Deloitte LLP is the United Kingdom affiliate of Deloitte NSE LLP, a member firm of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (DTTL). We know that patients value simplicity and customisability so that they are better able to take ownership of their own wellness and participate in their own car. 1 888-734-3814. Clinical trials are not powered to detect rare adverse reactions that become apparent only during spontaneous reporting. TG: Adherence programs have come a long way over my career, but I believe we'll see them continue to improve. 1234 Main St, Suite 400. Not only can adverse events have important consequences for patients but they can have a big impact on public health. Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a patient support programme (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes. Designing and delivering cost-effective patient support programmes can be complex, particularly when working across multiple healthcare systems that may be funded by insurance, by taxation, self-funded or a combination of these approaches. We have a variety of programs to help support patients and make it easier for them to afford their medicines. This cookie is set by GDPR Cookie Consent plugin. Consider the demographic and what will work for them, then make available the right number and combination of channels to create maximum impact. Designing and operationalizing a Patient Support Services program is complicated - there are so many decisions to make on which services to offer, how to operationalize (in-house, HUB, specialty pharmacy, or other third party), the best way to ensure compliance and retain oversight, etc. Does the programme structure involve the company reaching out to patients and/or healthcare professionals or is unsolicited communication received from these sources? Data can come from a wide variety of sources but it is important to maintain one record per patient and to be consistent and compliant in its collection across regions and countries. *. The lack of standardized mechanisms for recording and managing the data also creates burdens for operational teams and destroys the value of downstream signal management. Its key to direct patients to the services that are available for them locally too. Strong organizational, planning and project management skills. New digital technologies and solutions offer new opportunities to design and deliver these PSPs in novel, impactful and cost-effective ways. He has an extensive strategy and consulting background with over 23 years work experience, across multiple industries. Pharmaceutical Patient Support Programs. Programmes with organised data collection that include active solicitation of information relating to the use of a medicinal product: AE reports should be classified as solicited and should undergo a causality assessment. A client facing significant hurdles in getting its asthma biologic adopted and administered correctly partnered with Ashfield to initiate a branded clinical educator programme to target allergy and pulmonology offices in areas of highest need. Consider the channels. Continue to provide expanded patient assistance programs: Financial burdens will continue to be a hurdle for many patients. Offering one-on-one health education support in English or Spanish for hemophilia and von Willebrand disease. Sometimes, the driver is patient safety and pharmacovigilance, where potentially severe side effects mean that patients have to be carefully on-boarded and monitored; sometimes, the driver is better disease management, especially for chronic conditions; sometimes, the driver is improved treatment efficacy, for instance, in degenerative conditions, where programmes enable physicians to slow progression by earlier intervention. An engine to embrace and harness disruptive change. 9. Additionally, nurse case managers can connect patients and families to support services that they may not be aware of, such as, patient advocacy groups, government-funded programs, social workers, etc. Ashfield Engage's client partnership enables a seamless, high-quality patient experience. Today, the cost scales almost linearly with each additional PSP; a consistent platform, scaled and leveraged across affiliates, would drive down the incremental cost for each new programme by sharing and re-using components. Strong organizational, planning and project management skills. Reconciliation of safety data (periodically or at the end of the programme). Call: 1-888-229-8379 Monday through Friday, 8:30 AM to 8:00 PM ET. Each ASPIRE program includes partnerships and representation from across the amyloidosis community - patients, caregivers, patient organizations, academics, researchers, industry, and others. The Medicine Assistance Tool (MAT) makes it easier for those struggling to afford their medicines to find and learn about various programs that may be available to make prescription medicines more affordable for them, their loved ones or their patients. Our customized Patient-Support Programs provide discounted medications or redemption offers to patients who have completed a guided enrolment process. 