Besremi Supply Security Issues??

[Joey1025]

Sorry, guys - this could very much just be me being too paranoid - but I would like to ask if anybody has experienced or heard of the supply shortage issue with Besremi. Let me explain how I came up with this question.

A few weeks ago, I came across a news article reporting that in January there was a supply flight cancelled due to the storm. The manufacturer, Pharmaessential, explained that this was the reason why their sales revenue had a significant drop for that month. However, if the manufacturer had inventory in the US, would a delay of just one flight not be a problem? Does that mean Pharmaessential keeps no inventory in the US?

So I started to worry a bit. I then did my own research and found a prospectus issued by the manufacturer back in September 2022. The link is here (in Chinese): doc.twse.com.tw/pdf/202209_...

On page 735-736 (PDF pages), the manufacturer explained the need to build a new production facility in Taiwan, and one of the reasons was that they had experienced longer-than-expected customs inspections, which MIGHT LEAD TO SUPPLY INTERRUPTIONS.

(BTW, my family is from Taiwan, so yes, I do read some Chinese.)

And finally, I found this letter from the management of Pharmaessential to its European partner: jusmundi.com/fr/document/ot...

Pharmaessential suggested that the dispute between the parties had jeopardized its operation and could risk the supply of Besremi. This was an email back in 2020, so maybe the issue has been resolved. But it seems the manufacturer is still in dispute with its partner. I don't know if this will also influence the supply in the US.

My brother Jacob, who's currently using Besremi, reassured me that he has not experienced any supply issue with Besremi, and in any event, he can always go back to Pegasys. I still cannot get over this supply shortage concern. And hence the question.

Any input would be appreciated.

Thanks a million!

[hunter5582]

I have not run into any supply issues with Besremi. My concern is actually about the political instability in the region, specifically the risk of supply interruption due to conflict between Taiwan and China. This is a real risk and one that needs to be planned for. Perhaps we will hear more about this in the future.

Meanwhile, there does not seem to be any issues that I have heard of regarding adequate supply of Besremi in the USA. The more salient issue is access to Besremi as it is quite expensive. People do run into problems getting it approved by their insurance and with affording their copay. There is potential assistance from PharmaEssentia Source for anyone in this situation pharmaessentiasource.com/ .

[Joey1025 in reply to hunter5582]

Thank you, Hunter. Your input is always so helpful! Yes, I am also worried about the instability in that region and its implications for the supply of the medication.

Regarding access to Besremi, I have found that Besremi is now classified as a "preferred" treatment according to the NCCN guidelines. I assume this will somewhat help patients in obtaining approval from insurance companies? (I've seen some friends here having difficulties obtaining insurance approval for reimbursements.)

[hunter5582 in reply to Joey1025]

Hopefully NCCN status will help with the approval process, particularly ensuring that Besremi is on the formulary for different plans. It will be a higher-tier medication due its cost. It will always be harder to get approved than a cheap medication.

Unfortunately, too many people think that when an insurance company says NO that is the end of the story. Even when the prescriber does the first level appeal and the answer is till NO., that is not the end of the story. It is just the beginning. The patient has the right to appeal at several different levels and in several different ways. You just have to know how.

When I first tried to get Besremi approved, the Cigna plan managing my Medicare Part D responded "There are no conditions under which this request would be approved under Medicare Part D. We based this decision on the coverage criteria for: 2560 Medicare Part D Excluded Drugs - Plan Rules." This was the wrong answer. I knew Besremi was not an excluded drug, it just was not on the formulary yet. Fourteen hours of phone calls, requesting the "Plan Rules" that they could not find, filing a "Medicare Grievance", and discovering a mistake they made on how they handled the original appeal -- result was -Besremi approved. Note - they never did find the plan rule 2560 on which they said they based the decision.

Fortunately, I have a good plan and my monthly cap on any one med is $100 with a $2,000 annual cap. The good news for others on Medicare is that in 2025 there will be an annual $2,000 cap on med copays for everyone. That will be a huge help for many on Medicare as the regulations prevent the pharma patient assistance programs from helping people on Medicare with their copays.

Wishing you all the best.

[Lillysue19850705 in reply to hunter5582]

Hi Hunter and Joey,

Sorry for jumping into your conversation, and thanks to both of you for the useful information. Regarding the $2,000 copay cap in 2025, does that apply to all out-of-pocket expenses for patients, or is it strictly limited to copays (excluding deductibles)? Either way will be a good news. I assume the pharmaceutical companies and insurance companies will bear the expenses beyond the cap then?

[hunter5582 in reply to Lillysue19850705]

The cap is for out-of-pocket expenses for patients covered under a Medicare Part D plan. This should work the way any cap works. Once you reach the cap, authorized medication will be covered 100%. by the insurance plan managing your Medicare Part D benefit. This will, of course, be paid for up-front in what beneficiaries are charged for their coverage.

[Lillysue19850705 in reply to hunter5582]

Thank you! Good news!

[Joey1025 in reply to hunter5582]

Thanks Hunter and Lilly. Helps a lot.