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Market Access Strategic Execution Consultant

Market access needs courageous innovators to break the mold

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Two hundred forty three years ago, on July 4, a small startup decided to declare itself as a separate entity from its successful parent company that was then considered the wealthiest in the world. In a matter of a few short years, the large parent company was declining, while the startup has ascended to be considered the most powerful in the world. Small startup = United States; large parent company = Great Britain.

History is our biggest teacher, and the US independence teaches us that no matter how small or how large, the most courageous player gets the cake.

“Innovation” doesn’t happen with the wave of a wand by an Innovation Wizard. Innovation is brought about by real people all around us. Perhaps you’re sitting next to an innovator right now–or perhaps YOU yourself are an innovator–or perhaps the author of this blog is an innovator.

Innovators are courageous. They challenge the status quo, take risks, and accept failure as a natural process for innovation (IDEO’s risk-taking philosophy is “fail soon to succeed sooner”).

You still can’t think of a courageous innovator that you know? Let me help you out by giving you a few examples of courageous innovators that I know (fictitious names, but real incidents):

Nancy-the-rookie who performed a job worth millions, or more​

Nancy’s company lost a valuable client because her team produced a billable project that was ridden with errors. Nancy took it upon herself to conduct a Root Cause Analysis and spent approximately 40 hours of her own time interviewing team members and drafting a report, in which she concluded that her company could benefit from a more organized workflow in order to prevent such incidents in the future.

Nancy’s Root Cause Analysis report sparked changes at her company.

Fast-forward 2 years –> Nancy’s company has established swim lanes for all team members. Now, her company is able to produce excellent projects on predictable budgets, while keeping employees happy because the need to work nights and weekends has basically been eliminated due to the great efficiency.

Tyler-the-writer who delivered a presentation at a HUGE and FAMOUS national conference

Tyler, though operating under the title of a Medical Writer, is always looking for opportunities to establish himself as a thought leader. He stumbled upon an ad from a HUGE and FAMOUS national conference which was calling for speakers. Tyler decided, “why not?” He got permission from his manager, and her manager as well. Despite many, many, MANY obstacles, Tyler was accepted to speak at the HUGE and FAMOUS national conference. Not only that, Tyler and his co-speakers delivered such a ROCKING presentation, that it was chosen to be one of the online enduring presentations on the conference website.

Look around you for courageous innovators, read articles and books to become courageous yourself, and network to get fresh ideas.

If you are under pressure to deliver results and protect your margins, you should DEFINITELY be seeking out these courageous innovators, as they are the ones who bring in the trophies.

It’s time to make big strides and turn heads–let’s go.

How do you define your target audience? Create a Persona Profile–here’s an example

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Marketing effectively requires cultivation of empathy. On the contrary, cranking out tactics for the sake of doing so is a recipe for failure. 

Can you envision what your customers look like? Do you know what keeps them up at night? What are their priorities? What are their threats? What motivates them? 

Looking at your product through your customers’ lenses means to make their problem your own. Only then can you find a solution that will actually work, and thereby increase sales and revenue. 

I, myself, sometimes lose sight of the customers’ needs, which is why I follow Nancy Duarte’s advice and keep a Persona Profile on my wall to remind me to empathize with the target audience. I have even named my hypothetical customers to make them more human. I modify the specifics based on the product I’m working on, but the general profile remains the same.

After preparing the customized Persona Profile for the specific product (which can be a simple PowerPoint slide), then only do I internalize the value messages and craft a killer tactic that actually resonates with customers and inspires them to follow through on my call to action.

See below for an example of my high-level Payer Persona Profile.

It’s time to make big strides and turn heads. Ready. Set. Access.

Payer Persona Profile

Jeff, Heli, Sarah, Maggi, and Sam

Pharmacy Services at XYZ, Inc.

WHAT ARE THEY LIKE?

They're payers who are in the business of making and saving money. They can only keep their population and customers happy if they, themselves, are financially equipped.

WHY ARE THEY HERE?

To see how my product can help them make or save money.

WHAT KEEPS THEM UP AT NIGHT?

