In today’s global market access environment, pharmaceutical companies must consider the various headwinds and trends that will shape their future ability to get their therapies reimbursed and optimally prices. These trends dominate current discussions of market access within pharma companies. These trends, which feature prominently in syndicated and custom projects at Decision Resources Group, were also the hottest topics at the recent World Pharma Pricing & Market Access (PPMA) Congress 2018 in London.
At this 2-day event featuring 150 speakers, various presentations explored the trends that will shape the global market access environment for the next decade. A few observations from this Congress are presented below, along with how the industry should best respond the evolving landscape:
- Patient involvement in HTA and market access: Manufacturers and HTA bodies are advised to engage with patient organizations to gain context of the disease under study, ensure the appropriate selection of patient-reported outcomes (PROs), and leverage uptake. HTA bodies and regulatory authorities are increasingly promoting the participation of patients in the decision-making process (e.g. clinical reference groups in the UK, to ensure that any changes to the commissioning of specialised services involve patients and the public).
- Collaboration and early dialogue between manufacturers, regulators, and payers: Conversations should start as early as possible and should be maintained throughout the product’s lifecycle. These collaborations could have a considerable positive impact on timelines (i.e., avoiding market access delays) and budgets (i.e., allowing for savings). Manufacturers typically don’t start market access activities as early as they consider ideal, sometimes due to their own organizational structure, as different teams do not collaborate with one another due to conflicting interests. One of the main challenges to overcome is the limited clinical evidence to support initial market access negotiations.
- Real world data (RWD) as a tool to promote access: RWD is crucial to generate evidence and mitigate uncertainty. Patient-reported datasets make evidence generation easier compared to clinical trials (e.g., patients sign electronic consents and use mobile apps to track their health status). Thus, electronic clinical systems are anticipated to accelerate data collection and improve the decision-making process. Additionally, RWD has the opportunity to fill gaps that have not been addressed by traditional randomized clinical trials (e.g., study of comorbidities).
- Market access for rare diseases, immuno-oncology therapies, and CAR-T therapies: Payers demand significant clinical value at low risk. Therefore, new high budget impact therapies are an opportunity to negotiate creative contracts which involve complex financial constructs. Payers stress that evidence (i.e., need for appropriate comparators and PROs, well-defined patient population and disease burden, transparent processes, cost-effectiveness, country-specific data) will be key. Additionally, involvement in any kind of parallel activity with patients (e.g., patient support or education programs) could be a powerful lever to convince payers and differentiate products from existing competitors. With regard to combination therapies, payers note that market access negotiations for costly immuno-therapies used in combination are more favorable when both components are produced by the same manufacturer (e.g., Mekinist plus Tafinlar).
- Challenges of innovative contracts: Germany has not traditionally had an optimistic view on risk- and cost-sharing schemes due to the strict German data protection laws, the associated high administrative costs of such contracts, and the uncertainty regarding patient compliance and adherence to treatment. However, while the G-BA indicates that 95% of all contracts in Germany are currently simple rebate contracts, it states that outcome-based schemes could be considered in the future. Indeed, some other EU5 countries such as the United Kingdom and Spain are starting to see an increase in outcome-based schemes (e.g., Translarna for Duchenne muscular dystrophy), and indication-based pricing is already being used in Italy. Therefore, manufacturers should be creative and flexible in order to align the price of their therapies with the value each patient obtains from them. The main challenge is to improve data collection and analysis; an issue some big pharma companies have already started to address by investing in big data.
- Market access challenges in Emerging Markets (EMs): Sustainability is key. High out-of-pocket (OOP) costs and lack of public funding are the main challenges in EMs. Strong government-imposed added value taxes for drugs (i.e., mark-ups exceeding 100%) are severely restricting access. Some companies are counterbalancing these taxes with the creation of patient support/access programs aimed at increasing the discounts applied on their products and, therefore, the number of patients who can access them; however, drugs are generally still unaffordable for the majority of the population despite the efforts, due to the high bills individuals are facing, which go far beyond the affordability threshold of 5% OOP cost of total expenditure for the purchase of a medicine and easily exceed the 10% of yearly household income, which has been proved to have a catastrophic impact on families.
- EU HTA collaboration: As discussed in a recent blog post, the European Commission (EC) move to put forward a proposal to increase HTA cooperation among EU member states has undeniably generated a broad debate amongst stakeholders. Discussions held at PPMA 2018 seemed to acknowledge that each country assesses the value of a drug differently and that the new EC proposal will certainly not be a one-size fits all activity. Germany, in particular, shows a critical approach and is working on a statement by which the G-BA will formally oppose the new proposal. All in all, while payers and manufacturers agree that we will be seeing more HTA collaboration between member states in the future, they all warn that changes to the initial proposal to accommodate country-specific variations are surely expected.
As noted in the bullets above, the global market access landscape is a hotbed for change. Between new technologies and markets, more aggressive contracting by payers, and greater reliance on real-world data to guide decision-making, pharmaceutical manufacturers must see these emerging trends as opportunities to innovate and partner with other stakeholders in order to succeed over the next decade.