Categories
Digital Health

Deprexis DiGA approved! 11th Digital Therapeutics (DTx) reimbursed in Germany

Deprexis – Digital therapeutics (DTx) for depression has received DiGA fast-track approval for DTx prescription and reimbursement in Germany.

The innovative DiGA process allows for fast-track approval of digital therapeutics and is the first such program in the world. It was created by the 2019 Digital Healthcare Act and allows apps to be prescribed by doctors while costs will be reimbursed through German statutory health insurance. 

The federal regulator, BfArM, manages DiGA. To get through DiGA, there are certain conditions:

  • Safety and Suitability for Use confirmed by CE certification as a medical product in the lowest-risk classes
  • Data Protection Conformity to data protection legislation (EU-wide GDPR and German Federal Data Protection Act (BDSG)) 
  • Information security Assessment is based on the recommendations of the German Federal Office for Information Security (BSI) and specific parts of  IT-Grundschutz (ITbasic data protection) catalogs designated for healthcare apps. 
  • Interoperability Related to German central IT standards directory available via online platform vesta, managed by gematik
  • Availability of preliminary data on the health benefits provided. Data must show that patient-relevant endpoints, in particular morbidity, mortality, or quality of life, are positively influenced.

Check out the full guide for DiGA here.

Results of DTx DiGA assessment as of June 2022. Source: BfArM.

At the time of writing this, there were 59 applications for DiGA listing, 40 for provisional listing, and 19 for the final listing. So far BfArM has approved 11 applications and rejected one. 25 applications have been withdrawn. In theory, the full approval process should take three months.

Deprexis, the 11th DiGA-approved application is interesting on its own. The manufacturer of the app is GAIA Group, an offspring of Airbus which builds its products on a proprietary AI platform called broca.

Deprexis, Digital Therapeutics (DTx) for depression. Source: GAIA Group AG


The focus here is clearly not on UX, but on medical benefits. Deprexis may not have the nicest UX, but is a proper DTx providing a three-month-long highly individualized Cognitive Behavioral Therapy support program for patients with depression. Application is able to perform a dialogue with the patient, learning from the input on the way. It contains 10 content modules and is available online via desktop and mobile app interface. 

Deprexis is backed by clinical data from at least nine studies, one of which had a sample of 3,800 patients, which does not sound much in pharmaceuticals, but it is a lot in DTx. While in Germany it just received reimbursement, in the US the price for treatment is $400 one-time payment, or $540 in three monthly installments of $135 each.

Categories
Digital Health

Big Data, AI and Coronavirus COVID-19 (NCov-2019)

Coronavirus COVID-19 (NCov-2019) has tested some of the digital health capabilities such as AI-based predicitive models and real-time big data visualization. As a positive side effect, it has also allowed public to learn about epidemiology via video games.

 

AI-based predictive models caught COVID-19 faster than us

According to the news reports, two AI-based and one human volunteer-based warning systems were first to alert humanity about the threat coming from Wuhan.

HealthMap Project Website

The first to react was the automated HealthMap system at Boston Children’s Hospital, which scans online news and social media reports for signals of spreading disease. Its warning was very quick and accurate (pneumonia cases in Wuhan) – raised at 11:12PM local time on December 30, but it did not assign significance high enough to the message.

The second report came from a human. Marjorie Pollack from the Program for Monitoring Emerging Diseases (ProMed)  has based on similar social media reports received about 4 hours before the HealthMap warning. ProMed team’s analysis was more detailed than the first warning from AI but came about half an hour later.

BlueDot Explorer (screenshot from the website)

The third and most publicized report came from another AI-based model called BlueDot. BlueDot first became aware of the pneumonia cases in Wuhan on December 31st, and in addition to notifying their clients and government stakeholders directly, they publicly released their findings in the Journal of Travel Medicine on January 14th. While it was not truly the fastest, it is worth hearing how Kamran Khan, a Canadian MD, and founder of BlueDot explains the process behind.

Big Data Visualization to track Coronavirus COVID-19 (NCov-2019)

Dashboards showing the number of infected people, geographical spread and trends of the disease are useful to HCPs but also journalists and the public. This use case, although unfortunate, shows how important it is to be able to see and not only read data.

coronavirus covid19 dashboard
Screenshot of the COVID-19 dashboard by Johns Hopkins CSSE

The first and most known dashboard came from the team at Johns Hopkins University. The dashboard, first shared publicly on Jan 22, illustrates the location and number of confirmed COVID-19 cases, deaths, and recoveries for all affected countries. It has been accompanied by an article in The Lancet.

