Approved on Paper. Delayed in Real Life.

Jack is 61. Eight months ago, he was diagnosed with non-small cell lung cancer. His oncologist found the right targeted therapy, one matched to his specific genetic mutation, and has been administering it in-office ever since. Most days, Jack doesn’t think about how any of this works. He shows up, gets treated, and goes home.

But here’s what happens behind the scenes every time Jack is due for his next treatment cycle.

His oncology practice submits a prior authorization request. The payer comes back asking for proof that Jack tried a different drug first. He didn’t, because his doctor chose this therapy based on clinical evidence specific to Jack’s mutation. So, the office must build a case: gather records, write a letter of medical necessity, call the plan, and wait. That process takes days, and sometimes longer.

During that wait, Jack’s treatment is on hold. “We’re waiting on approval from your insurance!” And the fact of the matter is that Jack isn’t an outlier.  Cases like these happen every day.

In oncology and specialty buy-and-bill programs, this kind of case with a step therapy challenge or a prior authorization denial, is the normalized experience. If you articulate the entire experience out loud, it sounds completely backwards. Instead of improving efficiency, systems and dollars have been put in place to cover for inefficiency. But now, all of that has changed.

The Buffer That Paid for Inefficiency is Gone

For years, patient assistance programs didn’t have to justify their cost. They were funded indirectly through gross-to-net economics: the spread between a drug’s list price and what payers actually paid after rebates. That spread created a cushion at the portfolio level. It absorbed the overhead of running high-touch, labor-intensive hub programs without anyone having to account for it at the brand level.

That cushion has been shrinking for years and is now, for many brands, effectively gone. U.S. gross-to-net reductions hit $356 billion in 2024. Point-of-sale reforms and safe harbor changes are pushing rebates closer to the patient, dismantling the portfolio-level flexibility that once made program inefficiencies invisible.

The result: what used to be a background cost now has a line item and a name on it. Every dollar spent managing Jack’s prior authorization, appeal, and payer follow-up is now visible at the brand level. And brands are starting to feel it.

Want to understand the full scope of what gross-to-net compression means for patient access programs? Download our white paper: The Afterlife of the Gross-to-Net Pricing Model.

Automation Helped. Until It Didn’t.

When margin pressure first arrived, the industry responded with automation like electronic benefit verification or e-prior authorization. And for a while, it helped! Intakes became faster and a lot of the front-end friction evaporated. It looked, for a while, like the cost problem was being solved.

Then it plateaued.

Certain things became abundantly clear. Automation can’t fight a step therapy denial. It can’t call a payer or navigate a Medicare Advantage carve-out for Jack. That work is still manual. It still requires skilled reimbursement specialists. And it’s still happening at the same volume and complexity it always was, inside a cost structure that assumed a financial environment that no longer exists.

Industry benchmarks put cost per case at $40 to $95 for traditional labor-driven models, with oncology programs trending toward the high end. On a program running 10,000 cases a month, that’s $680,000 or more in monthly spend, on infrastructure that doesn’t flex when volume drops and struggles to scale when it rises. Automation sped up the easy work. The hard work, the work that gets Jack on his medication, is still waiting.

So, What Happens to Patients like Jack?

If the economics keep compressing and the operating model doesn’t change, something eventually gives. In reality, that looks like programs that get scaled back and staffing that gets reduced. In turn, response times slow down: the prior auth appeal that used to take two days starts taking five.

This isn’t hypothetical. It’s already happening to brands that chose to cut costs instead of fixing the model.

The downstream effect on the brand is real too. Slower access means slower adoption. Providers lose confidence in a program that used to make their lives easier and now adds friction. Prescriptions don’t get written. Revenue doesn’t materialize. And the ROI case for the patient access program, which used to be implied, now must be made explicitly, with data that most traditional hub models aren’t set up to produce.

If you’re realizing your current access model depends on economics that no longer exist, you’re not alone.

Most brands haven’t fully felt the impact yet because the system is still functioning, but barely. The pressure is already showing up in staffing, turnaround times, provider frustration, and rising operational costs. Some brand managers may have even started feeling the heat in internal meetings.

A More Sustainable Patient Access Model

The brands navigating this well are rebuilding the operating model underneath them. Instead of assigning every case to a specialist who determines next steps from scratch, workflow-driven reimbursement infrastructure routes cases through systematized pathways with embedded payer logic. The routine cases move efficiently through the system. The complex ones, Jack’s step therapy challenge, his Part B navigation, his appeal, get surfaced to a reimbursement specialist who has the time and context to handle them.

The cost difference is significant. Workflow-driven models bring cost per case into the $15 to $45 range. On a 10,000-case monthly program, shifting 60 percent of volume to this model reduces average cost per case from $68 to $49. That’s $2.7 million a year, without reducing access performance or touching the relationships that drive adoption.

Jack still gets his treatment. The office still gets the support it needs. And the program is financially sustainable in the environment that exists right now. Efficiency doesn’t mean less help. It means the right help gets to the right case at the right time.

The Brands That Adapt First Will Win

Patient access programs aren’t going away. If anything, as pricing becomes more transparent and direct-to-patient channels expand, access infrastructure becomes more central to commercial strategy, not less. The brands that treat it as a core capability rather than an operational afterthought will have a significant advantage.

But that requires building for the economics that exist, not the ones that existed five years ago. The financial cushion that absorbed these inefficiencies is gone. The programs that survive will be the ones that stopped depending on it.

Jack is still out there. He still needs his medication. And the question for every specialty brand right now is whether the program designed to help him is built to last.

If this hit close to home, the full picture is in our white paper: The Afterlife of the Gross-to-Net Pricing Model. It walks through economics, operating model alternatives, and a practical framework for transitioning without disrupting access.