The FDA panel’s tepid embrace of Pfizer’s RA drug tofacitinib last week has been matched by an equally anemic payer reaction. A study by the research firm Reimbursement Intelligence told MM&M criticism of the drug’s less-than-impressive ability to delay progression encouraged payers to put the drug out of immediate reach. CEO Rhonda Greenapple said 37% of polled payers said they would require patients to fail on at least two anti-TNFs before approving tofacitinib. Greenapple said that percentage was 25% before the FDA review.
Pfizer’s renal cell carcinoma drug Torisel (temsirolimus) failed to prove it could extend life for cancer patients on the cancer drug Sutent (sunitinib malate). The company announced Wednesday that the treatment “did not meet the primary endpoint of prolonging progression-free survival when compared to sorafenib.” The company said in a statement that the results do not discount the drug’s value. “Torisel continues to be an important part of Pfizer’s portfolio of therapies for advanced kidney cancer,” Mace Rothenberg, SVP of clinical development and medical affairs, said in a statement.
An oral home HIV test got a 17-0 endorsement from an FDA advisory panel Tuesday. The OraQuick home test uses saliva instead of blood to test for HIV and takes 20 minutes to return results, reported the New York Times. OraSure’s multi-component kit includes a hard case that serves a dual purpose: it houses the testing equipment and props up vials to make it easier for users to mix components. It also includes pre- and post-testing pamphlets, as well as instructions. It does not have the same accuracy rate as professional tests, said the Times.
