FDA approved Tyenne significantly cheaper biosimilar to Actemra

This is great news about the biosimilar to Actemra. Tyenne will lower the cost of treatment and it will be another option besides Prednisone.
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"At first prednisone really helped with my PMR, I went through the usual cycle of 20 mg down to 5-6mg, resume of symptoms, back to 20mg, etc."
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This is a very common scenario. I had so many problems at 7 mg of prednisone. It didn't matter how slowly I tapered my dose. The fact that I was treated with prednisone for 12 years suggests I tapered extremely slowly and perhaps too slowly.

My difficulty could be largely explained by a low cortisol level. Prednisone replaces the cortisol our adrenals produce. Over time, prednisone causes adrenal suppression which means that the adrenals stop producing cortisol. We begin to notice the symptoms of a low cortisol level when we taper below 7 mg of prednisone. Somewhere between 5-7 mg is considered to be the "physiological dose" of Prednisone that the body needs when the adrenals are suppressed.

The subsection called "adrenal suppression" in the following link explains the difficulties that can occur when our cortisol level gets too low.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3765115/
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I overcame my problem with a low cortisol level when Actemra was used instead of Prednisone. I believe PMR was still active in combination with a low cortisol level. In any case, Actemra controlled PMR but it didn't suppress my adrenal function.

You are correct that Actemra doesn't work as quickly as Prednisone. It took me 3 months to taper from 10 mg to 7 mg of Prednisone. After that, I tapered by 1 mg per week until I reached 3 mg of Prednisone.

An endocrinologist said 3 mg of Prednisone was a low enough dose that would prompt my adrenals to produce cortisol again. My adrenal function didn't resume very quickly. It was a slow process and waxed and wanted based on my symptoms of a low cortisol level. My cortisol level improved but it took more than 6 months until my endocrinologist deemed that my cortisol level was "adequate" and "probably safe" to discontinue Prednisone.

Actually, on further thought, you're right it was around 7mg, not 5-6. It's funny how it seems to be a quite precise barrier. You'd think it'd be more variable between individuals.

I also had a bit of trouble around 3mg and it took a bit of back and forth till I got off prednisone completely.

The minute by minute need for cortisol is variable and the body regulates the amount of circulating cortisol. We are unable to regulate our Prednisone dose as precisely as the body regulates our cortisol level which changes continuously based on need. The 7 mg physiological dose of Prednisone is just the average daily need. At best, it is just a rough estimate.

An interesting link from a case in New Zealand spells out how important it is to get personalized medical advice from qualified medical professionals. and not to listen to people on the internet.
https://www.medsafe.govt.nz/profs/PUArticles/June2021/Prednisone-treatment-follow-dosing-recommendations.html
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Actemra definitely made tapering off Prednisone so much easier for me. Before starting Actemra, my rheumatologist wanted me to taper my Prednisone dose as low as I could to establish a baseline. I was on 10 mg and tapered to 7 mg but the pain was too much so I went back to 10 mg.

My rheumatologist forewarned me that it could take up to 3 months for the effects of Actemra to be working. For that reason, I tapered by 1 mg per month for the first 3 months. I assumed Actemra was working because I was on 7 mg and didn't experience the same amount of pain as I did when I tapered down to 7 mg without Actemra.

I decided to put Actemra to the test and that was when I tapered by 1 mg per week. I breezed past the 7 mg dose and after 4 more weeks, I was on 3 mg. I remembered an endocrinologist telling me previously if I could ever maintain a 3 mg dose of Prednisone, she could probably help me. She also said as long as I needed higher doses of Prednisone to control my autoimmune conditions then it wouldn't be possible to discontinue Prednisone. Now it seemed like Actemra was controlling my autoimmune conditions instead of Prednisone. I wasn't sure what would happen if I discontinued Prednisone.

When I was on 3 mg of Prednisone my cortisol level was checked and as expected, it was low. My endocrinologist said I shouldn't attempt to taper any lower than 3 mg. My instructions were to wait and give my adrenals a chance to recover while staying on 3 mg of prednisone. My endocrinologist said I shouldn't increase my Prednisone dose unless it was absolutely necessary.

