Companies are using access strategies to expand access to their products in LMICs, yet efforts fall short for the poorest patients

• Of the 50 products analysed in this report, 41 are covered by an access strategy in at least one of the low- and middle-income countries (LMICs) in scope.

• However, among the 41 examples of access strategies, this analysis identified only four that include elements to improve affordability and availability, and only one that includes elements of considering payers’ ability to pay in both the public and private sector.

• Companies can strengthen their access strategies by considering alternative strategies to complement their current approaches, such as intra-country pricing or engaging with local organisations to ensure access for vulnerable patient population groups.

Generic and biosimilar medicine manufacturers expand access to medicine globally. As an integral part of the sector’s business model, they provide large quantities of medicines, and sell them at lower prices and smaller profit margins than originator companies. These companies primarily focus on producing and distributing generic or biosimilar versions of off-patent drugs – a category that includes most of the essential medicines. Some of these companies are also involved in manufacturing in-licensed products (i.e. on-patent medicines) via licensing agreements with originator companies, meaning that newer medicines can reach more people, in more countries, at more affordable prices.

However, while the low cost/high volume approach can inherently help expand access globally major challenges exist with both affordability and availability of essential medicines in LMICs. For example, even if a generic medicine (whether off-patent or in-licensed) is priced lower than the originator, it still may be unaffordable to large numbers of the patients who need it, especially those who rely on the private market and pay out-of-pocket. Another barrier to access is availability; for example, a company may target the most lucrative markets and not make its product available in many LMICs, in which case health systems and patients in those countries cannot take advantage of more affordable generic options.

What is an access strategy? The range of mechanisms that a company can implement to provide access to its products for a specific group of patients within a country. Access strategies with the biggest potential impact in terms of equitable access are those that aim to promote affordable access to medicine for all segments of the population by considering the payer’s ability to pay, and those that take the needs and characteristics of healthcare systems into account.

How were companies’ access strategies assessed? To understand how companies tailor their access strategies to reach people in LMICs, a sample of ten products from each of the five companies’ portfolios were selected for specific analysis. For each of the ten products, one example of a country-specific access strategy for that product was analysed.

Lack of comprehensive access strategies targeting vulnerable patients

Generic and biosimilar medicine manufacturers can take deliberate steps to improve access to their products in LMICs – engaging in “access strategies” that promote affordability and availability. All five companies in scope of this analysis – Cipla, Hikma, Sun Pharma, Teva and Viatris – are implementing strategies to expand the reach of their products in LMICs, with examples of access strategies identified for 41 of the 50 products analysed in this assessment.

Yet, there is limited evidence that companies are considering affordability for different payers when setting prices for their products. Payers can include public and private entities, organisations and patients paying out-of-pocket. Among the 41 access strategies, only 14 targeted both the public and private sectors and included comprehensive approaches for wider patient reach. Among the remaining 27 strategies, two were donation programmes and 25 exclusively targeted either the public or private sector, but lacked specific elements for improving access for vulnerable populations, including low-income patients and paediatric populations.

Out of the 25 strategies, nine target the public sector, with the government offering partial or total reimbursement for the products. By engaging in public sector contracts, such as tenders, companies can widen medicine access to a large number of patients. However, public payers may not always have enough funds to procure sufficient units of the medicine, leading to out-of-pocket payments. In such cases, companies must ensure that their access strategies consider private sector patients and their ability to pay.

_{A sample of maximum of ten products, deemed essentials for public health, were analysed for each company. For each of the ten products, companies were requested to provide one example of a country-specific access strategy covering that product, including a minimum of three low-income countries and three lower-middle income countries. Further examples could come from upper-middle income countries.}

Tenders are the main strategies used to promote access in the public sector

Among the 41 examples of access strategies submitted by companies, the access strategy most commonly used to promote access in the public sector is to engage in tenders, whether that involves a single procurer (e.g. a public health service) or multiple procurers (i.e. via pooled procurement).

These mechanisms allow governments and other tender issuers (e.g., public hospitals) to secure cost savings by inviting competitive bidding from manufacturers. They can also be a way for companies to improve access to their products in LMICs. Yet, their ability to enhance affordability might be restricted if negotiation is limited or market competition is lacking. Moreover, at times, manufacturing and distributing expenses for companies might exceed public sector payments, posing challenges to the viability of the business case.

Four companies reported using public sector tenders in countries in scope to expand access to the products selected for analysis. Additionally, two companies engage in supranational procurement to mitigate commercial risks and expand access to products. The access strategy examples shared by Viatris for four of its assessed products included participation in supranational procurement to expand access to the product – with examples submitted for Malawi, Namibia, Uganda and Zambia. Additionally, Cipla reports supplying abacavir/ lamivudine, an antiretroviral procured through the Global Fund to Fight AIDS, Tuberculosis and Malaria in at least one LMIC (Benin).

_{Companies utilise a variety of strategies to provide access, including tenders, pricing strategies, donations and patient assistance programmes. Of the 41 products, 14 have comprehensive access strategies, which include more than one component from the graph.}

Competitor-based pricing and local price controls shape private sector pricing

Collectively, the companies submitted 24 examples that included strategies focused on pricing in the private sector – specifically competitor-based pricing and/or local pricing control mechanisms.

For 17 of these 24 products, the country-specific examples of access strategies indicated that the product was only available through the private sector. For instance, in the examples provided for four antihypertensive medicines (telmisartan in Zambia, valsartan in Sudan, metoprolol in Nepal, and lisinopril in Nigeria), the companies supplied these products solely in the private sector. In these countries, only a small percentage of the population (around 3%) is covered by private insurance, meaning most pay out-of-pocket, while public sector coverage remains inadequate due to governments’ challenges in procuring essential products^.

Ultimately, a company’s use of competitor-based pricing and pricing mechanisms in ensuring equitable access might not significantly enhance affordability unless the company factors in the payers’ capacity to pay. The analysis reveals companies aiming to tackle affordability challenges for lower-income groups through the private sector, for example Viatris is implementing a patient assistance programme in India, offering financial support to low-income patients who pay out-of-pocket for the cancer drug bevacizumab. However, overall examples are limited.

What needs to happen next?

While companies are often incentivised to gain a competitive advantage to secure tenders in the public market or to supply in the private market, relying solely on competitor-based models falls short in terms of securing equitable access. Companies can continue to expand their access strategies to include more products in their portfolios and consider payers’ ability to pay in their pricing approaches. Engaging with the public sector is vital, encompassing strategies such as intra-country differential pricing for broader patient coverage, and participating in specific public sector programmes, such as those tackling NCDs. Equally essential is reaching vulnerable populations, especially the 43% of people in the poorest countries facing catastrophic healthcare expenses due to out-of-pocket costs. Lastly, companies can engage directly with the private sector, such as wholesalers, as well as social marketing organisations, private insurers, and NGOs to ensure medicines are accessible and affordable for those that need them.