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I’ll Take a Tube of Toothpaste and a Tetanus Shot: Five Factors Reshaping Retail Healthcare Delivery

The recent approval of CVS Health’s merger with Aetna is being heralded as nothing less than potentially “transformational” to the health care system. Innovative ideas to help streamline care and encourage cost effectiveness are not new as illustrated by the undefined collaboration between Amazon, Berkshire Hathaway and JP Morgan, nevertheless here is the joining of the consumers, delivery and payer stakeholders. Observers have remarked on the impact that this union may have on the role of the MinuteClinic, i.e., the retail clinics owned and managed by CVS Health. Will there be incentives for Aetna members subscribers to favor these clinics over traditional practices? If so, will their service offerings need to further expand?

A relatively recent phenomenon (the first clinic was established in 2000), their use has been driven by convenience. Where else can you get a flu shot while picking up laundry detergent and cotton swabs or quickly get that sinusitis checked out without an appointment? They have progressed significantly since their inception. For example, they were originally fee-for-service, but the majority of clinics now have negotiated contracts with major insurers.

While this sets up retail clinics as a go-to for wellness services and to manage simple acute illnesses, can they take it to the next level that being chronic disease management?

These contemplations have elicited the realization that retail clinics in general have not been on industry’s radar screen. To help get us up to speed and fully realize their potential in therapy development and commercialization, we provide five facts about retail clinics.

  1. Retail clinics are staffed by non-physicians

The simple premise behind retail clinics management is filling the need for a convenient way to get non-critical acute illnesses such as influenza and sinusitis quickly, along with wellness measure like those pesky booster shots that we put off until the last minute – no appointment necessary. According to the National Urgent Care Center Accreditation (NUCCA), retail clinics are a level IV – the lowest level of care. In essence, requirements include that providers must be certified in basic life support, provide basic on-site lab, offer no radiology or suturing and must post service limitations. Most noteworthy is how they are staffed. In accordance with level IV, retail clinics are staffed mainly by mid-level practitioners with the vast majority being nurse practitioners, with remote medical supervision by a licensed physician. This makes sense as it is a less expensive option and an on-site physician would essentially be overkill.

  1. Over 90% of retail clinics are managed by only five operators

The U.S. has approximately 2000 retail clinics. Five operators mainly represented by retail pharmacies followed by a supermarket and a big box store, run 92% of them. The remainder to a lesser extent, are run by physicians groups and delivery systems.

 Location and Market Share of Retail Clinics by Chain, 2017

 Clinic Location Clinic Operator Market Share
CVS Health (retail pharmacy) MinuteClinic 55%
Walgreens Walgreens Healthcare Clinic; Advocate 18%
Kroger The Little Clinic 11%
Walmart Care Clinic; Clinic at Walmart 4%
Rite Aid RediClinic 3%
HEB RediClinic 2%
All others 8%

Adapted from Drug Channels.

According to the Center for Financial Research & Analysis, CVS Health is the largest operator of retail health care clinics in the U.S. As of December 2017, CVS Health operated over 1100 retail clinics in 33 states under the MinuteClinic name including 15 newly opened ones. Furthermore in 2015 CVS Health acquired Target’s pharmacy business, consisting of 1,660 locations and 80 in-store health clinics, for approximately $1.9 billion. The 79 clinics purchased were re-branded as MinuteClinic. CVS Health is working on opening 20 new clinics within Target stores by the end of 2018. Additionally, CVS Health and Target plan to develop five to 10 small-format stores over a two-year period following the close of the transaction.

  1. Evolution from simple acute care and vaccines to chronic conditions is already taking place

There is already a movement by the retail clinic industry into the more complicated realm of chronic diseases. This wider scope of practice at certain retail clinics is facilitated through affiliation with larger health care systems which provide specialized physician oversight. Many now care for and manage patients with chronic conditions, such as hypertension, diabetes, and asthma. For almost a decade, CVS Health has been affiliating with the Cleveland Clinic and Target (now CVS Health MinuteClinics) has recently struck up an agreement with Kaiser Permanente. Though these are currently regional partnerships, by way of the integration of the clinics into their system and thus physician engagement, they have allowed for improved access to and coordination of care. This is germane to monitoring to manage chronic conditions while maintaining links to other clinical systems.

  1. Physicians groups may not necessarily be fans of retail clinics expanding beyond uncomplicated care and vaccines

While medical groups certainly see a role for retail clinics as they were originally intended, there is resistance against their expansion into areas such as chronic care. The American Academy of Family Physicians (AAFP) officially opposes the expansion of services offered by retail clinics, specifically those related to chronic disease management, as they fear fragmentation of care. They cite that the protocol-based decision and diagnostic models used in most retail clinics (they point out that they are non-physician led), may result in a missed opportunity to address more complex patient needs.

