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H. LUNDBECK A/S Schizophrenia Treatment Landscape Study Final country report - UK January 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 Nervenärztes 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) UK 104 PRFs (n) Representative sample PRFs (n) LAI oversample PRFs (n) 613 411 202 2 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 UK 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 348 (87%) 26 (7%) 27 (7%) 22 (6%) Country UK The ratio of oral:LAI antipsychotic prescriptions in the representative sample is 7:1 for all countries and 19:1 for UK LAI oversample* Oral (n) – Atypicals Oral (n) - Typicals 19 (9%) 10 (5%) LAI (n) – Atypicals LAI (n) - Typicals 113 (56%) 90 (45%) 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 in Germany) • Actively managing and treating patients with schizophrenia (decision maker) • Treating 10 or more schizophrenia patients per month • Majority of physicians LAI initiators • Qualified for 3-30 years • Representative mix of practice settings and regions within each market 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 • Seen by physician within the last 24 months (from date of interview) • Over-sample on patients receiving LAI treatments: • 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 Prescription counts in the treatment landscape study are an effective predictor of IMS values; the data generally correlates well with IMS values 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: in most EU countries, B22 tends to slightly underestimate IMS values (coefficient > 1) 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) Part B: Patient record form (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 - UK SETTING Around half of the physicians’ time is spent in a community care setting and half in a hospital setting Over half of all patients are stable with residual symptoms, but this reduces to just over 40% for patients on aripiprazole; around half of all patients have not had a relapse in the last 12 months MARKET SHARE In the UK, 91% of patients diagnosed with schizophrenia receive an oral therapy. Prescribing of aripiprazole is similar to the Global picture. All UK psychiatrists can initiate LAI medications; 12% of patients receive an LAI. Monotherapy is higher than other markets; only 9% of patients receive more than 1 treatment SWITCHING The main reason for switching away from previous treatment is poor tolerability and side effects, particularly for aripiprazole. Mode of administration is a key driver for LAIs Low adherence to oral therapy is a major reason why physicians will switch to an LAI INSIGHT A patient’s level of insight has a major impact on prescribing in over three-quarters of physicians, and the vast majority of physicians feel that they are more likely to prescribe an LAI to a patient with a low level of insight Around half of patients are moderately aware of their condition. Patients on LAI treatments have lower level of awareness than patients receiving oral treatments. Level of insight is similar to physicians’ estimates (slightly fewer are fully unaware than estimated) 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 insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 9 Section summary Three quarters of physicians have been practising for over 10 years and nearly half of their caseload is schizophrenia patients The majority of physicians’ time is spent working in Community Care (PCT) or hospital setting (mainly acute) Side effects are the major reasons why patients do not, or only partially adhere to their treatment, but a low level of insight into their disease is also a major driver for non-adherence The most common step taken to improve patient adherence is switching to LAI treatment, as this is perceived to be most effective by 80% of physicians Almost 60% of physicians felt they understood the term anosognosia, of whom the majority gave an accurate description. However 43% were not sure what this term means (high relative to other markets) A patient’s level of insight has a major impact on prescribing in over threequarters of physicians, and the vast majority of physicians feel that they are more likely to prescribe an LAI to a patient with a low level of insight 10 Physician profiling Physicians have been practising for 17 years on average. Just under half of their patients are schizophrenia patients. All physicians initiate LAI treatment in patients with schizophrenia 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 LAI treatment for patients with schizophrenia? Years qualified (S2) (n = 104) LAI treatment initiation (S5) 100% 0% % of physicians 100% 16.9 years in practice Source: Physician profiling. Base: all (n=104) Non-LAI initiator LAI initiator 0% SZ patients represent 46% of a physician’s total caseload 11 Physician profiling Physician profiling – the majority of physicians’ time is spent working in Community Care (PCT) 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? Supply: Hospital Pharmacy Relapse Private practice 2% Day Hospital Intermediary 2% 26% Supply: Hospital Pharmacy Community care (PCT) 47% Supply: retail Pharmacy % of physicians Hospital Acute care 32% Chronic care 8% Mixed Mostly-outpatients 52% Supply: retail Pharmacy Mostly inpatients Relapse Private Hospital 1% % 22% Supply: Retail Pharmacy Source: Physician profiling. Base: all (n=104) 12 Physician profiling Physician’s estimate that olanzapine, risperidone, and quetiapine are the most widely prescribed orals, and Risperdal Consta is the most widely 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 23% OLANZAPINE RISPERIDONE CLOZAPINE ARIPIPRAZOLE ASENAPINE OTHER ATYPICAL RISPERIDONE CONSTA 20% PALIPERIDONE PALMITATE 41% 12% 12% OLANZAPINE PAMOATE 2% AMISULPRIDE ZIPRASIDONE 20% 11% QUETIAPINE PALIPERIDONE LAI treatments 3% 5% 0% OTHER ATYPICAL 1% 1% 2% Note that patients can receive more than one drug, hence percentages add up to more than 100% Source: Physician profiling. Base: all (n=104) Note: this question can be compared to actual prescribing collected in the patient record forms (question B22, slide 54) 13 Physician profiling Control of metabolic side effects and negative symptoms are the two main unmet needs as perceived by UK 