Ready. Set. Access.

Market Access Strategic Execution Consultant

Staying relevant by staying up-to-date

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The health care landscape is in constant flux so it’s important to be connected to folks and stay abreast with the latest trends and insights that relate to market access. Next week will be a big week to learn much and meet many at the CBI 7th Annual Reimbursement and Access conference in Philadelphia, PA. Here are the sessions that I will be attending.

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

 

DAY 1

State of the industry: political and legislative trends impacting health care coverage and access

  • Evaluate the current political landscape and state of the President’s Blueprint
  • Anticipate new reimbursement models for PBM formulary management
  • Discuss the potential of point-of-sale rebates and the impact on the patient OOP cost
  • Gain insight into the state of oral arguments in the ACA legal challenge
  • Analyze how innovation will continue to force change within the health care landscape

Assess potential for changes to pharmaceutical pricing, discounting and reimbursement for the future

  • Over the last six months there have been a number of potential disruptors to pharmaceutical pricing. One of which was the potential removal of Safe Harbor Protection for Rebates. As we saw the official order withdrawn, in the same week the Most Favored Nation potential drug pricing policy was introduced. This session provides an update on current, proposed changes affecting pharmaceutical pricing and reimbursement. Point of sale rebates used to provide access to discounted medicines will also be discussed.

Realign access strategies to overcome challenges of copay assistance and PBM restrictions

  • Analyze the current landscape of models of PBM restrictions and state efforts to ban them
  • Discuss strategies to promote patient education and informed discussion to facilitate access
  • Gain insight into trends showcasing impacts to patient OOP spend, access and adherence
  • Hear considerations for manufacturers to identify the effect of copay accumulators and maximizers on brands
  • Develop strategies to continue to support patients and address compliance concern

Compliance spotlight: trends in enforcement and oversight--what companies can do to ensure compliance

  • Zero-in on top areas of focus, including relationships between manufacturers and charitable organizations, pre-approval communications, anti-kickback and pricing transparency
  • Gain insight into recent trends in enforcement oversight and focal points for 2020
  • Share key takeaways from recent high-profile cases to mitigate risk moving forward

New product launch in the era of precision medicine

  • Explore product launch scenarios and patient service paradigms
  • Delve into the role of digital health, how it assists and implications for channel strategies
  • Understand data needs and the role of the patient journey
  • Ensure teams, including the c-suite, are on the same page for consistent and timely effective decision support

Manufacturer spotlight--forward-thinking strategies to ensure market access and adherence

  • Gain insight into innovative reimbursement, market access and launch strategies
  • Discuss strategies to streamline income verification, refill reminders and electronic prescriptions
  • Employ technology to support patient access and adherence
  • Identify lessons learned and best practices to manage specialty pharmacies
  • Navigate from access to utilization — Education, data and pull-through

Medicare and marketplace coverage policies impacting access

  • Review the current state of policy affecting the six protected drug classes in Part D
  • Analyze the proposed shift of drugs from Part B to Part D and associated changes in total spending and patient cost-sharing
  • Discuss the increase in Medicare beneficiaries enrolling in Medicare Advantage Prescription Drug (MAPD) plans
  • Navigate complexities of changes allowing step edits in Part C on patient access
  • Gain insight into the potential ripple effects of Medicare changes on commercial coverage
  • Identify considerations to alleviate the impact of step therapies and prior authorization requirements

New product commercialization/launch scenario planning

  • Discuss timeline considerations for submitting NDAs, PDUFA dates, etc.
  • Employ strategies to ensure effective communication internally during launch
  • Identify best practices for due diligence for hub selection and patient assistance programs
  • Evaluate the evolution that can occur in all aspects of a launch’s timeline and maturity
  • Review the importance of redefining strategy based on the stage of launch

DAY 2

Changing the landscape for prior authorization and reimbursement support--reexamining the roles of the manufacturer and pharmacy

