• D. Maurice Kreis

Put Some ICER on that Toenail Fungus!

Updated: Oct 6

Toenail fungus is the most discouraging of scourges, ravaging the human family just when we already have enough troubles. But it’s an invisible epidemic, given that most of us are shod when outside the home.

That’s why I am coming out of the closet today to proclaim myself a chronic sufferer from this wretched disease. And it is also why I am so gratified that no less a distinguished organization than the Institute for Clinical and Economic Review (ICER) has finally given toenail fungus the attention it deserves.

By “attention it deserves” I mean the solitary reference to toenail fungus that occurs at page 34 of a remarkable white paper issued by ICER on September 28. Even if you have pristine toenails, you should read the paper, entitled “Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals.”

As my friends and family know, when I am not fretting about toenail fungus (i.e., most of the time) I am wondering and worrying about the high cost of treating cystic fibrosis in my capacity as a CF dad and consumer advocate. That’s what led me to ICER in the first place.

Earlier in September, ICER released the final version of its report on Trikafta and the other miraculous “modulator” CF drugs (Kalydeco, Orkambi, and Symdeko) developed by innovation powerhouse Vertex Pharmaceuticals. With the approval of Trikafta by the FDA a year ago, an effective modulator therapy is now available to about 90 percent of CF patients.

It’s a big deal, marking the first time there’s a treatment that addresses the underlying cause of CF as opposed to its symptoms. It’s also a big deal because of the price: $312,000 a year, per patient, for Trikafta.

ICER’s draft report on the modulators flatly and unambiguously declared that Trikafta is too expensive – way too expensive – and would still be excessively costly even if Trikafta cured CF outright (which it doesn’t).

Before finalizing the report on modulator therapies, ICER held a public forum in late August at which I had the honor of participating as an invited expert during the public policy discussion at the conclusion of the day-long virtual meeting. Unlike most advocates from within the CF community, I commended ICER for standing up to Vertex.

But I also said that it is imperative that patients not get caught in the middle, and see their access to life-saving or life-extending therapies, as the largely unregulated Big Pharma fights over pricing with third-party payors (i.e., insurance companies, Medicare, Medicaid, etc.). That’s still my bottom line – that people who suffer from diseases, especially chronic ones like CF for which more and more treatments are available, should never find themselves in the policy and monetary cross-fire when it comes to the outrageously high cost of medications and healthcare generally.

That’s why “Cornerstones of ‘Fair’ Drug Coverage” is bothering me, and why you should read it.

Given that the lead author of this ICER white paper is its thoughtful and compassionate president, Dr. Steven Pearson, it is not surprising that the report forthrightly confesses that it is “likely to fully satisfy no one.” According to Pearson and his co-authors, the “Cornerstones” document “will leave some patient advocates and clinicial representatives feeling that too much weight has been given to the importance of managing limited health care dollars.”

Well, not exactly – or, at least, not this patient advocate.

Rather, I object to the authors’ conclusion that “a strong ethical argument can be made to retain the option for plan sponsors and payers [i.e., your health insurance provider] to require higher cost sharing for drugs that are not reasonably priced.” According to Dr. Pearson and his colleagues, this is because there is “adequate evidence to demonstrate that paying more than appropriate for health gains in some segment of the patient population does more harm than good.” [Page 18]

Let’s be clear about what ICER is talking about here. “Higher cost sharing for drugs that are not reasonably priced” means your insurance company forces you, the patient, to shoulder more out-of-pocket costs if someone has decided that the drug is too expensive. Trikafta would be an excellent example, given that ICER itself has decided, after a very robust inquiry, that Vertex is demanding that insurance companies (and government payors like Medicare and Medicaid) pay too much for this drug.

Let’s say you’re on Trikafta. And let’s say there is no other alternative, given that modulators are mutation-specific and no cheaper modulator works for you. At $312,000 a year, even a 5 percent cost-share would mean an out-of-pocket annual bill of more than $15,000. That would likely put Trikafta out of reach for my family (which is why I am sort of glad that my daughter is among the 10 percent of CF patients whom modulators don’t help).

Talk about price signals! It can’t be a coincidence that this particular recommendation is written in passive voice. That’s always a sure sign the authors are feeling sheepish about what they are asserting.

Dr. Pearson and his colleagues laudably argue for consumer transparency (a consistent theme throughout the Cornerstones report), pointing out here that "[k]nowing prospectively all cost-sharing requirements will also help consumers make adequate financial plans to be able to cover all out-of-pocket costs.” The problem is that for all but the wealthiest families, there is literally no way to make “adequate financial plans” that include out-of-pocket costs of $15,000 a year for one drug. [Page 20]

Patients would likewise get caught in the cross-fire if insurers were allowed to adopt the recommendations in the Cornerstones report on prior authorization. In this context, “prior authorization” means going through the rigamarole of getting the insurance company to authorize a patient’s use of a particular drug before it can be prescribed.

The authors agree that prior authorization can trigger “an undue administrative burden that unduly constrains access.” But they contend that “the ethical balance shifts” in the case of drugs that are “deemed not to be reasonably priced.” They argue that “resources spent above a fair clinical value contribute to a net harm in the insured population by increasing insurance premiums out of proportion to the health gained.” [page 28]

Fair enough, but it hardly seems ethical to place the burden of redressing this wrong wholly, or even partially, on the back of a patient (or her family) who need the benefits of an unreasonably priced drug – again, e.g., Trikafta. There has to be a better way.

Which brings me back around to toenail fungus. Dr. Pearson and his colleagues offer this woeful malady as their textbook example of a condition that ought to be subject to “first-step therapy.” This means requiring patients to try a less expensive drug as a first step before trying a more expensive treatment. It’s okay for those toenails, say the authors, because “the clinical consequence of treatment failure is minimal.”

The problem with toenail fungus is that it’s an awful example. Basically, onychomycosis is an incurable disease; fungus, as a life form, is relentless and destined to rule the earth long after humans and even their most persistent insurance companies have been consigned to oblivion. Patients with almost every other condition have a running chance of beating it, and step therapy is a stumbling block in every instance.

Given the above critique, it might surprise you to learn that I’d still give this white paper an A. The authors are persistent and emphatic advocates for transparency – and they’re walking their talk through the sheer act of making this paper public. “Cornerstones of ‘Fair’ Drug Coverage” is the only document I’ve seen that lays out in detail the truth of how this system of blocking patient access to needed therapies actually works. That makes it a must-read for savvy healthcare consumers.



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