Without Doctor Input, the IRA Could Hurt Patients

In May, the Centers for Medicare & Medicaid Services took another step towards implementing the drug-price negotiation program established under the Inflation Reduction Act. The agency released draft guidance on how it plans to execute the program for the next 15 drugs that'll be selected for price negotiations in the coming years, with the prices actually taking effect in 2027.

CMS is trying to lower the cost of drugs, a laudable goal. But like many physicians, I'm concerned that the negotiation process could undermine the practice of medicine by limiting access to potentially lifesaving drugs. Insurance plans will inevitably take their cues from CMS for coverage determinations, drastically restricting prescribing options for physicians. When it comes to treating disease, one size doesn't fit all. Patients with the same condition often require different medicines based on factors including age, genetic makeup, comorbidities, and potential drug interactions. Clinicians consider all these nuances when crafting treatment plans.

CMS must grapple with these complexities as it undertakes the monumental task of negotiating prices. The agency is required to consider a drug's clinical benefit, whether the drug addresses unmet needs, and what alternative treatments exist. But it's hard to make these determinations without a deep dive into the kind of observations and clinical evidence that physicians acquire from extensive, everyday experience.

What is truly an alternative must be determined by a physician expert in the field. What to those outside of the field may seem like minor differences could be of paramount importance for treating physicians.

In short, CMS needs expert physician input.

In the first round of price negotiations, the only avenue for clinician input was through "patient-focused listening sessions." While interesting, these sessions were woefully incomplete and may have even deterred participation from non-patient stakeholders. The physician's voice was absent. Three-minute speeches with a handful of speakers and no time for questions are no substitute for substantive collaboration with medical experts. It isn't unusual for panels to spend hours debating the trade-offs between risks and benefits of medications in very specific settings; yet in round one, CMS ignored clinical nuance.

While CMS seems to be considering improvements to these sessions in year two, the agency still does not have a formal process for engaging clinicians -- at least not beyond asking doctors to voluntarily fill out a public form asking for specific and complicated data on the selected drugs within 30 days.

For example, CMS' selection among alternative treatments will affect how the agency sets expectations for clinical benefit and the price starting point. But there are more than 100 possible alternative treatments for CMS to choose from for the 10 drugs selected for the first round of negotiations. Without input from practicing, specialized clinicians, CMS could limit treatment choices. Of these 100 possible alternative treatments one could start by asking, which, if any, are worth limiting? This simple step is a formidable task.

Rigorous evidence shows the potential risks. Studies have shown, for instance, that patients from different racial and ethnic backgrounds can respond differently to the same medication. Even drugs within the same therapeutic class can have varying effectiveness and side effects, depending on the subgroup of patients.

CMS's decisions will create ethical dilemmas for physicians. Doctors want what's best for their patients, but they can't fight an uphill battle for coverage every time they want to prescribe a drug that's been deprioritized by the government's pricing regime. Having been fortunate to travel globally, I have seen first-hand the distress caused with this approach for patients with cancer diagnosed outside of the United States. The ethical responsibility of physicians is to recommend and prescribe the best treatments available for patients. Patients place their trust on us. Shall we now begin yielding to the economic pressures dictated by the government -- and settle for suboptimal, but more accessible, alternatives? I hope not.

The case for clinician voices goes beyond the negotiation process itself. As prices are finalized and the market begins to respond, it will be crucial to track how these shifts are playing out in exam rooms and at pharmacy counters across the country. CMS must put in place a procedure for systematic collection and analysis of this data. This evaluation should be conducted independently and feedback into agency decision-making in a process that allows for self-correction.

If CMS allows pricing, along with pharmacy benefit manager rebating pressures, to trump clinical nuance and patient-centered care, the damage could be immense. Physicians would feel coerced into prescribing based on financial considerations, rather than their expert judgment of each patient's case. The practice of medicine will inevitably change.

As IRA implementation moves ahead, CMS would be wise to seek doctors' expert opinions. By working hand in hand with the medical community, the agency can help ensure that the law achieves its goals without sacrificing the kind of care patients deserve.

To propose lower drug prices is politically advantageous but perilous. Recent data shows that the per capita spending on drugs in the United States has only modestly increased over the last 10 years, despite the advent of many new high price approvals. This is possible because of the very efficient adoption of generic medications. The pressure for patients is solely at the time they need to pull out a credit card for their co-pays. Co-pay limits would be the ultimate relief for those needing medications, and without patients and physicians having to worry about the use of best medications.

Dr. Fonseca, a practicing hematologist in Phoenix, has served as consultant to pharmaceutical companies.