When Developing New Contraceptives, Begin with the End in Mind
Contributing guest blogger, Kate H. Rademacher, is a Technical Advisor in FHI 360’s Contraceptive Technology Innovation department
Begin with the end in mind. A phrase that is frequently used, it can mean different things in different contexts. In the field of contraceptive research and development, we often use the phrase to highlight the importance of keeping the needs and perspectives of potential end users front-and-center as we design, test, and evaluate new products. This means incorporating acceptability research into all phases of product development—as we brainstorm ideal methods to fill gaps in the method mix, shape and refine Target Product Profiles for new methods under development, conduct pre-clinical and clinical research, and develop strategies for product introduction.
Another equally important dimension of beginning with the end in mind in our field is ensuring that the products we develop are ultimately affordable and accessible to all populations, including individuals in the lowest wealth quintiles. And, perhaps somewhat counter-intuitively, planning for affordability and accessibility must start at the very earliest stages of contraceptive development, long before we are sure that a product will actually reach the market.
Several steps need to be considered:
Specific, actionable, and binding terms must be included in contractual agreements with development partners. At FHI 360, whenever we work with outside collaborators, we ensure that all legal agreements include provisions that will require downstream licensees – including manufacturers and distributors – to offer affordable pricing in the public sector. We do this during the earliest stages of proof-of-concept testing. It is not enough to require that partners will make “good faith efforts.” Rather, specific, actionable provisions must be incorporated into agreements including clear definitions of terms, such as “preferential pricing” as well as potential remedies for non-performance by licensees.
The service delivery contexts in which methods will be provided must be taken into account when designing and developing new products. Products requiring refrigeration or otherwise place a burden on the supply chain will not be accessible for many of the poorest populations. New contraceptive methods should also be designed to reduce long-standing service delivery barriers that are particularly pronounced in low-resource settings. For example, at FHI 360, we are currently developing a biodegradable implant that would eliminate the need for removal services, and an injectable contraceptive that lasts for six months which would reduce the frequency of required re-injections. For each development program, the Target Product Profile— a planning tool which outlines criteria that the research team strives to achieve— must incorporate product characteristics that can impact service delivery. These include targets for cold chain, stability and storage conditions; the route of administration (e.g., self-administration); product presentation (e.g., pre-packaged, disposable); and infrastructure for service delivery (e.g., home and community provision).
At all stages of development, the development team must proactively work to keep the Cost of Goods Sold (COGS) as low as possible. We know from experience that international family planning markets are extremely price-sensitive. The recent price reduction of Sayana® Press demonstrates that even a difference of fifty cents (U.S.) or less can make a big difference for procurement agencies as they decide which products to buy with limited budgets. Low-cost manufacturing options must be identified throughout all phases of research, including early formulation development and manufacture of clinical trial supplies. All cost drivers must be considered– from the active pharmaceutical ingredient to the drug delivery system, from the design of the packaging to the consumables required for service delivery. We cannot expect low pricing if the COGS are too high. This can be a real challenge if new products in development use advanced and innovative technologies which are often costly. Because variable and semi-variable costs are largely driven by volume, it can also be hard to predict the COGS when potential demand for a new method is unknown.
If we do not take these proactive steps during early product development phases, there is a very real risk that final contraceptive products may not be affordable nor accessible to the populations we’re trying to reach. We have seen this dynamic play out in the field of family planning multiple times. For example, contraceptive implants remained unaffordable for large-scale procurement in developing countries for many decades. Access to and use of this method were limited until the global introduction of the more affordable Levoplant/Sino-implant (II) and implementation of the Implants Access Program which led to substantial price reductions of Jadelle® and Implanon/Nexplanon®. Another long-acting method – the levonorgestrel intrauterine system (LNG-IUS)– currently remains out-of-reach for many women in FP2020 countries largely because of the high price of existing products. The global landscape may be changing as new, more affordable LNG-IUS products become available, but it is a lengthy process. We must learn from the past and ask ourselves: what could we have done differently at the outset of these contraceptive development programs to ensure more affordable access? How can we apply lessons learned as we develop new methods? What meaningful steps can we take to begin with the end in mind?