Biosimilars for ophthalmologic indications are expected to save payers and the health system a great deal of money, based on the assumption that the comparator product (generally a reference product) is costly. However, this is not really the case. The most commonly used biologic for indications such as age-related wet macular degeneration or retinal vein occlusion is a compounded version of the reference drug Avastin®.
Compounded bevacizumab has been used for many years, and has generally been utilized without negative outcomes. It costs a fraction of the amount for Lucentis® or Eylea®. As a result, it has dominated the biologic market for these ophthalmologic indications, accounting for more than half of marketshare.
Yet Another VEG-F Inhibitor Option
The introduction of biosimilar versions of bevacizumab raises the next logical question: are compounded biosimilar versions less expensive and just as effective?
A new report from Cardinal Health released this week delves into this question with 80 ophthalmologists/retinal specialists who administer these intravitreal injections. Although some still prefer to use reference products like Eylea, comfort levels with compounded versions of biosimilar bevacizumab are already high amongst those surveyed. Outside of a preference for the use of high-dose Eylea (8 mg) vs. 2-mg doses of biosimilars (which potentially increases the time between injections), nearly four-fifths of the ophthalmologists said they will be at least “somewhat likely” to consider aflibercept biosimilars once they are available for use in their patients with retinal disorders.
Eighty percent of the respondents indicated they were comfortable using the biosimilar for this off-label ophthalmologic indications, which is the case for the injection of compounded bevacizumab. In addition, 88% believe that there were no specific retinal disorders for which biosimilars would not be prescribed.
Doctors’ greatest concern with prescribing compounded Avastin in ophthalmology has been the safety of the compounding process, which can result in a risk of endophthalmitis (less than 0.5%). Cardinal Health researchers asked the participants if any one biosimilar was associated with special challenges in terms of compounding. Thirty-five percent indicated that they had no difficulty using compounded biosimilars in their practice; 33% specified that they do not use compounded biosimilars for their retinal patients. Between 12% and 14% answered that they had problems compounding one of these specific bevacizumab biosimilars. Typically, Avastin was compounded for these practices through an outsourced facility. The researchers did not report whether these challenges involved finding a facility that can compound the drug or the existence of another issue.
Overall, 39% of the 80 retina specialists participating in the survey said they have not yet prescribed ranibizumab biosimilars or bevacizumab biosimilars. However, the majority stated that they would have little to no problem if the health plan or payer required that these biosimilars be used for their retinal patients.
Is It the Reimbursement Dollars or not?
The survey results raise some interesting contradictions, based on the real-world observations. The intravitreal injectable products are most-commonly purchased and reimbursed through the buy-and-bill method. They are covered under the medical benefit, purchased by the doctor’s practice, injected in the exam room, and reimbursed by the health plan. Therefore, a considerable financial incentive exists to favor higher-cost therapies. Cardinal Health researchers state that 70% of these specialists believe that costs-savings associated with biosimilars is at least “moderately important,” and that “more than 40% of participating retina specialists said cost savings are an ‘extremely’ or ‘very’ important consideration when evaluating whether to use biosimilars or reference products.”
In any case, the utilization of lower-cost ranibizumab biosimilars has been slow relative to the use of the reference products Lucentis and Eylea. According to the latest Samsung Bioepis Biosimilar Market Report, the two ranibizumab biosimilars have only 40% of the ranibizumab marketshare (and the ranibizumab marketshare overall is a fraction of that for Eylea).
It would be interesting to determine the actual cost difference between compounded Avastin and compounded bevacizumab biosimilars. Medicare, the principal payer for these products, reimburses something less than $100 per 1.25 mg for compounded Avastin, so there isn’t a lot of room for big savings. If Outlook Therapeutics, which is seeking FDA approval for its manufactured ophthalmologic bevacizumab formulation, prices its product higher than this figure, that might result in a step-therapy requirement, in which patients must try the lower-cost compounded bevacizumab biosimilar first.
If the responses from Cardinal Health’s research are accurate, at least some ophthalmology and retina specialists are willing to try bevacizumab biosimilars.
