Patient Support Programs Research Articles

PCR20 Diversity of Patient Support Programs for Severe Asthma Treated with Biologic Therapies – A Systematic Literature Review

PCR20 Diversity of Patient Support Programs for Severe Asthma Treated with Biologic Therapies – A Systematic Literature Review

Treatment Persistence of Ixekizumab in Adults with Moderate-to-Severe Plaque Psoriasis Participating in the Canadian Patient Support Program.

Patients with psoriasis (PsO) should adhere to and be persistent with treatment to maintain disease control. Patient support programs (PSPs) are useful to support patients with disease management. We aimed to understand the real-world patient profile and persistence of ixekizumab-initiating Canadian patients with moderate-to-severe PsO using PSP data. This retrospective observational study was conducted utilizing a Canadian PSP database (May 2016 to March 2020). Inclusion criteria were: age ≥ 18years with moderate-to-severe PsO, initiated ixekizumab, enrolled in the PSP for ≥ 6months, and provided informed consent. Psoriasis Area Severity Index (PASI), body surface area (BSA) involvement, and Dermatology Life Quality Index (DLQI) were collected at PSP entry. Adherence [using the proportion of days covered (PDC)] and persistence (using Kaplan-Meier curves) were assessed after 1-year and 2-year follow-ups. Differences in persistence between biologic-naïve and biologic-experienced patients were compared using Cox proportional hazards model after adjusting baseline parameters. In total, 1891 ixekizumab-treated moderate-to-severe patients with PsO were included. The mean [standard deviation (SD)] age was 52.3 (13.3) years; 51.1% of patients were 45-65years old and 61.4% were male. At baseline, the mean (SD) PASI score was 14.3 (8.1), the DLQI score was 16.5 (7.7), and BSA % was 17.4 (15.1). PsO lesions were commonly located on the hands (33.4%), face (28.6%), and feet (23.8%). Ixekizumab-treated patients were highly adherent [PDC ≥ 80%: 1-year (92.0%), 2-year (87.7%)] and persistent [1-year (90.4%), 2-year (85.6%)]. Biologic-naïve patients were more adherent (1-year, 94.6% versus 87.3%; 2-year, 90.3% versus 83.5%) than biologic-experienced patients. Significantly higher persistence in biologic-naïve versus biologic-experienced patients for 1-year (p < 0.01) and 2-year (p = 0.010) follow-up periods was observed after adjusting for baseline parameters. Patients with moderate-to-severe PsO overwhelmingly remained on ixekizumab treatment for more than 2years while participating in a PSP.

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines.

An increasing proportion of new drugs approved for market worldwide are now high cost, specialty medicines. Pharmaceutical marketers face the challenge of convincing payers, prescribers, and patients that the cost and complexity of care associated with specialty medicines is worth the trouble, and now offer patient support programs, free of charge, to patients prescribed their drug. We conducted a secondary, qualitative, interpretive analysis of 24 interviews with leaders of patient groups and members of hospital formulary committees in Australia to describe the work of pharmaceutical company-employed or contracted nurses who provide support to patients prescribed specialty medicines, and to prompt discussion around the policy implications of relying on industry-funded nursing care within publicly funded health systems. Participants affirmed the value of specialist, holistic, person-centered nursing care, but perceived gaps within the public health system related to the availability and provision of nursing care for people living with chronic disease. Consequently, participants described the pharmaceutical industry as addressing health system gaps through sponsorship or direct provision of medication-related nursing care, but recognized that care was contingent on commercial interest. Participants highlighted a number of ethical and policy concerns stemming from industry-funded nursing care of people prescribed specialty medicines related to patient safety, continuity of care, inducement to prescribe, and health equity. This analysis suggests that outsourcing necessary medication-related care to pharmaceutical companies has implications for the health system and equitable, sustainable pharmaceutical policy that extend far beyond the care encounter.

How to select a best-value biological medicine? A practical model to support hospital pharmacists.