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 metabolic side effects (including weight gain) 75% Control of negative symptoms 73% Relapse prevention/maintaining treatment response 54% Patient adherence 53% Level of functioning (e.g. in social situations, being able to live… 44% Overall quality of life 43% Control of positive symptoms 40% Patient satisfaction with treatment 40% Control of extrapyramidal side effects (including tardive dyskinesia,… 39% Early treatment response 36% Control of prolactin-related side effects (including sexual dysfunction) 30% Availability of atypical depots 29% Control of akathisia 21% Control of sedation 19% Control of aggressive symptoms (e.g. hostility and agitation) 18% Cost/reimbursement 13% Mode of administration 13% Requirement for blood monitoring and/or liver function/liver status 12% Frequency of dosing Transition from oral to depot medication Source: Physician profiling. Base: all (n=104) 8% 3% 14 Physician profiling Low patient adherence is perceived to be due primarily to the presence of side effects, but lack of awareness of the disease (insight) is also a major factor A6 What do you think are the main reasons for patient’s not adhering or only partially adhering to their treatment regimen? 87% Presence of side effects Not aware of illness (no insight into disease) Aware of illness/symptoms, but does not recognise the need… Belief that they are cured (lack of insight) Forgetting to take their medication Concerns about potential side effects 79% 55% 51% 49% 40% 30% Drug/alcohol abuse Aware of illness/symptoms, but unwilling to accept that they… Complicated medication regimens Other disease symptom(s) affecting ability to take… 29% 20% 16% 15% Lack of family support Cognitive impairment (not related to their schizophrenia e.g.… Cost of medication Other, please specify 12% 0% 1% Sells the drugs % of physicians Source: Physician profiling. Base: all (n=104) 15 Physician profiling The most common and effective step taken to improve patient adherence is perceived to be switching to LAI treatment 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 Switch to LAI injection 80% Switch to other oral antipsychotic with fewer side effects Switch to other oral antipsychotic with perceived improved effect 12% 2% 58% 54% 26% 0% 57% 38% 1% 4% 55% 41% 1% 1% 45% 45% Adjust the dose Source: Physician profiling. Base: all (n=104) 45% 51% Discuss reasons for non-adherence with patient Other (n=17) 42% 54% Re-engage caregiver/support network Ask patient to record drug taking Discuss risks of non-compliance Psychotherapy Dosette box / blister pack 19% 57% Simplify medication routine Initiate/add cognitive behavioural therapy (CBT) Do not personally use 19% 35% 56% % of physicians 16 Physician profiling Almost 60% of physicians felt they understood the term anosognosia, of whom the majority gave an accurate description. However 43% were not sure what this term means A8 Are you familiar with the term ‘anosognosia’? % of physicians Yes, to me this means… 58% 36% 7% Yes, I have heard of it but not sure what it means No, not at all Yes, to me this means… (coded responses) 81% 10% Lack of awareness of/insight into condition/disability Denial of illness 5% 5% 3% Unable to recognise faces Unable to recognise objects Lack of awareness of part of body Source: Physician profiling. Base: all (n=104); physicians who gave a definition of anosognosia (n=60) 17 Physician profiling Perceived knowledge of poor insight A8: Are you familiar with the term ‘anosognosia’? Yes, to me this means… (verbatim responses) “Denial that one is suffering from a disorder” (Psychiatrist, UK) “An impaired awareness of illness” (Psychiatrist, UK) “Inability to recognise the fact of having an illness/ impairment” (Psychiatrist, UK) “Unawareness of ones disease” (Psychiatrist, UK) “Lack of awareness about illness” (Psychiatrist, UK) Source: Physician profiling. Base: physicians who gave a definition of anosognosia (n=60) 18 Physician profiling Physicians estimate that over 60% of patients are moderately aware, or fully unaware of their disease. Physicians believe that insight in the majority of these patients can be improved 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 39% 24% % of physicians 37% Fully unaware Yes, insight can improve 65% Yes, insight can improve, but only to some extent No, insight cannot improve 55% 36% 34% 1% Moderately aware Source: Physician profiling. Base: all (n=104) 9% Fully unaware 19 Physician profiling Over three-quarters of physicians state that a patient’s level of insight has a major impact on prescribing. 85% of these are more likely to prescribe an LAI to a patient with a low level of insight 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 77% Major impact ... a low level of insight 22% 1% 85% Some impact No impact at all % of physicians 13% ... 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=104); right chart – physicians whose treatment decision is influenced by level of insight (n=103) 20 Physician profiling Majority of physicians consider non-adherence to treatment to be the main consequence of patients’ poor insight A12 What do you think are the main consequences of a patient’s poor/low level of insight into their schizophrenia? 82% Non-adherence to treatment 45% Worsening of symptoms Lower level of functioning 37% Creates mistrust between doctor-patient, making it more difficult to engage the patient in treatment 37% 34% Increased workload for treatment team 32% Lower quality of life (QoL) 16% Increased need for caregiver support 10% Lower health-related quality of life (HRQoL) Other 1% Increases the chance of admission to hospital % of physicians Source: Physician profiling. Base: all whose treatment decision is influenced by level of insight (n=104) 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 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=3887) (n=3887)2 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 Section summary Over half of all patients are stable with residual symptoms, but this reduces to just over 40% for patients on aripiprazole. Slightly more patients on aripiprazole are acute Around half of patients on all treatment options have not had a relapse in the last 12 months. Patients on aripiprazole have fared slightly better with nearly 