Drugs are becoming more expensive and they're struggling to find ways to keep them affordable for their population yet ward off unwanted attention from the press and politicians. It's difficult for them to maintain a positive reputation when their current financial calculators cannot keep up with the growing number of expensive specialty drugs.

HOW CAN I SOLVE THEIR PROBLEM?

If a specific type of their population uses my product in the correct manner, they will end up saving, and even making, money.​

WHAT DO I WANT THEM TO DO?

First, understand the right population for the product. Then, facilitate access of the product to all those patients.

HOW MIGHT THEY RESIST?

They will scrutinize each of my claims vigilantly. They will want to see evidence of my claims and their own numbers rather than national averages.

WHAT'S THE BEST WAY TO REACH THEM?

It's difficult to find time to get all of them together in one room--perhaps the maximum is 45-60 minutes. I will need to be creative in effectively communicating my message in a limited time period. If needed, I will have to resort to pre-reads or pre-views where they can access critical background information before-hand on their own time. Then, I can devote the live meeting to communicating my product's value proposition.

How to identify a good market access content developer

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Finding the right content developer feels much like finding the right pair of running shoes, or the right foundation (for those who wear makeup), or the right house to settle into. Once you find it, it’s really, really, REALLY hard to give up. A good content developer is someone you can rely on to get the job done well even while you’re on vacation or busy attending to another task. 

Medical writers and copy writers are not necessarily content developers, though there’s nothing stopping them from becoming one.

So what does a content developer look like?

Top 5's to Identify a Good Market Access Content Developer:

Commercialization is a team sport which cannot be played in solitude (just try to, and you’ll see what I mean). For this reason, effective 2-way communication is important to create a masterpiece. A client gives directions, and the content developer asks clarifying questions and provides suggestions.

Market access can be tricky because it requires understanding clinical knowledge AND the intricacies of the healthcare space–BOTH of which are constantly evolving. Put simply, it’s a matter of keeping up or moving over. The curious mind can keep up.

Why should anyone read 3 pages of information when the information can be conveyed in one short paragraph? Knowing the audience and the strategy enables laser-focused content.

Promotional material should ALWAYS be supported by sound evidence. Inaccuracy will lead to multiple rounds of revisions, wasted time, and thereby wasted money and diminished reputation.

Perhaps the most important trait is a psychological one which is hard to gauge in interviews and is not a focus for development in the corporate world. Having the can-do attitude enables innovative strides, persistence, timeliness, and solid delivery of a project (more on this in a future blog post).

It’s time to make big strides and turn heads. Ready. Set. Access.

Chronic low back pain: employers with onsite or near-site clinics can become a gold mine for market access​

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Opioids are currently considered the most effective pharmacologic options for the treatment of chronic low back pain. Although effective, opioids can be just as dangerous because of the risk of opioid addiction, which can be devastating for individuals and their families.

At least 3 innovating manufacturers are heeding this call and are soon to launch treatments for chronic low back pain without the risking addiction (lucky for patients and providers because they will have options–though this competition will pose an up-hill access and commercialization battle for the manufacturers). A top barrier for the manufacturers will be optimum formulary placement. The first entrant might enjoy the perks of being first-to-market as did Gilead in 2014 with hepatitis C , but not for long. Entrance of the other competitors for chronic low back pain will be justification for payers to demand rebates and rebate walls.

Of course, standing your ground with the right value story will certainly help you gain traction–but  have you considered all potential audiences for your value story (for example, employers with onsite or near-site clinics)?

According to PwC’s most recent Medical Cost Trend report, employers are fed up with the high health care costs and are taking matters into their own hands as they are now taking bold new steps in their efforts to contain costs. For example, they themselves are negotiating contract prices, setting up their own provider networks, and in some cases, building parallel health systems to take care of their employees at more manageable costs.

The most recent survey report from Mercer and the National Association of Worksite Health Centers suggests that general medical clinics are offered by 33% of organizations with 5,000 or more employees (up from 24% in 2012 and just 17% in 2007), and another 11% of employers of this size are considering adding a clinic by the end of this year. Based on consumer experiences with these clinics and the imminent entrance of Haven (comprised of JPMorgan Chase, Amazon and Berkshire Hathaway), it seems logical that such onsite workplace clinics will continue to become more prevalent.

