Social court Aachen decides: Legally health insured with an eye disease must receive the original drug

The Social Aachen ruled on 11/03/2010 that legally-insured patients with the disease wet age-related macular degeneration, the so-called "wet AMD," would have a claim for this disease treated with the drug Lucentis ® to be approved. A reference to the cheaper but for the ophthalmic area not approved funding Avastin ® is not allowed. Lucentis ® in Germany is thus the only agent approved for this disease.

Social court Aachen, sentence from March 11, 2010 - S 2 (15) KR 115/08 KN (not legally binding)

Macular degeneration and Avastin: News 24/11/2009

In a press release was issued today stated that the cost of testing by the British Ministry of Health have the drug Avastin again rejected as too expensive. According to the release, the verifier first relates to the treatment of Avastin and stomach cancer. A statement regarding macular degeneration, and Avastin and macular degeneration and the much more expensive Lucentis first remains to be seen.

Macular degeneration and Avastin: legal issues

Since 2005, the drug Avastin will be used against the problematic vessel growth in wet macular degeneration. To date, this drug is not for the treatment of macular degeneration officially approved. The manufacturer of Avastin, which is also the manufacturer of Lucentis plans, no approval of Avastin for the field of ophthalmology. Due to the lack of approval for the treatment of macular degeneration and official instructions are missing on potential adverse effects of its use in the eye. Nevertheless, it appears the administration of Avastin, a widely used allopathic methods for the treatment of wet macular degeneration to be.

Avastin was originally comes from the Cancer Research and for example, often used against cancer. In a tumor treatment, the drug Avastin is injected directly into a vein in your arm. Due to the propagation through the bloodstream, it often leads to side effects throughout the body. With the injection of Avastin in the area affected by wet macular degeneration eye, the dose used is much lower and is therefore considered to be fewer side effects. The drug Avastin inhibits angiogenesis on the one hand and seals from other vessels, hence the use in wet macular degeneration. It is an antibody with the drug bevacizumab, which vessel-building, called VEGF-Hormone (VEGF: Vascular Endothelial Growth Factor) is blocked, thus preventing the blood supply of tumors.

The goal, therefore, is a low release of VEGF hormone. .

It may have been found to block the Avastin on this mechanism of action and the abnormal growth of blood vessels in wet macular degeneration and seal leaking blood vessels. At best, it seems possible by a wet macular degeneration back into a dry macular degeneration and thereby preventing the normally serious vision loss through the abnormal vessel growth with a wet macular degeneration.

A so-called off-label therapy, so a drug that can also help with other diseases than those for which it was approved, is allowed in Germany, unless another approved method for this area is available. Since the approval of Macugen and Lucentis, therefore, a certain legal problem is the use of Avastin for wet macular degeneration. Ophthalmologists Avastin in wet macular degeneration in the eye splash move therefore in a legal gray area.
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Macular degeneration & Lucentis / Avastin / Macugen: Implementation of injections

The drug is intravitreal, i.e. directly into the back of the eye (vitreous body) was injected. This is in the so-called Pars Plana, instead of about 4 mm from the edge of the cornea removed. You turn in ophthalmology at such intravitreal injections to bring high drug concentrations at the site of action directly. This approach aims to also aimed to reach as low drug concentrations in the rest of the body, in order to reduce possible side effects outside of the eye. Since the effect of time in the vitreous and the retina by natural degradation decreases, a repeated injection every 4 (Lucentis, Avastin) to 6 (Macugen) reach weeks necessary to ensure a continuous effect on pathological vessel formation in wet macular degeneration. The injections are ambulatory and done under local anesthesia (drip anesthesia) and should be mostly painless. According to Pfizer, the therapy lasts for wet Macular Degeneration 1-2 years. Currently, initially given three injections in the monthly interval and then a decision is made whether more are needed. In most cases, to be expected that the treatment be carried out continuously at wet macular degeneration have, as always, there is a tendency to a renewed "undesirable" vessel growth (as is also the experience with PDT) shows that the cause (poor metabolism, blood flow in the macula, etc.), ie the dry macular degeneration persists.
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Macular degeneration and Avastin / Lucentis: Risks

Despite sterile precautions must be observed continuously during surgery of macular degeneration sufferers as it can possibly lead to an increase in intraocular pressure.

The following complications are also known:
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Macular degeneration and Avastin / Lucentis / Macugen: Achievements

As a big success in wet macular degeneration to improve the quality of vision is given. This means, for example, that the Amsler test "will be less crooked lines" or see the big spot in the middle of the field is smaller and thus the patient get better looks. The aim of most studies is to achieve a "stabilizing" effect. In the "Study jargon" "will improve" but often only as a slowing of the normally regarded held without treatment visual acuity loss in macular degeneration. Therefore, the success to the effectiveness of various drugs in the treatment of wet macular degeneration, which are circulating in the media can be seen, critical as they are often based on the study perspective.

