Scaling Up Access to Implants: A Summative Evaluation of the Implants Access Program

1. Increased Access to Implants

The IAP leveraged global family planning attention and efforts and recognized an opportunity for LARCs and implants specifically. This broader framing and positioning represented a critical evolution of the partnership in response to concerns from the family planning community that the efforts were focused on promoting a single method category.

The timing of the IAP’s launch aligned well with global efforts initiated in 2012, including the London Family Planning Summit, the formation of FP2020, and the United Nations Commission on Life-Saving Commodities for Women and Children report. These efforts aimed to dramatically increase global contraceptive access and options with accompanying new commitments from donors and governments. The IAP leveraged this global momentum and aligned with both the broader family planning ecosystem and emerging global family planning architecture in a way that catalyzed action, as stakeholders could connect the purpose of the program to the global family planning dialogue.

Interviewees noted that the many efforts and events in the family planning field at this time made it difficult to map clear causal linkages to attribute success. However, alignment with the broader family planning ecosystem was seen as critical to success for the IAP. Throughout the IAP’s lifespan, partners were able to draw on the momentum of the global family planning field, building on key events that expanded country and donor commitments to family planning (Table 2).

The IAP also filled a key need identified by global partners to make LARCs, and specifically implants, more available as part of a broader array of contraceptive methods made routinely available to clients in family planning programs. A 2012 United Nations Commission on Life-Saving Commodities for Women and Children report identified implants as one of 3 underutilized family planning products and identified the high price as the key barrier to enable greater access to implants.⁴ One interviewee noted that the link between the IAP and the commission’s recommendations was critical to making a case to donors to support the effort. Implants had also been identified as an underutilized commodity needing attention by the Caucus on New and Underused Reproductive Health Technologies as early as 2011, further confirming the need for attention to this method category.¹²

As a result, IAP partners came together around an innovative solution to the price barrier through 2 VGs that would kickstart the implants market for FP2020 countries.⁶ At the country level, the global momentum and accompanying donor and country commitments to family planning goals were key factors that contributed to the success of the IAP. By the end of 2013, 28 countries had made commitments in support of FP2020. By 2018, 11 countries had identified FP2020 commitments that specifically referenced access to implants as part of expanding contraceptive method choice.¹³ Country-level interviewees noted that political will toward family planning was critical to getting government stakeholders and other partners on board and aligned around a common plan to scale up access to contraceptive methods, including implants.

Ensuring that the IAP strategy aligned with the broader family planning agenda to increase access to a full contraceptive method mix with informed choice and quality service delivery was a key point of alignment in the early phase of forming the partnership. Although this was the approach from the outset at the country level, the global-level framing and positioning of this initiative within the broader family planning agenda was something that evolved during the initial years of the IAP and helped ensure the effort was not perceived as a push from donors for a single contraceptive method.

Although all stakeholders agreed that a price reduction was necessary to unlock demand for implants, there were differing perspectives on whether the agreed price was the right price for a long-term sustainable market. As a manufacturer representative explained, the significant reduction in price and resulting low margin made it difficult to garner their company’s support for investment in manufacturing capacity and limited what they could provide in terms of support to countries for policy change, provider training, and consumer education. The manufacturer noted that this could have an impact on the long-term sustainability of producing the product.

2. Addressed Price Barriers

The agreement to reduce prices, which was crucial to the success of the IAP, was made possible through the development of strong personal relationships as well as underlying business fundamentals. The IAP partnership sought to achieve a stable market for implants with sustained affordable prices through 2 VGs, building upon previous price reduction efforts initiated by the RHSC in 2010.¹⁴ The agreements made Bayer’s Jadelle and Merck’s Implanon (and later Implanon NXT) available to women in the world’s poorest countries at price reductions of approximately 50% through 2018. The aim of the VGs was to increase confidence in long-term demand, allowing manufacturers to make up-front investments that would lower costs and enable reduced prices for years to come.

