Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation

In a transformative week for market access, the CMS and Europe reimbursement pathway expansion delivered several pivotal coverage and pricing decisions reshaping patient access across cardiovascular, hepatic, and oncology therapies. From CMS’s national determinations on breakthrough devices to European HTA approvals in rare disease and cancer, these developments underscore a growing transatlantic alignment between regulators and payers accelerating patient benefit, driving innovation uptake, and redefining how clinical value is rewarded.

CMS Expands Coverage for Renal Denervation in Hypertension

The Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination for renal denervation (RDN) systems, marking a historic shift in hypertension management. Both Medtronic’s Simplicity Spyral (radiofrequency) and Recor Medical’s Paradise (ultrasound) RDN devices will now be reimbursed under Coverage with Evidence Development (CED)

This decision follows two decades of clinical investigation into device-based blood pressure control and offers a new option for patients with resistant hypertension. “This milestone enables physicians to offer patients more choices when managing hypertension,” said Medtronic’s Jason Weidman. Recor’s CEO Lara Barghout added that CMS’s decision “paves the way for broader, more equitable access to this breakthrough therapy.”

The policy mandates data collection on long-term outcomes, aligning with CMS’s broader strategy to link reimbursement to real-world evidence part of its evolving reimbursement pathway expansion framework emphasizing innovation accountability.

CMS Issues National Coverage for Impulse Dynamics’ CCM® Therapy

In another major win, CMS issued a National Coverage Determination (NCD) for Impulse Dynamics’ cardiac contractility modulation (CCM®) therapy under the Transitional Coverage for Emerging Technologies (TCET) pathway

The ruling instantly expands access for more than 66 million U.S. patients with heart failure, validating CCM® as an evidence-based, reimbursable treatment rather than an investigational device. CEO Jason Spees hailed the decision as “a victory for HF patients and families who deserve timely access to life-changing therapies.”

By incorporating CCM® into TCET, CMS underscores a growing trend toward adaptive reimbursement mechanisms that speed national coverage for technologies demonstrating durable clinical value. The decision also cements the agency’s shift toward proactive reimbursement evaluations a hallmark of the CMS and Europe reimbursement pathway expansion movement.

Sweden’s TLV Grants Subsidy for Ipsen’s Iqirvo in Primary Biliary Cholangitis

Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) approved Iqirvo (elafibranor) for inclusion in the national high-cost coverage scheme from November 1, 2025. The drug, developed by Ipsen, becomes the first new reimbursed option in over two decades for primary biliary cholangitis (PBC), a rare autoimmune liver disease.

The decision was supported by data from the ELATIVE Phase III trial, which showed 51% of patients achieved improved liver biomarkers versus 4% on placebo. TLV’s evaluation highlighted the drug’s high severity profile and Ipsen’s cost-sharing agreement with regional payers, ensuring sustainable access under Sweden’s value-based pricing framework. Earlier this week TLV has issued three landmark reimbursement decisions for Lojuxta (Chiesi Pharma), Omlyclo (Celltrion Sweden), and Osvyrti (Accord Healthcare).

This ruling exemplifies how European HTA agencies are balancing innovation incentives with affordability a defining trait of the CMS and Europe reimbursement pathway expansion trend.

AIFA Approves New and Biosimilar Drugs for Reimbursement

In Italy, the AIFA Board of Directors approved 11 new reimbursable therapies, including Altuvoct (efanesoctocog alfa) for hemophilia A, Truqap (capivasertib) for breast cancer, and multiple biosimilars of denosumab and aflibercept.

This broad approval reflects AIFA’s dual commitment to fostering innovation through orphan drug inclusion and reducing system costs via biosimilar competition. The move aligns Italy’s reimbursement priorities with EU-level market access acceleration policies and positions AIFA as a model for integrating clinical value with sustainability considerations.

The coordinated actions by CMS, TLV, and AIFA reveal a global convergence toward evidence-driven reimbursement systems that reward therapies demonstrating tangible patient benefit. As payers refine frameworks such as TCET and cost-effectiveness analyses, manufacturers are increasingly required to align launch strategies with evolving access expectations.

Ultimately, this CMS and Europe reimbursement pathway expansion marks a paradigm shift toward faster, data-anchored, and patient-cantered coverage decisions worldwide.

Shajini