Laying the Groundwork

The Global Market Successful drug delivery requires an in-depth knowledge of existing treatment supply networks at the global and national level.

New, faster, and simpler drugs — critical to the fight against TB — are likely to be introduced within the next five to ten years. However, as we work to advance the TB drug pipeline, it is vital that we simultaneously achieve an understanding of the market dynamics that will affect the delivery and adoption of a new regimen.

Recognizing that new cures will only be effective if they are available and affordable, the TB Alliance is overseeing a series of studies to analyze the way TB drugs are produced, distributed and delivered in key countries around the world.

In the Spring of 2007, the TB Alliance unveiled Pathway to Patients: Charting the Dynamics of the Global TB Drug Market, the first comprehensive analysis of how today's TB drugs reach patients on a global scale. The study analyzes the pricing, purchasing, procurement and distribution mechanisms for first- and second-line TB treatments in ten strategically selected countries — Brazil, China, France, India, Indonesia, Japan, the Philippines, South Africa, the UK, and the US — as well as an appraisal of the global first-line TB drug market.

THE GLOBAL FIRST-LINE TB DRUG MARKET RANGES FROM APPROXIMATELY US$310M-316M

The study points to the variability of the market dynamics among the countries studied, the array of complexities faced at all levels of the supply chain, and the highly fragmented nature of the global market. Research shows that providing the proper pathway for a new generation of faster and easier-to-use TB drugs to reach the patient will require a targeted and informed country-level and global strategy.

Findings from this and future studies will inform initial planning for the adoption and implementation of new TB drug regimens. Once a new regimen is ready for introduction, this research will allow stakeholders to speed the distribution of faster, more effective medicines — getting a better cure to those who need it.

Results from Pathway to Patients:

> Click here to download the Study Overview (.pdf - 880kb)
> Click here to download the Compendium of Findings
   (.pdf - 1,000kb)
> Click here to download the the peer reviewed, published findings   (.pdf - 380kb)


Comprehensive Results by Country:

> Brazil Case Study (.pdf - 516kb)
> China Case Study (.pdf - 828kb)
> France Case Study (.pdf - 576kb)
> India Case Study (.pdf - 1,300kb)
> Philippines Case Study (.pdf - 872kb)
> Russia Case Study (.pdf - 600kb)
> South Africa Case Study (.pdf - 1,500kb)
> UK Case Study (.pdf - 632kb)
> USA Case Study (.pdf - 844kb)

Global Procurement Overview:

> Global Procurement Overview (.pdf - 584kb)

Product Profile Analysis Defining the value proposition of new regimens

In extensive interviews, the TB Alliance has sought opinions regarding the current regimen from the perspective of payers, key influencers, and patients. These interviews have lead to a review of the attributes that key decision-makers would want in a new regimen with regard to safety, efficacy, drug delivery, side effect profiles, and cost in order to replace the current treatment scheme.

Published in August of 2009, "What Countries Want" identifies key issues around the methods used for testing new TB regimens, with a focus on the factors that would subsequently affect the adoption of these regimens.

General trends emerging from the study included:

• A vast majority of interviewees said drugs that shorten treatment duration would be of high value, with a reduction of two months from the current treatment regimen for drug-sensitive disease representing a significant improvement.
• Stakeholders said they would be willing to pay more for faster-acting TB drugs because drugs represent a relatively small portion of current TB program costs. In addition, a shorter therapy could help to increase adherence, thus increasing effectiveness and reducing the development of drug-resistant TB, which is considerably more expensive to treat.
• Recommendation of a new regimen by the World Health Organization was seen as necessary but not sufficient to drive adoption in most high-burden countries.
• Stakeholders in four of the five countries studied would require or prefer data from trials in their own countries, suggesting the need to conduct pivotal trials in multiple regions. Data on real-world effectiveness may also be necessary.
• The primary concerns about changing regimens vary widely among countries, suggesting that future efforts will be a mixture of meeting and tempering expectations.

To download the full report click here [.pdf - 560kb]

Regimen Change Experience with past TB regimen changes can guide future regimen changes. To explore the process, major players and success factors for recent public sector TB regimen changes, we conducted 166 interviews of country stakeholders in 21 of the TB high burden countries (HBCs).

Stakeholders described 40 distinct regimen changes for drug-sensitive TB. Once countries committed to consider a change, average timing was ˜1 year for decision-making and ˜2 years for roll-out. Stakeholders more often cited concerns that were program-based (e.g., logistics and cost) rather than patient-focused (e.g., side effects), and patient representatives were seldom part of decision making. Decision-making bodies in higher income HBCs had more formalized procedures and fewer international participants. Pilot studies focused on logistics were more common than effectiveness studies, and the evidence base was often felt to be insufficient.

Once implementation started, weaknesses in drug management were often exposed, with additional complications if local manufacturing was required. Best practices for regimen change included early engagement of budgeting staff, procurement staff, regulators and manufacturers. Thus, future decision makers will benefit from strengthened decision-making bodies, patient input, early and comprehensive planning, and regimens and evidence that address local, practical implementation issues.

> Click here to download the peer reviewed, published paper
(.pdf - 412kb)

Collaboration on Access The TB Alliance is one of a number of distinct Product Development Partnerships (PDPs). These organizations are developing health products for diseases where the medical need is great but the financial incentives for pharmaceutical companies are insufficient. The existence of these PDPs, with their various experiences in maximizing product access, provides a unique opportunity for information sharing.

With this in mind, in 2008 a group of access staff from PDPs formed the PDP Access Steering Committee and organized a meeting in Geneva:

• view the agenda (.pdf - 28kb)
• view the final meeting report (.pdf - 75kb)
• view the resulting publication (.pdf - 205kb)

Thanks to the support of the Rockefeller Foundation to the Concept Foundation, and of the Netherlands Directorate-General for International Cooperation (DGIS) to the Steering Committee, the group has remained active with the organization of a second meeting in July 2010:

• view the 2010 agenda (.pdf - 187kb)
• view the 2010 final meeting report (.pdf - 336kb)
• view links to the presentations

At this second meeting, we were also joined by representatives from endemic countries, donors, the WHO and implementing organizations, who all contributed useful perspectives.

The group has also generated discussion papers on seven topics:

• access strategies (.pdf - 868kb);
• country decision-making (.pdf - 260kb);
• regulatory issues (.pdf - 340kb);
• pricing (.pdf - 268kb);
• economics and financing (.pdf - 564kb);
• manufacturing and supply (.pdf - 668kb);
• pharmacovigilance (.pdf - 1,500kb).

Throughout the history of the Steering Committee, staff members at the TB Alliance have been enthusiastic participants and acted as co-chairs along with other PDP representatives.

Private Sector TB control is considered primarily a public health concern, and private TB treatment has attracted less attention. Thus, the size and characteristics of the private TB drug market remain largely unknown.

We have used IMS Health sales data to analyze private TB drug consumption in 10 high burden countries (HBCs), after first mapping how well IMS data channels overlapped with private markets in each country. Preliminary data indicate that there are very large private TB drug markets in four countries — Pakistan, the Philippines, Indonesia and India — with a wide variety of drug strengths and manufacturers.

Details will be made available soon.