Novartis’ new treatment for macular degeneration might have to fight against Roche’s cancer drug Avastin.
Novartis is developing brolucizumab as a follow-up medicine of Lucentis (ingredient: ranibizumab). Its competitor is not Bayer’s macular degeneration drug Eylea (aflibercept) but Roche’s Avastin (bevacizumab), industry watchers said.
|Roche’s colon cancer drug and macular degeneration treatment Avastin
Novartis said on Monday that the U.S. Food and Drug Administration accepted the company’s biologics license application (BLA) for brolucizumab for the treatment of wet age-related macular degeneration (nAMD) and a priority review request.
Brolucizumab proved efficacy and safety in phase-3 HAWK and HARRIER trials on over 1,800 patients with nAMD across about 400 sites worldwide.
Brolucizumab met the primary efficacy endpoint, showing non-inferiority to Eylea in best-corrected visual acuity (BCVA) at week 48.
Novartis hopes to roll out brolucizumab in the U.S. within the year, preparing it to beat Eylea. However, pharmaceutical industry analysts do not seem to agree with Novartis’ anticipation.
In the macular degeneration treatment market, colon cancer drug Avastin is more competent than Eylea.
The most significant issue in treating nAMD is Avastin’s use for broader indications in the U.S.
The controversy began in 2011 when a CATT trial result was published in the New England Journal of Medicine (NEJM) which demonstrated non-inferiority of Avastin to Lucentis in the treatment of AMD.
Just like in Korea, Avastin is much cheaper than Lucentis in the U.S. The price gap prompted ophthalmologists to use Avastin for eye disease, not for cancer frequently.
If a patient divides Avastin 100ml into multiple doses, he or she can benefit from four-time treatment of Lucentis.
In Korea, Lucentis 10ml’ maximum cap of insurance price is 828,166 won ($728.6), and the insurance benefit is limited to 14 times of use.
In contrast, the maximum insurance price of Avastin 100ml is 332,700 won, and 400ml, 1.08 million won. The off-label prescription usually costs over 100,000 won.
The Ministry of Health and Welfare said on April 1 that it would ease off-label prescription criteria through revising the rules on the off-label use of non-reimbursable drugs.
If the amendment takes effect, clinics can prescribe Avastin.
Avastin makes it easy for patients to get access thanks to its low price, but critics raised safety concerns over the use of the drug by dividing them into multiple doses.
In the U.S., patients who had injections from repackaged Avastin reported Streptococcus endophthalmitis, a serious eye infection. The FDA warned that repackaged intravitreal injections of Avastin could cause Streptococcus endophthalmitis.
Local experts said the authorities should preemptively check safety issues before the use of Avastin for macular degeneration spreads.