This view is bolstered in a 2017 article from the American Journal of Managed Care which cites that while there is strong user satisfaction demonstrated by a relatively high rate of return visits, people who use retail clinics are less likely to return to their primary physicians for subsequent visits. This raises continuity of care concerns.

There should be sensitivity toward the fact that retail clinics as viable competitors to physician practices, if services are greatly expanded to chronic disease monitoring and beyond.

  1. Adults on either end of age spectrum will likely fuel growth

The retail clinic trend lends itself to convenience with expanded care options created through strategic collaborations. This is expected to stimulate interest in retail clinics by adults on both ends of the age spectrum – millennials and seniors. In fact, a recent article in Forbes notes that millennials are largely ditching their primary physicians and opting for real-time care provided on their schedules.

On the other end of the spectrum, retail clinics are taking steps to further focus their services toward seniors. Most notably, Walgreens “Take Care” clinics and Humana is piloting a program in Kansas City markets, targeted to Humana’s Medicare Advantage patients. Jointly, the two companies will offer geriatrics-focused acute and chronic care, health navigation services, and health education. Notably, retail clinics are already offering the free Medicare wellness visits.

The CVS Health-Aetna merger is being regarded as transformational for the health care industry as the clinic and payer are now one. This is as disruptive as it gets. CVS Health will now have the ability to convert more of its brick-and-mortar locations into front-line clinics for basic medical services and monitoring of chronic conditions. CVS Health has said that by deepening its knowledge of and relationships with patients, CVS says that the combination could help Americans stick with medication regimens and stay out of the hospital. This indeed makes sense as minute clinics are situated where people shop on a daily basis and you can’t beat their proximity to pharmacists. This has the potential to increase a patient’s likelihood to actually fill their prescription and be more informed about it.

This may set the tone for other comparable non-traditional marriages. We are already seeing limited partnerships between Target’s MinuteClinics and Kaiser and Walgreens and Humana. If the model works, it is only going to grow.  While industry has been doing a good job of connecting with patients, nurse practitioners and pharmacists, there is a huge opportunity to better engage them within the ecosystem of the retail clinic.

Snowfish has pioneered a unique approach of mapping the disease state ecosystem including non-traditional competitors and key stakeholders designed to meet the needs of the particular product. To learn more, please feel free to contact us at sales@snowfish.net.

Melissa Hammond, GNP is Managing Director at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Brand Management, Medical Affairs, Stakeholder Mapping, Strategic Partnering

Cannabis – A Unique History

A few months ago, I planned an outing to the Trans-Allegheny Lunatic Asylum in West Virginia. I know it is an odd place to visit but I enjoy all types of history, including medically-related.  The facility opened in 1864 and reached its peak in the 1950’s, housing 2,400 patients. Changes in the treatment of mental illness and the facilities physical deterioration led to its closure in 1994. In this one facility I was able to experience first-hand, 130 years of approaches to the treatment of mental illness.

apothacaryOne of the most interesting rooms in this massive facility was the Apothecary. Here, medicines were formulated and dispensed. While the practice of psychopharmacology is considered a relatively modern phenomenon, it is clear that this is not the case. I witnessed compounds that appeared to date back to the early 1900s.

I was wondering what compounds were in use to treat patients. There was a compound manufactured by Parke Davis which contained iron, arsenic, and strychnine, chocolate coated too. For very valid reasons, that combination fell out of favor.

Then I saw another glass flask which was in fact more germane to the modern era. This one from 1906 had cannabis indica as its main ingredient. Clearly, marijuana had a role in treatment of patients over 100 years ago. Why has it taken so much time before an FDA-approved cannabis-based therapy was available? I began to wonder how cannabis and its function in medical practice, has evolved over time. Cannabis TLA

In the U.S., cannabis was widely utilized as an over the counter medicine during the 19th and early 20th centuries, described in the United States Pharmacopoeia for the first time in 1850. Then in 1937 with the passage of the Marihuana Tax Act, a federal restriction was placed on cannabis use and sale.  Subsequent to this event, cannabis was dropped from the United States Pharmacopoeia in 1942, with legal penalties for its possession increasing in 1951 and 1956 with the enactment of the Boggs and Narcotic Control Acts, respectively, and prohibition under federal law occurring with the Controlled Substances Act of 1970. These legislative actions posed significant constraints  on cannabis research by restricting procurement of the substance for academic purposes. In the present day, the Drug Enforcement Agency (DEA) website still labels cannabis a Schedule I drug which is defined as having “no currently accepted medical use and a high potential for abuse.”

