- Fiona Godlee, editor, BMJ
Drug
treatment for age related macular degeneration is one of medicine’s
success stories. As Ning Cheung and colleagues explain (doi:10.1136/bmj.e2970),
anti-vascular endothelial growth factors are preserving and restoring
vision to millions around the world. But a related and less edifying
story is stealing the limelight: ranibuzimab (Lucentis) versus
bevacizumab (Avastin). It casts a shadow over this great medical advance
and puts the world’s drug development and licensing systems under the
spotlight.
In its anti-cancer drug, bevacizumab, drug
developer Genentech has created what may be the world’s first “not me”
(as opposed to “me too”) drug, say Robert Campbell and colleagues (doi:10.1136/bmj.e2941).
Despite evidence that it works in macular degeneration, the
manufacturers and marketers (Roche in the US, Novartis in the UK and
elsewhere) are actively discouraging its use for this condition, even
going so far as taking legal action to prevent such off-label use. Why?
Because they want people to use their other drug, ranibuzimab, which is
licensed for treating macular degeneration.
The bottom
line is that ranibuzimab is about 12 times more expensive: Cheung and
colleagues report that the UK could save close to £300m (€368m; $485m) a
year if it were standard treatment. So are Roche and Novartis simply
fighting to protect their profits? They say no, that they are also
protecting patients from the cheaper drug’s higher risk profile.
Although data from the publicly funded CATT trial in the US found
similar effectiveness and safety for the two drugs in treating macular
degeneration, the safety of bevacizumab remains a worry. Concerns relate
to its greater systemic absorption and the fact that it has to be
decanted into smaller quantities for intraocular injection, which
introduces the risk of infection.
Whatever the
motivation, the company has done all it can to limit the use of
bevacizumab outside cancer, most notably by not applying for regulatory
approval for use in patients with macular degeneration. Some health
systems are finding ways round this, as Campbell and colleagues explain.
But the combination of legal threats, safety concerns, and financial
incentives to use ranibuzimab has maintained the more expensive drug’s
lucrative market. Sales in the US in 2010 topped $1.8bn.
In the UK, as Ingrid Torjesen reports (doi:10.1136/bmj.e3012),
efforts are under way to get bevacizumab approved for use in macular
degeneration despite resistance from Novartis. The National Institute
for Health and Clinical Excellence has said it could appraise the drug
if asked to by the Department of Health. Campbell and colleagues report
that the department is waiting for the results of the IVAN trial in the
UK, due to be published this month. But it is unlikely to resolve the
safety concerns. Neither this nor the CATT trial was big enough to
detect small but clinically relevant differences in adverse outcomes
such as stroke, they say. Long term postmarketing surveillance is needed
for that.
So what’s to be done in the best interests of
patients and the public purse? Campbell and colleagues call for clear
guidance to use bevacizumab from professional organisations, a review of
policies that discourage off-label use if there is good evidence for a
drug’s use, and better communication among health technology assessors
in different parts of the world.
Notes
Cite this as: BMJ 2012;344:e3162
Footnotes
- Follow BMJ Editor Fiona Godlee on Twitter @fgodlee and the BMJ @bmj_latest
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