Ready. Set. Access.

Market Access Strategic Execution Consultant

Curiosity is like a flashlight

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Imagine you’re on a camping trip and you’re hiking back to your tent in the pitch dark. You have little more than a flashlight to guide the way. You cannot see the tent from where you are because the flashlight is only able to reveal what’s 20 feet beyond you. Even then, you have faith that if you continue walking, the flashlight will continue to light up the next 20 feet until you finally reach your destination.

In market access, curiosity is like that flashlight. Having curiosity has helped me uncover so much knowledge. In fact, I’m learning new things all the time when I charge ahead with curiosity in my hand. 

Curiosity brings knowledge, which makes one valuable in market access.

Charlie Munger, considered to be Warren Buffett’s right hand man, is famously quoted for saying, “Go to bed smarter than when you woke up.”

Seth Godin, a renowned author and entrepreneur, says that he spends 16 hours per day learning, reading, or doing research.

Ask questions, watch, listen…you’ll be surprised at what you’ve been missing.

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

Oncology clinical pathways have become powerful market access barriers

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It’s no surprise to anyone that the cost of oncology care is hard to keep up with. According to the Summer 2019 Magellan RX Management Report, oncology agents account for 34% of the total medical pharmacy spend for commercial, 46% for Medicare, and 35% for Medicaid.

Medical benefit oncology drugs are a sore spot for payers as these drugs are difficult to manage with traditional utilization management tools such as step edits and quantity limits. As a matter of fact, many payers will admit that using these utilization management tools are like using blunt instruments. Many of these payers (but not all) see oncology clinical pathways as the answer to their prayers.

Oncology clinical pathways (decision algorithms used by providers to drive treatment decision making) are gaining traction as key value-based incentive tools that are slowly replacing traditional utilization management tools. According to the 2019 Genentech Oncology Trend Report, 48% of surveyed oncologists heavily rely on pathway recommendation when choosing between multiple drugs with similar mechanism of action such as anti-PD-1 immunotherapies (wow!). According to the report, payers incentivize oncology practices to use pathways by establishing preferred provider status among those who use specific pathways and claiming that pathways streamline PA processing. In return, practices incentivize or enforce their oncologists to utilize clinical pathways through electronic or EHR notification.

Since oncology clinical pathways influence 1 in 2 providers, they have become another potential barrier for market access teams. How can manufacturers ensure favorable placement of their products in competing clinical pathways? According to the Pharmaceutical Commerce Magazine, pathways-development committees strive to remain free from bias and are very strict about the type of information manufacturers can submit for consideration. Therefore, even though manufacturers cannot directly approach pathways-development committees, these committees look to various authoritative/peer-reviewed resources that can inform them about real-world evidence, head-to-head comparisons, and cost effectiveness. Such data can be communicated via peer-reviewed journals and meetings, AMCP dossiers, and ICER reviews–to name a few communication channels.

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

When driving your market access strategy, don’t forget to look in the rear view mirror

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I was talking to a friend who is the Market Access Director for a small biopharmaceutical company that is close to filing an NDA for a first-to-market product in a rare disease with a high level of unmet need. It was exciting to hear him present the drug’s promising clinical trial results–I’m so excited for all the patients who could benefit from this drug! My friend seemed equally as excited.

Then, I asked him, “Will you have any competition?” He confidently responded that their product would be the first and would be followed by 3 other products, but not for at least another 6 months. This scenario sounded like a rerun of my market access experiences in long-acting injectable antipsychotics, hepatitis C drugs, and immunotherapies in oncology. 

Sure, he may avoid market pressures for the first 6 months, but what then? Once the competitors start marching in, payers will view his product and all of his competitors’ products as the same, and will engage in a price war in a race to the bottom. This will not only pose a blow to his organization, but contribute to the gross-to-net bubble problem (discussed in a previous blog) which increases overall health care costs for the nation.