That said, over 28 states, the District of Columbia, Guam and Puerto Rico have taken their own initiative and have passed their own laws allowing for varying levels of cannabis use. Themajority limit this to medicinal cannabis used to treat a range of symptoms. The most common conditions include symptoms of cancer, glaucoma, human immunodeficiency virus, and multiple sclerosis. Recreational use is also legalized in eight states, CO, WA, OR, CA, NV, AK, MA, ME and more to soon follow.

The majority of states are treating serious medical conditions with cannabis and a smaller number are permitted recreational use.  I was clearly interested what is happening at the Federal Level.

EpiolexOn June 25th, 2018 GW Pharmaceuticals plc, announced that the U.S. FDA approved Epidiolex®  (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. The company noted that Epidiolex is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs. On June 27th, Revive Therapeutics announced that they have been granted Orphan Drug Designation for cannabidiol in the treatment of autoimmune hepatitis (AIH), a rare disease that causes inflammation of the liver.

There is a clear lack of consistency at the state and federal level concerning cannabis, particularly as a medical therapy. Over a hundred years ago it was legal and nationally available. Then it was completely banned. The majority of states and territories currently allow it for treating severe medical conditions. Eight states allow for recreational cannabis use. The Federal government after rigorous scientific testing approved GW Pharmaceuticals’ product and granted orphan status to Revive Therapeutics’.  All the while the DEA maintains cannabis as a Schedule I with “no benefit”.  Maybe someday this will get resolved but you got to wonder.  Is it the high cannabis can provide preventing the science?

Dave Fishman is President of Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development

As Companies Tackle “Age-Related Diseases”, How Much Do We Know About Geriatricians?

It is encouraging to hear the news of further investment  – $1B to be exact – into extending research collaboration between AbbVie and Calico focused on developing innovative therapies for “age-related diseases”. This partnership is evidence of the growing industry movement to embrace the differences across the lifespan and focus on therapies which can be tailored to this unique and medically complex population.

Such development initiatives underscore a very important stakeholder group  – geriatricians. While they are in high demand by patients, who are realizing their value,  their numbers are relatively meager as geriatrics does tend to have the appeal of other specialty tracks. Thus there is a low likelihood that an industry professional will come in contact with a geriatrician and it is often not clear what they bring to the table and how they differ from other clinicians such as internists and primary care.

According to the American Geriatrics Society, a geriatrician is “a medical doctor who is specially trained to meet the unique healthcare needs of older adults. Illnesses, diseases and medications may affect older people differently than younger adults and older patients often have multiple health problems and take multiple medications.”  Truly, this definition does not do this specialty justice. In fact, geriatrics is probably one of the most complex areas in which to practice.

As we age, common conditions tend to present “atypically”, therefore practitioners must have incredibly astute assessment skills and instincts. For example, a patient with a urinary tract infection may not necessarily have burning, but might have a dehydration and confusion. Similarly, an MI might present mild discomfort in the upper abdomen rather than crushing chest pain. Therapy options are also limited to some extent; there are certain drugs that have a high risk to benefit ratio in the elderly. So too, they must play detective when a drug reaction or interaction is suspected.

Due to the nature of their patient population, geriatricians often veer well beyond the realms of what is considered “medicine”. They must take a holistic approach to disease management and prevention. It is not unusual that a potential crisis is averted by maintaining or improving function through the incorporation of nutrition, hydration, psychiatric modalities, physical therapy, and referrals to social work. We think of geriatricians playing a critical role in the identification and management of dementia. What is often neglected is that their training readies them to take on the challenge of treating other chronic conditions in the presence of dementia.

In reference to training, there is no shortage of fellowship programs with 139 in the U.S. alone. In the U.S., geriatrics is not even a specialty, but rather a subspecialty of internal medicine. A residency in internal medicine with a one to two year fellowship for geriatrics is required for certification. In the EU, the training path differs by country with the norm being two to three years of geriatric concentration. Unlike in the U.S, 19 countries within the EU recognize geriatrics as a specialty.

As said before, geriatrics does not have the draw enjoyed by other specialties. Reasons range from funding and reimbursement to its perceived lack of “sexiness” by medical students and trainees. That said gaps are slowly being filled by non-physician clinicians such as nurse practitioners and physician assistants. Another trend is the geriatric concentration with certain specialists. Witness the geriatric psychiatrist, geriatric cardiologist, geriatric nephrologist, geriatric oncologist and even the geriatric emergency physician. This is driven on the appreciation that many of the patients seen in these specialty practices are older or elderly and the appropriate knowledge base is critical to ensure optimal management. Other innovative solutions such as continuing education for non-geriatric clinicians are also well established.