The IAP also supported ongoing efforts to introduce a prequalified generic product, Dahua’s Levoplant, in collaboration with DKT, to the market to increase competition and maintain the reduced price following the end of the price agreement. Prequalification of the generic product was achieved in 2017 after nearly a decade of effort. IAP partners funded technical assistance to the generic manufacturer and supported market entry through coordinated efforts with countries to consider procurement of the product. All 3 case example countries are planning to introduce Levoplant as an alternative implant. However, several interview participants identified additional provider training requirements as a barrier.

The reduced price achieved through the VGs was critical to scale up access to implants, allowing existing procurement resources to stretch further and dramatically increasing the number of implants procured for FP2020 countries between 2010 and 2018 (Figure 1). Manufacturers have committed to maintaining the new price through 2023, after the VGs formally ended in 2018. Whether the market has reached an equilibrium point with sustainable pricing and supply is yet to be determined and will require continued monitoring over the coming years as the market stabilizes.

The IAP’s engagement with manufacturers was built from established relationships between procurers, donors, and manufacturers who had been working together for many years on a range of family planning products. The VG was presented to manufacturers as a business case with a clear value proposition in terms of increased visibility and stability of long-term demand that would allow suppliers to produce higher volumes at a lower price, while still covering their cost of goods. The agreement was described by a manufacturer representative as a “win-win for all partners engaged with the IAP.” The win for manufacturers was the assurance of sufficient demand (either from procurers or guarantors) to ramp up production and expand capacity while maintaining or improving utilization rates. Further, it was also viewed as a win for manufacturers in terms of their contribution as part of corporate social responsibility and a source of pride for employees working on the product. The win for procurers came from the lower price as well as coordination of orders that emerged from the partnership, allowing them to optimize allocation of available supply and maximize impact. The IAP was also described by manufacturers as a win for women who would now have access to a modern contraceptive method that previously had limited availability and access.

One aspect of the reduced price agreement was to remove most supports for provider training that manufacturers had previously provided, such as training of master trainers or provision of commodities for training (e.g., model arms or placebo implants), thus transferring this financial responsibility to donors and governments. Manufacturers developed and shared global training materials which could be adapted to specific country contexts but, in general, did not provide additional supports. The exception was a limited amount of support that was made available during the transition from Merck’s Implanon Classic to Implanon NXT. Global stakeholders identified the shift in policy regarding training resources as a challenge. There was limited visibility among all partners into the resources that would be required to scale up training for providers as implants procurement increased and how those costs would be covered. The transition to Implanon NXT compounded this problem with additional training requirements. Providers who had already been trained in Implanon Classic required additional training for the updated insertion technology. This training had to be completed during a relatively condensed period as the Implanon Classic was being phased out and replaced by NXT. The intensive resource requirements for this retraining effort fell largely on donors and governments.

3. Enhanced Supply Chain Visibility and Coordination

The IAP built capacity at both the global and country level to address supply chain limitations and limit stock-outs. Although significant challenges remain requiring investment in systems and capacity, the tools developed have been broadened to additional products over time.

To reduce inconsistency of supply availability at the global and country level, the IAP sought to improve both the quality and visibility of the demand pipeline through a mechanism to support procurer and manufacturer coordination and improve associated data. The RHSC’s CSP group addressed this need, mitigating the risk of market disruptions related to the price reduction, such as the potential for overordering and stockpiling of the commodity or identifying where additional funding was needed for procurement to support rapidly growing demand. Through the IAP agreements, manufacturers shared all procurement data with JSI on a monthly basis to monitor progress to goals and identify imbalances between supply and demand. The CSP group contributed to IAP’s effectiveness and brought together key stakeholders who could review shared data on country orders and stocks on hand, identify supply issues that arose, and quickly coordinate action in response. As a manufacturer representative explained:

CSP group changed interactions. Organizations are now talking to each other, [about] who is delivering what to each country, and now they’re able to go into the field to get a clearer picture, and get more insight into the [demand] forecast.

