Nice update on its availability and well arranged info about it. This distributor is authorized to sell it. Seems in theory our Drs could start prescribing right now.
They even have this cartoon showing their expert busy fixing our marrow.
<<BESREMi® (ropeginterferon alfa-2b-njft) Injection Is Available From Onco360!>>
I wonder what the copays will be for those who are covered by Medicare Part D?
Probably a lot. Ropeg will be very expensive, likely over 50k/year full cost. I'm not in medicare yet. But I read that Medicare Supplemental (Medigap) coverage can be better than Medicare Advantage when you have expensive drugs. Of course its premiums are more and I'm not sure how that compares on B (doctor's office drugs vs D at-home drugs) .
I looked found some old prices in Euro, they said ~3000Eu per dose. This might be indication of the full price, but still doesn't answer the insurance questions.
I'm in Kaiser HMO in California with Advantage Supplement Insurance. Besremi is a "Tier 5" drug per the Kaiser formulary. I start on Besremi next week, and have max yearly drug copay of $7,000 before hitting the catastrophic coverage that reduces my drug cost copay to around $15-$20/month. A one dose syringe (good for two weeks) initial copay is around $2,900, so I will hit the $7,000 max in about in less than 3 doses. The max copay resets at beginning of each calendar year. Do not use a single dose syringe more than once. Although each syringe contains 500mcg I will cautiously start at 50mcg and titrate up over the next several months. I know it seems that throwing away 450mcg of the syringe seems wasteful, but this is not a drug you want to contradict or second guess the manufacturer's advice that could compromise its effectiveness.
That is correct about single dose. I believe there is no preservative in the Besremi. In addition, it is not safe to reuse a needle. I was in contact with PharmaEssentia about the difficulty with accurate dosing at the lower doses and how wasteful it is. There may be a smaller syringe at some point, but no clear plan.
It seems it’s only for PV am I correct?
Correct the trial was for PV without Splenomegaly. Notably FDA approved it more broadly for any phase of PV.
Your Dr can now legally prescribe it for any condition, on or off label, as is done for HU and PEG. The challenge will be getting insurance approval.
We've seen for PEG that making a case for off label use can get ins coverage.
From the current ph 3 ET Ropeg trial page, below, its utility in ET is indicated, consistent with the known history of PEG in ET. This page does suggest some "proper" dose adjustments, I would guess in proportion to the lower allele starting point.
clinicaltrials.gov/ct2/show...
<<Available clinical data and experience with P1101 in PV shows that the compound, with proper dose modifications, is effective in controlling disease in a significant proportion of subjects with ET. >>
Further my Dr and others, see below, say current knowledge leads to MPN as a continuum. My Dr says I have "MPN" rather than one of ET, PV. And it is known that starting INF early with lower allele is preferable. So I think with cooperation from our Drs it should be possible to start Besremi with insurance for treating our "MPN". I have set an arbitrary date of ASH 2021 next month to start my journey to switch. Maybe there will be more info to work with at ASH.
ashpublications.org/blood/a...
<<This is reflected by the 2016 revision of the World Health Organization (WHO) diagnostic criteria for MPN.2 In many cases, a continuum between these disease subtypes can be observed, as documented by the progression of ET and PV to secondary myelofibrosis (MF). Furthermore, boundaries between these 3 disorders cannot be well established, ..>>
My Pegasys is covered under Medicare Part D. Most Advantage plans have a bundled Part D drug plan but some do not, in which case you have the same choices as people with Supplemental Plans. If you have Part D, once you reach a certain level of cost, you pay 5%. By the second quarter of the year, I pay $55 per single use vial.
That is great and specific info for all (US residents) , thanks. Do you know what the full cost of your PEG doses is? (if you had no insurance)
I recently read that supplemental is generally better for those needing high cost drugs. But your experience suggests it depends on details of each.
If nothing else, this approval will make any INF more visible to the world for all MPN's.
Maybe even the UK NHS will give now Besremi a better outlook for coverage.
The cost of Pegasys, if you are uninsured, is about $1100 per single-use vial. I have no knowledge about the quality of Medicare Advantage bundled drug plans. Out of curiosity I costed drug plans with 3 vials per month of Pegasys and nothing else. Approximately $4500 per year.
It seems PEG can be dosed as required from one vial is that right? So a vial can last for multi doses if cared properly.
I think Besremi uses a prefilled pen that is less flexible in its use. So it could be that PEG at full cost of 4500 (depending on dose) is 90% less than Ropeg cash cost of 40+k.
It will be interesting how all this plays out with insurance.
My medicare advantage plan in Connecticut is charged $5495 by the pegasys supplier for (4) 180 mcg vials - a monthly supply. They agree to pay the supplier $3839 somehow and they pick up $3647 of the cost and charge me $192. The user withdraws the dose from the vial with a syringe through the septum so you could get multiple doses depending on how much you are taking - although they tell you to throw away whats left after a single dose from a vial.
That's close to $50k/year full price. Besremi is likely similar. I've read here some are using the PEG vial more than once with pharmacy guidance. But with good insurance it seems not worth the added complexity.
It will be interesting to hear any stories of members here who eventually switch to Besermi, both cost and benefit.
