Cost effectiveness of a filgrastim biosimilar

February 23, 2012 9:14 AM


Are biosimilars cost-effective? What about next generation originators which are promising to increase patient compliance and reduce treatment costs? An article which was published on Journal of Oncology Pharmacy Practice evaluates this by comparing three G-CSFs on the European market.

Filgrastim was one of the first targets of biosimilar manufacturers. In the EU, there are 3 filgrastim biosimilars approved under 7 brand names.

There scientists, Matti Aapro, Paul Cornes and Ivo Abraham wanted to evaluate the cost-efficiency of granulocyte colony-stimulating factors (G-CSF) and compared filgrastim (originator Neupogen-Amgen, biosimilar Zarzio-Sandoz) and pegfilgrastim (Neulasta-Amgen) against a time horizon of 1-14 days of treatment and across the EU G5 countries.

After giving some information about febrile neutropenia and the mechanism of action, usage and administration of G-CSFs,  the authors also described biosimilars and the situation in the EU and USA.

Countries: The analysis was focused on the European G5 counties, namely Germany, France, Italy, Spain and the UK.

Cost model: The model was a cost-efficiency model of the direct costs of a buyer or payer would incur when purchasing or covering any of the three agents in one patient during one chemotherapy cycle. Indirect costs were not included as the focus was on the actual cost of a purchasing or reimbursement decision: the incurred cost of delivering goods as subtracted from total revenue in the calculation of gross margin prior to consideration of administrative and selling costs.

Model assumptions and inputs: As a first assumption, the authors declared that, according to the basis of comparative noninferiority trials of Neupogen and Neulasta, and the approval process for Zarzio with Neupogen as its reference product, they assumed there were no significant differences in efficacy or safety between the three products.

Additionally, they considered the incidence constant and variability in incident and prevalent febrile neutropenia cases during any given cycle of chemotherapy a function of only the relative size of each country’s population. Besides, there were several other assumptions made by the authors, to be able to compare these three products in five different countries.

Results: The cost of Neulasta is fixed but the cumulative cost of treatment with Neupogen evolved from its unit dose cost of €128.16 (1 day) to €1794.30 (14-day course), compared to €95.46 to €1336.46 for Zarzio. The cost-savings associated with Zarzio over Neupogen treatment ranged from €32.70 for a 1-day to €457.84 for a 14-day regimen.

Discussion:  The principal findings of this comparative cost-efficiency analysis were that Neulasta yields a cost-savings benefit if G-CSF treatment equivalent to 12 or more days of Neupogen is required to bring the ANC back to the target of greater than or equal to 10,000/mm3, but that, under any treatment regimen, Zarzio is consistently more cost-efficient than both Neulasta and Neupogen.

Conclusion: Using the EU G5 unit dose costs for the three G-CSFs under consideration, the budget impact of prophylaxis or treatment of febrile neutropenia with Zarzio is cost-efficient under all possible treatment scenarios relative to Neupogen and to Neulasta – and across tumor types. In the absence of convincing evidence that pegfilgrastim is pharmacotherapeutically superior to standard filgrastim, there is no cost-efficiency rationale to treat with Neulasta over Zarzio, though there may be a small window of approximately 3 days where Neulasta is cost-efficient over Neupogen, the authors noted. Regardless, their analysis showed Zarzio to be the most cost-efficient approach to reducing the incidence of febrile neutropenia in chemotherapy-treated patients, thus providing the best value for the prophylaxis and treatment of febrile neutropenia.

Editor’s comment: This conclusion is an expected result as biosimilars offer cheaper treatment options and new-generation biopharmaceuticals will always be expensive than the previous one. But this study gives us a clear picture of the upcoming comparison studies, when biosimilars of monoclonal antibodies reach the market.

Source: Aapro M, et al. Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutopenia. J Oncol Pharm Pract. 2011; 0(0):1-9.

4 Comments

  • John
    Twitter: _TheSilverFox

    This is a great study on the cost-effectiveness of biosimilars. There have been serious claims regarding the potential savings and affordability of new low cost medications, which have been exaggerated in many cases. I appreciate this study because so few have been done to refute some of the outlandish claims of biosimilar development. Here is a great primer on biosimilars that includes some more details on biosimilar savings.

    http://bit.ly/A8ATby

  • Amy
    Twitter: NBiosimilars

    I would agree with John that this study gives a positive spin on biosimilar development. This study clearly dispels many of the rumors with actual factual information and not just someones out of this world opinion. Eventhough the development costs for for biosimilars will be high I hope that investors and potential biosimilar developers can see that this will pay off in the end.

  • Yamak
    Twitter: ymk108

    If you include Indian Bio-similar players like Biocon , Dr.Reddy’s Lab , Intas Biopharmaceuticals with this current comparison than its really fruitful. They have developed Cost effective & better quality bio-similar & will capturing regulatory markets in coming years.

    • Biosimilar News

      Sir, just to note to avoid any misunderstandings:
      This study was based on the prices in European G5 countries of three products and none of the Indian biosimilar players you mentioned have their products on the market in the EU, yet.

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