Apr15

ResearchKit: A Medical Research Revolution?

Research Kit Blog Image SizedIn what boils down to crowd-sourcing medical information, Apple’s ResearchKit promises to turn the iPhone into a powerful tool for medical research. But will it live up to that promise?

Apple is putting the power of clinical trials in our pockets with ResearchKit, the open-source software framework designed for medical and health research. It will help doctors and scientists gather data more frequently and more accurately from clinical research participants using iPhone apps, enabling faster insights at lower cost.

ResearchKit leverages the sensors and other capabilities of the iPhone to track movement, take measurements and record data. When granted permission from the user, ResearchKit can access data from Apple’s HealthKit app such as weight, blood pressure and glucose levels, which are measured by third-party devices and apps. ResearchKit can also request access from the user to access the accelerometer, microphone, gyroscope and GPS sensors to gain insight into a user’s gait, motor impairment, fitness, speech and memory.

Several world-class research institutions have already developed apps with ResearchKit for studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Using the built-in templates for informed consent, users decide if they want to participate in a study and how their data—and which parts of their data—is shared. Participants can perform activities and generate data wherever they are, providing more objective information than simply filling out forms for their activities.

More data will be generated through these apps for researchers to analyze than ever before. For example, just four days after its release, Stanford University School of Medicine’s MyHeart Counts app was downloaded 52,900 times, with over 22,000 users consenting to the study. But more data isn’t necessarily better data.

On the surface, ResearchKit sounds like the long-awaited answer to ongoing issues in traditional clinical trial processes, including limited participation due to proximity to institutions running trials, frequent data entry and the integrity of that data and limited data collection.

Apple has created three customizable modules to address the most common elements across different types of clinical studies: surveys, informed consent and active tasks. Programmers can use these modules as they are, build upon them or even create new modules of their own.

ResearchKit initially includes five active task modules that invite users to perform activities under semi-controlled conditions, while iPhone sensors actively collect data. The tasks can be a simple ordered sequence of steps or dynamic, with previous results informing what is presented. In this way, researchers and programmers can create custom apps for their relevant disease states. These modules simply record the data and pass it on to the researchers; Apple does not store it or track it in any way.

Since ResearchKit resides on the iPhone, it will be easier to recruit participants for large-scale studies, accessing a broad cross-section of the population. The data that it collects mostly comes from sensors and other apps; there is little chance of error in the measurements as compared to patients recording their data in paper-based diaries. Even the data that patients will enter themselves into ResearchKit apps will be more accurate: programmers can put limits on that data so that it fits within proper parameters.

Although ResearchKit solves many issues with clinical trials, it also creates some of its own.

Patient population

Apple promises access to a diverse, global population through ResearchKit, but that population might not represent the population as a whole.

IPhone users are more wealthy and educated than the general population, and minority groups are underrepresented in its user base. Additionally, ResearchKit is only available on iPhone 5 and newer models and the latest generation of iPod touch, which excludes a large segment of iPhone users.

On top of that, the patient populations for ResearchKit apps will be largely self-selected: those using the apps are already likely to be interested in their own health. So can the results generated from this narrowly defined population be extrapolated to the population as a whole?

Another point to consider with the self-selected patient population is that app desertion rate can be high, so researchers won’t have complete data from those who don’t finish the trial. This will also bias the data toward better outcomes since those who actually finish the trials are more motivated to see a positive outcome.

Data Validation

There is no validation that participants have a specific condition before they can enter a trial. This lack of verification can further skew the results of the trials. Going forward, tighter controls on who can enroll in each trial by verifying their basic information will lead to better qualified participants and more robust trial data.

Secure Communication

Verifying participants’ information might be hampered by the current lack of secure communication mechanisms between ResearchKit apps and their researchers’ servers.

