Approaches to increase uptake of biosimilars in Spain

Biosimilars/Research | Posted 13/05/2016 post-comment0 Post your comment

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been introduced in Spain to try and improve uptake of biosimilars in the country [1].

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The Assistance Direction of Pharmaceutical Management (ADPM), which comes under the General Authority of Healthcare Coordination, is the department of MHS in charge of making decisions about the region’s strategic plans regarding drugs and medical devices.

In 2010, the ADPM established a strategic approach to improve the uptake of biosimilars in the region. Biosimilars use was monitored via the use of indicators, which were included in the Contract Plan – an agreement signed between the MHS and hospitals in the region. In 2014, the indicator %Biosimilar Drugs Cost Value was included; and in 2016 the percentage of patients on infliximab biosimilar (new patients) was included.

The ADPM also implemented other approaches to try and increase uptake of biosimilars.

One approach was a first Framework Agreement, which was set up for somatropin in 2010. A second agreement was reached in 2014 and is still in effect. In this process, all somatropin brands available on the market (originator and biosimilar) were considered equivalent. The bid price in the Framework Agreement was then set as the price per mg of somatropin (€).

Other indicators have also been established in the Contract Plan, such as annual patient cost for chronic conditions requiring hospital drug dispensing from the hospital pharmacy departments. Somatropin, colony-stimulating factors, erythropoietin and biologicals are dispensed in the hospital pharmacy departments in Spain. Annual patient cost indicators have been established for human growth hormone patients (both adult and paediatric), rheumatoid arthritis, inflammatory bowel disease, psoriasis and cancer patients who need colony-stimulating factors. Each of these indicators also has an established annual standard cost that should be achieved. In this scenario, the prescription and dispensing of biosimilars help hospitals to stay within the annual standard costs laid down in the Contact Plan.

Finally, information flow in the healthcare system is an essential tool and a good quality flow of information is pursued in the MHS. The ADPM has an information database which provides sources of quantitative drug information for hospital. These include: 

  • Files containing information on all hospital drug procurements (obtained monthly).
  • Information about drugs being dispensed to ambulatory patients in each hospital pharmacy department (monthly).
  • Pharmacy-related indicators (three monthly). 

The information in the ADPM information system can be analysed and compared or even cross-referenced with other databases, e.g. drug consumption in the primary care setting. The information system also allows comparative information to be sent to hospitals. This allows hospitals to know their own information such as indicators, drug purchase information, and see how they are positioned with respect to the regional average.

This article is prepared based on the paper entitled ‘Best practice to improve biosimilars uptake: the experience of Madrid, Spain’ by Aranguren Oyarzábal A, López Centeno B, Alonso Castro V, Calvo Alcántara MJ, Cruz Martos E, Assistance Direction of Pharmaceutical Management, Madrid Health Service, Spain

Editor’s comment
Readers interested to learn more about market uptake of biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Product naming, pricing, and market uptake of biosimilars

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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1. Derbyshire M. Improving biosimilars uptake: experience gained in Madrid, Spain. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):89-91. doi:10.5639/gabij.2016.0502.021

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