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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

Patient Recruitment for Clinical Trials – A Strategic Approach

Patient recruitment is a critical component for drug development. A troubling statistic from the National Institutes of Health (NIH) reports that more than 80% of clinical trials in the United States (U.S.) fail to meet their patient recruitment timelines. This despite that 30% U.S. pharmaceutical industry’s time dedicated to clinical trials is spent on patient recruitment and enrollment. Such delays increase costs, deplete resources, and prolong the time before a therapy is made available to the public.

Patient recruitment is only a single aspect of conducting a clinical trial, albeit an important one, and often what most often keeps clinical operations professionals up at night. Getting the right subjects enrolled is complicated and involves multiple players including patients, physicians and other healthcare providers (HCPs), sponsors, and clinical trial research teams. However, despite growing knowledge in how best to leverage relationships with multiple stakeholder groups, most clinical trial recruitment is supported through traditional means. The most common is via patient medical records followed by using hospital-based registries and other data sources.  Other common practices are e-mails and alerts to physicians and patients about the trials currently available to them.  Other tools involve the use of social media such as Facebook and Twitter as well as engaging in public events such as health fairs and farmers markets.

Snowfish takes a more strategic approach to patient recruitment. Multiple stakeholder groups related to the disease state of focus, are linked together to create an integrated and unique picture. This involves understanding the needs of the patient and where they might reach out to seek out management of their condition or even ancillary support.  Key information might include: the target patient population, types of HCPs that treat the condition, where the patient is (physically) located, where patients obtain information/education on the condition, if they are likely to engage online and through social media, and the best ways to work with hospitals, advocacy organizations, health systems, and HCPs to identify eligible patients.

A good example is Alzheimer’s disease. As few therapies are available to treat it, the myriad of stakeholders involved in its management goes well beyond medical. While this includes geriatrics, neurology and primary care, AD support groups, advocacy organizations, caregivers, social networking groups, CMS wellness visits, geriatric education centers, community base care transitions programs, and state level AD programs are also integral in managing these patients. Most care is delivered outpatient though as the disease progresses, long term care facilities play a larger role.

It is not only understanding how the various stakeholder groups function individually but how they work together that are keys to develop an effective patient recruitment strategy. This aides in creating a unique and targeted promotional plan using the various channels such as internet, TV, radio, social media, health care fairs, state organizations, etc.

In 2014, Industry Standard Research conducted a study with industry leaders in patient recruitment and patient network services; 28% indicate the most prevalent best practice is to use a diverse range of recruitment outlets and approaches. Clearly, there is no one preferred approach to recruitment, rather a diverse offering of initiatives is needed for success.  Snowfish develops each patient recruitment activity with the understanding of the disease state, key HCPs, organizations that support patients and caregivers, and those that influence treatment decisions.

 

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

What’s it gonna take to put you in a cure? Five lessons learned from a consumer-focused stem cell therapy seminar

Getting to the source of all that ails you! No side effects! Learn all about it while having a great meal!

When one thinks of seminar on stem cell therapy, this is not necessarily what comes to mind. Rather the visual is a scientific symposium in which scientists enthusiastically remark on well-cited studies and hypothesize how this might eventually translate to FDA approved patient care. But this is the consumer-focused stem cell industry. This growing segment of health care consists of clinics which use the inhalation or injection of stem cells usually of umbilical origin, to treat a multitude of conditions. Deemed experimental by the FDA and other country-specific regulatory agencies, they are not covered by insurance and paid for by consumers out-of-pocket.

Going directly to the patient, they use various marketing tactics such as seminars held at a local restaurant or similar venues. The leader at one seminar was a non-clinician who could be described as a cross between a car salesperson and time share pitchman. Surprisingly though physicians are employed by these clinics, they were suspiciously absent. Nor were there any unaffiliated clinical key opinion leaders to speak to the therapy’s benefits. There were plenty of videotaped patient testimonials and even some studies showing clinical benefits of stem cell therapy, however no credible data drawn from the patients treated at the company’s clinics.

