ONE Safety Patient Engagement – Website Enhancement Opportunity

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Presentation transcript:

ONE Safety Patient Engagement – Website Enhancement Opportunity June 2018 Beverly Harrison, Sr. Director and Head, Patient Support, GMO

Background and Objective of The Website Analysis Company websites are a key communication channel for delivery of information to patients Company websites could be used to educate patients about safety related topics, as well as to encourage patient AE reporting in an efficient and user friendly manner Objective of the survey and analysis: To survey what patient directed safety education and AE related information is available on biopharma company websites To begin to reveal potential best practices

Website Analysis Approach Company Selection: The top 20 biopharma companies, as defined by 2017 global revenue, were selected to be surveyed Method: Patient AE reporting information and safety education pages were identified through Google searches with select key words and the company name (e.g. “Janssen side effect”, “Janssen patient safety”, “Janssen adverse events”) Google searches were conducted from a US location Company websites were also navigated from the links that emerged in the search results Notes: Global and US company webpages were analyzed, potentially introducing a US bias into the analysis This analysis did not include how companies may list safety or AE information on product specific websites for patients The relative ease of finding information on company websites was not a part of the analysis (this is an analysis of if the information exists or not, and what information is included)

Dedicated webpages with information for patient to report adverse event are common 17 of 20 companies surveyed have instructions for patients on how to report AEs on their websites Roche, Biogen, and AbbVie do not have any publicly posted information about patients reporting AEs to the company 11 companies have dedicated AE reporting pages Some include educational information on why AEs may occur, the importance of reporting, and how the company uses the information Some of the companies make clear efforts to use patient friendly language Some companies have interactive ‘portals’ that enable patients to enter information in a potentially easy-to-use, step wise manner 5 companies do this through their general ‘contact us’ page (including Janssen) For many of these ‘contact us’ pages, the info for patient AE reporting is not easily identifiable (a sentence or 2 among paragraphs of text), and generally use more technical, less patient friendly language. 1 company (Merck) has patient AE reporting info on both a dedicated page, and on its contact-us page

Multiple companies have general patient safety education webpages 9 of 20 companies have a dedicated safety education webpage (or set of linked webpages) All 9 companies explain the steps that they take in the development process, and in post marketing with PV, to evaluate and then track the safety of their products 8 companies include information about the dangers of counterfeit products, or link to pages on this topic 5 companies make apparent efforts to describe safety concepts in patient friendly language (laymen terms) 5 companies provide patient AE reporting information, or link to their dedicated AE reporting page from their safety education page

Detailed Findings and Examples

(1/2) Patient AE Reporting Information Website Survey Company Any contact info/ instructions for patient reporting AEs? Through general ‘contact us’ page? Through dedicated AE reporting web-page? Modes of contact Other Notes Janssen Yes Yes (link) No Phone Also have downloadable .pdf with global contact info and emails in addition to phone number Pfizer Links to Medicine Safety page, and has MedWatch info Roche N/A Instruct patients to contact personal physician (link) Merck Also directs patients to product pages Sanofi Instructs to contact HCP, gives FDA MedWatch info, and Sanofi, with description of information to provide BMS Also have link to a global site that provides #s for Ex-us countries to report side effects Bayer Online portal Explains what side effects/PV is, and then links to a portal to fill out select information in a step-by-step approach GSK Email, Phone Describes how GSK takes seriously, and how use data. Lists the information to provide. Novartis Online portal, email Explains what a side effect is, and why you should report side effects. Amgen Describes what AEs are, gives MedWatch information in addition to phone #, and recommends what information to report

(2/2) Patient AE Reporting Information Website Survey Company Any contact info/ instructions for patient reporting AEs? Through general ‘contact us’? Through dedicated web-page? Modes of contact Other Notes Shire Yes Yes (link) No Email Not necessarily patient or HCP direct – just states ‘to report suspected side effects’ on corporate contact page Biogen N/A Instructs patients to call your doctors, and/or to report to the FDA (link). Gilead Phone Nothing more than provides a number to call to ‘report an adverse event’ Celgene Online form, email, Phone, mail The most comprehensive out of any company in terms of number of available channels to report an AE Novo Nordisk Online form, Phone Includes definition of side effect, and why you should report. Eli Lilly Provides both Lilly phone number and FDA MedWatch info Teva Online Form General corporate contact page has form, in which AE reporting is an option to choose AbbVie No apparent information for Patient AE reporting Astra - Zeneca Online form Boehringer Ingleheim

