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  Issue 1 (2003)

GD News
Statement of the Society for Dermopharmacy:
Entry of Combined Topical Dermatics In Positive List

The Bundesministerium für Gesundheit und Soziale Sicherung (BMGS) (Federal Ministry of Health and Social Safety) has presented a draft for the planned positive list for drugs on 15 November 2002. Drugs, which are not considered in the final issue of this list, will be excluded in Germany from refunding by the Gesetzliche Krankenversicherung (GKV) (Legal Health Insurance) in the future. The draft of the BMGS does not list some of the combination drugs, which are of importance for topical Dermatotherapy although they come up to the general criteria for an entry into the positive list. According to the opinion of the GD Gesellschaft für Dermopharmacy e.V., the issue of the positive list to be passed should therefore be completed by these dermatics. Their lacking in the positive list would entail essential limitations in the care of patients suffering from dermatological diseases.

The present statement explains why the draft submitted by the BMGS concerning the positive list for drugs should be supplemented by so far not considered dermatics. The positive list for drugs is central object of the act designated by the Federal Government regarding a list of drugs qualified for prescription in the contract-medical care, in brief Arzneimittel-Positivlistengesetz (AMPoLG) (Positive List for Drugs Act). In particular it is referred in this statement to the dermatologics stated under D on pages 19 to 22 and here mainly the dermatological antimycotics listed under D01 as well as the topical glucocorticosteroids indicated under D07 in the present referee draft.

Significance of Combined
Topical Dermatics

Whereas combination drugs enjoy a comparatively low esteem in today's pharmaco-therapy in general, this does not especially apply to the external treatment of dermatological disease conditions. This fact is confirmed not only by leading textbooks of dermatology respectively Dermatotherapy but also by statistics concerning the prescription frequency. Thus in the Arzneiverordnungsreport 2002 (Schwabe U, Paffrath D. [Publ.] (Drug Prescription Report): Arzneiverordnungsreport 2002. Aktuelle Daten, Kosten, Trends und Kommentare. (Current Data, Costs, Trends and Comments. Springer, Berlin, 2002), four combination drugs among the ten most frequently prescribed ready-to-use drugs at the expense of the GKV in the year 2001 are stated in the chapter antimycotics. An in principle corresponding result is also contained in the chapter dermatics and wound treatment agents: the first combination drug is listed in position 12 and the second in position 15 as to prescription frequency.

The positive list in its present version does not question the prescribability of combined topical dermatics in general. This is for example reflected by the fact that for instance at antimycotics the combination of nystatine with zinc oxide and at glucocorticoids the combination of hydrocortisone with urea have been taken in consideration. Essential criteria for the entry of a drug in the positive list are its sufficient quality and informative value of proofs as evidence for the therapeutical effect. Moreover, at an indication-relevant assessment according to general evaluation standards more than a comparably minor therapeutical benefit should be present (§ 33a, chapter 7, clause 2 SGB V). The latter particularly applies to lacking of more useful therapeutical alternatives.

GD statements are official position papers of the society, which have been elaborated by the departments or other experts and approved by the GD managing committee for publication. The present statement concerning the positive list for drugs has been handed over to the Bundesministerium für Gesundheit und Soziale Sicherung (BMGS) (Federal Ministry for Health and Social Safety) asking for its consideration in the further legislative procedure concerning the positive list of drugs.

A detailed analysis of the draft established by the BMGS reveals that several combined topical dermatics are not listed although they come up to the general entry criteria. While on the one hand combinations of topical glucocorticoids with urea, zinc oxide and salicylic acid are considered, on the other hand for example combinations of glucocorticoids with vitamin-D3-Analoga and with anti-infectives are not indicated. This fact does not seem acceptable from a dermatological view regarding the special drug combinations as follows.

Calcipotriole in Combination with
Betamethasone Dipropionate

The combination of calcipotriole with betamethasone dipropionate is superior to the use of corresponding preparations with only one of the two components in the treatment of psoriasis vulgaris - supposing an ointment as vehicle. This applies both for the influence on the severity of the disease according to the generally approved PASI-Score and also relating to the moment of the arising of the effect which is equally relevant for patients. This could be recently shown in two major independent double-blind controlled multi-center studies in Europe in which also German patients were included and the results of which have been published in internationally recognized professional magazines (Kaufmann R et al.: Dermatology 205 [2002] 389-393; Douglas WS et. al.: Acta Derm Venerol 82 [2002] 131-135). As the product in question has only been recently approved and is available in the German market only as of 1 November 2002, the publications indicated might not have been submitted yet at the time when the BMGS established the draft for the positive list.

