 12 (6%) LAI (n) – Atypicals LAI (n) - Typicals 153 (79%) 43 (22%) Note that patients can receive more than one drug, hence percentages add up to more than 100% *The oversample was specifically on patients receiving LAI medication, however some patients were receiving concomitant oral therapy, as shown above 3 Physician and patient screening criteria Physicians • Psychiatrists and Nervenärztes (Germany only) • Nervenärztes : 30% + time spent in psychiatry Schizophrenia patients • Patients selected at random from existing records based on first initial of last name • Adult patient (at least 18 years old) currently diagnosed with schizophrenia • Actively managing and treating patients with schizophrenia (decision maker) • Seen by physician within the last 24 months (from date of interview) • Treating 10 or more schizophrenia patients per month • Over-sample on patients receiving LAI treatments: • Majority of physicians LAI initiators • Qualified for 3-30 years • Representative mix of practice settings and regions within each market • Physicians who initiate LAIs profiled 4 patients of any type & 2 specifically receiving a LAI medication • Physicians who do not initiate LAIs profiled 6 patients of any type 4 Data from this study have a good correlation with IMS data R² (R-squared) is a measure of how well the data from the survey ‘fits’ with IMS prescribing data, where 0 = no fit and 1 = perfect correlation The regression coefficient is a measure of effectiveness of B22 in ‘predicting’ the value of the IMS data IMS data summary: • • • • Time period: MAT Q2 2012 Data level: sum of Rx (000s) (absolute) ICD-10 indication(s): F20 Schizophrenia Locales: retail only olanzapine risperidone paliperidone palmitate Base: current prescriptions (representative patients) (n=4645) clozapine quetiapine aripiprazole paliperidone 5 Structure of questionnaire Part A: Physician profiling • Screening questions & physician profiling • Caseload • Setting • Perception based questions • Physicians overall prescribing of antipsychotics • Unmet needs • Adherence • Insight (anosognosia) B: Patient record forms (Completed PRFs) • • • • • • • • Patient demographics Disease profiling Hospitalisations Treatment profiling Adherence Insight Quality of life If on LAI: LAI specific questions These sections are sign-posted within the presentation with these labels: Physician profiling / perception PRF 6 Key thoughts - Germany SETTING The majority of physicians’ time is spent working in private practice or hospital setting (mainly acute), and around half of their time is spent with mostly out-patients Around half of all patients are stable with residual symptoms. Over two-thirds of patients on all treatment options have not had a relapse in the last 12 months MARKET SHARE Most commonly prescribed orals are olanzapine and risperidone. Risperdal Consta is the most prescribed LAI. Previous prescribing was higher for the typicals (especially orals). Risperidone and olanzapine are also common previous treatments SWITCHING Poor tolerability, patient request and poor efficacy/symptom control are the main reasons for switching away from previous treatment. Poor adherence with oral therapy is the main reason for prescribing LAIs, though more convenient dosing form is a key driver for paliperidone palmitate INSIGHT 51% of patients are fully aware of their condition, 42% moderately aware and only 7% fully unaware. This is better than physicians’ original estimates 7 Interactive Dashboard of all data will be provided This report has selected key points of interest for presentation purposes, but please note that more results can be accessed via the Interactive Dashboard: This will be provided in Excel format early in 2013 If you have any questions regarding the use of the dashboard, please contact Gitte Esmann (GIES) or the InforMed team (ObservationalStudySZ@in formed-insight.com) 8 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 9 Part A: Key take away message summary All physicians initiate (prescribe) LAI treatments The majority of physicians’ time spent working in private practice or hospital setting (mainly acute), and ~half of their time is spent with mostly out-patients Presence of side effects and lack of insight are perceived to be the two main reasons for low patient adherence to treatment Re-engaging with caregiver/support network is thought to be an effective tool in improving patient adherence The majority of physicians were familiar with the term ‘anosognosia’; most commonly defined as ‘lack of awareness of/insight into condition/disability’ Physician’s estimate that 80% of patients are fully or moderately aware of their schizophrenia, and awareness can improve even in those with very low levels of insight When asked directly, a patient’s level of insight has a major impact on prescribing decisions, with around three-quarters of physicians more likely to prescribe an LAI to a patient with a low level of insight than a high level of insight A low level of insight is considered by over half of respondents to result in nonadherence to treatment and general worsening of symptoms 10 Physician profiling Physicians tend to have around 14 years of experience. Patients diagnosed with schizophrenia account for 26% of their total (monthly) caseload. LAI initiation is 100% S2: How many years have you been practicing in your clinical specialty, after qualifying? S3: Thinking about an average month, approximately how many patients do you see in total? Of these, how many patients with schizophrenia do you personally treat or manage in a month? S5: Do you initiate depot treatment for patients with schizophrenia? Monthly caseload (S3) (n = 102) LAI initiation (S5) (n = 102) 100% 14.1 years in practice Source: Physician profiling. Base: all (n=102) Non-LAI initiator LAI initiator 0% % of physicians Years qualified (S2) (n = 102) SZ patients represent 26% of a physician’s total caseload 11 Physician profiling The majority of physicians’ time in Germany is spent working in private practice or hospital setting (mainly acute), and around half of their time is spent with mostly out-patients S7 Approximately what percentage of your time spent in direct patient care is in each of the following health care locations? A1 What percentage of your time is spent working with in-patients versus out-patients? 16% Hospital Day Hospital Acute care 27% Chronic care 9% Mix Intermediary 3% Supply: Hospital Pharmacy Supply: Hospital Pharmacy 54% Relapse Ambulatory Service 16% Supply: retail Pharmacy Source: Physician profiling. Base: all (n=102) 31% Mostly inpatients % Supply: retail Pharmacy Private practice 45% Mostly-outpatients 12 Physician profiling Physicians estimate that the most commonly prescribed orals are quetiapine, olanzapine and risperidone; Risperdal Consta is estimated as the most prescribed LAI A2 Thinking about the patients with schizophrenia that you see in a typical month, approximately what proportion would be prescribed each of the following treatments? Oral treatments 21% OLANZAPINE 13% 11% CLOZAPINE QUETIAPINE (Seroquel) 22% ARIPIPRAZOLE (Abilify) PALIPERIDONE PALMITATE 7% 12% 2% OLANZAPINE PAMOATE 3% 8% AMISULPRIDE ZIPRASIDONE (Zeldox) RISPERDAL CONSTA 21% RISPERIDONE PALIPERIDONE (Invega) LAI treatments 5% ASENAPINE (Saphris) 2% Other atypicals 2% OTHER ATYPICAL Note that patients can receive more than one drug, hence percentages add up to more than 100% Source: Physician profiling. Base: all (n=102) 1% Note: this question can be compared to actual prescribing collected in