Given the steady focus in the development of therapies for age-related diseases, it is more imperative than ever to partner with this very important stakeholder group. With a solid grasp on the role and qualifications of geriatricians, industry professionals can develop innovative ways to involve and provide value to them. Additionally, there are endless opportunities to assist non-certified clinicians to practice geriatric medicine through effective therapy development and education along with linking clinicians up with valuable resources.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish and a well-recognized industry expert in geriatrics. She can be contacted at Melissa.hammond@snowfish.net

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Management Consulting, Medical Affairs, Product Development, Stakeholder Mapping

5 Reasons Why You Don’t Use Prescription Data to Identify Your KOLs

Over the years we have heard a number of concerns regarding KOLs from company employees:

“I am worried that if he is asked how to use it, what will he say”?

“She is not loyal to us”.

“I don’t know why he is up there [speaking], he never prescribes our product”.

These are the concerns of anxious sales representatives, marketing professionals and even medical affairs directors when referring to certain speakers that I have worked with earlier in my career in medical communications. That put quite a damper on what were essentially excellent scientifically strong and intellectually stimulation educational presentations. In any case, the point is that when it came to KOLs, there appeared to be a greater interest in brand loyalty than in diverse experience, credibility and linkages to other individuals and groups. Such loyalty was measured in terms of prescriptions.

Since then for many in our industry, thankfully the definition of a KOL has gone beyond someone with allegiance to a particular product. Yet it is not uncommon to run into our colleagues who ask why we can’t just use prescribing data to identify KOLs, particularly beyond the national level. The rationale is that this will help to uncover the true clinicians – those who can speak from their vast patient-facing experience. While there is some validity to this, there are even more reasons why the process for KOL identification should not include prescription data, period. We have outlined the top five reasons for avoiding prescribing data in your KOL mapping efforts.

     1. Is not a measure of expertise

Prescription data is a measure of just that, prescriptions. That said, it only tells us the specific products that a clinician uses for their patient and the volume. It does not signify if the individual has expertise in a given area or even if they treat a lot of patients (see #4). To that point, we do hear that especially at the regional/local levels, it is critical that the KOL speaks from their experience.  There are more effective – and less expensive – means to do this.

     2. It has not been a great indicator of a KOL

In our 15+ years of experience in KOL mapping, we have found that prescription volume has not been an accurate marker of an ideal KOL. In fact, there is an inverse relationship between these two once you are at the national level.  Alternatively, KOLs at any level are found to have multi-faceted profiles with demonstrated abilities to take their expertise outside of their own practices and link with their communities.

     3. Can lead to malalignment with the organizations objectives

By labeling a KOL based off one set of data (prescription data) can lead to a host of problems.  Medical Affairs might be looking for KOLs to shed light on a disease state at an advisory board but soon realize their knowledge is limited. Marketing is looking for a KOL that can communicate issues to a wider audience but realize they have no public speaking or writing experience. This becomes even more apparent when a company use one set of KOLs for a variety of disparate tasks. We have always advocating using a unique profile we’ve develop to ensure the right match within an organization.

     4. May not represent who you think it does

It is well established that a good deal of the care delivered is no longer exclusively through physicians. With over 280,000 in the US alone, the role of nurse practitioners (NPs) has been expanding significantly and they have been functioning at a much higher capacity than ever before.  This includes varying levels of prescriptive privileges in all 50 states and the District of Columbia with NPs writing an average of 23 prescriptions a day per the American Academy of Nurse Practitioners.  What is not always realized is that a fair share of these treatments is not captured under the NP themselves, but rather a physician with whom they work with.

Consequently, while a particular physician may show up as having an incredibly large prescription volume for a particular product or class of therapy, the reality is that they have five NPs, all of whom are using the physician’s number for their own prescriptions. They are then captured under the physician and not the NP. On the flip side, when trying to use this to map NP KOLs, this data will likely misrepresent them as low-volume clinicians who do not see many patients.

The bottom line is that prescription data may not even be an accurate picture of an individual’s clinical experience. There are better sources.

     5. May open company up to media or government scrutiny.

For this very reason, prescription data should be considered a proverbial third rail in KOL identification. Due to activities years ago by some players that were less than savory, our industry is still shaking off a reputation that suggests that anyone tied to it is biased. Most recently, reports by CNN and other news outlets have tied money paid to clinicians for speaking and consulting, to their prescription patterns. While these reports tend to inspect the prescriptions following such payments, it is just as likely to trigger a red flag if it is found that a KOL who is also an established high prescriber is receiving significant honoraria for a number of activities.

Therefore, while the intent may not be to only collaborate with KOLs who are product loyalists, use of prescription data to identify them may nonetheless send the wrong message and impair the credibility. It can also open the company up to some unwanted attention.

