Earlier this month several members of Research Partnerships Market Access team, including Directors Brett Gardiner and Rachel Howard, joined over 1000 global delegates attending the virtual World EPA Congress. This year’s Congress covered a variety of topics from the inevitable impact of the COVID-19 pandemic to value-based pricing /access & evidence generation, rare diseases & orphan drugs, country/region market access updates and the increasing involvement of patients in access decisions. In this write-up we will take a look at some of the insights captured by RPMA team members in these topics over the three-day Congress.
Key theme: Impact of the COVID-19 pandemic on market access & pricing
As to be expected, COVID-19 remained a major talking point in this congress with several panel discussions focused around the impact of COVID-19 on health technology assessment (HTA) processes, market access and pricing. On Tuesday, Rachel attended the opening keynote panel discussion on the impact of COVID-19 on Market Access and Pricing, with representation from the pharmaceutical industry and a number of EU HTA bodies. A major point of discussion was the closer collaboration between politicians, decision makers, regulators and the industry over the past year. In the face of urgent needs to manage the pandemic, HTA processes have been found to be too time consuming as organisations have found it difficult to keep pace with developments. With the EU emerging as an increasingly influential buyer of vaccines, the panel suggested we may see more joint procurement applied in other areas such as orphan diseases and oncology. Or if joint procurement proves too challenging given local country needs, priorities and perceptions of burden of disease and value, at least more joint working in the context of outcome-based agreements. Rolling reviews may also be expanded to other disease areas to ensure rapid access.
Bryony Brennan, Senior Consultant, found a similar commentary around the time-consuming nature of HTA processes in the panel discussion dedicated to HTA in the time of COVID-19. This discussion focused on how HTA bodies have adapted their processes to cope with the increased time pressures, and sometimes reduction in resources, to allow them to continue assessing new drugs. Mark MacGregor of the Scottish Medicines Consortium (SMC) commented on how the pandemic has caused the SMC to focus on streamlining their processes, making informed decisions about which elements of their processes are nice-to-have. Through removing the ‘nice-to-have’ elements, including moving to a 1 rather than 2 committee approval process, they have increased the speed of HTA decisions. During the discussion the panellists were posed the question about which changes to HTA processes will last beyond the pandemic. Their responses suggest that this will be re-evaluated post the pandemic, but they do not anticipate things returning to the pre-COVID-19 situation with many of the efficiencies set to continue. Similarly, pricing negotiation bodies, including the pan-Canadian Pharmaceutical Alliance (pCPA) in Canada, have also implemented processes to find efficiencies and prioritise certain price negotiations. The pCPA is introducing a ‘Targeted Negotiation Process’ to help streamline criteria-fulfilling negotiations and ensure they reach resolution in a set timeframe.
Another session looked at a different impact of the pandemic - the backlog in FDA approvals, with COVID-19 having resulted in challenges to inspect manufacturing facilities outside of the US, for example. The resulting review delays have the potential to affect the entire ecosystem of access to innovation, both upstream and downstream, and companies need to factor this into their forecasts. Rebeca Nana, Senior Analyst, also learnt that COVID-19 has delayed cancer diagnosis with consequent impacts on healthcare budgets downstream.
In one of Thursday’s presentations, Catarina Lopes Pereira of medac discussed how COVID-19 has reignited interest in repurposed medicines, due to their potential to drastically reduce drug development timelines. Citing historical success stories such as aspirin and sildenafil, she drew attention to how repurposed medicines can suffer market access hurdles that may disincentivise their development. This is due to pricing and reimbursement systems having rules that can make it hard for manufacturers to command a premium price for new indications, such as forcing new price cuts and renegotiations. She called for a strong and fast policy response to overcome some of these hurdles in view of the potential repurposed medicines can offer in the current global health emergency.
Other hot topics: Value-based agreements (VBAs) & Evidence Generation
Another key theme that was pervasive throughout the Congress was the increasing importance of value-based contracting. Bryony attended a session by Ana Plata of UCB, where she demonstrated the shift from market/comparator-based pricing to value-based pricing. Ana highlighted the importance for pharma pricing teams to be aware of this shift together with a spread of innovative pricing/payment models and changes in pricing regulations (e.g. US pricing reforms and EU cross-collaboration) when preparing their future strategies and approach. With 48% of US payers already having one, or more, outcomes-based contract in place, pharma pricing teams need to have clear governance for innovative contracts, policies for portfolio and cross-border collaborations, and company-wide systems set up to leverage these changes. She stressed the increasing need for companies to plan their pricing strategies for product launch 3 years ahead and think carefully on their launch sequences considering the rise in importance of other countries compared to the current standard first launch countries.
