Thanks to the FDA’s Priority Review program, hepatitis C medications are being approved at a faster rate! This program provides a fast-track review of medications that could that treat serious conditions like hepatitis C. New approvals over the past few years include Sovaldi, Harvoni, Viekira Pak, and we have another one to add to the list!
On July 18th, 2017, the FDA approved Vosevi, a new three drug combination medication for Hepatitis C. Vosevi is the first and only hepatitis C treatment specifically for patients who have tried advanced treatment and haven’t been cured.
What is Vosevi prescribed for?
Vosevi is a combination medication indicated for the treatment of chronic hepatitis C in adults, and is a second line treatment for all 6 types of hepatitis C genotypes.
It will be available as a combination tablet in the strength of 400 mg/100 mg/100 mg. The recommended dose is one tablet, every day with food, for twelve weeks.
What are the most common side effects associated with Vosevi?
Common side effects include headache, fatigue, diarrhea, and nausea. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
Will Vosevi be a specialty medication?
Not sure. At this time there is no information stating that Vosevi will be considered a specialty medication; however, with all of the other Hepatitis C medications being specialty medications Vosevi will likely follow suit.
How much will Vosevi cost?
Gilead, the manufacturer, has not mentioned how much Vosevi will cost.
Epclusa, another hepatitis C medication manufactured by Gilead, is priced at $74,760 for a 12-week regimen. The cost of other 12-week hepatitis C medication regimens currently on the market such as Sovaldi and Harvoni cost $84,000 and $94,500 respectively. Therefore, it is expected that Vosevi will be priced right in line with the cost of these other treatments.
Gilead does offer a copay assistance program where eligible patients can pay as little as $5 per co-pay for Vosevi. To find out if you qualify, call 1-855-769-7284 to speak with a Vosevi Support Path specialist.
According to the Centers for Disease Control (CDC), approximately 36.7 million people around the world are living with HIV. As of June 2016, new data suggests that 17 million people living with HIV are currently receiving medication to treat it.
HIV medication, also known as antiretroviral treatment (ART), has made some key advancements in recent years. Some of these advancements include the use of less of pills and less unwanted side effects. Recently, popular HIV medication Isentress (raltegravir) experienced some advancements, with a new once-daily strength currently available in pharmacies.
What is Isentress indicated for?
Isentress is indicated for the treatment of HIV-1 infections in adults and pediatric patients weighing at least 40 kg or 88 lbs.
New high-dose Isentress is currently on the market as a film-coated tablet in the strength of 600 mg. It is to be taken as two tablets (1200 mg total) by mouth, once daily, with or without food. This new strength is similar to other Isentress products. However, unlike the others, high-dose Isentress can be taken once-daily, while other doses must be taken twice-daily. This advancement makes it easier for patients to take their medication and increases adherence.
Can different Isentress formulations be substituted for one another?
No. Isentress is available in many forms including film tablets, chewable tablets, and oral suspension. However, they may not be interchanged with one another due to the way they move throughout the body and are absorbed.
What are the most common side effects of Isentress?
Common side effects include diarrhea, stomach pain, vomiting and a decreased appetite. Be sure to speak with your doctor if you experience these side effects for a prolonged period of time.
How can I save on Isentress?
Unfortunately, the new high dose Isentress will not offer much savings from the other Isentress products. However, the Manufacturer, Merck, offers a co-pay card that can save privately insured patients as much as $6,800.
If you have diabetes, you’re probably no stranger to checking your own blood sugar with a little portable device known as a glucose meter. For those of you who don’t—to get a blood sugar reading, glucose meters require a small amount of blood to be placed on a test strip, and you need a new test strip every time.
Depending on your situation, your doctor might suggest checking your blood sugar multiple times per day with meals. Some of you may check your blood sugar upwards of 6 times a day. On the other hand, if you’re a newly diagnosed diabetic your doctor may not require you to check your blood sugar right away—though eventually you may need to test a few times per week.
No matter how often you check your blood sugar, the cost of test strips can add up quickly. Popular test strips can cost as much as (and sometimes more than) $1.50 each. That’s pretty steep if you’re testing a few times a day—almost $50 per month if you use one a day.
Especially if you need to test more often, you should be aware that there are a few meter systems that offer something like a subscription service. These companies offer unlimited test strips for a flat monthly fee.
There are several companies out there that offer unlimited test strips—here are just a few:
What is it? The Livongo program is available to individuals, their spouses, and dependents who are part of an organization that partners with Livongo. To register you must have type 1 or type 2 diabetes, have coverage, and a registration code. If you don’t have a registration code you are able to fill out a “Contact Us” form to learn more about their program.
