Medicare Denies Besremi Coverage - the Saga Begins

[hunter5582]

It appears that at this point Medicare is refusing to cover Besremi despite is being FDA approved in November. Here is the text of the denial letter I received.

Your request was denied

We have denied coverage or payment under your Medicare Part D benefit for the following prescription drug(s) that you or your prescriber requested:

Besremi 500 mcg/ml SYRINGE

Why did we deny your request?

We denied this request under Medicare Part D because:

Your request is for a drug that is excluded under your Medicare Part D benefit. The Social Security Act permits the exclusion of certain drugs or classes of drugs from coverage under your Medicare Part D plan. The Act also permits the exclusion of certain drugs or classes of drugs when they are prescribed to treat an excluded use. 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 only - NO FAX

You should share a copy of this decision with your prescriber so you and your prescriber can discuss next steps. If your prescriber requested coverage on your behalf, we have shared this decision with your prescriber.

You may obtain a copy of the criteria used to make this decision by sending a written request to Cigna,

I am, of course, going to appeal this decision. The problem appears to lie with Medicare rather than Cigna. I am researching the issue and will use what I find to mount an appeal.

There is some hope that Medicare will update the Part D formulary in early 2022. perhaps the issue will self-correct, but I m not counting on it. This is one of the things I will be looking into.

Many of us who would benefit from Besremi in the USA are over age 65 and on Medicare as our primary insurance. Even with good secondary insurance coverage like I have, the Medicare formulary can interfere with our access to the medications used to treat MPNs.

I am hoping that others in this same situation will share what they are experiencing with private insurance, Medicare, and Medicaid. Perhaps we can build a base of knowledge that will allow us to more readily access Besremi and other emerging treatments for MPNs.

This is just the beginning of the saga. I plan to post more as I learn more. please do the same with what you learn.

[Cja1956]

So I believe the reason that it wasn’t approved by Medicare is because the FDA just approved it. When I was put on Fedratinib back in November 2019, it had just been approved by FDA that August. My regular insurance covered it but when I went on Medicare at the beginning of 2021, only one plan out of all the drug plans approved it. But it was still around $8000 a year. Without coverage, it was $75,000 a year! This year, when I went online to look at other drug plans, they all covered it at about the same rate of approximately $8000. That’s still very expensive for me, so I applied for a grant last year through a patient assistance program and they are paying for it. They renewed my grant this year but I’m not taking it anymore. They told me they would keep me in the system for four months but if I don’t go back on it, I will lose the grant, which is fair, but scary. I do realize not everyone will qualify for a grant and I am very grateful for it.I wish you luck in your appeal.

[Wewo01]

I have a couple more years until I am on Medicare but my current insurance may also deny Besremi. We shall see! I plan on getting with Dr Savona on prescribing it. My deductible starts over in January, so i will have to come up with $10 grand up front! Oof! How ever I can help, let me know! Dr Savona knows the Dr who lead testing on Besremi in France and said it is a game changer for PV.

Keep us posted!

Kim

[hunter5582 in reply to Wewo01]

Fortunately on my supplemental drug plan I have a cap of $100/month per med and $2000/year for all meds. That, of course, only applies to meds that are approved. The effort is going to be on getting Besremi approved. No one would be able to afford the co-pay on a med that costs $180,000/year with no reasonable cap. Unfortunately, the retiree Medicare Rx plan formulary is just not as good as what regular employees have available. Sometimes Medicare does not help us.

[EPguy in reply to hunter5582]

I just came across this link:

benecard.com/besremi-approv...

<<PharmaEssentia has launched Besremi at a wholesale acquisition cost (WAC) of $6,988 per syringe.>>. That would be 84k/year. Still extreme but less than 180k. But maybe we see a higher retail cost

[gvibes in reply to EPguy]

Not sure about your math. $7000 x 26 inj/yr= $182000. its biweekly correct ? what a deal!

I'm going to wait this battle out - enough problems with insurance + pegasys seems to be working for me. Maybe in the future.

[EPguy in reply to Wewo01]

Game changer is quite a statement, it would be excellent. The implication is a large improvement over Pegasys. I've not seen such data, would be interesting.

[Wewo01 in reply to EPguy]

That is my impression of what he said. I have no experience with any other treatments, except HU, but I sure do want to try!

[EPguy in reply to Wewo01]

What the expert is likely noting is the sort of info in this familiar-to-us allele vs time plot. If this fairly represents PEG also, it could make sense to check allele as soon as 2 years.

