News & Events Adam Foster News & Events Adam Foster

Emerging Markets Series - Topic 2

At Windrose, we have been celebrating over a year since having acquired Parioforma, a leader in value, access and price assessments in non-traditional markets. The acquisition has strengthened Windrose’s expertise in emerging markets, which has been a significant driver of growth in recent years.

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News & Events Adam Foster News & Events Adam Foster

France Early Access Program Changes

Established in 1992, the Authorization for Temporary Use program in France (ATU) is among one of the oldest and most open early access programs in Europe.[1] It allows patients with rare or serious diseases access to drugs which are currently unauthorized in that indication. Although a complex process, it appeals to manufacturers, with recent funding for ATUs growing to over €1 billion a year.[2]

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News & Events Adam Foster News & Events Adam Foster

Emerging markets series - Topic 1

At Windrose, we are celebrating a year since having acquired Parioforma, a leader in value, access and price assessments in non-traditional markets. The acquisition has strengthened Windrose’s expertise in emerging markets, which has been a significant driver of growth in recent years.

Read More
News & Events Jerry Sandoval News & Events Jerry Sandoval

Japan Incorporates Cost-Effectiveness into Its HTA: What Manufacturers Can Do to Prepare

In April 2019, Japan introduced its first formal health technology assessment (HTA), driven by a cost-effectiveness analysis (CEA). The CEA was introduced to adjust the price of already reimbursed products, with the overarching aim of reducing expenditure and increasing efficiency within the healthcare system. The Ministry of Health, Labour and Welfare (MHLW) recently published the first price adjustments for several listed agents, including a 4.7% reduction for Novartis’ Kymriah, and a 0.5% reduction for GlaxoSmithKline’s Trelegy.[1-4] Here we look at what the new CEA entails, how it impacts already reimbursed products, and what the road to access may look like for new drugs in the future.

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News & Events Adam Foster News & Events Adam Foster

World Blood Donor Day 14 June 2021

Our team at Windrose have been reflecting upon the importance of donating blood; we understand that regular blood donations are needed all over the world, to ensure individuals and communities have access to safe and quality-assured blood and blood products.

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News & Events Adam Foster News & Events Adam Foster

Cystic Fibrosis Awareness Month – May 2021

Cystic Fibrosis (CF) is a rare, life-shortening, genetic disorder which affects multiple organs, predominantly the lungs and pancreas. CF is caused by a defective cystic fibrosis transmembrane conductance regulator (CFTR) gene, and both copies of the faulty CFTR gene must be inherited to develop CF. This defective CFTR gene causes the abnormal production of sweat and mucus.

Through sweating, CF patients lose excessive amounts of salt, causing abnormal heart rhythms, risk of shock, stroke, and decreased blood pressure. Mucus accumulating in the intestines and lungs results in malnutrition, poor growth, respiratory infections, breathing difficulties, and eventually permanent lung damage. Subsequently, lung disease is the most common cause of death in most CF patients.

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News & Events Adam Foster News & Events Adam Foster

What will the impact be of the Therapeutic Positioning Report Policy Changes in Spain?

Historically, Spain has had one of the longest and most complicated reimbursement processes in Europe. This was seen to be due to its lengthy process in developing Therapeutic Positioning Reports (IPTs) and a lack of transparency in evaluation criteria. To counteract these claims, Spain is planning to reform its IPT process in 2021.

What Drove Spain to Change their IPT process?

IPTs, introduced in 2013, were initially expected to take 3 months for the Spanish Agency of Medicines & Health Products (AEMPS) research and analysis. However, in recent years AEMPS analysis has been taking over 9 months, plus additional time for evaluation by the autonomous communities (CCAAs) (1).

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News & Events Jerry Sandoval News & Events Jerry Sandoval

Windrose Consulting Group’s Response to Medicaid’s Proposed Changes to Best Price Calculations

In recent years, there has been a growing interest between pharmaceutical companies and payers to implement Value Based Agreements (VBAs) based on clinical outcomes. VBAs are typically applied when access is not attained through “standard” value communication and negotiation, driven by uncertainties around the clinical evidence and / or financial impact of the drug in question. As more and more curative and transformative therapies such as gene therapies enter the market, payers are looking for innovative ways to pay for these next-generation medicines, which are often accompanied with an astronomical price tag.

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