60% having no relapse (although this is not statistically significant). Furthermore these patients have significantly higher levels of support from HCPs than patients on orals. They also score significantly better in terms of activities of daily living Only around 20% of patients are expected to become non-adherent within the next 3-6 months Around half of patients are moderately aware of their condition Patients on LAI treatments have lower level of awareness than patients receiving oral treatments. Level of insight is similar to physicians’ estimates (slightly fewer are fully unaware than estimated) 24 PRF Patient profile: male bias in the sample. Almost two-thirds of patients not in employment – higher in patients receiving LAIs B1to B5: demographics All patients Oral prescriptions (total sample) 37% female and 63% male Average age: 40 Age at diagnosis: 28 40% female and 60% male Average age: 39 Age at diagnosis: 28 Mean BMI = 24.94 (normal) Mean BMI = 24.81 (normal) LAI prescriptions 34% female and 66% male Average age: 41 Age at diagnosis: 28 Demographics Mean BMI = 25.32 (normal) BMI Employment status (paid vs. unpaid) Family status (top 2) Drug/alcohol use 9%: in paid employment 12% in unpaid employment 9%: in paid employment 12% in unpaid employment 42% living alone / independently 7% living with partner and children 39% living alone / independently 7% living with partner and children 25% mild use 22% moderate use 7% severe 25% mild use 21% moderate use 6% severe Source: Patient record forms. Base: all (n=613) 7%: in paid employment 10% in unpaid employment 45% living alone / Independently 6% living with partner and children 23% mild use 24% moderate use 10% severe 25 PRF Over half of the most recent consultations were scheduled or routine follow-ups. Over half of patients had their treatment 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 (55%) Treatment repeat (54%) Orals 54%: LAIs 57% Orals 54%: LAIs 61% Acute episode /relapse (30%) Treatment change (19%) Orals 32%: LAIs 31% Orals 22%: LAIs 23% Diagnosis (7%) Treatment initiation (11%) Orals 6%: LAIs 3% Orals 10%: LAIs 4% Side effects(7%) Treatment restart (11%) Orals 6%: LAIs 4% Orals 11%: LAIs 9% Referral (5%) Stop treatment (0%) Orals 4%: LAIs 3% Orals 0%: LAIs 0% Reason Action Source: Patient record forms. Base: All patients – rep sample (n=411) 26 PRF Over half of all patients are stable with residual symptoms, but this reduces to just over 40% for patients on aripiprazole (not statistically significant) B12a/b: Current status Please indicate the current status of the patient’s schizophrenia using the following options: Acute Stable with residual symptoms 55% Stable without residual symptoms Other 54% 53% % of patients 42% 31% 22% 24% 22% 1% All patients - rep sample (n=411) 25% 24% 22% 20% 1% All orals (n=394) 2% All LAIs (n=250) Source: Patient record forms. Base: All patients – rep sample (n=411). aripiprazole prescriptions (n=59) 2% aripiprazole (n=59) 27 PRF The overall severity of the disease has improved for all patients since their first consultation, with no differences between the treatment options B11: How would you rate the severity of the patient’s schizophrenia? Please answer on a scale of 1-7. 4.3 4.3 4.4 4.2 Mean score Extremely mentally ill (7) 3.2 3.2 3.2 3.2 All patients - rep sample (n=411) All orals (n=394) All LAIs (n=250) aripiprazole (n=59) Normal, not at all mentally ill (1) At first consultation Current severity Source: Patient record forms. All patients – rep sample (n=411). aripiprazole prescriptions (n=59) 28 PRF Around half of patients have not had a relapse in the last 12 months. Patients on aripiprazole have fared slightly better with nearly 60% having no relapse (not statistically significant) B8b: How many psychotic relapses has the patient experienced in the past 12 months? 0.7 0.7 0.8 0.6 13% 14% 15% 15% 37% 37% 36% 28% % of patients Mean # relapses 6 to 10 2 to 5 1 0 50% 49% 48% All patients - rep sample (n=411) All orals (n=394) All LAIs (n=250) Source: Patient record forms. All patients – rep sample (n=411). aripiprazole prescriptions (n=59) 57% aripiprazole (n=59) 29 PRF Patients are perceived to have a fairly good relationship with physicians and support from HCPs. Patients on LAIs score significantly lower than those on orals for all attributes. Patients on aripiprazole have significantly higher levels of support from HCPs than patients on orals B16a Patient circumstances: Please rate the patient’s situation in relation to the following attributes: • LAIs scored significantly higher than orals on all attributes at the 5% level • Support from HCPs is significantly higher for aripiprazole (4.0) than orals (3.8) at the 5% level Very high / very good (5) 4.0 3.8 3.8 3.5 4.0 3.7 3.8 3.6 3.4 3.5 3.1 Mean score 3.8 3.7 3.6 3.5 3.7 3.2 3.0 3.0 3.4 3.3 3.3 3.0 2.8 Very low / very poor(1) Relationship with physician Support from HCPs All patients - rep sample (n=411) Support from family / friends Socio-economic Current treatment Previous treatment factors (e.g. response response financial situation) All orals (n=394) All LAIs (n=250) Source: Patient record forms. Base: total (n=411) versus aripiprazole prescriptions (n=59) aripiprazole (n=59) 30 PRF On average, a patient’s schizophrenia is perceived to have some impact on all quality of life measures. Patients on aripiprazole fare better on activities of daily living than patients on orals B14 Quality of life: How much impact does the patient’s schizophrenia have on the patient’s…? • A patient’s schizophrenia has significantly more impact on activities of daily living if they are on orals vs. on aripiprazole, at the 5% level Profound impact (5) 3.6 3.6 3.7 3.3 3.3 3.3 3.3 3.6 3.6 3.7 3.5 3.7 3.7 3.8 3.6 Social relationships Ability to work Mean score 3.0 No impact (1) Overall quality of life Activities of daily living (e.g. household chores, shopping) All patients - rep sample (n=411) All orals (n=394) All LAIs (n=250) Source: Patient record forms. Base: total (n=411) versus aripiprazole prescriptions (n=59) aripiprazole (n=59) 31 PRF Only ~20% of patients are expected to become nonadherent within the next 3-6 months 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? 