TWN Info Service on Intellectual Property and Health
1 October 2024
Third World Network
www.twn.my

Health:  High Cost of Lenacapavir Sparks Debate over Affordable Access

Delhi, 1 October (Chetali Rao and K M Gopakumar) – The high price of Lenacapavir once again sparked  a debate on affordable access to HIV/AIDS medicines.

Globally people living with HIV/AIDS and other civil society organisations are expressing concern about the access to this new class of antiviral drug which has the potential to substantially reduce the risk of HIV/AIDS.

Lenacapavir, a long-acting antiretroviral by Gilead Sciences, may prove to be a powerful tool that may change the trajectory of the epidemic; however, Gilead’s patent monopoly and its exorbitant price may well blunt its impact. These factors are intertwined and severely undermine decades of  efforts of the global health community in rolling out treatment and care.

On 12 September 2024, Gilead announced the results of the major clinical trials of its long acting, injectable HIV prevention drug Lenacapavir. In the PURPOSE 2 trial, Lenacapavir was found to be 89% more effective at preventing HIV than daily oral preventive medication among gay, bisexual and transgender people. This follows the previous clinical trial results in the PURPOSE 1 trial which found the drug to be 100% effective as a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP), in stopping HIV acquisition among cisgender adult and adolescent women. The results from two more ongoing clinical trials in PURPOSE 3 for cisgender women in the United States. and PURPOSE 4 for  people who inject drugs are still awaited.

Lenacapavir which is twice-yearly injectable provides a remarkable advancement over the currently available PrEP options, which are either administered as a once-daily pill or a bimonthly injection. This has the potential to radically improve the HIV/AIDS prevention strategies.  However, a deep schism remains between the euphoria and access to this new drug.

Lenacapavir’s high cost is a significant barrier

Lenacapavir comes with a very steep price tag, which raises serious concerns about affordability and accessibility. In December 2022, the US Food and Drug Administration granted the approval of Lenacapavir, in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. The wholesale acquisition cost (WAC) during the initial year of therapy per person per year (PPY), is $42,250.

Lenacapavir is priced significantly higher compared to other PrEPs that are currently in the market. Gilead’s own oral PrEP drug DESCOVY is priced at $26,000 per person per year while ViiV’s long acting CABOTAGREVIR (CAB-LA) is priced at US$3,700 per vial, or $22,200 per person per year. Setting such a high price of the drug clearly makes it an outlier for low-and middle-income countries (LMICs), which will have to depend on its availability through either the patient assistance programs or wait for the drug to be supplied through large donors and global funding agencies.

An analysis led by researchers from Liverpool University have estimated that generic Lenacapavir can be produced at a fraction of Gilead’s price. According to the research, Lenacapavir could initially be mass-produced for a price of  $63 to $93 PPPY, which would fall to $26 to $40 PPPY, if the production volumes equals to treating 10 million people. The researchers studied the raw material shipments of the drugs from manufacturers in India and China who were already manufacturing the “building blocks” for the drug.

Gilead’s patent monopoly driving high cost

Gilead’s high price for Lenacapavir stems from the patent barriers surrounding the drug. The patent filing strategy for Lenacapavir emulates the classic Big Pharma trajectory of filing multiple patents to cover the same drug molecule. Such similar patents strategy has previously been observed for tuberculosis drugs like Bedaquiline where Janssen and Janssen had filed multiple patents covering the same drug.

Gilead has filed multiple patent applications for Lenacapavir globally in many countries, including in India, Thailand, Brazil, South Africa, Vietnam and many other African countries. In addition to compound applications, multiple secondary patent applications have been filed on various aspects including choline and sodium salt forms which have been described as being “non-innovative”. Though in countries like India and Thailand, the patent applications are still under examination by the respective patent offices, Gilead has already been granted patents on Lenacapavir in multiple LMICs including South Africa, Eswatini, Botswana, Lesotho, Namibia, Kenya which bear the world’s heaviest TB burden. Gilead’s gambit to extend its patent monopoly until 2037 and its strategy of ‘evergreening’ by filing secondary patents will block access to generic Lenacapavir and keep the price high, thus posing a major barrier to its access particularly in LMICs. While one of its patents is set to expire in 2034, in last year’s SEC filings Gilead has explicitly made clear that it expects Lenacapavir to remain on patent until 2037.

The table below illustrates the patent filings for LENACAPAVIR in some high HIV burden countries:

Source: 1. Indian Patent Office; MedsPal

Patents on Lenacapavir have been opposed in several countries including India, Thailand and Vietnam and if rejected by the patent offices, it would be step towards allowing access to generic formulations. In India, Gilead’s patents have been challenged by a patient group Sankalp Rehabilitation Trust, through the process of pre-grant opposition – one of the levers available under the Indian Patent Act to prevent the granting of secondary patents. According to Eldred Tellis, Director of the Trust, “Granting such patents would extend the monopoly to 2028, which could hinder access to affordable and generic versions of the drug”. The Indian patent law disallows the evergreening of patents and in 2012 the country’s apex court rejected a ‘secondary patent’ on the blood cancer drug Glivec (Imatinib Mesylate) by Novartis.

Other than India patent opposition have been filed in many other countries.

“Within the Make Medicines Affordable campaign led by ITPC, HIV and vulnerable population organizations in India, Argentina, Indonesia, Thailand and Vietnam have filed nine oppositions against Gilead’s lenacapavir patent applications – the Thai Network of People living with HIV (TNP+), Delhi Network of Positive People (DNP+), Fundación Grupo Efecto Positivo, Indonesia AIDS Coalition and the Vietnam Network of People living with HIV (VNP+)”, said Othoman Mellouk, Access to Diagnostics and Medicines Lead, International Treatment Preparedness Coalition (ITPC).

Momentum grows in calls to make Lenacapavir affordable

A statement released by Gilead stated that “it was executing an access strategy.” This strategy will prioritize “high-incidence, low-resource countries, which are primarily low- and lower-middle income countries.” and a voluntary licensing programme for “high-incidence, resource-limited countries”. Gilead said it was actively working to finalise the contracts. Gilead has previously also been found guilty of following a revenue driven pricing strategy and ignoring public access for two of its Hepatitis C drugs Sovaldi and Harmoni.

A Congressional Oversight Report found that “Gilead refused to offer substantial discounts and did not significantly modify its contracting strategy to improve patient access”. The investigation found “the company pursued a marketing strategy and final wholesale price of Sovaldi – $1,000 per pill, or $84,000 for a single course of treatment – that it believed would maximize revenue… Fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices.” Thus, going by Gilead’s past actions, it is uncertain whether the impeccable results of such a scientific breakthrough can translate to accessibility for those who need them the most.

Advocacy organisations like MSF and Make Medicines Affordable Campaign among others have publicly demanded Gilead to make the drug affordable. In a recent press release activists in the United Kingdom targeted Gilead’s London office, demanding global equitable access to Lenacapavir. Emphasizing the seriousness of the increasing HIV case numbers, activists rang a bell every 24 seconds to symbolise that someone new acquires HIV every 24 seconds (1.3 million people per year).

A statement released by Winnie Byanyima Executive Director of UNAIDS states, “The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030”.

It further said that the results “provides hope of accelerating efforts to end AIDS, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”