DRUG WAITLISTS : Want a new drug? It pays to wait.
| January 30, 2019
“Progressive drug waitlists protect patients and ensure value to self-insured employers.”
Last year marked a 21-year high for U.S. drug approvals, many of which received special designations to accelerate the review and approval process. While these drugs are making positive strides toward treating costly and chronic medical conditions, such as diabetes, arthritis and cancer, some won’t fulfill their clinical promise on the public market. Equally disconcerting, they may cost self-insured employers and patients millions.
The skyrocketing cost of pharmaceuticals and the expedited rate at which they are coming to market underscore the importance of pharmaceutical benefits managers (PBM). A PBM that uses services like a waitlist, can reduce or eliminate unnecessary prescription costs. John Nicolosi PharmD, Senior Vice President and Chief Clinical Officer of CerpassRx explains the importance of waitlists and how they benefit employers and employees alike.
Q: What is a drug waitlist?
John Nicolosi: A waitlist is a designation that withholds coverage for new-to-market drugs until they can be proven of value, whether through pure efficacy data or cost-to-clinical outcomes analysis.
Q: What value do drug waitlists provide?
John Nicolosi: One might describe a waitlist as extending the clinical trial. By withholding coverage on a drug, and ultimately reducing its use within employer populations, the PBM is implementing guardrails to protect against the typical high price tags of new-to-market drugs, until the drug can prove its value through clinical outcomes. Equally important to cost-assurance, PBMs should be looking at the drug’s safety and clinical effectiveness. While new-to-market drugs go through a rigorous trial period, access to the product is understandably limited. After approval for use by larger public markets, it’s not uncommon for post launch studies to reveal different health risks and outcomes than were demonstrated during clinical trial. Time on a waitlist allows drug makers to collect more data, recalling the drug should it prove harmful, reformulating or repricing the drug should it prove less effective as similar drugs on the market. The intent is to protect the health of patients and reduce the costs for both employers and employees.
Q: How long are drugs held on waitlists?
John Nicolosi: PBMs hold drugs on waitlists for 30 days to a year. It varies based on the drug’s clinical place in therapy.
Q: What if a patient needs a drug that’s currently waitlisted?
John Nicolosi: While other organizations restrict the option to remove a drug from the waitlist regardless of the circumstances for patients and employers, CerpassRx offers waitlists with almost unlimited flexibility. We collaborate with our employer clients to craft ideal formularies for their employees while delivering significant savings to employers through our contractual guarantee. The insight we gain through this process is easily applied when potential modifications to the formulary occur. Reviewed on a case-by-case basis, we may determine coverage for the waitlisted drug should key decision makers deem it appropriate. A simple pre-authorization releases the drug to be prescribed to a designated member–or even an employer’s entire population.
Q: How do PBMs determine whether a drug should be waitlisted or not?
John Nicolosi: The drugs covered or not covered will impact clinical outcomes and the health of an employer’s population, which ultimately affects time missed at work, productivity, and employee satisfaction. This makes in-house clinical expertise critical for PBMs, which is why CerpassRx is backed by a team of clinicians that understand efficacy data and the intricate details of formulary management. Outside of monitoring all phases of a drug during its clinical trial, we provide expertise around ancillary offerings, such as diabetic programs, substance abuse prevention, and specialty care management.
While drug waitlists largely act as a sort of price inflation protection for self-insured employers, the most progressive, collaborative PBMs also help protect patients from inflated out-of-pocket costs and poor treatment outcomes.
JOHN NICOLOSI | PharmD, Senior Vice President, Chief Clinical Officer; CerpassRx Dr. Nicolosi’s career began as a Supervisor of Prior Authorization Clinical Operations, followed by Management of several clinical accounts for Catamaran (formerly SXC Health Solutions). Following that he maintained accountability, retention, and growth as a Director of Account Management for the Hospital Segment of OptumRx, before joining CerpassRX as the Senior Vice President of Account Services and Chief Clinical Officer. He holds a Pharm D, in Pharmacy from Midwestern University and a BS of Community Health with a focus in Health Administration from the University of Illinois at Urbana-Champaign. Enjoy more of his industry insights, here.