This is up to the app developers to implement, as is HIPAA compliance and compliance with international research regulations. Even if secure communications are implemented properly by app developers, sharing personal medical information is a sensitive subject—especially with current data breaches. There will likely always be privacy concerns, especially in participants who don’t fully understand how their health data will be used.

Big Data

ResearchKit trials could potentially have hundreds of thousands of participants, each one with the potential to have inaccurate data. How will researchers separate the signal from the noise with such large amounts of data?

Cleaning that data will be a huge job, and further making inferences from that data to the general population could be difficult. Building trust in the trial results in light of the challenges listed here could be an uphill battle with the general public. More thought needed here.

Going forward, simple improvements such as data validation will go a long way toward more qualified patient populations and more robust trial outcomes. But how can ResearchKit be made available to a more representative patient population?

The answer could lie in the open source framework of ResearchKit. Researchers will have the ability to contribute to specific activity modules in the framework, like memory or gait testing, and share them with the global research community to further advance what we know about disease. And since it’s open source, there is the opportunity to expand into the Android realm as well.

On a global scale, Android is the far more popular operating system, and its user base is more representative of the population as a whole. It would benefit these clinical studies if users across platforms could use these apps.

That said, Android has a fragmented operating system with disparate hardware platforms that have differences in their sensors (accelerometers, GPS, gyroscopes), and even in chipsets from device to device. Researchers would have to account for all of these differences and build and test apps across platforms, which is nearly impossible on their limited budgets.

While ResearchKit is not the perfect solution for clinical trials research, it is a good first step, especially when it comes to to clinical trial recruitment, which has been the bane of the healthcare industry for far too long. Results of the pioneering ResearchKit apps—for asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease—will reveal the true utility of such a mobile, global medical research solution.

This article was originally published in Medical Marketing & Media.

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Apr8

An Observer’s View of the Cancer Wars

Cancer Word Cloud BlogWith the National Cancer Act of 1971, President Nixon officially declared that the US was at war with cancer. The goal of this war is to defeat cancer as a major cause of death through a better understanding of cancer biology and the development of more effective treatments.

In the 40+ years since the act’s inception, how much progress have we actually made?

Cancers overall still remain a major cause of death, however significant progress has been made in early detection, prevention and treatment:

• In December 2014, the American Cancer Society reported a 22% drop in cancer mortality over the last two decades, with a corresponding increase in the survival rate of all cancers in both men and women
• The completion of the Human Genome Project in 2003 made it possible to test the value of genomic approaches and identify underlying genetic changes that lead to cancers
• Emerging data since 2003 have significantly changed the way cancers are researched and have led to the development of new diagnostics, therapies, preventive measures, and early detection
• Research direction is currently focused on combining new compounds and diagnostics to help increase efficacy and reduce toxicity through the use of agents that target specific tumor pathways most relevant to a patient’s own disease
• Scientific advances in treatment have also been born out of our growing ability to harness the immune system to fight cancer

These scientific discoveries have led to a shift from an organ-based to a molecular-based approach, and the results are already having a profound impact on the way cancer is being treated and treatments are being personalized to patients. Personalized medicine is an ideal that is driving much of the future of cancer research. The hope is that tailoring treatment to patients’ individual needs based on their genetic data will improve outcomes and reduce adverse side effects. With our increasing knowledge of the human genome, this is steadily becoming a real possibility, and the advent of immuno-oncology brings another layer of individualized therapy into the clinic.

While many battles against cancers have been hard fought and won on several fronts, the “cure” to cancers still seems elusive, largely because cancer is a cluster of many diseases. Looking to the future, one of our greatest challenges may be translating our recent discoveries into treatments that address patients’ individual mutation profiles and truly treat the patient instead of the disease.

One of our biggest questions may be whether our healthcare system can afford the cost of “high-quality” cancer care. Most likely the answer will be no, but to address this challenge, the onus will be on the healthcare community (providers, payers, insurers) to determine how we will use our growing understanding of individualized cancer therapy to advance the quality and effectiveness of cancer care.

