EFCCA Report Highlights Unequal Access to Biologics and Biosimilars for IBD

April 25, 2018

The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars.

To compile the report, EFCCA surveyed 32 national associations about the availability and coverage of biologics and biosimilars in their respective nations. Associations participating in the survey represented Argentina, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Malta, New Zealand, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom.

Responders reported that adalimumab (Humira) is approved to treat IBD diagnoses in all of the participating countries. In addition:

In 17 nations (53%), adalimumab is fully covered.
3 nations (9%) had regional differences in terms of availability and reimbursement.
In 12 countries (38%), the treatment is available to all patients with IBD.
18 nations (56%) had preconditions for treatment; for example, in 2 nations, the therapy is available for patients with Crohn disease but not ulcerative colitis.

Reference infliximab (Remicade) is also approved to treat IBD in each of the participating countries.

In 19 nations (59%), it is fully covered.
2 nations (6%) had regional differences in terms of availability and reimbursement; for example, Germany specified that some regions of the country lack appropriate infusion equipment, and Italy and Spain noted that patients are encouraged or required to use a biosimilar rather than the reference infliximab.
In 14 countries (44%), the treatment is available to all patients with IBD diagnoses.
16 nations (50%) had preconditions for treatment; for example, in Finland, only pediatric patients receive the treatment, and in some other nations, step therapy is required.

Biosimilar infliximab, Inflectra, was reported as approved to treat IBD in 27 nations (84%).

In 17 nations (63%), Inflectra is fully covered.
In 3 (11%), it is partially covered.
In 12 countries (44%), the treatment is available to all patients with IBD diagnoses.
15 nations had preconditions for treatment; in Australia, the biosimilar is not on the national reimbursement registry and requires a gastroenterologist to undertake a prior authorization with an insurance company, and patients in Hungary are required to use the biosimilar if they initiated therapy after 2014.

Interestingly the same molecule, when marketed as Remsima, had differences in availability and coverage compared with the Inflectra-branded biosimilar. Respondents indicated that the Remsima-branded drug was approved for IBD in 25 nations (78%) and was fully covered in 12 nations (48%). However, only 11 nations (44%) reported preconditions for use.

“The outcomes of this survey also show clearly that access to new innovative therapies in different countries is far from equal,” write the report’s authors. “Apart from the differences between countries, there are also regional differences within the same country; these may be due to geographical or economic issues. Although it is understandable that access to health care services…can be very different, it puts patients in highly unequal positions.”