Wednesday, April 15, 2009

Stelara is likely to benefit from the fall of Raptiva however topicals continue to dominate

Psoriasis is a disease of the skin that affects millions of individuals worldwide. The therapeutic landscape for psoriasis is dominated by genericized and/or nonprescription topical therapy in terms of volume. In terms of value, however, the moderate to severe psoriasis market is bolstered by the use of biologics, first approved for use in psoriasis in 2003. Recent research into prescriber trends suggests that while biologics have made a significant impact in the treatment of psoriasis, topical therapies have not been displaced, especially in patients with milder disease; moreover the future may see moves towards improved phototherapy rather than greater uptake of biologics.

According to the 180 dermatologists interviewed as part of our recent feature Psoriasis - Biologics are yet to make topical treatments obsolete, psoriasis presentation and diagnosis patterns have remained constant over the past five years, indicating an essentially unchanged point of view among psoriasis sufferers. Psoriasis epidemiology is remarkable in that 54% of psoriasis sufferers are undiagnosed and this is because 80% of affected individuals have symptoms that are so mild that they never present to a physician. Even those patients that are diagnosed are not diagnosed immediately probably reflecting, at least in part the mild nature of the disease in many individuals. Of those patients that are diagnosed 36% of patients are estimated to be suffering from mild psoriasis, 38% from moderate psoriasis and 26% from severe psoriasis. Given that biologics are only indicated for moderate to severe disease it is clear why topical therapies dominate the market in terms of volume.

In stark contrast to the consistent epidemiological picture of psoriasis, treatment trends in psoriasis have shifted, reflecting payers’ and prescribers’ evolving priorities in terms of psoriasis. One ongoing trend is the choice of topical versus biologic therapy, a trend that is dependent on geography. Absence of approved biologic therapy in Japan leads to higher use of traditional systemic agents in this market. Elsewhere however the approval of biologics for the treatment of psoriasis has seen growth in this area, albeit of a hetrogenous and regionally varied nature. In the UK where biologics are available, NICE recommends that this class should only be continued if clinical improvement is demonstrated within 12 to 16 weeks. Elsewhere in Europe the estimated use of biologic therapy varies from market to market. Of course, the situation in the US is highly influenced by insurance companies seeking to control costs.

So what is the biologic of choice in psoriasis patients? On average, 41% European physicians surveyed in the abovementioned report prefer Raptiva (efalizumab) at first line, and 20% prefer Remicade (infliximab), despite this drug’s intravenous method of administration. EU physicians may have preferred Raptiva in 2008 because it had the longest history of use in psoriasis, but its recent withdrawal from the EU for safety reasons will create a significant space for other therapies, particularly Stelara (ustekinumab), approved in the EU in January 2009.

As highlighted in yesterday’s issue of DailyUpdates, Raptiva will be phased out of the US market over the next 3 months (press release). Genentech's decision was based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. The Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML, in patients receiving Raptiva. There have been three cases of diagnosed PML in patients receiving Raptiva.

According to the National Institutes of Health (NIH), between 5.8 and 7.5 million Americans have psoriasis. Of these more than 3 million are believed to have moderate to severe disease and would have been candidates for Raptiva treatment. However, Genentech estimates that just 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis. Raptiva has been therefore occupied a very small market share reflected in the fact that it has been generating sales worth just $105 million. Instead, among US dermatologists, 60% prefer Enbrel (etanercept) at first line, followed by 26% of physicians preferring Humira (adalimumab). Physicians in the US and the EU rated Stelara highly in terms of disease modification, maintenance of efficacy and dosing frequency. Clearly therefore there is considerable potential for Stelara to capture a significant portion of the market however, payers’ enthusiasm for Stelara will be crucial to the drug’s success.

While systemic therapies have revolutionized the management of moderate-to severe psoriasis, topical treatment remains the foundation of psoriasis therapy. In mild psoriasis, physicians from all countries surveyed report that at least 82% received topical therapy alone. In the US and Europe, topical therapy usage declines with increasing disease severity. In Japan, lack of biologic therapy appears to sustain high usage of topical therapy across all disease severities. Phototherapy is a treatment option for patients with moderate to severe psoriasis who have not responded to topical therapies. This is particularly the case is Germany where physicians estimate that phototherapy should be used by 54% of patients. The mean percentage of patients recommended to use phototherapy in the four other European countries is 26%; nearer to the US figure of 17% and the Japanese figure of 20%. According to US opinion leaders, technological advances in home phototherapy units, in combination with the expense and safety signals associated with biologic therapy, may inspire renewed interest in phototherapy among payers and prescribers in coming years.

The psoriasis market thus continues to evolve. As some biologics such as Raptiva fall others, most prominently Stelera will least for the moment. The use of topical agents continues however to dominate treatment choices in patients with mild disease and therefore the psoriasis arena as a whole. Commercial success in the psoriasis market will continue to demand a clear understanding not only of regional trends but also unmet needs including improved biologics for severe disease and cheap and safe alternatives to topical treatment for mildly affected patients

For further details on the psoriasis market see:

Psoriasis - Anti-TNF's lead another indication
Psoriasis - Biologics are yet to make topical treatments obsolete
The World Dermatological Market Outlook, 2009-2023


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