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Market Access

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

Spain Beats England To Tevimbra Reimbursement Recommendations

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

Will NICE’s New Medtech Evaluation Plans Hit the Target for Patients and Industry?

One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

With 75 Pipeline Candidates, TIL Therapies Gain Momentum in Solid Tumor Space

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