According to unpublished CSP data from JSI, the CSP coordination in 2018 resulted in recommended actions that avoided national stock-outs and/or shortages of implants in 24 countries, totaling an additional 7.5 million couple years of protection and averting approximately 1.8 million unintended pregnancies.¹⁵ The effectiveness of CSP was demonstrated early on and the scope quickly expanded to support multiple family planning products.

At the country level, partners developed family planning dashboards to integrate data across service delivery, consumption, and training databases to improve supply availability by targeting available and appropriate commodities at facilities with trained providers, building off of longstanding supply strengthening efforts in the family planning field. The dashboards used in Nigeria and Kenya were created initially in support of implants scale-up efforts, specifically around the transition to NXT. As capacity to use these analytical tools increased, the dashboards were expanded to cover all family planning methods in both countries. The dashboards offered data visibility to stakeholders that previously did not have access to all the data in an integrated manner. Although the dashboards improved implant supply availability and had important benefits for other family planning products as well, they did not solve the supply chain challenges.

Similarly, as part of overall capacity building efforts, implementing partners also developed job aids and training for commodity managers to improve supply planning, and trained health care providers on the importance of data and reporting to improve supply availability. Implementing partners often filled gaps in supply chain systems by facilitating communications between warehouses and supporting alternate distribution channels to get products to service delivery points, but these measures were described by interviewees as stopgap measures as opposed to sustainable systems improvements. Although IAP partners did provide technical assistance to individual countries and in regional workshops, capacity for national supply planning remains a barrier to achieving the forecast accuracy needed to ensure supply availability and maintain optimal national supply levels.

Overall, the most frequently cited challenge across country-level interviewees was supply shortages at both the national level and service delivery points. Despite some improvements in capacity for national supply planning, as well as in-country supply chain management, interviewees in the 3 case example countries noted a remaining need for overall system strengthening efforts to improve family planning supply chains and reduce shortages at service delivery points, as well as addressing global shortages that have resulted in stock-outs at central warehouses.

4. Leveraged Existing Service Delivery Capacity

The IAP leveraged existing service delivery capacity investments in training, expanded delivery models, and conducted community awareness and sensitization activities from participating organizations. These investments, while valuable and important to the success of the IAP, were not wholly sufficient and gaps remain.

MOH stakeholders in each country coordinated with donors and implementing partners to align around national goals and implementation plans to scale up LARCs, including implants. These plans in most countries reflected broader family planning commitments and formed part of national costed implementation plans to achieve family planning goals. Thus, the IAP was able to align strategically to leverage existing in-country capacity and expertise to expand access to family planning.

Leveraged Best Practices in Training. Improved approaches were needed to achieve training goals with limited available resources, especially during the introduction of NXT and phaseout of Implanon classic. IAP partners tested various training models, identifying appropriate cost-effective solutions that combined on-the-job training with follow-up supportive supervision, mentoring, and coaching. These approaches were feasible as the updated product required minimal differences in insertion techniques and no substantial changes to patient counseling procedures.¹⁶ Interviewees estimated that these approaches reduced training costs by up to 60% when compared to traditional in-service training models. The approaches also improved providers’ competency to perform implant insertions and removals by allowing more opportunities to practice and maintain skills and establishing mechanisms for continued supportive supervision. The on-the-job training approach also minimized disruption of health service provision that often results from off-site training. IAP partners shared these best practices in training innovations through the Operations Group, enabling widespread dissemination across country partners in a timely manner.

Country stakeholders identified several key challenges related to provider training, including maintaining high-quality counseling and minimizing bias toward provision of specific methods, including implants. To overcome these challenges, ongoing embedded mentoring and coaching models were designed to reinforce training messages and improve quality counseling; however, these models do require ongoing resources to maintain their efficacy. Interviewees also identified a persistent system-wide challenge of retaining trained providers in contexts of high turnover of health personnel.

Expanded Service Delivery Models. Although some countries utilized outreach services and liberalized task sharing policies to expand access, other countries relied on their existing delivery capacity.

