‘Discriminatory and dangerous’: Pharma companies and advocates slam Texas judge’s HIV coverage decision

Pharma companies have condemned a federal judge’s ruling that a Texas business shouldn’t be required to cover HIV-prevention drugs under religious freedom law.

Reed O’Connor

Braidwood Management, Kelley Orthodontics and a handful of Texas residents filed a complaint against the US back in 2020, arguing that an Affordable Care Act (ACA) mandate requiring the coverage of preventative services, including pre-exposure prophylaxis (PrEP) HIV drugs, violates their religious beliefs. US district judge Reed O’Connor sided with plaintiffs on Wednesday, writing in his opinion that the mandate infringes on Braidwood’s rights under the Religious Freedom Restoration Act.

He also ruled that the Preventive Services Task Force, which recommended the mandate, was formed in violation of the constitution’s Appointments Clause, which requires officers to be nominated by the president and confirmed by the Senate.

The Joint UN Programme on HIV and AIDS set a goal back in 2019 to end the HIV epidemic by 2030 — but progress has slowed, advocates say.

Gilead Sciences and ViiV Healthcare market a suite of drugs for HIV PrEP in the US, including the once-daily Truvada and Descovy, and ViiV’s long-acting injectable Apretude. ViiV was in the spotlight just a couple of months ago, when more than 70 advocates signed a letter urging chief executive Deborah Waterhouse to lower Apretude’s price.

A week later, ViiV inked a deal with the Medicines Patent Pool to allow generic manufacturers in 90 low- and middle-income countries to develop their own versions of Apretude.

The drug’s current list price is $3,700 per dose, according to GoodRx. Truvada has an average retail price of about $1,800, according to GoodRx, and Descovy goes for $2,039 per month, though generics are now available for Truvada.

“Preventing HIV must be a public health priority,” a ViiV spokesperson said of O’Connor’s ruling in an email to Endpoints News. “Guaranteeing that private insurance plans cover preventive services, like PrEP, is critical to ensuring health equity and helping end the HIV epidemic in the US. We will monitor this case as it develops, and we expect that its eventual final ruling will be appealed.”

O’Connor previously found the ACA unconstitutional in a 2018 decision, though that ruling was overturned by the Supreme Court.

Gilead told Endpoints that the recent ruling could affect thousands of patients who take PrEP daily.

Marwan Haddad

“We believe that healthcare decisions, including use of PrEP, are deeply personal and should be made freely by an individual in consultation with their healthcare provider,” a spokesperson said. “Efforts to restrict access to these potentially life-saving medications will not only threaten public health, but also disproportionately impact communities hardest hit by HIV.”

Marwan Haddad, chair of the HIV Medicine Association, said in a statement on Wednesday that he is “deeply disturbed” by the ruling, adding that it’s “one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship.”

“Religious refusal laws allowing the personal beliefs of employers or health care providers to dictate access to prevention, care and treatment services are discriminatory and dangerous. These laws ultimately hurt everyone,” he said.

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