Age of pharmaceutical blockbusters is over. Advertising, promotion and sales of drugs is restricted. Social media is new metrics for drug success. Many pharmaceutical companies try to measure the success of their launch based on weekly script trends. The difference between social media data and data derived from prescriptions is significant: social media data can predict the future, while script data record the past. Could we transform pharmacovigilance into customer experience management tool? European pharmacovigilance legislation calls for increased participation by patients and consumers in the pharmacovigilance process and company sponsored websites can be useful tools to this end. Online patient conversations and information is growing exponentially but understanding and leveraging that data remains a challenge for most pharmaceutical companies. Switching from one medicine to another is the major topic of patients on line discussions. Smaller and generic pharma companies have been quicker to embrace the patient voice as a valuable real-time information source as they felt it more intuitive, unbiased and cost-effective than traditional market research.
Citation preview
HOW TO TRANSFORM
PHARMACOVIGILANCE & ADHERENCE
INTO CUSTOMER
EXPERIENCE MANAGEMENT TOOLS
AGE OF BLOCKBUSTERS IS OVER
• Big data crunching • MedApps • Preventive medicine • eHealth records
• DNA databanks • Tissue and cell banks • Regenerative medicine • Nanotechnology
PROMOTION, SALES AND ADVERTISING IS RESTRICTED
Directives: • 2001/83/EC • 2004/27/EC Amending
Directive 2001/83/EC • EFPIA Code on the
Promotion to HCP • Rx vs Non-Rx • To Public vs to HCPs
• PATINET – central to
regulators
Predavač
Bilješke uz prezentaciju
EU Member States must prohibit the advertising to the general public of medicinal products which: Are available on medical prescription only; Contain psychotropic or narcotic substances; Are not intended for use without the intervention of a medical practitioner. The EFPIA HCP Code covers all methods of promotion including, but not limited to, oral and written promotional activities and communications, journal and direct mail advertising, the activities of Medical Sales Representatives, the use of internet and other electronic communications, the use of audio-visual systems such as films, video recordings, data storage services and the like, and the provision of samples, gifts and hospitality. As the industry focuses on understanding the guidelines and how to execute against them, we find that the larger point is that the regulators clearly recognizes the value of patient conversations on the Internet. The key for Pharma is how to leverage this new force in healthcare: the online empowered patient. We see the benefits that the Internet brings to patients every day. The more data we garner on patient experiences, the more informed the pharmaceutical industry becomes, in decision-making around medications and treatments. In this context, the patient insights available through user generated content can help pharma gain the relevant information they need to become true partners with patients and caregivers. Exceeding the Patient Demand for Responsiveness. Embracing social media will require a willingness to move beyond the tightly controlled environment to which pharma is accustomed to take their patient-focused communications to a whole new level. No doubt navigating in the realm of immediate, transparent and responsive social media communications will come with a steep learning curve.��For those willing to take it on the rewards can be great because immediacy, transparency and responsiveness are precisely what patients online have come to expect. It’s apparent in the hundreds of thousands of posts we see patients generate daily across more than 3,000 social health sites to voice their concerns, needs, fears and hopes when its comes to their health.
SOCIAL MEDIA IS NEW METRICS FOR DRUG SUCCESS
• Online patient conversations and information is growing exponentially
• Switching is a major topic of patient online discussion.
Predavač
Bilješke uz prezentaciju
Social media can predict the success of a new drug launch much faster than traditional methods. Many pharmaceutical companies try to measure the success of their launch based on weekly script trends. The difference between social media data and data derived from prescriptions is significant: social media data can predict the future, while script data record the past. Company Treato distills the patient voice from billions of patient-written social media posts on over 2,000 health blogs and forums. They filter out the patient experiences from the spam and other noise and analyze them using proprietary Natural Language Processing algorithms in our Big Data processing servers. The result is unique insights into drugs, conditions, and all that’s in between. Online patient conversations and information is growing exponentially but understanding and leveraging that data remains a challenge for most pharmaceutical companies. Smaller pharma companies have been quicker to embrace the patient voice as a valuable real-time information source as they felt it more intuitive, unbiased and cost-effective than traditional market research. “Social Media” for healthcare information is often incorrectly used interchangeably to refer to just two key networks, Twitter and Facebook. Consumers do not want to talk about sensitive health issues on their personal profiles. They are turning to thousands of anonymous health sites where they can ask questions and discuss their first hand health experiences without fear of personal exposure or their privacy being compromised.
