8th GD Annual Meeting, 30 and 31 March 2004,
Martin-Luther-University Halle-Wittenberg, Germany

Press Releases

Health reform: bitter pills for dermal patients

Wide-spread disease skin cancer: more than 100,000 incidences per year

The protein building block Agmatin improves dry skin

Breakthrough in the therapy of psoriasis

Press contact:

Dr. Joachim Kresken
Wiesengrund 6a
47918 Tönisvorst

Tel.: 02162-6517
Fax: 02162-80589
E-Mail: joachim.kresken@gd-online.de

Health reform: bitter pills for dermal patients

As of 1 January 2004 patients have to pay many dermo-pharmaceuticals out of their own pocket

(Halle, 31 March 2004) The health service reform involves drastic financial cuts for patients suffering from frequently recurring skin diseases. As the GD Gesellschaft für Dermopharmazie informs on the occasion of its 8th Annual Meeting in Halle on the Saale, in particular numerous dermo-pharmaceuticals for the prevention of diseases are no longer reimbursed by the compulsory health insurances and have to be paid now by the patients out of their own pocket.

Last year dermatologists issued in Germany a total of 36 million prescriptions. Thereof 52 percent account for nonprescription medicaments which are no longer refunded. "This fact will lead to a significantly higher financial burden particularly for patients suffering from chronic dermal diseases", fears professor Dr. Roland Niedner, department head of the Klinik für Dermatologie (Clinic for Dermatology) at the Clinical Center Ernst von Bergmann GmbH in Potsdam. What is available for sale over-the-counter in pharmacies may be prescribed by the physician only in certain exceptional cases to the debit of the health insurance fund in the future. "Among them are some essential ointments and creams which patients suffering from chronic eczema should apply to prevent the recurrence of the disease". However, also numerous dermo-pharmaceuticals which do not pertain to prophylaxis are no longer paid by the health insurance: thus women and men who tend to an excessive perspiration had got as yet a prescription for a gel containing the active substance aluminium chloride hexa hydrate on panel prescription. "Today patients have to pay the gel themselves. The costs for the gel amount to 15 to 20 Euro per month", professor Niedner calculated.

Medically sensible - though no longer refunded

A different example: ointments and creams containing the active substance hydrocortisone acetate which is frequently used in the abating phase of an acute neurodermatitis: the health insurances only refund prescriptions for adults if the active substance concentration is above 0.25 percent. "The application of the weaker concentration of 0.25 percent is however in many cases sufficient and medically more indicated than higher concentrations which are still reimbursed", professor Niedner explains. "Frequently it may be the case that the physician asks the patient whether he is willing to pay the more sensible product or prefers to use the less appropriate one with the higher concentration on panel prescription". The patient has to bear the costs for fifty grams of a 0.25-percent hydrocortisone cream - depending on the product - between 7.90 and 12.46 Euro in contrast to an extra payment of only 4.50 Euro for a panel prescription whereas he had to pay 4.50 Euro of statutory extra payment before in case of a panel prescription.

Refunding of prescription-free drugs only in exceptional cases

The president of the GD Gesellschaft für Dermopharmazie, Dr. Joachim Kresken considers a conjunction of compulsory prescription and refundability "questionable as concerns legal as well as health political aspects". As a rule, over-the-counter drugs are today - irrespective of their therapeutic effectiveness - no longer reimbursed by the compulsory health insurance. Exceptions from this rule only apply to prescriptions for children until the completed 12th year of age, adolescents with retarded development until the completed 18th year of age as well as to the treatment of severe diseases for which non-prescription drugs are considered to be the therapy standard.

For the practising dermatologist the question poses how to react on the omission of the refundability for prescription drugs. According to § 12 Sozialgesetzbuch (SGB V) (Social Security Code) each contract physician is further on in principle obliged to prescribe appropriately, sufficiently and economically. Dr. Kresken: "this means that also over-the-counter drugs are to be further applied if they are medicinally indicated, appropriate and sufficient for the treatment of a dermatological disease. A medically not justifiable switching to a more expensive prescription drug by the physician may be interpreted as breach of the precept of an economic prescription and taken up in the scope of cost effectiveness analyses".

"Green prescription"

Against this background, according to Kresken, it is recommended to continue prescribing over-the-counter drugs in the future, however not to issue the prescription on a panel prescription but on a so-called "green prescription". By using this recently established form, the physician signalizes the patient that he considers the prescription in question to be medically indicated and would have made it in the form of a panel prescription before coming into effect of the health service reform. In fact, patients are not able to submit the prescription for cost reimbursement at their health insurance, may however assert the amount in certain circumstances at their tax computation.