DisclaimerIn an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeWith the growing availability of biosimilars on the global market, clinicians and pharmacists have multiple off-patent biological products to choose from. Besides the competitiveness of the product’s price, other criteria should be considered when selecting a best-value biological. This article aims to provide a model to facilitate transparent best-value biological selection in the off-patent biological medicines segment.SummaryThe presented model was developed on the basis of established multicriteria decision analysis tools for rational and transparent medicine selection, ie, the System of Objectified Judgement Analysis and InforMatrix. Criteria for the model were informed by earlier research, a literature search, and evaluation by the authors. The developed model includes up-to-date guidance on criteria that can be considered in selection and provides background on the allocation of weights that may aid hospital pharmacists and clinicians with decision-making in practice. Three main categories of criteria besides price were identified and included in the model: (1) product-driven criteria, (2) service-driven criteria, and (3) patient-driven criteria. Product-driven criteria include technical product features and licensed therapeutic indications. Service-driven criteria consist of supply conditions, value-added services, and environment and sustainability criteria. Patient-driven criteria contain product administration elements such as ease of use and service elements such as patient support programs. Relative weighting of the criteria is largely context dependent and should in a given setting be determined at the beginning of the process.ConclusionThe practical model described here may support hospital pharmacists and clinicians with transparent and evidence-based best-value biological selection in clinical practice.

A nurse-led, telephone-based patient support program for improving adherence in patients with relapsing-remitting multiple sclerosis using interferon beta-1a: Lessons from a consumer-based survey on adveva® PSP.

BackgroundEvidence suggests that organizational models that provide care interventions including patient support programs may increase patient adherence to multiple sclerosis (MS) therapies by providing tailored symptom management, informational support, psychological and/or social support, lifestyle changes, emotional adjustment, health education, and tailored coaching, thus improving patients' overall quality of life across the disease course.ObjectiveThe main objective of this study was to describe MS patients' self-reported experience of a nurse-led, telephone-based PSP and to explore its potential role in improving disease and therapy management skills.MethodsSurvey data were analyzed from a subset of patients relapsing–remitting MS (RRMS) using interferon beta-1a already registered in the adveva® PSP from three Italian multiple sclerosis centers with a consolidated experience in RRMS disease, treatment management, and PSP programs.ResultsIn total, 244 patient data at baseline were analyzed, of which 115 had a follow-up of at least 6 months. Results from this study provide an early view into the role of this PSP in improving the patients reported overall experience regarding disease management and injectable therapy, thus potentially ameliorating treatment adherence and decreasing health care cost. Moreover, study findings confirm the role of providing a patient-focused support by addressing non-medication-related topics in the PSP consultations. Indeed, patients involved in the adveva® PSP program reported a better psychological status in the follow up as demonstrated by an increased optimism regarding their future, tolerance of disease uncertainty, and their perceived ability to benefit from external help and social support (informal caregivers).ConclusionsAs such, it is reasonable to conclude that the involvement in the adveva® PSP and the PSP's assistance in guiding patients on proper treatment self-management techniques is of great value to patients as it might contribute to improving engagement in their health care journey in terms of perceived self-care skills, emotional coping toward the future and the unpredictability of the disease course and their general attitudes toward the injection itself, involving pain tolerance.

Positive Airway Pressure Adherence, Mortality, and Cardiovascular Events in Patients with Sleep Apnea.