Bes-Allele plot

[EPguy]

"There are no conditions..." That is a most unfriendly response.

My guess is as Cja1956 says, it will ripen into approval soon. But it's possible PharmaEssentia has priced themselves out of the US market and we'll all end up with PEG till they fix that.

My commercial insurance said its default is "no" but it will be approved if we can show it is

"beneficial". I'm in the thick of it right now.

My understanding, as Cja1956 says, there are different Medicare plans with different coverages. Maybe there is one that will be useful here.

[hunter5582 in reply to EPguy]

I am locked into the plan I have as it is tied into my retirement benefits. It is actually a very good plan. However, my medical benefits were better and less expensive before I had to start on Medicare. As a retiree over age 65 I have to enroll in Medicare and have Cigna as supplemental "donut hole" insurance. Due to the IRMAA penalty being on Medicare costs more than not being on it. It is unfortunate that the increased cost does not come with improved access to medical care. If anything, access to care is reduced. It is what it is.

The important thing is to figure out how to access the medications we need. Whether Medicare or another medical coverage, we need access state-of-the-art treatment. Time to sally forth and tilt some windmills!

[EPguy in reply to hunter5582]

Most our non-USA members don't have to think about this stuff.

You're likely the best one here to figure this out and us US folks will benefit from your findings as usual. I never thought that Medicare could be a downgrade. It does seem to depend on the mysterious details of the plans.

On this page from the Company on financial assistance:

pharmaessentiasource.com/fi...

<<Not available to patients with prescription insurance plans through any federal or state healthcare programs, including but not limited to Medicare, Medicaid>>

Fits the idea that Medicare can be a downgrade.

[katiewalsh]

I’m in the US too but haven’t yet seen my specialist to prescribe it. What horse manure. It’s been demonstrated clearly by studies as the only drug to do what it does with fewer side effects. I’m also glad you’re taking this on because you’re very smart & competent. We’re lucky to have you tackling it. Let us know if we can help in anyway. Thanks Katie

[hunter5582 in reply to katiewalsh]

Please do let us know of anything you learn if you move forward on trying to access Besremi. I am hoping shared knowledge and experience will benefit us all. I am the first patient at the johns Hopkins MPN Clinic to be prescribed Besremi. My care team is learning along with me how to manage accessing Besremi for patients on Medicare. The answer will vary based on the specific Part D plan, but hopefully there will be a common thread that will benefit all.

Hope to share more in the days ahead.

[katiewalsh in reply to hunter5582]

I definitely will & agree about shared knowledge. I’m not officially PV so they may deny based on that. But if I’m prescribed it I’ll let you know.

[ladyanello]

Good luck, Hunter! It is available here in Portugal as a first line drug for PV but still contraindicated for those of us with thyroid issues, autoimmune diseases and depression so a no go for me. Probably try Hu again but with an anti viral this time...see what happens.

[hunter5582 in reply to ladyanello]

I believe that the thyroid disease is a caution. Autoimmune disease and significant depression are contraindications. All three together most likely is a bog no-go for the IFNs. I would think that ruxolitinib (Jakafi) would be a consideration, partially if you are HU-intolerant. Hope you find something that works for you.

[Buggerbear]

Hunter, if anyone can persevere this accomplishment for people in the US, it is you as with all your intelligence and knowledge!! I wish you the very best of luck as I will be following your journey. Sounds like I am not a candidate, due to me having private Federal insurance along with Medicare.

[hunter5582 in reply to Buggerbear]

Make that not a candidate for now. We are in the exact same boat. Primary Medicare and secondary government (county) retiree insurance. Unfortunately, I have to be on Medicare to maintain my retirement medical benefit.

If you are interested in pursuing Besremi, I would encourage you to do so. We need these requests to be hitting Medicare Part D plans to create the impetus for change.

All the best.

[Buggerbear in reply to hunter5582]

Thank you Hunter!! Always heard "the squeaking wheel gets the grease!" All of us with MPN's will have to fight together!

[Pte82]

hunter ask your doctor to request it directly from the manufacturer free due to your curcumstances.

[EPguy in reply to Pte82]

From the link above, reproduced here, the Co is not cooperative with Medicare. No idea why not, but if course it's about $.

pharmaessentiasource.com/fi...

[hunter5582 in reply to Pte82]

I will be ruled out automatically because I have Medicare. PharmaEssntia is going to insist that anyone on Medicare get Medicare to pay for it - at the full retail cost.

