Qsymia and Belviq can slow the progression of diabetes, but side effects and retail cost of about $200 per month are obstacles to formulary placement
David Bleich may be the sort of prescriber who calms the nerves of anxious insurers.
The chief of endocrinology at Rutgers Medical School in Newark, N.J., is willing to prescribe two new diet drugs that were recently approved by the Food and Drug Administration — and are being closely tracked on Wall Street — but only under certain circumstances. So far, he has judiciously favored one pill over the other after comparing side-effect profiles and the potential for weight loss.
Moreover, Bleich is focusing primarily on patients who are obese and unhealthy, such as people with uncontrolled diabetes, as opposed to those who may simply want to lose a few pounds for the sake of appearance. In his view, the new drugs — Qsymia and Belviq — are welcome but not to be used indiscriminately.
“Everything in life is about balancing risk and reward,” says David Bleich, MD, chief of endocrinology at Rutgers Medical School.
“I know the drugmakers would like us to prescribe these [pills] for people who are simply overweight or for cosmetic issues, but I have a little issue with that,” he says. “Everything in life is about balancing risk and reward. I will not be a prescriber of these medicines for otherwise healthy individuals who want to lose a little weight. That will not be coming off my prescription pad.”
Such caution comes at a time when payers can, nonetheless, expect to face more pressure to provide coverage for these medications. For starters, the American Medical Association last June declared that obesity is a disease, a step that was aggressively advocated for months by the American Association of Clinical Endocrinologists, the American College of Cardiology, and the Endocrine Society, among others.
The move was more than symbolic. The AMA’s own Committee on Science and Health opposed the declaration on the grounds that the metric used to gauge obesity — the Body Mass Index — is imperfect and that unnecessary prescribing may follow. But a growing number of physicians say they wanted to improve coverage so that treatment could be extended to more patients.
“It was a very controversial decision,” says Kim Allan Williams Sr., MD, an American College of Cardiology vice president and professor at Rush University School of Medicine. “But the reason for declaring this a disease was not so much for physicians, because most understand the implications. It was really about payers and employers — to let them know this needs to be treated like any other illness.”
Obesity was declared a disease primarily to let payers and employers know that it should be treated, just like any other illness, says Kim Allan Williams Sr., MD, an American College of Cardiology vice president.
Meanwhile, another front is opening up. Companies that sell these new drugs recently began a direct-to-consumer advertising campaign. Eisai, the company that markets Belviz for Arena Pharmaceuticals, is now advertising the pill in several widely read magazines, including Oprah Winfrey’s O and Cooking Light. And a promotional push is expected to expand in coming weeks.
The other manufacturer, Vivus, has yet to take such a step, but recently underwent a management overhaul that brought in seasoned veterans from big pharma — the new chief executive is from Johnson & Johnson — and Wall Street bets that a marketing deal with a large drugmaker will be reached soon to help sell the Qsymia pill. When that happens, payers can expect more attention.
“A big potential catalyst would be if Vivus does a partnership with a major pharmaceutical company and puts a lot of sales reps on the ground and utilizes reimbursement specialists to turn on the pressure,” says Simos Simeonidis, PhD, a biotechnology analyst at Cowen & Co. “This should jump-start the managed care process, because the pressure on managed care hasn’t happened effectively yet.”
“The pressure on managed care hasn’t happened effectively yet,” says Simos Simeonidis, PhD, a biotechnology analyst at Cowen & Co.
Indeed, many insurers have been, at best, stand-offish about these new drugs. There are several reasons, notably the prescription diet pill craze of the mid-1990s, which was a trying experience thanks to fen-phen, the weight-loss combo that ushered in pill mills but was tied to serious heart and lung problems. One of the pills, fenfluramine (trade name Pondimin), was withdrawn in 1997.
Other diet drugs appeared around the same time, but had similarly dismal results — they were relatively pricey, produced only modest weight loss for a brief while, and caused troubling side effects. In fact, one of them, Meridia, was later withdrawn. These experiences remain relatively fresh for payers, who are reluctant to embrace the latest crop of drugs, regardless of any AMA declaration.
The hesitancy reflects, in part, widely publicized concern over side effects. The FDA, in fact, delayed approval of both Qsymia and Belviq for approximately two years and rejected a third diet drug that is being developed by Orexigen Therapeutics. The drugmaker is currently running a large cardiovascular trial, scheduled to be completed next year, hoping to gain clearance.
Before winning FDA approval, though, Belviq had to overcome data suggesting a theoretical risk of an increase in cancer, cardiovascular adverse events, and valvulopathy, the same malady caused by fen-phen. Even then, the FDA required Arena and Eisai to conduct six post-marketing studies, including an outcomes trial, to assess long-term effects on cardiovascular risk.
As for Qsymia, the pill contains phentermine, the surviving half of the fen-phen cocktail, and topiramate, the active ingredient in the Topamax seizure drug, prompting concerns about cardiovascular and teratogenic risks, notably, cleft palates. Consequently, Qsymia may only be sold in certified pharmacies as part of a risk evaluation and mitigation strategy, usually referred to as REMS. Many large chains have signed up.
