October 10, 2012 4:26 pm
This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com
Vivus’ (NASDAQ:VVUS) weight-loss therapy, Qsymia, is expected to attain reimbursement from many payers, though some may take a few years, six experts told BioPharm Insight. One expert, however, expressed more skepticism on reimbursement prospects.
The US Food and Drug Administration (FDA) recently approved Qsymia for chronic weight management in obese adults and overweight adults with at least one weight-related medical condition. The Centers for Disease Control and Prevention (CDC) define obesity based on body mass index (BMI), a measure determined by weight and height. In adults, a BMI between 25 and 29.9 is considered overweight, while a BMI of 30 is defined as obese.
More than one-third of US adults (35.7%) are obese, according to the CDC. In 2008, medical costs associated with obesity were USD 147bn, the CDC estimated.
There is a growing awareness among healthcare providers, policymakers and the public that obesity is a disease and not a lifestyle choice, said Dr Timothy Garvey, professor and chair, Department of Nutrition Sciences, and senior scientist, Nutrition Obesity Research Center, University of Alabama at Birmingham. This includes an awareness of the social cost and suffering that patients with obesity have as well as the savings that would accrue for the healthcare system with adequate treatment, Garvey noted.
This is not the case in Europe, however. Qsymia faces grimmer approval prospects given the European Medicines Agency’s (EMA’s) stance on drug therapy for a condition largely viewed as a psychobehavioral disease, rather than a risk factor for hypertension and diabetes. European regulators will likely wait for US post-marketing data or results from a cardiovascular (CV) outcomes trial.
Vivus did not return a request for comment.
Changing view of obesity could help prospects
Qsymia’s big impact will be seen in diabetes, said Dr Donna Ryan, executive director for clinical research, Pennington Biomedical Research Center, Louisiana, and member of Vivus’ scientific advisory board. Diabetic patients who are also obese or overweight and and are given Qsymia may get taken off insulin or have their dosage and total number of medications reduced, she said. The drug’s impact on diabetes is why it will be reimbursed, she said.
Dr Xavier Pi-Sunyer, chief of endocrinology, diabetes, and nutrition, St Luke’s-Roosevelt Hospital, New York, director, New York Obesity Research Center, and a member of Vivus’ scientific advisory board, had a different opinion. The idea with anti-obesity drugs is that they could be used to treat patients for the rest of their lives, he said. As there are many obese and overweight people, and health plans are already “pretty stretched”, he did not think the drug will be reimbursed.
Many plans have certificates of coverage that exclude obesity drugs, said Jack Mycka, CEO, Medical Marketing Economics, New Jersey. Yet, Qsymia can still be successful and might even be a catalyst for changes in some of these old rules that payers sometimes hide behind, Mycka added.
When CMS started in 1977, there was operating guidance that obesity was not a disease, explained obesity consultant Ted Kyle, ConscienHealth, Pittsburgh. In 2004, CMS was persuaded to consider obesity a disease, which led pretty quickly to reimbursement for bariatric surgery, he said.
In 2011, CMS issued a national coverage determination for intensive behavioral therapy for obesity treatment, he added. CMS also recently initiated coverage on counseling therapy for treating obesity. It would likely cover a dietician and other structured programs involving larger numbers of healthcare providers, Garvey added.
The incorporation of the Edmonton Obesity Staging System (EOSS), used to identify obese individuals at greater mortality risk, may open doors for better reimbursement, noted Dr Frank Greenway, professor and director, outpatient clinical research, Pennington Biomedical Research Center, Louisiana. Payers would be able to limit reimbursement to those people with sufficient risk factors for mortality, he said.
Greenway described EOSS as: Stage 0 including individuals with a BMI greater than 30 but no obesity-related risk factors; Stage 1 including predisease; Stage 2 established disease; Stage 3 disease complications such as heart attack, neuropathy; and Stage 4 is end-stage disease.
Coverage inevitable over time
It was recently reported Qsymia is being covered by 30% of insurers. Most people did not expect much reimbursement of Qsymia, so 30% is better than expected, said Kyle. Qsymia’s post-approval program to monitor risks probably helps because it minimizes concerns about inappropriate prescribing, he added.
Further, more coverage for obesity treatment is inevitable over time because of the costs of leaving the disease untreated, he said. Dr William Herman, director, Center for Diabetes Translational Research, University of Michigan, reviewed published literature and found bariatric surgery to be more cost-effective, particularly in type 2 diabetes patients, compared to lifestyle or pharmacological interventions. Among lifestyle interventions, the range of cost-effectiveness was greatest because of the variability in both design and execution of the intervention programs, Herman said.
Herman’s analysis of pharmacological intervention focused on orlistat, because it was the only anti-obesity drug with a substantial number of cost-effectiveness studies. None of those studies showed orlistat plus diet was cost saving compared to placebo plus diet in otherwise “healthy” patients, assuming an incremental cost-effectiveness ratio of USD 50,000.
In patients with impaired glucose tolerance or type 2 diabetes, however, orlistat plus diet was cost-effective, Herman said. Still, orlistat has only modest efficacy and fairly poor long-term adherence and is probably not the best model for pharmacologic coverage decisions, Herman said.
Orlistat is available over-the-counter as Alli at half the dose of Roche’s (VTX:ROG) Xenical (orlistat), which requires a prescription.
Vivus’ fellow anti-obesity drug developer Arena Pharmaceuticals (NASDAQ:ARNA) saw the approval of Belviq this summer, ending a 13-year drought in anti-obesity drug approvals in the US. Orexigen’s (NASDAQ:OREX) Contrave could see the third nod from the FDA, following an interim look at its CV outcomes trial. The company is expected to resubmit its marketing application in 2Q or 3Q13.
Qsymia has an annual sales estimate of USD 1.6bn in 2019, according to BioPharm Insight data. The current wholesale price of Qsymia for a 30-day supply ranges between USD 120 and USD 183.90 for the low and highest doses. The generic components, phentermine and topiramate, are available, however, for approximately USD 37-USD 60 per month. The combination of the generics would be off-label use, however, presenting additional logistical and liability concerns to physicians.
Vivus’ stock has declined roughly USD 9 (30%) since receiving Qsymia approval in July.
Vivus’ current market cap is USD 2.1bn.
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