Managed Care - August 2012 - (Page 46)

ToMoRRow’s MEDiCiNE Study 1, which enrolled 3,128 patients, followed patients for an additional year. During the second year, subjects taking the placebo continued to take the placebo. Patients in the lorcaserin group were split into two groups randomly. In double-blind fashion, one group was continued on lorcaserin; the other group was switched to placebo. This crossover allowed the investigators to determine the effectiveness of the lorcaserin during the second year and to measure the response of ceasing the lorcaserin in those who were originally on active drug. The durability results in study 1 revealed that subjects who were randomized from active drug to placebo gained back much of the weight they had lost for a net two-year loss of only 1.2 kg (about three pounds), compared to those who were continuously on placebo. Patients remaining on lorcaserin for two years also gained some weight back during the second year, but at the end of two years they had still lost a mean of 6 kg, compared to a loss of 2.6 kg for patients on placebo for two years, for a net loss of 3.4 kg (about seven pounds). Safety is obviously a big concern when a drug could be indicated for 70 million or more people. The FDA warns in the package insert that lorcaserin is a serotonergic drug, part of a family of drugs that have been associated with potentially life-threatening serotonin syndrome and neuroleptic malignant syndrome when used in conjunction with selective serotoninnorepinephrine reuptake inhibitors(SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John’s wort, tryptophan, lithium, tramadol, dextromethorphan, and antipsychotics. ADVERTisiNG iNDEX AMCP 2012 Educational Conference ................................................ 6D Catamaran Corporate ......................................................................................3 Elsevier Gold Standard ..............................................................................9 Medical Directors Forum Corporate ................................................................................... 42 Novo Nordisk Corporate ...................................................................................C2 Victoza .........................................................................6A, 6B, 6C Regurgitant cardiac valvular disease, primarily affecting the mitral and/or aortic valves, has been reported in patients taking serotonergic drugs (e.g., fenfluramine/ phentermine — commonly referred to as fen/ phen) with 5-HT2B receptor agonist activity, which is thought to be caused by activation of the 5-HT2B receptor on cardiac interstitial cells. At therapeutic concentrations obtained when patients are administered 10 mg twice daily, lorcaserin is more highly selective for 5-HT2C receptors compared with 5-HT2B receptors. During the trial, 2.4 percent of patients receiving lorcaserin and 2 percent of patients given placebo developed valvular regurgitation at one year. None was symptomatic. Managed care implications While obesity is a major public health and therefore managed care issue, the addition of Belviq is unlikely to result in dramatic improvements in overall health, considering that most patients gained much of the weight back with a net loss of about three pounds one year after stopping lorcaserin. Even for those who stayed on the medication for two full years, the net weight loss was only about seven pounds. There were no data in the FDA submission on improvement of overall health of the patients in the various studies. It is unknown whether any of the patients resolved their diabetes, hypertension, or hyperlipidemia. It is also hard to conceive that the temporary weight loss for those not remaining on the drug is likely to lead to overall health gains. Although the daily cost has not been announced at the time of this writing, Arena CEO Jack Lief said on CNBC that “Belviq would cost about the same as a Starbucks venti latte in New York.” That would place the cost of the drug at more than $100 per month. Although lorcaserin is a step forward in the fight against obesity, it is, at best, a small step overall. With only about 50 percent of patients remaining on drug, and the limited weight loss, Tomorrow’s Medicine is still waiting for a solution to this growing problem. The author is a director in the value-based health department at Genentech. He has had no other industry affiliations in the past three years. The views expressed in Tomorrow’s Medicine are the author’s alone. 46 MANAGED CARE / AUGUST 2012

Table of Contents for the Digital Edition of Managed Care - August 2012

Managed Care - August 2012
Editor’s Memo
Contents
Legislation & Regulation
News & Commentary
Medication Management
Evidence Review
Compensation Monitor
Private Exchanges: Practice Makes Perfect
Hospitals and Providers Ganging Up on Plans?
Q&A: Kaiser Permanente’s Sharon Levine, MD
God Save the Health Care System!
Future Points to Greater PBM/Plan Cooperation
Formulary Files
Plan Watch
Tomorrow’s Medicine
Outlook

Managed Care - August 2012