- Twelve clinical commissioning groups in the north of England have won the right to used Roche’s Avastin off-label in the blinding condition wet age-related macular degeneration (AMD).
- The contested policy, which the U.K. High Court has now ruled as lawful, determined Avastin should be offered to certain patients with wet AMD “as the preferred treatment option.”
- The decision was largely cost-based. Avastin is around £28 ($37) per injection, compared with £816 ($1,017) per injection for Regeneron Pharmaceuticals and Bayer’s Eylea and £551 ($723) for Roche and Novartis’ Lucentis.
Avastin (bevacizumab) only has U.K. approval for metastatic colorectal cancer, yet it continues to be widely available in a preparation for ophthalmic use — and is often used off-label for wet AMD.
Back in 2015, 120 clinical commissioning groups (CCGs) got in touch with the General Medical Council, the Department of Health and NHS England to request clarity on whether physicians could use Avastin in wet AMD. At the time, a U.K. government minister ruled that its use was illegal.
The High Court’s decision overturns that ruling.
In what could be a game-changer for the U.K., Philippa Whipple, a judge for the High Court of Justice, found it lawful to use Roche’s Avastin instead of Eylea (aflibercept) or Lucentis (ranibizumab), both of which carry ophthalmology indications and recommendations from the U.K.’s National Institute for Health and Care Excellence.
All three drugs target the same signal protein, but Avastin’s per injection price tag is significantly lower.
Bayer and Novartis made several arguments to oppose the use of Avastin over Eylea or Lucentis:
- supplying Avastin to treat wet AMD was unlawful under EU codes
- Avastin did not have a marketing authorization for ophthalmic use
- the ophthalmic use of Avastin “fundamentally undermined the objective of the Medicines Directive”
- the ophthalmic use of Avastin undermined patients’ “rights of access” to Eylea and Lucentis
- the Q&A document and patient information leaflet with the policy were “misleading and inaccurate in material respects.”
The High Courts decision was met with mixed reactions.
“This extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust,” said Sheuli Porkess, deputy chief scientific officer of the trade body the Association of the British Pharmaceutical Industry, in a Sept. 21 statement.
“As we exit the EU and the UK Government is looking for regulatory co-operation between the UK and the EU, this confusion is deeply unhelpful,” she added.
Edit Kovalcsik, managing pharma analyst at GlobalData, stated on Sept. 24 that of the seven major pharmaceutical markets, the U.K. ranks second largest for AMD treatments.
Given that Avastin’s off-label use has already dramatically shaped the AMD market in the U.S., the High Court’s ruling could mean a similar splash is heading for the U.K.
“As a result of NICE’s new guidance brought out in January 2018, which deemed Avastin as safe and as effective as the licensed anti-VEGFs, and the court case won by the NHS CCGs last week, GlobalData expects that off-label Avastin use will penetrate the UK wet AMD space reducing UK AMD sales share,” Kovalcsik said.