Your Market Access Playbook is Dead. Now What?

“Those who, while they disapprove of the character and measures of a [system], yield to it their allegiance and support, are undoubtedly its most conscientious supporters, and so frequently the most serious obstacles to reform.”

Henry David Thoreau - Civil Disobedience, 1849

Takeaway
Real innovation in healthcare requires more than corporate reorganizations - it demands disobedience to outdated market access playbooks, obsolete payment models, and legacy thinking that keeps vital treatments from reaching patients.

The Warning Signs We're Ignoring

Recent developments we’re tracking:

• Drug maker keeps product on market despite FDA panel's 13-1 vote against efficacy
  “The silver lining... [the drug] will remain available ... under the accelerated nod it received back in 2016”
• FDA Commissioner's stark warning about political interference
  “It’s pretty clear that the gist of this administration… is to change a lot of things…”
• Effective obesity procedure denied coverage despite robust data
  "...insurance typically does not cover the procedure because they view it as cosmetic"
• FDA pulls common OTC ingredient after 30 years, citing efficacy concerns
  “…unanimously concluded that the current scientific data do not support [the] recommended dosage”

The Art of Disruption

Thoreau wasn't seeking incremental change when he wrote "It is not desirable to cultivate a respect for the law, so much as for the right."

RWE strategies and value frameworks from 2012 died. New players are writing new rules for evidence and access.

In today's healthcare system, where ineffective drugs stay on market, political interference threatens science, and proven treatments lack coverage - we've moved beyond the need for allegiance to outdated frameworks.

Principled disobedience to the status quo isn't just an option - it's a moral imperative.

Rearranging Deck Chairs

Real progress doesn't follow established pathways - it sees past systemic barriers to spot unconventional solutions. While others rearrange deck chairs on the Titanic, innovators are tackling:

• Internal resource constraints
  "We'll worry about payer evidence after trials."
• Market forces
  "Our institution is not comfortable purchasing without reimbursement."
• Timeline pressures
  "Real world outcomes won't be available for years."
• Legal barriers
  "Current policies prohibit this option."

The fundamental hurdle isn't process optimization or budgets - it's bridging the trust gap between innovators and implementers.

Rebels With Results: Innovation's New Playbook

• From Patient to Power Broker: A former patient reshaping FDA evidence evaluation, and broader representation in the drug approval process.
• Breaking Payment Barriers: Manufacturers creating novel outcomes models and pioneering funding solutions for million-dollar treatments.
• Revolutionizing Access: CMS reimagining Medicaid patient access to Cell and Gene Therapies.
• Democratizing Innovation: Academic medical centers building systems so developing countries can deliver CAR-T therapy.

Rule-Breaking: A Moral Imperative

When decision-makers take hard stances, there's often truth in their skepticism.

Providers and payers have been burned before by promised innovations that became costly experiments.

Look deeper at those opening headlines - they reveal agencies and companies stumbling through accelerated access, sloppy evidence review, and corner-cutting.

The result? Eroding trust and threats to cut federal resources - symptoms of a dying approach.

Moving Breakthrough therapies from lab to patient demands civil disobedience to disrupt the status quo. Every major market access innovation started with someone asking "Why do we do it this way?"

Rule-breaking solutions emerge from:

• Listening to those who disagree with you
• Understanding the history behind the hesitation
• Building evidence that addresses real-world concerns
• Acknowledging both real and perceived barriers to success on all sides
• Co-creating novel models to balance risks while driving equitable access

Outdated frameworks are crumbling under the weight of a system that can’t afford to live in the past.

Choose: Status Quo or Change?

Thoreau wrote, "if [the system] is of such a nature that it requires you to be the agent of injustice to another, then, I say, break the law."¹

True innovators refuse to tick the boxes of an outdated playbook.

They understand that Breakthrough science without breakthrough implementation is just expensive theory.

The market will reward those who transform access.

The question isn't whether we can navigate complexity - it's whether we're brave enough to break the rules that need breaking and deliver the transformation that patients need, not just for some, but for all.

Betsy J. Lahue is Chief Executive Officer of Alkemi, the global leader in solving meaningful business challenges for executives launching Breakthrough treatments.

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¹ On the Duty of Civil Disobedience, Henry David Thoreau 1849, original title: Resistance to Civil Government