Outreach events and mobile clinics, serving high volumes of clients seeking family planning services, provided training opportunities for providers while also offering family planning access to women in remote areas where distance to clinics can pose a significant barrier.

The 2012 WHO task sharing recommendations¹⁷ identified opportunities for expanding the cadre of health workers that could provide implants and other family planning methods. These recommendations built from prior successful experiences in countries that had implemented task sharing policies as a means of increasing access to family planning. All 3 focus countries considered opportunities for task sharing of implants delivery, but barriers in Uganda and Kenya, particularly resistance from higher-level health care workers, have prevented policy change. Kenya allows insertion by nurses and midwives but has faced resistance when considering policy change to allow insertions by community health workers. Uganda has supported task sharing to allow nurses and midwives to perform insertions in policy documents, but they do not yet have legal protection to do so.¹⁸ In 2014, Nigeria successfully approved a task shifting policy allowing community health extension workers (CHEWs) to insert and remove implants. The current status of national scale-up efforts to train CHEWs in implants insertions and removals in Nigeria could not be confirmed for this evaluation. As one implementing partner in Nigeria explained:

Changing the task shifting policy was a challenge, our nurses and midwives feel this was a duty for [they themselves]to provide so they were against it [task shifting to CHEWs] initially. However, we navigated through this by having an acceptable training manual for the entire health care system, which gave some level of comfort of any system we put in place. We also did a cost-benefit analysis and a big review of human resources for health and found that majority of health care workers were often CHEWs, so it prompted a conversation, that combined with data, was very successful.

Implant availability in private sector for-profit facilities has not experienced the same growth seen in the public sector.¹⁹ Interviewees in the 3 case example countries noted this as a challenge to increasing access to implants. The price agreement applies to procurers purchasing for public sector delivery and delivery through SMOs who could charge a maximum fee for the product. Private for-profit providers cannot purchase implant commodities at the reduced price agreed to through the VGs. The higher price for these providers combined with competition with typically free or reduced-cost provision of implants in the public sector could undermine any financial incentive for these providers to offer implants. Without sustainable mechanisms for private for-profit providers to purchase at affordable prices, implants likely will not reach women through these channels. In Nigeria, nearly 60% of women access family planning through private medical sources,²⁰ making access to the lower priced product for these providers an important factor to continue progress in increasing access to implants.

Conducted Community Awareness and Sensitization Activities. Demand generation was not an explicit objective of the IAP as there was an underlying assumption from the outset of latent demand for the method based on early experiences with introduction of free or highly subsidized implants.³ However, although country-level partners found that uptake was high as soon as providers were trained in some areas, they found low utilization and uptake in other areas. In general, partners found that the information and awareness gaps were around the benefits of family planning more broadly rather than implants specifically. Implementing partners were able to address these gaps through general information and communication efforts about family planning with an emphasis on the benefits of LARCs. These activities across the 3 case example countries used community health workers for knowledge and information sharing, as well as traditional and social media and mobile phone-based platforms. For example, successful activities were tailored to target audiences inclusive of male community members; religious, government and political leaders; health facility workers beyond service providers; and women in the community.

5. Encouraged effective global and country-level collaboration and coordination

Coordination at the global and country level was an effective element of the IAP from the beginning. However, challenges arose in aligning around goals and commitments particularly as different partners were engaged at different levels and different phases over time. The IAP coordinated global stakeholders through a formal governance structure that facilitated information sharing and communication and drove joint problem solving. This agile, responsive governance structure was a critical factor in achieving implants scale-up goals. As a manufacturer representative explained:

An aspect that made this unique and successful was the fact that the VG and the Oversight Board brought all the required experts around the table with 1 objective: scaling up access to this 1 method. People could act quickly and work together. Without that element, even with the VG, we would not have been as successful.

