Want to learn more about why we launched a global campaign calling on pharmaceutical corporation Johnson & Johnson (J&J) to lower the price of the tuberculosis drug bedaquiline to $1/day for everyone who needs it? Read our Q&A below.
Questions:
- What are you calling for and why?
- How much does J&J currently charge for bedaquiline?
- Who contributed what to the development of BDQ?
- J&J say they are already losing money by selling bedaquiline at around $2 per day (what it calls a ‘special effort’ price). How will they be able to reduce the price further?
- This campaign to reduce the price of bedaquiline only targets J&J. What about calling for multiple producers to bring the cost down instead?
- If bedaquiline must be used in combination with other drugs to treat DR-TB as part of a treatment regimen, why does this campaign focus only on one drug?
- How is MSF treating DR-TB and how is MSF accessing bedaquiline?
1. What are you calling for and why?
Médecins Sans Frontières (MSF) is calling on the pharmaceutical corporation Johnson & Johnson (J&J) to lower the price of its drug-resistant tuberculosis (DR-TB) medicine bedaquiline (Sirturo®), to no more than US$1 per day, everywhere. Bedaquiline should be affordable and accessible for those who need it in order to benefit as many people with DR-TB as possible and also in keeping with the collective contributions that went into the drug’s development.
Bedaquiline is one of only three new TB drugs to be developed in over half a century. When included as part of a treatment regimen, bedaquiline can cure more people of DR-TB than older, toxic treatments that need to be injected and often cause devastating side effects including permanent deafness and psychosis. In 2019, the World Health Organization (WHO) updated its treatment guidelines, recommending bedaquiline as a core drug of an all-oral treatment regimen for multidrug-resistant TB (MDR-TB).1 However, the current high price of bedaquiline remains a significant, but not the only, barrier to countries’ efforts to scale-up access to the drug, now an essential part of DR-TB regimens. As of August 2019, only 36,353 people had received bedaquiline worldwide since it was approved for use in 2012.
Bedaquiline was developed with considerable taxpayer, non-profit and philanthropic support. The joint effort behind the drug’s development is much greater than funding alone: many studies and operational research carried out by others, including MSF, were key in generating evidence to inform the use of bedaquiline, including its effectiveness against DR-TB. Essential to these studies were medical personnel, patients and other contributions through the health system, and specific funding.
Despite these joint efforts, it is J&J alone who owns patents on the compound in many countries. The key patent J&J holds on bedaquiline gives the corporation monopoly control over the drug until 2023 in a number of countries, meaning it has the upper hand during price-setting negotiations and can block potential alternative suppliers, effectively deciding who can have access. This is unacceptable, especially since J&J did not develop this drug on its own. Also unacceptable is J&J’s control over rights to sell the drug (‘marketing authorisation’) in countries – rights granted by regulatory authorities based on evidence generated largely through joint efforts of the global TB community. Those who contributed to its development should have a say in how this drug is priced and made available to people with DR-TB.
2. How much does J&J currently charge for bedaquiline?
At $1 per day, the price would be $600 per person for the 20 months of treatment that many people with DR-TB require. In comparison, today, the lowest price that J&J charges for 20 months of bedaquiline is nearly $1,200—more than $2 per day—which is what J&J is calling their ‘special effort’ price.2 This high price could affect the scale-up of the drug in countries affected by the DR-TB epidemic, including those that are still using the suboptimal regimen that has achieved treatment success rates of only 55% for people with MDR-TB and 34% for people with extremely DR-TB (XDR-TB). At this price, bedaquiline is still unaffordable in many low- and middle-income settings, which are hardest hit by DR-TB – especially considering that bedaquiline is just one of several drugs required to treat DR-TB, driving the total treatment cost far higher. Additionally, this ‘special effort’ price is only available to eligible countries through the Global Drug Facility (GDF), an organisation run by the Stop TB Partnership that supplies TB drugs to low- and middle-income countries.3 In July 2018, South Africa became the first and only country to access this deal outside of GDF.4 J&J has not been transparent about their pricing policies outside this list of countries.
3. Who contributed what to the development of BDQ?
J&J has not made available information on its actual R&D investments, nor the financial benefits or incentives it received for bedaquiline’s development. However, we know that the development of bedaquiline is the result of a joint effort by public and private entities, and the larger TB community—not by J&J alone. Clinical trials, operational research and safety monitoring for the drug have been supported by substantial public investments and contributions from the US government through the National Institutes of Health and USAID; UNITAID; health ministries in countries with high rates of TB that were engaged in the clinical trials and operational research; the South African Medical Research Council; academic institutions (University of Cape Town, University College London); non-governmental organisations (including MSF); and philanthropic donors.
