Medically reviewed by, Russell Braun RPH
Epidiolex is the first and only fully legal cannibidiol (CBD) product made from the marijuana plant. Many people have questions about Epidolex including:
How much does Epidiolex cost?
Is Epidiolex available at my local pharmacy?
Ever since Epidiolex was approved by the Food and Drug Administration (FDA) in June of 2018, cost and availability have been hot topics.
What is Epidiolex?
Epidiolex (cannabidiol) is purified pharmaceutical grade cannabidiol oil also known as CBD. Cannabidiol is the second most prevalent ingredient found in the Cannabis sativa plant. Hundreds different cannabinoids are found in this plant.
Most CBD oils are made from hemp, which is a cousin to the marijuana plant. Part of the reason Epidiolex is so expensive is because it is made from the marijuana plant.
Epidiolex does not cause a “high” or intoxication that is seen with marjuana because the tetrahydrocannabinol (THC) has been removed in the manufacturing process. Therefore, Epidiolex is contains CBD that does not cause a “high”. The World Health Organization states CBD exhibits no effects indicative of any abuse or dependence potential.
Is Epidiolex the same as other CBD oils?
CBD can be derived from either variety of the Cannabis sativa plant. The two forms are:
Marijuana is a controlled substance in the United States know as a schedule 1, the most restrictive type of controlled substance. The Drug Enforcement Agency (DEA) groups drugs based on risk of abuse or harm. When a drug has a high potential for abuse and low benefit from a medical standpoint it becomes a schedule 1 controlled substance.
For reference other examples of schedule 1 drugs include:
Most manufacturers of CBD oils do not want to take the time that is required to follow all of the processes involved in handling a schedule 1 substance to be able to create CBD oil. In addition, there are legal barriers that make getting into the market very expensive. Especially when they can obtain CBD from marijuanas cousin, hemp.
This is one important reason why Epidiolex cost is so high and availability is limited!
Is Epidiolex a Controlled substance?
When Epidiolex was first FDA approved in 2018, it was listed as a schedule 1 controlled substance by the DEA However, a few months later it was reclassified to a schedule 5. Drugs in this schedule have a lower risk of abuse, but still some risk. If no risk of abuse existed then they would just require a prescription from a doctor.
The change to schedule 5 was due to the fact that (THC) the psychoactive component has been removed. Furthermore, CBD alone does not have as large a risk of abuse. This is important to keep in mind that Epidiolex is a controlled substance, but other CBD products sold as dietary supplements do not require a prescription and are NOT controlled substances. The dietary supplement designation removes the need for these products to follow the same regulations Epidiolex does, making them less costly to produce.
Another reason Epidiolex ended up a schedule 5 controlled substance likely has to do with what it treats. Some other medications on the market to treat seizures have been classified as schedule 5 by the DEA.
What is Epidiolex used to treat?
Epidiolex (cannabidiol) is considered an anticonvulsant drug. It has been approved by the FDA for seizures specifically associated with the following diseases:
- Lennox-Gastaut syndrome
- Dravet syndrome
It can be used in patients 2 years of age and older. These are both rare forms of seizure disorder also known as epilepsy. Epidiolex is being tested in other more common forms of epilepsy as well.
Does Epidiolex work?
Clinical trials of Epidiolex showed the following lower rates of seizures for Lennox-Gastaut (20%-25%) and Dravet (26%) respectively.
It is common for patients with seizures to use a number of different drugs to control the disease. Therefore, many patients in these studies were using Epidiolex in combination with other medications.
This is important because Epidiolex gives doctors a drug that works in a different way in the body than other seizure medications. To date no other seizure medication works on the endocannabinoid system in the body.
Why was Epidiolex created?
CBD has been exploding in popularity over the past few years because of claimed medical benefits for many health conditions in addition to seizures. Dispensaries and online retailers have been popping up and have had very little to no regulation. Efforts to legalize marijuana, hemp and CBD in some states have created confusion and a lack of adequate legal oversight. Two major problems have arisen because of this lack of oversight
1. Products are being sold as CBD and they may not contain CBD.
2. Claims are being made that are not back by scientific data and research.
The FDA has started sending warning letters to companies that make claims of products that claim to contain certain amounts of CBD, but when tested did not. A study published in the Journal of the American Medical Association (JAMA) showed that only 31% of CBD products tested contained the amount of CBD that was on the label.
