Complex Cost Issues in Treating Dermatophytoses in India-"It All Builds Up".

India is currently witnessing a virtual epidemic of superficial fungal infections (tinea).[123] The current antifungal drugs market, both topical and oral, is a colossal Rs. 2,245 crores. Dermatologists do not have direct or indirect access to data concerning sales volumes and value growth of topical and oral antifungal agents available in India that reflect the need and preferences for using them. The financial burden of the current epidemic of dermatophytoses in India, especially widespread, recalcitrant dermatophytoses, is understated, underemphasized and has hitherto not been discussed. We frequently discuss various molecules and classes of antifungals, their optimum duration and dosages, their efficacy, safety, and superiority of one over the other. However, the resultant financial burden of rational as well as irrational antifungal drugs on affected individuals and their household contacts is largely ignored. Though dermatophytoses in the current context does not spare any socioeconomic group, it is a common observation that widespread chronic dermatophytoses commonly affects poor people living in overcrowded, often unhygienic places, especially where there is a lack of water, adequate sunlight and sanitation.[123] A majority of such patients have multiple, similarly afflicted household contacts, resulting in a magnification of financial burden of treatment.[12]

New drugs replace older ones at the cost of significant financial burden and antifungals are no exception. Private practitioners are documented to use more expensive broad-spectrum antibiotics.[4] That also stands true for newer antifungals. There has been a dramatic rise in the growth in the sales of relatively new oral and topical antifungal agents [Table 1]. Oral antifungals like itraconazole have recorded a dramatic growth, whereas the popularity of terbinafine has delined. Interestingly, the latter trend coincides with an increasing number of dermatologists experiencing unsatisfactory efficacy of the drug in treating the current forms of tinea.[5] On the other hand, higher antifungals like voriconazole, despite their prohibitive prices, seem to be growing. That is an alarming trend indeed considering that the drug is not routinely recommended for the treatment of superficial dermatophytoses but is now being tried by dermatologists out of sheer frustration of not being able to successfully treat their patients with the current armamentarium of available drugs. The relatively newer topical antifungals, such as luliconazole, sertaconazole, eberconazole, amorolfine, and ciclopirox, are currently widely used with their sales figures soaring [Table 1]. The most favored itraconazole and terbinafine are most often prescribed for at least four weeks and as long as six to eight weeks by dermatologists which is an expensive financial exercise in India unlike older cheaper molecules like griseofulvin and fluconazole.[1] Newer topical antifungals are also significantly more expensive than the older ones like clotrimazole and miconazole which are now perceived to be less efficacious compared to the newer ones. Application of newer creams, especially in widespread disease, is a significant burden and is often unaffordable. The exponentially growing popularity of newer antifungals is largely the result of personal positive experience of the dermatologist, literature made available from dermatologic resources and the industry, and finally the direct as well as indirect influence of pharmaceutical industry. A notable reason for the declining popularity of older antifungals like miconazole and clotrimazole is that they are also sold as cheap, over the counter brands that are advertised in the media, making them household names that patients self-medicate with. While cheaper and older azoles continue to be popular amongst general practitioners and public hospitals, the market trends show a dramatic popularity of newer oral and topical drugs [Table 1] in the private sector despite the higher cost.

Table 1

Interesting sales figures of some popular antifungal drugs in March 2017 and March 2019

Molecule	MAT March 2017 (Rs. Crores)	MAT March 2019 (Rs. Crores)
Itraconazole	361.4	815.9
Terbinafine	159.5	162.2
Voriconazole	19.5	26.1
Luliconazole	75.0	382.7
Ciclopirox olamine	7.3	15.5
Eberconazole	15.4	39.3
Sertaconazole	64.4	66.1

All data pertaining to sales of various drugs in this article are obtained from IQVIA (formerly Quintiles and IMS Health, Inc.), an American multinational company serving the combined industries of health information technologies and clinical research

Affordability of drugs is also directly related to patient compliance in India.[4] Poor patient compliance in adhering to costly antifungal treatment leads to recurrence and “difficult to treat disease”. Following facts and figures provide an insight into the financial constraints of a significant population of India in obtaining appropriate and adequate treatment of tinea by extrapolation. Though the numbers have halved since 2011, the current number of ‘extremely poor’ people in India is estimated to be 13.4%.[6](The word being defined by the world bank for an individual earning less than $1.90 per day).[6] Defining poverty line and those who have moved out of poverty to a middle income class are rather randomly calculated processes with varying methodology.[7] Asian Development Bank estimates that middle class comprises 38% of the Indian population and has been divided into three classes, those earning $2−4, $4−10, and $10−20 per day.[7] The overwhelming bulk of the middle class, however, is in the first category which is constantly in danger of slipping back into poverty due to economic shocks. And therefore an out of pocket expense for treating tinea is a significant burden for a significant Indian population, especially when multiple family members are affected. Another interesting phenomenon is the “70:70 paradox” in Indian health care expenses which refers to the fact that 70% of healthcare expenses are incurred by people out of pocket, of which 70% is spent on medicines alone.[8] In fact, this has been identified as a major cause of poverty and indebtedness in the country. While newer government schemes are increasingly being introduced, they concentrate on secondary and tertiary health care, and expenditure on skin care appears to be almost non-existent or very low in their list of priorities. The current scenario of dermatophytoses needs in-depth understanding and urgent intervention of the government that is presumably more concerned about diseases with increased mortality and does not take into consideration morbidity and the poor quality of life associated with this disease.

