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)

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.

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 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.