When I was working in a large health system’s patient safety department, we empowered patients to be their own advocate. If something didn’t seem right, feel right, or had not been explained clearly, we encouraged them to speak up.

This is something I’ve been thinking about quite a bit lately as mega high-priced cell and gene therapies make their way on the market with only scant acknowledgement from plan sponsors. As evidenced by our frequent posts, webinars, and pretty much sharing with anyone who will listen (sorry Amazon delivery guy), our firm has been closely ― some would say obsessively ― following these emerging therapies.

Don’t get me wrong, we are beyond thrilled at the potential for ground-breaking medical advances, particularly for those individuals grappling with incredibly challenging health situations. It’s just that we also believe these therapies should come with open, honest, and reasonable conversations around the benefits, risks, and costs.

Regardless of the presidential election’s outcome, change on the drug pricing front is imminent. The current system is not sustainable. If the ACA took the lid off drug pricing, who is going to put it back on? Can we really afford to wait for the federal government to act?

Human nature reminds us that every part of the supply chain is trying to grab as much of the pie as possible before it’s gone. Unfortunately, our healthcare system is no different. Plan sponsors need to take a seat at the table before it’s too late.

My internal alarm is triggered as I read the justifications for the exhorbitant price tags associated with cell and gene therapies. I am genuinely puzzled when I hear price justifications in terms of being in-line with lifetime treatment. Is this fair or is it wishful thinking based upon data that has been sliced, spliced, and extrapolated to meet a certain narrative? Of the therapies introduced so far, none cure the patient and restore them to a fully functional life.

Continued treatment ― typically very expensive treatment ― is still required. I cannot understand why payors and patients are being asked to bear the responsibility of upfront payment without long-term outcome data. It seems like patients and plans are the ones taking on the quality and safety risks for the sake of innovation. In effect, we are charging patients to participate in clinical trials without the standard accountability and safeguards that come with those studies.

Despite the challenges ahead, I am cautiously optimistic that we will strike a balance when it comes to the robust pipeline of therapies heading to market. Patients who have no treatment options today, may have multiple possibilities for their condition within the next several years. The key is to harness competition as fuel for both innovation and higher quality standards.

Let’s face it, all medications come with some level of acceptable side effects and adverse events. No one is asking for a 100% guarantee, but plans, physicians, and patients are entitled to a reasonable expectation that a paid therapy is effective, safe, and affordable.

There is a lot at stake. Afterall, such million dollar plus therapies unexpectedly hitting a plan have the potential to bankrupt a smaller company or adversely impact the stock price of a larger corporation, potentially resulting in extensive job losses and long-term economic hardship.

That’s why now is the time to speak out about standards for care and affordability. A system built around finding the highest possible price the market will bear is not sustainable. Especially when it means plans and patients are the ones being held hostage to foot the bill.

Kelly Prymicz, PharmD, RPh, is a consultant with the Chelko Consulting Group where she helps employer-sponsored health plans better understand and manage quality of care and waste issues associated with the prescription drug spend in their medical TPA and PBM administered benefits.