German laws, European VBCs, and trends in China, Brazil, and Saudi Arabia are changing the way global market access works.
The early afternoon of the Market Access/RWE—Beyond Borders: Market Access Expanded track at Pharma 2023, being held in Barcelona April 16-18, was information-packed and offered a changing view of global market access on a number of fronts.
In the first session, Christoph Glaetzer, chief value & access officer, Johnson & Johnson, outlined the impact of the recently passed GKV Financial Stabilization Act in Germany. The primary goal of the law is to stabilize the finances of the statutory health insurance (SHI) policies and introduced significant changes to the legal framework governing the pricing and reimbursement of pharmaceuticals. However, as Glaetzer notes, these changes are not without unintended consequences, specifically to Germany’s reputation as an innovation leader.
Similar to the US, Glaetzer noted that there is a problem with the overall healthcare spend, and the portion of pharmaceutical spend has actually remained flat for the past 10 years. Meanwhile, the initiatives that have been enacted under the law, including a new 20% rebate for combination therapies, reduction of the threshold for orphan drug P&MA, and new pricing “guardrails” for price negotiation, including mandatory volume-based price model components, which were previously optional.
Glaetzer concluded that the short-sighted policy will lead to lower investments in Germany due to lack of incentive for innovation, which may not be felt until 10 years from now, when it will be too late to course correct. “Germany looks to lose its leading status for patient access to new treatments,” said Glaetzer.
While value-based contracts (VBC) have been enacted, a presentation from Omar Ali, visiting lecturer for the University of Portsmouth, former adviser for the NICE Adoption & Impact Program Reference Panel, and current head of payers for Verapro, a contract and VBC consultancy, offered his company’s own involvement with 742 such agreements. On average, Ali noted that there is an eight-fold underreporting of VBCs.
Walking the audience through a case study of Cimzia, a biologic for rheumatoid arthritis entering into a crowded field, Ali offered the steps and concerns from the payers. UCB Pharma was able to pivot and address the concerns, ultimately enabling a VBC that engaged both physicians, patients, and payers.
Ali outlined that the three factors impacting VBCs—geopolitical, affordability and uncertainty—all of which are in play in the current environment. For example, all countries are facing some sort of impact from innovation, gene therapies are testing the limits of country affordability, and uncertainty for the long-term effects for gene therapies, as well as chosen endpoints, are pushing VBCs to the fore of payer negotiations.
Anthony Nash, head of market access, global partner business for specialty pharma company CSL Vifor, took the stage to discuss the current access landscape of China, Brazil, and Saudi Arabia. Changes in China over the past 20 years, including faster regulatory review times; focus away from generics and onto innovative medicines by China-based pharma; and universal health coverage, with a quick formulary addition of eight to nine months, have given China the edge in global market access.
Brazil offers a case study in the split of public and private health coverage, which is leading the country to consider VBCs more often, and the involvement of health technology assessment (HTA) agencies.
Finally, Saudi Arabia has targeted healthcare as part of its Health Sector Transformation Program of the Kingdom’s Vision for 2030. As such, the investment in innovations is skyrocketing with hundreds of startups, and a focus on telehealth to enhance citizens access to better care.
Nash noted that each country’s needs from Europe are different. For example, China needs Europe to bring more global clinical development programs to the country. Brazil, to be considered for parallel launch with Europe, and Saudi Arabia, a part of health economics and outcomes research (HEOR) evidence generation. In the longer term, Nash noted that China is developing retail pharmacy chains and online drug selling. Brazil is looking forward to more alternative payment models and Saudi Arabia, the privatization of healthcare.