Lower prices for high-price drugs - higher prices for low-price drugs

Changes in the course of the health service reform also include the prices of all prescription ready-to-use drugs. Some expensive drugs the pharmacy selling prices of which exceeded 29 Euro until 31 December 2003 are distinctly less expensive under the new regulation. Thus the price for a specific drug for the treatment of the malignant melanoma is now 1.863,31 Euro instead of 2.128,52 Euro. Vice versa the prices for products which were before in the one-digit area have increased by up to several hundred percent. One pack of 20 cortisone tablets (Prednisolon 2 mg) with a price of 1.58 Euro last year is now charged with 10,31 Euro.

Further changes: Also dermatological prescriptions including creams and ointments which are individually prepared in the pharmacy have become more expensive. The labor prices for pharmacists have increased from 2.24 Euro to more contemporary 5 Euro. An additional problem consists in the fact that drugs are only refunded for the indications for which they are authorized. Professor Niedner: "this has a negative impact above all in case of seldom skin diseases as many active substances have proven successful for a series of symptoms and diseases without a direct authorization established for their application". For example the active substance Ciclosporin available in the form of capsules and as solution which is among other indications also approved for the treatment of severe forms of psoriasis is equally effective for the treatment of lichen of the mucous membrane, is however not authorized for the treatment in this field of application.


Wide-spread disease skin cancer: more than 100,000 incidences per year

Manual workers as well as sunbathers are particularly jeopardized

(Halle, 31 March 2004) The number of patients contracting cancer of the skin is permanently on the rise. Far more than 100,000 people develop at present different forms of skin cancer in Germany year after year. Experts count on a yearly growth rate of three to eight percent. Thus skin cancer is considered to be a 'popular' disease and has become an increasing burden for the health care system, according to information spread in the course of the 8th Annual Meeting of the GD Gesellschaft für Dermopharmazie in Halle.

Basically three different types of cancer of the skin are distinguished: basalioma, spinalioma, and the malignant melanoma. Basalioma and spinalioma which are also denominated as "light cancer of the skin" are worldwide the most wide-spread cancers of the skin. They develop mostly at the so-called 'sun terraces' as nose, ears, bald head, lips or around the eye region and moreover at the hands and forearms. Concerned are above all roadmen, countrymen, seamen or mountain guides who have been oftentimes exposed to the sun not at all or insufficiently protected over years or decades. Nevertheless, both skin cancer types become often only perceivable in advanced age as the ultra-violet rays of the sun trigger a tumor with a time lag of ten to thirty years.

Basalioma and spinalioma

Basalioma with approximately 30,000 incidences annually is the most frequent cancer of the skin; looking like a small, grey-white knot. The spinalioma as well (approximately 20,000 incidences) is mostly knot-shaped however more intensely reddened. The preliminary stage of the spinalioma is called actinic keratosis and also 'horny skin' (tyloma); already every other adult person above 60 years of age is affected from this phenomenon. From these horny knots ("sun callosity") malignant spinaliomae develop in up to 15 percent of cases. In the advanced stage basaliomae or spinaliomae do not omit cartilage or bones which may entail severe disfigurations particularly in the face. Whereas the development of basalioma is locally limited, the spinalioma may affect the lymph nodes and form metastases - every tenth case is lethal. "Probably the light skin cancer types occur much more frequently than official statistics predicate", the dermatologist professor Dr. Thomas Diepgen of the University Clinical Center Heidelberg explains. Diepgen is spokesmen of the task force 'Licht.Hautkrebs.Prävention' (Light.Skin Cancer.Prevention) which has been established by the Gesellschaft für Dermopharmazie last year. It belongs to the targets of the expert group to generate more public awareness for the light cancer of the skin types, to press ahead the research in this field, to further prevention and effectuate the incorporation of these types of cancer into the cancer index.

Life-threatening malignant melanoma

Even more threatening than the light types of cancer of the skin is the malignant melanoma which already commences at a very early stage to form metastases. In many cases the tumor is only a few millimetres thick, when it has already settled in distant organs. In the advanced stage the course of the disease is in most cases lethal. Experts assess that at present up to 10,000 persons per year come down with the malignant melanoma in Germany.

The major cause for the significant increase of all skin cancer types is according to the experts' opinion the intense contact of the skin with sunlight. "The leisure time behaviour and the apparel habits have drastically changed in the last decades", Diepgen expounds. In fact, the temporal part of the vacation is less than 10 percent however the UV-strain by sunlight in this time is in many cases higher than in everyday life. Professor Diepgen "mainly the infantile radiation exposure as well as intense radiation causing sunburn during the vacation have proven to be particularly dangerous". Additional important reasons for the augmented incidence of cancer of the skin is the increased life expectancy of the population as well as the steady decrease of the ozone layer and the UV-exposure of the skin as a consequence thereof.

