OBR Daily Commentary

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NICE Draft Guidance Recommends Maintenance Treatment for Follicular Non-Hodgkin's Lymphoma

(NICE) Dec 3, 2010 - The National Institute for Health and Clinical Excellence (NICE) has today (3 December) issued preliminary draft guidance recommending the use of rituximab (MabThera, Roche Products) as a first-line maintenance treatment for certain patients with advanced follicular non-Hodgkin's lymphoma.

(Posted: December 03, 2010)

quotesThe PRIMA study showed a significant improvement in progression-free survival (PFS) with the use of rituximab in a standard maintenance protocol following a rituximab containing induction regimen. At the time of presentation, there was no improvement in overall survival (OS) in the maintenance arm. This result leads to difficult discussions with patients and among Hem/Onc physicians concerning this improvement in the time in remission but no improvement in survival. Is this clinically meaningful? Is it cost effective? NICE evaluates these questions in their decisions for the use of agents whereas cost-effectiveness is not an issue the FDA is charged with evaluating. The use of maintenance rituximab has been adopted by most physicians in the US; however, under new economic scrutiny with bundled payments this might need to be re-evaluated in the future if a therapy only improves PFS and not OS. Hopefully with further follow-up the PRIMA trial will also be positive for OS which will minimize the controversy for the use of maintenance rituximab. quotes

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UK's Body NICE Blocks Novartis's Kidney Cancer Drug Afinitor

(SmartMoney/Dow Jones Newswires) Nov 25, 2010 - The U.K. health cost body Friday said it refuses to back Novartis AG's kidney cancer drug Afinitor as a second line treatment due to lingering cost and efficiency concerns even as the Swiss pharma giant, which said it will appeal the verdict, has cut the price for the drug.

Robert A. Figlin, MD., FACP (Posted: November 29, 2010)

quotesThis decision is just another example that highlights the challenges in drug development. In this case we have a drug Afinitor that has demonstrated clinical efficacy following prior VEGFr TKI therapy in metastatic renal cell carcinoma and is approved for use in the United States and the EU. It is not that the data is being questioned as much as the value added to this patient population of the treatment effects. The medical oncology community (ie: physicians, industry, patient advocate groups, health care providers) will consistently be asked to not only prove a drugs effectiveness using standard metrics of benefit (ie: PFS, OS )but also demonstrate why a health care dollar should be used for this intervention vs another. This is a challenging time for drug development as the clinical trials often ask questions that answer only part of the effectiveness question for a particular therapy. It should be the oncology community at large including all interested parties that set the agenda for what constitutes "effectiveness" when the health care dollar is not unlimited. This announcement today will be just one of the many future similar challenges we all face in caring for our patients.quotes

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UK's NICE Recommends Roche's Herceptin For Stomach Cancer

(SmartMoney/Dow Jones Newswires) Nov 23, 2010 - The U.K.'s National Institute for Health and Clinical Excellence Wednesday said it recommended Roche Holding AG's Herceptin oncology drug be made routinely available on the publicly funded National Health Service to certain patients with metastatic gastric cancer.

Howard S. Hochster, MD (Posted: November 24, 2010)

quotesFor once NICE leads the pack on approval of a new cancer drug. This seems fairly revolutionary for the nation which never believed in paclitaxel for ovarian cancer and the agency that approved oxaliplatin (for reimbursement) only in potentially resectable metastatic colorectal cancer to the liver. Of interest, they are focused more on the high HER-2 expressors, which may be IHC 3+ or FISH high copy number. We are not aware of the analysis presented to NICE and what percent of patients fall into this group. In any case, in the US, few patients fall into this group, but hopefully the FDA will follow suit shortly. ASCO will need to develop the specific testing guidelines (IHC, FISH or both) to match the approval.quotes

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Dean Gesme, MD

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Debu Tripathy, MD

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H. Jack West, MD

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Robert A. Figlin, MD., FACP

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