October 22nd is National Prescription Drug Take Back Day!

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On Saturday, October 22nd, the Drug Enforcement Administration (DEA) will be holding its 12th National Prescription Drug Take Back Day. At the end of this blog is a link to find a location by zip code. Held from 10:00 AM - 2:00 PM, the purpose of this event is to provide the public with a safe, responsible and convenient way to get rid of prescription drugs, while at the same time providing education on how medications can potentially be abused.

During the last event, which was held earlier this year in April, the DEA and its national, community and tribal law enforcement partners collected a total of 447 tons of unwanted medications. There were about 5,400 collection sites available across the United States. For the event on the 22nd of October, there will be 4,700 collection sites in operation nationwide, and the service provided by local law enforcement agencies and other community partners will be completely free of charge to the public.

Since the first National Prescription Drug Take Back Day six years ago, there have been approximately 6.4 million pounds of drugs collected – this alone just goes to show how successful the events have been. The DEA explains that 6.4 million Americans aged 12 and up abuse prescription drugs, and with drug overdoses being the leading cause of injury-related death in the U.S., it becomes increasingly more important for the public to have a safe way of disposing unwanted medications.

If you have unwanted medications at home, we highly encourage you to take advantage of this opportunity. Locating a collection site near you is easy. Simply click here, select "locate a collection site near you," and either enter your zip code or your county, city and state – upon submitting your information, you will be presented with a list of participants and the specifics of the collection site.

For more information, click here or give us a call at (888) 797-2479.

Mylan Advocates for EpiPen to be Approved as a Preventive Medication

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Mylan, the maker of the EpiPen, which recently raised costs significantly, causing an outrage among many, is now attempting to push the United States Preventive Services Task Force (USPSTF) into including EpiPens on their list of preventive medical services. While this would seem like a move in the right direction for patients (if EpiPens were approved it would result in a $0 copay), the payor (health plans, unions, employer groups, etc) would likely disagree. The reason for this? Having EpiPens on the USPSTF’s list of preventive medical services would allow the drug maker to continue to raise prices, with those costs landing in the laps of insurers or payors.

Along with patients who rely on EpiPens, Mylan would be amongst those who reap the benefits of having the medication on the preventive medical services list. This is because raising their prices would no longer result in a public outcry once patients become eligible to receive the treatment without a copay. However, it is important to keep in mind that costs could later be passed back on to consumers and patients in terms of higher premiums or higher co-pays for different drugs, according to an article in the New York Times.

Predictions About Approval

Ultimately, the decision to include EpiPens on the list of preventive drugs lies in the hands of physicians and public health experts who have been federally appointed to the United States Preventive Services Task Force. Although it can be argued that using an EpiPen can prevent a reaction that can go so far as being fatal if taken at the right time, a potential setback is that currently, there are no prescription medications for diagnosed illnesses on the USPSTF’s list of preventive medical services.

For more details surrounding Mylan’s latest efforts, check out the full story in The New York Times here.

As experts in the pharmaceutical industry, we at PBIRx are very familiar with the current situation surrounding EpiPens and are constantly reading and researching to stay on top of the latest news. If you have questions, please connect with us on social media so that we can further discuss. For additional information, contact us at (888) 797-2479.

U.S. FDA Announces Approval of Amjevita

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On September 23, 2016, the U.S. Food and Drug Administration officially announced their approval of Amgen’s Amjevita as a biosimilar to Humira. Amjevita is the fourth biosimilar to receive approval from the U.S. FDA, and has been approved to treat seven of ten Humira indications.   

Approved Indications

As is stated in the FDA’s press release, the indications that Amjevita has been approved for are (in adult patients):

1. Moderately to severely active rheumatoid arthritis.
2. Active psoriatic arthritis.
3. Active ankylosing spondylitis.
4. Moderately to severely active Crohn’s disease.
5. Moderately to severely active ulcerative colitis.
6. Moderate to severe plaque psoriasis.
7. Moderately to severely active polyarticular juvenile idiopathic arthritis (for patients four years old and up).

The biosimilar is NOT approved for use in pediatric Crohn’s Disease, Hydradenitis Suppurativa, and Uveitis. The approval of Amjevita signifies an important milestone for California based Amgen, as this is their first biosimilar to receive FDA approval. As a reminder, in order to be approved by the U.S. FDA, a biosimilar must prove that it is extremely similar to a biological product that has previously received approval, and there must be no clinical differences between the two products where purity, potency and safety are concerned. 

