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Paying to lose

Efficacy beyond weight loss key to reimbursement for new obesity drugsHow doctors think Belviq, Qysmia will be used in subgroups of obese patients

Now that FDA has approved two obesity drugs, the next challenge is getting payers on board, as only about 30% of prescriptions for weight loss drugs are currently reimbursed.

The latest to cross the finish line, Vivus Inc., is banking on the efficacy of Qsymia phentermine/topiramate and its REMS to help it develop a prescriber base and eventually convince payers of the drug's value.

Arena Pharmaceuticals Inc. and partner Eisai Co. Ltd. are not yet saying much about their reimbursement strategy for Belviq lorcaserin, although the biotech has said it is developing an education program aimed at ensuring safe use and high compliance(see BioCentury, July 9).

However, Vivus, Eisai and Orexigen Therapeutics Inc., which hopes to be next in line with its Contrave naltrexone/bupropion, all have said they expect that patients initially will pay for the drugs out of pocket. Vivus and Orexigen then expect to migrate their products to employer health plan riders and eventually full coverage by third-party payers.

Healthcare consultants contacted by BioCentury believe getting third-party reimbursement will hinge on showing benefits beyond weight loss, including reductions in concomitant medications and improving employee productivity.

Half the battle

On July 17, Vivus' Qsymia (formerly Qnexa) became the third obesity drug approved in the U.S. - and the second one this summer.

FDA approved Belviq lorcaserin from Arena and Eisai on June 27. Xenical orlistat from Roche has been on the market since 1999.

Of the three drugs, Qsymia produced the greatest weight reduction in clinical trials, with a placebo-adjusted weight loss of up to 9.4%. Belviq had a placebo-adjusted weight loss of 3.3%, and Xenical's placebo-adjusted weight loss was 3%.

Unlike Belviq and Xenical, Qsymia was approved with a REMS to reduce the risk of teratogenicity associated with the topiramate component of the drug (see BioCentury, July 19, 2010 & Feb. 27).

The REMS includes a medication guide, restricted distribution system and voluntary prescriber education. The distribution system is composed of five mail-order pharmacies.

According to Barbara Troupin, VP of scientific communications and risk management, Vivus will provide prescribers with educational materials describing the teratogenic

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