Buyer beware, the table below list of companies that have been issued a warning letter from the FDA in 2018 and 2019!
|Koi CBD LLC||Pink Collections Inc.||Noli Oil LLC|
|Natural Native LLC||Whole Leaf Organics LLC||Infinite Product Company LLLP|
|Apex Hemp Oil LLC||Bella Rose Labs||Sunflora Inc|
|Healthy Hemp Strategies||Private Salon LLC||Organic Industries Inc|
|Red Pill Medical Inc||Sabai Ventures Ltd||Daddy Burt LLC|
|Rooted Apothecary LLC||Herbal Healer Academy, Inc||Alternative Labatories|
|Curaleaf Inc||Advanced Spine and Pain LLC||Nutra Pure LLC|
|PotNetwork Holdings Inc||Signature Formulations LLC|
If you have purchased a CBD product from one of these companies talk to your doctor or pharmacist about next steps.
Greenwich Biosciences, the manufacturer of Epidiolex went the route of seeking FDA approval for their product. Other CBD products fall under a category of medications called dietary supplements. These products are not FDA approved for the diagnosis, cure, mitigation, treatment or prevention of any disease. Many people do not understand how these are different than prescription or over the counter medications that do have to meet FDA standards.
It is important to remember this when looking at claims made by websites and stores that sell these products. The FDA does not allow them to make claims of curing any disease. As a result if you see products that make these claims it should raise a caution flag in your mind!
Remember CBD comes in a variety of dosage forms……not just oil. Examples include:
Charlottes web is a brand of CBD oil that is sold online and was created for use in seizures before Epidiolex was available. It adheres to good manufacturing processes and is one potential option you could talk to your doctor about that costs less than Epidiolex. For more details on Charlottes Web click here.
How much CBD is in Epidiolex?
Epidiolex is available as a 100mg/ml oral liquid solution. The normal dose ranges from 5 mg to 20 mg per kilogram of body weight taken twice a day. Consequently, a normal sized adult weighing 70 kilograms they would take between 350 mg to 1400mg split evenly in two doses per day.
Do you need a prescription for Epidiolex?
Epidiolex is a prescription only drug, that has been FDA approved. Given that it is FDA approved, that means it is legal to prescribe in all US states. In addition to being a prescription medication it is also a schedule 5 controlled substance. Therefore, the sale and use of the medication is more closely tracked and monitored.
Can you just buy Epidiolex?
First of all, you must see a doctor and have them write a prescription for Epidiolex. Therefore, you can’t just buy Epidiolex like you can other CBD products online and at retailers. Remember, you get what you pay for. Epidiolex went through clinical trials to prove it was safe and effective so it provides an additional layer of assurance. Finally, it is manufactured under FDA guidance to ensure it actually contains the amount of CBD it states on the bottle. In contrast, the same is not always true for other forms of CBD.
Epidiolex and drug testing
Greenwich Biosceince uses several refinement processes to remove everything except CBD in Epidiolex. The result is less than 0.1% tetrahydrocannabinol (THC), the active ingredient in marijuana, remains. Given this fact, Epidiolex is not a schedule 1 controlled substance like marijuana even though it is made from that plant.
But, is it still possible to fail a drug test when taking Epidiolex?
Even though the chance is very low, there is still potential for a positive drug test with Epidiolex. However, the chance is much lower than with other CBD formulations. The reason is they are allowed to be legally sold with as much as 0.3% THC. Also, they could be manufactured in ways where contamination with THC could make the levels higher than 0.3%.
What does Epidiolex cost?
Epidiolex comes in bottles that are 100 milliliters of clear CBD oil. Consequently, each bottle costs around $1377. The dose each patient requires is based on their weight so an exact monthly cost can vary.
When Greenwich Biosciences launched the drug they advertised the average cost would be a whopping $32,500 per year! That comes out to a monthly price tag of $2,708. Epidiolex cost can be more than many can afford because seizure prevention is an ongoing problem.
The company claims that their price was in line with other anti-seizure drugs on the market for similar conditions. The thought is that insurance would cover the drugs and patient assistance would also be made available by Greenwich.
How to reduce Epidiolex cost
1. Epidiolex generic?
Epidiolex (cannabidiol) is a brand-name prescription drug. As a result, there is no generic version. However, the patent is set to expire in 2022, which is not that far off given it was first made available in 2018.
2. Are there therapeutic alternatives to Epidiolex?
A therapeutic alternative is a drug that had different chemical contents, but has the same effects as other drugs for treating a condition. Epidiolex has no generic alternative, but has many therapeutic alternatives. All of these therapeutic alternatives have generics which also means they will be substantially cheaper. Before trying the Epidiolex copay coupon make sure to try one or more of the alternatives listed in the table below.
|Brand name||Generic name|
3. Use drug discount apps to research
Typically, drug discount apps such as GoodRx or Blink Health can be used to find discounted prices at pharmacies. Epidiolex is only available through specialty pharmacies so these apps don’t have cost information to comparison shop. Because, Epidiolex is very expensive even discounted prices would still be unaffordable.