Anti-infectives Combined
with Glucocorticoids

Anti-infectives combined with glucocorticoids are used among other applications for the initial therapy of bacterially infected eczema. In Germany there is for example a ready-to-use drug available in the market for this indication on the basis of fusidic acid in combination with betamethasone-17-valerate.

Extensive investigation has also been made regarding the combination of fusidic acid with hydrocortisone. Although the published studies concerning their disposition and reference to their selected publication mode are not fully satisfactory (Ramsay CA et al.: J Eur Acad Dermatol Venerol 7, Suppl 1 [1996] 15-22; Poyner TF, Dass BK: J Eur Acad Dermatol Venerol 7, Suppl 1 [1996] 23-30), nevertheless among experts the opinion is ascertained that this combination is superior for the treatment of the atopical eczema compared with the sole application of hydrocortisone. The reason is that an essential significance is attributed to the target germ of the fusidic acid, staphylococcus aureus in the genesis of the disease (Wilkinson: Int J Dermatol 139, Suppl 3 [1998] 37-40). Therefore, under the aspect of an optimal treatment of the patients also combinations of fusidic acid with glucocorticoids such as hydrocortisone and betamethasone-17-valerate should be added to the final positive list.

The same applies to the combination of Miconazole with Fluprednidene-21-acetate. Investigations made in Germany for this combination product (Nolting S. Rogalla K: Int J Dermatol 34 [1995] 125-128) have indubitably proven that the inflammation symptoms at an inflammatory-characterized dermatomycosis show an initially better reaction to the combination product than to the corresponding mono-product, which only contains miconazole.

Combination of Diclofenac
with Hyaluronic Acid

The gel preparation of Diclofenac in combination with hyaluronic acid introduced for some time now is formally not a combination drug. This comparably new preparation that seems in particular undoubtedly scientifically proven by current publications has possibly been regarded in the context of topical antiphlogistics respectively anti-rheumatics. It is however, approved for the treatment of the actinic keratosis and should therefore be considered in the positive list under dermatologics.

The actinic keratosis is a numerically significant disease, which is increasingly frequent in the middle and higher age of life, especially caused by UV-strain of the skin. In fact it is a carcinoma in situ from which the actual spino-cellular carcinoma is produced in at least ten percent of all cases. The usual impact to date of the pharmaco-therapy is only partly proven by fully applicable scientific studies. To mention are here podophylline, usually applied in the frame of the extemporaneous prescription, as well as above all the 5-fluoro-uracile available as ready-to-use drug.

Differently as with these preparations for Diclofenac/hyalurenic acid gel, unlimited expressive vehicle-controlled blind studies are available as to effectiveness and tolerability. They were only published in the years 2001 and 2002 (Wulf JE et al.: Int J Dermatol 40 [2001] 709-713; Rivers JK et al.: Br J Dermatol 146 [2002] 94-100) and confirm original findings dating from the year 1997 (Rivers JK, McLean DI: Arch Dermatol 133 [1997] 239-1242). It is expressly stated that hyaluronic acid does not formally serve as medicinal active component in this case but as auxiliary agent, which probably makes an essential contribution to the bioavailability of the active agent Diclofenac in the given context. From a legal point of view it is undoubtedly considered as mono product whereas the effectiveness is only proven for the stated gel formulation with hyaluronic acid.

Target of the Present

The GD intends to make a contribution with this statement so that patients suffering from dermatological diseases and insured in the GKV can be supplied at best with appropriate dermato-therapeutics also after the introduction of the positive list for drugs. The GD, however, does not understand its task in this context to establish a complete list of dermatological drugs which are to be additionally included in the positive list. When considering such supplements for instance the balneotherapeutics and active agent-free basis preparations which have been approved as drugs have to be borne in mind, which are indubitably important in the overall context of the management of the atopical eczema and several other dermatoses. These products are not least significant under the aspect of saving glucocorticoids in the frame of the so-called interval therapy, which may be connected with a risk minimization for the patient and a cost reduction for the insurer.

It is the GD's intention to stress with this statement that the draft established by the BMGS does not consider some combination drugs important for the topical dermatotherapy although they undoubtedly comply with the prerequisites for an entry into the positive list. In case these drugs should also be lacking in the finally passed version of the positive list, this fact would lead to considerable limitations in the supply of GKV-patients suffering from dermatological diseases.


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