Rationale: Randomized controlled trials showed no effect of positive airway pressure (PAP) therapy for obstructive sleep apnea (OSA) on cardiovascular (CV) risk. However, patient selection and low PAP adherence preclude the generalization of their data to clinical samples. Objectives: To evaluate the association between hours of PAP use, mortality, and CV morbidity in real-life conditions. Methods: Data from the Pays de la Loire Cohort were linked to health administrative data to identify incident major adverse cardiovascular events (MACEs; a composite outcome of mortality, stroke, and cardiac diseases) in patients with OSA who were prescribed PAP. Cox proportional hazards analyses were conducted to evaluate the association between MACEs and quartiles of average daily PAP use over the study period. Measurements and Main Results: After a median follow-up of 6.6 years, 961 of 5,138 patients experienced MACEs. Considering nonadherent patients (0-4 h/night) as the reference group, adjusted hazard ratios (95% confidence intervals) for MACEs were 0.87 (0.73-1.04) for the 4-6 h/night group, 0.75 (0.62-0.92) for the 6-7 h/night group, and 0.78 (0.65-0.93) for the ⩾7 h/night group (P = 0.0130). Sensitivity analyses using causal inference approaches confirmed the association of PAP use with MACEs. The association was stronger in male patients (P value for interaction = 0.0004), patients without overt CV disease at diagnosis (P < 0.0001), and those belonging to the excessively sleepy symptom subtype (P = 0.060). Conclusions: These real-life clinical data demonstrate a dose-response relationship between PAP adherence and incident MACEs in OSA. Patient support programs may help improve PAP adherence and CV outcomes in patients with OSA.

Understanding the Treatment Preferences of People Living with Schizophrenia in Australia; A Patient Value Mapping Study.

PurposeTo examine the treatment and long-term outcome preferences for people living with schizophrenia.Patients and MethodsSixty-six Australian adults, living with schizophrenia completed a novel online survey with six sections: Demographic characteristics; Disease history; Quality-of-life; Patient support programmes; Discrete Choice Experiment, and Best-Worst Scaling exercise.ResultsParticipants indicated that they preferred to be involved in treatment decision with their doctor. A minority of participants reported having been previously involved in a patient support programme (28.8%) and only one in six participants had a National Disability Insurance Scheme (NDIS) package (16.7%) with over a third of participants indicating that they were ineligible (37.9%). Participants’ average quality-of-life score was 60%.ConclusionRecent hospitalisation influenced the relative importance of treatment attributes, with effectiveness on hearing voices being the most important treatment attribute. The most important long-term goals were having a stable place to live, being independent, and physical health. People with schizophrenia care about their long-term functional recovery outcomes, rating symptom control and independence as their highest priority. They want to be part of the treatment conversation with their doctors. Therefore, psychiatrists are encouraged to use shared decision-making to establish the treatment course that best aligns with individuals’ long-term goals.

P1728: THE FUTURE OF MYELODYSPLASTIC SYNDROME – PATIENT PRIORITIES AND OUTCOMES THAT MATTER

Background: Without a definitive curative option available to many patients, learning to live with myelodysplastic syndrome (MDS) and manage symptoms effectively becomes a priority in their care. Anaemia is an almost universal feature of MDS but other cytopenias are common and may be linked to bleeding and infection. Individuals suffer differently and better individualisation of care is needed. Most MDS patient information offers scant appreciation for disease heterogeneity, variable response to treatment and each patient’s likely trajectory. Aims: We undertook to discuss what matters most to people living with MDS and provide feedback on discussions in patient support programmes. The aim was to inform lived experience views on research prioritisation in MDS. Methods: We conducted a 2-part interactive online workshop using Zoom and the online platform Miro, with the assistance of a skilled technical facilitator, to replicate a face-to-face environment (eg white board, post-it notes and sticky dots for voting). Patients were invited to generate questions about their condition which they felt should be addressed by research or a change in how their care is delivered. These were then grouped into themes, and reframed to create individual non-overlapping topics. Using a model inspired by the James Lind Alliance Priority Setting Partnerships, patients voted on the importance of each topic, creating a final “prioritised” list of issues. Results: 14 participants of varying age and experience took part raising 56 unique questions under the themes of: Prognosis; End of life; Treatment; Supportive Care; Medical Staff Training; Diagnosis; Communication; Organisations; resource sharing. Using the voting system, patients prioritised 14 key outcomes (shown in Figure 1). These reflect the symptoms of MDS, improving quality of life (QoL), communication, access to healthcare professionals and individualising care. Image:Summary/Conclusion: There are few studies in MDS where QoL is the primary outcome, hence the paucity of evidence around best practice when prioritising this. Given the pervasiveness of anaemia in MDS, managing this, and subsequent fatigue is of vital importance. Although haemoglobin (Hb) levels have been found to be correlated to QoL, it is widely reported that other factors are important in determining QoL and need for transfusions can vary despite a stable Hb level. Indeed, a key finding from patient discussions showed that Hb levels and the need for transfusions is not comparable between different patients and even non-comparable over time meaning that the maximal benefit and timing of transfusions cannot be determined from Hb level alone. Better communication with patients can ensure transfusions are given to improve symptoms. Previously, evaluation of success of transfusion and the clinical decision to transfuse has been determined only by the effect on Hb levels. This workshop highlighted patient dissatisfaction with the ‘numbers-led’ approach and the need for an alternative method to determine when to transfuse. While studies show using liberal transfusion targets improve QoL there are conflicting results showing a prolonged increase in Hb requires more transfusions which would in turn require more time in hospital. Further research is required to define optimal transfusion policies and improved use of blood products alongside other key outcomes highlighted in this workshop. There is growing evidence that treatment needs to be individualised and with the growing use of lifestyle monitoring devices such as smartwatches, this wealth of information could be utilised to determine transfusion need.

