Month: December 2019

Decade

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Decade (noun)
a period of 10 years

My gram once told me that I was the least sentimental person she’d ever met because I was throwing out an envelope that a card came in. In reality I am a very sentimental person, but once thing I’ve never really done is looked back. Is there a difference between second guessing decisions / choices and looking back longly / wistfully? Yes.

For me this decade brought illness and pain I couldn’t have dreamt up. It brought the things that everyone goes through in 10 years, but what it gave was much more. It gave me improved health, spending more time with family and close friends, a new path professionally, and more ability to give back to others.

So while it’s a new decade for everyone, and for me personally (turning 50), Jan 1 is no different from any other new day and the ability to experience life and opportunities to help others.

I know the troubles the planet is going through seems insurmountable right now, but never underestimate the ability of one person or a small group of people, to change the world.

Wishing you a happy, healthy, prosperous, and peaceful new year!

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Treatment

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Treatment (noun)
medical care given to a patient for an illness or injury

On the heels of three generics for fingolimod* being approved by the FDA for use in the U.S., I thought this post might help people understand the following:

  • Generic
  • Biosimilar
  • Cost for these medicines (including patient assistance programs)

But first an important question to ask:

Is more always better? The answer, it depends.

Generics
When people think of generics, medicines like Tylenol vs acetaminophen come to mind, which is true. HOWEVER, when it comes to medicines that treat diseases like multiple sclerosis it’s not that simple. Even with acetaminophen it’s not that simple. There are things like stabilizers for the drug that need to be taken into consideration in terms of tolerability. Generic does not equal, well, equal.

Biosimilars
Biosimilars are even more complex given how medicines like monoclonal antibodies are developed, and as it states directly in the name “similar.” Generally, the data and information necessary to demonstrate the safety and effectiveness of a reference product will include clinical trials for the disease indications being sought by the manufacturer.**

Rule of thumb for MS and other diseases is if someone is stable on treatment, you don’t want to rock that boat by changing and you can rest assured in the U.S. PBMs like CVS Caremark and Express-Scripts will remove these brands from their formularies pushing people to change meds that work for them (the former has already done it with Avonex for 2020). All this despite what doctors and people living with MS might want or need.

Costs
People assume that these medicines will be cheaper, and for complex drugs that isn’t the case. In the U.S. generics and biosimilars come out around the same cost as the brand because that is what the market will bear, and, to date, we don’t have any government body governing the cost of the medicines which are set by the pharmaceutical companies. And patient assistance programs (PAPs), while currently desperately needed, help, they also add to the problem. Pharmaceutical companies get massive tax breaks for these programs along with great PR. If the cost of medicines in the U.S. were highly regulated like they are in other countries, there wouldn’t be a need for PAPs

While above is simplified for ease of reading, this knowledge is derived from 25 years of working in clinical research and 10 years living with MS. I am always happy to answer questions or point people to information that can help. You can contact me through the website or via social media any time!

Please also see this post about medicine from earlier this year.

To further understand drug costs, check out the great work of Patients For Affordable Drugs

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* Of note: Novartis has ongoing patent disputes and fingolimod generics will not be available for the public until these suits are settled, despite FDA approval.

**accessed December 7, 2019 https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval

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