AE Reporting Page Examples 1 Sanofi-Genzyme: Example of relative simplicity Brief note encouraging patients/HCPs to report Explains what a side effect/AE is Gives steps to take if you are a patient that believes you are experiencing a side effect (first contact HCP) Provides FDA MedWatch info as one avenue to report Provides contact info for Sanofi-Genzyme with an overview of what information will be requested Bayer: Advanced portal that may enhance user experience and intake efficiency Explains why side effects may occur Why capturing side effects post-approval is important Ties together the importance of PV for Bayer and various stakeholders including patients Relatively advanced intake portal for reported AEs 2

Sanofi-Genzyme Reporting Page (link) 1 Sanofi-Genzyme Reporting Page (link) Why collect side information Explanation of what side effects/ AEs are Instructions for contacting, and what may happen afterwards Information to have ready when contacting about side effect/AE

Bayer Reporting Page (link) Portal (link) 2 Bayer Reporting Page (link) Portal (link) What side effects are, and why collect side effects/ AEs Why important to Bayer, importance of stakeholder collaboration Portal that takes you through in a stepwise manner to provide side effect information

(1/2) General Patient Safety Education Information Survey (non-product specific) Company Patient Safety Education Page(s) Layman description of safety concepts Education on steps the company takes/ activities performed for patient safety Information about counterfeits on safety education page or linked AE reporting info, or link to AE reporting pg? Notes Janssen No Pfizer Yes (link) Yes Also has information on disposing of unused medicines, and sharps disposal. Roche Roche has a significant amount of patient safety information – but notably does not encourage patients to report AEs Merck Lots of info, but relatively technical and not written in a very patient friendly manner. Provides AE reporting info directly., Sanofi Some info on AE reporting page, but don’t consider to be at the same level as others BMS Bayer Clean and interactive knowledge tour of the benefits and risk of drugs. GSK Novartis Amgen Lots of info, but relatively technical and not written in a very patient friendly manner.

(2/2) General Patient Safety Education Information Survey (non-product specific) Company Patient Safety Education Page(s) Layman description of safety concepts Education on steps the company takes/ activities performed for patient safety Information about counterfeits on safety education page or linked AE reporting info, or link to AE reporting pg? Notes Shire No Biogen Gilead Do have counterfeiting information on website Celgene Novo Nordisk Yes (link) Yes Eli Lilly Teva AbbVie Astra - Zeneca Don’t have webpage, but do have patient safety information in a downloadable PDF. Boehringer Ingleheim

Patient Safety Education Website Examples 1 Pfizer: A comprehensive patient safety education site The pages breaks the information into sections. Topics include: The patient role in drug safety (e.g. shared decision making) Concept of benefit/risks The steps taken to analyze drug safety in different phases of its life The different stakeholders in safety Information on how to dispose of unused medicines, sharps, and counterfeits Bayer: A ‘knowledge tour’ educates patients about the benefits and risk of drugs The knowledge tour covers B/R drug development. Topics include: Overall concept of B/R, and the B/R of drugs are determined Tips for patients for how to interpret the PI How to react to statistics quoted about drugs by the media (‘risk literacy’ Warnings about changing doses/ splitting pills with out discussing with HCP/Pharmacist What to do if you experience a side effect Counterfeits 2

Pfizer Patient Safety Education Website (link) 1 Pfizer Patient Safety Education Website (link) Education information segmented into categories Links to other topics and AE reporting pg.

Bayer’s home page to explain benefit-risk (link) 2 Bayer’s home page to explain benefit-risk (link) Bayer has multiple resources on its website, including an interactive ‘knowledge tour’, and a patient oriented series of PV education videos on YouTube. Video topics include: What is PV? How does PV work? PV – You can help to improve patient safety Bayer YouTube Videos https://www.youtube.com/watch?v=wbQUy8_mj9s https://www.youtube.com/watch?v=VjqqaGOqUm8 https://www.youtube.com/watch?v=pjW1UiTp0G0 Bayer is an example of a peer who is actively positioning patients as partners with their safety activities https://www.bayer.com/en/risks-benefits-drugs-patient-information.aspx

Bayer Patient Knowledge Tour About B/R (link) 2 Bayer Patient Knowledge Tour About B/R (link) Bayer’s ‘Knowledge Tour’ goes through various B/R related topics from the patient perspective, and is interactive through videos, downloadable education brochures, and ‘quizzes’