In the best case, if any risks and side effects, can convert the said vessel growth inhibitor-related macular degeneration, a wet to a dry macular degeneration. Of course, in the course of treating macular edema disappear and thus the distortion and vision loss caused thereby. Nevertheless, the dry form of macular degeneration are and hence the tendency to progressive visual loss.

According to doctors can do something 20% of all patients with wet macular degeneration can not be helped. The most common reason is that the disease has already progressed to macular degeneration too far (scars in the retinal center). The injections, according to the manufacturer must be repeated one or two years of regularly every 4-6 weeks for the duration as.
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Makuladegeneraton & Avastin / Lucentis: Approval

Avastin, it is said in the trade press, is now the world health standard.

The same company that makes Avastin has also admitted in late January 2007, a new drug for wet macular degeneration for the German market. The newer drug called Lucentis, ranibizumab contains the active ingredient, but inhibits vascular growth in macular degeneration in the same way as Avastin. These are modified to cleavage product of Avastin. Clinical studies, it is said, could prove, however, that Lucentis and Avastin for macular degeneration contribute equally well. However, Lucentis was specifically tested for the treatment of macular degeneration and officially approved it. An authorization for Avastin for use in wet macular degeneration is not planned by the manufacturer.
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Macular degeneration & Lucentis: side effects

The manufacturer of Lucentis reported side effects of this drug in treating macular degeneration (also associated with the injection procedure) side effects: Serious adverse events were associated with the injection process and <0.1% of intravitreal injections have occurred, were endophthalmitis, rhegmatogenous retinal detachment. Partial tear of the retina and iatrogenic traumatic cataract. Adverse effects occurred in controlled trials more frequently in Lucentis-treated patients with macular degeneration than in the control group: Very common: conjunctival hemorrhage, eye pain ...and another 59 side effects (very frequent, frequent and occasional) of Lucentis injections for wet macular degeneration ..
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Macular degeneration and Avastin / Lucentis: Fee

Treatment with Lucentis costs about € 1.600, - per injection. A Avastin treatment costs about € 40, - per injection. The newer drug to treat macular degeneration with almost the same drug is so expensive at the 40-fold.

It has been calculated for all patients treated with macular degeneration in Germany with Avastin, would have to spend the funds estimated to be 100 million €. However, to treat the same number of patients with Macular Degeneration with Lucentis, would approximately three billion euros each year to spend. This represents about one-eighth of the entire German pharmaceutical budget.

In the U.S., the U.S. firm Genentech said in October 2007 in a letter to all ophthalmologists in the U.S., which they could not get more from December in macular degeneration the drug Avastin. The manufacturer would like you to apply only the drug Lucentis for the treatment of macular degeneration.
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Macular degeneration and Avastin / Lucentis: particular side effects

Reported that adverse events were now aware that could make use of Avastin and Lucentis for macular degeneration of the question. Shortly after Lucentis was approved in Germany for treating macular degeneration (late January 2007), studies from the United States told of dramatic side effects. In the United States used against Lucentis macular degeneration for some time

There was a study of 5,000 affected by macular degeneration, in which not only the effectiveness of Lucentis in macular degeneration, but should be explored especially the side effects and safe use of Lucentis.

Six months after studies showed that increased obviously in the treatment of macular degeneration with Lucentis, with correct dosage, the risk of suffering a stroke, four times.

Whether the risk of prolonged use of Lucentis for macular degeneration may possibly even increase, was not yet known. In the press it was said, eye doctors had already suspected the like, as the drugs of Lucentis and Avastin not only selectively inhibit angiogenesis in the eye with macular degeneration, but throughout the body affected by macular degeneration patients. Of particular concern are Lucentis and Avastin, therefore, in view of the fact that most of those affected by macular degeneration have already reached an age in which they often have long been suffering from cardiovascular ailments.
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Macular degeneration & Macugen: General

The drug Macugen was approved in February 2006 in Germany for the treatment of wet macular degeneration. It is like Avastin and Lucentis is injected directly into the vitreous cavity of the eye affected by macular degeneration. On the Web site of Pfizer, the current German manufacturer of Macugen is reported that Macugen for macular degeneration every 6 weeks, then nine times per year injected into the eye needs.
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Macular degeneration & Macugen: side effects

About Macugen, or in connection with the injection process, the following side effects in the treatment of wet macular degeneration are known:

Adverse Reactions: The safety data are a summary of all potentially on the procedure and medication related adverse events in the 295 patients in the treatment group that was treated in controlled studies with 0.3 mg.

Eye diseases according to frequency: The following ocular adverse reactions were assumed to be of possible causal relationship related to treatment (either with the injection procedure or Macugen). In most cases, these side effects have been attributed to the injection procedure.

Very common: inflammation of the anterior chamber of the eye, eye pain ...and 94 other side effects (very frequent, frequent and occasional) injections of Macugen for wet macular degeneration. .

Post market introduction: Rare cases of anaphylaxis / anaphylactoid reactions, including angioedema have been reported in patients who received pegaptanib combined with other drugs as part of the injection preparation.

Please also note the expert information.
Stand: Januar 2006

In case of any irregularities that might indicate complications, the doctor should be notified as soon as possible.
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