Treatment of dermatophytoses with newer and more efficacious topical and oral antifungal drugs is not covered in most government health schemes.

Following is the chain of circumstances leading up to both valid as well as unnecessary expenses. Most patients, especially economically disadvantaged, buy creams over the counter or as prescribed by general practitioners as the first line of management of tinea.[1239] These are very often fixed drug combinations (FDC) containing a potent steroid, antifungal, and antibacterial agent. Such irrational formulations are known to be major culprits in the alarming epidemic like scenario of tinea that India is witnessing.[10] Those visiting overburdened government hospitals often complain about considerable inconvenience like long waiting periods, going from counter to counter, and at times feeling neglected. Free antifungal drugs most frequently are only limited to older azole creams like clotrimaozole, miconazole, and oral antifungals like griseofulvin and fluconazole. Newer, preferred antifungals are not available free of cost in most of these hospitals. Patients of extensive dermatophytoses often complain of receiving inadequate quantities of topical antifungals and have to purchase the deficit from the market or are found to apply inadequate quantities that result in inadequate clearance of the disease. There are also claims that drugs supplied to government hospitals are at times of questionable quality and have lower efficacy than ones manufactured by reliable companies. All these issues become a deterrent to patients who remain inadequately treated even after being subjected to the inconvenience of visiting a public health system. As a result, a large number of disgruntled patients again consult a general practitioner a, cheaper alternative to a dermatologist who most often prescribes irrational steroid containing FDCs or inappropriate doses of antifungal drugs for an inadequate duration. A large number of patients also seek recommendations directly from local pharmacists and suffer the same fate as they do with general practitioners. It is noteworthy to mention that while the sale of pure antifungal creams amounts to Rs. 1040 crores, for antifungal and steroid combinations it is approximately 1,310 crores, a testimony to the popularity of these FDC creams. Patients continue to use these creams without medical supervision, sometimes try a multitude of different molecules and brands and in spite of spending large amounts of money remain untreated. Many suffer common and often severe side effects of the potent steroids present in these FDCs. Finally, a visit to the dermatologist becomes inevitable for these patients where the cost of consultation fees, investigations, travel to and from clinic, decrease in productivity, or loss of working hours translate into a significant financial burden. Many patients do not buy even prescribed medication and shop for cheaper alternatives. It is the experience of many dermatologists that cheaper brands of antifungal drugs manufactured and marketed by little known companies with doubtful credentials often lack efficacy compared to brands manufactured by well-known companies. Patients are also known to buy less than the prescribed quantity for financial reasons and discontinue upon getting symptomatic relief. Many share their prescription with other affected members of the household who often apply them erratically. Such erratic patterns of treatment result in a large number of inadequately treated patients despite spending large amounts of money over a long period of time. This particular patient population harbours a smouldering, active, and inadequately treated tinea that is often recurrent, recalcitrant, and widespread and becomes an important pool of infection in the community.

It is WHO's observation that irrational use of medicines is a major problem worldwide. WHO estimates that more than half of all medicines are prescribed, dispensed or sold inappropriately and that half of all patients fail to take them correctly. The overuse, underuse or misuse of medicines results in wastage of scarce resources and widespread health hazards” is particularly relevant to the issue of the current situation of dermatophytoses in India.[11] A hard-hitting editorial in the Indian Journal of Dermatology, Venereology and Leprology addressing many issues regarding rational therapy in dermatology also makes compelling reading and enables the reader to extrapolate and appreciate the link between irrational therapy and associated financial burden.[12]

This article is aimed at sensitizing medical personnel from all fields as well as policy makers to the financial burden of treating superficial dermatophytoses, especially extensive disease, which is most often incurred out of pocket, at every stage. The current rational, reasonably efficacious and preferred treatment of dermatophytoses is a potential significant burden for almost two-third of the Indian population who would find the financial burden of treatment heavy. Ineffective and often hazardous treatment with irrational FDCs is a colossal loss of hard-earned money for the common citizen, a fact that the regulatory authorities refuse to pay attention to despite several communications from Indian Association of Dermatologists, Venereologists and Leprologists. It is a matter of shame that the senior functionaries of the government regulatory agencies choose to ignore the almost epidemic like a scenario of superficial fungal infections and do not ban the hundreds of irrational topical FDCs that most patients of tinea are primarily exposed to for variable periods of time.[10] The need of the hour for the Indian government is to implement Schedule H under which topical steroids have been categorized, intervene in controlling this epidemic like scenario of tinea by ensuring free availability of the newer and more efficacious oral as well as topical antifungal drugs, ban the production and sale of irrational and hazardous topical FDCs containing steroids, and fund more countrywide research in the area of dermatophytoses.

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Conflicts of interest

There are no conflicts of interest.