Currently, there are multiple dashboards showing diverse aspects of the epidemic of COVID-19. The list of dashboards with working links can be found at ESRI website.

Coronavirus virally spreads a game for people want to know

Due to the virus business slows down. Except for Ndemic Creations, a studio that in 2012 developed Plague Inc. A game that simulates a viral epidemic.

Plague Inc. is a game, but it is based on science and realistically shows the spread of viral infections amongst the human population. In the game, the player is supposed to infect all humans before the cure is available. It is so successful in teaching about epidemiology, that it has been endorsed by the CDC. During the COVID-19 outbreak, it has reached the top of charts on the Apple Store. According to its developers, similar peaks in popularity have accompanied the Ebola outbreak in Africa in 2014-2016.

Categories
Pharma Marketing

ACI’s Digital Marketing in Healthcare

On the 26th and 27th of October in London, I had the pleasure of participating in the ACI’s Digital Marketing in Healthcare Conference. This relatively small event has gathered an unusual, interesting set of speakers and guests coming not only from the pharmaceutical industry and its vendors.

Tom Macfarlane (Accenture) speaks at ACI Digital Marketing in Healthcare Conference, London 2016


As it often happens on such occasions, I have particularly enjoyed conversations over coffee outside of the conference room. It has been a pleasure to meet and talk to:

  • Simeon Mellor [@MellorSimeon] from AstraZeneca (on digitalisation of procurement and shared services in Poland)
  • Caryn Kavovit and Linda Bew from London office of WebMD (on disease awareness campaigns and differences between US and UK market)
  • Ann-Charlotte Beckman running the Swedish Netdoktor (great stories on disease awareness campaigns for Pfizer’s Viagra)
  • Nicole Ferguson from Iq Digital Media Marketing (on content marketing in Germany and Switzerland)
  • Rob Wyer [@robwyer] from Swii.ch (on measuring and impacting behavioural changes via digital channels)
  • Yamelis Figueredo from BMS (on challenges of global versus local approach to digital marketing in pharmaceutical industry

Of course, this does not mean that presentations were not valuable. Due to Chiltern Railway’s failure I have not been able to hear highly appreciated presentation of NHS’ Head Of Digital Primary Care Development, Tracy Grainer [@tracey_grainger].
I have enjoyed a comprehensive review of digital space in healthcare by Tom Macfarlane [@tomwmacfarlane], Director and Lead of IDMP offering in Accenture Life Sciences. Tom has touched on all critical points in the current discussions on digital marketing in healthcare. Patient engagement, regulatory environment, technological advancements of EHR and IOT/QS. Very dense, highly engaging presentation.
I have been lucky to share the panel with two great speakers. Looking at their biographies one could expect them to confront each other:
A disrupting future personalised by Dr Tobias D. Gantner, CEO and Founder of HealthCare Futurist who genuinely hacks the healthcare industry to make the future happen now. Tobias gave us some feel of Steve Jobs reality distortion with his ideas such as a wifi connected baby pacifier filled with temperature and pressure sensors and enabled with paracetamol ejection device.
A traditional, sales-driven approach of Dr Graham Leask, a pharma executive with 20 years of experience in pharmaceutical sales and marketing, now a marketing strategy lecturer at Aston University in Birmingham. Well, experienced does not mean being backwards or conservative. Dr Leask has actually preached the same multichannel, measurable, digitally enabled approach to marketing as offered by the author of this text.
The same story has been told over again by Anders Tullgren, President of Intercontinental Markets in BMS and Carmen Chavarri running Digital for Neuroscience franchise of Shire in Spain. Uri Goren from Teva has opened an interesting topic of using digital channels to crowdsource healthcare solutions with patient advocacy groups.
I have left ACI’s Digital Marketing in Healthcare Conference feeling that the industry as a whole has finally embraced digital channels. Whether it is Chloe Wates‘ selection of speakers or just a reality of today? What are your thoughts?