the patient record forms (question B22, slide 54) 13 Physician profiling Control of negative symptoms is the main unmet need as perceived by physicians in Germany. Control of metabolic side effects, and relapse prevention/maintaining treatment response is also considered to be important by ~two-thirds of physicians A3: Thinking in general about current treatments for schizophrenia, which of these areas do you feel require most improvement? Please select up to 7 options Control of negative symptoms 75% Control of metabolic side effects (including weight gain) 65% Relapse prevention/maintaining treatment response 62% Patient adherence 55% Overall quality of life 53% Patient satisfaction with treatment 40% Level of functioning (e.g. in social situations, being able to live… 37% Availability of atypical depots 35% Early treatment response 34% Control of positive symptoms 29% Control of sedation 29% Control of extrapyramidal side effects (including tardive… 23% Control of prolactin-related side effects (including sexual… 22% Cost/reimbursement 19% Control of aggressive symptoms (e.g. hostility and agitation) 10% Frequency of dosing 9% Transition from oral to depot medication 9% Control of akathisia 9% Requirement for blood monitoring and/or liver function/liver… Mode of administration Source: Physician profiling. Base: all (n=102) 7% 3% 14 Physician profiling Presence of side effects and lack of insight are perceived to be the two main reasons for low patient adherence to treatment A6 What do you think are the main reasons for patients not adhering or only partially adhering to their treatment regimen? 77% Presence of side effects 74% Not aware of illness (no insight into disease) 48% Belief that they are cured (lack of insight) Concerns about potential side effects 42% Forgetting to take their medication 42% Other disease symptom(s) affecting ability to take medication (e.g. delusions, hallucinations) 39% Aware of illness/symptoms, but does not recognise the need for treatment 38% Aware of illness/symptoms, but unwilling to accept that they have schizophrenia 31% Cognitive impairment (not related to their schizophrenia e.g. dementia, learning disability) 22% 18% Lack of family support 14% Drug/alcohol abuse 12% Complicated medication regimens Cost of medication Other, please specify 2% 4% Related to the disease itself (n=2) Lack of efficacy (n=2) % of physicians Source: Physician profiling. Base: all (n=102) 15 Physician profiling Re-engaging with caregiver/support network is thought to be an effective tool in improving patient adherence. Discussion with the patient is also believed to play a large role in the process A7 Please indicate which of the following steps you commonly use to improve non-adherence / partial adherence in your practice, and how much impact these have on adherence Use, with good impact Use, with limited/ no impact Re-engage caregiver/support network Do not personally use 67% Discuss reasons for non-adherence with patient 32% 63% Switch to depot injection 37% 58% 40% Simplify medication routine 56% 44% Switch to other oral antipsychotic with perceived improved effect 56% Switch to other oral antipsychotic with fewer side effects 55% Adjust the dose Initiate/add cognitive behavioural therapy (CBT) Others include: High frequency of visits (n=6) Psychological education (n=4) Source: Physician profiling. Base: all (n=102) Other (n=11) 39% 44% 46% 54% 26% 16% 5% 58% 37% % of physicians 16% 47% 16 Physician profiling The majority of physicians are familiar with and can define the term ‘anosognosia’. 80% of physicians defined it as ‘lack of awareness of/insight into condition/disability’ A8 Are you familiar with the term ‘anosognosia’? % of physicians Yes, to me this means… 75% 23% 2% Yes, I have heard of it but not sure what it means No, not at all Yes, to me this means… (coded responses) 80% 13% Lack of awareness of/insight into condition/disability Denial of illness 4% 3% Lack of awareness of part of body Inability/lack of recognition/ vague Source: Physician profiling. Base: all (n=102); physicians who gave a definition of anosognosia (n=77) 17 Physician profiling Perceived knowledge of poor insight A8: Are you familiar with the term ‘anosognosia’? Yes, to me this means… (verbatim responses) “Not acknowledging that one is ill” (Psychiatrist, Germany) “Disease is not realised/acknowledged” (Psychiatrist, Germany) “Lack of understanding of the disease in schizophrenia” (Psychiatrist, Germany) “Not realizing their own disease” (Psychiatrist, Germany) “Neglect, not seeing the deficits” (Psychiatrist, Germany) Source: Physician profiling. Base: physicians who gave a definition of anosognosia (n=77) 18 Physician profiling Physicians estimate that 42% of patients are fully aware of their schizophrenia. Physicians feel that awareness can improve even in those with very low levels of insight A10 Approximately what proportion of your patients at the current moment fit into each of the following categories in relation to their awareness of their schizophrenia? A11 If a patient is moderately aware / fully unaware of their schizophrenia for a year or more, do you believe the patients’ insight into their disease can improve? Fully aware Moderately aware 38% 20% % of physicians 42% Fully unaware Yes, insight can improve Yes, insight can improve, but only to some extent 72% 57% No, insight cannot improve 33% 27% Don’t know 1% Moderately aware Source: Physician profiling. Base: all (n=102) 7% 3% Fully unaware 19 Physician profiling A patient’s level of insight has an impact on prescribing in almost all physicians. Physicians state that they are more likely to prescribe an LAI to patients with a low level of insight than a high level A13a How much impact does the patient’s level of insight into their schizophrenia have on your treatment decision, if any? A13b Are you more likely to prescribe a LAI medication to a patient with… ... a high level of insight 70% Major impact 0% ... a low level of insight 28% 2% Some impact No impact at all % of physicians 77% 23% ... either high or low insight – it does not have a big influence on my decision to prescribe a depot medication Note: this question can be compared to actual prescribing of LAIs in patients depending on level of insight collected in the patient record forms (question B22, slide 51) Source: Physician profiling. Base: left chart - all (n=102); right chart – physicians whose treatment decision is influenced by level of insight (n=100) 20 Physician profiling A low level of insight is considered by over half of respondents to result in non-adherence to treatment and general worsening of symptoms A12 What do you think are the main consequences of a patient’s poor/low level of insight into their schizophrenia? Non-adherence to treatment 61% Worsening of symptoms 54% Lower level of functioning 47% Lower quality of life (QoL) 38% Creates mistrust between doctor-patient, making it more difficult to engage the… 25% Increased need for caregiver support 24% Increased workload for treatment team 20% Lower health-related quality of life (HRQoL) Other 17% 1% % of physicians Source: Physician profiling. Base: all (n=102) 21 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 22 Understanding the data charts for Section B – patient record form data NB – This is not actual data Acute Stable with residual symptoms 68% 63% 16% 19% 15% 2% Stable without residual symptoms 69% 67% 16% 15% 1% 17% 16% 1% All patients - rep sample Patients receiving orals Patients receiving LAIs (n=3759) (n=3778) (n=2204) This