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.

EpiPen Voluntary Recall

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On Friday, March 31, the FDA alerted consumers to the voluntary recall of 13 lots of Mylan's EpiPen and EpiPen Jr Auto-Injector products that are used for emergency treatment of severe allergic reactions.  The recalled products were distributed from December 2015 through July 2016.  These devices may contain a defective part that could result in its failure to activate. This recall impacts the 0.3mg and 0.15mg strengths.

For updates, lot numbers and additional information, go to: www.Mylan.com/EpiPenRecall. 

Consumers should keep and use their current EpiPen products, if needed, until they get a replacement.  If you have a recalled EpiPen product, contact Stericycle to provide a container to return the recalled medication.  You will also receive a voucher to redeem for a free replacement product.  Please contact Stericycle at 877-650-3494.

If you have any questions or concerns, contact Mylan Customer Relations at 800-796-9526 or at customerservice@mylan.com . 

PBIRx has notified all clients and brokers of this recall and will always be proactive to our consumers when we receive important pharmacy information that may impact their health.

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.

Change is on the Horizon for the Affordable Care Act

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

President Trump and the Republican-led Congress plan to ‘repeal and replace’ the Affordable Care Act, also known as Obamacare with expected details to be revealed  by early to mid March.  Early leaks refer to changing or eliminating the individual mandate, income based subsidies, Planned Parenthood funding, current Medicaid funding and all the law’s taxes. The leaks also mention capping the employer sponsored insurance at the 90th percentile of current premiums and allowing states to determine mandatory or essential benefits. (http://www.politico.com/story/2017/02/house-republicans-obamacare-repeal-package-235343 )

In January, a budget resolution was passed that called for major changes to the law to be made in a subsequent bill.  President Trump signed an executive order (https://www.whitehouse.gov/the-press-office/2017/01/2/executive-order-minimizing-economic-burden-patient-protection-and) that calls for federal agencies to ‘waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the act’ that would ‘impose a fiscal burden’ on states, healthcare providers, individuals and others in the health industry.  The only response to this order has come from the IRS which has told tax preparers and software firms that it will not automatically reject tax returns that fail to state whether the tax filer had health insurance during the year.  The IRS noted that the rule change does not change the taxpayers’ responsibility to obtain health insurance and pay any penalty for noncompliance.  

In his first speech to Congress on February 28th, President Trump laid out five broad ideas that he wants the ACA replacement to address:

• Ensure that Americans with pre-existing conditions have access to coverage
• Provide tax credits and expanded Health Savings Accounts to buy health coverage
• Give State Governors resources and flexibility needed with Medicaid
• Implement legal reforms that protect patients and doctors from unnecessary costs that drive up the cost of insurance and work to bring down the artificially high price of drugs
• Give Americans freedom to purchase health insurance across state lines.

http://www.businessinsider.com/trump-state-of-the-union-speech-on-obamacare-repeal-replace-2017-2

At this point, it is believed that people who purchased insurance for 2017 should be covered for the remainder of the year.  The uncertainty, though, will come in 2018.  Some insurers are pulling out of the individual insurance market.  Humana has already announced it will not participate in the exchanges next year.  The CEO of Aetna has told reporters that they may pull out of Obamacare “market-by-market, based off of the level of competition and whether it can achieve an adequate return on capital”, but will decide after reviewing rates by mid May.  (http://www.cnbc.com/2014/02/06/aetna-may-pull-out-of-obamacare-ceo.html ) Insurers have been given an extension until the end of June to tell the federal government if they plan to participate in 2018.

Until a bill is passed, there is much unknown regarding the fate of the Affordable Care Act, and the future for an estimated 20 million people who are currently insured.

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.

