To topple access barriers to Vertex Pharmaceuticals’ potentially lifesaving, yet often out-of-reach cystic fibrosis therapy Trikafta, a buyers club has resurfaced with a plan to introduce a discounted generic of the drug in certain parts of the world.

Under the strategy, the new generic of Trikafta—which combines the CFTR modulator drugs ivacaftor, tezacaftor and elexacaftor—will cost $12,750 a year for adults and $6,375 annually for kids, well below the $370,000 list price the medicine carries in the U.S., the buyers club said in a Thursday press release.

Trikafta, which generated full-year sales of $11.02 billion last year, still possesses numerous patent protections around the world. But the buyers club believes it has plotted a workaround by tapping Bangladeshi manufacturer Beximco to produce a generic option.

Given its classification as a least developed country (LDC), Bangladesh is not beholden to pharmaceutical patents under the World Trade Organization agreement on trade-related aspects of intellectual property rights (TRIPS). That means Beximco can legally manufacture and export generics of patented drugs, the buyers group explained.

As for the potential reach of the Trikafta generic, many countries have legal exemptions in place that allow people to purchase and import medicines for personal use, the group explained, noting that patients, families, doctors and health service employees can now “register their interest” in the cheaper copycat on the buyers club website.

The buyers club effort looks poised to predominantly benefit patients in low- and middle-income countries (LMICs) where Trikafta is either cost-prohibitive or unavailable outright. Patients in the U.S., however, are less likely to benefit, given that it is often illegal for people to import drugs into the country for personal use if they haven’t been approved by the FDA.

On the other hand, certain countries like the U.K.—where at least one of the organizations behind the buyer's club is based—do allow patients to import certain medicines for personal use, under strict conditions.

The generic will carry the name Triko and become available for purchase starting in the spring of 2026, according to the buyers club, which was borne out of the efforts of multiple advocacy and cystic fibrosis (CF) patient groups.

Vertex’s pricing and patenting strategy around Trikafta and predecessor CF meds has long been controversial, and the buyers club did not hold back in calling out the company for creating “deep inequality in access to the treatment.” 

Cystic fibrosis, a progressive, genetic disease of the lungs, pancreas and other organs, is thought to affect more than 188,000 people around the world, the buyers club pointed out, citing a 2024 paper critical of current Trikafta access levels. Among that group, some 60% are diagnosed and just 27% are on treatment for their disease, according to the organization. The Cystic Fibrosis Foundation estimates that around 105,000 people have been diagnosed with CF across 94 countries.

Treatment disparities appear rife when looking at LMICs, where researchers last year estimated that around 82% of undiagnosed CF patients live. Meanwhile, just one LMIC reported patient reimbursement for Trikafta, versus 35 high-income countries at the time the paper was written.

Vertex, for its part, did not directly respond to Fierce Pharma’s request for comment on the purchasing group’s announcement. Instead, a spokesperson pointed to a “CF facts and figures” page on the company’s website, where Vertex asserts that it is “committed to develop and provide access to our CF medicines to as many eligible people living with CF who can potentially benefit from them.”

Vertex contends that its approved modulators are suitable for around 90% of people living with CF and states that its medicines are currently treating more than 75,000 people with CF globally, or about two-thirds of the disease’s diagnosed patient population.

The company’s CF drugs are available in over 60 countries, more than 50 of which have secured “broad access agreements,” Vertex notes. Additionally, the company has rolled out a pilot donation program in tandem with the group Direct Relief to provide Trikafta to eligible patients in 14 countries, including Ukraine, Nepal, India, Egypt, Ivory Coast, Sri Lanka and El Salvador.

But for the buyers club and advocacy groups behind its access push, those efforts are not enough.

“We’ve watched children suffer and die while a treatment sat on the shelf, priced out of reach,” Gayle Pledger, part of organizations Just Treatment and Right to Breathe, said in a statement.

“Today, that changes,” she continued. “[W]e’ve proven that patient power can change what billion-dollar corporations refuse to. Governments must act fast to take all the necessary steps to make this lifesaving drug available for every eligible patient.”

This is hardly the first time Vertex has taken flak over the availability of its CF meds, and the company had a previous run-in with the buyers club in 2019 over an earlier combo therapy, according to Stat News.

In that instance, the group elected to work with Argentinian drugmaker Gador to produce a cheaper generic of Vertex’s Trikafta predecessor Orkambi, which weds the cystic fibrosis transmembrane conductance regulator (CFTR) potentiator ivacaftor with the CFTR corrector lumacaftor.

Meanwhile, a paper published in The Journal of Cystic Fibrosis in 2022 argued that while Vertex’s arsenal of CFTR modulator drugs has the “unparalleled opportunity to increase quality and length of life for almost all CF patients,” the therapeutics are “so expensive they are essentially unavailable unless reimbursed by the government or health system authorities.”

That paper, which had the same lead author who penned the studies cited in the buyers club press release, estimated that just 12% of some 162,000 people thought to have CF worldwide were receiving Trikafta.

The company's access agenda again came under fire in 2023, when a coalition of CF patients and families, helmed by Vertex Save US and the U.K.’s Just Treatment, petitioned governments in South Africa, Brazil, India and Ukraine to either revoke or suspend Trikafta patents. Outside the U.S., Trikafta goes by the name Kaftrio.