That’s why it’s important to keep an eye on the rear view mirror. Doing so enables market access strategists to condition the market in their favor for situations foreseen in the near future. The rear view mirror should give information about the competition’s product profile and product journey. The driver (market access strategist) would then study the rear view mirror to identify opportunities and act on them appropriately.

In my friend’s example, the competitors have a high incidence of acute kidney injury, which is already a significant concern for this patient population. Fortunately, his drug had no reported incidence of acute kidney injury. Great…now we were getting somewhere. 

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

IPI Model has picked the wrong target, and an unfair scapegoat

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As promised on my previous blog, here’s my full take on the Advanced Notice of Proposed Rulemaking (ANPRM) (which is essentially a PRE-proposed rule) for CMS’ proposed International Pricing Index (IPI) Model. 

The Trump administration is claiming that the IPI Model will help to curb the skyrocketing health care costs. On the contrary, there seems to be a consensus among manufacturers and providers that although health care costs are skyrocketing, targeting Medicare Part B drugs in the proposed manner will actually INCREASE overall health care costs and DECREASE quality of care.

Here’s the proposed IPI Model in a nutshell:

  1. The IPI Model would impact selected drugs that are administered by providers in the outpatient setting (clinics and hospital outpatient departments) IF they are prescribed within predetermined locations
    1. The ANPRM hasn’t specified which drugs or which geographic locations would be impacted. Nonetheless, the impact would be significant as it would cover 50% of Part B drug claims (wow!)
    2. The ANPRM states that  radiopharmaceuticals and certain ESRD drugs would be excluded from the IPI Model
  2. CMS would set the Medicare payment amount for the selected Part B drugs to closely align with international prices
  3. Private vendors would be allowed to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business (essentially, the drugs would have to be “white bagged”) 
  4. Physicians would be reimbursed a FLAT add-on payment for administering these selected Part B drugs (instead of ASP plus 4.3%)

I studied the publicly available comment letters submitted in response to this ANPRM in order to learn about the implications of the proposed IPI Model. Here are my two main takeaways:

  1. Manufacturers and providers BOTH agree that decreasing the list prices and increasing PBM involvement will actually increase overall health care cost and decrease quality of care
  2. A sound alternative to the currently proposed provisions of the IPI Model is a value-based care initiative. I think that’s an excellent way for providers, manufacturers, and payers to meet half-way–though implementation of such innovative payment systems is new and therefore has its own challenges.

Below is a visual summary of the proposed IPI model and its implications. 

Now that you know about the proposed provisions of the IPI Model, what now? Well, it’s not too late. Its important to put up a fight against the IPI Model for 2 reasons:

  1. The IPI Model, if finalized, would serve as a hook for President Trump’s campaign to counter the Democratic opponents who are intently discussing their own proposed health care reforms. Since the IPI Model is based on the assumption that high health care costs are due to high drug prices, manufacturers would become scapegoats for President Trump’s 2020 campaign
  2. If your drug happens to be targeted by the IPI Model, then you will have to lower your list price to the international pricing index (ouch!)

When the proposed rule for the IPI Model is released, make your voice be heard. Another strategy is to partner with provider organizations (such as COA and AMA) to double the strength of your team.

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

Trump’s International Price Index model is bad news for market access

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I have learned to take legislative developments as a grain of salt. However, it seems like the International Price Index (IPI) model is an exception.

Christina Sandefur of Goldwater Institute, Mallory O’Connor of Mallinckrodt Pharmaceuticals, and Ross Margulies of Foley Hoag provided eye-opening insights into the political and legislative trends impacting market access at the CBI 7th Annual Reimbursement and Access conference. 

There seems to be a consensus among these folks that the IPI model, which would peg drug prices to the same prices that are paid overseas, is likely to be enforced in some form (despite the precedence of Trump’s other other rules being rendered either illegal or ineffective). Seema Verma just announced this week that CMS is working ‘fast and furious’ to release the proposed rule for the IPI model as the administration is facing increasing pressure to release a concrete healthcare plan in time for the 2020 election. 