Categories
Pharma Marketing

(Not) The Best Pharmaceutical Ads – Lions Healthcare 2016

Lions Healthcare 2016 Awards for the best pharmaceutical advertising have been announced.  See the winners.
As every year, what they show is that pharma advertising lacks creativity. What is more important, 2016 Lions Healthcare Pharma winners are not those most efficient in conveying the message and changing prescription behaviors.
Lions Healthcare is a contest made by agencies and for agencies. Looking at the winners, but also at the shortlist of submission it is clear that agencies have no idea how to operate in regulated markets. They are creative while talking to general public, on disease awareness or about medical devices.
When it comes to branded, promotional communication directed to healthcare professionals pharma marketers are on their own. Or they get offered a dead fish, which has been a winner in 2015.

Cannes Lions 2015


In the 2016 Lions Healthcare Awards, no agency has been able to get a prize for creativity while providing multichannel content that is fact-based and scientifically proven. Oh, well, indeed – McCann has made some disgusting posters for Pfizer’s Xalatan,  get the prize, and left us not impressed, again.
Does it mean that advertising agencies are creative only when they can lie or stretch facts? Is it really too hard to clearly state the advantages of pharmaceutical products that extend or save lives? Somehow, hundreds of pharma marketers and thousands of sales reps are able to produce and convey such messaging every day. Is it bland? Maybe. We are still waiting for agency content that would be both creative and at the same time compliant. Saying that, please take a look at the 2016 Lions Healthcare Grand Prix and Gold Lions below.

GRAND PRIX – LIONS HEALTHCARE 2016

BREATHLESS CHOIR – PHILIPS

A Breathless Choir | Presented by Philips


By: OGILVY & MATHER LONDON
Category: PHARMA >  COMMUNICATIONS TO NON-HEALTHCARE PROFESSIONALS > DEVICES & DIAGNOSTICS

GOLD – LIONS HEALTHCARE 2016

THE NAZAR INITIATIVE – ASTER HEALTHCARE

Aster’s The Nazar Initiative


By: THE CLASSIC PARTNERSHIP ADVERTISING
Category: PHARMA >  PHARMA COMMUNICATIONS TOOLS & DEVICES > HCP DEVICES & DIAGNOSTICS

GOLD – CAMPAIGN AWARD – LIONS HEALTHCARE 2016

GAMEBOY/STUDENT/PAINTER – PFIZER CORPORATION HONGKONG



By: McCANN HEALTH
Category: PHARMA > COMMUNICATIONS TO NON-HEALTHCARE PROFESSIONALS > PHARMA, VACCINES & BIOTECH – BRANDED COMMUNICATION

GOLD – LIONS HEALTHCARE 2016

LAST WORDS – INDIAN ASSOCIATION OF PALLIATIVE CARE (IAPC)

#LastWords IAPC


By: MEDULLA COMMUNICATIONS
Category: PHARMA > COMMUNICATIONS TO HEALTHCARE PROFESSIONALS > EDUCATION & AWARENESS
 

Categories
Digital Health MedTech Pharma Marketing

MoovCare – a clinically proven mHealth app in lung cancer treatment

MoovCare, a mHealth app to help patients with lung cancer presented at the annual American Society of Clinical Oncology (ASCO) meeting.

moovcare on tablet
MoovCare tablet interface

An Israeli company Sivan Innovation and the Cancer Institute of Western France are behind MoovCare – a mHealth application presented at the ASCO annual meeting in Chicago.


MoovCare claims to be the first application of its kind. It allows controlling lung cancer treatment based on reports on outcomes submitted by patients via web or mobile-connected devices. It enables the early identification of relapse or complications requiring rapid and specific care.
According to the clinical data from the III phase randomized study on 300 patients as presented at ASCO, this mHealth application provides direct benefit in terms of prolonged survival.


The main advantage of using the app in lung cancer therapy is early detection of relapse, which is symptomatic and typical for lung cancer. This allows optimal treatment and in turn increases of survival rate among patients.


An additional effect of the app is improved treatment compliance (observance of scheduled visits, lower number of inopportune phone calls, lower number of imaging). All this at a comparatively very low cost of less than 10 000 USD versus 265 000 USD per one CT-scan for Lung Cancer.

How does MoovCare work?

