ALTHOUGH HERCEPTIN’S DOMINANCE OF THE BREAST CANCER DRUG MARKET IN EUROPE IS THREATENED BY POTENTIAL BIOSIMILAR EROSION, THE UPTAKE OF BIOSIMILARS MAY BE HAMPERED BY EUROPEAN ONCOLOGISTS’ AND PAYERS’ PERCEPTIONS OF BIOSIMILARS

Interviewed Payers in Europe Have Concerns Regarding the High Cost of Emerging Therapies, Particularly Targeted Therapies That Contain Two Premium-Priced Agents, According to a New Report from Decision Resources

November 16, 2011—Burlington, Mass.—Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the dominance of Roche/Genentech/Chugai’s Herceptin (trastuzumab) in the HER2-positive breast cancer market in Europe is threatened by the potential entry of biosimilar trastuzumab beginning in 2014. However, the uptake of biosimilars may be hampered by brand loyalty and underlying skepticism among surveyed European oncologists and interviewed payers regarding biosimilars’ efficacy and safety. Interviewed payers in the EU5 (France, Germany, Italy, Spain and the United Kingdom) believe that the ultimate deciding factor will be the price differential between branded Herceptin and biosimilar trastuzumab.

The new European Physician & Payer Forum report entitled Positioning of Current and Emerging Targeted Agents in Breast Cancer: Physician & Payer Perspective on Treatment and Reimbursement Decisions in Europe finds that, despite the advantage of its oral formulation, GlaxoSmithKline’s Tykerb/Tyverb continues to face strong competition in Europe from Herceptin in the second- and subsequent-line settings for the treatment of breast cancer. Surveyed EU5 oncologists indicate that the main reasons they do not switch patients to Tyverb plus Roche/Chugai’s Xeloda is because they believe that continuing treatment with Herceptin is more effective or they have concerns regarding compliance with Tyverb/Xeloda’s oral formulation. In the United Kingdom, where Tyverb/Xeloda is not recommended by NICE, two-thirds of surveyed oncologists versus approximately one-fifth elsewhere (France, Germany, Italy and Spain) cite reimbursement restrictions as the reason they do not switch patients from Herceptin to Tyverb/Xeloda.

“In order to maintain its overall HER2-positive breast cancer franchise, Roche/Genentech/Chugai have adopted a strong defensive strategy which includes the development of a subcutaneous formulation of Herceptin and the development of two second generation HER2-targeted agents—pertuzumab and Herceptin-DM1,” said Decision Resources Analyst Niamh Buckley, Ph.D. “Assuming subcutaneous Herceptin is priced equivalently to the intravenous brand, one-half to three-quarters of surveyed oncologists across the EU5 consider the advantage of subcutaneous delivery to outweigh the lower price of a biosimilar trastuzumab in the metastatic maintenance setting. However, some interviewed payers indicate that if biosimilars become available first, then subcutaneous Herceptin may be considered a luxury by reimbursement authorities.”

The report also finds that interviewed payers have concerns regarding the high cost of emerging therapies, particularly therapies that contain two premium-priced targeted agents such as Herceptin plus pertuzumab. In all countries—especially Germany, Italy and the United Kingdom—evolving cost-containment measures can constitute a powerful barrier to the prescribing of these expensive therapies.

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