Side Effects

As with all treatments, possible side effects have been provided for prescribers and patients to review. The most serious to note are malignancies and infections, and the FDA explains that they expect the most common side effects to be infections and reactions at the injection site. Just like Humira, Amjevita also comes with a Boxed Warning that alerts of an increased risk of serious infections that could potentially result in hospitalization or be fatal.

Although Amjevita has received its approval now, FiercePharma reports that it could be a while before it actually makes its way into pharmacies. This results from a 180-day notice period that is required, as well as a legal issue between AbbVie and Amgen. AbbVie, which is the manufacturer of Humira, has reportedly sued for patent infringement and requested that the courts block Amjevita upon receiving FDA approval. AbbVie, recognizing that they will lose market share to biosimilars, has also had several Average Wholesale Price (AWP) increases for Humira in the past 12 months of over 28% dramatically impacting payor’s pharmacy benefit spend. 

It will be interesting to see how biosimilars are treated by Pharmacy Benefit Managers and how biosimilars are accepted and dispensed by physicians and health plans in 2017. 

If you have questions about the FDA’s latest approval and how it could impact your current health care spend, please give us a call at (888) 797-2479. We at PBIRx are always on the lookout for new approvals and analyzing how they will affect pharmacy benefit spend, and would be happy to speak with you further about the topic.

Rising Drug Costs, the Government, and the 2016 Election

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Election year is always bound to include debate and discussion over major topics that the public has their eyes and ears on, and this year, one of the most pressing that we are following is rising drug costs - one piece of the health care puzzle that has been at the forefront of many conversations.

Thanks to recent price hikes, such as the one seen with EpiPens, it appears that more people are looking for answers from officials about the issues surrounding exceedingly high prescription costs. During a forum sponsored by RealClearHealth and Express Scripts earlier this month, congressmen and industry leaders took an interest in how the rising cost of drugs should be addressed. While some attendees from the left feel that caps on prescription drugs or negotiations between the Centers for Medicare & Medicaid Services and pharmaceutical manufacturers are the answers, others are looking for more transparency and expressed that there needs to be more congressional oversight. Another opinion is that the FDA needs to have a more efficient process for approving new drugs, as they currently have a “backlog of generics to approve,” which encourages prescription costs to keep rising (additional details about the forum available here, via RealClearPolitics).

The Presidential Candidates and Their Health Care Plans

A recent article by MedCity News reports that Democrat Hillary Clinton just announced her plan for how she will respond to “unjustified price hikes for long-available drugs.” Considering that drug makers have hiked prices for about 400 generic drugs by more than 1,000% between 2008 and 2015 alone, part of Clinton’s plan is to “establish dedicated consumer oversight at our public health and competition agencies.” She strives to bring together representatives of federal agencies that are responsible for ensuring health and safety, as well as fair competition, in order to create a group that is dedicated to protecting consumers from such price increases. Should we experience another price hike similar to what happened with EpiPens, for example, it would be this group’s duty to respond (read the full details of Hillary’s health care plans here).

Republican Donald Trump has also expressed his viewpoint on health care reform, with one of his main priorities being to repeal Obamacare. Should he be elected President, some of his other plans include:

1. To require price transparency from all health care providers, while permitting individuals to find the best prices for their medical needs.
2. To remove existing barriers to entry into free markets for drug providers that are offering reliable, safe, and cheaper products.
3. To give individuals the opportunity to fully deduct their health insurance premium payments from their tax returns under the current tax system.

Initiatives such as these have been designed for the purpose of reducing health care costs for more Americans, according to the campaign. Additional details about Trump’s plans can be found here.

Other Government and Health Care News

Insurers such as UnitedHealth Group Inc., Aetna Inc., and Humana Inc. recently announced that they will be pulling back from the Obamacare individual insurance market next year, and as such, earlier this month, President Obama and other health advisers met with other insurance companies to discuss how the marketplace can be strengthened before the open enrollment period begins in November. The President did openly acknowledge that improvements could be made to benefit both consumers and insurers, and says that his administration will focus on enrolling individuals who are still without health coverage, such as young adults. More on this available here, via The Financial Express.

As election day gets closer, be sure to connect with PBIRx on social media and check our blog regularly for updates on health care’s role in the election. For additional information, please call (888) 797-2479.