Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that has been introduced in Spain to try and improve uptake of biosimilars in the country .
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 try and improve the uptake of biosimilars in the region. The introduction of this approach meant that since this time all biosimilars use has been monitored through the evaluation of hospital drug procurements.
In 2014, in order to implement the strategic approach for biosimilars, the MHS signed a Contract Plan with the hospitals in the region. This Contract Plan contained indicators and objectives related to different issues and included incentives for compliance with the indicators. Pharmacy related indicators represent about 15% of all the indicators in the Contract Plan. An indicator for the tracking of biosimilars of somatropin, erythropoietin and filgrastim, defined as %Biosimilar Drugs Cost Value, was included in the 2014 Contract Plan.
The method used to work out this indicator was:
%Biosimilar Drugs Cost Value = Purchase cost of biosimilars of somatropin, erythropoietin or filgrastim/Purchase cost of all brands of somatropin, all brands of erythropoiesis stimulating agents or all brands of colony-stimulating factors.
Three variables were considered during the definition of this indicator:
• All three available drugs at that moment (somatropin, erythropoietin and filgrastim) should be monitored in a single merged indicator. This allowed each hospital to choose the most suitable group of drugs to work on.
• Denominator of the indicator: not only biosimilars and their corresponding originator drugs were considered in the denominator, but also the other drugs within the same ATC code group. This meant that filgrastim, lenograstim and pegfilgrastim would be included for the example of filgrastim. This approach implies equivalence among different drugs with similar uses in the same ATC code and measures the impact of the biosimilar with respect to the whole ATC group.
• The cost of drug purchase was selected as the measured value (both in the numerator and denominator) to evaluate the economic impact. Price (including discounts) was chosen in 2014, but was changed for the following years to the official laboratory price (price without discounts). This decision was made on the one hand to minimize the bias when high discounts for originator drugs could be obtained, and on the other hand to minimize the resulting distortion when comparing different hospitals with different discounts.
A second indicator, defined as the percentage of patients on infliximab biosimilar, was created at the end of 2014 in order to evaluate the introduction of biosimilar infliximab. It was a follow-up indicator and was not included in the Contract Plan in 2015. It was designed to study two scenarios:
2.1. Percentage of new patients starting on (biosimilar) infliximab in a set period of time out of all new patients starting on infliximab (originator or biosimilar) in the same period of time.
2.2. Percentage of new patients starting on (biosimilar) infliximab in a set period of time out of all patients with a prescription for infliximab (originator or biosimilar) in the same period of time.
These indicators were measured by making the following decisions:
• Infliximab biosimilar monitoring should be measured with an independent indicator: biosimilar infliximab introduction measured as the first indicator (%Biosimilar Drugs Cost Value) would be imperceptible, as the ATC code group for infliximab encompasses many drugs with a very high economic impact.
• The measure value: as the economic impact of biosimilar infliximab could be difficult to appreciate in hospitals with a high infliximab charge, the number of patients on infliximab was selected as the measured value for this indicator.
• The two indicators were designed in order to track two different approaches. The first to track the scenarios where the biosimilar is used in new patients starting on infliximab, and the second to track the switch from the originator to the biosimilar in patients with good control of the disease. Which approach was used was a policy decision made at each hospital.
After a whole year (2015) of monitoring of both infliximab indicators, a decision was made to include the first indicator in the current 2016 Contract Plan. This plan therefore includes both the %Biosimilar Drugs Cost Value and the percentage of patients on infliximab biosimilar (new patients).
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
Readers interested to learn more about market uptake of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
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Improvement in uptake of biosimilars in Spain
1. Derbyshire M. Improving biosimilars uptake: experience gained in Madrid, Spain. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016; Epub ahead of print