  • Explore the existing landscape regarding manufacturers’ and pharmacy providers’ roles in the PA process
  • Identify regulatory and payer enforcement trends regarding PA activities
  • Address HIPAA, privacy and confidentiality considerations regarding access to PHI, including the role of third-party hubs
  • Discuss activities of PBMs and PBM-owned pharmacies when independent providers submit PA requests

Trends in benefit design and the continued shift to high deductible plans

  • Review recent trends in prescription drug pricing and coverage/formulary design
  • Gain insight into efforts to promote value-based insurance design in both public programs and the commercial market
  • Explore best practices and innovations in pharmacy management and reimbursement
  • Examine implications for consumer affordability (premiums and OOP costs)

Pathways to improvement--insight on achieving a value-driven, transparent and affordable health care system

  • Explore how CMS’ interoperability mandate will use transparency to fix every problem in health care (and what new problems it will create)
  • Gain insight into ACA and how it might be the path to universal coverage after all
  • Discuss commercial risk adjustment and the challenges it is currently facing

Paving the way for global access and commercialization

  • Hear considerations for support that allows product access outside of the U.S.
  • Leverage various access programs to access medicines prior to EU or in-country licensing
  • Capture data, develop relationships and use insights to determine if it makes sense to launch in a particular country
  • Gain insight into best practices to build a European presence

Building value and establishing market access pathways for cell and gene therapies

  • Explore approaches and considerations to achieve market access and secure reimbursement
  • Overcome challenges in reimbursement evaluation given the robust pipeline and potential significant costs
  • Analyze value-based agreements and payment options
  • Employ best practices to better anticipate challenges and make plans to mitigate

Payer negotiations for improved profitability--a role play exercise

  • Examine payer dynamics, a market overview and access challenges
  • Complete a SWOT analysis for an incumbent company, new entrant and PBM
  • Leverage PBMs competition and preferred/exclusive formulary access to secure high rebates
  • Tackle the development of proposals by PBM, incumbent company and new company (formulary position, rebate rate, copay buydown, prior authorization, step edit and price protection)
  • Determine the impact of negotiation outcome on patients and PBM clients
  • Debrief on negotiation outcome

How your agency can rise above the rest

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Winning new clients is what brings in revenue, enabling you to continue offering your services, keep your staff employed, and make a difference in the world. That’s why your organization spends much fund, talent, and time on pitches and conference attendance in hopes to develop business. 

But have you considered your client’s perspective? The most common complaint from clients is that agencies show up on pitches with their so-called “big guns” who can make an impression with their deep knowledge and vast experience, though these people HARDLY get involved in the actual projects, leaving clients feeling like they’ve been tricked. I think the clients are catching on, which is why they’re now beginning to request that the actual team members who will be involved in the project to attend pitches.

How should this inform your business development strategy? EXECUTION of the project is equally as important as the initial win. Your pitch didn’t stop on game day–the marathon actually continues through the end of the project (which can be 2 months, or even a year). Top-notch execution means the piece has effective messages and supporting points, it’s accurate, it’s designed effectively, clients are satisfied on review teleconferences, and timelines are managed efficiently. 

Execution of a project is actually a form of marketing. You don’t have to take my word for it. Think about a time when you lost a client due to inaccuracies on a project. On the contrary, think about a time when you impressed a client so much with your impeccable work that (s)he felt obligated to tell 10 other people about your greatness, which lead to new business coming to you (instead of you going to it).

What kind of execution Dream Team can keep winning business for you? You need a team who is accurate, trustworthy, can collaborate effectively, is up-to-date on the trends, has insightful knowledge, and has the chops to develop effective communication tactics. Those fortunate to have a writer with all of these traits are sure to bring home the gold.

Your agency’s execution team is what sets you apart from the rest, so invest in a good one.

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

 

Plan to have a smoother Q4

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Brand planning season is quickly drawing to a close–are you ready for the fourth quarter madness? 

In past years, what was it about Q4 that made it so unbearable? Was the it the unexpectedly high workload, the limited availability of writers to get the job done, the clashing priorities of planning for the Holidays vs. getting things done at work? 