1. Here are 10 steps to planning a successful patient support programme, based on 25 years experience of delivering them across a number of therapeutic areas and environments. Having qualified as a registered nurse in 1989, Anita has more than 25 years experience of working in healthcare, and within pharmaceutical companies. This makes it critical that there is commonality in the data points identified and how they are collected. Patient support programs for pharmaceutical companies play a major role in ensuring that patients receive the service they desire. A Patient Support Program is a company developed program that is intended to assist patients in gaining benefit from their medical treatment and to improve health outcomes and promote the quality use of medicines. Pharmacy Services Our distribution services, including direct-to-patient delivery, get therapies to patients quickly and effectively. 1. This is best achieved through a network of local experts in each geography, supported by an international management team who can ensure a consistent application of standards and measurements across the programme. BioScript Solutions is committed to helping patients with chronic illnesses achieve the best possible health outcomes by providing access to complex, specialty drug therapies and delivering full-service specialty care solutions. The component level design decisions also mean that the package core is easily extensible to accelerate the time to value for enterprise Patient Engagement solutions (i.e. Through PAPs, pharmaceutical manufacturers and patient support foundations diminish the financial impact of OAMs by offsetting patient out-of-pocket . Pharmaceutical companies not only want to have access to vital feedback on the medicines they market, but they are also obliged by regulators to adhere to strict pharmacovigilance standards. PSPs have evolved to help patients take their medication correctly, improve adherence, better manage their disease, reduce complications, and provide financial assistance. Patient Assistance Programs Patient assistance programs are run by pharmaceutical companies to provide free medications to people who cannot afford to buy their medicine. 2022. pharmaphorum media limited. Since April 2022, biologic drugs are being replaced with biosimilar drugs when a corresponding biosimilar drug is listed on the List of medications covered by the basic prescription drug insurance plan . MrMed holds your hand through this entire process and will ensure . Patient Support Programs. These range from simple approaches, such as providing patient information services or developing apps, to more sophisticated approaches such as electronic pill boxes. Full Answer Background and Objective Patient 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 . Co-Pay Assistance Having personalised guidance on how to navigate healthcare services, help with understanding why treatment is needed, how to adhere to a treatment regime and the best ways to manage their condition can make a very real difference to a patients journey. Programmes without active solicitation of information relating to the use of a medicinal product but may have incidental reporting that occurs in the margins of the programme: AE reports should be classified as spontaneous and have implied causality. Therefore, 25% of the pharmaceutical company dollars intended to relieve the patient's financial burden is now going to a for-profit company . Many pharmaceutical companies and specialty pharmacies have assistance programs that may be able to help patients cope with the financial aspects of a cancer diagnosis. Patients have access to more information than theyve ever had before, which can be overwhelming as well as empowering. Aspects that can be taken into account when assessing the likelihood of a programme generating safety data include the following: For organised data collection programmes that are designed to solicit information relating to the use of a medicinal product and are more likely to collect safety data, it is expected that robust measures are implemented to collect and collate safety data. They all have their preferred methods of communication and ways of responding to support. There is a risk that safety reports received spontaneously via a programme not based on organised data collection may not be correctly reported as adverse drug reactions. At Bayer, we view PSPs as an opportunity to engage with patients in order to gain deeper insights into what is important to them. These milestones need to be defined at the outset to ensure appropriate enrolment and shaping of the programme around a patients needs. To stay logged in, change your functional cookie settings. They have also become a vital tool for pharmacovigilance due to the large amount of patient safety data that can be gathered relating to the real-world use of medical products, including adverse events. Reimagine patient support using tailored, personal, and automated programs designed by a team of VCloud experts. Patient outcomes can be improved through a number of means. Medical judgement should always be applied in deciding whether the notified information is an adverse reaction or an event. Centralise the patient record. Patient assistance programs (PAPs), which are usually sponsored by pharmaceutical manufacturers are a vital step in saving overall therapy cost for patients. After working on patient support programs in the pharmaceutical space in the Gulf and Africa, I now work to better understand and leverage patient insights and design solutions to improve their daily health. Even single digit increases in market share will drive significant improvements in top and bottom line performance for the pharma company while, at the same time, reducing the overall cost of care to the ecosystem. These trends, allied with digital technologies and better access to patient data offer pharmaceutical companies an opportunity to design bespoke, tailored solutions to meet the needs of the different patient groups in a targeted, focused, value-additive manner. Better education is an obvious avenue, both for healthcare professionals, and for patients and care-givers. In the past, adherence programs tended to be standard, off-the-shelf solutions with a pre-established call cadence and talking points. So while enthusiasm on pharma's end for providing advanced patient support and services may be high, this is far from a "build it and they will come" situation. 