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Market Access Strategic Execution Consultant

Legislative Trends

Collaborations Among Stakeholders

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Collaborations Among Stakeholders

How can us market access professionals (strategists, writers, editors, and everyone else) possibly do our work if we’re not curious enough to seek out our customers’ voice?

In market access, we often treat our asset as our own child and customers’ needs as a stepchild. This backfires on the business as the stepchild always turns out to be the Cinderella of the story.

Isn’t the goal of manufacturers, payers, and providers ultimately the same? To keep patients healthy enough so they stay out of the health care system? It’s just that the market demands each stakeholder to address this call in a different way.

AMCP’s Partnership Forum is a platform where these stakeholders collaborate on tactics and strategies to drive efficiencies and outcomes.

Tapestry Networks is another platform that brings together such stakeholders.

I wonder if there are other such collaborative platforms out there.

Today is the First Day of Your Product’s Life Cycle

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Today is the First Day of Your Product's Life Cycle

What a phenomenal shape the circle is.

Where does it begin? Now, where does it end.

Is it possible that the circle could’ve started at any another point?

Yesterday ended last night. Today is the first day of the rest of your product’s life.

70% of launches fail. There’s evidence to suggest that the first year sets the trajectory for the rest of the product’s life cycle.

Cycle = circle.

Even if your drug has already launched, do you get another chance to begin?

How you got here is not how you will get there. 

The asset inventory is what it is. It takes months-years to generate new evidence. What will you do in the meantime? Your product already has what it needs to penetrate the market in a way that no other product can–if you allow it.

Take a page from Zig Ziglar’s playbook: If you give them enough of what they want, they will give you everything you want.

Your Customers Should Feel Heard

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Your Customers Should Feel Heard

Everyone has a problem.

Believing that your customers have no problems is just as true as believing that everyone posting smiling photos on Instagram has no problems.

What’s the problem of your customers? What keeps them up at night? What makes it dreadful for them to come back to work the next day? Why are they right to think this way?

The sequel to this would be: How can you show up to delight them? But let’s not get ahead of ourselves. 

Customers feeling like they’re heard is in itself a TREMENDOUS stride forward.

Nurture trust. Nurture relationship.

If your neighbor knocked at your door with freshly baked cherry pie, would you accept it? What if a stranger did the same thing: would you accept it?

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.

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