data is based on all patients (PRFs) in the representative sample (i.e. the depot oversample has been removed). This gives you the best indication of the total patient population Other 16% 0% Patients receiving aripiprazole (n=632) These sub-groups are based on all patients receiving orals / LAIs / aripiprazole. These take all patients from both the representative sample and the oversample. Therefore a patient may be included in all sub-groups (if they are receiving both an oral and LAI, for example) 23 Part B: Patient & disease profiling - key take away message summary 64% of the last consultations were scheduled or routine follow-ups with 63% of patients getting repeat prescriptions Around half of all patients are stable with residual symptoms, but this is significantly higher for LAIs (62%) vs. orals (50%) Overall severity of the disease has significantly improved for all patients since first consultation. Severity of disease is significantly higher at first consultation for patients on LAIs vs. patients on orals Over two-thirds of patients on all treatment options have not had a relapse in the last 12 months Around 80% of currently stable patients are expected to continue being adherent in the near future across all treatments Negative symptoms are most commonly experienced across all treatments. Patients on typical LAIs experience significantly more positive symptoms (77%) than those on typical orals (62%) Around half of patients are fully aware of their schizophrenia, although this is significantly lower in patients on LAIs compared to orals. Level of patient insight is higher than physician estimates 24 PRF Patient profile: There is a male bias in the sample. 19% of patients are in paid employment. There is a significantly higher drug/alcohol use in LAI patients compared to oral patients B1 to B5: demographics Demographics BMI Employment status (paid vs. unpaid) Family status (top 2) Drug/alcohol use All Patients – Total sample (n=590) Oral prescriptions (n=379) LAI prescriptions (n=243) 38% female and 62% male Average age: 39 Age at diagnosis: 27 41% female and 59% male Average age: 38 Age at diagnosis: 27 34% female and 66% male Average age: 40 Age at diagnosis: 27 Mean BMI = 25.2 (overweight) Mean BMI = 25.2 (overweight) Mean BMI = 25.7 (overweight) 19% in paid employment 21% in unpaid employment 18% in paid employment 21% in unpaid employment 17% in paid employment 21% in unpaid employment 28% living alone / independently 17% living with parents 42% do not use 29% mild use 19% moderate use 6% severe Source: Patient record forms. Base: all (n=587) 30% living alone / independently 17% living with parents 26% living alone / independently 17% living with partner without children 45% do not use 30% mild use 16% moderate use 6% severe 38% do not use 28% mild use 23% moderate use 6% severe • Significantly more LAI patients are reported with moderate drug/alcohol use than oral patients, at the 5% level 25 PRF Majority of recent consultations were scheduled or routine followups (64%), and the majority of patients (63%) had their current treatment regimen repeated B6a: What was the main reason(s) for the patient’s most recent consultation? B6b: What action was taken regarding the patient’s schizophrenia treatment? B8a: How many times have you seen the patient for their schizophrenia in the last 12 months? Most frequent Least frequent Scheduled or routine follow up (64%) Treatment repeat (63%) Orals 62%: LAIs 68% Orals 63%: LAIs 70% Acute episode /relapse (21%) Treatment change (15%) Orals 24%: LAIs 16% Orals 17%: LAIs 12% Diagnosis (10%) Treatment initiation (12%) Orals 9%: LAIs 6% Orals 11%: LAIs 7% Referral (5%) Treatment restart (6%) Orals 5%: LAIs 8% Orals 6%: LAIs 5% Side effects (5%) Stop treatment (2%) Orals 5%: LAIs 5% Orals 0%: LAIs 1% Reason Source: Patient record forms. Base: all patients – rep sample (n=393) Action 26 PRF Around half of all patients are stable with residual symptoms. This is significantly higher for patients on LAIs vs. patients on orals B12a/b: Current status Please indicate the current status of the patient’s schizophrenia using the following options: • Significantly more LAI patients are stable with residual symptoms than oral patients, at the 1% level • Significantly more oral patients are stable without residual symptoms than LAI patients, at the 5% level Acute Stable with residual symptoms Stable without residual symptoms Other 62% 50% % of patients 48% 40% 33% 27% 25% 24% 22% 21% 20% 15% 3% Total (rep sample) - (n=393) 3% All orals (n=379) 2% All LAIs (n=243) Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 3% aripiprazole (n=67) 27 PRF The overall severity of the disease has significantly improved for all patients since first consultation. Severity of disease is significantly higher at first consultation for patients on LAIs vs. patients on orals B11: How would you rate the severity of the patient’s schizophrenia? Please answer on a scale of 1-7. • Severity of disease has significantly improved for all patients since first consultation, at the 1% level • Severity of disease is significantly higher for LAI patients than for oral patients at first consultation, at the 5% level 4.7 4.7 4.9 4.8 Mean score Extremely mentally ill (7) 3.8 3.9 4.1 4.0 All patients - rep sample (n=393) All orals (n=379) All LAIs (n=243) aripiprazole (n=67) Normal, not at all mentally ill (1) At first consultation Current severity Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 28 PRF Over two-thirds of patients on all treatment options have not had a relapse in the last 12 months B8b: How many psychotic relapses has the patient experienced in the past 12 months? Mean # relapses 0.5 0.6 0.5 0.5 9% 11% 12% 8% 22% 15% 22% % of patients 21% 6 - 10 relapses 2 - 5 relapses 1 relapse 69% 66% 72% 68% 0 relapses Total (rep sample) - (n=369) All orals (n=354) All LAIs (n=227) Source: Patient record forms. Base: All patients – rep sample (n=369). aripiprazole prescriptions (n=63) Aripiprazole (n=63) 29 PRF In patient circumstances, relationship with physician is rated most positively; this is significantly higher for oral patients vs. LAI patients. LAI patients also have significantly worse previous treatment response than oral patients B16a Patient circumstances: Please rate the patient’s situation in relation to the following attributes: Very high / very good (5) • Orals scored significantly higher than LAIs on relationship with physician, support from family/ friends, socio-economic factors at the 5% level, and previous treatment response at the 1% level Mean score 4.0 4.0 3.9 4.1 3.4 3.4 3.5 3.3 Very low / very poor (1) Relationship with physician Support from HCPs All patients - rep sample (n=393) 3.8 3.7 3.7 3.9 3.7 3.5 3.5 3.2 Support from family / friends 3.1 3.1 2.9 3.1 Socio-economic Current treatment factors (e.g. response financial situation) All orals (n=379) All LAIs (n=243) Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 3.6 3.5 3.6 3.3 Previous treatment response Aripiprazole (n=67) 30 PRF Physicians believe impact on quality of life and ADLs are similar across patient groups. Impact on social relationships is significantly higher for patients on LAIs vs. patients on orals B14 Quality of life: How much impact does the patient’s schizophrenia have on the patient’s…? Profound impact (5) • A patient’s schizophrenia has significantly more impact on social relationships if they are on LAIs vs. on orals, at the 5% level Mean score 3.7 3.7 3.8 3.8 No impact (1) Overall quality of life 3.8 3.6 3.7 3.6 3.6 3.4 3.5 3.4 Activities of daily living (e.g. household chores, shopping) All patients - rep sample (n=393) Social relationships All orals (n=379) All LAIs (n=243) 4.0 3.9 3.8 3.9 Ability to work aripiprazole (n=67) Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 31 PRF On the whole, the majority of patients who are currently stable are expected to be very adherent in the future B34 You described the patient as currently “stable with/without residual symptoms”. Despite the patient being stable, do you anticipate him/her to become non-adherent within the near future? 