Hate delays getting your prescriptions approved?

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Putting limits on the price of expensive drugs may sound like a great way for a state to save its residents money and encourage them to fill their prescriptions and stay healthy. That is what the new wave of prescription drug affordability boards, or PDABs, in 11 states are promising.

But not so fast. One certain consequence of the upper payment limits (UPLs) that many of these boards plan to implement, will be to make it harder for patients to get medicines they need. If your health plan has ever blocked access to a physician's prescription, you know what I mean.

Researchers are warning that these UPLs will increase the use of "step therapy" and "prior authorization" — two insurance maneuvers that both patients and doctors despise.

With "step therapy," your physician prescribes a drug, but your insurer or its pharmacy benefit manager (PBM) won't approve it until you have tried a different drug and gotten an inadequate response — a process bluntly called "fail first." It can lead to needless suffering, adverse reactions and even death.

James K. Glassman

CancerCare, a nonprofit that for 80 years has been providing counseling and support groups, warns, "Waiting for the cheaper drug to fail can take weeks or months. Meanwhile, the cancer may get worse, and the patient may get sicker."

Of course, step therapy also saves billions of dollars for insurers, and it was already on the rise even before PDABs. A major study published in Health Affairs Scholar last year looked at 17 large commercial health plans and found that their step-therapy requirements jumped by more than one-third between 2017 and 2021.

A similar tactic is prior authorization, not allowing a doctor's prescription to be filled until your insurer or PBM approves it. "Patients may wait days, weeks or even months" for authorization, says the American Medical Association. In an AMA survey, 26% of doctors said prior authorization often leads to abandonment of treatment altogether as patients tire of waiting.

Another way to limit access is through formularies for health plans. These lists of covered drugs have tiers with varying out-of-pocket requirements through copays (fixed amounts) and coinsurance (percentages). Some medicines are excluded from coverage outright so the health insurer will not pay for them at all.

A study by the consulting firm Xcenda found that exclusions of medicines from plan formularies are "skyrocketing," — up 36% just between 2020 and 2022. Even without exclusions, plans are putting critical medications into "non-preferred" tiers, where out-of-pocket costs are much higher.

PDAB price controls will exacerbate these trends. An April study by HealthHIV, an advocacy and research group for people living with HIV/AIDS, concluded that health plans will increase step therapy and prior authorization and to move drugs subject to UPLs "into non-preferred tiers on a plan formulary, which may affect accessibility."

Physicians and other providers at hospitals, clinics, and pharmacies — which are compensated based on the cost of medicines — "may need to consider alternative medications for their patients…altering treatment plans and impacting patient care," said HealthHIV.

No wonder some of the staunchest opponents of price-setting by PDABs are patients and their caregivers. Patients relying on Trikafta, for cystic fibrosis, and Genvoya, for HIV/AIDs, strongly objected to UPLs for those drugs. "We are passionately defending our access," Siri Vaeth, the executive director of the Cystic Fibrosis Research Institute, told the Colorado PDAB, which eventually ruled both medicines "not unaffordable," in large part because of financial support from governments and drug manufacturers themselves.

But PDABs have targeted other drugs for price controls. If you have a chronic condition, you can expect UPLs will cause significant disruptions in your access to the medicines that help you live better — or keep you from dying.

This is a high price to pay for a policy that is unlikely to reduce patients' out-of-pocket costs. Partnership to Fight Chronic Disease and Avalere recently published a report containing off-the-record interviews with health insurance officials that found that more than 80% of them "did not anticipate that UPL-related savings would be passed on to patients."

In a classic case of a government policy that sounds good politically but has terrible unintended consequences, UPLs will make it harder for patients to get the medicines they need while at the same time not reducing what they pay at pharmacies.

Oregon's PDAB on June 25 voted unanimously to "pause" drug reviews until at least January to reconsider its mandate. Other boards would be wise to do the same before they harm the people they're supposed to help.

James K. Glassman, a former under secretary of state and senior fellow at the American Enterprise Institute, advises health care companies and nonprofits.