Market Access

Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.

EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.

Tumor infiltrating lymphocyte therapies show promise for solid tumors, with a first FDA approval, but face manufacturing and access challenges as development continues.

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.

Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.

Marking another step in Dr Reddy’s diverse corporate strategy, the company has signed a memorandum of understanding with Kainomyx for the development and commercialization of anti-malarials in multiple markets.

Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.

Merck & Co. won European Commission approval for Winrevair on top of other medicines for pulmonary arterial hypertension and expects an initial EU launch in Germany.

Cost watchdog NICE has blocked Leqembi’s use, but a pricing deal could unlock access to the beta-amyloid targeting drug

National authorities urged to address knowledge gaps and generate evidence about the dynamics of mpox transmission.

While the drug regulator has approved Eisai/Biogen’s early Alzheimer’s disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address.

The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

The European Alliance for Cardiovascular Health is three years old in September. Its remit to improve patient health has attracted strong support from stakeholders, but more investment and attention are required to ensure its momentum towards implementation is not lost. Experts at MedTech Forum 2024 explained what is at stake.

The Africa CDC says the donation of more than 215,000 doses of mpox vaccine is a “crucial step” in tackling the latest outbreak.

A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly. 

An emergency use listing means the vaccines can be approved for use in lower-income countries where they are not licensed, and will allow international organizations like Gavi and UNICEF to procure them for wider distribution.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

Lupin’s CEO highlights market access strategy as a key tool to ensure biosimilars success in the US while being relieved the company didn’t launch a Humira biosimilar. She also mentions Amazon and Mark Cuban have not upset market dynamics for generics in the US and a Lucentis biosimilar is closer to a global launch post Phase III trial success

Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.