Avastin/Lucentis Update 16: And Now the Germans Join the Battle
The following is re-printed with permission of the publisher.
German health insurers launch study to compare Avastin to Lucentis in AMD
by Arjen Peters, APM Health Europe
BERLIN, Sept 19 (APM) – Several obligatory scheme health insurers in Germany have launched an evaluation of Roche's cancer drug Avastin (bevacizumab) in the treatment of wet-form age-related macular degeneration (AMD).
The objective is to compare the clinical efficacy but also the satisfaction of patients treated with Avastin in comparison to Novartis's Lucentis (ranibizumab), Eva Hansmann, head of the German federation of surgical ophthalmologists (BDOC), told APM.
Eventually, when the data collected has been evaluated, the German Federal Healthcare Committee (G-BA) will decide whether the off-label use of Avastin in AMD can become a service provided by the health insurance obligatory scheme, she added.
The initiative was taken at the beginning of May by the three health insurers Barmer, DAK and IKK Nordrhein in cooperation with the BDOC and the association of surgical ophthalmologists in North Rhineland (VOA Nordrhein).
Between times, other health insurers have manifested their interest in the project.
Each patient who is eligible for a treatment is informed on the current situation: three compounds equivalent from a therapeutic point of view but with annual costs of 14,100 euros for Lucentis, 9,350 euros for Macugen (pegaptanib) from Pfizer and 650 euros for Avastin.
"The three treatments are reimbursed. It is up to the patient to choose. We ask them to sign a consent form because of it being a study," a spokesperson for Barmer health insurers told APM.
NOVARTIS LEGAL CASE REJECTED
A legal case from Novartis to obtain an interim ruling for the immediate discontinuation of the study was rejected at the end of August by the Social Court in Düsseldorf.
The initiative does not have disproportionate disadvantages for the company and does not constitute anti-competitive practices but, on the contrary, increases the doctor's freedom of treatment and the patient's freedom of choice, the judges considered.
The health insurers' effort to sensitise the insurees to costs is considered in the verdict as being of "superior public interest" which is aimed at controlling health expenditure.
Novartis however remains confident about the outcome of the case, when it is treated on the merits.
"The Düsseldorf verdict is in complete contradiction with a previous judgement from the Federal Social Court," a spokesperson for Novartis' German arm said.
The Federal Social Court stipulated that a drug prescribed off label can be reimbursed in Germany only when there are no approved equivalent treatment alternatives.
The use of Avastin in AMD should consequently have ceased at the time of the launch of Lucentis, a derivative of Avastin, in February.
However, the treatment for AMD is not included in the current services immediately reimbursed by the German health insurance. Each case requires individual authorisation. The patient must pay the bill which is then reimbursed afterwards.
"Thanks to this particularity, doctors can continue to suggest Avastin instead of Lucentis," Eva Hansmann emphasised.
The federal insurance office (BVA) is assessing the legal validity of the study, a spokesperson for BVA told APM.
The German initiative is far from being unique. Ophthalmologist associations in the U.S. and the UK are reportedly preparing similar measures.
INDICATION EXTENSION IN ITALY
In Italy, Avastin received an indication extension at the end of May for AMD from the Italian medicines agency (AIFA), also at the request of ophthalmologists, Eva Hansmann explained.
In Germany, Avastin is largely used in AMD. In 2006, 25,000 out of the 35,000 treatments have employed cancer drugs. The 10,000 other treatments were mainly using the anti-inflammatory triamcinolone (6,200 cases) then Macugen (2,800 cases) and Lucentis (1,200 cases).
"Doctors are already used to Avastin in AMD while Lucentis is an unknown domain. The treatment for AMD is therefore clearly more secure with Avastin than with Lucentis," she said.
PROPOSITION RECEIVED WITH RESERVES
The health insurers are holding back with regard to the proposal from Novartis to finance treatments above sales figures of 315 million euros;.
"The game played by the industry is touching on insolence. They want to force a drug's sales and block the use of a treatment at least as effective but 22 times less expensive by refusing to develop it in this indication," commented a source close to the case.
Avastin and Lucentis are both vascular endothelial growth factor (VEGF) products by the U.S. company Genentech.
The German health insurers are looking unfavourably at the industrial manoeuvring around these products: Avastin is licensed to Roche and Lucentis to Novartis. Roche is the main shareholder for Genentech and Novartis holds 33% of Roche's capital.