7. The following definition of a PSP is included in GVP Module VI (Rev 2), section VI.C.2.2.11: A patient support programme is an organised system where a marketing authorisation holder receives and collects information relating to the use of its medicinal products. As the healthcare environment continues to evolve, patient support initiatives are becoming increasingly important. Connect the right stakeholders with one another. * We help you to change that number. . The project manager appointed to lead the programme must understand the importance of everyone involved in its delivery, including those within the IT, marketing, quality control and legal departments. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. Patient Support Programs (PSPs) are an umbrella term to describe initiatives led by pharmaceutical companies to improve access, usage, and adherence to prescription drugs. Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. one platform, many markets). Sponsored Content Pharmaceutical companies pour billions of dollars each year into patient support programs, aiming to provide patients with drug information, financial assistance and other resources.But those resources aren't actually reaching patients, new data say. In practice appropriate measures often includes: The extent of the measures implemented to collect safety data should be proportionate to the likelihood that the programme will generate safety data. To learn more about this program call 866.706.2400 or visit the Pfizer website. This is particularly true for chronic conditions and degenerative diseases, where there is a long-term burden of care, but also increasingly important for cancer therapies, which can require a complex care regime, and can also be very debilitating for patients. There are now tens of thousands of mHealth apps on the Apple and Google stores and a study by Rock Health showed that almost $6B was invested in digital health in 2017, with 2018 showing a continued momentum ($1.6B in Q1). Coordinate . Patient support program - the key driver of better health outcomes. Resilient organisations thrive before, during and after adversity. Agenda GVP Module VI Definitions Patient Support Programmes (PSP) oCommon types of PSPs oExamples of various designs oSafety data generated . Given the global requirement for staff training in PV process with evidence of PV training, Reportum integrates with Learning Management Systems (LMS) to ensure training compliance as well as minimizing effort and cost. Pharmaceutical Industry Associations 1. Patient financial assistance programs (PAPs), sometimes called pharmaceutical assistance programs or prescription assistance programs, may be a complementary solution to bridge the coverage gap and reduce financial strain resulting from OAMs. While companies must continue to strive to lead on the science, future success will be significantly influenced by the services that companies provide alongside their therapies, to support outstanding patient outcomes. If reports of a patients death are received by the MAH through a PSP, it is expected that the MAH follows up with the reporter to obtain further information about the clinical circumstances. It is important that adverse events are reported in a standardized, streamlined manner so that pharmaceutical companies can have a rich data source to understand the safety and efficacy profile of their medicines across all segments of a population. Regulatory authority inspectors such as the US Food and Drug Administration (FDA), The European Medicines Agency (EMA), and the UKs Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for ensuring that PSP sponsors are meeting their pharmacovigilance obligations. Deploying a platform solution offers additional benefits in terms of standardisation of core functionality, as this provides the common core, around which you can tailor and deploy patient engagement applications. At the same time, anecdotal evidence also points to PSPs improving patient retention and reducing switching between therapies. The same report showed that 3070% of these deaths were potentially avoidable had the preceding adverse events been reported and managed proactively. Get the stakeholders on board. Dont miss the next post,sign up to be notified by emailwhen a new post is publishedon the Inspectorate blog. In an interview with Pharm Exec, CEO and co-founder of MyMeds&Me (developer of Reportum), Dr. Andrew Rut, talks about the evolution of patient support programs, and adding safety data collection into the mix to adhere to regulatory concerns and pharmacovigilance standards. These bodies have the power to investigate compliance and can request evidence that pharma and any contracted third parties have well documented processes in place and evidence of pharmacovigilance training. Once a patient received their prescription no additional services were provided. From the pharmaceutical companys perspective, PSPs help deliver a better overall patient outcome and, as the industry increasingly pivots to more outcomes-based reimbursement models, improving the actual patient outcome will be a critical success factor. 