[Pte82 in reply to hunter5582]

My wife was refused for a treatment used to treat ALM by Medicare because her Myelofibrosis, though borderline, was not ALM yet. The Inrebic was ineffective and she could no longer walk. The doctor contacted the company and her treatment was started without cost. She is walking now and is no longer transfusion dependent

[hunter5582 in reply to Pte82]

That is great to hear. I may pursue something with PharmaEssentia if my efforts with Medicare do not succeed. The bigger picture is that everyone with PV who prefers Besremi should be able to access it directly and have it covered by their insurance, including Medicare. We need systems solutions when dealing with these sorts of issues. It will take all of us working together to make something like this happen. Hopefully others here in the USA will move forward with their efforts to access Besremi if that is what they prefer.

Systems change only happens when people are willing to make it happen. It is too easy for healthcare systems to ignore the needs of people with rare disorders like MPNs. We can only ensure that our needs are addressed if we choose to make it so.

Hopefully Medicare will self-correct regarding access to Besremi, but we cannot assume that it will be so. It is up to us to ensure that this happens.

[EPguy]

Interesting note is Medicare is covering the new Alzheimer's drug (aduhelm) even as it doesn't really work. They are even increasing Medicare bills for all just to cover it.

We have a drug that really does work, and the patient numbers will be small. In a rational place this comparison should be worth something. But against stone faced bureaucrats rationality is carefully rationed.

[hunter5582 in reply to EPguy]

This is the politics of Medicare coverage. I expect many seniors called their elected representatives who pushed Medicare to cover it. It is not about efficacy. It is about getting reelected. Once I have the information to move forward, contacting my Senator (Joe Manchin) is one of the options I may need to explore. One of my docs told me that one of her patients did this in a similar situation. That patients was successful in accessing the medication.

[Joetcalr]

This conversation makes me feel so grateful for the UK's NHS, (which worryingly is being nibbled away at by privateers). I have enough problems sorting house insurance etc, I'd be dead if I had to be dealing with medical insurance too! Good luck with it Hunter.

[EPguy in reply to Joetcalr]

For curiosity from a US member, do you know whether Besremi easily available through the NHS now?

[Joetcalr in reply to EPguy]

I don't know sorry, but someone will I hope.

[JohnSC in reply to EPguy]

Not yet. It is being assessed for approval and my understanding is that approval is dependent on negotiating an acceptable price.

[hunter5582 in reply to Joetcalr]

Thanks. Here in the USA, Medicare is the closest thing we have to a NHS. Sadly it can make it more difficult to access healthcare than a regular decent quality private insurance program. This seems to particularly pertain to medications. the Medicare Part D formulary I have to use now is definitely not as good as what I had prior to reaching age 65 and being forced onto Medicare. I really wish I could scrap Medicare altogether, but am required to be on it or I will lose all of my insurance. Sadly, there is an income penalty (IRMAA) for middle class wage earners that actually makes being on Medicare (with the essential secondary coverage) cost more than just having decent employer supported insurance.

It is what it is. We each have to work to navigate the healthcare system we find ourselves in. We have to be our own best advocates.

All the best.

[hunter5582]

The saga continues. Many phone calls to various branches of Cigna Customer Service, Cigna Administrative Appeals, Medicare..... After a length series of calls, I made some progress getting the information I need - I hope. The decision was based on the coverage criteria for: 2560 Medicare Part D Excluded Drugs - Plan Rules. Getting this document has been quite difficult as no one seems to know where it is. There is a customer service rep who is researching it and will get back to me on Friday. How very odd that a document used to make coverage decisions is so hard to find!

As it turns out Besremi is not an excluded class of meds per Medicare. It is up to each plan to decide which meds are excluded. This is a different classification than Non-formulary. Non-formulary meds can be covered under certain circumstances. Excluded meds cannot.

For those seeking Besremi under one of the various Medicare Part D plans - you may find a different answer. it is up to each plan to make decisions about excluded meds not on the Medicare list of excluded classes of meds. The companies can exclude medications that are FDA approved based on their own criteria. Cost is, of course, the core issue. This is true in many healthcare systems, including some nationalized health systems. Sadly, Medicare is prohibited from negotiating drug costs with companies, so the high cost of Besremi may preclude access via many Medicare (and other) health plans.

Will continue to pursue this quest. Updates will be forthcoming.

[ggrana]

I have UHC and was also just denied so I will appeal. Why do they have to make this difficult for us ? We are going thru enough and don’t need this added stress . Merry Christmas ! God bless you all !