7% 8% 5% 8% 7% 5% 5% 11% 8% 8% 6% 2% 8% 2% 12% 10% 2% 4% Don’t know Yes, I anticipate the patient to become non-adherent within the next 6 months 79% 79% 76% 84% 80% 82% Yes, I anticipate the patient to become non-adherent within the next 3 months No, I don’t have any reason to anticipate non-adherence in the near future Total (rep sample) (n=297) Atypical orals Typical orals (n=267) (n=36) aripiprazole (n=49) Atypical LAIs (n=147) Typical LAIs (n=54) Source: Patient record forms. Base: all patients that are currently stable with/without residual symptoms (n=297) 32 PRF Negative symptoms are most commonly experienced across all treatments. Patients on typical LAIs experience significantly more positive symptoms (77%) than those on typical orals (62%) B29 Current symptoms Please indicate which symptoms the patient currently experiences as part of their schizophrenia • Patients on typical LAIs experience significantly more positive symptoms than patients on typical orals, at the 5% level • Patients on typical orals experience significantly more other symptoms than patients on aripiprazole, at the 5% level Positive symptoms (hallucinations, delusions, thought disorder, changes in behaviour, disorganised speech) Negative symptoms (lack of interest, social withdrawal, emotional flatness, inability to concentrate) Other symptoms (suicidal thoughts, aggression, irritability, sexual dysfunction, cognitive deficits, anosognosia) Mean number 1.3 of symptoms 1.7 % of patients 76% 1.3 1.7 79% 53% Total (rep sample) (n=393) 1.2 1.8 1.4 1.8 82% 82% 1.7 2.2 77% 71% 62% 60% 59% 1.4 2.1 53% Atypical orals (n=359) 60% 52% Typical orals (n=45) Source: Patient record forms. Base: rep sample (n=393) oral (n=359) versus LAI (n=184) 77%77% 72% 55% 49% Aripiprazole (n=67) Atypical LAIs (n=184) Typical LAIs (n=60) 33 PRF Based on the PRFs, around half of patients are fully aware of their schizophrenia, although this is significantly lower in patients on LAIs compared to orals. Level of patient insight is higher than physician estimates B15: Is your patient aware that he/she has schizophrenia? Note: this question can be compared to A10 in the physician perception section (slide 19) • Significantly more patients on orals are fully aware of their schizophrenia vs. patients on LAIs, at the 1% level % of patients Mean score 2.4 2.4 2.3 7% 7% 10% 2.2 43% 42% Fully unaware 42% 53% Moderately aware Fully aware 51% 57% 51% 37% Total (rep sample) (n=393) All orals (n=379) All LAIs (n=227) Aripiprazole (n=67) Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 34 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 35 Interactive Dashboard of all data will be provided This report has selected key points of interest for presentation purposes, but please note that more results can be accessed via the Interactive Dashboard: This will be provided in Excel format early in 2013 If you have any questions regarding the use of the dashboard, please contact Gitte Esmann (GIES) or the InforMed team (ObservationalStudySZ@in formed-insight.com) 36 Part B: Patient journey - key take away message summary Hospital psychiatrists tend to be responsible for seeing the patients first, diagnosis and treatment initiation, with office psychiatrists playing a key role in treatment initiation of typical LAIs Approximately 50% of patients are currently managed in private practice. Around 1/3 are managed in an out-patient setting; this is significantly more for aripiprazole patients vs. both atypical and typical orals Approximately 90% of patients are currently managed by the respondent physician. Psychiatric nurse involvement is minimal Duration between symptoms and consultation tends to be much longer than time between first consultation and diagnosis, and diagnosis to treatment (35 weeks vs. 13 weeks vs.10 weeks) Around 1/3 of patients have been hospitalised within the last 12 months (including current hospitalisations) 37% of patients switch from one antipsychotic to another after their stay in hospital. 17% were discharged on a LAI formulation 37 PRF Hospital psychiatrists play a key role in first seeing patients, with involvement increasing at diagnosis and treatment initiation. Office psychiatrists’ involvement is high with initiation of typical LAIs B10b: And which of the following healthcare professional(s) are/were responsible for each of the following? First saw / Diagnosed / Initiated treatment Atypical First saw Patients currently on Oral prescriptions 16% Diagnosed 22% Initiated tx 24% 18% 38% 52% 13% First saw 15% 13% 44% 14% 12% Diagnosed 22% 58% 8% 9% Initiated tx 21% 61% 7% 53% Typical Typical First saw Atypical Patients currently on LAI prescriptions 11% 11% 49% Diagnosed 16% 58% Initiated tx 16% 56% Yourself GP 7% 13% 11% First saw 10% 8% 38% Diagnosed 10% 52% Initiated tx 10% 54% Other Psychiatrist, Hospital 16% 18% 48% Other Psychiatrist, Office “Yourself” indicates that management is by the person completing the survey. Refer to slide 12 for physician settings Source: Patient record forms. Base: oral prescriptions (n=379); LAI prescriptions (n=243) 38 PRF Approximately 50% of patients are currently managed in private practice. Around 1/3 are managed in an out-patient setting; this is significantly more for aripiprazole patients vs. both atypical and typical orals B10a Please indicate which of the following settings the patient is currently managed in? Note: this question can be compared to physician practice setting (slide 12) • Significantly more patients on aripiprazole are managed in an out-patient clinic vs. patients on both typical and atypical orals, at the 1% level % of patients Hospital, acute care Day hospital 48% 52% 31% 29% Out-patient clinic Private practice 56% 45% 22% 40% Private hospital 47% 34% 57% 30% 4% 3% 3% 16% 17% Total (rep sample) (n=393) Atypical orals (n=359) 22% 1% 2% 2% 15% 16% 15% Atypical LAIs (n=184) Typical LAIs (n=61) Typical orals (n=45) Aripiprazole (n=67) Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 39 PRF Approximately 90% of patients are currently managed by the respondent psychatrist, with 6% other Nervenärtze currently involved in Germany. Psychiatric nurse involvement is minimal B10b Please indicate which of the following Healthcare professionals are responsible for current management of the patients Yourself Other psychiatrist, hospital Neurologist Geriatrician Psychiatric nurse Other GP_Primary Care Physician Other psychiatrist, office Clinical psychologist Nervenärtze Paediatrician / adolescent specialist Don’t know / not applicable 4% 7% 3% 6% 4% 11% 89% 89% 87% Total (rep sample) (n=393) Atypical orals (n=359) % of patients 3% 6% 2% 5% 7% 3% 4% 9% 3% 5% 2% 6% 8% 8% 3% 7% 5% 91% 89% 90% Atypical LAIs (n=184) Typical LAIs (n=61) Typical orals (n=45) aripiprazole (n=67) “Yourself” indicates that management is by the person completing the survey. Refer to slide 12 for physician settings Source: Patient record forms. Base: All patients – rep sample (n=393). aripiprazole prescriptions (n=67) 40 PRF Duration between symptoms and consultation tends to be much longer than time between first consultation and diagnosis, and diagnosis to treatment (35 weeks vs. 13 weeks vs.10 weeks) B9: Thinking about the patient’s schizophrenia, what was the time period between… … first experiencing symptoms and first consultation (with yourself or another physician)? … first consultation and receiving diagnosis? … diagnosis and initiation of treatment? B7b How long has the patient been in your care? Symptoms --> consultation First consultation --> diagnosis Diagnosis --> treatment 45 39 35 35 Time (weeks) 24 18 13 10 11 10 6 1 Total (rep sample) (n=261) All orals (n=248) Aripiprazole (n=48) All LAIs (n=129) Source: Patient record forms. Base: All patients – rep sample (n=261). aripiprazole prescriptions (n=48) Base: all patients with stated timeframes, note actual sample size varies slightly for each part of the question, sample shown is maximum 41 PRF Around 1/3 of patients have been hospitalised within the last 12 months (including current hospitalisations) When hospitalised: B17 Has the patient ever been hospitalised for their schizophrenia? % of patients Mean number of hospitalisations in the last year 1.6 1.5 2.4 1.3 1.5 3.4 4% 3% 2% 1% 4% 2% 19% 13% 20% 19% 17% 13% 44% 44% 44% 21% 21% 51% 43% 67% 22% 11% 13% Total (rep sample) (n=393) Atypical orals (n=359) 13% 18% 27% 10% 15% Typical orals aripiprazole (n=45) (n=67) 9% 8% Atypical LAIs (n=184) Typical LAIs (n=61) Source: Patient record forms. Base: all (n=393); Orals (n=379) versus aripiprazole (n=67) versus LAIs (n=243) Yellow box - patient record forms for those who have been hospitalised in the last 12 months/duration (n=181/105) Don't know No Yes, more than 12 months ago Yes, within the last 12 months Yes, currently hospitalised 42 PRF 37% of patients switched from one antipsychotic to another after their stay in hospital. 17% were discharged on a LAI formulation (compared to 13% overall proportion of patients receiving a LAI in Germany) B21b: Was the patient discharged on a LAI formulation? B21a How was the patient’s antipsychotic treatment changed during his/her stay in hospital? % of patients Switch from one antipsychotic to another 37% Add-on of an antipsychotic to regimen 15% 11% 9% Don't know 82% No Yes 2% 0% 0% Other Don’t know % of patients Change in dosing of existing antipsychotic Antipsychotic treatment prescribed for the first time ever Change in formulation of existing antipsychotic Switch from an antipsychotic from another therapeutic category Switch to an antipsychotic from another therapeutic category Antipsychotic treatment stopped, with no other therapies initiated 15% 17% 11% 0% Source: Patient record forms. Base: Representative sample. Patients who received an antipsychotic treatment change at discharge from hospital (n=46) Source: Patient record forms. Base: Representative sample. Patients who have been hospitalised in last 12 months (n=83) 43 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 44 Interactive Dashboard of all data will be provided This report has selected key points of interest for presentation purposes, but please note that more results can be accessed via the Interactive Dashboard: This will be provided in Excel format early in 2013 If you have any questions regarding the use of the dashboard, please contact Gitte Esmann (GIES) or the InforMed team (ObservationalStudySZ@in formed-insight.com) 45 PRF Profile of patient: Patients who are less adherent are significantly more likely to have drug/alcohol use, and significantly less likely to be in paid employment and living alone B1to B5: demographics Fully adherent Demographics BMI Employment status (paid vs. unpaid) Family status (top 2) Drug/alcohol use Partially adherent Not at all adherent 39% female and 61% male Average age: 40 Age at diagnosis: 27 36% female and 64% male Average age: 38 Age at diagnosis: 27 29% female and 71% male Average age: 37 Age at diagnosis: 29 Mean BMI = 25.3 (overweight) Mean BMI = 25.5 (overweight) Mean BMI = 23.7 (normal) 23% in paid employment 19% in unpaid employment 12% in paid employment 24% in unpaid employment 32% living alone / independently 16% living with partner without children 15% living with parents 54% no use 28% mild use 12% moderate use 4% severe 5% in paid employment 16% in unpaid employment 23% living alone / Independently 19% sheltered accommodation 16% living with parents 32% living with parents 21% living alone / independently 13% living with support from caregiver 26% no use 32% mild use 29% moderate use 6% severe 18% no use 26% mild use 24% moderate use 26% severe Source: Patient record forms. Fully adherent (n=360), partially (n=206), not at all adherent (n=38) 46 PRF Patients who have lower level of adherence are significantly more severe, and have significantly lower levels of insight. They also appear to have a higher number of relapses and rate of hospitalisations B1to B5: disease profile Fully adherent Partially adherent Not at all adherent Timeframes Age at diagnosis: 27 Years in current psychiatrists' care: 3.9 Age at diagnosis: 27 Years in current psychiatrists' care: 4.2 Age at diagnosis: 29 Years in current psychiatrists' care: 3.6 Relapses in last year Number of relapses: 0.4 Number of relapses: 0.7 Number of relapses: 1.4 Normal / borderline ill: 17% Moderate: 73% Severely ill: 10% Normal / borderline ill: 6% Moderate: 78% Severely ill: 16% Normal / borderline ill: 5% Moderate: 68% Severely ill: 26% Insight Full aware 61% Moderately aware: 36% Fully unaware: 3% Full aware 25% Moderately aware: 64% Fully unaware: 11% Full aware: 8% Moderately aware: 55% Fully unaware: 37% Hospitalisations Ever hospitalised: 77% Never hospitalised: 20% Ever hospitalised: 80% Never hospitalised: 15% Ever hospitalised: 87% Never hospitalised: 13% Current severity Source: Patient record forms. Fully adherent (n=360), partially (n=206), not at all adherent (n=38) 47 PRF Prescribing behaviour does not seem to be influenced by level of adherence B22 Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Fully adherent – 61% Atypical LAIs Typical LAIs 36% Typical orals 8% Mean # treatments = 1.26 % on more than 1 treatment = 21% 47% 13% 61% 12% Not at all adherent – 6% 26% 11% Atypical orals aripiprazole Partially adherent – 35% 8% 73% 13% 58% 5% 12% Mean # = 1.36 % on more than 1 = 30% 13% Mean # = 1.37 % on more than 1 = 37% Source: Patient record forms. Fully adherent (n=360), partially (n=206), not at all adherent (n=38) Note: data taken from total sample (not representative sample). Therefore figures are not indicative of market share 48 PRF Patients who have higher level of insight are more significantly more likely to be in paid employment, living independently, and not using drugs/ alcohol vs. patients with lower levels of insight B1to B5: demographics Fully aware (high insight) Demographics BMI Employment status (paid vs. unpaid) 42% female and 58% male Average age: 38 Age at diagnosis: 27 Mean BMI = 25.0 (overweight) 32% in paid employment 21% in unpaid employment Fully unaware 36% female and 64% male Average age: 39 Age at diagnosis: 27 31% female and 69% male Average age: 39 Age at diagnosis: 28 Mean BMI = 25.7 (overweight) Mean BMI = 23.7 (normal) 8% in paid employment 20% in unpaid employment 36% living alone / independently 12% living with parents 22% living alone / independently 19% living with parents 55% no use 31% mild use 12% moderate use 1% severe 31% no use 30% mild use 27% moderate use 7% severe