The Impact of Patient Support Programs in Europe: A Systematic Literature Review

Background and ObjectivePatient support programs aim to provide solutions beyond the medication itself, by enhancing treatment adherence, improving clinical outcomes, elevating patient experience, and/or increasing quality of life. As patient support programs increasingly play an important role in assisting patients, numerous observational studies and pragmatic trials designed to evaluate their impact on healthcare have been conducted in recent years. This review aims to characterize these studies.MethodsA systematic literature review, supplemented by a broad search of gray literature, was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane recommendations. Observational studies and pragmatic trials conducted in Europe to evaluate the impact of patient support programs, published in English or Spanish between 17/03/2010 and 17/03/2020, were reviewed. Two patient support program definitions were applied starting with Ganguli et al.’s broad approach, followed by the European Medicines Agency definition, narrowed to Marketing Authorization Holders organized systems and their medicines. The quality of publications was assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement 22-item checklist.ResultsOf the 49 identified studies following the Ganguli et al. definition, 20 studies met the European Medicines Agency definition and were reviewed. Patient support program impact was evaluated based on a wide range of methodologies: 70% assessed patient support program-related patient-reported outcomes, 55% reported clinical outcomes, and 25% reported economic impacts on health resources. Only 45% conducted a comparative analysis. Overall, 75% of the studies achieved their proposed objectives.ConclusionsThe heterogeneity of the observational studies reviewed reflects the complexity of patient support programs that are built ad hoc for specific diseases, treatments, and patients. Results suggest that patient support programs play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction. However, there is a need for standardizing the definition of patient support programs and the methods to evaluate their impact.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40271-022-00582-y.

Роль программ поддержки пациентов в реализации ценностно-ориентированного здравоохранения

Patient support programs as a new institutional phenomenon take over part of the functions of the Institute of Healthcare in drug provision, diagnostics, clinicians and patients education, infrastructure support. Purpose: to evaluate the role of patient support programs (PPMS) by describing the mechanisms of their implementation. Materials and methods. On the basis of open sources of information and scientific literature data, the initiatives to launch PPP in Russia of medicines and medical devices were analyzed. Results. The most common programs are that combine financial and information mechanisms. The key principle of the development of the PPP is orientation to the patient’s pathway. Typical tools for the implementation of PPP include the following: hotline, SMS-informing, patronage service, online monitoring, patient training, insurance. The effectiveness of the PPP is assessed by four groups of indicators: patient adherence, quality of life and patient experience, clinical outcome indicators, cost savings. Conclusions. Health authorities and medical professionals should be aware of the possibilities of programs to achieve the goals of improving the quality and accessibility of medical care, and can also help to systematically assess the effectiveness of such programs from the perspective of public health.