10% 5% 9% 11% 11% 10% 10% 21% 21% 18% 13% 12% 13% 11% Don’t know 7% 8% 7% Yes, I anticipate the patient to become non-adherent within the next 6 months 14% 68% 70% 65% 69% 73% No, I don’t have any reason to anticipate non-adherence in the near future 43% Total patients Atypical orals (rep sample) (n=275) (n=317) Typical orals (n=28) Yes, I anticipate the patient to become non-adherent within the next 3 months aripiprazole (n=40) Atypical LAIs (n=112) Typical LAIs (n=83) Source: Patient record forms. Base: all patients that are currently stable with/without residual symptoms (n=317) 32 PRF Positive and negative symptoms are more commonly experienced than ‘other’ symptoms. >80% of patients on typical orals experience positive symptoms. More patients on aripiprazole experience negative vs. positive symptoms B29: Current symptoms Please indicate which symptoms the patient currently experiences as part of their schizophrenia Positive symptoms Mean no. of symptoms 1.4 1.2 1.6 1.3 Negative symptoms 1.8 1.3 1.2 1.2 Other symptoms 2.0 1.3 1.7 1.2 83% 72% 68% 68% 67% % of patients 64% 67% 68% 74% 71% 69% 63% 63% 61% 55% 49% Total (rep sample) (n=411) 51% 48% Atypical orals (n=368) Typical orals (n=36) aripiprazole (n=59) Source: Patient record forms. Base: total (n=411) versus aripiprazole prescriptions (n=59) Atypical LAIs (n=141) Typical LAIs (n=112) 33 PRF Only 15% of patients are reported to be fully unaware of their condition. Patients on LAIs have significantly lower levels of awareness than patients on orals. Level of insight is similar to physicians’ estimates (slightly fewer are fully unaware than estimated) B15: Is your patient aware that he/she has schizophrenia? Note: this can be compared to the physician perception question (A10) • Patients on LAI treatments have significantly lower levels of awareness than patients on oral treatments, at the 1% level Mean score 2.2 2.2 2.1 15% 15% 20% 2.5 12% % of patients Fully unaware 47% 51% 46% Moderately aware 51% Fully aware 38% 38% Total (rep sample) n=411 All orals (n=394) 29% All LAIs (n=250) 37% aripiprazole (n=59) Source: Patient record forms. Base: total (n=411) versus aripiprazole prescriptions (n=59) 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 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 Section summary Hospital psychiatrists tend to be the key HCPs for the consultation, diagnosis, treatment and the management of the patients across all treatment options Psychiatric nurses are not involved at all in the UK (less than 1%) Duration between symptoms and consultation tends to be much longer than time between first consultation and diagnosis, and diagnosis to treatment (89 weeks vs. 52 weeks vs. 46 weeks) Around 1/3 of patients have been hospitalised within the last 12 months. Patients have been hospitalised significantly more on atypical LAIs, although approximately half of the hospitalisations were >12 months ago The largest proportion of patients currently hospitalised are those on typical orals – this is significantly more than those on aripiprazole or LAIs During hospital stays, over half of patients are switched from one antipsychotic to another. 20% of patients were discharged on an LAI (compared to 12% overall level of LAI prescribing) 37 PRF Hospital psychiatrists tend to be responsible for seeing the patients first, diagnosis and treatment initiation. Similar for orals and LAIs B10b: And which of the following healthcare professional(s) are/were responsible for each of the following? First saw / Diagnosed / Initiated treatment Oral prescriptions LAI prescriptions Atypical Atypical First saw 18% Diagnosed 26% Initiated tx 27% 15% 37% 0% 50% 0% First saw 20% 17% 51% 15% Diagnosed Initiated tx 10% Diagnosed 19% 1% Initiated tx 26% 46% 57% 0% 17% 11% 53% 11% Typical Typical First saw 16% 8% 14% 25% 22% 44% 0% 0% Yourself First saw 6% 14% 25% 56% 58% GP 17% Diagnosed 12%0% 17% Initiated tx 13%0% Other Psychiatrist, Hospital 41% 55% 59% 26% 21% 17% Other Psychiatrist, Office “Yourself” indicates that management is by the person completing the survey. Refer to slide 12 for physician's setting Source: Patient record forms. Base: oral prescriptions (n=394); LAI prescriptions (n=250) 38 PRF Overall, patients tend to be managed in acute hospital setting or outpatient clinic. Fewer patients on atypical LAIs are managed in an outpatient clinic compared to atypical 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) % of patients • Significantly fewer patients on atypical LAIs are managed in an out-patient clinic compared to atypical orals, at the 1% level 9% 10% 3% 2% 2% 2% 40% 8% 6% 3% 41% 41% 14% 3% 2% 14% 2% 44% 3% 29% 17% Don't know / not applicable 1% 5% Other, please specify 37% Judicial/forensic setting (prison) Out-patient clinic (CMP) 42% 42% Total (rep Atypical orals sample) (n=411) (n=368) 36% 37% Typical orals (n=36) aripiprazole (n=59) Source: Patient record forms. Base: all rep sample (n=411) 43% Atypical LAIs (n=141) Hospital, acute care 37% Typical LAIs (n=112) 39 PRF One third to a half of patients tend to be managed by hospital psychiatrists. Psychiatric nurses are not involved at all in the UK (less than 1%) B10b: Please indicate which of the following Healthcare professionals are responsible for current management of the patients Yourself Other psychiatrist, hospital Neurologist Geriatrician Paediatrician / adolescent specialist Don’t know / not applicable % of patients 19% 36% GP_Primary Care Physician Other psychiatrist, office Clinical psychologist Psychiatric nurse Other 20% 25% 37% 17% 19% 32% 44% 16% 15% 26% 46% 41% 17% 10% 14% 18% 18% 8% Total (rep sample) (n=411) Atypical orals (n=368) Typical orals (n=36) 14% 17% 16% 6% aripiprazole (n=59) Atypical LAIs (n=141) Typical LAIs (n=112) “Yourself” indicates that management is by the person completing the survey. Refer to slide 12 for physician's setting Source: Patient record forms. Base: all rep sample (n=411) 40 PRF Duration between symptoms and consultation is much longer than time from first consultation to diagnosis, and diagnosis to treatment (89 wks vs. 52 wks vs. 46 wks) 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? 