Family status (top 2) Drug/alcohol use Moderately aware Source: Patient record forms. Fully aware (n=276), moderately (n=264), fully unaware (n=49) (low insight) 2% in paid employment 20% in unpaid employment 16% living alone / independently 31% living with parents 31% no use 16% mild use 20% moderate use 22% severe 49 PRF Patients who have higher levels of insight have significantly lower severity, higher levels of adherence, and less hospitalisations. They also appear to have a lower number of relapse each year B1to B5: disease profile Fully aware Moderately aware (high insight) Fully unaware (low insight) Timeframes Age at diagnosis: 27 Years in current psychiatrists' care: 3.9 Age at diagnosis: 27 Years in current psychiatrists' care: 3.9 Age at diagnosis: 28 Years in current psychiatrists' care: 2.8 Relapses in last year Number of relapses: 0.3 Number of relapses: 0.6 Number of relapses: 1.2 Normal / borderline ill: 23% Moderate: 72% Severely ill: 5% Normal / borderline ill: 6% Moderate: 77% Severely ill: 17% Normal / borderline ill: 4% Moderate: 59% Severely ill: 37% Adherence Full adherent: 80% Partially adherent: 19% Non-adherent: 1% Full adherent: 46% Partially adherent: 47% Non-adherent: 16% Full adherent: 24% Partially adherent: 47% Non-adherent: 29% Hospitalisations Ever hospitalised: 73% Never hospitalised: 24% Ever hospitalised: 82% Never hospitalised: 14% Ever hospitalised: 73% Never hospitalised: 14% Current severity Source: Patient record forms. Fully aware (n=276), moderately (n=264), fully unaware (n=49) 50 PRF Patients with lower level of insight are more likely to receive atypical LAIs and less likely to receive atypical orals B22: Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Fully aware – 47% Moderately aware – 45% (high insight) Atypical LAIs Typical LAIs Aripiprazole Typical orals (low insight) 28% 36% 7% Atypical orals 6% Mean # treatments = 1.17 % on more than 1 treatment = 18% 40% 14% 70% 14% Fully unaware – 8% 13% 58% 11% 51% 0% 9% Mean # = 1.26 % on more than 1 = 22% 11% Mean # = 1.12 % on more than 1 = 20% Source: Patient record forms. Fully aware (n=276), moderately (n=264), fully unaware (n=49). Note: data taken from total sample (not representative sample). Therefore figures are not indicative of market share 51 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 52 52 Part C: Overall prescribing, reasons for prescribing and switching - key take away message summary Most commonly prescribed orals are olanzapine and risperidone. Risperdal Consta is the most prescribed LAI. Previous prescribing was higher for the typicals (especially orals). Risperidone and olanzapine are also common previous treatments The mean age of patients in Germany is 38 years old. Patients prescribed aripiprazole are significantly younger than patients on oral treatments The majority of all prescriptions are repeat Treating positive symptoms is the most common reason for prescribing, especially for oral treatments. General attributes is significantly more of an important driver for LAI prescribing Delusions and hallucinations are major reasons for prescribing current treatment. For aripiprazole, lack of interest, social withdrawal and inability to concentrate are significantly more important than for orals Poor adherence with oral therapy is the main reason for prescribing LAIs, though more convenient dosing form is a key driver for paliperidone palmitate Poor tolerability, patient request and poor efficacy/symptom control are the main reasons for switching away from previous treatment. Poor tolerability and poor efficacy are stronger reasons for orals Weight gain and sedation are the main side effects experienced. Over half of patients receiving aripiprazole do not experience any side effects; this is significantly more than patients on orals 53 PRF Current prescribing: Most commonly prescribed orals are quetiapine, olanzapine and risperidone. Risperdal Consta is the most prescribed LAI B22: Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Oral treatments OLANZAPINE 19% RISPERIDONE 12% QUETIAPINE 19% ARIPIPRAZOLE 5% PALIPERIDONE PALMITATE 2% 16% OLANZAPINE PAMOATE 1% AMISULPRIDE ZIPRASIDONE RISPERDAL CONSTA 18% CLOZAPINE PALIPERIDONE LAI treatments 2% 10% OTHER ATYPICAL 3% ASENAPINE OTHER… 1% TYPICALS TYPICALS 5% 9% Mean # treatments = 1.37 % on more than 1 treatment = 31% Note that patients can receive more than one drug, hence percentages add up to more than 100% Source: Patient record form. Representative sample (i.e. minus LAI over-sample) Base: oral prescriptions (n=379), LAIs prescriptions (n=243) Mean # = 1.28 % on more than 1 = 23% Note: this question can be compared to physician’s estimated prescribing (question A2, slide 13) 54 PRF Previous prescribing: Previous prescribing was higher for the typicals (especially orals). Risperidone and olanzapine are also common previous treatments B35 Previous treatments Which antipsychotic treatment(s) were prescribed as part of the patient’s previous treatment regimen? Oral treatments OLANZAPINE 15% RISPERIDONE 14% CLOZAPINE RISPERDAL CONSTA 1% 5% QUETIAPINE PALIPERIDONE PALMITATE 9% ARIPIPRAZOLE 0% 6% OLANZAPINE PAMOATE PALIPERIDONE AMISULPRIDE ZIPRASIDONE LAI treatments 0% 5% 1% OTHER ATYPICAL ASENAPINE 44% have not received any previous treatment 0% OTHER… 1% TYPICALS 23% TYPICALS 9% Note that patients can receive more than one drug, hence percentages add up to more than 100% Source: Patient record form. Representative sample (i.e. minus LAI over-sample) Base: oral prescriptions (n=379), LAIs prescriptions (n=243) 55 PRF The mean age of patients in Germany is 38 years old. Patients prescribed aripiprazole are significantly younger than patients on oral treatments B1: Please provide the patient’s year of birth (note, the patient must be 18 years of age or over): B22: Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Mean age (years) • Aripiprazole patients are significantly younger than patients on oral treatments, at the 1% level 38.1 38.2 Total (rep sample) (n=393) All orals (n=379) 39.7 34.2 All LAIs (n=243) Source: Patient record form. Representative sample (i.e. minus LAI over-sample) Base: All PRFs (n=587) aripiprazole (n=67) 56 PRF The majority of prescriptions are repeat B24 Current treatment details. Treatment status - start, repeat, switch, re-start? Other 5% 7% Switch Repeat Restart (have used the drug within the past 6 months) 5% 7% 9% % of all prescriptions 19% 49% Start (i.e. newly initiated, not used the drug previously) 6% 10% 12% 8% 7% 36% 25% 44% 61% 46% 67% 46% 16% 38% 45% 18% Risperdal consta paliperidone olanzapine (n=107) palmitate (n=55) pamoate (n=22) olanzapine (n=79) Source: Patient record form, prescription level. Base: current oral prescriptions (n=379) 100% 7% 50% 13% 18% 67% 61% 5% 8% 7% 13% 12% 8% 10% 12% clozapine (n=51) quetiapine (n=84) 23% risperidone (n=77) 7% 25% 12% aripiprazole (n=67) paliperidone (n=4) amisulpride (n=42) CAUTION: Low bases (<n=30) asenapine (n=1) 57 PRF Detailed analysis of treatments: LAIs B24 & B36 Drug grids (full text in notes) LAIs Risperdal Consta Mean dose (mg) Current & previous Mean duration of prescribing Previous / current Formulation Current & previous Mean satisfaction (1=very poor, 5 = very good) Current / previous Mean adherence (1=fully adherent, 3=non-adherent) Current / previous 43.2 mg 11.2 / 8.7 months IM depot injection – 99.1% IM acute injection – 0.9% 3.7 / 3.4 1.4 / 1.6 4.2 / 2.0 1.3 / 1.8 3.7 / 1.7 1.4 / 1.3 IM depot injection – 90.5% IM acute injection – 9.5% paliperidone palmitate 