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Mar27

(In)Sanity Check

Blog Image Insanity2Here’s an all-too-familiar story about a team in Ogilvy CommonHealth – trying to launch a Value Prop, get a label update, overhaul 2 separate iPad assets, and submit 2014 work for an last-minute award. And that’s on top of our regular day-to-day items! As I sat to write this, and looked at the items on my to-do list, I realized that I’m not alone in the fight to keep my sanity in the midst of agency chaos.

As workers in advertising, we have our own type of sanity…but that doesn’t mean it can’t be healthy. Here are the things I’ve seen work for myself and others, to keep us relaxed and sane in even the most stressful environments:

  1. Write everything down – Starting your day (and week) with a to-do list is essential. Add whatever pops up, and cross items off as they’re accomplished. Spend the first 2 minutes in the office (or at home with your first cup of coffee) looking at your calendar. Jot down what meetings you have, what needs to be accomplished. Keep a running list of what you know will be “hot” within the coming days, so you can get ahead of them if time allows.
  2. Take 3 deep breaths – This is helpful for when you want to send a sassy response to an email, or are trapped in a heated meeting. Taking some deep breaths will help lower your heartrate, which will in turn help you make more level-headed decisions.
  3. Take your eyes off of your devices before bed – I know, I’m just as addicted to my email/texts/Facebook/Instagram/Pinterest as you. But take 15 minutes in bed to read a book or do a crossword puzzle. It’ll help you disconnect and start relaxing.
  4. And while we’re talking about bed, sleep – Resting your mind and your nerves will help in all aspects of work and life. If you’re having trouble sleeping because your mind is always racing, refer back to Step 2: slowing your heartrate will help your body relax into sleep. You’re not you when you’re sleep deprived.
  5. Treat yo’ self! – In the wise words of Tom Haverford and Donna Meagle, “treat yo’ self!” It doesn’t have to be extravagant or unnecessary, but treat yourself to something that you know you deserve. It can be as simple as a Starbucks run, or a drink with a friend after work. Give yourself the time that you deserve to reset and recharge.

These are simple solutions. But when we’re in the throes of work, it can be hard to step back and remember to take the needed time for ourselves.

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Feb20

Idea Is King, Guard It With Your Life

OHW Blog Image 2.20.15“In the dizzying world of moviemaking, we must not be distracted from one fundamental concept: the idea is king.” – Jeffrey Katzenberg, former Disney Chairman (’84-’94)

This fundamental concept also holds true in healthcare communications. All great work starts with a great idea. But arriving at a great idea is not enough. In our highly scrutinized and regulated world, a great idea is at risk of an untimely death at numerous points in its life. From internal creative reviews and client presentations to market research and medical/regulatory review, a great idea is often pushed aside because it looks and feels different than the status quo. A great idea makes people feel uncomfortable. But that is exactly what it should do: grab our attention and challenge our thinking.

Healthcare advertising is plagued with bad clichés, overused metaphors, and happy slice-of-life imagery. Contrast these campaigns to the quality of the work that many creatives in our industry include in their own portfolios. The difference is amazing. It’s an eye-opening experience to see the original idea that devolved to the happy couple sitting on a park bench with a benign, lackluster headline. We need to come together as a united community—creatives, account, planning, digital, and analytics —to courageously support great ideas, protecting their creative integrity all the way through final execution. Because in healthcare, great ideas can lead to more than awards; they can help save and improve lives.

 

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Also posted in Branding, Creativity, Culture, Design, Great Ideas, Healthcare Communications, Marketing, Media | 1 Response
Feb12

So What’s Your EHR Strategy?

EMR Blog Image2As pharmaceutical marketers, we no longer live in a world of traditional marketing where we can cast a wide net and hope we’re engaging with the right customers. We need to move communications to where our physicians are. Additionally, pharmaceutical companies have shifted away from traditional face-to-face tactics to more digital interactions, spending 25% of their marketing budgets on websites and online media.