These apps and websites can also be used for searching for the best price on the therapeutic alternatives listed in the table above. In some cases, these discount prices on the generics may be better than what the cost is with insurance.
4. Will Epidiolex be covered by insurance?
Because Epidiolex is an FDA approved medication insurance will cover the drug in some cases. Other CBD products available online or at local retailers will NOT be covered. In cases where insurance does cover Epidiolex, they may ask the doctor to complete a prior authorization.
A prior authorization is an approval your doctor must obtain by answering specific questions about the patient and the medication. The insurance then decides based on the answers if they will grant the prior authorization. Without the approval, the insurance will not pay for the medication.
Example Epidiolex criteria that may be needed so that the insurance will cover the cost include:
- Must be over 2 years of age
- Treating either Lennox-Gastaut syndrome or Dravet Syndrome
- Tried and failed another common anti-epileptic drug(s) on the market
- Prescribed by or consulted with a neurologist
*Criteria can vary from insurer to insurer.
Keep in mind that the type of insurance you have will make a big difference in cost.
- High deductible health plans (HDHP) will have a large deductible that will come from your pocket or the Trintellix coupon.
- Preferred provider organizations (PPO) will have a set copay amount.
HDHP vs. PPO also explains more on the differences between these types of insurance.
Does Medicare cover Epidiolex?
Medicare may cover Epidiolex, however there would be a prior authorization and possible other limits in place for coverage.
5. Are there samples available?
Before trying any new medication the best practice is to try samples. Most brand name drugs will have samples that the manufacturer provides to doctors. Sampling the medication allows a trial where it can be determined if the medication is going to be well tolerated or not. For the best outcome I recommend bullet journaling medication effects. Ask for enough samples to last at least a month in order to properly document effects.
Samples allow patients to determine if the drug will be effective and what the side effects are like before spending any of your own money.
Epidiolex is more complex than other medications because it can only be filled by specialty pharmacies and is a schedule 5 controlled substance. Therefore, samples may not be available from your doctor.
6. Patient Assistance Programs (PAPs)
Greenwich Biosciences offers a patient assistance program called the Epidiolex Engage Patient Support Program. The program is designed to help patients take Epidiolex at no or low cost.
To be eligible for this assistance patients must meet the following criteria:
- Be a resident of the United States
- Have an FDA approved diagnosis
- Those with insurance approved on case by case basis
- Medicare Part D patients are eligible
- Income at or below 500% of the Federal Poverty Level (FPL)
Anyone who is close to the 500% FPL level should still apply. The applications are approved on a case by case basis and anyone slightly over that mark could still get assistance.
The Epidiolex Engage Patient Support application can be downloaded here. It is also important to note that doctor must complete the paperwork sign and return to Greenwich Biosciences.
State Prescription Assistance Programs (SPAPs)
Some states have there own state pharmaceutical assistance programs that are run by the state. They normally focus on low-income patients and also offer some type of Medicare Part D coverage as the Epidiolex copay coupon program does not apply to Medicare, or anyone with government insurance.
A state by state listing of SPAPs can be searched on Medicare.gov.
7. Specialty pharmacies
At this time there are only five pharmacies that can fill an Epdiolex prescription, see list below. These specialty pharmacies are a great resource to help you complete the PAP paperwork. They do this type of work every day and therefore provide expert knowledge in obtaining financial assistance.
- AllianceRx Walgreens Prime
- Amber Pharmacy
- CVS Specialty
8. Epidiolex copay cost savings program
After trying the steps mentioned above, an Epidiolex copay coupon may be the best option because it does lower copay or deductible costs. Once you confirmed that Epidiolex worked and was well tolerated, a coupon can be obtained here.
Eligible commercially insured patients can get Epidiolex for as low as $0 for the first 30 days. If samples from your doctor are not available this could be used as a sample instead. Also, copays may be as low as $25 thereafter. The higher your income the higher your copay will be with this copay cost savings program.
Please remember the maximum the Epidiolex copay savings program pays is $3000 per year!
Depending on your deductible this copay savings program may still not pay your entire out of pocket Epidiolex cost.
9. Epidiolex vs. other forms of CBD oil
The number of companies doing cannabis research is increasing dramatically. Many are partnering with larger drug companies as well especially since Epidoilex won FDA approval.
The Epidolex cost of $32,500 per year is very expensive and non prescription CBD oils are certainly more affordable in most cases. Discuss the brand of CBD you are considering using with your doctor. Many brands are not reputable and could contain things other than what are on their label. Above all, your doctor and pharmacist can steer you to a product that will be safe and cost effective if you chose to use CBD oil.
Click here to get Dr. Jason Reed’s exclusive list of medication questions you MUST ask your doctor, for FREE!
Share your story
Have you tried Epidiolex? Did it work well for you? Please chime in below with your comments and thoughts.