Are institutional recommendations and guidelines good for patients?
By Mike Wokasch

It depends. It depends on the level of scrutiny and expertise applied by the prescribing physician in assessing the information used to support the recommendations and guidelines.

Institutional assessments are most helpful when driven by clinically meaningful patient benefits resulting from comprehensive reviews of clinical data by therapeutic area experts — assuming they are unbiased with no conflicts of interest. This is a rather idealistic perspective when you consider most clinical data are from trials designed for regulatory approval and do not necessarily performed to reflect real-world clinical practice or typical patients. Credibility of the data and the sources of the data can also be suspect when it comes from the manufacturer. Moreover, even with large clinical trials, few are comparative between competing brands or products considered good treatment alternatives. Even at this, few clinical trials are designed to demonstrate superiority. This makes recommending one brand or treatment option over another difficult and often indefensible.


Do you think institutional recommendations benefit patients?
  • 1. Yes
  • 2. No
Without a strong clinical basis for suggesting or recommending a specific treatment choice, institutions must assume comparability and jump to the financial impact of product choices. Is there a generic or therapeutic alternative that costs less? Treating individual patients moves to finding the lowest cost option for “the masses” presenting with a particular disease and set of symptoms (think ICD-9/ICD-10 codes). Again, this might be less disconcerting if recommendations and product selection are supported by clinical data and not driven by financial impact.

So what is the solution? Can institutional recommendations benefit patients and at the same time not burden the healthcare system with expensive prescription drugs when less expensive alternatives might be as effective and safe?

Despite the often controversial decisions and recommendations, the rigor of the National Institute for Health and Clinical Excellence (NICE) process in the U.K. seems to at least have taken a step in the right direction. By demanding clinical data transparency and real-world cost implications to justify price, NICE has taken institutional product evaluations and recommendations to a level of credible assessment. While some may argue, it is far from perfect, the NICE process forces manufacturers to provide data supported value propositions for the real world. If a manufacturer cannot prove the value of its product for which it is intended, why should the market pay a price that cannot be justified?

As the U.S. healthcare market becomes even more managed and cost conscious under the Affordable Care Act, expect to see more demands for proof of value, especially for expensive prescription drugs with marginal benefits over already-available treatments. To ensure patients have access to necessary treatments without compromising affordability requires rigorous NICE–like processes to support prescribing recommendations and reimbursement decisions. Do individual institutions or healthcare systems have the expertise, time and financial resources to credibly assess treatment options or should this be a centralized NICE-like process?

Mike Wokasch, a pharmacist by training, is a 30-year pharmaceutical industry veteran, having held a number of positions of increasing responsibility at several large pharmaceutical companies including Merck, Abbott, Chiron, Bayer and Covance. Wokasch was also an executive at several technology-based companies including Promega, PanVera and Aurora Biosciences. He is the author of the book, "Pharmaplasia," which explores the changes needed in the pharmaceutical industry as it adapts to healthcare reform.