How companies are improving access to medicines and vaccines

Improving availability and reach means assessing every medicine and market differently to take account of all the variable factors, from production to delivery.

Patents, pack size, cost, storage and expertise delivery all variable factors in medicine and vaccine access
Companies support access differently for each product and each LMIC

When it comes to access to medicine, there is no ‘one-size-fits-all-products’ approach. For each product, pharma companies, often working with partners from the global health community, must build tailored approaches and take account of a wide variety of factors.

These range from commercial concerns such as patent status, and cover product characteristics – such as pack size, whether a vaccine needs a cold-chain, or whether it needs to be administered by trained health professionals.

Importantly, the companies must address the needs and circumstances of specific populations, including their ability to pay. When the products in question are antimicrobials, the question of responsible use must also be front and centre of all decisions, to minimise the risk of drug resistance and ensure sustained effectiveness.

In this section, the Benchmark looks at examples of specific medicines and vaccines, some on-patent and some off-patent, to explore how pharmaceutical companies are expanding access to specific products.

CASE STUDY 1: IMPROVING ACCESS TO ON-PATENT VACCINES

Products:

18 vaccines from four large research-based companies. These include vaccines against pneumococcal disease, meningococcal disease, diphtheria, tetanus, and pertussis.

Why do vaccines need a different approach for improving access, compared to medicines?
Vaccines are a cornerstone of the modern health care system. Vaccination is an important component of primary health care and an indisputable human right. Vaccines are also an important tool against antimicrobial resistance.

Yet despite tremendous progress, far too many people in the world - including nearly 20 million young children each year - still lack adequate access to vaccines. Most unvaccinated children live in low- and middle-income countries (LMICs), where health systems are often under pressure.

17 million children missed out on life-saving diphtheria and tetanus vaccines in 2020, and pneumonia kills more children each year than any other disease. Safe and affordable vaccines are the best way to prevent these infections.

How do LMICs typically gain access to vaccines?
Vaccines are usually procured supranationally: they are purchased from multilateral organizations, such as Gavi, The Vaccine Alliance, The Pan American Health Organization (PAHO), and UNICEF.

Gavi supports vaccines against 17 infectious diseases, including pneumococcal conjugate vaccine (PCV), in 57 countries, and has helped vaccinate more than 822 million children in the world’s poorest countries, averting more than 14 million preventable deaths.
The Advance Market Commitment (AMC) for pneumococcal vaccines has enabled the procurement of a total of 161 million doses of PCV for lower-income countries.
Companies can also distribute their vaccines through National Immunisation Programmes (NIPs) initiated by local governments, such as in India or Thailand, often through a competitive bidding process with specific terms on prices, quantities, delivery, and contract duration.
In humanitarian emergencies, vaccines can be distributed through humanitarian organisations, such as Médecins Sans Frontières (MSF).
How are prices negotiated?
Pneumococcal vaccine prices are negotiated between companies and UNICEF under the Advance Market Commitment and are made available to Gavi countries at a maximum price of $2.90 per dose.
GSK and Pfizer have agreed to freeze prices for their pneumococcal vaccines (Synflorix and Prevnar 13) in Gavi-graduated countries for up to 10 years after graduation.
For most vaccines, companies also apply tiered pricing policies that allow them to adjust the prices of their vaccines to countries’ ability to pay, setting higher prices in middle and high-income countries and offering lower prices in low-income countries.
In LMICs not supported by pooled-procurement mechanisms such as Gavi, PAHO or UNICEF, companies still have a responsibility to ensure that ability to pay is taken into account.
How are companies involved?
Companies play an active role in expanding access to their vaccines. All vaccine manufacturers in scope apply a tiered pricing strategy for their vaccines, which allows for pricing flexibility.
However, except for prices for pneumococcal vaccines distributed through Gavi (Synflorix and Prevnar 13), companies do not yet transparently disclose the prices of their vaccines in LMICs.
How does this approach help ensure supply can match demand?
The development and production of vaccines is usually complex. Gavi works closely with its industry partners, including GSK and Pfizer, to provide vaccines with forecasts of up to five years for large volumes.
For their part, companies can improve production scale by offering new packaging features with multi-dose vials. Improving the production line can also reduce manufacturing costs and lead to lower selling prices.

