BeiGene

Access to innovative therapies remains a key issue for the pharmaceutical industry and health authorities worldwide. In oncology in particular, there have been many advances over recent years, with a number of ground-breaking therapies being launched; however, only a small proportion of eligible patients have access to these treatments. The most recent Patient W.A.I.T Indicator Survey in 2022 showed that there is huge disparity in the rate of availability of oncology products. By January 2022, all of the 41 oncology products that received regulatory approval between 2017 and 2020 were available to patients in Germany compared to zero availability for patients in Malta. Patients in some countries can wait more than seven times longer than patients in other countries to get access to the same medicine.

Inequitable access is not just an issue of developing or emerging countries; huge disparities also exist within Europe, where there are significant differences in the time taken in the availability of medicines and varied from 1 month to 66 months (>5 years) since the first marketing authorisation for oncology treatments approved between 2014 and 2019. This reflects disparities in company launch sequences as well as the time it takes to complete reimbursement and pricing processes in certain countries.

This issue of inequitable access to treatments is a complex and multifaceted problem that needs to be addressed urgently. The root causes for this disparity range from economic factors, such as the cost of treatments to systemic issues within the healthcare system, such as slow and complex regulatory or reimbursement processes, and inefficient or duplicative efforts for evidence requirements from regulatory and health technology assessment (HTA) bodies.

Attempts at addressing some of these root causes such as streamlining HTA processes though the EUnetHTA joint clinical assessment (JCA) initiative in Europe might make some impact in addressing inequitable access, however, is it not yet clear how this will work in practice and there is still a lot of uncertainty whether pharmaceutical companies may still be required to duplicate efforts to satisfy the requirements of each of the member states as there is currently little alignment between the member states on the methodology of the JCA.

While the JCA is a worthwhile aspiration, the reasons behind inequitable access are multifactorial and can only be solved through strong collaboration among different stakeholder groups.

Pharmaceutical Companies and Health Authorities Need to Partner Together to Ensure Equitable Access to Medicines

Both pharmaceutical companies and health authorities can each play their part to bring medicines to patients quickly and affordably, and work together and with other stakeholders to identify the root causes of inequitable access and develop solutions that are sustainable and scalable. For example:

Pharmaceutical companies can:

• Use innovative and flexible pricing strategies to make essential medicines available and affordable to serve all eligible patients

• Support pre-reimbursement or early access programmes, particularly in countries with limited healthcare budgets, that provide medicines at reduced or no cost to patients, ensuring equitable access as well as quicker access for patients without having to wait for the outcome of reimbursement negotiations

• Pursue regulatory and reimbursement approvals across countries regardless of their healthcare budgets and pricing structures

Health systems can:

• Collaborate together to streamline their evidence requirements and approval processes for new treatments, both in terms of regulatory and reimbursement approvals. In order for cross- country collaborations to be successful, health authorities will need to align their requirements so that the methodologies and evidence submitted in joint submissions can be applied across all the member countries, without the need to duplicate efforts or submit additional evidence

• Be more flexible in their evidence requirements and take on greater uncertainty for innovative treatments with immature data that have the potential to improve health outcomes for patients so they can be made available sooner

• Be more open to accepting new pricing and payment models that accelerate patient access whilst managing uncertainty to payers and rewarding innovation for the pharmaceutical industry

“Both pharmaceutical companies and health authorities can each play their part to bring medicines to patients quickly and affordably, and work together and with other stakeholders to identify the root causes of inequitable access and develop solutions that are sustainable and scalable”