“Unlike traditional forms of advertising, digital technologies enable tailoring of advertisements to individual physicians on the basis of data from clinical encounters,” according to Christopher Manz, MD, and David Grande, MD, MPA, from Penn Medicine, who recently gave a point of view on electronic health records (EHRs) in The New England Journal of Medicine.

Digital marketing provides us with tools to communicate more effectively with our customer through more individualized and personalized engagements, ensuring that the correct message is being delivered at the appropriate time. With new tools coming out weekly, it is easy to get caught up in the hype. Choosing a tactic simply because it’s the “newest” or “coolest” option will not guarantee success. Without the right strategy, we are just wasting time and resources. A strong digital marketing strategy is essential for communicating with our customers and staying ahead of our competition. The key is understanding our customers as well as a brand’s overall strategic and marketing objectives and then selecting the appropriate digital channel(s) that will help reach our target audience and goals.

As brands fight for share of voice in an overcrowded digital space, it’s time for companies to stop looking at the traditional online engagements as the cornerstone of HCP engagement and focus more on targeted engagements within electronic medical records (EMRs). According to market leaders, EMRs will become the dominant communications stream for physicians, and pharma has been slow to engage in the EMR format.

There has been tremendous growth of the EMR marketplace over the last few years. According to the latest government statistics, 72% of office-based physicians are using an EMR or EHR system, up from 48% in 2009, driven by meaningful use, which provided incentive payments for physicians and hospitals to implement them. EMR is now the center of physician workflow, and its data offers valuable insights into practice management and the physician-patient dynamic. This data can be leveraged to better serve patients and physicians by providing the tools that they need, such as patient education or reimbursement support. To that end, aligning with the right EMR solution should increase HCP engagement. What is encouraging, according to Manhattan Research’s latest Taking the Pulse survey, is that 71% of physicians are interested in interacting with pharmaceutical companies in this way, so we as pharmaceutical marketers need to capitalize on this channel in a strategic way that brings value to both providers and patients.

Integrating With the HCP Workflow

So how can we leverage the use of EMRs to benefit healthcare providers, patients and payers? With the demands placed on them today, physicians have less time for each patient, pharmaceutical reps, and for searching for information between appointments. Marketing to HCPs through EMRs will better integrate with a physician’s daily workflow and shift the mindset from disruptive marketing to a partnership. Physicians use EMRs for their tools, and the more information physicians are getting through these systems, the more opportunity for marketers to provide value. Leveraging EMRs to deliver meaningful assets to physicians when they are with patients represents a prime opportunity to change the behavior of our physicians.

There are several ways to reach physicians through EMRs. One obvious component is providing information about a brand at the point-of-prescribing that is of high clinical value to physicians. Additionally, according to Taking the Pulse, at least 40% of HCPs say patient education, samples, vouchers, patient financial support and product information are features they are most interested in seeing in EMRs. Other examples include formulary data and safety updates. EMRs can also be used for direct marketing to physicians through banner ads, industry-sponsored clinical resources and emerging solutions.

Marketing to HCPs through EMRs is not without its obstacles. There are approximately 600 EMR system vendors with only a handful offering partnerships with pharma companies. Therefore using EMRs is not a one-size-fits-all approach to marketing, and it might be required to customize materials for each platform. There are also concerns about privacy, interruption of the HCP process by forcing information during a clinical decision, and the intricacies of integration with EMRs. These all need to be considered when determining if and how an EMR plan and roll-out is right for your brand.

Looking to the Future

EMRs represent an opportunity for marketers to communicate to physician throughout a product life cycle—from clinical trial recruitment to workflow “interventions.” The opportunity for marketers in EMRs is here, and physicians want pharma involvement. But it’s imperative that a brand has a clear EMR strategy to capitalize on this channel opportunity and ensure we are providing a fully integrated communications plan.