Patient satisfaction with clinical pharmacy services and the affecting factors: a literature review

Service quality is measured to assess the consistency of medical services provided to fulfill patient expectations. This article provides an overview of patient satisfaction with clinical pharmacy services and the influencing factors. A literature search from MEDLINE and EBSCO databases was performed with the keywords “patient satisfaction”, “pharmacy service”, “hospital pharmacy service”, and “clinical pharmacy service”. The inclusion criteria for articles are original articles, full papers, articles in English, and published in 2011–2021. A total of 25 articles from 1,118 articles discussed patient satisfaction with clinical pharmacy services such as counseling, drug therapy monitoring, patient support programs, and pharmaceutical care. Generally, patients are satisfied with clinical pharmacy services such as counseling, drug therapy monitoring, patient support programs, and pharmaceutical care. The most influencing factors with clinical pharmacy services are the quality, convenience, ease of information, and confidence in pharmacist competence. Pharmacists should equip themselves with the appropriate knowledge and competencies in clinical pharmacy services for benefits their patients.

Privacy as the Price of Drug Access

In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.

A84 SECURE ELECTRONIC DOCUMENT SIGNING UPTAKE IN BIOLOGIC PRESCRIBING FOR IMMUNE MEDIATED DISEASES

BackgroundThe COVID-19 pandemic drastically impacted workflows in gastroenterology practice. Physicians managing immune-mediated diseases (IMDs) must complete special authorization (SA) and prescription renewal (Rx) forms for patients on biologic therapy. This adds significant administrative burden potentially leading to delays in therapy initiation and care continuity. Historically, document completion has largely been paper-based, with forms faxed between patient support programs (PSPs) and physician offices. Disruption of normal office processes during the pandemic necessitated the movement of existing paper-based workflows online. The use of secure electronic document signing (SEDS) platforms has allowed physicians to receive and complete documents digitally.AimsTo evaluate the impact of SEDS-based biologic documentation on clinical practice. Objectives were 1) to determine if the use of SEDS platforms increased timeliness of document returns compared to traditional workflows 2) assess whether SEDS usage is acceptable and sustainable and 3) assess MD satisfaction with SEDS platforms.MethodsThis was a retrospective audit of SEDS and paper-based biologic document workflows from a single PSP (Abbvie Care). Outcomes of interest were the number of documents completed monthly using SEDS, new monthly users, and the number of active monthly users between April 1, 2020-March 31, 2021. Time (days) to SEDS completion (vs. paper process) was determined by reviewing timepoint data for SA and Rx documents from May 2019-January 2020 (‘pre- SEDS’) and for SEDS documents from May 2020-January 2021(‘SEDS’). The return time (RT) was defined as the time between date sent to a physician’s office by the PSP to the date returned to the PSP. Documents in the pre-SEDS cohort with a RT exceeding 30 days were excludedResultsIn totality, 5573 SA and Rx documents were completed by 383 physicians using the SEDS platform from April 2020-March 2021. A mean of 14.6 (sd 21.8) documents were signed per physician. The number of monthly electronic documents processed increased from 104 in April 2020 to 800 in March 2021. Active monthly users increased from 24 in April 2020 to 213 in March 2021 (31 new users monthly). A total of 19,387 paper documents were processed during the ‘pre-SEDS’ period and 3,317 electronic documents processed in the ‘SEDS’ period. The mean RT in the ‘pre-SEDS’ period was 8.03 days (Sd 8.2) and the ‘SEDS’ period was 1.11 days (sd 2.6).ConclusionsThis data demonstrates acceptability, appropriateness, and improved processing efficiency of a SEDS platform improving timeliness of patient care. Next steps in this research include surveying physicians to understand the work-flow impact of SEDS, functionality, long-term sustainability, satisfaction and impacts on disease related outcomes.Funding AgenciesNone

Patient-reported outcomes: The anal cancer patient lived experience.

