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The Impact of Generics on MS Treatment

Medications used to treat MS have all been developed relatively recently, are still, which means that the majority of them are still patent protected. Until these patents expire, no generics can be manufactured and brand name medications are the only option. As the patents for these extremely expensive medications expire, more and more generic options will become available and the treatment landscape will undoubtedly change. We have already seen this happen with Copaxone, which is manufactured by Teva. There are currently multiple generic versions of the Glatiramer Acetate injection available, and insurers have made many patients switch off Copaxone on onto generics. A generic version of Ampyra, a medication used to increase walking speed and lower extremity strength, will also be available shortly. Since we will be seeing more and more generic options, I wanted to take a look at the differences between brand and generic medications, and how they will impact MS treatment.

The journey to generic

When a pharmaceutical company develops a brand new drug they are required to do extensive clinical research and gain approval from the FDA before they can manufacture and market their product. The process of developing a drug, running clinical trials, and getting FDA approval is expensive and complicated. In fact, the entire process from start to finish takes an average of 12 years, and many drugs fail to ever get FDA approval. If a drug is approved by the FDA, the pharmaceutical company that manufactured it holds a patent on the chemical composition of the drug, allowing them to recuperate the costs that are incurred during development. This means that no other company can replicate the medication, and it guarantees that all of the profits go to the original manufacturer. Once the patent on the brand name drug is expired then the market opens up, and other pharmaceutical companies can manufacture generic versions of the same drug. Generics are often significantly less expensive because they do not have to spend the enormous amount of time and money on research and development.1

Differences between generic and brand name drugs

Once a company has produced a generic medication they file an Abbreviated New Drug Application (ANDA) with the FDA’s Office of Generic Drugs. In order to be approved the drug must be comparable to the original drug in dosage, strength, route of administration, quality, effectiveness, and intended use. If it is proven that the generic drug performs at the same level as the brand name drug then they are not required to do additional clinical trials.1

Generic drugs have the same safety and effectiveness as the brand name drugs but can differ in a couple of ways. First, the cost of generic drugs is an average of 80-85% lower than brand name drugs according to the FDA. Additionally, generic medications may have different binders, fillers, and coatings which can affect how fast the medication works, and if you can take them with food. Some patients may have allergies or sensitivity to these ingredients, which is important to keep in mind when switching from a brand name to a generic medication.1

You can find more information about generic drugs on the FDA’s Question and Answer page here.

Unique challenges in MS

As a healthcare provider, I am very comfortable prescribing generic medications to my patients. In fact, I often prefer generics because my patients can afford to take them and more people have access to critical medications. However, there are some unique considerations in MS that are worth noting. Anyone with MS who has been on a disease-modifying therapy (DMT) is likely familiar with the patient assistance programs (PAPs) offered by the pharmaceutical companies. These services typically provide 24/7 access to an MS certified nurse, copay assistance, educational programs, and even freebies like cooling equipment. Anytime I start a patient on an injectable therapy, their nurse will go out to the home and teach them how to self-inject. When I have a patient lose their insurance, I am able to get them medications, their treatment is not interrupted, and they work with me to get coverage with insurance changes. These services are not just perks, they have become invaluable resources that I utilize every day to care for my patients. They increase compliance and satisfaction with treatment, which ultimately helps me care more my patients more effectively.

Continuing patient assistance programs

I am relieved that Mylan, who now has generic versions of Glatiramer Acetate daily and three times weekly, has shown a commitment to continuing PAPs. Their program, Mylan MS Advocate ©, offers injection training from a specialized nurse, 24/7 phone support, and $0 co-pay assistance. Their Autoinjector and mobile application also lives up to the quality that we have seen from Teva.2 Teva has already seen the financial impact of having a generic competitor on the market. Copaxone is the company’s best selling medication, making over $1 billion in the past quarter, and profits have already been threatened. In response, Teva announced that it will be laying off 20-25% of its workforce to cut costs.3 For now, it is unclear what the financial uncertainty of big pharmaceutical companies means for patients, or if they will affect PAPs.

There is no doubt that treating MS early leads to better outcomes, but due to cost, some are left unable to afford treatment. On average, the cost of DMTs have increased by 400% since 2004, and are continuing to rise.4 Generic medications are a safe, reliable, and practical solution to the ballooning price of MS treatments and will help make treatment accessible to all. My hope is that we see more people have access to treatment, and that patient support programs continue to be a priority for all medications, regardless of whether they are brand or generic.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The MultipleSclerosis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. Center for Drug Evaluation and Research. Generic Drugs - Generic Drug Facts. U S Food and Drug Administration Home Page. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm167991.htm. Accessed December 18, 2017.
  2. Patient and Caregiver Resources | Mylan. Glatiramer Acetate. https://www.glatirameracetate.com/en/patient-support. Accessed December 18, 2017.
  3. Teva Pharmaceutical Is Reportedly Planning Thousands of Layoffs in the U.S. Fortune. http://fortune.com/2017/11/23/teva-pharmaceutical-layoffs-generic-drugs/. Accessed December 18, 2017.
  4. Make MS Medications Accessible: Recommendations. National Multiple Sclerosis Society. https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Advocacy/Recommendations-Make-MS-Meds-Accessible.pdf. Accessed December 18, 2017.