 

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Feb6

Expensive medicines and where it’s all going?

Aussie Blog Image2The Australian Commonwealth spending on PBS drugs is currently around $9 billion AUD per annum.  It is forecast to be over $15 billion by 2023. We are seeing this upward trend due to the increasing incidence of chronic illnesses and conditions, the ageing population of Australia and the cost of new PBS medications.

We know the hurdle to getting drugs listed on the PBS is higher than ever.  But when they get listed why are these medications so expensive for governments and should we listen to those criticising the Pharmaceutical Companies who discover, commercialise and manufacturer these medications?

Bruce Booth wrote an interesting article recently on Forbes.com where he looked at two very different calculations around the total cost of drug development.  All things equal, and dipping into a Tufts Centre for the Study for Drug Development, it looks like the cost is now upwards on $2 billion USD per drug.  That’s huge by anyones standards.  But consider the journey to approval.

  • It takes an average of 10 years to bring a discovery to the approval stage.
  • Only 8% of drug candidates make it from discovery to the market – and that’s regulatory approval not reimbursement.  Reimbursement is a further stumbling block.
  • The cost of failures is the largest part of the overall cost in this analysis.

70% of the calculated cost of developing a new drug is that cost associated with the failures along the way. In a good article, Booth suggests we need to do things better, faster and cheaper.

I tend to agree. New technologies and the digital world we live in should mean we can share new information, new clinical data and new treatments more rapidly. Most products in the drug-pipeline are now complex, highly technical and often target new pathways and therefor HCPs will need to have a more in-depth understanding of the mechanism of action and science behind these innovative compounds and classes of drugs.

The other question is how can the ‘Big Data’ we keep reading about help us develop the right products for the right patients in a healthcare landscape that is constantly changing and evolving?  A load of patient, HCP and product data itself won’t help us.  We need to be able to analyse and sift through it to find meaningful truths and insights that change the way we develop and commercialise new medicines.  This will make a difference.

 

Originally published on Ogilvy CommonHealth Australia’s blog: http://www.ogilvycommonhealth.com.au/blog

 

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Nov21

The Glue in Life, and the Agency

glueWhat’s the glue in your life?

For me it is fitness. Running, triathlon, setting goals, eating clean, and having a training plan. That’s the glue that keeps it together for me, the hub around which my world revolves. When I am working towards a new goal, it makes me more balanced, positive and happy.

For others it’s other physical activity: yoga, cross-fit, hiking. Or other ways of being healthy: being a vegan, eating paleo, meditation. Or for you, it could be external: your pet, your children, your significant other. Your house, your car, your boat. It’s what you brag about, how you improve yourself, the destination and the journey. We all have something that feeds and rewards us, holds us together in mind and body and spirit. That’s our glue. One key to success and balance is to figure out what, exactly, your glue is.

So what is the glue at Ogilvy CommonHealth Worldwide? Or rather, who?

Who is usually the first one in the office, and the last to leave? Who can rattle off the status of two dozen jobs from memory in 10 minutes during hot sheet? Who do we see in the corridors lugging those big job bags from floor to floor, securing, organizing or maintaining job cards, status reports, cover sheets, portal links, med/legal submissions, tagging and linking, night coverage plans, weekend plans, job number lists, finance reports, archiving, uploading files, downloading files, launches, RFPs, pitches, comps, spec sheets….

The glue that holds an ad agency together is the Traffic Coordination department, now known as Project Coordination (PC). PC is the hub of it all—from inception to completion, this group shepherds jobs from manuscript to release. PC works with every department—edit, copy, art, studio, account, business management, finance, project management, and production. If you don’t know something about an account, ask PC. There’s no better launch pad for new account executives or other staff positions at our agency than PC.

PC is a great place to learn, and a great place to stay. It’s everyone else’s glue, and it’s what makes us whole. It’s my glue too. What’s yours?