MoovCare mHealth app lung cancer Mode of Action – Sivan Innovation
MoovCare mHealth app lung cancer Mode of Action – Sivan Innovation


MoovCare is being “prescribed” to ambulatory patients. Patients are asked to fill in the web-based form each week, self-assessing 12 clinical parameters and having a free text field to enter any information they consider of importance. Data are securely passed and processed within the application. An algorithm behind MoovCare analyses the data provided and in case of any anomaly detected reports it to the oncologist and hospital dashboard. Based on the alert from Moovcare healthcare providers can contact patients and take any necessary action.
Company and research behind MoovCare.


MoovCare is a product of Sivan Innovation. Founded in 2014 in Jerusalem by Daniel Israel, Sivan Innovation is an Israeli E-health start-up and R&D company.

The research presented at ASCO has been conducted by Dr. Fabrice Denis at the Cancer Institute of Western France


MoovCare is a perfect example of how digital innovation, mHealth, and IoT trends are positively impacting healthcare and patient outcomes. We look forward to seeing more of such innovations coming not only from startups such as Sivan innovation but also from Big Pharma companies with their vast R&D resources.
 

Categories
Pharma Marketing

Super Bowl 2016 Ads Cry for Total Ban of DTC Pharma Marketing

2016 Super Bowl ads by pharmaceutical companies are perfect examples why DTC should be banned.
Every year NFL championship game is a show off for creative advertisement. In 2016, however, pharmaceutical companies joined the show to leave viewers in disgust. Viewers of the Super Bowl have been exposed to truly engaging stories.
First, Astra Zeneca and Daiichi Sankyo  shared effort:
https://youtu.be/yr78_7Kip3Q
We cannot imagine how the first brief looked like, but the message of the ad is that if you take opioids and get constipation, Astra Zeneca offers prescription drug for it. The ad is supposed to be serious, socially conscious and artistic. It has been instantly ridiculed in social media.
The “poo” issue is seemingly important to Pharma industry as Valeant came with yet another ad on the topic, promoting Xifaxan, an antibiotic prescribed for irritable bowel syndrome. Now it seems we are fine regardless whether it is diarrhoea or constipation.

Valeant marketers could not stop themselves, and delivered another great piece. No poo involved just a fungal infection on the toenail. Hope you are not eating.

Hurray, it seems we (pharma) have just solved all the most important problems of our patients with those products.
At K-message we truly understand the commercial side of pharmaceutical industry. However, examples above show how badly we can end when marketers are allowed to advertise directly to consumers. Those ads are clearly directed to expand the market for products, that would otherwise not be prescribed.
In case of AstraZeneca there is some value behind the ad, as it raises important issue in the country addicted to opioid painkillers. Maybe we would be happier seeing a warning against opioid’s overdose (19 000 deaths last year), but fine, some patients really need strong painkillers and the should not suffer with constipation.
Valeant has no excuse. Those ads are just stupid, they include meaningless animations and slapstick gags to deliver message that will only make it harder for HCPs. I can now imagine how hard it will be to refuse antibiotic for the patient who just ate too much.  In the US problem with eating disorders is serious even without this appalling advertisement.
There was one more ad related to health, that was not aired due apparent ethical concerns. It promotes vegan lifestyle and the moral concern was that it shows people making love.

Well, if PETA’s call for veganism backed with love is immoral and those DTC ads are, something is really wrong with our ethics.
DISCLAIMER: All ads presented for purely informational purpose. We do not endorse any of the products mentioned (except of love). All trademarks belong to their owner.

Categories
Pharma Marketing

Interactive Outdoor Ad to Detect Flu in Poland for GSK

GSK’s OTC product Theraflu has launched a really hot campaign in cold Poland. During the flu season agency has placed interactive outdoor city lights. Enabled with a thermometer and interactive application, ads allowed passers-by to check themselves for early flu detection.

Categories
Digital Health MedTech Pharma Marketing

Internet of Things in Healthcare and Pharma

Internet of Things becomes one of the most impactful trends in Healthcare and Pharma industry. According to the Big Data in Internet of Things (IoT): Key Trends, Opportunities and Market Forecasts 2015 – 2020 report by Mind Commerce Publishing, value of Internet of Things in Healthcare will reach $117 billion by 2020. With CAGR of 15.1%, Healthcare will be the fastest growing segment in the whole IoT market.
See also: IoT in Financial Services and Banking
 

Telemedicine consult: Dr. Juan Manuel Romero, a cardiologist in Sonora, Mexico, engages in a pre-op consultation with Alma Guadalupe Xoletxilva, ...
SeaaDr. Juan Manuel Romero, a cardiologist in Sonora, Mexico, engages in a pre-op consultation with Alma Guadalupe Xoletxilva. Wikimedia Commons.