Epinephrine Devices and the Current State of the Market

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

The recent media coverage of Mylan’s EpiPen® Auto-Injector brand pricing has given rise to many changes and options in the adult and pediatric epinephrine device marketplace, including Mylan’s new lower cost generic.  In recent weeks, CVS began marketing the Impax Laboratories generic epinephrine equivalent to Amedra Pharmaceuticals’ Adrenaclick®.  Coming in February, Kaléo will be marketing the return of the Auvi-Q® Auto-Injector, a product once marketed by Sanofi Pharmaceuticals prior to a voluntary recall in October 2015.

Most of the current information that is being advertised is focusing on how the patient will save money, not how the Employer will save money.  Plans and patients need to be sure to read the fine print provided by manufacturers, pharmacies and their PBMs. For example, CVS is offering the Impax Laboratories generic equivalent to Amedra Pharmaceuticals Adrenaclick® for a cash price of $109.99, the lowest on the market.  In addition, Kaléo will be offering the Auvi-Q® Auto-Injector for patients without commercial or government insurance for the cash price of $360 and for free if patients have a household income less than $100,000. For patients with commercial or government insurance, the out-of-pocket cost will be $0.

https://www.cvs.com/content/epipen-alternative
https://kaleopharma.com/kaleo-announces-u-s-availability-and-pricing-to-patients-of-auvii-q-epinephrine-injection-usp-auto-injector-for-life-threatening-allergic-reactions/

Depending on the Pharmacy Benefit Manager, the changes to an Employer’s pharmacy drug coverage may include:

• Exclusions for brand name epinephrine devices (i.e. Cigna, United Healthcare) only allowing payment for a generic;
• A Preferred Tier with a Plan Sponsor rebate for generic and brand epinephrine devices;
• A Maximum Allowable Charge (MAC) for a generic equivalent epinephrine device and allowing the patient to select a product.

Table 1 shows the options for generic and brand name epinephrine devices that are currently available or will be available in February 2017.

Table 1.  Epinephrine Devices in 2 Pen Quantities per Box

Brand Name	Active Ingredient	Manufacturer	NDC
EpiPen® Auto-Injector EpiPen Jr.® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Mylan	0.3 mg - 49502-500-02 0.15 mg – 49502-501-02
Generic Equivalent to EpiPen®	Epinephrine Injection USP 0.3 mg and 0.15 mg	Mylan	0.3 mg - 49502-102-02 0.15 mg - 49502-101-02
Adrenaclick® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Amedra Pharmaceuticals	0.3 mg – 52054-804-02 0.15 mg – 52054-803-02
Generic Equivalent to Adrenaclick® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Impax Laboratories	0.3 mg - 54505-102-02 0.15 mg – 54505-101-02 *single pens also available
Auvi-Q® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Kaléo	0.3 mg – 60842-023-01 0.15 mg – 60842-022-01

Epinephrine is used as a life-saving treatment for patients requiring emergency treatment from allergic reactions including anaphylaxis.  Anaphylaxis results from exposure to an allergen, such as nuts or venom from a bee sting, which causes the body to release a flood of chemicals from the immune system.  Signs and symptoms of anaphylaxis include a skin rash, nausea and vomiting and a rapid, weak pulse.  This immune reaction can lead to shock from a drop in blood pressure and narrowing of the airway, blocking normal breathing.  Anaphylaxis requires an immediate trip to the emergency room and injection(s) of epinephrine.  Without immediate treatment, anaphylaxis can lead to unconsciousness or death.

As always, cost will be the driver for epinephrine device selection by both patients and insurers.  PBIRx can discuss with clients how to manage these epinephrine device options by analyzing current utilization and implementing cost savings programs.   Our dedicated pharmacists are developing strategies to offer our clients and their members the best savings available in the marketplace.

PBIRx, an independent pharmacy-focused company, provides analytical, consulting and auditing services utilizing a strong Clinical Department with state of the art technology to advocate for the Plan Sponsor and their employees.  Our clinical recommendations benefit both the Plan Sponsor and the employees versus the profitability for the pharmacy benefits manager.  

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.