The long history of skin cancer

It is already long ago since medical science has set a focus on the cancer of the skin. In 1775 already as one of the first occupational diseases, an increased skin cancer risk has been delineated for chimney sweepers. It took however more than 100 years until 1894 to establish a relationship between occupationally conditioned sun strain and the development of cancer of the skin for seamen: physicians designated the pathologically modified body surface as seamen's skin. However, cancer of the skin which has been caused by intense sun radiation at the place of work has not been recognized to date as occupational disease. However, a rethinking seems to take place, states professor Diepgen: "In the last years several skin cancer types have been recognized as occupational disease and indemnified. We dermatologists should also make a contribution that further cases are reported and indemnified and that definite UV-light-induced skin diseases are included to the list of occupational diseases".

An adequate protection for everyone

As essential significance is attached to the UV-light for the generation of all skin cancer types, sun protection is the first and predominant measure. No matter whether in the professional or private sphere - protection from skin cancer is feasible. Here are the possibilities in detail:

A sudden and intense sun exposure should be avoided in general. Staying in the shade and wearing of sun-impermeable clothing are preferable.
Persons being prone of getting sunburn in summer after a short period of time should avoid longer sun exposures in general.
Jeopardized are mainly light skin types with blond to strawberry blond hair and a predisposition for spreckles. Also persons having many birth-marks and moles should be very cautious.
Children are to be protected from intense sun exposure. Important are a headdress and sun-impermeable clothing.
In fact, the application of sun protection products is reasonable, it is however not sufficient for the protection of the skin from skin cancer. Attention should be paid to the fact that self-tanning products do not protect from carcinogenic UV-radiation.
The sole criteria for the selection of sun protection products should not be the light protection factor. The individual aptitude of a sun protection product may be subject to considerable variation. In particular risk groups as persons affected by acne, neurodermatitis or a light disease should seek advice from a dermatologist or in the pharmacy.
Skin changes caused by sun exposure or artificial UV-radiation should be attentively observed and a dermatologist visited at a very early stage.


The protein building block Agmatin improves dry skin

New therapy method also viable for patients suffering from neurodermatitis

(Halle, 31 March 2004) Millions of people are afflicted with dry skin. Frequent implications are pruritus, inflammations, scaly and reddened skin. Urea-containing preparations among other possibilities are able to produce relief in this matter. However, not all persons concerned tolerate these preparations. According to latest findings, a solution could be the protein building block Agmatin as experts of the GD Gesellschaft für Dermopharmazie explained on the occasion of the Annual Meeting in Halle on the Saale.

Persons who have contracted neurodermatitis suffer in particular from dry skin. However, also diabetics or patients with nephropathy may be concerned. First indices of dry skin are a feel of tension or itching frequently followed by inflammations. Dry skin may be contingent on inheritance, occupational skin strains, too frequent washing or climatic stress as cold or low air humidity. "In case skin is dry, the general cause are too little or inferior lipids in the topmost skin layer", private lecturer Dr. Johannes Wohlrab, assistant managing medical director at the Dermatologische Klinik (Dermatological Clinic), Martin-Luther-University Halle-Wittenberg explains. "Further reasons may be a reduced sebum formation or a lack of hydrophilic substances, the natural moisture-retentive factors of the skin". As consequence, the protective layer of the skin, the so-called hydrolipid film is disturbed with the consequence that irritants, allergens and pathogens cannot be sufficiently averted.

New active substance allows gentle treatment

A remedy may be hydrophilic molecules which are applied in the form of ointments, creams or lotions on the skin. There is a series of substances having these properties. To these belongs for example the substance urea which is at the same time part of the natural humectant factors. "Urea increases the water absorption capacity of the topmost skin layer as well as the resistance of the skin towards bacteria or fungal diseases. Moreover, urea takes a pruritus-soothing effect, according to congress head Wohlrab. "Admittedly, urea may produce skin irritations at particularly skin-sensitive persons such as those suffering from neurodermatitis who account for a large part of the persons concerned". Less straining is obviously the treatment with an active substance which can be regarded as a preliminary stage of urea: the protein element Agmatin. Agmatin is a substance which is very similar to the amino acid L-Arginin from which urea can be produced through the skin cells. "For the topical application of an Agmatin-containing cream almost the same positive values are achieved as concerns the water absorption capacity of the skin as for the application of a urea-containing cream of the same concentration", Dr. Wohlrab states. "However, differently as for urea-containing products no skin irritations occur during the application of Agmatin and the effect is persistent as could be determined in a placebo-controlled case study with neurodermatitis patients". Moreover, experts assume that by a regular application of an Agmatin-containing cream the germ density on the skin and consequently the jeopardy of inflammations can be reduced. In this matter continuative studies are still pending.