Internet of Things: Definition

Internet of Things (IoT), sometimes called also Internet of Everything, is a concept of enabling Internet-based connection between computing devices embedded into everyday objects. Internet of Things is already technically feasible and applied in multiple scenarios. With wider adoption, Internet of Things brings revolutionary changes to existing processes in most, if not all industries..

Video: Healthcare – The Internet of Things and Big Data
https://www.youtube.com/watch?v=qO9unY31820
Video: Internet of Everything | True Stories of the Connected: Rural Healthcare in Northern Canada

Internet of Things in Healthcare and Pharma

Internet of Things applications are impacting all three stages of health care: prevention, diagnosis and treatment.
Wearable sensors and quantified self software embedded in smart-watches are good example of using Internet of Things in Healthcare for disease prevention and healthy lifestyle promotion. Going forward, wearable or digestible connected sensors are part of diagnosis useful especially in remote areas and in chronic conditions.
As for the treatment itself, connected packages and medication dispensers such as CleverCap, MedMinder or Philips Lifeline are used to improve patients adherence to the treatment. A step forward from adding connectivity to packages is putting it directly on medication. Proteus Digital Health, a company backed by Novartis and Oracle has already received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices.
https://www.youtube.com/watch?v=-hhOtjdkU34
Video: Proteus Digital Health – Your Health, Powered By You

Internet of Things in Clinical Environment: MBANs

MBAN stands for Medical Body Area Network and is a concept of low power network of body sensors worn directly or in close proximity to the patient. MBAN is connecting to the hub via LAN of health care facility (ie. hospital). MBAN allows constant monitoring of patient’s health parameters while in the facility, even while moving. Outside of the facility, MBAN may also serve patient – for example by connecting blood sugar level sensor with insulin injection pump.
https://www.youtube.com/watch?v=vloCv3J-Wo8

Video: Medical Body Area Networks (MBANS) should expand patient monitoring

Internet of Things and Big Data

With wider adoption of connected wearable sensors and MBANs the amount of available relevant real world evidence becomes so huge, that medical research may, at least partially, shift its paradigm from experimental to statistical approach. Instead of setting up costly trials and recruiting patients with specific conditions, investigators will be able to perform analysis of existing data gathered from already diagnosed and treated population.

Video: Data analytics: Changing the practice of medicine

Categories
Digital Health MedTech Pharma Marketing

Wearables in healthcare to be promoted by NHS England. What’s next?

NHS England has announced its plans to provide free WiFi in hospitals to push for adoption of wearable technology. It hopes that wearables can be used in clinical settings. At K-message we looked at wearable technology and quantified self impact on pharma in early 2014. Although NHS’s announcement brings wearables in healthcare one step closer, there is still a lot to do.

According to the research quoted by NHS over a fifth of patients with diabetes will have experienced a largely avoidable hypoglycemic episode whilst in hospital. Wearable technology may help doctors to detect deterioration early and act without delay. NHS England hopes, that connected sensors will be used to monitor health of people with long term conditions such as diabetes, heart failure, liver disease or asthma. The information gathered by wearable technology will be uploaded directly into patients’ records through the digital health services platform.
Nowadays, NHS maintains highly successful application (50 million hits per month) NHS Choices, that allows UK citizens to search and register for GP visit, book prescription and register for other services. NHS Choices provides also preliminary symptom checker, medical knowledge database and health related news promoting healthier lifestyle.
From the pharmaceutical marketing perspective embracing wearables in healthcare clear opportunity. Wearable (but also ingestible and implantable) devices and sensors will provide us with valuable real world evidence.With the mass adoption of such sensors assessment of treatment efficiency and drug safety will improve on unimaginable scale.  Use of wearables in healthcare may also greatly impact treatment adherence (making patient to take medication as and when prescribed). In general, it moves medicine from population-based to individual data based, truly personalized healthcare.

wearable sensors nature
The types of physiological data points and the wearable sensors under development or on the market to monitor them. – Nature.com