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Nov12

Ebola Goes Viral

Ebola Blog Image2“It’s like the film with Dustin Hoffman and the monkeys,” said the woman next to me on the tube the other day. “No, it’s more like that other film with the monkeys,” said her companion. “The one where animal rights protestors release them and unleash a zombie virus on the UK.”

The truth, thankfully, is that the most recent Ebola outbreak is nothing like either of these movies. The Ebola virus has yet to mutate into a new strain that spreads like flu as it does so rapidly in Outbreak, and it seems somewhat unlikely that it is going to turn us all into flesh-eating un-dead as happens in 28 Days Later. But what exactly is it like, how much of a threat does it pose, and how are we supposed to communicate the bare facts of virus and disease in an atmosphere of panic and misinformation?

The other day, news outlets were tracing the steps of one of Ebola’s recent victims. New Yorker Dr. Craig Spencer had been all around town since returning from aid work in Guinea. He had taken the subway, visited a meatball stand and hung out at a bowling alley in Brooklyn. Normal things that a person might like to do after returning to their hometown after an intense trip abroad. But Dr. Spencer started running a high fever and was soon diagnosed with an Ebola virus infection.

Despite most reports suggesting that he had interacted with only a handful of people since becoming symptomatic, The Gutter, the bowling alley visited by Dr. Spencer, was forced to close down for two days and underwent a mass disinfection. The Meatball Shop remained open but was host to a PR stunt in which the city’s mayor visited for a meal in front of a host of cameras to prove to the general public it was safe. Which of course both of these places should be. There is nothing about the pathogenesis of Ebola that suggests we can catch it from a bowling ball or a restaurant table. Indeed the virus can barely survive for long outside the body, especially on hard, dry surfaces.

Hysterical news reporting of disease is nothing new. This time, like many other times before, it has been served up with a dollop of xenophobia. The problem, almost ignored when it is abroad and confined to countries that barely register on the Western consciousness, is treated like an unmitigated disaster when it hits home shores. Like the wave of homophobia that emerged in the wake of the HIV/AIDS crisis of the early ’80s, the tabloid media emphasis is on minimizing personal risk rather than pressuring organizations such as the UN and the WHO to act on the virus itself. We are encouraged to shut our borders, be suspicious, be vigilant, and most importantly, be afraid.

If there is something that feels different this time around, it’s the social media factor. In 2009 when swine flu panic was at its peak, we were all on Facebook, but fewer of us were active on Twitter. The surges of popularity in micro-media over the past few years have completely changed the way we consume and digest news, but also the speed at which stories spread.

Take the case of this video, which was recorded in a Chilean hospital a few weeks ago. The announcement you hear roughly translates as: “Can I have your attention, please. We have a patient who is suspected to have Ebola. Please leave the room and go to another hospital.” After the patient who took this video posted it on YouTube, it received almost 140,000 views. Soon the story migrated to Twitter, where the hashtag #EbolaChile was used over 200,000 times. All this happened incredibly fast and internationally, even though it was later revealed that the suspected Ebola was actually a case of malaria. Indeed, it has not gone unnoticed that the Ebola news is spreading faster than the virus itself.

But when things are over-egged on Twitter it only ever results in topic fatigue and silliness. Recently, actress Anne Hathaway was accused of refusing to shake an Argentinian journalist’s hand due to fear of contracting the virus. Others are making mockery of the intense US media coverage, with some users suggesting that “EBoLa could be the name of an obnoxious Manhattan neighborhood” or that “the only part of the Ebola guy that upsets me is how rich his social life seems in comparison.”

With the fast pace of social media reporting, topics that have had everyone enraged on one day can be forgotten the next. But whilst it’s easy to laugh at the jokes made at the expense of the media hysteria in the US, for the people of the West African countries most affected it is a genuine threat, and it’s not going away.