Overall, the definition of a KOL has evolved, with the ideal being one who is a trustworthy and capable expert who can convey their knowledge to others in order to improve patient care. So too have the methods for identifying them. With the multi-faceted approach which combines multiple and varied sources, such as what Snowfish provides, credible KOLs can be effectively mapped and engaged for all types of innovative programs. Whereas prescription data has value for many functions such as sales and marketing, for the reasons stated, it should be omitted from KOL mapping efforts.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes including KOL identification and mapping, designed to meet the needs of the particular product. To learn more, please feel free to contact us at sales@snowfish.net.

Melissa Hammond, GNP is Managing Director at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting, Medical Affairs, Product Development, Stakeholder Mapping

Staking out Success in New Product Planning

Figures-around-the-tableNew therapies entering the market face a fiercely competitive landscape and companies continue to work committedly to establish and maintain their edge. One way has been to get the right individuals and groups on board for expert guidance and to build momentum. Stakeholder engagement has always played a role in the product planning phase but this has historically been limited to leading physicians and researchers.

The stakeholder universe is way more complicated than that. Unlike years past, we have finally come to the realization that physicians are not the be-all-end-all and that optimal disease prevention and management requires a collaborated effort of interventions and disciplines. It truly “takes a village”.

Further adding to the complexity is that that understanding these stakeholders and what they are about is not enough. We also need to know their inter-relationships. Appreciating the synergies of these stakeholders and how they work together within a particular disease landscape can help define a strategy of how a product can best fit once it is launched. To achieve this most effectively, an approach should leverage clinical insights, analytics, and business acumen.

The process starts with assessing the stakeholder landscape. All stakeholders that have direct or even tangential influence are reviewed and analyzed. We tend to start by looking several degrees of separation from the “usual suspects” and then proceed to exclude those that are irrelevant. As seen below, clinicians only comprise small segment of the overall stakeholder landscape.

Government Public/Private Partnerships Patients
Non-Pharmacologic Approaches Professional Societies Payers
Diagnostics Clinicians Think Tanks
Hospital/Provider Groups Caregivers Corporate Initiatives
Advocacy Groups Competitors Celebrities

Now, doing this type of analysis requires more than a few sources. Rather a tremendous amount (I’m talking about 100+ sources) of information should be gathered and from “disparate” sources. We have found that often combining dissimilar datasets provides the most valuable insight. Additionally, there is no need to recreate the wheel, a lot of data exists both in the public domain and on many company’s servers. The secret ingredient to understanding stakeholder significance and interaction is not the data itself, but the ability to determine the types of data to include how to analyze it. Algorithms should be developed that incorporate an understanding of the entire disease state “ecosystem” including clinical, institutional, financial, advocacy, supportive, advocacy, and others.
Once a wealth of information is captured in a relational database, there is virtually an endless number of stakeholder analyses that can be conducted.

Snowfish has pioneered this unique approach of building custom stakeholder landscapes designed to meet the needs of the particular product. Individuals and policies are able to be assessed across multiple groups and companies are able to plan their pre-launch and launch activities on a very detailed level. To learn more, please feel free to contact us at sales@snowfish.net.

David Fishman, MBA is President at Snowfish a strategic consulting firm that has almost two decades working exclusively with the pharmaceutical, biotech, and medical device industries. Please go to snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Alzheimer’s – Science Sets Sail to Meet the Tsunami

AD Image

Departure of the Winged Ship by Vladimir Kush

The Grim Facts

It’s been called a coming “tsunami” with good reason. One in eight elder Americans have Alzheimer’s Disease (AD) and one in three elder Americans die with AD or another dementia. As baby boomers enter their golden years, the AD population is expected to nearly treble from 5.3 million in 2015 to 13.8 million by 2050, at an estimated cost of 1.1 trillion dollars and one in three of every Medicare dollar. Other developed nations face similar crises.

Government Responds

AD-SummaryMany national and state governments have recognized the tsunami threat and have put forward plans to address it. In 2011 President Obama signed the National Alzheimer’s Project Act (NAPA) with its number one goal to “Prevent and Effectively Treat Alzheimer’s Disease by 2025.” But behind the bold proposals actual government funding has been lack-luster. However, last month Congress passed a spending bill increasing Alzheimer’s research funding, effectively doubling the current $586 million to $1 Billion per year.

Presidential hopeful Hilary Clinton has proposed doubling funding again, calling for “rapidly” ramping up NIH spending on Alzheimer’s disease to $2 billion per year. While other leading presidential candidates have offered no such specific plans, they have been supportive: Bernie Sanders says he “believes very strongly” in more AD funding. Donald Trump, said that AD was a “total top priority for me”. In subcommittee hearings, Ted Cruz has strongly advocated more money be spent on AD Research. Marco Rubio said that a “Manhattan Project-style focus” is required on AD research.

With these greater gusts behind its sails can science now reach the NAPA goal and head off the tsunami?

