Legislation removes FDA involvement when patients seek experimental medications. Here’s what critics and proponents say.
FDA incentives have hastened the development of “orphan drugs” for rare diseases, but some worry that regulators are not always demanding clear evidence for drug efficacy.
External, non-payer generated data can inform formulary decision-making—if payers know their strengths and weaknesses.
CMS’ 5-Star Rating system requires proactive intervention to improve patient medication adherence, and leaves plans with little room to rest on their laurels.
A University of Massachusetts clinical consulting pharmacist shows how assessing budget implications can be accomplished.
Pre-drug-approval forecasting and budgeting is increasingly important for payers. Is a safe harbor for manufacturers necessary?
The specialty drugs market will see more approvals in 2017 than 2016. Top areas to watch include cancer, multiple sclerosis, and HIV.
Value-based insurance designs for diabetes care improve outcomes, but monetary gains may take years.
Recent and pending drug approvals emphasize the growing importance of niche agents for very specific cancer patient populations.
Just last year, the FDA approved Exondys 51 (eteplirsen) for DMD, over the recommendations of FDA scientists and an external scientific advisory committee. Read more.