National Prescription Drug Take-Back Day

The Drug Enforcement Administrative (DEA) has announced another opportunity for consumers to dispose of unneeded and expired prescription drugs during the DEA National Prescription Drug Take-Back Day, which will be held Saturday, April 28, 2018. On this day, from 10 AM to 2 PM, thousands of temporary collection sites will be available across the country to accept unneeded prescription drugs, including controlled substances, for safe and legal disposal. To date, DEA’s Take-Back Day initiative has collected a combined total of more than 900,000 pounds of unneeded medications, helping to prevent diversion, misuse, and abuse of the drugs. Follow this link to find the site in your area for drug disposal. 

https://www.deadiversion.usdoj.gov/drug_disposal/takeback/    

The National Association of Boards of Pharmacy (NABP) AWARXE® Prescription Drug Safety Program encourages consumer participation in DEA Take-Back Day events and provides information about the importance of safe drug disposal in helping to curb prescription drug abuse rates. Consumers who are unable to participate in the DEA Take-Back Day can find locations of permanent drug disposal sites using the AWARxE Drug Disposal Locator Tool.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs for 25 years. 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.

Brand Names vs Generics - Is There a Difference?

The cost difference between a brand name drug and its generic equivalent can be hundreds of dollars. Generic drugs are equal substitutes for their brand name counterparts. The FDA conducts rigorous reviews on all generics to make sure these medications meet the same standards as the brands.

• A generic medication works in the same way and provides the same clinical benefit as its brand-name version. 
• Any generic medication modeled after a brand-name medication must perform the same in the body as the brand-name medication. 
• FDA scientists review the manufacturers’ procedures and FDA inspectors go to the generic drug manufacturer's facility to verify standards 
• Placebos labeled with a brand name can prompt as much relief for conditions such as headache andheartburn as tablets containing the actual drug 
• Direct-to-consumer advertising for drugs totals about $5 billion annually 
• When multiple generic companies market the same product, market competition typically results in prices about 85% less than the brand name. 

Drug companies must submit an Abbreviated New Drug Application (ANDA) for approval to market a generic drug. An ANDA must show that the generic is equivalent to the brand in the following ways:

• The active ingredient is the same and the inactive ingredients of the medication are FDA-Approved
• Extensive "stability tests" prove that generic versions are effective for, at minimum, the same amount of time as the brand-name, if not longer. 
• Evidence must be provided that each step of the manufacturing process will produce the same result each time.

Plan sponsors typically implement a plan design so that the member has to pay the difference between the brand cost and generic cost, even if the doctor indicates brand on the prescription. However, plan sponsors who do not, are paying significantly higher costs for members who choose the higher cost brand drug.

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.

Update on HIV drugs

Up to 25,000 Americans with HIV are currently multidrug resistant, of which 12,000 are in urgent need of a new treatment option because their current treatment regimen is failing them.

On February 7, 2018, Gilead pharmaceuticals introduced Biktarvy, a new 3-drug combination tablet. It is approved as a complete regimen for initial treatment in patients with no treatment history. The cost is approximately $36,000 per year. On the same day, Mylan introduced Symfi Lo, which is a new product; but it contains 3 older drugs; efavirenz (Sustiva), tenofovir disoproxil (Viread), and lamivudine (Epivir). The annual cost is about $24,000. Symfi, which contains a higher dosage of efavirenz, will be hitting the market within the coming weeks.

One month later, on March 8, 2018, TaiMed Biologics introduced Trogarzo (ibalizumab-uiyk), an intravenous treatment approved to be used in combination with other antiretrovirals. In contrast to Biktarvy, this is to be used only in patients who have failed multiple other HIV drugs.  It is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications. It carries a hefty price tag of approximately $118,000 per year.

Though several new generics for HIV/AIDS are now available, they likely would not create significant disruptions to the market due to the current preference and ease of use of combination therapies. Two generic products have been introduced: Mylan launched a generic version of Bristol-Myers Squibb’s Sustiva (efavirenz), and Teva Pharmaceutical Industries Ltd. launched a generic version of Gilead Sciences’ Viread (tenofovir disoproxil fumarate). These two products are mainly used in combination therapies with other drugs that still have patent protection. “Switching a patient to take two or three individual HIV/AIDS drugs instead of a two-or-three-drug combination has never been successful,” stated Mesfin Tegenu, the President of PerformRx.

https://aishealth.com/archive/hbd-20180226-ndbn022318-02

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.