Let’s resolve to make Q4 different this year. We are afforded the time over the next 2-3 weeks to get our ducks in a row before our clients return back to pavilion after Labor Day and send an urgent message to get a project done by tomorrow–or worse yet, yesterday. 

Urgency is going to arise as it does every Q4, but it doesn’t have to be stressful–as a matter of fact, I believe that we can actually ENJOY the ride if we have a Plan A, Plan B, and Plan C up our sleeves.

Seek out the status of ALL projects that still need to be started, or have yet to be finished (think way back to a lingering project that your team started in January). This may require some communication with team members (who may still be on vacation), so now is the time to begin digging up the information.

Match-up the projects with internal writers. Be cognizant of writers’ skill sets and availability over the next quarter (it’s helpful to know if someone has planned a 2-week vacation during Diwali, Thanksgiving, or Christmas).

Match-up projects with freelance writers. Being smart about knowing which projects to assign internally vs. outsourcing to freelancers is critical and can save your organization lots of money–at a time when revenue is scrutinized the most. Who are your go-to freelancers? What are their skill sets? Have you recently heard of a new freelancer that’s supposed to be really good, but don’t know her exact skill sets? NOW is the time to reach out and understand the freelancer’s capabilities, so you’re not scrambling later when time is of the essence. Who knows, that freelancer may just knock your socks off, leaving you wondering where she was all this time.

In the famous words of Benjamin Franklin, “By failing to prepare, you are preparing to fail.” Don’t fail. Plan now, when you still have time on your side.

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

Become a shortcut Ninja to save 8 days per year (at least)

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If you ever get the privilege to watch software developers at work, you’ll notice they rarely move their their hands off of the keyboard because they know that keystrokes are faster than hovering a mouse, which is faster than than a swiping on a trackpad. 

On the flip slide, if software developers ever get the privilege to watch market access folks at work, they’ll laugh. Unlike the techies, us market access folks reach for the mouse (or worse yet, trackpad) with every other breath that we take, thereby sluggishly accomplishing tasks which should ideally take a mere few seconds.

I read a study suggesting that an individual can save 8 DAYS per year by learning keyboard shortcuts. I believe this is still an understatement, especially if a job requires an individual to be on the computer all day, everyday. 

In the spirit of lifelong learning, let’s make it a priority to learn and implement some simple keyboard shortcuts. There are many, many useful shortcuts out there–just Google “keyboard hotkeys” or “keyboard shortcuts,” and go to town. Let’s dedicate an hour everyday this week to learning and practicing shortcuts for the applications that we use the most. There are even apps out there that can help us practice until it becomes muscle memory.

Here are a few useful shortcuts from The Miller Group for a jump start on the journey to becoming a shortcut Ninja and to spare the humiliation from a software developer.

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

Useful Keyboard Shortcuts for Market Access

Alt+Tab

We tend to work with several applications at once. Use Alt+Tab to scroll through your opened applications and and easily switch between them.

 

Ctrl+Backspace

My favorite! Instead of hitting backspace to delete one character at a time, hold down the Ctrl key and tap backspace and delete entire words. Delete large paragraphs or sentences much quicker, without the help of a mouse.

Ctrl+Home or Ctrl+End

Need to jump to the top or bottom of your document? Use Ctrl+Home to move your cursor immediately to the top without scrolling. Use Ctrl+End to jump to the end.

Win+Home

Another favorite of my mine! Win+Home minimizes all applications except for the currently active window. This shortcut is useful when you need to switch to the desktop but don’t want to lose your current window.

Ctrl+Shift+T

Have you ever accidentally closed a browser tab and needed to get it back? Lose the mouse and use Ctrl+Shift+T to open the last closed tab in your browser.

Ctrl+F

Next time you need to find text in the current document/page, simply type Ctrl+F.

