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SA’s most influential medical scheme says it has been negotiating with US pharmaceutical manufacturer Vertex over the price of its blockbuster cystic fibrosis drug Trikafta for more than three years but is still “nowhere near” reaching an agreement.             

The efforts by Discovery Health Medical Scheme (DHMS) are being closely watched by cystic fibrosis patients, as its previous successes in negotiating prices for expensive new treatments have been felt throughout the entire industry.

Trikafta is at the centre of an international campaign by patient advocates, who are challenging what they say is the company’s failure to make its groundbreaking drug available at an affordable rate in low- and middle-income countries while blocking access to cheaper generic copies.

The drug is suitable for most cystic fibrosis patients and dramatically slows the progression of the rare, inherited disease, but its high price has made it unattainable for patients in many parts of the world. The US list price of Trikafta is $322,000 for a year of treatment, or about R6m. 

“It is extraordinarily expensive and unaffordable for most funders, bearing in mind this is lifelong treatment,” said Ron Whelan, chief commercial officer at Discovery Health, which administers DHMS. Vertex’s latest discounted offer was “nowhere near economically viable”, he said, declining to specify the company’s offer but adding: “We are not even in the ballpark yet.”

“Sadly, this is the tip of the iceberg. The proliferation of high-cost drugs ... is a huge and concerning problem,” he said.

Vertex said last week in response to Business Day’s questions that it was negotiating prices with healthcare funders in SA and had reached an agreement with a local distributor to import Trikafta under a section 21 authorisation, since the product is not registered with the SA Health Products Regulatory Authority (Sahpra). It declined to name the distributor or provide further details, but Whelan confirmed that it is not Southern Rx, the distributor owned by Discovery Health’s parent company, Discovery.

Section 21 authorisation enables the importation of an unregistered medicine that has been given the green light by another stringent regulator on a patient-by-patient basis.

The statement Vertex provided to Business Day is the same as one it made to the Cystic Fibrosis Association in December, disclosed in court papers filed as part of a legal challenge to its patents.

Vertex has filed patents on Trikafta and other cystic fibrosis treatments in SA, but has not sought to register the drugs with Sahpra. In February, cystic fibrosis patient Cheri Nel and the Cystic Fibrosis Association launched an application in the high court to break Vertex’s patent on Trikafta and issue compulsory licences that would enable the registration, importation and local production of cheaper generic copies of the treatment. Vertex filed notice of its intention to oppose the application last week.

Nel included in her affidavit an analysis of Vertex’s financial position drawn from publicly available documents. She concluded the company was debt-free and cash-flush and could afford to lower the price of Trikafta.

Business Day previously reported that Trikafta generated revenue of $7.69bn in Vertex’s 2022 financial year, or 86% of its total revenue for the period.

DHMS has 215 registered cystic fibrosis patients among its 2.8-million beneficiaries, said Whelan, most of whom would benefit from Trikafta.

As it is not a prescribed minimum benefit, schemes are not obliged to pay for Trikafta, but DHMS provides cover of R30,000 a month ex gratia to cystic fibrosis patients who secure a generic version of Trikafta called Trixacar, produced by Argentinian pharmaceutical company Gador.

Patients obtain Trixacar with a section 21 authorisation issued by Sahpra and pay between R60,000 and R70,000 for a month’s supply, depending on the exchange rate, said Whelan.

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