Comments

  • SueK
    8 months ago

    My doctor just prescribed Ampyra. My pharmacy phoned asking if we wanted this filled. It would by $3000 a month leaving us with a copay of $650. Perhaps some may mind no problem with the cost, but we certainly cannot afford this. They looked up the generic which is made by Mylan and is already on the market. Some savings! $2700 a month. Mind you, this is the same company that raised the price of EpiPens from $100 to $700 without warning. I am sorry, but this is a fine example of what is wrong with the profit driven pharmaceutical industry. So I will have to do without. Despite assistance programs, being on Medicare Disability I am locked out from receiving any. And let’s not forget the Doughnut Hole which most of us on MS treatments reach very quickly. There are no simple answers besides 1) do not get sick and 2) make sure you are wealthy in case you do.

  • Mariella
    11 months ago

    At some point this month I’ll be switching from Copaxone to a generic Glatiramer because of the fluctuating price of this generic which affects my copay tremendously, over passing the annually limit of my copay assistance.
    🙁 From Copaxone 40mg to generic Glatiramer after 7 years. Hope an smooth transition.

  • Pradeepms76
    1 year ago

    I am on Avonex Inj for last 8years. Having trouble with walking and imbalance. Currently got my hands on generic drug of Ampyra sold as Dalstep 10mg. Many MS patients are unaware of the generic medicine Dalstep 10mg Dalfampridine Extended Release Tablets. I have tried to collate as much information as possible in dalstep.blogspot.com.

    Hope it will be useful for MS patients suffering with imbalance and walking.

  • Shelby Comito moderator
    1 year ago

    Thank you for sharing your experience here with us, @pradeepms76! Best, Shelby, MultipleSclerosis.net Team Member

  • OKgal
    2 years ago

    This is a very informative article, so thank you. While my neurologist states Mylan’s version of glatiramer acetate is identical to Copaxone, he approves of me continuing brand name merely due to already having the PAP in place with Shared Solutions. My stance is I prefer not to be a guinea pig of a drug pushed out through ANDA. I had enough struggles with my body accepting Teva’s glatiramer acetate four years ago and didn’t want to have to go through the same with the generic version. If the push comes to switch to generic through my payer, I will most likely be discussing a change in medication altogether as there are so many new options available. It’s a lot to think about and consider, but for now I am able to continue with brand name.

  • Bettybeem
    2 years ago

    It has been my experience that some generic medications are not effective and, in one case, was dangerous. The generic for Nuvigil was totally ineffective. My neurologist stated that many had had the same reaction. The generic for Nexium was also ineffective. My blood pressure shot up to 180/100 on the generic for my blood pressure medication. One has to be extremely cautious when switching from brand name to generic medications.

    In response to some of the other comments, in December, 2015, I switched from Copaxone to Aubagio. I am 76. It is my understanding that DMT should be continued regardless of age. It was a joint decision my neurologist and I made. I definitely wanted an immunomodulator. One issue in selecting any MS medication is that very little research is done involving the “mature” MSer. I continue following the exercise program my physical therapist has developed for me. We occasionally modify it. I also play the violin in a community orchestra and hone my chamber music skills in the summer. I’m also learning to play the viola and alto clef. Playing music activates all areas of the brain. Learn to play an instrument, exercise, be proactive in your health care, and continue to follow your dreams.

  • Cathy Chester moderator
    2 years ago

    Excellent piece, Stephanie, and a good educational moment about generics. Thanks for sharing your knowledge with us.
    Cathy

  • potter
    2 years ago

    I am facing life without a DMT, my husband is retiring and we can’t afford a DMT, his insurance at work currently pays for it. There are also have a couple of studies that show that people over the age of 60 shouldn’t be on a DMT. It is harder on your body than the help it gives. I am sure once the insurance companies hear about this they will be cutting off the seniors. I am 65 and I just had a relapse so I am worried about the future. Potter

  • itasara
    2 years ago

    I asked about coming off Copaxone with my neurologist. He did not think it was a good idea. I’ll be 70 in March. I read a lot about MS and I have heard that older patients may not need to be on DMTs but I don’t personally think there is enough knowledge to come up with a specific date of when to stop of if anyone should ever stop. I know someone whose neuro said she does not need to take them any more. She is 34 years and was on Avanex for about 13 years. She does great and supposedly her MRI’s look great (whatever that mean.) I was 54 when I was diagnosed and had no real clue beforehand.

  • Cathy Chester moderator
    2 years ago

    Potter,

    I am sorry for what you are dealing with right now. Insurance is ridiculously scary for many seniors. Please remember to reach out to the pharmaceutical company to find out about their patient assistance program. Explain your situation and tell them you’d like assistance. Right now I am on a grant for Copaxone through Optum RX which the nurses at Teva (Shared Solutions) first told me about. Good luck to you and thanks for being part of our community.

    Cathy, moderator

  • Azjackie
    2 years ago

    Really helpful article. Thank you.

    I went through a switch to generic for Ampyra. They discontinued PAP. I can’t afford it without it. Good that it was “supplemental” to my DMT. I am following my Neurologist’s guidelines for weening off. He was very upset with the pharmaceutical co correlating my financial situation to PAP.

    If Gilenya discontinues I will be faced with whatever is meant to be without medication. We’ll see.

  • itasara
    2 years ago

    I also thought this was a very helpful article. Last time I ordered my Copaxone I was desired the myelin version. I was very upset. No one asked me. My doc didn’t contact me. When I asked him he said it was only a month on the market and he had not researched it. He ordered the brand name and I switched it back. I don’t like being left out of the loop. Bad enough insurance companies make decisions without the patient and apparently the doctor as well.

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