Brexit has stunned the world and shaken the foundation of many industries, including the pharmaceutical industry. The decision for the United Kingdom (UK) to leave the European Union (EU) is creating more questions than answers. There are many details that will be ironed out in the coming days, months and possibly even years, but pharma should be paying particular attention to how the Brexit will affect drug development, regulatory and health technology assessment (HTA) process and drug pricing.
Using data from the Context Matters Market Access Platform (MAP), the GetReal team analyzed mentioned uncertainties in regulatory and reimbursement assessments and evaluated when RWE could be included in the drug development process to reduce these uncertainties.
A Wall Street Journal article on March 13 reported that Bristol-Myers Squibb’s cancer drug Opdivo® has outperformed Merck’s similar drug, Keytrudo®, by falling back on an “old, mass-marketing approach.” Merck’s product is paired with a diagnostic test used to identify patients expressing the PD-L1 protein, in whom the drug would be the most effective. Merck’s trials only included patients expressing this protein, and the FDA approved the drug only in those who test positive for it.
Health Technology Assessment (HTA) agencies have been widely promoting their interest in taking relevant patient data into account during the drug review process. The effort to make a place for the patient voice in reviews is promising in an economic climate where the cost of innovation is under constant scrutiny. However, it raises two critical questions:
- How much weight does the patient data have in the HTA decision process?
- Are submissions by patient and professional groups associated with positive decisions?
The recent and frequent outcry over expensive drugs has made evident the gap in the United States’ healthcare system. While no perfect system exists, other countries have health technology assessment (HTA) agencies to evaluate efficacy and/or cost-effectiveness and inform reimbursement decisions.
What might the U.S. learn from countries like England, Germany, and France in structuring a methodology for evaluating drugs?
The ongoing debate around the high cost of drugs in the United States, especially in oncology, has produced interesting responses from special interest groups. The American Society for Clinical Oncology (ASCO) is the latest to enter the fray, believing they may have found a solution for drug valuation in the United States. Does ASCO’s new framework solve a problem in the drug evaluation process in the United States, or does it expose a serious and still unmet need?
A drug’s market share is dependent on several external factors, one of which is the drug’s health technology assessment (HTA). We analyzed HTA decisions from NICE, HAS, IQWiG, HIS, and SMC for rheumatoid arthritis (RA) drugs, specifically examining the subpopulations established by the HTA agencies through restrictions against the European label, and noting whether these restrictions changed over time.