Then there is the issue of actual weight loss. On this score, clinical trials for Qsymia showed patients taking the pill for up to one year lost an average of 8.9% versus a placebo, and 70% lost at least 5% of their body weight.
Patients taking Belviq lost up to 3.7% of their body weight versus those on placebo, and 47% lost 5% or more after a year.
In other words, the pill that demonstrated greater weight loss also has a more problematic safety profile, which may make for a difficult treatment proposition. The Cowen survey, for instance, found that 68% of obesity specialists believe Qsymia to be more effective.
It also reported that 20% of primary care physicians said the safety profiles of both drugs would discourage prescribing.
Another factor that may affect coverage is the potential pool of patients. “If insurers realize that 35% of their covered lives are overweight and another 30% are obese — and, therefore, may be prescribed one of these medicines — there’s no way they can afford to cover them,” says Timothy Garvey, MD, who heads the University of Alabama Diabetes and Research Training Center.
The potential pool of patients who are overweight or obese is huge, says Timothy Garvey, MD, of the University of Alabama.
“But in high-risk individuals with prediabetes, there is data showing medicines can reduce the progression of the disease in about 80% of patients. And if it costs systems $6,000 a year, on average, with diabetes, but $2,000 a year without diabetes, this can lead to savings,” says Garvey, who also chairs the obesity scientific committee of the American Association of Clinical Endocrinologists. He has been a consultant to Vivus and has held stock in the drugmaker.
All this helps explain why insurers such as Wellpoint and Aetna do not include either pill as a standard benefit on their formularies. Insurers are eager for additional information on the new drugs. “We and our clients are interested in the value of the medications; their impact on outcomes, including productivity; and the potential for medical cost offsets,” says Ed Pezalla, national medical director for pharmacy policy and strategy at Aetna. “Aetna is working on projects to answer these questions for our clients.”
That may not happen for a while, though. As Simeonidis notes, such data will not become available for four or five years. “The only thing that can change is the pressure to cover, and that has to come from demand,” he says. “So if big companies want coverage because their employees want it, then there may be a push. Otherwise, insurers will resist, although they could do their own analyses.”
A key question, though, is whether physicians and consumers will generate a groundswell of demand. For one thing, the pills are not cheap. A 30-day supply of the recommended 7.5mg dose of Qsymia costs $182.99 at CVS, and the wholesale acquisition price for a one-month supply of Belviq is about $200. Of course, these costs are before consumers use coupons that the drugmakers are distributing to reduce copayments.
Cost and coverage, however, were cited by slightly more than half of primary care physicians and obesity specialists as the most significant hurdles to widespread adoption of the pills, according to the Cowen survey. Affordability, in fact, overshadowed questions about safety, efficacy, and the use of generic substitution, when applicable.
“I see two scenarios,” says Randy Vogenberg, PhD, a principal in the Bentelligence consulting company and a member of Managed Care’s editorial board. “Those who can afford to buy the pills will do so, but the majority of people will be put through a benefit design matrix. There will be some coverage, but it will not be easy to get. This is going to be closely scrutinized. There’s just no incentive for health plans or pharmacy benefit managers to cover.”
The issues weigh on David Martin, who is vice president for managed markets, value, and access at Eisai. He says that Belviq is mostly on Tier 3 in formularies with copayments around $60, but maintains that the medications are still not very expensive. “This market is hugely underdeveloped and largely cash,” he says. “So obviously copayment cards or patient savings cards and vouchers make all the sense in the world.
“Compared to a generic phentermine, they might be expensive, but compared to some diabetes medicines, they’re relatively inexpensive. We’re pretty confident we’ve addressed the cost issues,” he continues. He also waxes optimistic about seeing significant changes in both medical and pharmacy benefits over the next 6 to 18 months and expects some employers to add coverage.
The total number of prescriptions written for Qsymia was about 108,000 in the third quarter this year, up 33% from the second quarter, according to IMS Health data cited by Needham analyst Alan Carr. And Belviq is showing weekly growth in new prescriptions of about 2.5%.
Just the same, the numbers are not terribly impressive and, in fact, are not resulting in big sales. This underscores the uncertain welcome the drugs are receiving in the marketplace. Carr forecasts Belviq sales of just $46 million this year and expects Qsymia sales to reach only $30 million. Of course, this is still the early going for both drugs, but the poor start does not bode well.
As a result, Eisai is doubling its sales force to roughly 400 by the end of the year, hoping to reach 65,000 physicians. And as new Vivus management settles in, Simeonidis, the Cowen analyst, expects the drugmaker to increase its own efforts at promoting its pill to payers, physicians, and consumers. The overall push may accelerate further, he adds, after Orexigen wins FDA approval for its own drug.
The next step in treating obesity is to “accept the risk of a drug that has potential to help,” says Caroline Apovian, MD.
“The AMA has finally started step one — that obesity is a disease and it’s OK to treat it,” says Caroline Apovian, MD, a professor of medicine and pediatrics at the Boston University School of Medicine, who also chairs the obesity guidelines effort at the Endocrine Society and serves on the advisory board at Arena Pharmaceuticals.
“As with treatments for other chronic diseases that have risks, the next step is to accept the risk of a drug that has the potential to help with obesity.”