New Rheumatoid Arthritis Drug

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

On May 22, 2017, the FDA approved a new drug, Kevzara (sarilumab), manufactured by Sanofi/Regeneron Pharmaceuticals, indicated to treat adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs.  The patient receives one injection every two weeks at a cost of approximately $39,000 per year.  

This new drug will come with a boxed warning that cautions it may predispose patients to bacterial, fungal, viral or other infections.  Before use, patients should be tested for latent tuberculosis. PBIRx will continue to keep our members informed of the latest drugs available as well as their possible side effects.   PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Diabetes Drug Safety Communication

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

PBIRx has been informed by the FDA Safety Information and Adverse Event Reporting of increased risk of leg and foot amputations with the use of canagliflozin brands (Invokana, Invokamet, Invokamet XR).  The FDA will be requiring new warnings including Boxed Warning to be added to the canagliflozin drug labels to describe the risk.

The FDA has the following recommendation:

"Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet.  Talk to your health care professional if you have questions or concerns.  Do not stop taking your diabetes medicine without first talking to your health care professional."

Please follow the link to the FDA article:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

FDA Approves ALS Drug

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On Friday, May 5th,  for the first time in 22 years, the FDA approved Radicava (edaravone) to treat patients with ALS, also known as Lou Gehrig’s disease.  The Centers for Disease Control and Prevention estimates that there are approximately 12,000 to 15,000 Americans who have this disease, which attacks and kills nerve cells that control voluntary muscles.  A year’s course of the medicine will cost about $145,000 before discounts.

Radicava is an intravenous infusion administered with an initial treatment cycle of daily dosing for 14 days followed by 14 days without drugs.  The treatment then follows with dosing on 10 of 14 days followed by another 14 days without drugs.    The efficacy for this treatment was proven in a six-month clinical trial in Japan.  At Week 24, individuals receiving the drug experienced less of a decline on a clinical assessment of their daily functioning than those who received the placebo -- the patient’s symptoms deteriorated more slowly.  

Radicava does have side effects.  The most common reactions are bruising, headaches and gait disturbance.  Other risks include hives, swelling, shortness of breath and allergic reactions to sodium bisulfate that may cause anaphylactic symptoms.

If you suffer from ALS, contact your doctor to find out if this new drug may benefit you.

For additional information:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

https://www.forbes.com/sites/matthewherper/2017/05/05/fda-approves-first-new-drug-to-treat-als-in-22-years/#770a82f27fb3

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.