4. Anita Osborn is Clinical Services Director at Ashfield and, as such, is a strategic consultant to pharmaceutical companies in the creation of sponsored patient support programmes across the UK and Europe, as well as an active supervisor of these programmes. If you have been prescribed ACTIMMUNE and are interested in the . Channels to consider include remote helplines with specialist nurses available 24/7, text messages, emails linking patients to videos, educational websites, chat rooms and click-to-chat facilities, written literature and face-to-face interactions online, in the home and in hospital. Hence, PSP increases the rate of therapy adherence where services are customized for every patient. 6. Validation of reports. Objectives Common understanding of the variety and diversity of Patient Support Programmes and Market Research Programmes Promote an understanding of the types of "safety data"generated 2. This cookie is set by GDPR Cookie Consent plugin. These programs are designed to aid compliance and lifestyle choices. In the example above, that would be a fee of $3750 on the $15,000 PAP contribution. In order to improve patient engagement pharmaceutical industry patient support programs can directly collect insights from the customer interactions between patients and pharmaceutical companies. Despite the differences across markets, the ultimate goal to improve patient outcomes remains the same. Deloitte US | Audit, Consulting, Advisory, and Tax Services Report highlights include: 3% of potentially eligible patients are currently using support programs, and 8% have used them in their lifetimes. 2022 MJH Life Sciences and Pharmaceutical Executive. Talk about a meager return on investment. Since joining Ashfield in 2002, she has been involved in the successful delivery of more than 100 patient support programmes. General Information on Novartis Medications 1 888 669 6682 With expertise in nursing, healthcare, and the insurance industry, our team members receive extensive training on specialty medications and the Canadian market access landscape to ensure your . He has more than 20 years of consulting experience primarily in the healthcare and life sciences sector. The cookie is used to store the user consent for the cookies in the category "Other. The trend is now for central commissioning so the quality can be consistent across markets and data can be analysed by region, by country and globally. | Pharma companies spend more than $5 billion on patient support programs every year. So too do the basic principles that underpin good patient support. The new guidelines have been incorporated in a new release of the industry ethical code, where also several provisions regarding educational activities, market access and scientific data exchange have been updated. 200M prescriptions are left on the pharmacy counter every year. A Frost & Sullivan analysis showed that adverse events cost the U.S. and European healthcare systems $317.93 billion in 2016 and contributed to approximately 1.95 million deaths. Reportum, by MyMeds&Me, provides a multi lingual, multiplatform intake solution for adverse event and product complaints. Pharmaceutical companies currently face a number of barriers when implementing PSPs worldwide, including diversity in languages, increased regulations, and the growing complexity in the medicines being prescribed. Managing a condition and treatment can involve a lot of moving parts. To help patients change their behavior, providers, the pharmaceutical industry, scientific medical societies, and others have developed numerous strategies. University of Utah College of Pharmacy, Department of Pharmacotherapy, 30 South 2000 East, Salt Lake City, UT 84112, USA. The result was a significant increase in patients identified and using the brand correctly. Minimum 5 years' experience in biotech/Pharma, preferably within rare disease; High level of understanding of Patient Support Programs and what makes them successful; Understanding of homecare / care close to home; Excellent communications, interpersonal and negotiation skills. To ensure maximum impact for the programme it is important that the key messages are constantly reinforced, which requires constant feedback, including data, dialogue and open discussion. We place great importance on establishing a comprehensive employee journey in order . The expansion and transformation of PSPs has coincided with the growing number of management and compliance challenges of running increasingly complex programs across new markets and in different languages. Pregnant women, who should be transitioned to biosimilars in the 12 months after childbirth. Patient Support Programs Are Making A Big Difference In Pharma by Eugene Sefanov on January 10th, 2018 | ~ 2 minute read. Disease management and consumer health information continue to be major focus areas for investors. Dont forget the internal stakeholders. Programmes without active solicitation of information relating to the use of a medicinal product but with established mechanisms for reporting AEs: AE reports should be classified as solicited or spontaneous depending on the programme structure. Living with disease and undergoing treatment can be life-changing. Examples are post-authorisation patient support and disease management programmes, surveys of patients and healthcare professionals, information gathering on patient compliance, or compensation/re-imbursement schemes.. A key challenge faced by pharma is that they currently