• Module VI of the Good Pharmacovigilance Practice Guidelines
• Prescription Medicines Code of Practice Authority (PMCPA) issued helpful guidance for the industry on digital communications
• Company sponsored websites • MedApps
• Non-company sponsored websites
Source: http://www.pmcpa.org.uk/
Predavač
Bilješke uz prezentaciju
European pharmacovigilance legislation calls for increased participation by patients and consumers in the pharmacovigilance process and company sponsored websites can be useful tools to this end. Companies have a high degree of control over company-sponsored websites, which are important sources of safety information and can be designed to facilitate pharmacovigilance. Web pages can provide access to adverse event reporting tools or include free text fields, to report suspected side effects. Other components like 'Terms and Conditions' or formal site registration can be used to enable companies identify and contact users to validate and follow-up on safety information. Moderation processes can also be implemented for companies to define actions to be taken in response to safety information being posted. On company-sponsored websites, details of all adverse events or product complaints for the company's products needs to be collected and documented. The date the information was posted on the site and the date that anyone from the company or working on behalf of the company first becomes aware of the information must also be acknowleged. Companies may release company sponsored apps for smart phones and tablet computers, where the app user can post comments on a non-company-sponsored site such as the app store through which the app is made available. Companies would not routinely be required to monitor app review comments posted on these platforms which are considered non-company sponsored digital media. However, if the company periodically reviews these comments for other purposes, any adverse event or product complaint identified should be collected and reported appropriately. Adverse event reporting is performed according to strict timelines but as there is no legal requirement to monitor non-company sponsored sites. Day zero is the day that the company first becomes aware of the adverse event or product complaint. Content generated via the app itself is to be treated as a company sponsored digital activity. Companies may become aware of adverse events or product complaints on non-company-sponsored public portals or micro-blogging sites where content can be viewed by many site users. The company has a responsibility to follow-up these reports and should consider the most appropriate method of follow-up to protect patient confidentiality. For example, the company may direct the site user to contact the company via the company website, email or phone to provide further information.
ARE WE AT THE TURNING POINT ? “Janssen Healthcare Innovation is developing products and services to transform the patient experience and promote better health outcoes . We have identified improving medication adherence as one of our key initiatives .” Diego Miralles, M .D ., Head of Janssen Healthcare Innovation
“We have a better picture of what patients want from us and expect from us. That allows our R&D staff to think about the patient much earlier on in development and ultimately will lead to a much better solution for patients in the long run.” John Koconis, president and CEO, LEO Pharma Inc.
YES
Predavač
Bilješke uz prezentaciju
Negative trends: •Weaker pipelines •More rigid reimbursement rules – comparison to gold standard •Greater transparency / internet •Competitive pressure – disrupting trends •Success of innovations not just measured in clinical trials, but in real life Disruptive trends: Era of Blockbusters is over Big data chanching eHealth records DNA databanks Tissue and cell banks Regenerative medicine MedApps Solution : Disrupt of be disrupted!
WHY THE FOCUS ON ADHERENCE NOW? • Payers, Providers,
Regulators and Pharma have shared goal to achieve best outcomes from medicine use
• Real life value of medicines to patients and society is compromised by poor adherence
• Increased behavioral understanding and digital technology has created new opportunities
DRUGS DON'T WORK IF PATIENTS DON'T TAKE THEM
RESPONSIBLE MEDICINE USE
RESEARCH: PREVALENCE OF NON-ADHERENCE IN ASTHMA
1/5 of adult patients never fill the script
Average adherence rate: 47.5%
Rate of clinically sufficient treatment days: 34%
Self-monitoring (daily peak-flow): 39%
Diary over 6 months: 16.5%
Correct usage of inhaler: 25-30%
Prof Stephan Mühlig, TU Chemnitz
CAUSES OF NON-ADHERENCE
BUDGET FOR ADHERENCE PROGRAM
CASE STUDY: ECEMA MED-APP
Baseline Parents record current behavior for 2 weeks using eczema app.
Support programme Patients receive education pack + 30 min coaching call with eczema specialist nurse
Follow up Parents record adherence & outcomes post intervention for 2 weeks, and for another week at months 2 & 3
Source: Mrs. Marianne Gries, Regulanet Confernece
CASE STUDY: ECEMA MED-APP
• A UK phone coaching programme to bring emollient adherence closer in line with NICE guidelines
• Increase adherence & patient happiness, reduce eczema symptoms and referrals to the GP & Specialist
• Avg. 206% increase in adherence, 100% reported increased happiness, 81% reported significant reduction in eczema symptoms.
- Average 206% increase in emollient use - 81% of patients recorded a significant improvement in eczema symptoms 3 months after the support intervention
- Significant reduction in average GP visits after intervention. 1.9 pre coaching call down to 0.13 in following months
Results independently analysed by The Robertson Centre for Biostatistics, Glasgow University
STUDY: Improved emollient use reduces atopic eczema symptoms and is cost neutral in infants: before-and-after evaluation of a multifaceted educational support programe J M Mason; BMC Dermatology 2013, 13:7
CASE STUDY: MED-APP + MED-DEV + CLOUD
regulanet ®
250+ staff and associates
FarmavitaR+ RA Community (www.farmavitar.com) 1000+ registered users
worldwide
JV Partners Germany; England, Croatia; Portugal;
FarmavitaR+ 30+ staff and associates
FarmavitaR+ - 15 countries EU – Czech, Slovakia, Hungary, Slovenia, Croatia, Bulgaria. Romania Non-EU – Turkey, Ukraine, Serbia, Bosnia&Herzegovina, Montenegro, Macedonia, Kosovo, Albania regulanet® - 90 countries Rest of EMEA, USA, Japan, Brazil, Russia, India, China, Canada, GCC countries, Mercosur countries, Africa Our talent pool, worldwide