The Science

To date there exists no effective cure for AD, nor any effective prevention. Worse still, there is scant understanding of the disease, its causes are unknown, as is its method of action on the brain. But there are clues for medical scientists to follow: from autopsies, for instance, it’s known that the brains of AD patients have distinctive plaques of the protein amyloid beta (Aβ), and also tangles of the protein tau.

Competing hypotheses for the cause of AD include: Mutations in various genes; reduced synthesis of the neurotransmitter acetylcholine; extracellular amyloid beta (Aβ) deposits; tau protein abnormalities; poor functioning of the blood brain barrier.

Here’s a glimpse at two of the most recent promising discoveries by AD researchers:

An Environmental Toxin

Back in the 1950s many native peoples of the island of Guam, the Chamorros, were dying of a paralytic disease with dementia symptoms. In post-mortems, US Army doctors noticed abnormal collections of proteins in the brains of sufferers similar to those of AD patients.

Fast-forward to the late 1990s when researchers led by Dr Paul Cox picked up the trail, visited Guam and found high levels of Beta-N-methylamino-L-alanine  (BMAA) in water pools and the seeds of the local cycad palm trees. BMAA  is an environmental toxin made by certain bacteria. The Chamorros use these seeds to make flour for tortillas and also cook fruit bats which eat the Cycad seeds and also showed high levels of BMAA.

And now Dr Cox and colleagues at the University of Miami’s Institute of Ethnomedicine have reported the results of an experiment on BMAA. Monkeys fed fruit laced with BMAA developed similar abnormal proteins (tangles) in the brain, proving the causal effect of BMAA. Further studies show BMAA mimics an amino acid called L-serine and inserts itself into brain proteins, causing them to misfold and tangle.

Currently clinical trials are testing whether giving patients L-serine tablets might prevent the misfolding effect.

The work was published in the January 2016 issue of the journal Proceedings of the Royal Society B

Brain Inflammation

AD Researchers at the Centre for Biological Science at the University of Southampton in England have recently found that “inflammation in the brain can in fact drive the development of the disease.” And that blocking a receptor in the brain that regulates immune cells could “protect against the memory and behavior changes seen in the progression of Alzheimer’s disease.

The researchers, lead by Diego Gomez-Nicola, first compared brain tissue samples from AD patients with those from healthy people of the same age. The Alzheimer’s samples were found to contain more of immune cells called microglia than healthy ones.

The research team then conducted a study on mice bred to develop the characteristics of Alzheimer’s. The mice were given a drug which blocks CSF1R, a receptor that regulates microglia. The treated mice were able to demonstrate “fewer memory and behavioral problems.” than the untreated mice.

The work was published in the January 2016 issue of the journal Brain.

The Future

Whether either of these two particular recent discoveries eventually lead to a method to prevent or treat AD is unknown. But with more and more funded AD research under sail there is reasonable hope that the effects of Alzheimer’s Tsunami can be at least reduced and a cure found within our lifetimes.

Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have long experience of working on geriatric issues, and particularly on AD and other dementias. We have built comprehensive databases and reports for clients on every aspect of the AD landscape, based on our own research and a wide variety of resources. Snowfish attends the major AD meetings including NAPA Advisory and NIH Alzheimer’s Summit meetings.

Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net.  We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Medical Affairs, Product Development

Combining Care with Cure: A New View on Palliative Care

Palliative CareQuality of death… No, that is not a misprint. It is actually the main premise of a recent report released by the Economist Intelligence Unit (EIU) which exposed the global disparities in the availability of palliative care relative to the estimated need.

While a key objective of shedding light on the value of palliative care particularly given the aging of society was met, the use of the term “death” indeed misrepresents the main intention of these types of services. In fact, it is quite common for many stakeholders within the medical industry including clinicians, patients and therapy manufacturers to equate palliative care with end-of-life care or hospice.

Rather, palliative care is a valuable complement to an actual treatment which ideally takes place throughout the course of disease management. According to the World Health Organization (WHO), palliative care is:

An approach that improves the quality of life of patients and their families facing               the problem associated with life-threatening illness, through the prevention and                 relief of suffering by means of early identification and impeccable assessment and             treatment of pain and other problems physical, psychosocial and spiritual.

In the context of palliative care “life threatening” should not mean imminent death, but refers to a condition that can ultimately result in a person’s demise. According to a 2013 report titled, Essential Medicines in Palliative Care, these interventions should:

  • Provides relief from pain and other distressing symptoms;
  • Intends neither to hasten or postpone death;
  • Will enhance quality of life, and may also positively influence the course of illness;
  • Is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications

These points drive to the fact that end of life care or preparing for death are only a small fraction of palliative care. As echoed by Diane Meier, MD a primary-care geriatrician and director of the Hertzberg Palliative Care Institute at Mount Sinai School of Medicine in New York City, “The vast majority of patients who need palliative care are not dying”. She supports that all patients regardless of their ability to recover from serious illness should be receiving palliative care measures.