2 Background: Anal Cancer incidence and deaths from the disease have been rising in the United States for the past two decades. Data published in the Journal of the National Cancer Institute (11/19/2019) indicate from 2001 to 2015, anal cancer overall incidence increased by 2.7% per year and deaths rose by 3.1 % each year. This data indicates that anal cancer may be one of the fastest growing causes of cancer incidence and mortality. Now, especially with data indicating the rise in incidence rate, it is imperative that the anal cancer patient lived experience be better understood, including gaps in awareness and prevention education that may lead to earlier diagnosis. The Raymond Foundation in partnership with the anal cancer patient community is amplifying the patient voice by facilitating a series of impactful roundtable conversations to underscore the patient lived experience. Methods: From March–August 2021, the Raymond Foundation convened virtual roundtable conversations and individual interviews with 171 anal cancer patients and survivors. Overarching themes from our conversations included: Barriers to earlier diagnosis and awareness, Frustration and anger by the lack of new treatment protocols, Quality of life after diagnosis, including daily distress levels leading to allostatic load. Results: 94% of patients/survivors reported lack of anal cancer awareness and prevention education that may have led to a later stage diagnosis; 93% reported feeling stigmatized with a marked decrease in quality of life post diagnosis; 90% reported feeling embarrassed when discussing their diagnosis with family and friends; 86% reported frustration and anger by the lack of new treatment options; Anxiety (81%), Fear (78%) Depression (73%) were common daily distress concerns; Reported physical effects of the disease and treatment, include Radiation Proctitis (71%) Fecal Incontinence (68%) Urinary Incontinence (65%). Less than half (44%) of patients felt empowered and comfortable advocating for themselves regarding their healthcare and treatment decisions. Conclusions: Anal cancer patients have many unmet needs–both physical and psycho-social. Their voices and lived experiences provide a roadmap to better understand these unmet needs. Based on our patient-reported outcomes research, we will continue our outreach and partnership with the anal cancer community to provide patient support, education and awareness programs and campaigns that help meet the needs of the anal cancer patient community.

SECURE ELECTRONIC DOCUMENT SIGNING UPTAKE IN BIOLOGIC PRESCRIBING FOR IMMUNE MEDIATED DISEASES

BACKGROUNDThe COVID-19 pandemic drastically impacted workflows in gastroenterology practice. Physicians managing immune-mediated diseases (IMDs) must complete special authorization (SA) and prescription renewal (Rx) forms for patients on biologic therapy. This adds significant administrative burden potentially leading to delays in therapy initiation and care continuity. Historically, document completion has largely been paper-based, with forms faxed between patient support programs (PSPs) and physician offices. Disruption of normal office processes during the pandemic necessitated the movement of existing paper-based workflows online. The use of secure electronic document signing (SEDS) platforms has allowed physicians to receive and complete documents digitally.AIMSTo evaluate the impact of SEDS-based biologic documentation on clinical practice. Objectives were 1) to determine if the use of SEDS platforms increased timeliness of document returns compared to traditional workflows 2) assess whether SEDS usage is acceptable and sustainable and 3) assess MD satisfaction with SEDS platforms.METHODSThis was a retrospective audit of SEDS and paper-based biologic document workflows from a single PSP (Abbvie Care). Outcomes of interest were the number of documents completed monthly using SEDS, new monthly users, and the number of active monthly users between April 1, 2020-March 31, 2021. Time (days) to SEDS completion (vs. paper process) was determined by reviewing timepoint data for SA and Rx documents from May 2019-January 2020 (‘pre- SEDS’) and for SEDS documents from May 2020-January 2021(‘SEDS’). The return time (RT) was defined as the time between date sent to a physician’s office by the PSP to the date returned to the PSP. Documents in the pre-SEDS cohort with a RT exceeding 30 days were excludedRESULTSIn totally, 5573 SA and Rx documents were completed by 383 physicians using the SEDS platform from April 2020-March 2021. A mean of 14.6 (sd 21.8) documents were signed per physician. The number of monthly electronic documents processed increased from 104 in April 2020 to 800 in March 2021. Active monthly users increased from 24 in April 2020 to 213 in March 2021 (31 new users monthly). A total of 19,387 paper documents were processed during the ‘pre-SEDS’ period and 3,317 electronic documents processed in the ‘SEDS’ period. The mean RT in the ‘pre-SEDS’ period was 8.03 days (Sd 8.2) and the ‘SEDS’ period was 1.11 days (sd 2.6).CONCLUSIONThis data demonstrates acceptability, appropriateness, and improved processing efficiency of an SEDS platform improving timeliness of patient care. Next steps in this research include surveying physicians to understand the work-flow impact of SEDS, functionality, long-term sustainability, satisfaction and impacts on disease related outcomes.

