|GD - Online||Press Releases 2004|
8th GD Annual Meeting,
30 and 31 March 2004,
Health reform: bitter pills for dermal patients
Dr. Joachim Kresken
(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.
sensible - though no longer refunded
Refunding of prescription-free
drugs only in exceptional cases
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".
Lower prices for high-price drugs - higher
prices for low-price drugs
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
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.
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:
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.
(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:
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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