Regional Availability of and Reimbursement Models for Biologic Therapies to Treat RA Patients with Moderate to Severe Disease

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint
stiffness and loss of function, ultimately leading to disability if untreated. RA also has significant systemic featureRA Patientss in many patients that appreciably impact upon their quality of life, including fatigue and depression. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1

Modern RA treatment paradigms (i.e. “treat to target”) focus on achieving remission/low disease activity to minimize joint damage and disability. Biologic agents targeting key inflammatory mediators (TNF-alpha, IL-1, IL-6), key cells and activation pathways of the adaptive immune system such as B cells and T cell co-stimulation pathways, have revolutionized the treatment of RA and many other immune-mediated inflammatory diseases (IMIDs), and have rapidly been introduced into accepted treatment paradigms2,3 when earlier disease modifying anti rheumatic disease (DMARD) agents such as methotrexate (and others) are insufficient to reach these target goals.

Because of their great success, biologic agents have dominated the commercial landscape for RA therapy for many years and have driven the continued development of additional biologics targeting similar or novel pathways. This has resulted in increased competition for RA patients and investigators for RA clinical trials. Understanding the global landscape for efficiently identifying the appropriate patients for these studies requires a clear understanding of the complex and geographically diverse factors, including cost, varying reimbursement/insurance coverage issues, etc., that drive patients’ ability to access these treatments.

Covance has a global presence that allows for a comprehensive understanding of the regional, country and even province level variability of access to biologic agents that would be highly effective for RA patients with active disease. And thus, Covance indirectly has a better understanding of which countries/municipalities may have RA patient populations and treating physicians/investigators with the greatest interest in participating in clinical trials involving biologic agents.

For example, our ongoing surveillance of country/region specific access to biologics suggests that groups of RA patients in Eastern Europe, Latin America, Asia and, perhaps surprisingly, Australasia have very limited access to biologics treatment even when local treatment guidelines suggest their use is indicated. Patient access to biologics is greatest in Western Europe and North America where there are significant levels of reimbursement through government funding and/or private healthcare insurance. The table below provides an overview of the current regional status of patient access to biologics for the treatment of RA.

Region Median Percentage of RA Patients Receiving Biologics
(%)
Range of RA Patients Receiving Biologics
(%)
Funding
Western Europe 23 1 – 30 Largely funded by government or health insurance (partially or fully)
Eastern Europe 10 1.5 – 25 Mix of full government funding (e.g. Croatia, Latvia, Romania), partial government funding (e.g. Bulgaria, Czech Rep), patients responsible for majority/all funds (e.g. Russia, Ukraine)
North America 23.75 17.5 – 30 U.S. – mix of government, patients, and employers. Canada – levels of government funding vary between provinces/territories.
LATAM 12.5 10 – 25 Mix of full government funding (e.g. Brazil, Chile) or patients/private health insurance responsible for majority/all funds (e.g. Mexico)
Asia 12.5 5 – 25 Mix of partial government funding (e.g. Japan) or patients/private health insurance responsible for majority/all funds (e.g. Hong Kong, Philippines)
Australasia 10 5-15 Patients make a small co-payment
Israel 30 30-30 Most biologics are covered by the national health insurance

 

The above data help identify ideal geographic placement of studies depending upon the target patient population and desired patient characteristics such as biologic naïve or biologic experienced. This information, together with the Covance Xcellerate® Trial Design solution that contains investigator performance metrics on >1,400 rheumatologists active in Phase II-III clinical trials over the past five years, allows us to partner with our RA clients to optimize selection of study geography. The paradigm shift to biologic treatments for RA has yielded markedly improved response rates and long term clinical outcomes for RA patients as well as commercial success for developers. As a consequence, a great deal of interest remains in developing additional innovative compounds and more recently, biosimilar versions of the established biologics. This has led to a crowded field for recruitment of RA patients (especially those who are naïve to biologics/TNFi) and the need for new strategies to identify such patients for efficient clinical trial recruitment.

If you are currently planning an RA clinical study, Covance has the global infrastructure and access to unique proprietary databases allowing for optimized country selection, aligned with your specific target patient population and ensuring recruitment meets your expectations.


References

  1. http://www.who.int/chp/topics/rheumatic/en/
  2. http://www.rheumatology.org/Portals/0/Files/ACR%202015%20RA%20Guideline.pdf
  3. https://www.eular.org/recommendations_management.cfm