94 89 85 Time (weeks) 74 52 46 49 46 39 43 13 6 Total (rep sample) Oral treatments aripiprazole (n=59) LAI treatments (n=411) (n=394) (n=250) Symptoms --> consultation First consultation --> diagnosis Diagnosis --> treatment Source: Patient record forms. Base: all rep sample (n=411) 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. Patients have been hospitalised significantly more on atypical LAIs than atypical orals, although approx. half of the hospitalisations were >12 months ago. Significantly more patients on typical orals are currently hospitalised than on aripiprazole and LAIs B17: Has the patient ever been hospitalised for their schizophrenia? B18: How many times has the patient been hospitalised for their schizophrenia in the last 12 months? B19: What was the duration of the most recent schizophrenia-related hospital stay? Mean number of hospitalisations in last year 1.4 1.4 1.5 1.3 1.3 1.5 4% 4% 3% 3% 4% 9% 2% 9% 21% 20% % of patients 14% 22% 47% 36% 40% Don't know 55% 41% 44% No 11% 17% Yes, more than 12 months ago 23% 17% 14% 18% 17% 17% 14% 19% Total (rep sample) (n=411) Atypical orals (n=368) Atypical LAIs (n=141) Typical LAIs (n=112) Typical aripiprazole orals (n=36) (n=59) Yes, within the last 12 months Yes, currently hospitalised 36% 18% When hospitalised: • Significantly more atypical LAI patients have been hospitalised than atypical orals, at the 5% level • Significantly more patients on typical orals are currently hospitalised than on aripiprazole and LAIs, at the 1% level Source: Patient record forms. Base: all (n=411); yellow box - patient record forms for those who have been hospitalised (n=306) Orals (n=394) versus aripiprazole (n=59) versus LAIs (n=250) 42 PRF Over half of patients were switched from one antipsychotic treatment to another during a hospital stay. 20% of patients were discharged on an LAI (compared to 12% overall level of LAI prescribing) B21a How was the patient’s antipsychotic treatment changed during his/her stay in hospital? B21b: Was the patient discharged on a LAI formulation? % of patients Antipsychotic treatment prescribed for the first time ever 22% 59% Switch from one antipsychotic to another Switch from an antipsychotic toanother therapeutic category Add-on of an antipsychotic to regimen Antipsychotic treatment stopped, with no other therapies initiated Change in dosing of existing antipsychotic Change in formulation of existing antipsychotic 5% 0% 2% % of patients Switch to an antipsychotic from another theraputic category Don't know 80% No Yes 0% 7% 2% 20% Other Don’t know 2% 0% Source: Patient record forms. Base: Representative sample. Patients who received an antipsychotic treatment change at discharge from hospital (n=41) Source: Patient record forms. Base: Representative sample. Patients who are currently hospitalised / have been hospitalised in last 12 months (n=71) 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 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 Patients who have lower level of adherence are more likely to be female and be currently in employment. They also seem to have lower use of drugs / alcohol B1to B5: demographics Fully adherent Partially adherent Not at all adherent 37% female and 62% male Average age: 40 Age at diagnosis: 28 36% female and 64% male Average age: 41 Age at diagnosis: 28 53% female and 47% male Average age: 34 Age at diagnosis: 28 Mean BMI = 25.0 (overweight) Mean BMI = 24.9 (normal) Mean BMI = 23.7 (normal) Demographics BMI 11%: in paid employment 13% in unpaid employment 2%: in paid employment 7% in unpaid employment 7%: in paid employment 13% in unpaid employment Employment status (paid vs. unpaid) Family status (top 2) Drug/alcohol use 30% living alone / independently 8% living with partner and children 51% no use 25% mild use 17% moderate use 6% severe 33% living alone / independently 4% living with partner and children 30% no use 23% mild use 35% moderate use 10% severe Source: Patient record forms. Fully adherent (n=445), partially (n=162), not at all adherent (n=15) 47% living alone / independently 7% living with partner and children 40% no use 33% mild use 27% moderate use 0% severe CAUTION: Low bases (<n=30) 46 PRF Patients who have lower level of adherence tend to have higher number of relapses and rate of hospitalisation. They also have lower level of insight B1to B5: disease profile Timeframes Relapse s Current severity Fully adherent Partially adherent Not at all adherent Age at diagnosis: 28 Years in psychiatrists care: 3.0 Age at diagnosis: 28 Years in psychiatrists care: 2.5 Age at diagnosis: 28 Years in psychiatrists care: 2.8 Number of relapses: 0.6 Number of relapses: 1 Number of relapses: 1.2 Normal / borderline ill: 35% Moderate: 61% Severely ill: 4% Normal / borderline ill: 13% Moderate: 80% Severely ill: 7% Normal / borderline ill: 0% Moderate: 80% Severely ill: 20% Insight Full aware: 42% Moderately aware: 44% Fully unaware: 14% Hospitalisations Ever hospitalised: 77% Never hospitalised: 20% Full aware: 19% Moderately aware: 60% Fully unaware: 21% Ever hospitalised: 81% Never hospitalised: 15% Source: Patient record forms. Fully adherent (n=445), partially (n=162), not at all adherent (n=15) Full aware: 7% Moderately aware: 47% Fully unaware: 47% Ever hospitalised: 87% Never hospitalised: 13% CAUTION: Low bases (<n=30) 47 PRF Prescribing of LAIs does not seem to be linked particularly to level of adherence. Patients who have lower level of adherence are more likely to be prescribed atypical orals. They are also more likely to be receiving more than 1 treatment B22 Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Fully adherent – 39% Atypical LAIs (n=117) 26% Typical LAIs (n=89) aripiprazole (n=39) Typical orals (n=27) 6% Mean # treatments = 1.1 % on more than 1 treatment = 12% 20% 18% 57% 9% Not at all adherent - 22% 17% 20% Atypical orals (n=253) Partially adherent – 39% 33% 71% 12% 11% Mean # = 1.2 % on more than 1 = 83% 80% 13% 7% Mean # = 1.7 % on more than 1 = 40% Source: Patient record forms. Fully adherent (n=445), partially (n=162), not at all adherent (n=15) CAUTION: Low bases (<n=30) Note: data taken from total sample (not representative sample). Therefore figures are not indicative of market share 48 PRF Patients who have lower level of insight are more likely to be male, not be in employment and have higher use of drugs / alcohol B1to B5: demographics Fully aware Moderately aware (high insight) Fully unaware (low insight) 41% female and 59% male Average age: 40 Age