First, I would like to extend my gratitude to the board for helping me stay long in ARNA for the past 6 months as I have been reading this board non-stop since February. This is my first post and perhaps I should have been participating in this board sooner. I'd like to chime in my two cents from my unique perspective and experience. I'm currently a practicing pharmacist working in a community pharmacy setting with about 10 years of experience. I graduated from a top 5 college of pharmacy and have experience in both the community and hospital setting. The following is my opinion and I'm long ARNA and plan to stay long even given Qsymia's approval for the following reasons:
1) Qsymia is the obvious mixture of topiramate and phentermine in a controlled release capsule. The phentermine is immediately released while the topiramate peaks in the evening. The idea is to control hunger better throughout the day with this formulation. The problem I have with Qsymia and the reason I've never invested in VVUS is because it's not novel. I have patients currently taking phentermine and topiramate off-label for weight loss. Most take 1/2 to 1 tablet of the phentermine 37.5 mg dose and either the 50 mg or 100 mg topiramate dosage. The cost is cheap. Most of my patients have insurance coverage that covers topiramate because the insurance cannot discern it's use i.e. weight loss vs. migraine prevention vs. seizures vs. bipolar disorder. Phetermine 37.5 mg tablets is in the $20-30 price range and I'd say more than 90% of insurance companies will not cover this drug. It will be interesting to see how VVUS prices this drug.....
2) Qsymia will only be available by speciality mail order pharmacies certified to dispense and by physicians certified to prescribe Qsymia. One thing I can tell everyone is that patient's generally hate mail order mandates. There are tons of issues with mail order such as the drug doesn't arrive in time leaving the patient without medication and the process can be cumbersome for getting the RX from the physician to the mail order to the patient which can create communication issues and timely arrival of the RX. I've reviewed the REMS for Qsymia and believe it resembles that of isotretinoin (Accutane). For those unfamiliar with this drug, it is used to treat acne. Pharmacies and physicians must follow the iPledge online program. Females must have monthly pregnancy tests and everyone gets periodic labs to check for certain abnormalities. All this information has to be reported to the iPledge system in order for the patient to get the medication and the patient also has a questionnaire. Qsymia REMS reminds me of this program. With that being said, most dermatologists don't prescribe isotretinoin first-line due to the risks and time consumption following the program since topical medications are available such as tretinoin, adapalene and benzoyl peroxides combined with antibiotics etc. Most patients must try all these topical options or oral antibiotic options in some cases and must fail these treatments before getting put on isotretinoin. In this analogy, I believe the prescribing trend will be similar to the Qsymia vs Belviq situation with patients trying Belviq first before going to Qsymia for the above listed reasons. There's a reason Topamax (topiramate) has coined the nickname "dopamax." One plus for VVUS is that by doing mail order, the patient won't have someone like myself recommending the cheaper generic alternative to Qsymia (assuming the price is substantially higher) or Belviq for that matter in a community pharmacy setting. The question that also comes up of whether prescribers will feel mandated to prescribe Qsymia vs. it's generic counterparts (phentermine + topiramate). I feel it will be 50/50. Some may be afraid to prescribe now due to REMS while others that have been prescribing this for years may continue to do so and follow the REMS program unofficially and document such events in the patient chart.
3) While Belviq's weight loss is not equal to that of VVUS, I expect weight loss clinics to begin to experiement with phetermine + lorcaserin combo in refractory patients. IMO this does carry some legal liability with the prescriber since there are no studies confirming the combo is safe and effective. It has the promise to be just as good with weight loss as Qsymia hopefully without the restrictions. Along the same lines, why not combine with a fat blocker such as orlistat for additional weight loss?
4) A1C, A1C, A1C!!! This cannot be overstated enough. If we take an overweight type 2 diabetic that is using Metformin + Januvia + glipizide and has an A1C of 7, it's likely lorcaserin could replace one of these oral meds, preferably the expensive Januvia and save the patient money as well as the healthcare system. Januvia is a few hundred bucks a month.
5) I'm not concerned about lorcaserin's cardiovascular effects, but I am concerned with Qsymia's effects. There was no clear signal from clinical trials regarding lorcaserin's risk of valvulopathy or MACE. The FDA is being cautious requiring the post-approval trials. There were signals with Qsymia such as the increased heart and a few MACE reports. I'd be fairly afraid of putting a hypertensive patient with comorbid disease states on this drug given some of the unknowns surrounding this medication. Most obese patients just don't present with obesity either, but can present with metabolic syndrome. Why risk the patient's health with a more risky treatment with Qsymia when Belviq is available?