LinkedIn
Twitter
Blog

Monthly Archives July 2018

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