[hunter5582 in reply to ggrana]

I expect there are two issues. It takes time to change formularies and rewrite the rules at large insurance companies. Besremi was just approved in November so some insurers have not caught up yet. The otter issue is cost - $180,000/year. Just a bit more than Jakafi and lot less than hydroxyurea. On the bright side, maybe it will get easier to get Pegasys approved since it "only" costs about $53,000/year.

The only way things are likely to change is if we make it so. People have to be willing to push for the medication of their choice and not take no for an answer. You have to be willing to appeal the decision. This requires researching the underlying rules on which the decision is made for your insurance plan. It takes time and energy to do so. Our providers can help with this, but most do not have the time to research each and every coverage plan to negotiate the process. That is something we need to be willing to do.

I hope your appeal is successful. please do let us know how things turn out.

[EPguy in reply to hunter5582]

I don't know if it will be helpful in reality, but I have posted charts etc here on how/why Bes is "beneficial". My intent was to use for my insurance request. So far my Dr is taking care of it, but I'll use it if/when it gets rejected.

If it might be useful or others, I can provide the MPN Voice links for convenience.

[hunter5582]

It will depend on the plan and what the reason for declining Besremi is. At this point, efficacy appears irrelevant to the reason for denial on my Medicare Part D plan. Besremi is "Excluded" - which is different than "Non-formulary." When a med is excluded, it does not matter how well it would work. The plan will refuse to cover it no matter what. If the reason for refusal is that Besremi is "Non-formulary" then efficacy could matter. The fact that it is now one of the few drugs FDA approved for PV could also matter. One possibility built into some plans allow for non-formulary meds to be approved when the formulary meds are ineffective, contraindicated, or simply not available. This even allows for off-label use for some meds when there is evidence in the literature to support it.

At this point the issue is not going to be the efficacy of Besremi. It needs to make it onto the formularies for our various plans. The challenge is going to be its cost. The good news is that Jakafi is almost as expensive and it is available on many plans. Hopefully this will set the precedent for Besremi.

[EPguy in reply to hunter5582]

Excluded is severe and only deciphering the bureaucracy can get at that one.

For my commercial PPO they said it's not on the formulary. This typically is bec there are cheaper equivalent options according to below. The insurance rep seemed confident she would find some but came back to me empty handed, confirming on the phone that there aren't any. They said it can be approved if we show it's necessary. This seems to match the details below, but not helpful for Medicare.

That's interesting info on Jakafi cost. Supports the idea that both Medicare and private plans will get easier maybe next year.

From:

safemedication.com/pharmaci...

<< If a medication is “non-formulary,” it means it is not included on the insurance company’s “formulary” or list of covered medications. A medication may not be on the formulary because an alternative is proven to be just as effective and safe but less costly. If you and your doctor believe that the non-formulary medication is necessary, you will need to request that your insurance make an exception based on your case, or you will need to pay the full cost yourself or out-of-pocket. If you have Medicare, it is your right to file an appeal and get a decision that is unique to your situation. >>

[hunter5582 in reply to EPguy]

The folks in the appeals department did make clear that there is a difference between "non-formulary" and "excluded". I have been able to get non-formulary meds approved in the past. An excluded med is a different situation. That apparently means the Medicare Plan has specifically decided they will not under any circumstance approve a medication. I have requested a copy of the Plan Rules (with the list of excluded meds) from Cigna. They were not able/willing to provide it. I filed a formal Medicare grievance regarding not providing the Plan Rules since I need them to file my appeal.

We will see what happens.

[EPguy in reply to hunter5582]

Seems the issue on these "Plan Rules" is with Cigna rather than directly with Medicare. Is that right? Or is it still not clear?

[hunter5582 in reply to EPguy]

That is correct. The issue is with my specific Medicare Part D plan. Medicare does not prohibit specific drugs, just certain classes of drugs. Besremi is not in the classes of drugs excluded.

[Elizka]

I'm so sorry!

[hunter5582 in reply to Elizka]

"It ain't over 'till the fat lady sings!" Having heard no unsolicited opera, I am moving forward with an appeal. The appeal has to be put forward based on solid information about the rules that drive the decision making. That is why I am doing the research to structure the appeal properly. To borrow another quote "We shall never surrender!"

[HFrank]

Hi hunter Does this mean it is covered by Medicaid?

fm.formularynavigator.com/F...

[hunter5582 in reply to HFrank]

This means that Besremi is covered as a Tier 2 med by this specific plan. Requires prior authorization. Not sure if there are any other requirements to getting it authorized. Not sure it it would be available on a Medicaid plan administered elsewhere