The Market Access Equation: How Health Technology Assessment (HTA) is Rewiring Business Models in Healthcare

For decades, getting a new medicine to market meant proving safety and efficacy to regulators. Today, that’s no longer enough. Increasingly, the decisive factor is Health Technology Assessment (HTA), the process by which governments and payers evaluate whether a new technology is worth funding.

In practical terms, HTA determines not just whether patients get access to innovation, but also how companies design trials, set prices, and even structure their business models.

Case in point: the UK’s National Institute for Health and Care Excellence (NICE). When the oncology drug pembrolizumab (Keytruda) was first assessed, NICE initially rejected it for some indications, citing uncertainty over cost-effectiveness. Only after Merck entered into a confidential patient access scheme, effectively lowering the price, did the drug gain wider approval.

Similarly, in Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) has signaled a stronger push for real-world evidence. Manufacturers are now required to supplement trial data with post-launch effectiveness studies, reshaping how companies allocate R&D resources.

“These decisions send shockwaves back up the pipeline,” says one market access consultant. “You can’t wait until a product is ready to launch to think about HTA, you need to design your evidence strategy around it from day one.”

Three big shifts stand out:

• Pricing: Companies are increasingly turning to outcome-based agreements. Novartis, for example, struck deals where reimbursement for its gene therapy Zolgensma is tied to patient outcomes, addressing HTA concerns about sustainability.

  
  

• Evidence generation: Real-world data, patient-reported outcomes, and long-term follow-ups are becoming standard. Without them, products risk being sidelined by HTA bodies.

  
  

• Business models: From subscription payment models for antibiotics in the UK to risk-sharing schemes in oncology, firms are experimenting with structures that align more closely with payer priorities.

The equation is clear: regulatory approval may open the door, but HTA decides if innovation walks through it. And in doing so, it is no longer just shaping patient access, it is fundamentally reshaping how companies do business.

As NICE’s former chief executive Sir Andrew Dillon once observed, “The value of innovation is not measured only in the lab, but in the health systems that can afford to deliver it.”