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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Case Studies Adam Foster Case Studies Adam Foster

Case Study: Value proposition and pricing & market access strategy assessment for a last-line advanced bladder cancer therapy

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

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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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