While not characterized as such, the therapeutics industry has been long engaging in
palliative care. These measures are designed to treat the often debilitating symptoms associated with an illness or its treatment such as pain, anxiety, depression, cachexia, nausea/vomiting, constipation, and dyspnea.

Among non-drug interventions, pharmaceutical management is an essential part of alleviating them and the industry is marketing and developing a multitude of therapies for this purpose. Despite all of the efforts in this area, companies fail to tout their palliative care portfolios.

The reason is likely due to points made earlier; the perception that palliative care equates to preparing an individual for death. As an industry, we revel in the thrill of the “cure”, “control” and “putting disease into remission”. There is likely poor awareness of the benefits of palliative care beyond relief of individual suffering even though a significant amount of evidence supports that palliative care in addition to conventional medical care results in improved quality of life, higher satisfaction with medical care, lower rates of readmission/emergency department visits, and even greater survival in certain diseases (cancer).

Is there benefit for the industry to formalize our role in palliative care?

Absolutely – though significant analysis is critical to determine how this should be defined. It can be as simple as pulling disparate agents into a single portfolio or creating a subset of within a given disease state portfolio to provide a coordinated method for “care and cure”. Products may be incorporated with other non-pharmaceutical methods and even certain types of training to offer a whole palliative care “service”.

Regardless of the nomenclature used by the EIU to discuss palliative care, the report is still
worth a read. It reinforces that the need for palliative care is growing. The aging of our society brings with it the increases in diseases such as cancer, arthritis, dementia and chronic obstructive pulmonary disease which will expand the need for primary care.

This is a ripe opportunity for the therapeutics industry to take hold of. The therapies are already being marketed and the relationships with stakeholders are in place. Through sharing of information and coordination, the therapeutics industry can take advantage of this significant opportunity – to move the focus away from quality of death with disease to living in comfort with disease.

 

Melissa Hammond, MSN, GNP is Managing Director at Snowfish at commercial insights firm. She is an expert in aging and aging issues as it relates to therapy development and commercialization. Please go to www.snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Open Payments Wabi-Sabi

Cracked Face

Unlike the Western World’s cultural devotion to “perfect beauty”, in Japanese art and culture the aesthetic of “Wabi-Sabi” – beauty that is “imperfect, impermanent, and incomplete” is much admired. As beauty is in the eye of the beholder, perhaps Open Payments is thus a delight for Japanese data analysts!

Open Payments had a difficult birth – the initial release in September 2014 contained payments for just the last five months of 2013 and was maimed by problems correctly identifying recipient healthcare providers, leaving 2/3rds of the over $3 Billion in payments as “de-identified”, making the dataset pretty useless for solid analysis.

The second release of Open Payments, on June 30th 2015, corrected that very ugly flaw, for both the revised 2013 and new 2014 data, boasting that all the payments were now “matched with total confidence to a particular covered recipient”. But there are plenty of lessor flaws that can trip up the unwary analyst.

Uncommon Teaching Hospital Names, Chopped or Not

Payments to around 1,200 teaching hospitals are in the dataset. CMS chose to use Open payments2the “PECOS” name of the hospital that had been originally registered with Medicare. Unfortunately these names can be quite different from the well-known hospital names we know today. For instance, you may be looking for payments to the famous Memorial Sloan Kettering Cancer Center. But its PECOS name is Memorial Hospital for Cancer & Allied Diseases. And that’s the name you will have to search for in the 2013 data. But to make it harder still, for the 2014 data CMS decided to truncate the names down to 36 characters (and upper case them), so you need to change your search to “MEMORIAL HOSPITAL FOR CANCER AND ALL” to find Sloan Kettering in the 2014 data.

Unique IDs, With a Catch

But, you may reasonably argue, CMS keeps a unique ID for each teaching hospital, right? Argh, yes and no! In their infinite wisdom they decided to change all these “unique” IDs for the 2014 data, so Sloan Kettering has ID 102 in the 2013 data, but ID 1265 in the 2014 data!

Non-covered Entities Munch on the Research Dollars

For research, as well as payments to physicians and teaching hospitals, payments to other “Non-covered Entities” are collected. These are typically hospitals, including, strangely, teaching hospitals. The thing is these mysterious Non-covered entities, in pac-man-esque fashion, are munching the vast bulk of research dollars:Research Payment Recipients

But Where’s the Beauty?

