Will Merck’s Ohtuvayre pricing strategy face EU pushback during HTA reviews?

Merck & Co., Inc.’s $10 billion acquisition of Verona Pharma may have secured a groundbreaking COPD therapy, but its European commercial journey is far from guaranteed. With Ohtuvayre (ensifentrine) already recording early U.S. uptake, all eyes are now on how health technology assessment (HTA) bodies in Europe will evaluate its cost-effectiveness. Known for demanding strong clinical and economic justifications before granting market access, EU regulators and payers could significantly influence whether Merck turns Ohtuvayre into a global success or faces a prolonged reimbursement battle.

How might EU health technology assessments respond to Merck’s pricing of Ohtuvayre compared to U.S. launch strategies?

Ohtuvayre entered the U.S. market in August 2024 with Verona Pharma employing a targeted formulary strategy and value-based messaging focused on reducing COPD exacerbations. Merck, inheriting that momentum, is expected to maintain a premium pricing stance in the U.S., where commercial payers have historically supported breakthrough inhalers that demonstrate hospital cost offsets.

In Europe, however, pricing flexibility is far narrower. HTA agencies such as Germany’s IQWiG, the U.K.’s NICE, and France’s HAS typically use incremental cost-effectiveness ratios (ICERs) and quality-adjusted life year (QALY) benchmarks to determine reimbursement. Ohtuvayre’s clinical trials showed statistically significant lung function improvement, but HTAs will demand real-world data proving that these outcomes translate into reduced hospitalization rates and improved patient-reported quality of life. Without such evidence, Merck may be forced to accept narrower indications or restricted reimbursement tiers—especially in markets with tight COPD treatment guidelines.

Institutional sentiment suggests that Merck’s early submission strategy will hinge on emphasizing Ohtuvayre’s dual PDE3/PDE4 inhibition as a unique mechanism for persistently symptomatic patients. Analysts believe positioning the drug as a complementary, rather than competing, therapy to LAMA/LABA or triple-combination inhalers could strengthen its cost-effectiveness narrative.

What factors could influence EU payer decisions and shape Merck’s pricing flexibility?

Europe’s mixed single-payer and multi-payer systems will impose additional hurdles on Merck’s pricing strategy. Countries operating reference pricing models, including Spain and Italy, may benchmark Ohtuvayre against legacy COPD therapies like Spiriva, Trelegy Ellipta, and Breztri Aerosphere, which are often available at steeply discounted rates due to generic or tender-based competition. Nordic countries, which rely on competitive tendering, are also likely to demand significant price concessions for broad hospital formulary inclusion.

Merck’s global experience in navigating HTA negotiations could, however, mitigate some of these challenges. Risk-sharing or outcomes-based contracts—where reimbursement levels are tied to real-world patient outcomes—may become a viable tool for gaining early access. Such agreements have been increasingly adopted in oncology and rare disease markets but are now gaining traction in chronic conditions, including respiratory care. By linking reimbursement to metrics like exacerbation reduction or hospitalization avoidance, Merck could improve acceptance of premium pricing in cost-sensitive markets.

Could HTA challenges delay Merck’s broader European rollout and affect its COPD market share goals?

Even after EMA approval, European reimbursement timelines remain a major roadblock. Payer negotiations can take 9–18 months post-approval in markets like France and Italy, potentially slowing revenue realization. During these delays, competitors are pushing forward with next-generation inhalers and fixed-dose combinations, risking erosion of Ohtuvayre’s first-mover advantage.

Merck is expected to counter these risks by initiating early-access programs in select EU markets, particularly in countries where compassionate-use pathways can be leveraged for severe COPD patients. Simultaneously, post-marketing studies designed to generate real-world evidence will likely be prioritized. Experts argue that strong observational data on reduced exacerbations and improved patient adherence could tip HTA evaluations in Merck’s favor, especially in markets where adherence and quality-of-life improvements carry significant weight in reimbursement decisions.

What long-term impact could pricing negotiations have on Merck’s global COPD strategy?

Success in Europe will not only unlock a multi-billion-dollar market but also shape Ohtuvayre’s pricing narrative in other regions. Many Asia-Pacific and Latin American countries reference EU pricing benchmarks, meaning concessions in Germany, France, or the U.K. could indirectly pressure margins elsewhere. Conversely, a strong premium pricing case supported by HTA approvals could help Merck establish Ohtuvayre as a gold-standard add-on therapy globally.

Industry observers believe that Merck’s respiratory ambitions extend beyond COPD, with ensifentrine also being evaluated for bronchiectasis. Demonstrating value early in COPD could pave the way for faster HTA acceptance of future indications. For now, the challenge lies in executing a pricing strategy that balances access with profitability—one that justifies the $10 billion acquisition and cements Merck’s position in a highly competitive respiratory market.