An example of how the governance structure supported problem solving was with the formation of the Implants Removals Task Force. Access to implants removal services was not a focus of initial IAP efforts, but over time, programmatic concerns about barriers to accessing removal services was escalated through the Operations Group. In response to this growing need, the IAP developed an Implants Removals Task Force in 2014 to coordinate efforts and provide programmatic guidance. This group identified standards that needed to be in place to assure quality removal services.²¹

As another example, working together with the 2 manufacturers and key procurers, the IAP Operations Group supported the development of standardized packaging, as opposed to customized packaging by procurer, for both implant products. This simplified packaging was a critical component for suppliers to meet the reduced price commitment, and at the same time, improved supply chain performance by allowing manufacturers to build up inventory without the need for customized packaging by procurer. Further, in 2015, several IAP partners, including UNFPA and CHAI, collaborated to develop a standardized consumables kit that combined the necessary supplies required for both implant insertion and removal.

According to interviewees, the collaboration and coordination among partners at the global level also contributed to coordination among partners at the country level. Coordination efforts led by government stakeholders that brought together the MOH, donors, implementing partners, SMOs, and the private sector around national scale-up plans were identified as a key success factor across case example countries. This coordination was important at both the national and subnational levels and served to strengthen efforts and minimize duplication across family planning programs.

However, the partnership also faced key challenges in terms of accountability and commitments toward common goals, particularly during the early phase of the partnership. The VG agreement negotiation relied on a small group of stakeholders to align on key parameters to ensure confidentiality and minimize potential conflict of interest. The broader set of partners were engaged at different levels and at different phases of the negotiation process to secure commitments and achieve alignment. The VG agreements inherently created the potential for tensions between those accountable for the guarantee and those providing the majority of the procurement resources. This tension, which was noted by several interviewees, was addressed to some extent through the governance mechanisms but remained a challenge throughout the life of the partnership.

6. Continued Efforts and Expanded Resources

The outlook for sustainability of the gains realized by the IAP is strong given commitments made by partners and the plans to continue and expand resources. However, price remains a concern among many key stakeholders. An internal sustainability assessment of the IAP completed in 2017 found that support for supply planning, operations, and market dynamics at the global level should continue to sustain progress, but that these functions would need to be integrated into existing institutions given the formal end of the IAP in 2018. To support such a transition, these functions will need to be expanded to include family planning methods generally, not just implants.

Several mechanisms from the IAP have already evolved into institutionalized systems. CSP, as a workstream of the RHSC, continues, and efforts are underway to transition the data visibility tools and processes to support supply coordination to the Global Family Planning Visibility and Analytics Network. This platform will capture and use supply chain data from multiple sources and organizations to provide enhanced visibility for decision making across multiple family planning products. Discussions are also ongoing with the United States Agency for International Development (USAID) regarding the feasibility of folding the IAP’s Operations Group into USAID’s Method Choice community of practice (formerly LARC community of practice). The Implants Removal Task Force is also in the process of evolving its mandate to include IUDs.

At a country level, multiple factors point to the likelihood of maintaining efforts initiated under the IAP to increase access to implants. Countries have developed and adapted national implants training methods and curricula for health workers, and in the case of Uganda, included implants training into a standard curriculum for health worker education programs.²² In addition, the family planning dashboards that support linking of trained providers with family planning commodities are in use at a national level in several FP2020 countries, significantly improving forecasting efforts. Finally, coordination between in-country implementing partners and with the MOH has improved, which is essential to manage resources and organize programmatic efforts.

The sustained low unit price of the implants products was consistently cited by interviewees as the most critical factor to maintaining achievements at the country level. Although the VG ended in 2018, manufacturers have committed to maintaining the current price through 2023. While this can be considered a key success of the IAP, the price reduction needs to be sustained beyond this period to ensure long-term implants access, and manufacturers will ultimately need an effective business case to do so. An equally critical factor to ensuring sustainability is maintaining government commitment and political will to continue efforts to improve access to implants, and the family planning method mix more broadly. Key remaining challenges that were identified to maintain and expand progress at the country level are to ensure capacity and access to affordable commodities for the private sector and to ensure training and human resource considerations to meet the growing demand for implants removals.