While the therapy is not covered by insurance and the delivery of the information is a bit campy with little scientific rigor, one could not overlook the fact that these seminars get pretty packed. It could be the free lunch, but it also may be attributed to other factors that draw in potential patients. Industry should keep stem cell clinics on the radar screen as part of the overall ecosystem. While not a “traditional” competitor they are nonetheless competitors in the mind of the consumer.  Below are five things learned from attending a consumer stem cell therapy seminar.

  1. Companies knock out the middle man and go directly to the consumer

Consumer-focused stem cell clinics aim straight for the patient, bypassing clinicians completely. This may make sense to them as it is the patient who is shelling out anywhere from $5K to $12K for a series of treatments. Companies host consumer-focused website, advertisements, and will invite prospective patients to local-level educational seminars held at upper-end restaurants. At seminars, part of the presentation involves signing people up for evaluations right on the spot, and no one gets served their food until the pitch is over.

  1. They sell hope

Clinics claim that through the injection or inhalation of stem cells, they can cure or significantly decrease the severity of a multitude of diseases from COPD and arthritis to neuropathy, ALS and dementia. Terms such as “turn back the clock” accompany testimonial videos in which elated patients exclaim how they got their life back again.

Scanning the seminar attendees, it is clear that many are striving for hope. Most were older adults and quite a few had mobility issues with others struggling with dementia.

  1. The overarching message is that of cynicism of standard medical treatment (this includes the FDA and pharma)

A main assertion is that standard medical treatment does not work for many illnesses and even downright harmful due to adverse side effects. A seminar leader even went as far to say that the FDA keeps stem cell therapy experimental to protect the pharmaceutical companies by keeping people permanently dependent on medications rather than curing their illnesses.

As mentioned in item 1, stem cell clinics circumvent the standard medical system, thus going straight to the consumer. In fact, patients were discouraged to discuss this therapy with their own doctors being told that they might be intimidated since they don’t know enough about it.

  1. They boast “positive” side effects

Stem cell clinics speak not only to the lack of side effects normally found with conventional treatments, but their having benefits that go beyond the condition being treated. They allude to a fact that the stem cells employed are supposedly not specific which is why they can be used for a wide range of conditions. So for example when used to treat an arthritic knee, they claim that patients might also report improved vision or lessen symptoms of dementia.

  1. There is a focus on empowering the patient

Consumer empowerment is a driving force within the ecosystem for any disease, and its key components must be fully appreciated when building a product strategy. There is the sentiment shared by some that they have been failed by standard medical care. This has not been lost on the consumer-focused stem cell industry. One of the companies’ main criticisms is that patients have no control and that they are at the mercy of their physicians, hospitals, and the therapeutics industry. Offering a “cure” over alleviating symptoms provides a greater sense that they are in control of their disease and their lives.

Patients are getting more informed and thus more empowered, which are all very positive things. Understanding the multiple ways they interface with the health system and the endless options – traditional and non-traditional – that they are exposed to, is instrumental to product positioning, uptake and ultimately success. It is critical that consumer-focused stem cell and other non-approved treatments not be discounted and rather be included as a viable component of a disease ecosystem map.

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 Management Consulting

Pharma Payment Mechanics

Car and MoneyTop Gear

The Centers for Medicare and Medicaid Services, CMS, recently released the latest 2017 Open Payments data, providing now a total of over four years of pharma payment data for analysis. The total database now contains details of over 74 million payments to nearly one million physicians and over four thousand hospitals.

Research payments have shown a healthy average annual increase of 14.8%, with 2017 payments totaling $4.66 Billion. Not so the “General” payments, covering the gamut of the typical payments such as consulting, speakership, food & beverage, royalties etc. which has been rising at an average annual rate of 3.4%, only about 1% over inflation, to a total for 2017 of $2.82 Billion.


Open Payments mid bar

Chart - Research vs General Payments

Under the Hood

Digging deeper, we see some trends within the General payments. Staple general payments to physicians, like Food & Beverage ($237 Million in 2017) and Travel ($188 Million in 2017), are basically flat at under 2% per annum – just under the rate of inflation, while Gifts are the same in 2017 as they were in 2014, at $29 Million.