It was uncomfortable for me to stay on 3 mg of Prednisone but I managed. Some days I felt well and other days were not so good. That is why I say my low cortisol symptoms waxed and waned for a long time.

When my cortisol level was recheck 6 months later, my endocrinologist said it "might be safe" to discontinue Prednisone. She said no tapering was needed from 3 mg to zero as long as my cortisol level was adequate. My endocrinologist said my cortisol level was adequate at the time my lab was checked but it might not be adequate in the future.

The body needs a variable amount of cortisol that depends on the situation. The adrenals are capable of producing much more cortisol when needed in response to stressful situations. My endocrinologist didn't know how well my adrenals could do that if I encountered an unanticipated stressful situation. I was told IF I discontinued Prednisone, I should take it again for any reason "if I felt the need." My endocrinologist said ideally, I should tell her before taking Prednisone again but if there was a sudden need, she didn't require that I tell her first.

I basically went from 3 mg to zero by tapering 1 mg per day. Suddenly I was off Prednisone for the first time in more than 12 years!

I don't think there is any tapering method that works better and any other method. There isn't any research study that says any tapering method works better than any other tapering method. The empirical evidence says the taper should be slow and on a case by case basis.

Hello, I have been diagnosed with GCA of the Aortic in the heart. I have PMR for about three years now. I am 70 yrs old and have a Medicare Advantage Plan. They said my co pay is like $458, for Tyenne. I wanted Actemra but the said it wasn't covered in part B of Medicare, doesn't seem right. I am being scheduled for infusion soon. Thank you for the post
Ellen

@elleninz
Some insurance polices and even some national health insurances like Canada's will only approve Tyenne because it is cheaper than Actemra.

Whoever told you Actemra isn't covered by Part B is incorrect. Here is the output from Google AI:

"Yes, Actemra (tocilizumab) infusions are generally covered by Medicare Part B when administered by a healthcare provider in an office or outpatient setting. Coverage applies if the drug is considered medically necessary for FDA-approved indications, such as rheumatoid arthritis or giant cell arteritis.

Key Coverage Details:
Part B Coverage: Covers IV infusions (often in a doctor’s office/hospital) as they are not typically self-administered.
Part D Coverage: Self-administered subcutaneous (injection) forms of Actemra are usually covered under a Medicare Prescription Drug Plan (Part D) rather than Part B.
Costs: If you have Original Medicare, you will typically pay a 20% coinsurance after meeting the Part B deductible.
Requirements: Coverage may require prior authorization, ensuring the drug is ordered by a specialist (e.g., rheumatologist). "

I take weekly Actemra injections, so they are covered under Part D. Part D has a maximum copay of $2100 this year. I met that limit with my first 2 monthly refills of Actemra, so I won't have any more copays for medications this year.

Thank you that’s what I thought.
Ellen

@elleninz Since you are on an Advantage Plan there is likely nothing you can do to move from infusions to injectables. I started Tyenne mid-January and am hitting my $2100 limit next week. I am on classic Medicare so all my drugs for the remainder of the year will be covered 100% by insurance. You could talk to you Advantage Plan mangers and ask if the $2100 limit applies to your program. If it does then you would have a choice to move to injectables. I like the injectables because it gives me freedom to travel and not have to time my travel around an infusion date. I also believe the drug has a more consistent amount in my system with a weekly injection vs. the highs and lows that a monthly infusion would bring to the table.
BTW, Tyenne is actually a bio-identical drug to Actemra. They both have the very same active agent. Bio-logics most often have similar active agents and not identical active agents which is why they are called bio-similar. Generic pills all have identical active agents.

I have GCA, and started Actemra infusions Feb. 2025. About 3 months ago, Medicare switched the infusion coverage to Tyenne. I don’t notice any difference, and I like the monthly infusions. They are covered %100 by Medicare part B, although I have original (classic) Medicare and also a Supplemental policy Plan F that covers all deductibles, copayments, etc. My understanding is that the weekly injections are covered under Part D (the drug plan, so coverage depends on your Medicare Advantage drug coverage.

@sjc123

I think everything you posted is true.

Hi All, thank you for the feed back, I start Tyenee March 12 as an infusion, Looks like my insurance will cover this, and if and when I feel comfortable I could switch to injectables. Again what a great group! Ellen