That is because there is no preservative in the PEG. Piercing the vial to draw the dose can compromise what remains in the vial. What some people are doing is to wipe down the exterior of the vial with an alcohol wipe to disinfect it each time to (hopefully) avoid compromising the remaining PEG in the vial. This is not recommended by the pharmacy I use, but some people are doing it out of financial necessity.
Seems it's a good idea only if one has no reasonable cost access and a compounding pharmacy sets it up. Anyway GoodRx says Besremi plans to make it affordable.
goodrx.com/conditions/cance...
<<Although Besremi's list price isn't currently available, PharmaEssentia Source offers financial assistance options for Besremi....>>
Hi ETMany thanks for posting ,
It is also most useful for first time Peg.users as it has an
excellent instruction section,
Bobbie
I have been waiting for this to be approved in the US. I was planning on starting Pegasys if Ropeg wasn't approved.
See my post today on the price, 180,000 k/year! Lets hope insurance/medicare has a way to make it work. My ins co seems ok with it.
My health care provider is UC Davis Heath Care (outstanding) and insurance is Blue Cross. Most things seem to get approved. I except it to be covered. Fingers crossed
"Cancer" drugs tend to be approved more easily, esp rare ones. Since what we have became "cancer" ~2008 all the $ trials and focus got started.
My ins person looked for alternate drugs, I told her you won't find any, and she said you're right. That ups the odds of approvals.
Do yo have an MPN expert at Davis that you like? One small test is how aware they are of the years of data for INF its implications. My 1st Hem said it's no better than HU.
UC Davis Health is actually in Sacramento, CA. My hemo is well trained in MPN's. He was a fellow under the amazing Dr. Gotlib at Stanford. My local hemo said he thinks RoPeg will get approved since my insurance approved Pegasys and it was off label. I didn't know that about cancer drugs being approved more easily. Good to know. You seem very informed and help this community by being so!
Some of the warnings are scary. I honestly don't have any ongoing issue with my PV. None. Maybe a little more tired because of my low ferritin levels, but wow. Look at this list:
BESREMi can cause serious side effects that may cause death or may worsen certain serious diseases that you may already have. Tell your healthcare provider right away if you have any serious side effects during treatment with BESREMi. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking BESREMi. These symptoms may go away in some people after they stop taking BESREMi.
Mental health problems, including suicide: BESREMi may cause you to develop mood or behavior problems that may get worse during treatment with BESREMi or after your last dose, including irritability (getting upset easily), restlessness and agitation, confusion, depression (feeling low, feeling bad about yourself or feeling hopeless), unusually grand ideas, acting aggressive, acting impulsively, or thoughts of hurting yourself or others, or thoughts of suicide. If you develop any of these symptoms, you, your caregiver, or family member should call your healthcare provider immediately. Your healthcare provider should carefully monitor you during treatment with BESREMi.
New or worsening autoimmune problems: BESREMi may cause autoimmune problems (a condition where the body’s immune cells attack other cells or organs in the body), including thyroid problems, increased blood sugar (hyperglycemia), and type I diabetes. In some people who already have an autoimmune problem, it may get worse during your treatment with BESREMi. Tell your healthcare provider if you have tiredness, are urinating often, or if you are very thirsty.
Heart problems: BESREMI may cause heart problems, including problems with your heart muscle (cardiomyopathy), heart attack, abnormal heart rhythm (atrial fibrillation), and decreased blood flow to your heart. You should not use BESREMi if you have high blood pressure that is not controlled, congestive heart failure, a serious abnormal heart rhythm, narrowing of the arteries to your heart, certain types of chest pain (angina), or a recent stroke or heart attack. If you have a heart problem before you start using BESREMi, your healthcare provider should monitor you closely during treatment with BESREMi.
You're right about that. It has a black box warning, the top warning drugs can get.
So does HU, see here. Looks even worse. All quite scary. But only HU gets all the stuff about carcinogen, and INF is not normally considered to be that. Ropeg seems likely to have fewer such effects than PEG. See my post in replies here.
healthunlocked.com/mpnvoice...
It is important to be closely monitored by your Dr on INF esp the early phases.
In spite of all the INF warnings, the experts generally say it's "well tolerated".
------
Treatment of patients with DROXIA may be complicated by severe, sometimes life-
threatening, adverse effects. DROXIA should be administered under the supervision of a
physician experienced in the use of this medication for the treatment of sickle cell
anemia.
Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a
tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed
transspecies carcinogen which implies a carcinogenic risk to humans. In patients
receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia
vera and thrombocythemia, secondary leukemias have been reported. It is unknown
whether this leukemogenic effect is secondary to hydroxyurea or is associated with the
patient’s underlying disease. The physician and patient must very carefully consider the
potential benefits of DROXIA relative to the undefined risk of developing secondary
malignancies.
---
Thanks for reply. I didn't take HU because of the risks and it just didn't make sense to me. I wanted to take something that possibly reduced my risk for progression and RoPEG seems to be the only drug we have for that.
That's great you can put off the "poison pills". Well worth doing so.
I needed to start HU to get my CBCs down. Worked perfectly for that, complete response, and still working. But I found Ropeg within a week of my Dx last year and have been watching its progress since.
In case you've not seen, this post is why we need to be asking about INF.
Besremi - NHS
Clinical Trial Exceed ET
