Belviq's Battle of the Bulge

Arena Pharmaceuticals’ and marketing partner Eisai’s Belviq – the first FDA-approved drug to treat obesity in over a decade – is making progress with payers and beefing up sales forces to target primary care physicians. DTC support began in September.

Perhaps the most significant development in obesity of late is the recognition by payers – and more to the point, employers – that obesity in the workforce has a clear and measurable effect on productivity. Obesity increases the risk of type 2 diabetes, colon and other cancers, sleep apnea, liver disease and coronary heart disease, to name a few, and all of those can mean time off the job. According to CDC estimates, medical care costs related to obesity were roughly $147 billion in 2008. That figure doesn’t include worker productivity costs and chronic absence from work.

Despite a somewhat limited efficacy – in clinical trials Belviq only helped patients lose about 5% of their body weight, in combination with dietary changes and exercise – the product has been added to big PBM formularies including Express Scripts, and other insurer groups including Tufts, the Health Alliance Plan, and a host of state Blue Cross Blue Shield plans.

Gary Palmer, chief medical officer and VP medical affairs at Eisai, Arena Pharmaceuticals’ marketing partner for Belviq, told PharmExec during the Cleveland Clinic’s annual Medical Innovations Summit (this year the summit focused on obesity and diabetes) that payers are saying, “these are our people, we want them to be healthy, and there are productivity issues with obesity.”

Palmer says the obesity market is underdeveloped. “There’s been poor education in this area, and doctors themselves are not really that well trained in [treating] obesity.” Formerly a VP in cardiovascular and metabolic health at Pfizer, and then CMO and VP at Bristol-Myers Squibb, Palmer joined Eisai in 2010 and says the obesity market is “in a place where the cholesterol market was maybe 15 or 20 years ago.” Jack Lief, CEO at Arena Pharmaceuticals, Belviq’s originator company, says that just two percent of obese patients are currently receiving pharmacotherapy. “It’s a big untapped market,” says Lief.

As a result of Belviq’s launch success so far, says Palmer, Arena and Eisai have decided to double the sales force. The expansion will bring the number of reps to 400 by the end of the year, and Eisai hopes to reach some 65,000 physicians as a result. The larger sales force is an attempt to reach a primary care audience specifically, says Palmer. “We originally started with specialists” – endocrinologists, cardiologists, gastroenterologists – “and now we are expanding the sales force to go increasingly to the primary care doctors.”

Not all payers are on board just yet. Government plans in the US, namely Medicare and Medicaid, “still have a specific exclusion” from covering obesity medications, notes Palmer, but the outcomes study that FDA required as a condition of Belviq’s (lorcaserin) approval might assuage lingering fears related to previous products in the category, and previous iterations of lorcaserin. Lief says the cardiovascular outcomes study “is going to create a lot of interest…it’s a big long-term [five-year] study with 12,000 or so patients. Hopefully we’ll see reductions in co-morbidities over a longer period of time, as patients lose weight.” Palmer says the trial will begin enrolling patients in the coming months.

To promote awareness of the drug among patients, Eisai launched print ads in September in a number of consumer magazines, and Palmer says “we’re certainly evaluating” television ads, too. “We’re not going to start [televised DTC ads] just yet, but in the near future we probably will move to that.” Lief points to user reviews on Drugs.com as evidence of positive patient experiences, adding that patients “claim that they’re really enjoying their sleep much better,” and that “they’re not hungry.” With diet and exercise, says Lief, patients can be “very successful” with Belviq.

In addition to traditional consumer advertising, the companies launched Belviq with a number of financial assistance options, such as free Belviq vouchers for the first 15 days, and $75 off the monthly cost of the drug for one year, to help patients without insurance coverage afford their prescription. A pharmacist at CVS told PharmExec that a one-month supply of Belviq – 60 capsules – cost $239 without insurance. Vivus’s Qsymia, the second new obesity drug approved just 20 days after Belviq, cost the exact same amount – $239 – for a one month supply (30 capsules), at least at CVS. Both drugs were approved in the summer of 2012; Belviq is administered twice a day and Qsymia is given once a day, in the morning. Qsymia launched last December, a full six months before Belviq, despite being approved 20 days after Belviq. A spokesperson for Belviq said the launch was delayed while the DEA finalized its scheduling designation – the Belviq scheduling decision was finalized in May 2013. Both Belviq and Qsymia received a schedule IV designation, joining drugs like Xanax, Valium and Ambien.

Belviq is currently approved only in the US. On the global front, Arena/Eisai have filed in Switzerland, Mexico and Canada, and plan to file soon in Brazil. Arena partnered with CY Biotech in Taiwan and Ildong Pharmaceuticals in South Korea, to manage regulatory filing in those countries.

Analysts noted that Vivus competitor Qsymia got off to a slow start, despite beating Belviq to market, but the product gained steam in the spring (perhaps in anticipation of bathing suit season?) before ultimately missing sales estimates in the second quarter. As for Belviq, Lief declined to give PharmExec a sales goal for Belviq’s first year, but insisted that the launch was meeting expectations, whatever they might be.

On a panel at the Cleveland Clinic Summit, Steve Nissen, chair of cardiovascular medicine, alongside Wesley Day, VP, clinical development at Vivus, Jack Lief and Gary Palmer of Arena and Eisai, plus Michael Narachi, CEO at Orexigen Therapuetics – which has it’s own phase 3 obesity drug, Contrave, partnered with Takeda in North America – said the FDA doesn’t have a good grasp of obesity either. “We’re dealing with a section of the FDA that’s scientifically weak,” said Nissen. “FDA’s last guidance in obesity was in 1997. Draft guidance was issued in 2007, and it still hasn’t been completed…I fault the FDA for being inconsistent and murky in this area. Vivus’s Day added that outcomes and safety trials “are too limited…you can’t look at possible efficacy attributes” in the outcomes studies, he said.