99.8 mg 7 / 1.8 months IM depot injection 96.4% IM acute injection – 3.6% IM depot injection – 100% olanzapine pamoate 290.3 mg 0 / 18 months Source: Patient record forms, prescription level. Base: LAI prescriptions IM depot injection 100% 58 PRF Treating positive symptoms is the most common reason for prescribing, especially for oral treatments. General attributes is significantly more of an important driver for LAI prescribing B33 Why did you prescribe (drug X) to the patient? Category totals All treatments - rep sample To treat - positive symptoms To treat - negative symptoms Oral treatments 77% 77% 55% 45% 44% Side-effect profile 47% 46% Patient level attributes 38% 55% 71% 54% To treat - other symptoms General attributes LAI treatments 38% 48% 44% 33% 55% 56% 47% Anticipated positive impact on overall quality of life Anticipated positive impact on overall functioning (cognitive and social) Source: Patient record form, prescription level. Base: oral prescriptions (n=379), LAIs prescriptions (n=243) 59 PRF Delusions and hallucinations are major reasons for prescribing current treatment. For aripiprazole, lack of interest, social withdrawal and inability to concentrate are significantly more important than for all orals B33 Why did you prescribe (drug X) to the patient? • Delusions are significantly stronger reasons for prescribing orals vs. aripiprazole, at the 1% level • Lack of interest, social withdrawal and inability to concentrate are all significantly stronger reasons for prescribing aripiprazole vs. orals, at the 5% level Hallucinations Delusions Thought disorder Changes in behaviour Disorganised speech Lack of interest Social withdrawal Emotional flatness Inability to concentrate Suicidal thoughts 52% 52% 47% 45% 44% 48% 47% 47% 43% 42% 41% 35% 25% 44% 40% 39% 38% 33% 32% 31% 34% 32% 27% 25% 45% 32% 30% 25% 27% 27% 34% 25% 22% 18% 13% 5% 3% Total (rep sample) - (n=468) 13% 14% All orals (n= 518) Source: Patient record form, prescription level. Base: all PRFs (n=587) oral prescriptions (n=518), LAIs prescriptions (n=309) All LAIs (n=309) 4% aripiprazole (n=105) 60 Delusions and hallucinations are the main reasons for prescribing both oral and LAI treatments B33 Why did you prescribe (drug X) to the patient? Orals Top 3 reasons for prescribing All orals (n=379) Delusions – 52%, Hallucinations – 47%, Anticipated positive impact on overall quality of life – 46% All Atypical orals (n=487) Delusions – 53%, Hallucinations – 47%, Anticipated positive impact on quality of life– 47% risperidone (n=112) Delusions – 57%, Anticipated positive impact on overall functioning – 54%, Thought disorder – 54% paliperidone (n=5) Hallucinations – 80%, Lack of interest – 80%, Social withdrawal – 80%, Emotional flatness – 80%, Inability to concentrate – 80% olanzapine (n=103) Delusions – 55%, Hallucinations – 53%, Anticipated positive impact on overall quality of life – 45% aripiprazole (n=105) All typicals (n=96) LAIs Top 3 reasons for prescribing All LAI (n=243) Hallucinations – 48%, Delusions – 47%, Thought disorder – 42% Atypical LAIs (n=224) Thought disorder – 45%, Hallucinations – 44%, Delusions – 44%, Risperdal consta (n=134) Hallucinations – 43%, Thought disorder – 41%, Delusions – 40% paliperidone palmitate (n=67) Delusions – 51%, Anticipated positive impact on overall quality of life – 51%, Hallucinations – 49% olanzapine pamoate (n=23) Thought disorder – 65%, Delusions – 48%, Social withdrawal – 48%, Inability to concentrate – 48% Typical LAIs (n=89) Hallucinations – 57%, Delusions – 55%, Anticipated positive impact on overall quality of life – 38% Anticipated positive impact on overall functioning – 54%, Anticipated positive impact on overall quality of life – 52%, Hallucinations – 45% Delusions – 44%, Hallucinations – 43%, Anticipated positive impact on overall functioning (cognitive and social) – 43% Source: Patient record form, prescription level. Base: oral prescriptions (n=518), LAIs prescriptions (n=309) CAUTION: Low bases (<n=30) 61 PRF Poor adherence with oral therapy is the main reason for prescribing LAIs, though more convenient dosing form is a key driver for paliperidone palmitate, significantly higher than for typical LAIs B26 Why was the patient prescribed a LAI formulation treatment? • A more convenient dosing form is a significantly stronger reason for prescribing palperidone palmitate vs. typical LAIs, at the 5% level Poor adherence with oral therapy Poor treatment response / residual symptoms Patient request Family request Side effects/tolerability of previous treatment Anticipated side effects/tolerability of prescribed treatment More convenient dosing form Other, please specify Don’t know 7% 33% 44% 36% % of patients 34% 11% 12% 10% 11% 14% 10% 29% 21% 15% 8% 11% 9% 20% 9% 30% 30% 35% 18% 11% 60% 58% 61% All LAI (n=242) Atypical LAIs (n=184) Risperdal consta (n=107) Source: Patient record forms. Base: currently receiving LAI (n=242) 27% 18% 14% 14% 25% 23% 8% 7% 8% 41% 25% 27% 24% 77% 65% 45% paliperidone palmitate olanzapine pamoate (n=55) (n=22) Typical LAIs (n=60) CAUTION: Low bases (<n=30) 62 PRF Poor tolerability, patient request and poor efficacy/symptom control are the main reasons for switching away from previous treatment. Poor tolerability and poor efficacy are more significant drivers for orals B37 Why was (drug X) switched or discontinued from the patient’s previous regimen? • Poor tolerability is a significantly stronger reason for switching/ discontinuing orals vs. LAIs, at the 1% level • Poor efficacy is a significantly stronger reason for switching/ discontinuing orals vs. both LAIs and aripiprazole, at the 5% level Poor efficacy/symptom control Patient request Availability of a new treatment option Mode of administration (i.e. change to different formulation) Don’t know % of treatments 8% 4% 5% 5% 41% Poor tolerability/complaints about side effect(s) Family request Inconvenience / not easy to use Other, please specify 9% 6% 3% 5% 5% 27% 38% 12% 12% 9% 3% 5% 5% 45% 33% 56% 53% 30% 55% 38% 42% 34% 28% Total (rep sample) - (n=264) All orals (n=255) All LAIs (n=202) aripiprazole (n=40) Source: Patient record forms Base: all switched / discontinued treatments (n=408) 63 Poor tolerability, patient request and poor efficacy/symptom control are the main reasons for switching away from previous treatment B37 Why was (drug X) switched or discontinued from the patient’s previous regimen? Orals Top 3 reasons for switching All orals (n=255) Poor tolerability/complaints about side effects – 56%, Poor efficacy/symptom control – 42%, Patient request – 38% All Atypical orals (n=244) Poor tolerability/complaints about side effects – 58%, Poor efficacy/symptom control – 42%, Patient request – 39% risperidone (n=60) Poor tolerability/complaints about side effects – 53%, Patient request – 43%, Poor efficacy/symptom control – 38%, paliperidone (n=3) Poor tolerability/complaints about side effects – 67%, Patient request – 67%, Poor efficacy/symptom control – 33%, Family request – 33% olanzapine (n=39) Poor efficacy/symptom control – 59%,Poor tolerability/complaints about side effects – 56%, Patient request – 38% aripiprazole (n=40) All typicals (n=33) Poor tolerability/complaints about side effects – 55%, Patient request – 45%, Poor efficacy/symptom control – 28%, Patient request – 51%, Poor efficacy/symptom control – 42%, Poor tolerability/complaints about side effects – 36% Source: Patient record forms , prescription level. Base: all switched / discontinued treatments LAIs Top 3 reasons for switching All LAI (n=202) Poor