at diagnosis: 28 34% female and 66% male Average age: 38 Age at diagnosis: 28 39% female and 61% male Average age: 45 Age at diagnosis: 28 Mean BMI = 25.1 (overweight) Mean BMI = 24.8 (normal) Mean BMI = 25.2 (overweight) Demographics BMI 18%: in paid employment 17% in unpaid employment 5%: in paid employment 12% in unpaid employment 3%: in paid employment 2% in unpaid employment Employment status (paid vs. unpaid) Family status (top 2) Drug/alcohol use 32% living alone / independently 10% living with partner and children 32% living alone / independently 6% living with partner and children 26% living alone / independently 4% living with partner and children 52% no use 29% mild use 14% moderate use 3% severe 37% no use 24% mild use 28% moderate use 8% severe 55% no use 18% mild use 18% moderate use 8% severe Source: Patient record forms. Fully aware (n=214), moderately (n=295), fully unaware (n=106) 49 PRF Patients who have lower level of insight tend to have a higher number of relapses, rate of hospitalisation and have lower level of adherence B1to B5: disease profile Fully aware Moderately aware (high insight) Fully unaware (low insight) Age at diagnosis: 28 Years in psychiatrists care: 3.4 Age at diagnosis: 28 Years in psychiatrists care: 2.5 Age at diagnosis: 31 Years in psychiatrists care: 2.4 Number of relapses: 0.5 Number of relapses: 0.8 Number of relapses: 1.1 Normal / borderline ill: 47% Moderate: 52% Severely ill: 0.5% Normal / borderline ill: 23% Moderate: 74% Severely ill: 3% Normal / borderline ill: 11% Moderate: 69% Severely ill: 20% Adherence Full adherent: 86% Partially adherent: 14% Non-adherent: 0% Full adherent: 65% Partially adherent: 33% Non-adherent: 4% Full adherent: 61% Partially adherent: 33% Non-adherent: 7% Hospitalisations Ever hospitalised: 73% Never hospitalised: 22% Ever hospitalised: 80% Never hospitalised: 16% Ever hospitalised: 83% Never hospitalised: 11% Timeframes Relapse s Current severity Source: Patient record forms. Fully aware (n=214), moderately (n=295), fully unaware (n=106) 50 PRF Lower likelihood to be prescribed atypical orals in patients who are fully unaware B22: Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Fully aware – 38% Moderately aware – 47% (high insight) Atypical LAIs Typical LAIs Aripiprazole (low insight) 21% 24% 13% Atypical orals Mean # treatments = 1.1 % on more than 1 treatment = 11% 27% 20% 65% 10% Fully unaware -15% 25% 60% 10% Mean # = 1.1 % on more than 1 = 13% 55% 7% Mean # = 1.1 % on more than 1 = 18% Source: Patient record forms. Fully aware (n=214), moderately (n=295), fully unaware (n=106) 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 insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 52 Section summary Based on the PRFs, olanzapine and risperidone are the most widely prescribed oral treatments. Risperdal Consta and typicals are the most widely prescribed LAI medications Previous prescribing was higher for the typicals (orals and LAI). Risperidone and olanzapine are also common previous treatments The majority of prescriptions are repeat, but nearly 30% of aripiprazole prescriptions are new The main reason for prescribing is to treat positive symptoms. Treating general attributes is also a key driver for LAI treatments With regards to symptoms, delusions is the major reason a drug is prescribed. Although not in the overall top ten, low risk of metabolic side effects is a key driver for prescribing aripiprazole (53%) Over 70% of patients are prescribed an LAI due to poor adherence with oral therapy The main reason for switching away from previous treatment is poor tolerability and side effects. Mode of administration is a key driver for LAIs Weight gain is a major side effect across all treatments though extrapyramidal side effects are also a key side effect for LAIs. Over half of patients on aripiprazole do not experience side effects 53 PRF Current prescribing: Based on the PRFs, olanzapine and risperidone are the most widely prescribed oral treatments. Risperdal Consta and typicals are the most widely prescribed LAI medications B22: Current treatments Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? Oral treatments OLANZAPINE 24% RISPERIDONE 15% QUETIAPINE 17% ARIPIPRAZOLE 3% PALIPERIDON E PALMITATE 1% 15% OLANZAPINE PAMOATE 1% AMISULPRIDE 1% 7% ZIPRASIDONE 0% ASENAPINE 0% OTHER ATYPICAL OTHER… 0% TYPICALS RISPERDAL CONSTA 21% CLOZAPINE PALIPERIDONE LAI treatments TYPICALS 6% 9% Mean # treatments = 1.2 % on more than 1 treatment = 17% 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=394), LAIs prescriptions (n=250) Mean # = 1.2 % on more than 1 = 17% Note: this question can be compared to physician’s estimated prescribing (question A2, slide 13) 54 PRF Previous prescribing: Was higher for the typicals (orals and LAI). 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 22% RISPERIDONE CLOZAPINE 2% PALIPERIDON E PALMITATE 9% ARIPIPRAZOLE 3% 0% 30% have not received any previous treatment 6% OLANZAPINE PAMOATE 0% AMISULPRIDE 0% 3% ZIPRASIDONE 0% ASENAPINE 0% OTHER ATYPICAL OTHER… 1% TYPICALS RISPERDAL CONSTA 18% QUETIAPINE PALIPERIDONE LAI treatments TYPICALS 10% 16% 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=394), LAIs prescriptions (n=250) 55 PRF The mean age of patients is ~40 years old. There is no significant difference in the age of patients by drug type B1: Please provide the patient’s year of birth (note, the patient must be 18 years of age or over): Mean age (years) B22: Which antipsychotic treatment(s) are being prescribed as the patient’s current regimen for schizophrenia? 