Organizations like the CDC are doing a good job of keeping up sensible dialogue about Ebola by producing factsheets on the disease and its transmission. These are clearly designed to alleviate fears about how the virus has been spread without shying away from the facts of how it is affecting the West African countries hit by the epidemic. The UN has been providing updates on the current situation, and what they are doing to combat the spread of the disease whilst the WHO have tweeted audio files from their recent press conference. The challenge for these organizations is that there is a lot of repetition in the messages that they have to send out. The advice about the virus is quite basic and in order for them to communicate this effectively they have to find new and interesting ways to dress up the facts, so as not to appear repetitive.

When developing our own disease awareness initiatives we can learn from the social media reaction to Ebola. Twitter can be a maelstrom of misinformation and flippancy, and it is important to provide clear, concise and meaningful content such as infographics and video. Although rather than share PDFs, like the organizations mentioned above, we should think about content that is easily viewable and sharable within a Twitter client. Most importantly we should remember that it’s easy for a story to get lost in a medium that moves as fast as social. Bitesize content should be deployed regularly to keep up the momentum, and we need to find creative ways of saying the same messages in different ways so we make our point without switching off our audience.

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Oct17

At Face Value

At Face Value ImageThe recent 60 Minutes episode on the “eye popping” cost of cancer drugs painted pharmaceutical manufacturers and community oncologists as greedy scoundrels only interested in making huge profits at the expense of desperate cancer patients.

Reporter Lesley Stahl keyed in on a common target in the debate over rising healthcare costs—drug price, and a new term being used by oncologists: “financial toxicity.”  The program singled out ziv-aflibercept (Sanofi-Aventis) as a high-priced agent for metastatic colorectal cancer that cut its price in half only after three doctors at Memorial Sloan Kettering wrote a negative op-ed article in the New York Times suggesting that manufacturers determine drug prices similar to how one shops in a Turkish bizarre.

To emphasize the industry’s greed, the producers highlighted imatinib (Novartis), and although they acknowledged it was indeed a true advance in the treatment of chronic myeloid leukemia when it was approved, they chose to focus only on how the price has more than tripled over the past decade despite the availability of several newer, more effective treatment options.

Media coverage like this, along with ongoing policy discussions, continue to focus on whether the cost of new cancer therapies is putting urgently needed, life-saving therapy out of the reach of patients.

The Personal Side

Ogilvy CommonHealth Worldwide supports a number of organizations, including a number focused on cancer and oncology patients. One such nonprofit is the Cancer Research Institute (CRI), an organization founded in 1953 and dedicated to harnessing the power of the body’s own immune system to conquer cancer. Through their efforts, and the efforts of other institutions like them, a promising new class of therapy called immune-oncology (IO) has emerged.

Think about that—over six decades of research, funding, clinical trials, and education has led to some of today’s most promising IO agents. I imagine there are a lot of lost bets along the way; despite the millions of dollars that go into the research and development of new cancer treatments, only 13% of all compounds in development are ever approved for use in patients.1

But through the perseverance, commitment and investment of many, including the pharmaceutical manufacturers, what today is a reality would not have been possible.

I had the opportunity to attend CRI’s annual event and had the pleasure of meeting many post doc fellows and researchers, and I can assure you the value they saw in their work was not the profit their research would have for their companies, but the life-saving impact it would have for patients urgently awaiting new treatments.

One such person I met at the CRI event was “Sue,” a young woman recently married and living with a rare form of cancer (angiosarcoma) diagnosed in less than 300 people per year. She told me about how appreciative she was of the funding from CRI, manufacturers, and industry to the work she was doing and the hope that she’ll one day play a role in helping cure people like herself living with a deadly form of cancer.

Which made me think… If manufacturers and nonprofit organizations like CRI did not sustain the commitment and investment (in the billions) in search of new therapies, including areas of rare disease, what would become of patients like Sue, without the combined efforts and commitment of these institutions?

