Brand drugs in the U.S. have two main methods of protection from generic competition. 1) The U.S. Patent and Trademark Office protects innovation by awarding patents. 2) The U.S. Food and Drug Administration offers exclusivity protections.
The following analogy helps to illustrate the difficulty in predicting a generic launch date due to complex brand protections. Think of the brand drug as being protected by a safe. The door to the safe may have one or more locks. Each lock has a timer that is counting down. Once the time runs out on the lock, it opens and remains open. Those locks represent the patents and exclusivities that protect the brand from generic competition.
There are two main scenarios for this analogy. First, without doing anything, all of the locks will open automatically at some point in the future. Generic drug manufacturers could wait for all patents and FDA exclusivity to expire. For the opportunists and/or impatient, actions can be taken to open the safe early instead of waiting.
To open the safe early, you must have certain capabilities in picking locks (proving invalidity or non-infringement in a Paragraph IV challenge). The type of lock (a patent protecting an indication vs. a patent protecting a dosage form) must be taken into consideration. Some locks (exclusivities and patents) are very advanced and essentially unable to be bypassed in the time remaining before it opens automatically (expires). Other locks are easily “picked” once you have the basic knowledge and capabilities.
Each brand drug will have a unique combination of patents and exclusivities that may have varying expiration dates (timed locks). Beating a patent (picking a lock) on one drug may or may not help you with future patent challenges. All of these factors demonstrate why it is so difficult to predict a generic launch date.Tags: brand, generic
GetMyRx is a prescription delivery service application that is available for mobile Apple devices. This new App allows retail pharmacy customers to scan and send a new prescription or refill into a local pharmacy and then get their prescription delivered within 4 hours. The App is easy to use, utilizing a step-wise approach for patients to enter necessary information. The App is able to scan the user’s insurance card and the new prescription or refill label using an in-app camera feature. The written prescription must be surrendered to the pharmacy upon delivery of the medication. Then, all the user has to do is enter their patient information, their doctor’s name, and a delivery address, and the pharmacy will do the rest. The delivering pharmacy takes care of transferring the prescription (if necessary) and calling the user to confirm the order and obtain the user’s credit card information. The App is free to download and the delivering pharmacy cannot charge a delivery fee, so the prescription will cost the exact amount it would cost in-store. GetMyRx charges pharmacies a software licensing fee for using its proprietary technology platform.
Currently, this service is only available in the Miami, Florida area, but developers are looking to expand to New York and San Francisco soon. Expansion of the availability of this App will largely depend on state law. In certain states, pharmacies cannot fill prescriptions unless they have the original prescription or the prescription was electronically sent by an authorized practitioner, so the prescription scan option would not be available in those states. Another drawback is that the user cannot choose which pharmacy to get the new prescription from, the App automatically matches the user to the nearest pharmacy using the service. Pharmacies interested in being a part of the GetMyRx network can email the company at firstname.lastname@example.org. More information about the GetMyRx App is available at http://www.getmyrx.com.
The Johnson & Johnson Official 7 Minute Workout is a free mobile App by Wellness & Prevention, Inc., a division of Johnson & Johnson. It is available for iPhone, iPad, iPod Touch and Android devices. This App is based on research by the American College of Sports Medicine that suggests a 7 minute, high intensity interval training (HIIT) session can be as effective as longer workouts to build muscle, lose weight and improve cardiovascular health.
The App includes the “7 minute workout”, a workout routine that only requires the user, a chair, and a wall. In the 7 minute workout, the user will perform 12 exercises for 30 seconds each with a 5-10 second break in between each exercise. Exercises include jumping jacks, abdominal crunches, pushups and many others that require minimal to no equipment. The App also includes two additional ways to work out: the “smart workout” is a customized workout based on age and other factors, and the “Workout library” which contains 36 exercises and 12 additional workouts that can be customized by the user. This customization of workouts allows for over 1,000 variations.
The user is able to customize and build their ultimate workout by liking or disliking exercises on the screen during a workout and the App will remember which exercises they do not like. The user is able to set reminders and share their results and accomplishments with friends on social media, to help keep motivated on their fitness goals.
The 7 minute workout is a visual app that can provide a variety of exercises for a quick workout for our time-starved population. This may be an ideal workout while on a business trip. The exercises are straightforward and easy to perform. If you are interested in the Johnson & Johnson Official 7 Minute Workout App, you can obtain more information and download it for free at https://7minuteworkout.jnj.com.
