A new, non-contractual voluntary agreement has been implemented in the UK since the start of January 2024 and is set to run for 5 years, between the Department of Health and Social Care (DHSC)*, NHS England, and the Association of British Pharmaceutical Industry (ABPI).

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.

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.

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.

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

Since entering the World Trade Organization, China’s Pharmaceutical industry has experienced rapid growth in value, from $123.7 billion in 2016 to an estimated $573.5 billion in 2022

We are pleased to release the next edition of our Windrose Consulting Group: Global News Roundup for Q1 2023.

We are pleased to release the next edition of our Windrose Consulting Group: Global News Roundup for Q3 2022.

In this Q&A, we are featuring Jude Baroudi and his career journey and highlights to date.

In an article, published on Pharmexec, Anaïs Frappé, Amy Morgan and Crystal Leung, review market access opportunities in China through private payers, and how Commercial Health Insurance (CHI) can bring value before, during, and after NRDL inclusion.

On August 16th, 2022, President Biden signed the Inflation Reduction Act into law, which will bring reforms to Medicare spending and coverage, impacting manufacturers’ long-term P&MA strategy and payer decision-making.

Windrose Consulting Group’s take on The Foreign Data Problem: Implications of the FDA’s New Criteria for Foreign Data Submissions.

We are pleased to release the next edition of our Windrose Consulting Group: Global News Roundup for Q2 2022.