Technology providers seeing vast business opportunity are joining those efforts. Then, they go back seeing how hard it is to operate in strictly regulated market.We all may remember how Google’s Larry Page and Sergey Brin were discussing their work on sensor contact lenses for diabetes (with Novartis/Alcon) and longevity medicine project of Calico. Their learning was in Sergey Brin’s words:

“Generally, health is just so heavily regulated. It’s just a painful business to be in. It’s just not necessarily how I want to spend my time. Even though we do have some health projects, and we’ll be doing that to a certain extent. But I think the regulatory burden in the U.S. is so high that think it would dissuade a lot of entrepreneurs.”

 
For pharmaceutical companies and healthcare providers this regulatory burden is given for their core business. For them, raise of wearable devices and mobile health applications raises some issues. Our smartphones, fitbits, jawbones and misfit shine wearables are not meant to be medical devices. Data acquired by wearables may not be accurate as they do not hae to be. They are not designed to the clinical and healthcare standard – there are no backup systems if the battery goes down, if user switches the phone in silent mode etc. Today wearable technology for pharma is still not good enough to bet patients safety on it. FDA’s guidance allows wearables in healthcare only as general wellness, low risk devices.
 
The solution may come from the alliance of pharma and technology. Novartis with Google and Qualcomm, UCB with MC10, GSK with Medidata have chosen this direction. Another may be innovative startups companies willing to align with regulatory and compliance burden for a benefit of entering profitable niche leftover by more established players.
K-message believes that finally wearables and more generally, the internet of things will change and shape the future of healthcare and pharmaceutical industry. If you know or, even better, make a product or service intended to be a part of this future we will be happy to cover your story.

Categories
Pharma Marketing

Traditional interaction with HCPs beats digital in impact on prescriptions?

Digital marketing loses against traditional interaction with HCPs says Cegedim Strategic Data (CSD). According to the study called Global Promotions Audit, traditional interactions are still much more common and more efficient in impact on prescription behavior.
To be honest, such a result is completely against what we preach at K-message. Digital tactics are supposed to reach wider audience, and properly executed can change behavior efficiently. What is more, we know that efficiency of digital can be measured.
CSD’s study, at the first sight, says otherwise. Why is that?
CSD collects data from physicians in Top 5 EU, USA, Japan, Brazil, Russia, China, Belgium, Canada and Poland. The research is part of syndicated panel, and respondents are physicians from primary and secondary care disciplines.
Obviously, digital maturity of surveyed markets differs, and CSD provides results by country. Even in the most advanced Japan, only 34% of contacts is classified as digital. For USA it is 24%, Poland 20%. Other countries have much lower proportion of digital interaction – Germany 5%, Brazil, Italy and Russia 2%, China just 1%.

Digital contacts by country Cegedim Strategic Data
Digital contacts by country Cegedim Strategic Data

This has to skew results. We do not know the size of the sample of German or Chinese HCPs, but even if it is 100 doctors per country, we cannot say anything relevant about impact of any factor that affected only few respondents in the group.
From CSD data, we can see that in 11 of 13 markets, a predominant channel of digital interaction with HCPs is emailing. This again puts digital in unfavorable light. Does an e-mail from sales rep counts as an interaction with HCP? Can we reasonably expect that e-mail alone will change HCPs decision for prescriptions? We should not, and this brings another surprise.
The most positive impact of digital interaction on prescription is declared in Canada where 55.6% of digital interactions led to positive intention to start or increase prescribing promoted brand. The most skeptical towards the digital were doctors from France, still 17.1% of those declared positive impacts.
CSD says that in every country impact of traditional interaction with HCPs was higher than for digital. But what are we comparing here? It is an email campaign versus face to face and telephone detailing, on-site meeting or event, delivery of printed materials.
Those results mean that HCPs should receive a proper, multi-channel campaign that combines e-mail (automated with marketing automation tools), remote detailing, on-site events supported with webcasts, websites that allow rich interaction and include order form for additional materials in print or in automated detailing.
CSD’s story is that their result shows a need for more of traditional approach. This is simply impossible due to market environment. But it would not be smart either. What we read from the data is that emailing alone can bring 20 to 50% impact on prescription, so pharmaceutical marketing job is to invest more in multichannel approach.