Reference book dry skin

Detailed information concerning dry skin has been compiled by the Gesellschaft für Dermopharmazie in a reference book which can be downloaded at www.gd-online.de. Besides the description of symptoms and causes for dry skin the brochure gives also practical advice regarding cleansing and care. Moreover, the Gesellschaft für Dermopharmazie has published a guideline under the title "Dermocosmetics for the cleansing and care of dry skin" which has equally been published at its homepage. It has been established for experts, developing, producing, testing, analyzing, marketing and giving advice as to their application.


Breakthrough in the therapy of psoriasis

Efalizumab allows a persistent and safe governing of the medium and severe psoriasis

(Halle, 31 March 2004) Numerous examinations point to the fact that primarily immunological causes are responsible for the development of psoriasis. In this connection activation and proliferation of T-lymphocytes are of major significance. The new T-lymphocyte modulator Efalizumab intervenes in this process thus allowing a rapid and durable control of skin manifestations. Controlled studies including more than 3.000 patients have shown that mainly persons suffering from medium to severe psoriasis benefit from this highly-effective systemic immunotherapy. As experts in Halle explained in the course of the Annual Meeting of the GD Gesellschaft für Dermopharmazie, Efalizumab will be presumably available in Germany this year.

Efalizumab is a recombining humanized monoclonal antibody which has been specifically developed to block the adhesion of T-lymphocytes at target cells. By establishing a bond to the CD11a-surface antigens of the T-lymphocytes, Efalizumab inhibits several steps in the immunological cascade taking place in the case of illness:

the primary activation of T-lymphocytes
the migration of T-lymphocytes into the skin lesions
the interaction of the T-lymphocytes with keratinocytes.

Thus, the inflammable processes are stopped, and a normalization of the disturbed differentiation and proliferation of keratinocytes is developed. Whereas previous therapy attempts aimed at suppressing the immune system in different ways, Efalizumab intervenes for the first time in the immunologic processes.

Extended therapy duration improves clinical picture significantly

The effectiveness, safety and tolerability of Efalizumab has been analyzed in four randomized, double-blind, placebo-controlled phase-III-studies. In the frame of a study comprising 1.242 patients, the effectiveness of the product in the dose 1 mg/kg weight has been compared with placebo. Efalizumab and placebo were injected subcutaneously once a week. First improvements of the skin appearance already showed after two weeks. After twelve weeks the psoriasis Area and Severity Index (PASI) had improved with 56 percent of the patients by at least 50 percent, at 28 percent of the patients even by at least 75 percent.

In the second part of the study, patients were given either for twelve additional weeks Efalizumab or placebo depending on the therapy success. At 77 percent of the patients in a group with extended active-substance intake the therapy success remained whereas this was the case with only 20 percent in the placebo group. After terminating the therapy the pathology in all groups returned gradually to its initial value. Nevertheless, one third of the patients which had been treated with Efalizumab over 24 weeks still showed an improvement after 36 weeks of more than 50 percent of the PASI in comparison with the commencement of the study.

In the course of a long-term study conceived for three years the effectiveness and tolerability of Efalizumab had been analyzed based on 290 patients. The dose administered was at 1 mg/kg weight per week with the possibility of an individual increase to up to 4 mg/kg weight per week. Within the first six months half of the patients achieved an improvement of the PASI by at least 75 percent, 22 percent even attained an improvement by at least 90 percent. After 21 months the percentage of the patients reaching an at least 75-percent improvement increased to 64 percent. 31 percent of the patients even achieved an at least 90-percent amelioration.

Improvement of quality of life and good tolerability

The administering of the product once a week offers distinct benefits regarding the compliance: the injection is easy to learn and viable in everyday life. Also a development of tolerances could not be noticed so far.

The side-effect profile of Efalizumab is particularly favourable. Symptoms similar to influenza may appear, such as headaches, fever and ague, queasiness and muscle pain. Mainly these side-effects acutely occurred only for the first two injections and abated in the aftermath. According to the experience with Efalizumab gained so far there is no evidence for an immunosuppression neither an indication for an increased tumor risk.

Efalizumab will probably be available in Germany still this year. The application for authorization was filed on 26 February 2003 with the European authorization authorities EMEA. In Switzerland Efalizumab has already been authorized and is planned to be introduced under the name Raptiva in the second quarter of this year. Producer is the company Serono, the third-largest biotechnology company of the world. In Germany the registered office of the company is in Unterschleißheim in the vicinity of Munich.


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