CASE STUDY 2: NOVARTIS’ APPROACH TO EXPANDING ACCESS TO OFF-PATENT MEDICINES
Products:
Amoxicillin and amoxicillin/ clavulanic acid, off-patent antibiotics produced by Novartis.
How: Novartis uses equitable and competitive pricing and participates in tenders.
Impact: Amoxicillin is used to treat a variety of common bacterial infections, such as pneumonia, dental abscesses, and urinary tract infections. Novartis reached more than 10 million people in LMICs to date.
Where: Novartis Healthy Family programmes are active in India, Kenya, Uganda and Vietnam. Novartis SubSaharan African Unit (SSA) reaches 45 of the countries in scope.
Details: Novartis, through Novartis Access, Novartis Healthy Family and Novartis SSA, offers its generic antibacterial products at tailored prices to governments, non-governmental organisations and other institutional customers in lower-income countries.
Novartis’ access pricing policy means prices start at USD 1 per treatment, per month. Its SSA unit takes a high-volume, low-price approach to increasing patient reach. In 2020, more than four million patients in eligible countries were ensured access to amoxicillin through Novartis Access and Novartis Healthy Family.
More than 1.7 million patients were ensured access to amoxicillin and amoxicillin/clavulanic acid through Novartis SSA Unit in the public sector.
Novartis has publicly set a goal to increase patient reach two-fold by 2022 and five-fold by 2025 through its SSA unit. In 2020, Novartis, through its Sandoz division, committed to selling some of its medicines, including antibiotics used to treat patients with COVID-19-related symptoms, at zeroprofit to governments in up to 79 eligible low-income and lower-middle-income countries.
Novartis participates in competitive bidding. Tender prices are set using Novartis’ cost of goods with an additional minimum acceptable margin, as well as historical data and local insights from its customers.
Making use of local insights may include considering the most recently awarded prices, the most recently awarded companies, and the maximum tender price set by the relevant National Health Insurance Scheme.

CASE STUDY 3: PFIZER’S DONATION PROGRAMMES FOR OFF-PATENT MEDICINES
Pfizer, Azithromycin (Zithromax) Donation Programme
Pfizer is part of the International Trachoma Initiative (ITI), established in 1998. In 2020, 31.1 million treatments were shipped to 12 countries through the ITI. As of April 2020, nine countries in scope have been validated by WHO as having eliminated trachoma as a public health problem.
These countries are Cambodia, China, Lao People’s Democratic Republic, Ghana, Mexico, Morocco, Myanmar, Nepal, and – most recently – Gambia. More than 95 million people have benefited from Pfizer’s donation programme.
Pfizer extended its donation programme until 2025, to align with WHO’s new target date of 2030 for global trachoma elimination.
Pfizer, fluconazole (Diflucan) Partnership Program
Pfizer and its partners have distributed more than seven million doses of fluconazole (Diflucan) to governments and non-governmental organisations (NGOs) over the past two years to people suffering from AIDS-related fungal infections, such as cryptococcal meningitis and esophageal candidiasis.
Nine countries in scope are benefiting from this donation programme, including Botswana, Cameroon, Malawi, Rwanda, Swaziland, and Lesotho.

