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.

Potential ripple effects for gene therapy access

Bluebird bio, one of the world’s earliest innovators in the gene therapy space, recently announced that they will move away from launching and operating in Europe as a company, driven primarily by misalignment around the value and prices of their rare disease portfolio.

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]

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.

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.

We are excited to announce the promotion of Kate Hogan to Senior Consultant at Windrose Consulting Group.

Kate has shown great leadership skills, as well as impressive management of large and very high-profile projects.

We are thrilled to see Kate’s progression, which has been instrumental in our continued growth.

We are pleased to announce the opening of our new office in Lucerne, Switzerland.

On June 7th, the FDA granted accelerated approval for Biogen’s amyloid beta-directed anti-body Aduhelm (aducanumab), the first potentially disease-modifying treatment and first approval for Alzheimer’s disease (AD) in nearly two decades.

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.

A global pharmaceutical company was exploring a potential partnership with one of several companies developing a new anti-CGRP to treat and prevent migraines

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.

Product X is seeking approval in locally advanced or metastatic urothelial carcinoma (i.e. bladder cancer) as a monotherapy and as a 2nd Line (2L) option

Product X is expected to gain accelerated approval based on an open label, single-arm Phase II study

Objective: Develop a clear understanding of US payer perceptions of key value drivers and potential price ranges, and to form the basis for preliminary payer value story and proposition

We are delighted to announce the promotion of Zameer Merchant to Principal at Windrose Consulting Group.

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).

A global pharmaceutical company was developing a new product for the treatment of Parkinson’s disease; the product had a novel mechanism of action and was in early phase of clinical development

Windrose Consulting Group are pleased to announce the October promotions within our team.

Windrose Consulting Group acquires Parioforma as part of its global growth strategy to further enhance its capabilities in non-traditional markets.

A global pharmaceutical company’s R&D portfolio included several combination products across multiple different disease states.

A biopharmaceutical company was developing the first gene therapy for a rare disease. It was expected to be a one-time therapy that would replace the current chronic standard of care.

A global pharmaceutical company was planning to launch a next generation vaccine into a competitive market with the aim of replacing the current standard of care, which was a vaccine that they also owned.