The Flip Side

So today, patients are being asked to absorb a larger portion of their prescription costs as a result of more aggressive payer cost management and growing pressure on healthcare budgets overall.

However, it’s important to recognize the overall savings to the system cannot be recognized in terms of savings for a patient individually. And the true value of cancer medicines goes well beyond the cost of a particular drug.

R&D of novel treatments has the potential to not only help patients today, but also provide longer-term value by investing in therapies for tomorrow. By limiting our view to a short-term cost savings approach, the potential to develop new, innovative treatment approaches, like IO, may never occur.

So when considering the price of drugs, remember this reflects the cost and risk of medicine development, the complexity inherent in treating cancer, as well as value to the patient, the healthcare system, and to society. So don’t take price at face value!

The Rest of the Story

So while the producers of 60 Minutes focused solely on the “devastating” side effect of cancer (the bill), a far worse side effect would be if manufacturers chose to cut the amount (billions) they now invest at risk to commercialize new therapies. This would be especially detrimental in rare disease areas like angiosarcoma, where the investment will outweigh the profit—and ultimately the patient would have the most to lose.

Through an environment and policy framework incentivizing and rewarding research, a healthy competitive environment will pave the way for new advances so desperately needed, and everyone benefits.

One thing is for certain, the path forward should focus on continued (albeit targeted) investments, improving access to these important oncolytic advances, development of biosimilars, and for crying out loud, doing a better job communicating the value proposition (aka, demonstrate product value) of emerging therapies to providers, payers AND patients.

Reference: 1. DiMasi A, Reichert JM, Feldman L, Malins A. Clinical approval success rates for investigational cancer drugs. Clin Pharmacol Ther. 2013;9(13):329-335.

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Sep23

Access to High-Cost Medications: A Balancing Act

UKBlogImageSmallAs continuing innovation moves us further toward personalized healthcare and the development of targeted treatments, how can patients across Europe ensure they have fair access to high-cost medications?

Securing reimbursement remains one of the biggest challenges to delivering market access for new treatments. The debate around balancing tight health budgets with fair access for patients is shaping the way governments and payers respond to these advancements. Cancer treatments are a specific concern, especially those designed to target rare and aggressive cancers, and as such have a particularly high development cost per patient.

So what’s the way forward?

This was the question posed by the Ogilvy Healthworld UK Market Access team earlier this summer when we brought together a panel of leading experts in front of an audience of industry figures, academics and patient representatives.

The panelists discussed the issue from the viewpoint of each of the 4P’s of healthcare—payers, prescribers, policymakers and patients—to chart out the future course of reimbursement.

What was the outcome?

After a far-ranging debate, five key ideas stood out as important for taking the conversation on the introduction of high-cost medicine ahead:

1. While schemes like the UK Cancer Drugs Fund have been a success, they may prove unsustainable in the long term. New systems to assess and support the uptake of new treatments must be a national priority.

2. Three key areas that will affect the cost of medication over the next decade are:

– Technological development; as new innovations make treatments more expensive, not cheaper

– How care is delivered; and potential cost-savings that can be made in reforming healthcare systems

– Whether health systems can reform the way that healthcare is funded to support uptake of new technology

3. New treatments will not necessarily lead to cost-efficiencies, but rather higher costs for payers. This means that demand and pricing must be controlled to maintain a healthy balance between supporting innovation and ensuring access to new medicines for patients.

4. Current value assessments are too narrow and need to be reformed to better reflect their full value. As newer medicines that raise costs are developed, a more complex assessment model will be necessary to ensure that their total cost/ benefit to the healthcare system can be successfully mapped.

5. If payers are to be able to afford new high-cost medicines, cost-efficiencies must be found in the delivery of services. Although healthcare systems should remain a center of healthcare delivery across Europe, it was agreed that the way they operate must fundamentally change to provide care in the most effective way possible. This should be focused on reducing hospital visits and supporting “community-based care” systems.

 

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