However, Entertainment payments although the smallest of the payment categories, trebled in size last year to $1.5 Million.

Chart - Entertainment

Formula One Drivers

In terms of physician-company collaborative relationships, we also see a shift from Speaker roles (down 2.6% per annum to $612 Million in 2017), to Consulting roles (up 5.4% to $429 Million).

Speakers vs Consultant

Where the Rubber hits the Road

The utility of Open Payments data goes well beyond an overview of who is doing what. Targeted analysis may be performed of this rich dataset which can help in critical decision making:

  • 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 the 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 and other KOLs, find who is funding them, and how you stack up against them.
  • 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 drive these payment analyses?

With our long experience in healthcare data analytics and proprietary name matching software, Snowfish can perform custom analyses for you in a short timeframe, and provide automatic refreshes to the analyses whenever new data is released.

We have a white paper available for you 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!

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

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

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

ASCO Recommends Geriatric Assessment

elvis-costelloSinger Elvis Costello was just forced to cancel his tour to recover from surgery that he underwent to treat cancer. We wish him the best for a full recovery. While termed as “very aggressive”, news reports have noted that it his tumor is small and should be “defeated” through this single procedure. At this time, it is not clear to us as to the exact type of tumor or its makeup and if he requires any follow-on therapy to keep the tumor at bay. At age 63, Mr. Costello a.k.a. Declan Patrick MacManus will likely to be managed like most adults with his tumor type, grade, and stage. But according to new recommendations from the American Society of Clinical Oncologists (ASCO) if he were at least two years older and chemotherapy an option, he should ideally receive a geriatric assessment to determine his treatment path.

ASCO has already stressed the need for better treatment of older adults with cancer and despite that 60 percent of cancers occur in those over 65, they are severely underrepresented in clinical trials. Furthermore, due to physiologic changes related to aging and comorbidities, this group tends to have issues with poor tolerability and toxicity to oncology therapies. “Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” said former ASCO President Julie M. Vose, MD, MBA, FASCO. “As we age, for example, the risk of adverse reactions from treatment significantly increases. In 2015, ASCO released landmark recommendations urging for a broadening of clinical trials to include older adults.

What is promising is that progress is being made. The AbbVie/Calico partnership includes oncology as a target of its research efforts. The approval of Vyxeos ™ a treatment for acute myeloid leukemia (AML) was based on studies which included patients 60 to 75 years old, a population that has long been poor candidates for standard therapy due to concerns of toxicity and therapy resistance.

These are only initial steps and there remains a lack of data in older adults for the majority of cancer therapies particularly chemotherapy, making treating them kind of a crap shoot. This is where ASCO envisions geriatric assessment filling a key need. Used for years within other specialties and disciplines, geriatric assessment helps to determine a particular management pathway for an older adult through evaluating physical ability, psychological status, nutrition, cognition, social circumstances and other, coexisting medical conditions. It is underused in oncology practice – with less than 25% of eligible patients receiving a geriatric assessment. Consequently, oncologists have not had the tools to establish the risk to benefit ratio of oncology therapies in older adults and key signals have been missed. With geriatric assessment, oncologist will be able to determine potential for poor tolerance to chemotherapy through identifying signs of dementia, fall risk, frailty, and comorbidities to name a few.

While geriatric assessment will likely improve decision making in oncology one patient at time, there is potential for a more pronounced impact. Its use may enhance overall awareness of the impact of aging on oncology practice and pave the way for more studies in older adults with more innovative therapies.  Widespread use of these assessment tools can also generate data able to be used by ASCO and the oncology community to make a case for changes in the ways that studies are evaluated in order to encourage inclusion of older adults. This is key to success of cancer treatment because with the aging population expected to double in just less than 50 years, so will the number of individuals with cancer.

Melissa Hammond, MSN, 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. Melissa is an expert in aging and aging issues as it relates to therapy development and commercialization.

