The weight loss drug Qsymia will soon be available at retail pharmacies following approval from the Food and Drug Administration for a change to the distribution options specified in the Risk Evaluation and Mitigation Strategy (REMS).
REMS are required by the FDA when drugs are potentially harmful, especially when used in ways other than intended. A REMS can include a Medication Guide, Patient Package Insert, a mandatory Pharmacist Consultation, or other elements to assure safe use.
When Qsymia was initially approved by the FDA in 2012, the REMS limited the sale of the drug to mail-order pharmacies to ensure women were given instructions on how to use the drug and to prevent pregnant women from taking the drug in order to reduce birth defects.
Now, retail pharmacies that go through a certification process will be able to provide Qsymia, in addition to the existing network of certified mail-order pharmacies.
Qsymia (pronounced kyoo-SIM-ee-uh) is a prescription medicine for weight loss that works by suppressing appetite and increasing satiety (feeling of fullness). It is designed to be used with a reduced calorie diet and increased physical activity to help patients lose weight.
The medicine is available in four different doses to allow for flexibility in treatment and to ease the transition to the higher doses. It is taken as a once-daily pill taken orally.
Common side effects of Qsymia are paresthesia (tingling of hands and feet), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
Appropriate patients for Qsymia are adults with an initial body mass index (BMI) of 30 or greater, or 27 and greater with at least one obesity-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol.
Some people should not take Qsymia, including women who are pregnant or plan to become pregnant, or individuals who have glaucoma, thyroid problems, use medicines called monoamine oxidase inhibitors (MAOIs), or allergic to drug ingredients.
Qsymia is available by prescription only. It is currently available through the mail-order service of certified pharmacies (CVS, Walgreens, Walmart, Express Scripts), but is expected to be available by July 2013 in select certified retail pharmacies as well. These pharmacies will be listed in a pharmacy finder on the company’s website (www.Qsymia.com).
Cost of Qsymia
The cost of taking Qsymia is about $5.00/day, although this amount can vary depending on the dosage taken and where the medicine is purchased.
Many people who want to use the medicine may initially have to pay for it on their own as only about one-third of private insurers cover the cost and it is not yet covered by Medicare Part D. VIVUS, the biopharmaceutical company that developed Qsymia, is working with private insurers and the government to increase coverage in the future. The company also is optimistic that some employers will help with the cost in company wellness programs.
Weight Loss Medicine and Bariatric Surgery
Bariatric surgery is the most effective approach for significant weight loss and long term weight management, but surgery is not for everyone.
Some individuals do not qualify for surgery and some would rather try a medically supervised weight loss program. Other patients may be required to participate in a six month period of medically supervised weight loss before being granted approval for weight loss surgery.
In these instances, weight loss medicine such as Qsymia may be prescribed to assist patients in their weight loss efforts. Qsymia should be used together with better nutrition and regular exercise.
Impact of Qsymia REMS Modification
The FDA’s approval to allow the sale of Qsymia in certified retail pharmacies is expected to simplify the process of prescribing and dispensing the drug and improve the experience for both the physician and the patient.
According to Peter Tam, president of VIVUS, the company believes “that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial, and usage.”
Source: VIVUS Press Release “VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies” April 16, 2013.