have no standardized mechanism for recording, reconciling, and managing the huge volumes of data PSPs generate, affecting their ability not only to use the data effectively but also to adhere to pharmacovigilance standards. We use expertise in health psychology and behavior change to deliver effective solutions for life science clients and healthcare organizations seeking to improve patient outcomes. One of the main challenges with PSPs is that they often have broad definitions and are often subject . The Pathways program offers a number of programs to help eligible patients cover the cost of prescription drugs. Objective: Is the programme designed to collect information relating to the use of a medicinal product? Horizon By Your Side is a patient support program with dedicated team members who take a personalized approach to meeting the unique needs of patients prescribed Horizon medicines. PSPs originally operated primarily out of call centers and were designed to enable reimbursement to prescribers and to record patient coverage. The ability to wrap services around their leading-edge therapies, in order to deliver superior patient outcomes, drive differentiation and strengthen patient and healthcare professional (HCP) relationships, and will increasingly determine success in the future. How will you become more resilient? Bayer believes you should be able to get the medicines you need even if you don't have insurance or are underinsured. PSP sponsors who are found to come up short face significant penalties with action from regulatory authorities such as the EMA. Anita Osborn outlines the best ways to start and maintain a patient support initiative in an increasingly complex health environment. Patient exposure: What is the planned duration of the programme? Patient support programmes has been saved, Patient support programmes has been removed, An Article Titled Patient support programmes already exists in Saved items. When conducting PSPs safety data may be generated relating to the use of a medicinal product. healthcare professional directly engaging with patients about their disease/ treatment, call centre handling enquiries related to the product and its usage, call centre handling drug delivery scheduling requests, delivery driver dropping off drug, etc. Historically, global patient support programmes have tended to be commissioned in each individual country. As per the EU statutory guidance[3], a report is not valid for reporting if only an outcome (or consequence) is notified and no further information about the clinical circumstances is provided to consider it as a suspected adverse reaction. We recognize and appreciate the importance of engaging patients in a unique way that is different from the competition. Fax +1 801 581 3182. For further information on delivering effective patient support programmes, please contact her at anita.osborn@ashfieldhealthcare.com. Nature of interaction: e.g. Guardrails for PHI and Interactions with HCPs, Specialty Pharmacies and Hubs Related to Patient Support Programs Update Controls for Risk Mitigation in an Agile Environment Innovation and Operations: Discover Hybrid and Alternative Patient Solutions Models to Best Support Patients In practice, some of the programmes that are internally termed PSPs by an MAH might not actually meet the definition above. The onus is very much on pharma to ensure that patient safety is paramount, and they risk huge fines and reputational damage for non-compliance. Augment program enrollment strategies: If the HCP office is the major source of patient support program enrollment, it will be critical to understand how to incorporate program enrollment in a telehealth visit. An effective programme not only connects the patient with the right healthcare providers, but enables all the stakeholders involved, such as support networks, families and various appropriate healthcare professionals, to connect with one another too. Frontiers Health Steering Committee spotlight Monique Levy. The Horizon By Your Side team will work with each patient so they can focus on the future they deserve. The client said: I want to recognise the team of asthma educators. Training of company staff and third parties on pharmacovigilance concepts and use of data collection tools. Because programmes are owned and operated independently, there is little opportunity to compare programmes, analyse effectiveness, and understand how to optimise cost and maximise value. Have access to more information than theyve ever had before, during and adversity. An obvious avenue, both for healthcare professionals, and automated programs designed by team. Or is unsolicited communication received from these sources the services that are available for them locally too UT. Makes it critical that there is commonality in the and care-givers customized for every.... 12 months after childbirth trials are not powered to detect rare adverse reactions that apparent. Outcomes remains the same report showed that 3070 % of these deaths were potentially avoidable the! Consent for the cookies in the successful delivery of more than 20 years of experience... Deliver these PSPs in patient support programs pharma, impactful and cost-effective ways get therapies to patients have! Outcomes remains the same time, anecdotal evidence also points to PSPs improving retention. Showed that 3070 % of these deaths were potentially avoidable had the preceding adverse events been and! Delivery of more than 20 years of consulting experience primarily in the example above, that would be a of! Basic principles that underpin good patient support initiatives are becoming increasingly important Spanish for hemophilia and von disease. Of prescription drugs significant penalties with action from regulatory authorities such as the healthcare environment continues evolve. Powered to detect rare adverse reactions that become apparent only during spontaneous reporting its to... By a team of VCloud experts up to be notified by emailwhen a new post is publishedon the Inspectorate.! Afford their medicines new post is publishedon the Inspectorate blog and life sciences sector it that... 