39.7 39.2 Total (rep sample) (n=411) All orals (n=394) 41.5 37.4 All LAIs (n=250) Source: Patient record form. Representative sample (i.e. minus LAI over-sample) Base: All PRFs (n=411) aripiprazole (n=59) 56 PRF The majority of prescriptions are repeat, but nearly 30% of aripiprazole prescriptions are new B24 Current treatment details. Treatment status - start, repeat, switch, re-start? Other Switch Repeat Restart (have used the drug within the past 6 months) % of all prescriptions Start (i.e. newly initiated, not used the drug previously) 8% 9% 7% 54% 63% 6% 14% 38% 74% 61% 59% 44% 25% 100% 13% 5% 21% Risperdal Consta (n=19) 9% 12% 11% 26% 25% paliperidone palmitate (n=8) 10% 8% 16% 16% olanzapinepamoate olanzapine (n=87) risperidone (n=74) (n=0) clozapine (n=57) Source: Patient record form, prescription level. Base: all prescriptions (n=644) 22% 29% quetiapine (n=64) aripiprazole (n=59) *paliperidone (n=2) CAUTION: Low bases (n<30) 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 33.4 mg 25.5 / 146 weeks 1.0 % IM acute injection 99.0 % IM depot injection 3.8 / 2.9 1.2 / 1.9 100% IM depot injection paliperidone palmitate 81.3 mg 21 / 80 weeks 100% IM depot injection 3.8 / 2.8 1.1 / 1.8 olanzapine pamoate 214.2 mg 26 / 61 weeks 11.1 % IM acute injection 88.9 % IM depot injection 3.9 / 2.0 1.3 / 2.0 100% IM depot injection Source: Patient record forms. Base: LAI prescriptions 58 PRF The main reason for prescribing is to treat positive symptoms. Treating general attributes is also a key driver for LAI treatments B33 Why did you prescribe (drug X) to the patient? Category totals All treatments - rep sample To treat - positive symptoms Oral treatments 86% 86% To treat - negative symptoms 42% 43% To treat - other symptoms 39% 42% Side-effect profile 42% General attributes 44% Patient level attributes 49% LAI treatments 39% 81% 39% 44% 22% 43% 48% 62% 48% 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=394), LAIs prescriptions (n=250) 59 PRF Delusions is the major reason a drug is prescribed. Although not in the overall top ten, low risk of metabolic side effects is a key driver for prescribing aripiprazole (53%) B33 Why did you prescribe (drug X) to the patient? Delusions Hallucinations Thought disorder Anticipated positive impact on overall quality of life Anticipated positive impact on overall functioning (cognitive and social) Changes in behaviour Social withdrawal Irritability Low risk of extrapyramidal side effects (including tardive dyskinesia) (not including akathisia) Lack of interest 71% 71% 68% 67% 57% 55% 52% 41% 41% 39% 36% 28% 27% 23% 23% 45% 42% 40% 40% 44% 43% 44% 40% 40% 37% 39% 35% 29% 29% 30% 25% 22% 23% 41% 36% 26% 21% 25% 18% 10% Total (rep sample) - (n=446) All orals (n=469) Source: Patient record form, prescription level. Base: oral prescriptions (n=469), LAIs prescriptions (n=302) All LAIs (n=302) aripiprazole (n=73) 60 Delusions, hallucinations and thought disorder 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 LAIs Top 3 reasons for prescribing All orals (n=469) Delusions 71%, Hallucinations 57%, Thought disorder 44% All LAI (n=302) Delusion 67, Hallucinations 52%, thought disorder 44% All Atypical orals (n=431) Delusions 73%, Hallucinations 57%, Thought disorder 44% Atypical LAIs (n=165) Delusions 68%, Thought disorder 49%, Hallucinations 48% risperidone (n=102) Delusions 75%, Hallucinations 59%, Thought disorder 54% Risperdal Consta (n=114) Delusions 66%, Hallucinations 49%, Thought disorder 46% paliperidone (n=4) Delusions 100%, Thought disorder 100%, Frequency of dosing 75% paliperidone palmitate (n=34) Delusions 79%, Frequency of dosing 65%Thought disorder 62%, olanzapine (n=114) Delusions 72%,Hallucinations 51%, Thought disorder 50% olanzapine pamoate (n=13) Delusions 69%, Changes in behaviour 54%, Mode of administration 46% Typical LAIs (n=145) Delusions 62%, Hallucinations 54%, Thought disorder 40% aripiprazole (n=73) All typicals (n=64) Delusions 68%, Low risks of metabolic side effects (including weight gain) 53%, Hallucinations 45% Delusions 50%, Thought disorder 45%, Hallucinations 44% Source: Patient record form, prescription level. Base: all prescriptions (n=644) oral prescriptions (n=394), LAIs prescriptions (n=250) CAUTION: Low bases (<n=30) 61 PRF Over 70% of patients are prescribed an LAI due to poor adherence with oral therapy B26 Why was the patient prescribed a LAI formulation treatment? 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 21% 11% 44% 25% % of patients 16% 11% 20% 20% 18% 6% 7% 9% 9% 13% 78% 73% 74% All LAI (n=250) Atypical LAIs (n=141) Risperdal Consta (n=102) 8% 9% 10% 23% 7% 10% 9% 10% Source: Patient record forms. Base: currently receiving LAI (n=250) 11% 18% 11% 6% 10% 9% 56% 28% 36% 71% 78% paliperidone palmitate olanzapinepamoate (n=28) (n=9) 82% Typical LAIs (n=112) CAUTION: Low bases (<n=30) 62 PRF The main reason for switching away from previous treatment is poor tolerability and side effects. Mode of administration is a key driver for LAIs B37 Why was (drug X) switched or discontinued from the patient’s previous regimen? % of treatments Don’t know Mode of administration (i.e. change to different formulation) Availability of a new treatment option Patient request Poor efficacy/symptom control 7% 8% 7% 7% 6% 6% 7% 29% 28% Other Inconvenience / not easy to use Family request Poor tolerability/complaints about side effect(s) 21% 5% 7% 12% 29% 41% 5% 7% 6% 45% 44% 21% 73% 27% 48% 46% Total (rep sample) - (n=310) All orals (n=302) Source: Patient record forms. Base: all switched / discontinued treatments (n=483) 36% All LAIs (n=241) 22% aripiprazole (n=41) 63 Poor efficacy and symptom control is the main reason for switching from a patient’s previous regimen for both orals and LAIs B37 Why was (drug X) switched or discontinued from the patient’s previous regimen? Orals All orals (n=302) All Atypical orals (n=282) Poor efficacy / symptom control 48%, poor tolerability 45%, patient request 28% risperidone (n=58) paliperidone (n=5) Poor tolerabily/complaints about side effect(s) 60%, Patient request 60%, olanzapine (n=50) Poor efficacy/symptom control 54%, Poor tolerability/complaints about side effect(s) 44%, Patient request 34% All typicals (n=27) Top 3 reasons for switching Poor efficacy / Symptom control 36%, Mode of administration 29%, Poor tolerability/complaints about side effect(s) 27% All LAI (n=241) Poor efficacy/symptom control 48%, Poor tolerability/complaints about side effect(s) 46, patient request 29% Poor tolerability/complaints about side effect(s) 50%, Poor efficacy/symptom control 41%, Patient request 26% aripiprazole (n=41) LAIs Top 3 reasons for switching Poor tolerability/complaints about side effect(s) 73%, Patient request 41%, Poor efficacy/symptom control 22% Atypical LAIs (n=128) Mode of administration (i.e. change to different formula) 36%,Poor efficacy/symptom control 34%, Poor tolerability/ complaints about side effect(s) 23% Risperdal Consta (n=83) Mode of administration (i.e. change to different formula) 