How much does it cost? Livongo is free if you qualify through your employer, insurance, or other coverage. They don’t specify a certain quantity that you’ll receive at one time, but since the app monitors your use, they will ship you more supplies before you run out.
What features does it offer? You can get unlimited test strips and lancets delivered to your door. The Livongo mobile app also automatically uploads your blood sugar readings, and gives you access to view them online. It provides real-time tips based on your reading, and can notify someone you choose if your readings are outside your target range. You can also add info about what you’ve eaten to get a better understanding of your readings.
What is it? One Drop is a diabetes management platform. It lets you log your daily activities and see the relationships that food, insulin, and activity have to your glucose levels. You can download the app for free on iOS or Android, and they offer a paid monthly subscription for supplies.
How much does it cost? The One Drop meter costs $79.95. This is a one-time cost, and it includes the meter, lancets, a lancing device, a case, and test strips. Then, they offer monthly ($39.95) or annual ($399.95) subscriptions for unlimited test strip delivery—they’ll calculate how many test strips you’re using, and send you the amount you need. If you’re sure you want to commit, the yearly subscription will save you $79 per year—about the cost of the meter kit. The advantage of month-to-month is that you can cancel at any time.
What features does it offer? Along with the meter kit and test strips, you’ll have 24/7 access to talk to a Certified Diabetes Educator. The app can be used to track your blood sugar, reorder supplies, and let your doctor see your progress if you choose, so they can offer even more support. The app will also let you know when you’re running low on test strips, and how many you have left. There’s no extra cost based on how many test strips you use.
What is it? Offered by Roche, the manufacturer of Accu-Chek, this program offers a free meter for first time users and lets you subscribe to delivery one to six month supplies of test strips. Each package also comes with food and other “favorite” items suggested by Roche.
How much does it cost? You can choose whether to receive one or two boxes of 50 test strips in each shipment. A single 50-count box costs $30, and two boxes is $50. You can save a bit if you order more at a time—you also get to choose whether to receive your shipment will be delivered every one, two, three, or six months.
What features does it offer? In addition to test strips, you’ll get free “discovery” items that include snacks and skincare items, and free shipping. If it’s your first time using Accu-Chek, you’ll also get to choose a free meter. Billing is automatic, which can be an upside for convenience, but it’s something to be aware of if you just want to try the program out for a month or two.
What is it? Good Glucos is a customizable test strip subscription program. It comes with a meter, but doesn’t have an app like some other programs. One unique feature: Good Glucos gives away a 12-month subscription to someone in need for every 12 subscribers.
How much does it cost? Subscriptions start at 100 test strips per month for $35. However, you can customize your subscription by telling them how ofter you’re testing, and by setting your shipping frequency—but be aware that more strips will add to your cost. Shipping and your meter are free.
What features does it offer? Shipping is free, and your first package will come with 10 lancets as well as a free meter. Unlike some other services, they do not have an app to help you log and track your blood sugar, but if that isn’t important to you, this is one of the lower cost options. There’s no contract, so you can try the program for as long or as short as you’d like.
What is it? Like One Drop, Dario is a diabetes management platform. They offer an app in addition to the test strip subscription that can track your blood glucose, meals, and excercise, and offer insights, alerts, and reminders. The app is free, but it’s available for iOS only—there’s no Android option yet. If that works for you, the Dario meter plugs directly in to your phone for an easy connection with the app.
How much does it cost? The Dario smart meter costs $69.99, and comes with a disposable 25-test strip cartridge and lancing device. They do also offer lancets at $5.99 for 100. Test strip subscriptions are delivered every three months, and you can choose from quantities of 50 per month up to 300 strips per month. The cost starts at $49.50 for a three month supply, up to $225. You can also choose their “pay as you go” option instead of subscribing to get 50, 100, 200, or 300 test strips in a single shipment. 50 strips start at $20, up to 300 for $120.
What features does it offer? The meter connects directly to your phone through the headphone jack, and lets you use the app to read and track your blood glucose. You can also access all of your information through their web portal to make it easier to share with your doctor (or track yourself). Test strips come in 25-strip cartridges that you load into the meter for easy access.
In response to the current opioid epidemic, the FDA has been encouraging drug companies to create abuse-deterrent pain medications. These medications have properties that make it harder, or less rewarding, for a person to inject or snort them, and are typically resistant to crush or extraction. Some abuse-deterrent pain medications that you may have heard of include Xtampza ER (oxycodone) and Hysingla ER (hydrocodone), and now we have another to add to the list! The FDA recently approved Arymo ER (morphine), an extended-release tablet for the treatment of pain, and it is now available in pharmacies.