efficacy/symptom control – 34%, Patient request – 33%, Poor tolerability/complaints about side effects – 30% Atypical LAIs (n=164) Patient request – 35%,, Mode of administration – 28%, Poor tolerability/complaints about side effects – 27% Risperdal consta (n=96) Patient request – 33%, Poor efficacy/symptom control – 29%, Poor tolerability/complaints about side effects – 29% paliperidone palmitate (n=50) Patient request – 38%, Poor tolerability/complaints about side effects – 32%, Mode of administration – 28% olanzapine pamoate (n=18) Poor efficacy/symptom control – 50%, Patient request – 39%, Mode of administration – 33% Typical LAIs (n=40) Poor efficacy/symptom control – 68%, Poor tolerability/complaints about side effects – 40%, Mode of administration – 28% CAUTION: Low bases (<n=30) 64 Main efficacy related reasons for switching from previous treatment are lack of control of delusions, hallucinations and thought disorder B37b Which symptom(s) was [drug X] poor in controlling? –symptoms Orals Top 3 uncontrolled symptoms LAIs Top 3 uncontrolled symptoms All orals (n=106) Delusions – 63%, Thought disorder– 58%, Hallucinations – 54% All LAI (n=69) Delusions – 68%, Thought disorder– 65%, Hallucinations – 58% All Atypical orals (n=102) Delusions – 62%, Thought disorder– 59%, Hallucinations – 53% Atypical LAIs (n=43) Delusions – 65%, Thought disorder– 60%, Hallucinations – 58% risperidone (n=23) Delusions – 65%, Hallucinations – 61%,Thought disorder– 43%, Risperdal consta (n=28) Delusions – 64%, Hallucinations – 57%,Thought disorder– 54%, paliperidone (n=1) Delusions – (100%) paliperidone palmitate (n=6) Delusions – 67%, Thought disorder– 67%, Hallucinations – 67% olanzapine (n=23) Hallucinations – 65%, Delusions – 61%, Inability to concentrate - 39%, olanzapine pamoate (n=9) Delusions – 78%, Thought disorder– 67%, Hallucinations – 56% aripiprazole (n=11) Delusions – 64%, Thought disorder– 64%, Hallucinations – 64% , Lack of interest – 64% Typical LAIs (n=27) Delusions – 74%, Thought disorder– 74%, Hallucinations – 59% All typicals (n=14) Delusions – 93%, Thought disorder– 64%, Hallucinations – 64% , Changes in behaviour – 64% Source: Patient record forms , prescription level.. Base: previous treatments that were switched due to poor efficacy / symptom control CAUTION: Low bases (<n=30) 65 PRF Weight gain and sedation are the main side effects experienced. Over half of patients receiving aripiprazole do not experience any side effects; this is significantly more than patients on orals B23: Please indicate which side effects the patient has experienced as a result of taking [drug X], if any? • Significantly more patients on aripiprazole experience no side effects than those on orals, at the 1% level • Patients on aripiprazole experience significantly less weight gain and sedation, but significantly more akathisia than oral patients, at the 5% level • Patients on LAIs experience significantly more extrapyramidal sside effects and akathisia than oral patients, at the 5% level No side effects Weight gain Sedation Metabolic side effects (excluding weight gain) Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia) 60% Akathisia Prolactin-related side effects (including sexual dysfunction) Injection site reactions 44% % of patients 43% 28% 26% 43% 27%26% 26% 21% 17% 9% 8% 9% 7% 7% Total (rep sample) - (n=468) 0% All orals (n=518) Source: Patient record form, prescription level. Base: oral prescriptions (n=518), LAIs prescriptions (n=311) 12% 10% 6% 6% 11% 9% 7% 6% 7% 7% 1% 2% 18% 16% 2% 4% 1% All LAIs (n=311) 0% 1% aripiprazole (n=105) 66 Weight gain and sedation are the main side effects experienced B23: Please indicate which side effects the patient has experienced as a result of taking [drug X], if any? Orals Top 3 side effects % No side effects LAIs Top 3 side effects All orals (n=518) Weight gain– 27%, Sedation– 26%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia)– 9% 44% All LAI (n=311) Weight gain– 26%, Sedation – 21%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 17% 43% All Atypical orals (n=487) Weight gain– 28%, Sedation– 26%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 7% 44% Atypical LAIs (n=224) Weight gain– 22%, Sedation – 18%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 9% 53% risperidone (n=112) Sedation – 22%, Weight gain – 20%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 14% 44% Risperdal consta (n=134) 50% Sedation – 40%, Prolactin-related side effects (including sexual dysfunction) – 20% Weight gain – 21%, Sedation – 19%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 13% 40% paliperidone palmitate (n=67) Weight gain – 18%, Sedation – 12%, Akathisia – 9% 66% olanzapine pamoate (n=23) Weight gain – 39%, Sedation – 35%, Metabolic side effects (excluding weight gain) – 26% 35% Typical LAIs (n=91) Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 35%, Weight gain– 34%, Sedation – 27%, 20% paliperidone (n=5) olanzapine (n=103) aripiprazole (n=105) All typicals (n=91) Weight gain – 36%, Sedation – 29%, Metabolic side effects (excluding weight gain) – 13% Weight gain – 18%, Sedation – 16%, Akathisia – 12% Sedation – 25%, Weight gain – 19%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia – 18% Source: Patient record form, prescription level Base: oral prescriptions (n=518), LAIs prescriptions (n=311) % No side effects 39% 60% 39% CAUTION: Low bases (<n=30) 67 Report contents Physician insights • Physician profiling • Based on physician’s perception: insight and adherence Patient insights (based on PRFs) • Patient and disease profiling • Patient journey • Patient analysis by level of adherence and insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 68 68 PRF Around 2/3 of patients on Risperdal Consta were previously on the oral formulation of the same drug. Almost half of patients receiving paliperidone palmitate were switched from an oral version of a different drug B25 What treatment was the patient (currently on LAI), receiving before their LAI medication? Don’t know No previous treatment Oral formulation of a different drug Oral formulation of the same drug 11% 9% % of patients 12% Another LAIs treatment 8% 9% 5% 9% 7% 13% 11% 8% 12% 18% 5% 9% 5% 20% 18% 10% 22% 17% 22% 22% 44% 64% 64% 46% Risperidone (n=19) Olanzapine (n=8) 51% 32% 20% All LAIs (n=242) Atypical LAIs (n=184) Risperdal Consta (n=107) Source: Patient record forms. Base: currently receiving LAI (n=242) Paliperidone palmitate (n=55) Olanzapine Typical LAIs (n=60) Pamoate (n=22) CAUTION: Low bases (<n=30) 69 PRF For almost half of all patients, satisfaction with adherence to oral therapy is the main reason why patients are not on an LAI. Patient unwillingness is also stated as the reason for over 1/3 of patients B28 Why is the patient not currently on a LAI formulation treatment? 45% Satisfactory adherence with oral therapy 37% Patient unwillingness 35% % of patients Satisfactory treatment response to oral therapy 17% I never offered a depot formulation to the patient 14% The right drug is not available as a depot formulation Family unwillingness 4% Cost/reimbursement 4% Practical reason e.g. not being able to attend hospital for injection 3% Patient current condition/symptoms 3% Unsure how to approach injections with the patient 3% Formulary restrictions Low experience / familiarity with depot treatment 1% 0% Source: Patient record forms. Base: not currently receiving LAI (n=327) 70 InforMed Insight are members of the following market research professional bodies and abide by their codes of practice: 71