The IPI model will be dangerous for market access for a couple of reasons:

  1. PhRMA believes that lowering US drug prices to that of an international price index would disincentivize R&D efforts and would also lead to a lag in market entry for new products.
  2. The Community Oncology Alliance (COA) believes that the Competitive Acquisition Program (CAP) portion of the IPI model could eliminate wholesalers altogether and make PBMs as the sole middlemen in the drug distribution channel.

Experts believe that the proposed CMS rule for IPI model will likely be released this Fall and the final rule will likely be released in Spring 2020. 

The IPI model, as it currently stands, would apply to Medicare Part B single-source products and biologics.

Given the timeline of the IPI model and its serious implications, I believe that it’s critical for all market access teams to be educated on this topic and unite with providers in order to put up a fight.

I, myself, have embarked upon a research project to learn more about the implications of the IPI model for clients and determine what actions should be taken.

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

Launch excellence for market access teams: best practices to meet your business objectives

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New product launches can be challenging, causing much distress and havoc that could’ve been avoided with the proper insights, planning, and coordination. 

Tami Carten, a highly experienced and effective senior leader in market access, offered sage advice for launch best practices at the CBI 7th Annual Reimbursement and Access conference. I believe that operating under her 3-fold execution strategy will enable you to save time, money, and sanity–irrespective of the market landscape and unique product profile. Tami’s strategy ensures the correct mindset and involvement of the right resources to achieve your business goals. After all, there’s a budget for everything, so it’s important not to waste it with meaningless action.

Here, I present a visual rendition to summarize Tami’s strategy for launch excellence. Check against her best practices to make sure you haven’t overlooked something.

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

Launch excellence: meet business objectives with this 3-fold execution strategy

Intelligence and dependability over all other qualities

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When you meet a content developer for the first time, what questions do you ask in order to understand if she’s the perfect fit for your job? Most people pass judgement based only on these 2 questions: “Do you have experience in writing xx project?” and “What’s your rate?”

Are these questions enough? Or should you be probing more?

In the spirit of summer vacations (since it is August), imagine you’re taking a family trip to the beach. You should be confident that (a) the GPS will actually guide you to the correct destination, and (b) your vehicle will safely take you to your destination without breaking down. If you didn’t have confidence in these two things, you would download another GPS app and you would get another car, right?

Apply the same logic to your market access projects: much of your project depends on your writer, so you should be confident that she is (a) intelligent (understands the market and relevant trends–if not, then can find out the information on her own; understands the customer/audience needs; is clinically savvy) and (b) dependable (sticks to the project to the end–no matter what; is mindful of timing; is willing to work with the team at-large).

An intelligent and dependable content developer can bring peace of mind to your team and is worthy of showing off to your clients–both of which help to bring in revenue for your organization.

In my experience, finding a content developer who is BOTH intelligent and dependable is rare. You are lucky to have found her, so take notice.

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

Effective advisory reports are concise and actionable

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An advisory report summarizes an advisory board meeting and relays key information that informs business decisions. The advisory report comes into the hands of many key decision makers who are all very busy. Therefore, it’s critical that someone takes the time upfront to create a concise and actionable report that can be easily understood. 

Here are some tips that can help you create an advisory report that your client will fall in love with: 

  • Provide the plethora of information into bite-size morsels that can be easily understood. Think of how you can categorize the information so that it makes sense (this might require some thinking).
  • Within each category, start with the ideas that resonate the most. Then, work your way down to the ideas that resonate the least.
  • Try to eliminate bullets using effective visualization (this can also require some critical thinking).
  • Craft the executive summary slide in such a way that readers can grasp key concepts right away.
  • Craft the conclusion slide effectively so that your recommendations and rationale are easily understood.

Prior to drafting the advisory report, you might want to confirm with the client if they have a particular format in mind. After completing your initial draft, run it by your team members for feedback; after all, 2 heads are better than 1. 

Below an example of what a basic advisory report can look like.

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

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.

 

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