What is Arymo ER indicated for?
Arymo ER is indicated for the treatment of pain severe enough to require daily, long-term opioid treatment. Arymo ER is specifically indicated in patients where alternative treatment options are inadequate.
How is Arymo ER to be taken?
Arymo ER is available as an extended-release tablet in the strengths of 15 mg, 30 mg, and 60 mg. Your doctor will decide which dose of Arymo ER is right for you. Tablets should be taken one at a time with enough water to ensure complete swallowing.
Common side effects include constipation, nausea or sedation. Be sure to speak with your doctor if you experience any of these for a prolonged period of time.
Are there any other products similar to Arymo ER?
Arymo is most similar to Embeda (morphine/naltrexone), the first abuse-deterrent extended release morphine. However, there are advantages to Arymo ER. Specifically, Arymo ER has the new proprietary Guardian Technology, a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist. This technology means that Arymo ER tablets are more difficult to manipulate for the purpose of misuse and abuse, as it has increased resistance to cutting, crushing or grinding.
How does the FDA encourage abuse-deterrent pain medications?
Expanding access to abuse-deterrent medications is one part of the FDA’s opioid action plan. This plan is a set of concrete steps aimed at reducing the impact of opioid abuse on American families. The FDA believes that once less expensive generic abuse-deterrent formulations are available, prescribers will be more likely to consider them for their patient’s pain reduction.
How can I save on Arymo ER?
Manufacturer Egalet has created the My Arymo ER Patients Savings program to help commercially insured patients save on their medication. Eligible patients can pay as little as $0 for their first fill, and $10 for subsequent fills. For more information about this program, see the manufacturer’s website here.
For more information on this approval, you can also read the manufacturer’s press announcement here.
In an effort to compete with the popular asthma medication Advair, Teva Pharmaceuticals announced their simultaneous release of the dry powder inhaler AirDuo RespiClick, and its authorized generic fluticasone/salmeterol. Although manufacturers don’t typically release both the brand and the generic simultaneously, this is big news, as fluticasone/salmeterol is the first and only combination inhaler!
AirDuo and its authorized generic are both indicated for the treatment of asthma in patients 12 years of age and older. Asthma is a condition in which a person’s airways becomes inflamed, narrow, swollen, and filled with mucus. Signs and symptoms of asthma can include wheezing, shortness of breath, cough and chest tightness. Asthma is considered a reversible airway disease meaning that the problems can generally be solved with treatment.
Both of these inhalers are considered maintenance or controller inhalers, so they must be used consistently to help your breathing and prevent asthma flare-ups.
What is an authorized generic?
According to the FDA, an authorized generic “is most commonly used to describe an approved brand-name drug that is marketed as a generic product, without the brand name on its label.”
An authorized generic is the exact same drug as the branded product, yet in most cases, the generic is significantly cheaper than the brand product. In this case, generic fluticasone/salmeterol is the exact same as AirDuo RespiClick.
Why were the brand and the generic released simultaneously?
Teva Pharmaceuticals released both the brand and the generic at the same time to address the need for more affordable asthma treatment options in the United States.
In a press release, Teva discussed their decision to release both Airduo RespiClick and its authorized generic. The President and CEO of Global Specialty Medicines at Teva Discussed that their “intent is to meet the needs of patients, providers, and payers in the U.S. seeking greater access to lower-cost asthma inhaler technology, while also allowing Teva to compete in the highly competitive asthma combination controller market.”
How should you use a drug powder inhaler?
AirDuo RespiClick and fluticasone/salmeterol will be available as a dry powder inhaler in strengths of 55 mcg/14 mcg, 113 mcg/14 mcg, and 232 mcg/14 mcg. Regardless of your strength, you should be taking one inhalation twice daily.
Dry powder inhalers are different from typical inhalers that require hand-breath coordination, like aerosol inhalers. When using a dry powder inhaler, it is important to breathe in quickly and deeply through your mouth to deliver the dose of medicine to your lungs.
Make sure that you rinse your mouth with water, and spit, after using these inhalers to prevent thrush, a fungal infection in the mouth. AirDuo and its authorized generic must be disposed of 30 days after removal from the foil pouch, and should not be used with a spacer or holding chamber device.
The most common side effects include headache, cough, thrush, back pain or the common cold.
Are there any other medications similar to AurDuo RespiClick and fluticasone/salmeterol?
Yes. Advair Diskus, Advair HFA, Dulera, and Symbicort are examples of other similar controller inhalers. These medications can be very expensive, especially since they are not available as a generic yet.
If you are currently using any of these inhalers and would like to switch to AirDuo RespiClick or its authorized generic, be sure to speak with your doctor.