Moreover, as bedaquiline was granted orphan drug designation in the US, J&J further benefitted from a 50% tax credit on qualifying clinical research and development (R&D) expenditure, as well as exclusive US marketing rights for seven years. In addition, J&J also received a Priority Review Voucher (PRV) from the US Food and Drug Administration (FDA) for registering a drug for a tropical disease. PRVs are a lucrative government incentive that can be used to expedite FDA review of another product, or sold. Between December 2017 and April 2019, PRVs sold for $80-130 million,5 and previously, in 2015, for as high as $350 million.6 J&J used its PRV to expedite FDA review of guselkumab (Tremfya), a blockbuster psoriasis drug, getting a four-month jump on the market. This drug sells for nearly $60,000 per patient per year in the US and is predicted to yield nearly $3.5 billion in sales for J&J by 2024.
4. J&J say they are already losing money by selling bedaquiline at around $2 per day (what it calls a ‘special effort’ price). How will they be able to reduce the price further?
Firstly, it’s important to note that J&J has not been transparent about how much it is charging for bedaquiline outside this ‘special effort’, given that not all countries are eligible for the lowest price. The lack of transparency around this information is deeply problematic, as it keeps countries and other payers in the dark during negotiations. Secondly, researchers have calculated that bedaquiline could be produced and sold at a profit for much less—as little as 25 cents per day if at least 108,000 six-month treatment courses were produced per year.7 Thus far, J&J has refused to open its books to show the financial outlays of actual costs of developing and manufacturing the drug, taking into account the US government incentives awarded to J&J. Transparency, across the board, is essential.
5. This campaign to reduce the price of bedaquiline only targets J&J. What about calling for multiple producers to bring the cost down instead?
Indeed, the arrival of multiple producers on the market would provide a more sustainable solution to reduce the price of bedaquiline. We saw this with HIV: Twenty years ago, the price charged for the triple cocktail of drugs to treat HIV was over $10,000 per person per year, because of patent monopolies. Now, the same treatment is available for less than $100 per person per year, thanks to robust competition among generic manufacturers.
This campaign targets J&J because, despite the joint efforts behind the drug’s development, the corporation controls the marketing authorisation, availability and price of bedaquiline, and has a patent on the base compound of bedaquiline until 2023 that prevents other manufacturers from entering the market. We ultimately want to see multiple producers of the drug, competing to drive prices down, in parallel with countries scaling-up the use of bedaquiline, as recommended by WHO. Until we have other producers on the market, we are dependent on J&J for this drug, and therefore are pressing the corporation now to reduce bedaquiline’s price to $1/day for everyone who needs it.
We’ve discovered that J&J is working tirelessly to retain and extend its monopoly using a notorious pharma tactic known as patent ‘evergreening’. Patent evergreening is when corporations file for additional patents on known forms or combinations of existing drugs, thereby lengthening their monopoly. J&J recently filed for additional patent applications in a number of countries, including India, on the salt form of bedaquiline. If granted, J&J’s monopoly would be extended from 2023 to 2027, delaying entry of price-lowering generic manufacturers by four additional years. This patent application does not merit patenting under India’s patent law, and we are urging J&J to refrain from attempts to extend its monopoly and are pursuing legal challenges to the company’s patent in India. In February 2019, MSF supported a patent challenge filed by two DR-TB survivors against J&J’s application in India.8 We are also urging the Indian government to override the patent and encourage its TB drug manufacturers to supply bedaquiline to its TB programme by issuing a what’s called a compulsory license, especially considering that DR-TB is a public health emergency. This can be an effective way of overcoming patent barriers to access critical health products, and if J&J refuses to reduce the price, other countries could follow suit and use the high price as grounds to issue a compulsory license.
6. If bedaquiline must be used in combination with other drugs to treat DR-TB as part of a treatment regimen, why does this campaign focus only on one drug?
Although bedaquiline is just one of four or more medicines needed to compose a regimen, this campaign focuses on bedaquiline because it is a core drug for the treatment of DR-TB, and therefore should be available to all people who need it.
