According to a new report from the IQVIA Institute for Human Data Science, the types of medicines being developed, the way technology contributes to health, and how the value of health is calculated are all changing dramatically.

The study, 2018 and Beyond: Outlook and Turning Points, analyzes several healthcare trends in which stakeholders and decision makers are increasingly using real-world evidence (RWE) and technology to solve the problems of human health. The Institute’s analysis produced 10 predictions that promise to transform healthcare cost and spending, drug development and delivery, and approaches to determine the societal value of medicines.

“This report focuses on the most recent real-world evidence and analysis to balance emotion and intuition that can sometimes overshadow critical healthcare decisions,” said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science. “Based on that analysis, we’re convinced these evidence-based predictions will begin to come to pass later this year.”

Some of the key inferences of the study are that in 2018, FDA will issue its first framework addressing the potential for RWE to support regulatory submissions and drug safety monitoring. As big data gathered in real-world healthcare settings becomes more prevalent and robust, it is increasingly being used across the entire healthcare system for evidentiary purposes. With this shift, regulators will be both enabled and challenged to accelerate the pace of their review through new data-derived protocols, insights and approaches. It’s expected that this evidence, paired with existing clinical trial data, will foster more collaborative approaches between life sciences companies and the FDA around areas such as trial design and post-market surveillance.

From 2018 through 2022, between five to eight new therapies will launch each year within a new generation of cell-based therapies, gene therapies and regenerative medicines. This wave of next generation biotherapeutics will stretch the definition of a “drug” as we know it. Some are engineered for individual patients, while others transform previously untreatable or chronic diseases with curative results in a single dose. Others upend spending paradigms because they carry an extremely high cost per patient relative to traditional therapies. Providing access to these clinical advances will be a challenge for governments and insurers without methods to determine which patients are eligible for treatments, negotiated payments based on outcomes, or ability to spread costs over time.

Use of telehealth will expand. Nearly every privately insured patient in the U.S. will have some form of access to telehealth this year, though few will use it. In 2018, telehealth visits will account for 3-3.5 per cent of visits, up from 2.6 per cent in 2017. Over the next five years telehealth will grow between 4 and 7.5 per cent of visits as patient concerns about being treated by a random doctor are outweighed by the dramatically lower co-payments offered by their insurers. Advocates of telehealth argue that most of the reasons to see a provider in person can be supported remotely. For payers, concerns about measurable benefits and/or potential fraud are being addressed by technology and are outweighed by cost savings relative to inappropriate use of emergency or urgent care.

Spending on branded medicines will dip. In 2018, net brand spending will decline in developed markets by 1-3 per cent. This has the effect of reducing net spending overall on brands in developed markets by approximately $5 billion, to a total of $391 billion for this year. Net brand spending will remain flat in the next five years, despite the expected entry of new branded medicines. The overall impact on payers, however, should be the same in 2022 for brands as it was in 2017. Manufacturers will continue to develop and launch drugs, but the inherent unpredictability of medicines spending will drive continued caution among payers regarding reimbursement and access.

Specialty brands will drive growth in developed markets. In 2018, the $318 billion specialty medicines market will represent 41 per cent of developed market spending, up from $172 billion in 2013. In fact, specialty drugs will contribute all of the growth in medicine spending in 2018, however, those increases will be offset by spending declines in traditional therapies.

New wave of biosimilar competition and opportunity emerges. In 2018, $19 billion of current biotech spending in developed markets will have competition from biosimilars for the first time. That amount is significantly greater than the $3 billion in biosimilar revenue that became exposed in 2017, and it adds to the $26 billion already facing competition. The new exposure to competition in 2018 is the largest single-year change to date and signals the start of the next large wave of biosimilars.

The benefits of a functioning biosimilar market include expanding access and cost savings across public and private healthcare systems. While overall it appears that the next decade will provide sufficient incentives to encourage biosimilar challengers, the greatest uncertainty around biosimilars is whether all medicines that can be challenged in the next decade will indeed face competition and from how many companies.