P621 Secure Electronic Document Signing Uptake in Biologic Prescribing for Immune Mediate Diseases

BackgroundThe COVID-19 pandemic drastically impacted workflows in gastroenterology practice. Physicians managing immune-mediated diseases (IMDs) must complete special authorization (SA) and prescription renewal (Rx) forms for patients on biologic therapy. This adds significant administrative burden potentially leading to delays in therapy initiation and care continuity. Historically, document completion has largely been paper-based, with forms faxed between patient support programs (PSPs) and physician offices. The use of secure electronic document signing (SEDS) platforms during the pandemic has allowed physicians to receive and complete documents digitally. The aim of the project was to evaluate the impact of SEDS-based biologic documentation on clinical practice in order to 1) Determine if the use of SEDS platforms increased timeliness of document returns compared to traditional workflows 2) Assess whether SEDS usage is acceptable and sustainable and 3) Assess MD satisfaction with SEDS platforms.MethodsThis was a retrospective audit of SEDS and paper-based biologic document workflows from a single PSP (Abbvie Care). Outcomes of interest were the number of documents completed monthly using SEDS, new monthly users, and the number of active monthly users between April 1, 2020-March 31, 2021. Time (days) to SEDS completion (vs. paper process) was determined by reviewing timepoint data for SA and Rx documents from May 2019-January 2020 (‘pre- SEDS’) and for SEDS documents from May 2020-January 2021(‘SEDS’). The return time (RT) was defined as the time between date sent to a physician’s office by the PSP to the date returned to the PSP. Documents in the pre-SEDS cohort with a RT exceeding 30 days were excluded.ResultsIn total, 5573 SA and Rx documents were completed by 383 physicians using the SEDS platform from April 2020-March 2021. A mean of 14.6 (sd 21.8) documents were signed per physician. The number of monthly electronic documents processed increased from 104 in April 2020 to 800 in March 2021. Active monthly users increased from 24 in April 2020 to 213 in March 2021 (31 new users monthly). A total of 19,387 paper documents were processed during the ‘pre-SEDS’ period and 3,317 electronic documents processed in the ‘SEDS’ period. The mean RT in the ‘pre-SEDS’ period was 8.03 days (sd 8.2) and the ‘SEDS’ period was 1.11 days (sd 2.6).ConclusionThis data demonstrates acceptability, appropriateness, and improved processing efficiency of an SEDS platform improving timeliness of patient care. Next steps in this research include surveying physicians to understand the work-flow impact of SEDS, functionality, long-term sustainability, satisfaction and impacts on disease related outcomes.

SECURE ELECTRONIC DOCUMENT SIGNING UPTAKE IN BIOLOGIC PRESCRIBING FOR IMMUNE MEDIATED DISEASES

The COVID-19 pandemic drastically impacted workflows in gastroenterology practice. Physicians managing immune-mediated diseases (IMDs) must complete special authorization (SA) and prescription renewal (Rx) forms for patients on biologic therapy. This adds significant administrative burden potentially leading to delays in therapy initiation and care continuity. Historically, document completion has largely been paper-based, with forms faxed between patient support programs (PSPs) and physician offices.

Patient-Support Program in Diabetes Care During the Covid-19 Pandemic: An Italian Multicentric Experience.