How leveraging technology can save your business

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What is the most annoying part of your job? Copy Supervisors may say, “having to REPEATEDLY coach my team on how to annotate and reference because they continue to make the same mistakes;” Account Supervisors may say, “having to REPEATEDLY estimate the resources and budget for different projects of the same type;” Account VPs may say, “having to REPEATEDLY create similar upfront slides for every pitch.” Doing something REPEATEDLY can become burdensome and thereby deplete the joy out of performing a duty and ultimately result in sloppy work. 

Believe it or not, failure to perfect these mundane tasks that lurk in every role can cost you your business. I believe that these tasks deserve to be perfected rather than ignored; but I also believe that humans don’t have to do them–find a way to leverage technology to do these mundane tasks accurately for you. It’ll save you time, sanity, and your business.

Here’s my personal story:

How I found a way to save writers 4+ hours per project

Back when I wrote my very first Payer Value Proposition, I remember staying up until 3:30 AM to finish the first draft–simply to reference the slides in the client-specific format. The entire night I was sulking over how I was losing sleep over a task that I admittedly felt was below me. Eventually, I finished referencing and handed over a completed draft on time.

But the next day, I was determined to find a way to make technology perform this mindless work for me so that I would never have to reference again–ever. Victory was mine when I found out that Zotero (a free online citation manager) and EndNote (a paid citation manager) could create the references for me–without the introduction of human errors. Having learned how to save 4+ hours per project, I now created more time to execute additional projects, catch-up with colleagues, learn a new skill, or step out for some fresh air.

Seeking out ways to leverage technology to perform tasks efficiently and accurately can enable you to get it right the first time, avoid time-consuming re-do’s, and impress your clients with impeccable accuracy. On the contrary, you risk losing your business by enduring the mundane tasks without learning how technology can do them for you.

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

How to create a short, yet effective, deliverable from mounds of references

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Can you think of a time when your team was asked to distill 1,000s of pages of information into a concise training deck, brochure, white paper, or speaker presentation–on a topic that your team didn’t know much about? To me, these are exhilarating adventures where I’m offered the opportunity to get my analytical and problem solving skills firing on all cylinders.

Despite so many resources out there, someone is paying you to create a new piece to serve a specific purpose because it doesn’t exist in the public domain. How do you do it? Everyone has their unique approaches, but here I share the approach that works for me.

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

How to create a killer piece from 100's of sources

Gather information

Before hitting the books, start by asking your team members or clients the right questions to understand the purpose of the project, the baseline knowledge of the audience, and any sources that they are already aware of.

Scour publicly available sources

Remember to only use reliable sources. If the information is relevant to your topic, pull it into your information management application (I prefer Zotero and OneNote over Word because they can categorize information so that it's easily retrievable via tags and bookmarks). More importantly, be EXTREMELY CURIOUS during this phase as this will enable to ask questions and seek out the right information. This step is the most time-consuming, so it's important that you stay focused and pace yourself.

Create an outline

Create broad categories and weave-in the information from your research into the outline (this is where you'll be glad you used Zotero or OneNote over Word, because retrieving the information will be a BREEZE). Once you've created broad categories and weaved in the information that you already have, take a second look and ask yourself what other information you still need in order to tell a complete story. Finally, re-shuffle the categories in an order that tells compelling and easy-to-digest story.

Socialize the outline

Two heads are better than one. Now it's time to step out of your vacuum and show your plan to teammates and/or clients.

Create a draft

Ideally, you should assign the writing to the same person who conducted the research and developed the outline, because it will buy you time and efficiency in the long run. In this phase, also have an idea of the graphics that you plan to use to convey your messages effectively.

Socialize the draft

Again, two heads are better than one. Ask for the opinions of your teammates and/or clients.

Refine and follow-through to the end

Usually 3 cycles of feedback-and-refining suffice in order to reach a place where everyone on the team is happy with the work. This is also where you introduce your design team and editorial team into the project. Finally, follow-through on the regulatory process in order to get your piece approved and ready for use.

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.

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