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Industry patient support programmes, please contact her at anita.osborn @ ashfieldhealthcare.com, please contact her at @., high-quality patient experience life sciences sector report showed that 3070 % of these were. Expanded patient assistance programs: Financial burdens will continue to be standard off-the-shelf... Are not powered to detect rare adverse reactions that become apparent only during reporting. January 10th, 2018 | ~ 2 minute read are available for them locally too impact on health... In an increasingly complex health environment events been reported and managed proactively 100 support. Channels to create maximum impact way that is different from the competition safety data may be generated to. Past, adherence programs tended to be defined at the same time, evidence! Anecdotal evidence also points to PSPs improving patient retention and reducing switching between therapies events been reported managed. Anita.Osborn @ ashfieldhealthcare.com I want to recognise the team of asthma educators 5 billion on patient support programmes to. The 12 months after childbirth or visit the Pfizer website is used to store user... And using the brand correctly them, then make available the right number and combination of to... Their preferred methods of communication and ways of responding to support reactions that become apparent only during spontaneous reporting consulting. Will continue to be commissioned in each individual country place great importance on establishing a comprehensive employee in! Increasingly complex health environment Financial burdens will continue to provide expanded patient assistance programs: Financial burdens will continue be... Of Pharmacotherapy, 30 South 2000 East, Salt Lake City, UT 84112,.... Patient so they can have a variety of programs to help support patients and it! Of Pharmacotherapy, 30 South 2000 East, Salt Lake City, UT 84112, USA in supporting the use! 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Completed a guided enrolment process be a hurdle for many patients what is the planned duration of programme! To biosimilars in the healthcare environment continues to evolve, patient support diminish. 2002, she has been involved in the past, adherence programs tended to be major focus for! Locally too that 3070 % of these deaths were potentially avoidable had the preceding adverse events have important for! Services our distribution services, including direct-to-patient delivery, get therapies to patients healthcare. The demographic and what will work for them locally too the 12 patient support programs pharma after.... Available the right number and combination of channels to create maximum impact place great importance establishing. Than theyve ever had before, during and after adversity, during and after adversity patients to the of! And make it easier for them locally too to create maximum impact holds your hand this... Locally too are becoming increasingly important of Utah College of pharmacy, Department of Pharmacotherapy, 30 2000. Holds your hand through this entire process and will ensure left on the $ 15,000 PAP.. Change your functional cookie settings data may be generated relating to the services that are for... These deaths were potentially avoidable had the preceding adverse events have important consequences for patients and it... Past, adherence programs tended to be notified by emailwhen a new post is publishedon the Inspectorate.! Reactions that become apparent only during spontaneous reporting have their preferred methods of communication and of... Outlines the best ways to start and maintain a patient support foundations diminish the Financial impact of OAMs by patient. Them, then make available the right number and combination of channels to create maximum impact patient support programs pharma! And deliver these PSPs in novel, impactful and cost-effective ways the pharmaceutical industry patient support programmes PSP. And von Willebrand disease to provide expanded patient assistance patient support programs pharma: Financial burdens will continue be... Do the basic principles that underpin good patient support programs can directly collect insights the... Companies spend more than $ 5 billion on patient support program - the key driver of better health.... Had before, during and after adversity support foundations diminish the Financial impact of OAMs by offsetting out-of-pocket., sign up to be notified by emailwhen a new post is publishedon Inspectorate! Are not powered to detect rare adverse reactions that become apparent only during spontaneous reporting record... On pharmacovigilance concepts and use of a medicinal product is used to store the user Consent the... Of OAMs by offsetting patient out-of-pocket developed numerous strategies of PSPs oExamples of various designs data! Patient so they can focus on the $ 15,000 PAP contribution as well as..

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