Last twist in the pharmaceutical soap opera which opposes Roche to the State. Avastin® will indeed be used to treat age-related macular degeneration, against the advice of the Roche laboratory, which originally manufactures this drug against cancer. As a result, the State promises great savings: this treatment is billed thirty times less than its competitor, Lucentis®.
Since 2012, the two camps have been keeping score… But the game finally seems lost for the Swiss pharmaceutical giant Roche, which markets Avastin®. On several occasions, the laboratory has reaffirmed its opposition to the use of its product to treat AMD, originally marketed against cancer. However, the latter costs thirty times less than the other treatment prescribed against AMD, Lucentis®. While an injection of Lucentis® is billed at 895 euros, it would cost around ten euros for Avastin®, with equal effectiveness. The reimbursement of these injections weighs on the Social Security budget and even represents the first item of expenditure for the Social Security…
The discovery of the ophthalmological properties of Avastin® proves to be a godsend for the reduction of public expenditure. On August 27, the government forces Roche’s hand to be able to put in place an application decree allowing temporary use of Avastin® in the treatment of AMD. It will take effect on September 1, 2015 and “will allow significant savings to be made, while respecting patient safety”commented the Minister of Health, Marisol Touraine, in a press release.
Why does Roche refuse to use its own treatment?
For the first time, the temporary use of a drug is decreed without the agreement of the manufacturing laboratory. Because Roche’s refusal stems from strictly financial arrangements with its competitor Novartis, manufacturer of the very expensive Lucentis®. The two firms are suspected of illegal agreements, distorting competition. The case has been ongoing since 2014, when the competition authority raided the premises of the laboratories. A rare procedure.
Originally, Lucentis® was developed by Roche, which finally left its marketing to Novartis, which pays it royalties on the sales made. It is therefore easy to understand why Roche opposes the use of its own drug. Especially since the financial interests of the two laboratories are closely linked: Novartis owns a third of the capital of Roche.
A hope of savings for the Secu
Due to lack of demand for use by the manufacturer, the situation of Avastin® remained at a standstill until 2014. A year ago, the Assembly passed a law authorizing the temporary use of a drug for purely economic reasons, taking over the reins of the Avastin® business.
The only interest of this drug is to be cheaper. Compared to Lucentis®, Avastin® has the same efficacy and the same side effects. Since 2012, six studies have confirmed these results. Not surprising conclusions, because the two molecules, ranibizumab and bevacizumab, are extremely close. Both attack the formation of neovessels, feeding tumors. Thus, if Lucentis® is used in ophthalmology, it could also treat cancers, as specified in 2014 at the Health magazineFrançois Chast, Head of the Cochin Hospital Pharmacy Department.
Avastin® more expensive than expected?
On the strength of these results, the French Medicines Agency (ANSM) voted unanimously for the recommendation of temporary use(1) of Avastin® in patients suffering from AMD. It will be tested for a period of three renewable years, in certain hospitals in the Paris and Lyon region, for example. Temporary use must take place under strict administration conditions, reserved for hospital staff.
A question then arises for hospital pharmacists: how to repackage an anticancer solution usually administered by infusion? According to the ANSM, Avastin® must be injected into the eye using intravitreal syringes. Because of this repackaging, the Avastin® bill could then be higher than expected… From 10 euros, according to the publication in the Official Journal, to 78 euros according to The world.
Mop up 5% of the Social Security deficit
Until then, France was the only country in the world where Avastin® was prohibited in the treatment of AMD. In the United States, 55% of patients are treated with the molecule. One of the avenues for improvement for packaging could be found in Germany, where a laboratory (Apozyt) directly markets Avastin® at doses suitable for the treatment of eye disease. In early 2013, Novartis sued the laboratory for unfair competition before the European Court, before being dismissed…
Even if it turns out to be more expensive than expected, the use of Avastin® should make it possible to make considerable savings by absorbing nearly 5% of the Social Security deficit, according to François Chast (2). The drug is prescribed for the treatment of the wet form of AMD, which is 20% of cases. In France, this degeneration remains the leading cause of visual impairment for people over 50.
—
(1) The Temporary Use Recommendation (RTU) allows a drug to be used outside of its primary use
(2) Estimate based on Avastin® at around 30 euros