On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for haemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (Poli), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag. Partly in response to such drugs, risk-sharing agreements (RSAs) have increased in popularity and aim to mitigate the risks of including high-cost drugs on reimbursement lists and healthcare plans. GlobalData takes this opportunity to review the various types of RSAs and their evolution over time.

79% of risk-sharing agreements are finance-based

According to GlobalData’s risk-sharing database, over 1,000 RSAs were made in the last decade across 28 countries and roughly 100 companies. These agreements are either finance-based (with specified budget caps, discounts, or restrictions for a particular patient or disease population) or performance-based (with a specified endpoint or definition of response that determines whether the payor will cover the treatment on an ex post facto basis). An overwhelming 79% of known RSAs are finance-based, ranging in complexity from simple discount schemes to more complex risk-based financial arrangements. While performance-based RSAs initially grew in popularity, ease of implementation allowed finance-based models to dominate. Countries with a high willingness for performance-based models, such as the UK, saw this RSA type peak in 2019 before continually declining. 

Most finance-based agreements are discount schemes, including simple discounts, compulsory discounts on ex-factory prices, or other types of discount price negotiations. For example, in Sweden, the proposed arrangement for Sanofi/Regeneron’s Dupixent (dupilumab) included a tripartite price negotiation involving Sanofi, the Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket, TLV), and local councils. The three agreed on a confidential price, and the TLV determined whether the drug was cost effective for the eligible patient population.

52% of RSAs focus on oncology 

RSAs are predominantly arranged within oncology (52%) since these drugs typically rely on RSAs to gain reimbursement. Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. However, more highly innovative/high-cost treatments, within infectious disease and neurology space, are likely to enter the market for rare disorders, increasing the number of non-oncology RSAs.

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Because RSAs traditionally involve high cost/highly innovative drugs, GlobalData has reviewed the top brands according to volume of RSAs granted and Anatomical Therapeutic Chemical (ATC) code. Using this categorization, programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors saw the greatest percentage of RSAs granted. Undoubtedly, this has played a factor in the success of market-leading PD-1 inhibitors, Merck & Co.’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab), based on the high volume of RSAs arranged for these drugs. Their widespread agreements are established in the UK, followed by seven additional countries (Australia, France, Netherlands, Spain, Poland, Italy, and Canada).

Risk-sharing agreements grow at a rate of 24%

Since 2012, the increasing number of countries pursuing RSAs has been limited, but the elevated volume of agreements arranged each year has resulted in an average annual growth rate (AAGR) of 24%. Notably, 2022 saw the greatest number of RSA deals arranged, surpassing the previous record in 2017, when the first gene therapy, Novartis’s Kymriah (tisagenlecleucel), was approved and priced at $475,000.

56% of RSAs have been established as arrangements in the UK 

The UK leads the total global number of RSAs made since 2012 (56%), many of which are simple, discount-based patient access schemes (PAS). The National Institute for Health and Clinical Excellence (Nice) and the pharma industry have engaged in these and other similar schemes since the 2000s to provide flexible pricing and PAS as a market access method for drugs that would otherwise not be considered cost-effective by NICE/Scottish Medicines Consortium (SMC) evaluations. The UK is followed by Australia, an early adopter of risk-sharing, and the US, where risk-sharing mechanisms have increased in popularity due to the evolving complexity of the contracts.

As the number of RSAs continues to grow, oncology and rare indications will remain the focus of these agreements for entering key markets like the US and UK. It is also likely that further RSA frameworks will be established in Latin America, after Argentina and Brazil recently became pioneers by reimbursing Novartis’s Zolgensma (onasemnogene abeparvovec) under novel RSAs. Further breakdowns on RSAs are available within GlobalData’s Risk sharing database.