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 Management Consulting

Stakeholder Deep Dive: Professional Societies/Advocacy Groups

In this segment we focus on another set of stakeholders who are in the “usual suspects” category, but are really more complicated than meets the eye. Professional societies and patient advocacy groups have long been considered critical partners at all stages of a therapy’s lifecycle, including the early product planning phase. Their value is underscored by their role as the face of the key constituents that companies rely on to help informs product development and direction and to get the word out to others in their networks.

Professional societies and patient advocacy groups also value these relationships which range from joining forces with companies to further objectives such as education, support, or advocacy to viewing industry as just a trough of money used to support their own individual efforts. That said, while many groups may rightly be considered stakeholders and thus essential to engage, it is OK to put them into buckets based on how much they will allow industry to be actively involved.

We appreciate the challenges that organizations face related to industry partnering.  Rightfully so, it is in their best interest to remain unbiased and focused on the interests of their constituencies. Thus historically, these groups have had a somewhat on-again/off-again relationship with industry. Over the past decade that in order to remain financially stable, societies and advocacy groups need some level of industry funding. A ProPublica survey noted that more than two-thirds of responding patient advocacy organizations reported that they had received some level of industry funding in their last fiscal year with 12 percent received more than half of their money from industry.

Our own conversations with representatives from dozens of organizations has revealed that membership dues and fees for educational programs do not cut it anymore. Also, certain organizations that were primarily membership based are branching out, with a desire to reach communities that go well beyond their paying members. To ensure to optimize industry collaborations, professional and advocacy organizations have brought on specialized industry relations professionals. Most come directly from industry.

Resources are not infinite how does one increase the likelihood that a professional/advocacy group engagement strategy will be a win-win for all? Zero in on four major components:

  1. Alignment with the company on key objectives related to the disease state
  2. Their level of willingness to collaborate with industry as partners on meaningful programs and outreach, and
  3. Are their resources to collaborate with industry.
  4. If the relationship provides for interfacing with the executive team.

There is a variety of indicators which can be incorporated into a detailed analysis which utilizes complex analytics and innovative profiling. This process will help to identify the society/advocacy group partners upfront that present the best opportunities from the perspective of setting direction and ongoing collaboration as well as the level of investment required.

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.

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 contact us at sales@snowfish.net or +703-759-6100 to learn more about our services.

Posted by Dave Fishman  |  0 Comment  |  in Management Consulting

Data: Are You Using it as Effectively as You Could Be?

There is a tremendous amount of data out there, are you using it to inform your product launches? Every life science professional is well aware of Rx data, ICD-10, CPT codes, and procedure volumes. They are also quite familiar with all the clinicians that focus on a disease state. The question is do you understand the landscape outside of these traditional metrics?

We have built a practice that involves using a multitude of non-traditional data inputs to inform and accelerate product launches. These can also be linked to the traditional metrics. In certain cases, we have used over a hundred different sources to inform decisions and increase product acceptance. Below is just a small sample of the diverse types of data that we have used from a multitude of sources.

U.S. Census Data Associations Hospital Rankings Community Resources
Clinical Trial Sites Public/Private Partnerships Sunshine Act Data Geriatric Emergency Departments
Nursing Home Minimum Data Set (MDS) Medicare 5 Star Advantage Metropolitan Statistical Area Data Veterans Per Area
Income Level Support Groups ­­­Investigators NIH Grants
KOL Data Centers of Excellence Medicare ACOs Competitive Product Data
Clinical Trial Sponsors Hospital Infection Rates Domestic Violence Groups Insurance Formulary Committee

This data can be used to provide insights that are unique and targeted for a particular product. These may include, but are not limited to:

  • What are the best areas to place clinical trial sites?
  • Which hospitals have high levels of infections rates that might be amenable to a new product?
  • What KOLs are working with various companies around which products?
  • Which is a leading center of excellence and which clinicians are associated with the institution?
  • What is the best professional society or patient advocacy group to work with around a given disease state?
  • What are the relevant support groups within 15 miles of a target area?

The questions that can be posed and the answers that may be gleaned will be vast if you are willing to simply move beyond the traditional tools.  So, I will close with are you leveraging all the tools in your bag?

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 Management Consulting

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