PurposeTelephone coaching and health apps are effective means to support subjects with diabetes. Patient support programs (PSP) on type 2 diabetes are scanty, and none has been conducted in Italy. In a pilot phase, conducted during the COVID-19 pandemic, we aimed to examine the feasibility and acceptance of such program.MethodsThe “BE THere for diabetes CARE” (BETHCARE) project is a real-world PSP conducted through telephone and digital coaching system to provide educational and emotional support to Italian adults with diabetes receiving long-acting basal insulin degludec. This pilot phase was conducted in 11 centres that enrolled a total of 63 patients (89% with type-2 diabetes). Counselors contacted patients to define a set of emotional, physical and nutritional targets, and monitoring calls were performed on a monthly basis. Data were collected on socio-demographic and anthropometric characteristics, selected clinical information, quality of life, achievement of targets and patient satisfaction.ResultsFifty-eight subjects (92%) chose to participate by telephone and 5 (8%) by mobile app. Most participants (ie, ≥80%) evaluated counselors’ calls “useful/very useful”, duration of calls “adequate/adequately long”, were satisfied with the educational pathway and declared to be more confident in diabetes management after the program. About half of participants were confident to maintain their targets after the PSP. Achievement of nutritional targets improved during counseling, from a mean score of 1.56 at week 1 to 1.88 at week 16 (p-value = 0.03). No significant variations in the achievement of emotional and physical targets emerged. Mean patients weight decreased from 84.9 kg (week 1) to 84.3 kg (week 4) and then levelled off (84.2 kg, week 16).ConclusionThis project demonstrated the feasibility and patient appreciation of a PSP in diabetes care, which is particularly important for a chronic disease of the elderly and during a pandemic period when face-to-face counseling is problematic.

A quantitative analysis of risk-sharing agreements with patient support programs for improving medication adherence

Medication adherence is a challenge for patients, drugmakers, and payers. To promote adherence, some payers adopt a form of pay-for-success value-based risk-sharing agreements. Drugmakers reduce prices for meaningful improvement in adherence and share patient information and resources with payers; as a return, payers run patient support programs and put drugs on a tier with lower copays. We use a game-theoretic approach to investigate the optimal program effect and the optimal prices with and without improvement in adherence, measured by Proportion of Days Covered, under such an agreement. Since negotiation power impacts how prices are determined, we consider several pricing settings: the payer or the drugmaker sets both prices or sets one price simultaneously or sequentially. Although a discount for improved adherence tends to promote adherence, it may not always be achievable nor guarantees better adherence. The drugmaker with strong negotiation power can align its interest with social welfare but the payer may not. The payer with strong negotiation power can improve more adherence than the drugmaker. Balanced negotiation power contributes either the most or the least to adherence depending on contract form and decision sequence. Although cost-sharing by the drugmaker expects to increase program efforts, it may not be true. We find that the policymaker prefers different levels of cost-sharing under different pricing settings. The payer may have a first-mover advantage when setting the price without improved adherence; the drugmaker, however, does not have such an advantage.

Assessing the Beneficial Impact of a Patient Support Program in Secukinumab-Treated Patients with Psoriasis in Italy.

PurposeFor patients with psoriasis, treatment adherence and persistence are fundamental if therapeutic goals are to be met. Patient Support Programs (PSPs) may be used as a support tool to assist patients and health care professionals optimize treatment and improve disease management.Patients and MethodsIn Italy, the PSP PSOLife CARE, which began on the 9th of February 2017 and is ongoing, aimed to support patients with psoriasis under therapy with secukinumab (Cosentyx®). A team of medical professionals including Dermatologists, Psychologists, Nutritionists, and field Nurses provided outpatient treatment as well as remote support via phone calls. Patients had a standard duration in the Program of 6 months. This report analyzes the data of patients who benefited from the Program from February 2017 to August 2020, for a total observation of 42 months.ResultsWe provide here a descriptive report on the benefits of participation in the PSOLife CARE Program for patients with psoriasis and medical professionals involved in their care. Throughout their time in the PSOLife CARE Program, patient satisfaction remained consistently high with sustained improvements observed in all aspects of quality of life (ie emotional, social, physical, and economic). Despite exiting from the Program, most patients continued to adhere to secukinumab. Medical professionals also reported positive outcomes on their interactions with patients, with more than half of those surveyed rating the overall quality of the Program as “Outstanding”.ConclusionBy supporting treatment adherence, the PSOLife CARE Program may have empowered patients to better manage their psoriasis, increasing their satisfaction with treatment and quality of life.