Employers that are self-insured and those with onsite or near-site clinics can be potential gold mines for market access–especially for the small and mid-size biopharmaceutical companies. I believe that buy-in of such employers through effective business-to-business interactions is a great way to increase access to therapies for chronic low back pain.

It’s time to make big strides and turn heads. Ready. Set. Access.

Innovation and outcomes data can ward off the biosimilar threat

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Biologics, for the longest time, had been enjoying freedom from generic erosion. Now, biosimilars are an impending threat to these biologics.

FDA approval of a biosimilar is only the first hit. Upon FDA approval, payers are already using publicly available data and approved labeling to see how they can leverage biosimilars in their contracting strategies.

Even so, the LAUNCH of the biosimilars is what really puts a dent in the revenue. Biosimilar launch is an important milestone, considering only 7 of the 20 currently FDA approved biosimilars have launched into the market (see Figure 1 below for my summary of approved and marketed biosimilars in the US). Threat of patent litigation is the biggest hurdle to overcome for biosimilars before they can launch into the market.

Figure 1

Despite biosimilar launch, the reference product might be able to retain a reasonable market share—UNLESS, the biosimilar is designated as interchangeable by the FDA. The FDA recently issued the final guidance on interchangeability designation last month. I believe that biosimilars deemed as interchangeable by the FDA can cause a lethal blow to the reference product (in terms of market access and subsequent market share), because that’s when a biosimilar can truly behave like a generic drug and cause that “generic erosion” that we all know about.

So, what are the options for manufacturers of the reference products? 

A) Take cover, you’re in for a hit
B) Start a campaign to downplay the importance of biosimilars
C) Innovate to bring a meaningful change to the market

When in doubt, go with ‘C.’ The adage didn’t always serve me well in pharmacy school, but that IS the correct answer here (former commissioner of the FDA, Scott Gottlieb, would agree with me).

The biosimilar threat is real. However, having a good pulse on the market will enable a sound strategy to retain—and perhaps even grow—the market share of the reference product.

According to an insightful analysis by Rand, Amgen has been able to successfully put up a fight against not just 1, not 2, not 3, but 4 biosimilars in the market through innovation. 

Genentech’s Herceptin (trastuzumab) is up for a similar fight against an army of 5 biosimilars (already approved, though yet to launch). Innovation seems to be the name of the game for Genentech as well: interestingly, in February 2019, FDA approved Genentech’s Herceptin HYLECTA, a subcutaneous version of the intravenous Herceptin. If Genentech can successfully serve this innovation up to payers and organized customers, such as IDNs, with the proper outcomes data, I think Genentech will be just fine.

Innovation is certainly a steep climb, and Amgen and Genentech are clearly taking the high road to accept this challenge.

This just goes to show that there is ALWAYS room for improvement. Furthermore, those who are agents of change that continue to improve, take the cake. In the famous words of Steve Jobs, “Innovation distinguishes between a leader and a follower.” 

It’s time to make big strides and turn heads. Ready. Set. Access.

Effective market access teams can help save billions in revenue leakage

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Adam Fein of Drug Channels has slapped a whopping $153 billion label on the gross-to-net bubble problem—this was how much biopharmaceutical companies were losing in 2017 alone due rebates and other reductions. When biopharmaceutical companies are unable to make the case to differentiate their products, they end up having to provide massive rebates to payers (40%, 50%, 60%, and sometimes even more) in order to secure a favorable formulary placement.

Effective market access teams can justify the uniqueness of their products despite other players in the same therapeutic area. From my experience, there is a hook for EVERY product IF the right questions are asked. For example, “patients with which comorbidities can benefit most from my product,” or “which drug-drug-interactions does my product avoid, in contrast to the competitors,” or “patients with which genetic profile can benefit from my product?”

Market access may be complicated, but it’s possible as it is noble. Patients are looking to this team to ensure that they can gain access to the treatment they need. Furthermore, it’s the market access team that’s charged with helping to solve the $153 billion problem.

It’s time to make big strides and turn heads. Ready. Set. Access.

Krishna Patel, PharmD
Market Access Strategy and Execution Consultant
info@sojusllc.com
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