UK MHRA’s International Recognition Procedure (IRP) launch marks a key post-Brexit Health Technology Assessment (HTA) milestone, in an effort to speed up patient access to new medicines in the UK

Affordability challenges can hinder patient access to medicines in many countries, especially those with low income or limited public health coverage. Thus, pharmaceutical companies are increasingly interested in exploring patient-targeted affordability solutions to widen access in the out-of-pocket (OOP) sector.

In recent years, Denmark has shifted from its “added medical value” framework for evaluating new medicines and indication expansions in heath technology assessments (HTA) in favor of a quality-adjusted life year (QALY) approach, similar to that of NICE’s approach in the UK.

In April 2023, medical regulatory authorities of Colombia (INVIMA), Cuba (CECMED), and Mexico (COFEPRIS) signed the “Declaration of Acapulco” for the creation of the Latin American and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC)

Despite changes to the IPT process in 2020, Spain continues to have a long and uncertain reimbursement process, where the average time to reimbursement is ~17 months. This article reviews the recent lawsuit against the Spanish MoH, and likely reforms for Spanish HTA processes in 2024.

Kristina Funk and Adrian Jung have been promoted to Senior Analyst roles.

Windrose Consulting Group are pleased to welcome the latest members of our team into the UK office; Katharine Gilbert, Myrto Vouga and Sharon Lau.

EU HTA marks the beginning of efforts to streamline and harmonize the Health Technology Assessment (HTA) processes and outcomes across European Union (EU) member states. Despite its imminent rollout (from January 2025*), key uncertainties remain around its implementation and likely success.

On September 1st, 2023, UnitedHealthcare completed its first phase as part of a two-phase approach to eliminate prior authorization requirements for various procedures and services across their commercial, Medicare, and Medicaid plans

The Centers for Medicare & Medicaid Services (CMS) announced on June 22nd a detailed plan regarding its coverage of new Alzheimer’s treatments, following the full approval of Eisai’s Leqembi by the FDA.

Maja Warrum has been promoted to Senior Engagement Manager; Mattia Belloni has been promoted to Engagement Manager; Georgina Powell has been promoted to Senior Consultant; and both Paige Stitzel and Steven Lin have been promoted to Senior Analyst roles.

Windrose Consulting Group are pleased to welcome our latest hire to the UK office, Katherine Yang, as a Senior Analyst.

Our theme for the 2023 All Hands meeting was “Embracing Growth”, and the team had a busy week full of engagement, connection, and camaraderie.

Windrose Consulting Group are pleased to welcome our latest Senior hire, Mickey Popli, to our US office as a Principal.

Windrose Consulting Group are pleased to welcome six new Analysts: Anusha Keshireddy, Daniel Jackson, Janani Gurumurthy, Noah Blase, Rohit Palekar, and Witt Holmes, into the Philadelphia office.

We are pleased to release the next edition of our Windrose Consulting Group: Global News Roundup for Q2 2023.

In 2019, the Swiss Federal Council modified the Therapeutic Products Act (TPA) to facilitate market access, improve drug safety, and increase transparency in Switzerland’s P&MA system.

Windrose Consulting Group are pleased to welcome Tyler Will to our Philadelphia office.

In this Q&A, we are featuring our Summer Interns, Amy Brinster, Aashray Gupta and Isaac Tolley

Windrose Consulting Group are pleased to welcome two new starters, Giulio Mazzotta and Andrey Buzuk into our Swiss office.