As highly expensive rare disease drugs increasingly dominate pharma companies’ pipelines, VBAs were discussed as a solution to help balance the inherent risks and cost that can hamper payers’ willingness to pay for these drugs. Bryony attended a session on Wednesday by Mercedes Echauri of Takeda. In her talk Mercedes stressed the opportunities posed by VBAs in addressing the risk of existing uncertainties between payer and pharma company for high cost drugs. She argued that VBAs provide benefit to all aspects of the health economy. However, some countries are less ready and open to adopt VBAs than others – with a lack of infrastructure and heavy resource burden required for implementation among the key challenges. In a risk-sharing agreement panel discussion payer education and cross-border sharing of VBA experiences, within acceptable boundaries for confidentiality, was suggested to help overcome such barriers. On this theme Mercedes highlighted TRUST4RD, RWE4Decisions and H2O as initiatives to support VBAs.
Region and country-specific examples of VBAs and the lessons they provide were discussed at multiple sessions throughout the congress. Italy was widely cited as a pioneer in the field of VBAs. Artemis Rizoglou, Senior Analyst, attended a talk on VBAs in the Netherlands where they were discussed as a vital tool to overcome budget challenges assuming capabilities are built to identify opportunities, design partnership solutions, and track outcomes metrics. A further talk highlighted a couple of examples of where a company had managed to negotiate a successful outcomes agreement with the payer, skipping the usual HTA route, e.g. Vertex’s portfolio subscription model with NHS England providing full access to Orkambi, Symkevi and Kalydeco. He stated the importance of engaging early with payers, providing flexible financial agreements and considering combining multiple VBAs to best overcome payer uncertainties.
Outside of Europe, Birgit Holz of Sanofi highlighted the increasing prevalence of innovative managed entry agreements in both mature and emerging markets, with increasing country initiatives to encourage the use of VBAs. Examples included the 2017 Algerian Republic publication N֯ 77 introducing two new laws that allow financial and outcomes-based agreements and in the USA in 2020 the Centers for Medicare & Medicaid Services (CMS) issued value-based purchasing for drugs. Amer Omar of Lupin provided examples of increasing openness and infrastructure for VBAs across MENA, particularly the Gulf countries, and emphasized the importance of understanding the patient journey in these countries when designing such agreements.
Other hot topics: Market-specific developments
Outside of COVID-19 and VBAs, the Congress hosted a plethora of talks providing the latest overviews and stances on market access and HTA processes in different markets/regions, a snapshot of which is shown in this section.
Russia: Laura Hindley, Analyst, attended a talk by Vladimir Mladov from BIOCAD on the increasing importance of Russia-specific evidence generation in Russian HTA evaluations. This highlighted the different risk bias assessment tool used in Russian HTA processes compared to Cochrane used by the EMA.
China: Bryony attended a talk by Samuel Taylor from Pfizer on market access in China where he discussed that the National Reimbursement Drugs List (NRDL) is the holy grail due to the potential size of opportunity but volume-based pricing is a concern for price erosion and that entry into the NRDL is not a guarantee of success. Companies need to enter into NRDL negotiations with strong value communication and with a real understanding of Chinese payer needs. The Chinese private market opportunity is likely to be an area of innovation with the opportunity to use localized VBAs but entry into this market will take time and creativity.
LATAM: Rebeca joined the sessions focused on LATAM markets in which a revision of the HTA processes and the potential ways to improve the decision-making were discussed. As with Europe the LATAM -region has discussed the creation of a single pan-LATAM access system to ease the process from registration to reimbursement. However, there is still a long way to go before such a system could be set up, particularly in light of the young HTA organizations/process characteristic of LATAM countries and the differences on the system across the region. Furthermore, there is still work to do in linking the HTA outcomes with the allocation of resources in LATAM due to several factors, such as the lack of transparency during the evaluations in some countries, as well as the agreement on the definition and the implementation of value frameworks on the assessment. Marc García, Analyst, attended a country-specific talk by Jonas Sertorio from the Brazilian Ministry of Health, which discussed how to get access to medicines through the public pathway in Brazil and the increasing role of public consultation as part of the acceptance process.
Canada: Michael Burnill, External Engagement Liaison, joined talks relating to Canadian pricing containment and HTA bodies. The talk by Luc Boileau from Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec, Canada, centered around the HTA agency’s thinking about assessing value of rare disease treatments. Next, a talk by Dan McLean of the pCPA, the public plan joint price negotiation body for federal, provincial and territorial governments, discussed their new streamlined pathway and a move to become more independent of its individual government members. Further, in Canada, supplementary private health insurance is key to covering outpatient drugs. Laurene Redding from BeiGene discussed the ways in which private insurers can keep their benefits affordable and accessible in a time of increasing drug prices and budget constraints, including tiering, increased use of managed plans, mandatory first use of generics/biosimilars, patient cost sharing, and annual maximums.
Concluding thoughts
Globally we are now moving away from crisis measures and are looking forward to the post-COVID-19 era. It is no longer in question that payers and health systems across the world have been permanently changed by the pandemic, what is yet to be fully determined is which of these changes are here to stay. As more highly expensive rare disease drugs than ever are being brought to market, and cell and gene therapy moves beyond rare diseases to more prevalent indications, payers’ budgets are simultaneously facing unprecedented downwards pressure as a result of COVID-19. Streamlined processes, improved evidence generation and increasing openness to innovative contracting capable of reducing uncertainty without adding to administrative burden will therefore be essential to manage access while ensuring affordability.
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