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Physician Views: What commercial impact for Eylea from the Protocol T study in diabetic macular oedema?

Physician Views: What commercial impact for Eylea from the Protocol T study in diabetic macular oedema?


It seems that controversy over the use of off-label Avastin as a much cheaper alternative to Lucentis for the treatment of various ophthalmic indications is never far from the surface.

A recent article published by the British Medical Journal claims that Novartis (which markets Lucentis in Europe) sought to block studies in the UK that were comparing the effectiveness of the two drugs for the treatment of wet age-related macular degeneration (AMD).

It is the US market, where Roche markets both Avastin and Lucentis (the latter is a fragment of the former's full antibody), where off-label use is more extensive, but the practice occurs across numerous global markets.

Lucentis is not the only approved AMD therapy impacted by the practice, although Regeneron Pharmaceuticals and Bayer's Eylea has performed extremely well since launching in 2011. With approval of Lucentis and Eylea for the treatment of diabetic macular oedema (DME) having occurred last year, however, and with this indication expected to act as a key driver of growth for Eylea in particular, some emphasis is shifting to off-label Avastin use in the DME setting.

This is particularly pertinent for Regeneron and Bayer as data from the NIH-sponsored Protocol T study, which was published in February, appears to confirm Eylea as a notably superior therapy to both Lucentis and Avastin for the treatment of DME (ViewPoints: Protocol T could be the gift that keeps on giving for Regeneron's Eylea).

Converting any clinical advantage to the commercial setting may prove challenging, however, given the significantly lower cost of Avastin, at around $50 for a single injection versus approximately $1950 per injection for Eylea.

Reasons to Purchase

To better ascertain the impact of the Protocol T study results on uptake of Eylea, FirstWord is this week polling both US and EU5-based ophthalmologists. Specifically we are asking them…

  • Which therapy (Lucentis, Eylea or Avastin) they expect to be using most frequently for the treatment of DME in five years' time?
  • How significant a role do you think data from the NIH-sponsored Phase III Protocol T study will play in driving overall usage of Eylea for the treatment of DME?
  • In the first-line setting, what level of overall switching (or alternative new start drug) from off-label Avastin to Eylea they expect to occur on the basis of data from the Protocol T study?
  • Whether they expect this level of switching/alternative new start drug (i.e. Eylea in favour of off-label Avastin) to be more pronounced in DME patients with severe vision impairment?
  • Whether they agree with the suggestion that the authors of the Protocol T study results have understated the benefit that Eylea demonstrates versus Lucentis and Avastin for the treatment of DME, possibly in deference to their belief that the performance of Avastin looks 'good enough' given its much lower price?

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