Lower Cost Basaglar Will Compete with Higher Cost Basal Insulins

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Basaglar, a Lilly/BI (insulin glargine injection),  a “long acting human insulin product” for pediatric type 1 diabetes mellitus and adult type 2 diabetes mellitus,  is the first FDA approved “follow on biologic” in the insulin class launched on December 15, 2016.  Lantus, a Sanofi highly prescribed insulin glargine injection, alternative form to Basaglar, will definitely be affected due to Basaglar’s lower cost.  Lantus was the top selling insulin in the US for the past decade or more with over $5 billion in sales in 2013 and now its reign is finally coming to an end.

Long–acting insulin (basal insulin) plays an extremely important role in the treatment of diabetes in children and adults. Lantus was the first basal insulin approved by the FDA in 2000 and has dominated the insulin market for years.  Lantus had significant and consistent price increases throughout its tenure including two in 2013, which increased its cost by over 15 percent.  The cost of this life saving medication has taken a dramatic economic toll on payers and patients alike.  The impact of its price increases was most dramatic because diabetes is an ever growing epidemic that accounted for $245 billion in health care expenses in 2012.  Now there is finally some relief for those who have been so affected by the costs of insulin.

Basaglar’s current list price for a pack of five pens is $316.85, which puts it at a 15 percent lower cost to Lantus (Lilly/BI) and Toujeo (Sanofi), a 21 percent lower cost to Levemir (Novo Nordisk, insulin detemir injection) and a 28 percent lower cost to Tresiba (Novo, insulin degludec).  Plan Sponsors offering pharmacy benefits to their employees or members need to be talking to their PBMs and Pharmacy Benefit consulting partners to determine current Lantus utilization along with PBM Lantus rebates to determine if there is a significant cost savings by preferring Basaglar. 

Consulting firms like PBIRx, that focus both on how to achieve positive health outcomes and how to lower prescription drug costs for their clients, will discuss strategies that save money and improve health, versus PBM strategies that focus solely on optimal PBM profits.  Based on individual client’s needs and cultures, PBIRx’s strategies will include taking advantage of Basaglar’s lower cost while focusing on what is best for each client, i.e. do not restrict Lantus, but offer lower copay for Basaglar; implement exclusion that requires Basaglar for all new long acting insulin utilizers; implement Basaglar as first step for long acting insulin, etc.

Bagaslar has already been introduced in several countries under the name Abagaslar.   In some countries switching requires a managed care approach with blood glucose monitoring along with possible dosage adjustment.  Currently in the U.S., the doctor must write a Basaglar prescription; though many states are enacting laws and regulations that allow pharmacists, sometimes only with patient consent, to substitute with the new, or a similar product. 

Lantus cost per Rx is estimated at $600 to $800 per prescription and is in the top ten of plan drug costs.    With the estimated current Basaglar 15 percent lower and conceivably 30 percent lower cost in the future, clients are looking seriously at this savings opportunity. CVS/Caremark and United Health have already moved Lantus off of the 2017 national formularies in favor of Basaglar  

At the IDF conference in December, Dr. Matthew Riddle estimated that “50 percent of all people with type 2 diabetes would benefit from biosimilar insulin glargine (Bagaslar), compared to just 25 percent of patients benefiting from the reduced hypoglycemia and flatter glucose profile seen with next-generation brand name basal insulin analogs such as Novo Nordisk’s Tresiba and Sanofi’s Toujeo.” https://diatribe.org/fda-approves-new-insulin-glargine-basaglar-first-biosimilar-insulin-us.   

PBIRx can discuss with clients how to manage these new generation insulins to achieve protection of cost trends while allowing access to any patient that may benefit.  PBIRx does this through their custom RxSAVINGS clinical programs that are carefully constructed by their staff of PharmDs to utilize the latest product information, treatment guidelines, and the expertise of the prescribing physician.

PBIRx has identified all Lantus utilizers for all of our clients by plan cost, number of prescriptions, number of members and number of prescribers.  Along with our clinical team of pharmacists and the client’s PBM clinical team, strategies are currently being discussed so that our clients and their members can take advantage of savings sooner than later.