Cardinal Health Foundation has teamed up with Edheads, a non-profit organization that specializes in educational web development, to make an educational video game called “Trauma”. This game is designed to help educate and raise awareness of prescription drug abuse for students in middle school, high school, and college.
This free online game can be found at http://www.edheads.org/activities/trauma/index.shtml.
The video game begins with the player being greeted by Dr. Ashner, an ED Physician, and Dr. Bennett, an ED Pharmacist. The player is a resident starting their emergency medicine rotation and will help to stabilize an automobile accident victim.
The video game takes the player through many activities and tests that would be conducted in stabilizing a patient in the emergency room. Throughout the game the player is educated on the dangers of prescription drug abuse, the effect it can have on parents, and the consequences that come from abusing prescription medicine.
Overall, this game is a useful tool in educating middle and high school students on the dangers of abusing and misusing prescription medication. Healthcare providers need to promote the safe and effective use of prescription medications everyday to patients. Pharmacists can advocate the use of the “Trauma” game to schools, community groups, and churches to spread awareness of prescription drug abuse not just to students or patients, but to the whole community.
Price changes are a fact of life in pharmacy. PHSI monitors many prices that affect all stakeholders in pharmacy.
Pharmaceutical manufacturers monitor the price changes of products in therapeutic categories where they compete. Conclusive and up-to-date monitoring of a drug’s wholesale acquisition cost (WAC) and corresponding average wholesale price (AWP) provides insights into both the reimbursement of prescriptions at the pharmacy and manufacturer strategies. Pricing data can help you analyze and forecast prices for pharmaceutical products in the pipeline and factor into decisions concerning future target drugs.
Pharmacy Benefit Management companies (PBMs) closely monitor generic pricing to establish and maintain appropriate maximum allowable cost (MAC) prices. Published prices play a role in payer reimbursement to the pharmacy and rebates from manufacturers.
Retail pharmacies need current WAC and/or AWP prices to track expected reimbursement results. Plus, monitoring the fluctuating costs in the generic marketplace can ensure pharmacies establish their usual and customary cash price at a competitive and profitable level.
PHSI is an expert in monitoring price changes with valued partners in all 3 stakeholder segments and assists clients navigate the changing competitive landscape.Tags: chain, PBM, Pharma
The Centers for Medicare & Medicaid Services (CMS) announced on November 27, 2013 that the new Federal Upper Limit (FUL) for multi-source generic drugs will be finalized in July 2014. The new FUL is at least 175% of weighted Average Manufacturer Price (AMP) for multi-source products with at least two A-rated generics available to retail pharmacies nationwide. This is a significant change from the previous FUL calculation (150% of the lowest Wholesale Acquisition Cost [WAC]). The new FUL is expected to decrease prices for most drugs while a select few drugs may see FUL increases.
Many states have implemented their own Maximum Allowable Cost (MAC) list (also known as SMAC) for Medicaid to achieve savings greater than the previous FUL. If the state uses a SMAC list, a review and adjustment may be required to comply with the new FUL. The SMAC list must deliver the same or more savings to the state when compared to the new FUL.
States may also use the National Average Drug Acquisition Cost (NADAC) similar to the AAC implementation in Alabama, Oregon, and other states. If States decide to use NADAC pricing, they must submit state plan amendments (SPAs) to CMS to clarify and gain approval to update their pharmacy reimbursement methodology.
PHSI constantly works with payers, pharmacies, and pharmaceutical manufacturers to explain how FUL and NADAC impact each organization. Do not delay in preparing for these changes. It will be important to monitor your state(s) to determine if they will be adjusting the SMAC list or changing to NADAC as the basis for reimbursement.Tags: CMS, generic
Over two million people have now enrolled to obtain insurance coverage via insurance exchanges, with the effective date of January 1, 2014. Due to the late enrollment surge in December, many people do not yet have an identification card or plan number.
The government considers people “enrolled” after they select a health plan. The first month’s premium for people that signed up in December is due no later than January 10, 2014, and identification cards and plan numbers will be issued only after the premium is paid.
Retail pharmacy is often where healthcare coverage is first experienced. Prescriptions needed in January before the new identification cards arrive create a conundrum for retail pharmacy. Walgreens, CVS, and Walmart have all announced that they will help patients verify coverage, answer questions, and provide up to a 30-day supply of medication during the month of January, at no upfront cost, to patients who demonstrate they have signed up for an exchange plan.