41%, Poor efficacy/symptom control 35%, other 20% paliperidone palmitate (n=36) Poor tolerability/ complaints about side effect(s) 50%, Patient request 28%, Poor efficacy/symptom control 25% olanzapine pamoate (n=7) Poor efficacy/symptom control 57%, Availability of a new treatment option 43%, Mode of administration(i.e. change to different formulation) 43% Typical LAIs (n=113) Poor efficacy/symptom control 39%, Poor tolerability/complains about side effect(s) 32%, Patient request 25% Poor efficacy symptom controls 37%, Poor tolerability/complaints about side effect(s) 23%, Patient request 22% Source: Patient record forms. Base: all switched / discontinued treatments CAUTION: Low bases (<n=30) 64 Lack of control of delusions and hallucinations are the main lack of efficacy reasons resulting in a switch from the previous treatment B37b Which symptom(s) was [drug X] poor in controlling? – symptoms Orals Top 3 uncontrolled symptoms LAIs Top 3 uncontrolled symptoms All orals (n=144) Delusions 74%, Hallucinations 62%, Thought disorder 41% All LAI (n=87) Delusions 74%, Hallucinations 55%, Thought disorder 38% All Atypical orals (n=136) Delusions 74%, Hallucinations 62%, Thought disorder 43% Atypical LAIs (n=43) Delusions 77%, Hallucinations 47%, Thought disorder 42% Risperidone (n=24) Delusions 71%, Hallucinations 46%, Thought disorder 38% Risperdal Consta (n=29) Delusions 79%, Hallucinations 48%, thought disorder 31% *paliperidone (n=1) Thought disorder 100%, Disorganised speech 100% paliperidone palmitate (n=9) olanzapine (n=27) Delusions 78%, Thought disorder 70%, Hallucinations 52% olanzapine pamoate (n=4) aripiprazole (n=9) All typicals (n=10) Hallucinations 67%, Delusions 44%, emotional flatness 44% Delusions 67%, Thought disorder 67%, Social withdrawal 56% Delusions 75%, Irritability 75% Delusions 70%, Hallucinations 64%, Thought disorder 34% Typical LAIs (n=44) Delusions 60%, Hallucinations 50%, Source: Patient record forms. Base: previous treatments that were switched due to poor efficacy / symptom control CAUTION: Low bases (<n=30) 65 PRF Main side effects are sedation and weight gain. Over half of patients on aripiprazole do not experience side effects B23: Please indicate which side effects the patient has experienced as a result of taking [drug X], if any? No side effects Metabolic side effects (excluding weight gain) Weight gain Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia) Akathisia Prolactin-related side effects (including sexual dysfunction) Sedation Injection site reactions Other, please specify Don’t know 38% % of patients 37% 56% 36% 29% 29% 26% 25% 23% 22% 19% 16% 12% 9% 9% 7% 6% 9% 5% 1% 8%9% 7% 2% Total (rep sample) - (n=446) 5% 1% All orals (n=469) Source: Patient record form, prescription level. Base: oral prescriptions (n=469), LAIs prescriptions (n=302) 2% 6% 12% 14% 7% 4% 4% 1% All LAIs (n=302) 15% 5% 0% 1% aripiprazole (n=73) 66 Weight gain is a major side effect across all treatments though extrapyramidal side effects are also a key side effect for LAIs 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 All orals (n=469) Sedation 29%, Weight gain 25%, Metabolic side effects (excluding weight gain) 9% 38% All Atypical orals (n=431) Sedation 30%, Weight gain 25%, Metabolic side effects (excluding weight gain) 9% 38% risperidone (n=102) Sedation 22%, Weight gain 18%, Prolactin-related side effects (including sexual disfunction) 18% *paliperidone (n=4) Prolactin-related side effects including sexual dysfunction) 50% 50% Weight gain 48%, Sedation 37%, Metabolic side effects (excluding weight gain) 13% 30% Sedation 15%, Akathisia 14%, Weight gain 12% 56% Weight gain 28%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia) 28%, sedation 20%, 34% olanzapine (n=114) aripiprazole (n=73) All typicals (n=64) LAIs % No side effects Weight gain 23%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia) 22%, Sedation 19% 36% Atypical LAIs (n=165) Weight gain 24%, Sedation 15%, Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia, 9% 39% Risperdal Consta (n=115) Weight gain 24%, Sedation 18%, Prolactin-related side effects (including sexual dysfunction) 17% 35% paliperidone palmitate (n=34) Weight gain 21%, Akathisia 18% 50% olanzapine pamoate (n=13) Weight gain 38%, Akathisia 15%, 54% Typical LAIs (n=145) Extrapyramidal side effects (including tardive dyskinesia) (not including akathisia 37%Weight gain 22%, Sedation 22% 30% All LAI (n=302) 35% Source: Patient record form, prescription level. Base: oral prescriptions (n=469), LAIs prescriptions (n=302) Top 3 side effects 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 insight Treatment landscape • Overall prescribing, reasons for prescribing and switching • Exploration around LAI treatments 68 PRF Over half of patients on Risperdal Consta were previously on the oral formulation of the same drug. Over half of patients receiving typical LAIs 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 12% 7% % of patients 11% 9% 10% 8% 10% 10% 5% Another LAIs treatment 11% 18% 11% 29% 7% 11% 13% 21% 28% 40% 64% 54% 67% 55% 45% Risperidone (n=10) Olanzapine (n=7) 29% 9% All LAIs (n=250) Atypical LAIs (n=141) Risperdal Consta (n=102) Source: Patient record forms. Base: currently receiving LAI (n=250) Paliperidone palmitate (n=28) Olanzapine Pamoate (n=9) Typical LAIs (n=112) CAUTION: Low bases (<n=30) 69 PRF Satisfaction with adherence and / or response to oral therapy are the main reasons why patients are not on an LAI B28 Why is the patient not currently on a LAI formulation treatment? Satisfactory adherence with oral therapy 51% Satisfactory treatment response to oral therapy 41% Patient unwillingness 32% I never offered a depot formulation to the patient 15% % of patients The right drug is not available as a depot formulation 11% Patient current condition/symptoms 5% Family unwillingness 4% Practical reason e.g. not being able to attend hospital for injection 2% Formulary restrictions 1% Cost/reimbursement 1% Unsure how to approach injections with the patient 1% Low experience / familiarity with depot treatment 0% Other Source: Patient record forms. Base: patients not currently receiving LAI (n=352) 8% 70 InforMed Insight are members of the following market research professional bodies and abide by their codes of practice: 71