Despite its pretty darn ugly flaws, Open Payments can produce very interesting results, if analyzed carefully to avoid the booby traps. Here are some of the types of valuable analysis that can be performed:

  • By drug: Identify the most highly paid physicians in certain activities for a target list of drugs, categorized into speaking, consulting, and research engagements.
  • By competitors: Analyze your competition – see how your competitors compare in their marketing budgets, and where and on whom they spend their money.
  • By KOLs: Analyze the work of your own KOLs, find who else is funding them, and how you stack up against them.
  • By Institutions: Discover which institutions are receiving major research funding in your areas of interest, and from which of your competitors.
  • By Partners: Find new partners for your business plan, and analyze current partners, by identifying companies making complementary products who are spending in your target areas.
  • Trend Analysis: Find trends in your area of interest – who are the rising stars, and which types of work is becoming more valuable, and for which drugs.

How Do I Do These Tricky Analyses?

Snowfish offers a white paper, Healthcare Big Data: CMS Open Payments, covering the Open Payments database and its possibilities in more detail, and also have a real example of an analysis in Excel. The example shows the 30 most highly paid psychiatrists and neurologists, where we calculate the total payments made to each physician in each of a number of categories, and show not just the companies making the payments but also the associated drugs for the payments.

If you are interested in learning more about Snowfish’s industry-leading approach to healthcare data discovery and mining, and how we can help with your custom Open Payments analyses, please feel free to reach out to us.  This is the time to capitalize on this fascinating new opportunity.

Martin Snowden is Director or Technology at Snowfish. He is an expert at database integration and analysis. Snowfish integrates, clinical, analytic, and business insights for life sciences companies. We have worked with nearly three dozen companies for over a decade and leveraging big data to help increase a company’s competitive advantage. Snowfish can be reached at (703) 759-6100 or via e-mail at info@snowfish.net. We are also on the web at www.snowfish.net.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Management Consulting, Medical Affairs, Product Development, Strategic Partnering

Beyond KOL Identification & Mapping, What’s Next?

For decades, we have regarded physician key opinion leaders (KOLs) as the “rock stars” of the life sciences industry. Like the musical ones, these leaders have influenced trends and packed rooms. The press would chase them to get a window into what they are thinking. I guess one key difference is that they tend not to destroy hotel rooms.

Similar to a star musician’s impact on a large record label, the life science industry has long depended upon these influencers who were predominantly physicians, to ensure a therapy’s success.

Enter social media and other drivers of product uptake. The music industry has witnessed songs being made available digitally via an immeasurable number of sources and thus easily shareable. The artists themselves are no longer the main promoters of their product as others (mainly fans) through their endless articles, blogs, Tweets and reviews carefully guide our tastes in music. Technology has also opened a path for lesser known independent artists to gain widespread exposure.

Comparable dynamics are observed in the world of medicine. The physician is no longer the sole gatekeeper to access to the product of medical care. We all know that payers can make or break a particular treatment through their level of willingness to cover it.

Other clinicians such as nurse practitioners and pharmacists have been stepping up for some time now, to provide care and counseling. Widespread availability of information has patients more informed than ever. They are sharing their knowledge electronically as well as banding together to advocate for greater access and policy changes. Societies representing patients and professionals sponsor guidelines and position statements to guide disease management. Additionally, there is the role of research consortiums, support groups, social activities, technological modalities (such as telemedicine), and even home care and government-provided services to consider.

Physician KOLs, while still important, must be regarded as a key entity of a larger ecosystem of critical stakeholders. As every disease state or therapeutic area has its clinical specialists, it also involves the cooperation of other groups that are essential to ensuring that a disease is well managed and treatment takes place. Snowfish has worked with clients to define the larger ecosystem. Our analysis has spanned a broad and diverse constituencies including:

Centers of Excellence Mid-Level Practitioners
Payers Celebrities
Competitors                                     Think Tanks
Patients                                              Government/Policymakers
Caregivers Private/Public Partnerships  
Societies                                              Diagnostic Providers

Physician KOL mapping is ubiquitous within the life science industry. This is clearly not enough. Utilizing sophisticated analytics while taking a creative and forward thinking approach to data sources will help to zone in on the most important stakeholders which will not only build momentum around a product but an entire offering.

While our industry still has our obvious “rock stars” and needs to continue to cultivate them, it is evident that there are others who are exerting their influence in less than obvious ways. Identifying and engaging them will best ensure that for any given company, the music will never stop.

Melissa Hammond, MSN, GNP is Managing Director at Snowfish, LLC, a commercial insights firm. Snowfish has expertise in analysis of non-physician stakeholders and KOLs. Snowfish offers stakeholder identification and profiling to help companies understand who to engage not only today but ten years out. 

Please go to www.snowfish.net or call +703-759-6100 to learn more about our services.

Posted by Melissa Hammond  |  0 Comment  |  in Brand Management, Medical Affairs, Product Development, Strategic Partnering