Putting a month’s supply of medication at risk to support a smooth transition and ensure that patients do not go without their medication is a strong demonstration by these retailers that they place great importance on patient care.
A concern exists about potential sticker shock when patients find out their medication is not covered, they have a 20% or 50% co-insurance for prescription medications, or that they have no reduction in costs until their deductible is met. Will these pharmacies have an uncollectable receivable for a medication that has already left the pharmacy and been consumed? Time will tell. Retailers may engage CMS in discussions on resolving these issues, if they have not done so already, in order to support the ACA rollout.
Medication synchronization is the organization of a patients’ prescriptions so that all prescriptions can be filled on the same day each month. This process is convenient for the patient and should increase medication adherence for health plans. Previously, one of the biggest hurdles surrounding medication synchronization for pharmacies was how to bill prescriptions that were, essentially, early refills.
In May 2012, The National Council for Prescription Drug Programs (NCPDP) developed submission clarification codes to help meet the market needs surrounding synchronization. Two new submission clarification codes, one for “shortened days supply fill” and another for “fill subsequent to a shorted days supply fill” can be used to communicate clarifications from the pharmacy to the health plan regarding short-filled medications for the purpose of medication synchronization. The first code indicates that a medication is short-filled for the purpose of synchronization, and the second code can be used for the subsequent full refill of the medication to prevent “refill too soon” claims rejections. NCPDP has also developed a code that health plans can use to communicate with pharmacies. This newly approved message code identifies for the pharmacy that the prescription copay was pro-rated.
The new NCPDP codes were developed in response to a CMS requirement mandating that health plans administering Medicare Part D plans pro-rate co-pays associated with refill synchronization. This requirement goes into effect Jan. 1, 2014 and will offset Medicare Part D patients’ out-of-pocket expenses for synchronization. The same requirements are not in place for patients with commercial plans. However, that does not mean that plans do not support medication synchronization, but are able to decide whether to implement this functionality to support medication synchronization for their commercial members.
On December 11th, the FDA approved generic versions of Cymbalta (duloxetine delayed-release capsules) from six manufacturers, although only five manufacturers initially launched their products. Additional manufacturers have submitted ANDAs but have not yet received final approval. Most pharmacies had generic Cymbalta in stock as of December 18th. PHSI received information that generic Cymbalta is available from a single source to some pharmacies for now and supply issues are a concern.
PHSI research shows that when five generic suppliers are in the marketplace, pharmacy costs for the generic product range from 25% to 35% of the brand innovators’ cost. A similar decrease in cost is expected to occur for generic Cymbalta, although initial reports are showing less of a discount than anticipated, most likely due to supply issues.
At launch, generics are often more profitable for pharmacies than their brand counterparts. PBMs and health plans will also want to ensure that their patients are being converted to generic Cymbalta in the coming weeks. Payers will add a MAC to this drug when they see significant price savings. Utilizing generics provides a benefit to all parties involved in the transaction.
The WebMD, LLC sponsored “Medscape Mobile” App provides many benefits to health care professionals. This App is available for free on Android, iPhone/iPad and Kindle Fire operating systems. Users must register under their career title to receive material pertaining specifically to their profession. For instance, a diabetes-endocrine pharmacy specialist could receive only diabetes and endocrine news and access to their own personalized list of searched drugs. The pharmacist can also participate by leaving input to any article or save and share the articles to colleagues or social networks. Users can access thousands of evidence-based articles and information on over 8,000 brand and generic drugs, OTCs, and herbals.
One of the many useful features in the App is the access to over 100 specialty medical calculators. An example is the TIMI score calculator for ST elevation in acute MI patients to help determine drug therapy.
Overview of point-of-care tools accessible via the Medscape Mobile App include:
The Medscape Mobile App also provides CE credits in 32 specialty areas and enables the user to save activities and track credits earned. Additional tools include a health care facility search to find pharmacies, physician’s offices, and hospitals in the user’s area and formulary information for prescription drugs.
This App serves as a multidisciplinary unit for a medical team in need of quick access to point-of-care features, guidelines, and what’s covered on patients’ formularies. One drawback is the 8.1 MB size, larger than some medical apps, and could pose a problem if the user’s device has limited memory. More information can be found at http://www.medscape.com/public/mobileapp.