One of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, Decision Resources, finds that the testing rate for epidermal growth factor receptor (EGFR) mutation?a predictor of response the EGFR inhibitor erlotinib (Tarceva?, Genentech/Roche/OSI/Chugai) ?in non-small-cell lung cancer (NSCLC) patients, will increase by approximately 50% over the next 12 months, according to surveyed U.S. oncologists.

In line with increased EGFR mutation testing, approximately 40% more patients who harbor mutant EGFR will receive erlotinib despite the fact that more than half of erlotinib prescribers indicate that obtaining reimbursement for first-line use is burdensome. However, if the emerging EGFR inhibitors gefitinib ( Iressa?, AstraZeneca) and/or afatinib (also known as BIBW 2992 Tomtovok?, Boehringer-Ingelheim) were to be approved for advanced NSCLC patients with mutant EGFR, surveyed oncologists indicate that both would threaten Erlotinib’s market position in the treatment of this niche population.

The new U.S. Physician & Payer Forum report entitled “How Will Clinician and Payer Attitudes to Mutation-Specific Prescribing Shape the NSCLC and CRC Markets?” finds that, first-line prescribing of erlotinib in NSCLC patients with mutant EGFR would increase further were erlotinib to be approved by the U.S. Food and Drug Administration for this indication. Furthermore, despite significant proportions of surveyed physicians identifying advantages of gefitinib and afatinib over erlotinib, if the drugs were to become available, only a minority of surveyed oncologists indicate that approval for use of these drugs in NSCLC patients with mutant EGFR would justify a price premium over erlotinib.

“Forty percent of surveyed managed care organizations indicate that if Iressa and Tomtovok were priced at a 20% premium to Tarceva they would be excluded from the formulary,” said Decision Resources Analyst Janie Cox, Ph.D. “Even at a comparable price to Tarceva, up to 25% of managed care organizations would exclude these drugs?and if they were covered, insufficient efficacy data is cited as the main hurdle to preferred brand status for both Iressa and Tomtovok.”

The report also finds that surveyed oncologists are increasingly likely to test for Kirsten rat sarcoma viral oncogene homolog (KRAS) and, to a lesser extent, B-type Raf Kinase (BRAF) mutation in colorectal cancer (CRC) patients. KRAS mutation predicts a lack of response to Cetuximab’s (Erbitux?, Imclone/Bristol-Myers Squibb/Merck Serono) and panitumumab (Vectibix? , Amgen/Takeda), which are consequently labeled for treatment of KRAS wild-type patients only, while BRAF mutation?which is mutually exclusive of KRAS mutation in CRC patients?may also predict a lack of response to these agents, and therefore offers potential for further targeting treatment of KRAS wild-type patients.

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