While an international campaign by patient advocates and health activists gathers momentum, Discovery Health says it has been negotiating with US pharmaceutical manufacturer Vertex over the price of its cystic fibrosis drug Trikafta for more than three years but is still “nowhere near” reaching an agreement.
US pharma giant Vertex is in the crosshairs of health activists not just in SA but also in India, Brazil and Ukraine, with a potentially precedent-setting legal challenge launched by patients over its patents on prohibitively expensive lifesaving treatments.
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, reports BusinessLIVE.
The legal challenge is in response to what activists say is the company’s failure to make its 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.
“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.”
Vertex said last week 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.
Vertex has filed patents on Trikafta and other cystic fibrosis treatments in SA, but has not sought to register the drugs with Sahpra.
Last month, cystic fibrosis patient Cheri Nel and the Cystic Fibrosis Association launched an application in the High Curt 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 2.8m 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.
if the High Court application to override Vertex’s patents on Trikafta in SA and award compulsory licences to patients and generic pharmaceutical manufacturers succeeds, it will be a first, as no compulsory licences have been awarded in SA, and it would mean third parties could make the drug without Vertex’s consent, increasing competition and driving down prices.
Medicines Sans Frontieres (MSF) and the Treatment Action Campaign (TAC) are seeking leave to join the application as friends of the court, both of which have successful track records in campaigning for access to cheaper medicines.
“TAC and MSF seek to demonstrate to the court … the value of compulsory licences as a mechanism for ensuring that patents do not violate people’s right to health, including the right to access medicines,” said public interest law group Section27, which is representing the activists.
TAC and MSF will argue that courts should interpret compulsory licensing as a legislative measure that contributes to the progressive realisation of the right to access medicines in section 27(2) of the Constitution, it said.
Most cystic fibrosis patients die young, but Trikafta and several other treatments patented by Vertex have extended life expectancy. However, their price means the drugs are unaffordable to most patients in low and middle-income countries, including SA.
Vertex director of international communications Daria Munsel said the company aimed to make its cystic fibrosis medicines available to as many patients as possible worldwide, including SA.
“As seen in other rare disease areas, bringing medicines to patients in SA is challenging. The current regulatory framework presents numerous hurdles that do not support a viable path to sustainable access. We believe that a ‘Section 21’ application on a named patient basis provides the fastest and most efficient route to sustainable access,” she said, referring to provisions in the Medicines and Related Substances Act permitting the importation of medicines that have not been registered in SA on a patient-by-patient basis.
“We have signed an agreement with a local distribution partner for the medicines in SA and are in discussion with stakeholders in the private insurance system,” she added.
Business Day PressReader article – Health activists seek to join legal fight (Open access)
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