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.
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