Over the past decade, Japan’s pharmaceutical pricing system has undergone several key changes in response to growing fiscal pressure and rapid population aging.

In a recent article published on Pharmaceutical Executive, we look at the Emergence of Cancer Vaccines: Reframing Value Demonstration, Pricing, and Access

Windrose Consulting Group has acquired Zenith Access Network, a leading market access consultancy specializing in Greater China and emerging Asia-Pacific (APAC) markets

Innovative pharmaceutical products are constantly seeking access to developed and emerging markets across the globe, but gaps in clinical evidence and limited real-world data often leave uncertainty around their true value and impact on health and societal benefits.

After 10 months of Joint Clinical Assessment (JCA) is it possible to identify some early advice for pharma companies?

In a recent article published on Pharmaceutical Executive, we explore The Most-Favored-Nation Policy; it’s Outlook and Implications Beyond U.S.

The National Reimbursement Drug List (NRDL) has long been a critical vehicle for pharmaceuticals in China, providing patient access to treatments through centralized public insurance.

“Brand-brand” combination therapy launches have become an increasingly popular strategy for manufacturers looking to maximize the value of their successful monotherapy launches.

In a recent article published on Pharmaceutical Executive, Anais Frappe and Mattia Belloni explore the role of non-OS endpoints, and advocate for a more systematic and balanced recognition of these endpoints, alongside OS, in HTAs. 

Historically, Germany has been the only country in Europe to maintain transparent list-net pricing. However, the 2022 AMNOG guardrails set the pricing opportunity relative to the G-BA outcome, whereby “No Additional Benefit” rating can result in price parity with off-patent comparators.

The FDA issued guidance for new products in chronic weight management setting a threshold for their efficacy to be at least a 5% mean change from baseline in body weight vs. placebo at 1 year.

In this Q&A, we are featuring our 2024 Summer Interns; Amol and Ushaan

With less than a year to go until the launch of the Joint Clinical Assessment (JCA) in January 2025, its successful implementation relies on the readiness of each EU market and their willingness to incorporate the JCA into current HTA processes.

The recent FDA approval of two groundbreaking gene therapies for sickle cell disease —Casgevy and Lyfgenia—marks a significant milestone in the field, offering life-changing treatments for patients suffering from this debilitating genetic disorder.

On January 5th, 2024, the FDA allowed Florida the ability to import prescription drugs from Canada on a provisional basis.

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)