An Unintended Consequence for High HIV Drug Prices

In order for access to preexposure prophylaxis (PrEP) to remove its over-reliance on Section 340B of the Public Health Services Act, changes to access for HIV care and PrEP need to be adopted, according to an article published in The New England Journal of Medicine.

Authors from Harvard Medical School wrote a perspective detailing why less than a quarter of the 1.2 million people eligible to take PrEP to reduce HIV infection are taking the medication. They began by acknowledging that until 2021, PrEP medications cost between $1200 and $1900 per month. After a congressional investigation, generic PrEP medications are available for $21 per month, the perspective authors noted, which is a benefit to patients in terms of access as well as health care cost savings. Despite this, the authors said, a more expensive medication, emtricitabine 200 mg/tenofovir alafenamide 25 mg, is being prescribed which is an unexpected downside of the 340B Drug Pricing Program.

Section 340B of the Public Health Service Act was enacted by congress in 1992, the authors said, and requires drug manufacturers to make discounted medications available to health centers that serve uninsured and low-income patients. As the authors explained, insurers reimburse 340B facilities for their medications near their list price which generates revenue known as the 340B spread that clinics can put towards other health services. When the price of the drug is high, the spread increases, too, the authors noted.

For emtricitabine 200 mg/tenofovir alafenamide 25 mg, for example, and another PrEP, emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg, 340B clinics are paying between $300 and $800 for a one-month supply of those medications. That can produce a monthly spread of as much as $1,600 per patient, the study authors said. The clinics can fund important health services through this revenue, the authors noted, but said “there are unintended consequences of a system that’s so dependent on high drug prices to sustain itself.”

This effect reveals itself in a variety of ways, the authors argued:

When clinics that are not 340B entities, they are left with limited financial options for uninsured or low-income patients. While yes, the 340B program has generated revenue and innovation in the HIV-prevention space, the gaps that remain leave patients that may not seek care at traditional health centers vulnerable due to a variety of stigma or structural barriers to care.

“But pockets of innovation—concentrated among well-financed providers—do not translate into the easy-access approach to PrEP that’s needed to address widening disparities in use,” the authors wrote.

Clinics are incentivized to prescribe high-cost medications even when generic medications, that are cheaper and as effective, are available. The pressure to prescribe the high-cost, brand-name medication may indirectly influence prescribers’ medication choices as well as the patients’ views that generics or another brand-name drug are inferior.

“In a national cohort of mainly gay and bisexual men, 32 percent of PrEP users who switched to [emtricitabine 200 mg/tenofovir alafenamide 25 mg] were motivated by the perception that it’s safer than [emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg], whereas only 6% reported having a clinical reason for switching,” the authors wrote.

The authors realized that sweeping changes to 340B may threaten to destabilize the entire system, but that some changes could be implemented to safeguard prescribing practices. For example, the federal government could negotiate fair prices for PrEP medications and labs for the uninsured or Medicaid beneficiaries and could build a network of PrEP providers. This plan, they noted, has been endorsed by President Biden and would allow for PrEP medication disbursement to be based on clinical evidence and not on the “spread” incentive.

“Although 340B will continue to facilitate access to discounted drugs, a national PrEP program would ensure that overreliance on 340B does not dictate clinical decision making,” the authors concluded. “A decade after the emergence of PrEP as a powerful HIV-prevention tool, it’s time to ensure widespread availability by promoting access to safe, effective, and sustainably priced medications, rather than providing incentives to prescribe higher-cost alternatives.”