CASE STUDY 4: GENERIC MEDICINES MANUFACTURERS’ APPROACH TO EXPANDING ACCESS TO OFFPATENT/GENERIC MEDICINES
Companies: Aurobindo, Fresenius Kabi, Teva
How: Aurobindo and Fresenius Kabi mainly distribute their off-patent/ generic medicines through tenders or direct-selling contracts. Teva stands out for its product donations.
Where: Global-scale, Malawi
Details: Aurobindo applies affordable pricing policies for its off-patent antibacterial and antifungal medicines in all sales segments and participates in tenders in countries where its medicines are registered. Tenders can be an effective tool for governments to obtain discounts.
Fresenius Kabi makes its generic medicines available in hospitals in the countries in which it operates, mainly by participating in tenders or through direct sales contracts with hospitals.
In many countries, generic medicines are subject to mandatory price control mechanisms, that result in lower prices compared to originator medicines.
Teva is partnering with Global HOPE and Direct Relief to donate antibiotics to paediatric immunocompromised cancer patients in Malawi. The goal of the initiative is to treat 4,000 paediatric patients in Malawi over the next five years.

CASE STUDY 5: EXPANDING ACCESS TO TB MEDICINES
Products:
MDR-TB* medicine bedaquiline (Sirturo) – Johnson & Johnson.
MDR-TB medicine delamanid (Deltyba) – Otsuka and Viatris.
M/XDR-TB** pretomanid (Dovprela) – Viatris.
How: Most TB medicines are procured via the GDF-Stop TB Partnership, which ensures that national TB control programmes have uninterrupted access to quality-assured medicines by providing direct procurement services and securing competitive prices, contingent on good stewardship practices.
Companies can also use additional access strategies to reach people in poorer countries directly, such as voluntary licensing agreements, patient assistance programmes, or bidding in national tenders.
Impact: Since its creation in 2001, the Global Drug Facility (GDF) has facilitated access to TB medicines and diagnostics in more than 140 countries, making quality-assured treatments available to over 32 million people with TB. GDF supplies longer and shorter all-oral regimens for drug-resistant TB, and child-friendly medicines for both drug-sensitive and drug-resistant TB.
GDF has secured price reductions of over 50% for most drug resistant tuberculosis (DR-TB) medicines, primarily by reducing risks to suppliers and minimising their transaction costs. 128 countries have received drug-sensitive TB medicines via the GDR since its inception, reaching almost 34 million adults and 2.5 million children.
Where: Up to 150 countries and territories – including all 102 LMICs in the Benchmark’s scope – are eligible for the ‘access’ price for bedaquiline, delamanid and pretomanid when procuring via GDF. Companies reported country-specific donations and patient assistance programmes (e.g., in India and South Africa) and responding to both country and GDF global tenders.
Details: GDF-Stop TB partnership provides the on-patent TB medicines in scope of the Benchmark at defined global access prices. Bedaquiline is priced at US$340 per six-month treatment course with an escalating percentage of free goods depending on volume thresholds, resulting in a prorated price of US$272 per six-month treatment in 2021.
Per six month treatment-course, pretomanid is priced at US$364, and delamanid at US$1700. Otsuka has geographically exclusive licensing agreements with Viatris and R-Pharm.
Viatris received a technology transfer from Otsuka, allowing it to produce delamanid in India. However, the delamanid produced by Viatris does not currently meet quality assurance requirements of donors, as it is not approved by a Stringent Regulatory Authority or the WHO Prequalification Programme.
Viatris has agreed to donate 400 cumulative treatment courses of pretomanid directly to the Indian National Tuberculosis Elimination Programme and to the South African Conditional Access Programme.
In April 2021, Viatris also launched a named patient access programme to provide access to individual patients in countries where pretomanid is not yet registered or available, free of charge or on par with GDF access pricing, depending on eligibility.

* Multidrug-resistant tuberculosis
** Multidrug- and extensively drug-resistant tuberculosis
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4. Gavi The Vaccine Alliance. Pneumococcal vaccine support. Published 2021. Accessed October 21, 2021. https://www.gavi.org/types-support/vaccine-support/pneumococcal
5. NHS. Amoxicillin: antibiotic to treat bacterial infections - NHS. Published 2021. Accessed October 21, 2021. https://www.nhs.uk/medicines/amoxicillin/
6. Novartis. Healthy Family Programs. Published 2021. Accessed October 21, 2021. https://www.novartis.com/esg/access/creating-sustainable-business-models/
healthy-family-programs
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