Improving availability of patient-friendly tuberculosis preventive therapy

MedAccess’ volume guarantee will help increase availability of an innovative treatment for latent tuberculosis.

Global partners working to tackle the tuberculosis (TB) epidemic have announced the latest in a package of measures to increase supply security and availability of a short-course TB preventive therapy (TPT).

In February, the Clinton Health Access Initiative (CHAI) and Unitaid, through its IMPAACT4TB project led by the Aurum Institute, announced a package of interventions to support manufacturer Macleods Pharmaceutical Limited for the commercialisation of its fixed dose combination (FDC) TPT product known as 3HP.

Now MedAccess, in partnership with CHAI and Unitaid, has executed a volume guarantee agreement with Macleods to support increased access to the 3HP FDC and extend pricing transparency in low-resource settings. This agreement, combined with IMPAACT4TB’s existing commercialisation and implementation support and the leadership of organisations such as PEPFAR, USAID, the Global Fund (GFATM), Stop TB Partnership’s Global Drug Facility (GDF) and iPlus solutions, provides Macleods with the visibility required to:

• Continue to optimise production activities and scale up capacity to produce approximately 1.5 million 3HP patient courses in 2021 and make best efforts to ensure production meets increasing demand in 2022 and beyond;
• Extend its commitment to make 3HP available at $15 per patient course and create a pathway to increase availability and expand access over time.

Reducing the pill burden

3HP is one of several regimens recommended for treatment of latent TB infection. The term 3HP comes from the dosing schedule, once weekly doses taken over three months, and the abbreviations of each of the two drugs included in the FDC, isoniazid (INH) and rifapentine (RPT). In the past, TB preventive treatments have required patients to take multiple pills daily for six months or more. The 3HP FDC reduces the pill burden and treatment duration for patients, increasing the likelihood that they will take and complete the full treatment cycle.

Over the past 18 months, rifapentine suppliers have faced a number of challenges, including COVID-19 restrictions and evolving regulatory and quality standards. Macleods has dedicated resources to overcome these challenges and initiated a gradual scale up from July to December 2021 to meet growing demand. The volume guarantee gives Macleods additional assurance to continue expanding production capacity and work closely with procurers to ensure a stable, secure and affordable supply of 3HP to help meet demand now and in the future.

Increasing global access

The price per patient course agreed under the package will be available for 138 low- and middle-income countries, as well as the international organisations supporting procurement under a pre-agreed set of conditions. IMPAACT4TB will continue to support demand generation and catalytic procurement activities in 12 target countries.

TB is the leading infectious disease killer globally. In 2019, it claimed an estimated 1.4 million lives. Latent TB is often cited as the reservoir of the TB epidemic. Worldwide, an estimated 1.7 billion people are living with latent TB, usually without symptoms. Without treatment, 5-10% of people with latent TB will develop active TB in their lifetimes.

MedAccess is a social finance company, wholly owned by the UK’s CDC Group. Its work on this partnership was funded by UK aid through the Foreign, Commonwealth & Development Office.

Quotes from the partners

“Tuberculosis remains a leading cause of illness and death worldwide, particularly among people living with HIV and those with compromised immune systems,” said Hema Srinivasan, Chief Access Officer at MedAccess. “By increasing availability of shorter, more user-friendly regimens to prevent active TB infection, we hope to support communities around the world in ending the TB epidemic.”

“As a result of this innovative partnership, countless people in low- and middle-income countries will now have access to treatment that is more affordable and easier to take,” stated Dr. David Ripin, Chief Science Officer and Executive Vice President for Infectious Disease at CHAI. “Effectively treating tuberculosis before patients become ill significantly reduces the spread of this deadly disease, bringing us one step closer to elimination.”

“As a responsible pharma company, we strive to bring to market effective products that can have a social impact – we believe 3HP is one such product. This partnership to expand access to 3HP will generate a meaningful reduction in healthcare expenditure and TB burden in LMICs,” stated Vijay Agarwal, Business Development Director – Macleods Pharmaceutical Limited.

About 3HP

In 2018, WHO added 3HP as a recommended regimen for TPT. This new shorter regimen significantly reduces the duration and pill burden over the course of treatment and is more easily tolerated by patients. With the FDC, a complete course of treatment for eligible adults is included in one box, further addressing concerns about the 3HP pill burden and ensuring that TPT can be provided conveniently for individuals at risk for TB.

About  IMPAACT4TB

The Increasing Market and Public health outcomes through scaling up Affordable Access models of short Course preventive therapy for TB (IMPAACT4TB) project aims to protect people most vulnerable to developing active TB. IMPAACT4TB is funded by Unitaid and led by the Aurum Institute in consortium with the Clinton Health Access Initiative, KNCV Tuberculosis Foundation and John Hopkins University, in collaboration with the World Health Organization (WHO) and the Global Drug Facility (GDF). The four-year grant will prioritize short-course TB preventive treatment for people living with HIV and children under five, and subsequently all those in close contact with TB patients in 12 high-burden countries.  For more information see www.unitaid.org and www.impaact4tb.org.