MSF is also working to address price and patent barriers of other drugs that make up DR-TB regimens, including linezolid, delamanid and pretomanid. For example, in 2014 MSF publicly challenged pharmaceutical corporation Pfizer’s prices of linezolid in South Africa (at the time Pfizer charged around $65 per daily pill; which, if taken for two years amounted to around $49,000 for the one drug alone).9 Delamanid, developed by pharmaceutical corporation Otsuka, is fraught with access issues: the drug is patented in many countries until 2023, including in India, and the price of a six-month treatment course remains very high ($1,70010 for countries procuring through the GDF), with many people needing the drug for up to 20 months, taking the price much higher. Delamanid’s high price contributes significantly to the costs of treating XDR-TB in MSF’s operations in Mumbai, India, and in other contexts. MSF pressured Otsuka to initiate a technology transfer to their partner Mylan in India for the production of delamanid. This should lead to cheaper delamanid on the market by mid-2020 for countries supplied by Mylan.i Pretomanid, the third new TB drug developed in over half a century, was approved by the US FDA in August 2019 as part of a regimen (BPaL: bedaquiline + pretomanid + high-dose linezolid) for the treatment of XDR-TB or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or nonresponsive. MSF has stressed that the drug was developed by the not-for-profit organisation TB Alliance utilising primarily taxpayer and philanthropic resources, and therefore must be made affordable to everyone who needs it.11
Reducing the price of re-purposed and new classes of these drugs is one part of MSF’s commitment to simplifying DR-TB treatment regimens. MSF, in partnership with research institutes and ministries of health in affected countries, is also engaged in two major clinical trials that aim to identify improved, shorter treatment regimens for DR-TB: TB PRACTECAL and endTB. Among the drugs being trialled are bedaquiline, linezolid, pretomanid, and delamanid. Outcomes for these trials are expected in 2022.
7. How is MSF treating DR-TB and how is MSF accessing bedaquiline?
MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps, and rural areas. MSF cares for people with DR-TB in over 25 countries. In 2018, MSF provided TB treatment to 19,400 people, including 2,840 people with DR-TB. As of September 2018, across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs, including 1,530 with bedaquiline, 633 with delamanid, and 227 with a combination of both medicines.
MSF is currently procuring bedaquiline through GDF at $400 per person for six months of treatment for all its DR-TB projects and clinical trials.
i Countries include Afghanistan, Bangladesh, Brazil, Cambodia, Democratic Republic of Congo, Ethiopia, India, Kenya, Mozambique, Nigeria, Pakistan, South Africa, Tanzania, Uganda, and Zimbabwe, and all countries where Otsuka has no commercial presence.
References:
1 WHO. WHO consolidated guidelines on drug-resistant tuberculosis treatment. [Online]. 2019 [Cited 2019 Jul 31]. Available from: https://www.who.int/tb/publications/2019/consolidated-guidelines-drug-resistant-TB-treatment/en/
2 Johnson & Johnson. Statement on Johnson & Johnson’s Commitment to TB in India. [Online]. 2019 Feb 13 [Cited 2019 Apr 11]. Available from: https://www.jnj.com/our-company/statement-on-johnson-johnsons-commitment-to-tb-in-india
3 Stop TB Partnership. Information on Bedaquiline. [Online]. [Cited 2020 Feb 17]. Available from: http://www.stoptb.org/gdf/drugsupply/bedaquiline.asp
4 Stop TB Partnership. South Africa ensures reduction of prices for Bedaquiline to benefit the world. [Online]. 2018 Jul 23 [Cited 2020 Feb 17]. Available from: http://www.stoptb.org/news/stories/2018/ns18_053.asp
5 Meiling B. The bar lowers yet again for PRV prices, with Kyowa/Ultragenyx selling at $80.6M. [Online.] 2018 Aug 1 [Cited 2019 Sept 2]. Available from: https://endpts.com/the-bar-lowers-yet-again-for-prv-prices-with-kyowa-ultragenyx-selling-at-80-6m/
6 Hensley S. Price Rises For Ticket To A Quicker Drug Review By FDA. [Online] NPR.org: 2015 [cited 2019 Sept 2]. Available from: http://www.npr.org/sections/healthshots/2015/08/19/432887081/price-risesfor-ticket-to-a-quicker-drug-review-by-fda
7 Gotham D, Fortunak J, Pozniak A, Khoo S, Cooke G, Nytko III FE, Hill A. Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017;72(4):1243-1252. [Cited 2019 Jul 24]. Available from: https://doi.org/10.1093/jac/dkw522
8 Médecins Sans Frontières. TB activists for first time challenge TB drug patent in India. [Online]. 2019 Feb 7 [Cited 2019 Apr 11]. Available from: https://msfaccess.org/tb-activists-first-time-challenge-tb-drug-patent-india
9 Médecins Sans Frontières. Linezolid Fact Sheet. [Online]. 2014 June 30 [Cited 2019 Apr 11]. Available from: https://msfaccess.org/linezolid-fact-sheet
10 TB CAB. Advocates call on Otsuka to reduce the price of delamanid. [Online]. 2018 Oct 17 [Cited 2019 Apr 8]. Available from: http://tbonline.info/posts/2018/10/17/advocates-call-otsuka-reduce-price-delamanid/
11 Médecins Sans Frontières. Pretomanid – third new TB drug in over half a century must be affordable. [Online]. 2019 Aug 14 [Cited 2019 Sept 2]. Available from: https://msfaccess.org/pretomanid-third-new-tb-drug-over-half-century-must-be-affordable
