Dismay at Competition Commission’s decision on cystic fibrosis drug

The Competition Commission’s announcement that it will not refer cystic fibrosis drug manufacturer Vertex to the Competition Tribunal has been met with dismay by health activists campaigning for lower prices.

Vertex’s triple combination product Trikafta has transformed the treatment of cystic fibrosis, a rare genetic disorder that leads to an over-production of mucus in patients’ lungs. But its high cost has rendered it unaffordable for most governments and insurers, and triggered an international campaign by activists pressing for lower prices.

Trikafta costs about $300,000 per patient per year in the US, and generated more than 90% of the company’s $9.87bn in sales revenue in 2023.

In 2022, the Competition Commission initiated a complaint against Vertex for allegedly engaging in exclusionary practices and excessive pricing on four of its cystic fibrosis drugs, including Trikafta. At that stage, Vertex had registered its patents on Trikafta in SA, but had neither registered the drug with the medicines regulator nor appointed a local distributor to import it.

The Competition Commission said it had decided not to refer Vertex to the tribunal because it had begun supplying Trikafta through a local distributor. “This makes Trikafta available locally at prices that enable cystic fibrosis patients to access treatment,” it said in a statement.

“Separately, financial assistance is available through a patient assistance programme managed by a non-government organisation, and eligible cystic fibrosis patients who belong to certain medical schemes get Trikafta at no cost as they also receive some financial assistance from their medical aid schemes,” it said.

Vertex appointed Equity Pharmaceuticals to import and distribute Trikafta using the provisions of Section 21 of the Medicines Act, which enable access to unregistered medicines that have been approved by stringent regulators such as the US Food and Drug Administration.

Vertex indicated during the course of the investigation that it had opted for Section 21 authorisation because there was insufficient demand to warrant registering Trikafta with the SA Health Products Regulatory Authority, said the competition commissions’ divisional manager for conduct Mapato  Ramokgopa. She declined to be drawn on the price of Trikafta, saying it was confidential.

The international patient advocacy group Right to Breathe said contrary to the competition commission’s assertion that access to treatment had been secured, Trikafta remained out of reach for most SA patients.

“It’s not provided at all in the state sector, and not on lower level insurance (medical scheme) plans. Sixty three percent of eligible patients don’t have access,” said Right to Breathe’s Gayle Pledger.

Patient advocate Rida Viljoen, from the SA Cystic Fibrosis Association, said most medical scheme patients who belonged to lower tier plans could not afford to buy up. “It’s not a rosy picture at the moment,” she said.

Health Justice Initiative Founder Fatima Hassan expressed disappointment at the Competition Commission’s decision, saying Vertex had employed a “sophisticated misuse” of SA’s medicine registration system to avoid disclosing its prices.

The health department publishes the prices of all registered medicines sold in the private sector, as well as the price of registered medicines purchased for public sector patients. However there is no legal requirement to disclose the price of drugs imported under section 21 authorisation.

Vertex said 11 medical schemes provided cover for Trikafta. “Almost 50% of all eligible patients in SA are already receiving our triple combination therapy (Trikafta). In our opinion, a licence application would not speed up the process for broad access to our cystic fibrosis medicines,” it said. 

Medical scheme administrator Discovery Health said 159 cystic fibrosis patients who were members of Discovery Health Medical Scheme’s executive and comprehensive plans had access to Trikafta funding of up to R400,000 a year.

Discovery Health CEO Ron Whelan declined to comment on the price of Trikafta or the additional funding required by patients.

Three of Discovery Health’s smaller client schemes provided cover for Trikafta on a discretionary basis, he said.

Vertex declined to comment on the price of Trikafta in SA or indicate whether it funded the Access to Innovative Care Foundation, the charity assisting patients secure treatment.

kahnt@businesslive.co.za