Besremi versus Pegasys

[Flynn2107]

Is Besremi better than Pegasys. I can't find a good comparison study between the two. Study shows that both can reduce jak2 allele burden, but does one work better with fewer side effects? The Proud-pv study for Besremi did not include et/pv patients with enlarged spleens while the Pegasys study did include enlarged spleen patients. Here in the US we are waiting for Besremi approval, Pegasys is already approved.

[hunter5582]

I expect that we will not know the answer to that question for some times yet. I suspect that efficacy will be pretty much the same. It is thought that Besremi may be easier to tolerate since it is a slower release formulation, but I do not know of any data to support that. Time will tell of both fronts. Here in the USA I think that having Besremi approved specifically for PV will make it easier to access. While Pegasys is FDA approved, it is off-label for PV. It typically requires a higher level of authorization in most insurance formularies. Hydroxyurea is also off-label for PV, but it is much easier to get approved since it is so much cheaper.

I am taking Pegasys now. I plan to switch to Besremi when it becomes available. We will see how it goes.

[Flynn2107 in reply to hunter5582]

Thanks for your reply hunter5582, you always post the most knowledgeable responses. My doctors thinks I should wait until Besremi is approved, but I think I want to get on Pegasys now and maybe switch like you are doing. Currently on HU and my hct is staying below 45%, but my jak2 burden is at 88% so I want some interferon sooner than later. Hope you are tolerating the Pegasys well, did your insurance cover it? Are you in the US ?

[hunter5582 in reply to Flynn2107]

Yes my insurance did cover it. Medicare primary and Cigna secondary and managing my Rx. It required a higher level of authorization but was not a problem to get approved. I tolerating PEG well, far better than HU. If you would prefer starting on PEG sooner and switching to ROPEG, I would say to go for it. Your body. Your choice.

[HFrank in reply to hunter5582]

Nice reply. The Besremi is not approved yet in the US., and Pegasys is the best available Peg-INF so far. Hunter5582!!

Does any information about Rouche will stop Pegasys supply recently? Thank you a lot.

[hunter5582 in reply to HFrank]

I heard something about some versions of it being discontinued in a a few years. Not sure what they will ultimately do.

[HFrank in reply to hunter5582]

Thank you a lot. The Pegasys is the good PEG-INF, and hope this could be available for a long time.

[Zanzibi in reply to hunter5582]

Hunter5582 I know you wrote this a year ago, but I am wondering if you made the switch and if it made a difference? I have been on Pegasys for a while (for ET) and am wondering if there are benefits to switching to Besremi now that it is available.

[hunter5582 in reply to Zanzibi]

I made the switch as I had pre-planned to do. I decided to start on the interferon therapy prior to Besremi approval. I went ahead with the switch as Besremi has FDA approval for PV and Pegasys is used off-label. In addition, there is some thinking that Besremi may be easier to tolerate than Pegasys. I was aware that I may need steadily higher doses and wanted to ensure tolerance for the higher dose.

In my case, there does not seem to be much difference between Pegasys and Besremi in terms of efficacy or tolerance. Others have experienced a different reaction to PEG and BES. Some have reported tolerating PEG better. It just goes to show that we are all different in how our MPN proesents and how we respond to the medications.

Besremi is in clinical trials for ET now. I expect it will be several years before it would get FDA approval. Given how expensive it is, I would think that approval for the prescription would be difficult to get. Many insurance plans require that there be support in the literature for the off-label use of a medication. Besremi is too new for this to be the case. Pegasys has been in use to treat ET for quite a while. It is considered a first-line treatment option for ET, so approval is easier to get even though it is off-label.

Suggest you review your question about Besremi with your MPN care team. The MPN Specialist can review what we currently know about Besremi for ET and whether there would be any benefit to switching in your case.

All the best.

[Zanzibi in reply to hunter5582]

Thank you for the quick and helpful reply. My oncologist was able to get Besremi approved for me, but I am not sure it is worth making the change and certainly would cost quite a bit more.

[hunter5582 in reply to Zanzibi]

It depends on your insurance plan. Pegasys and Besremi cost the same out-of-pocket for me. How much more it would cost is a pretty reasonable thing to evaluate. I expect you can sort this out with your oncologist.

All the best.

[SoledadBarcelona]

Hello, flynn,I am in the same situation. I asked to the European goverment for it. I am waiting. Maybe there is a similar way in USA.

I decided to wait for Besremi because I have my symtons and numbers controlled by my helpcarer team

[AnBee]

My Heamatologist told me it is something to do with the patents or competition in the market place and probably not much different to Pegasys.

[EPguy]

I found this old post. With the approval of Besremi your question now is of even more interest.

PEG and Ropeg (Besremi) use polyethylene glycol (PEG) to control the release of the INF molecule. The earliest INFs had less of a control element. The maker of Besremi states that the PEG site is well controlled:

<<The proline linker facilitates the synthesis of a single positional isomer which further increases its stability and half-life.>>

cancer.gov/publications/dic...

Pegasys has multiple possible pegylation sites. The maker of Besremi states that the single site is a reason Besremi acts longer, more evenly over time, with a more mild profile.

In this study comparing them:

pubmed.ncbi.nlm.nih.gov/129...

<<However, the different PEG moieties attached to the native protein, the site of attachment and the type of bond involved lead to vast differences with respect to the pharmacokinetics (including absorption, biodistribution, metabolism and elimination) and pharmacodynamics of these two compounds.>>

Further for Pegasys there are several different sites to which PEG can attach, I assume this is the "moieties" noted above.

sciencedirect.com/topics/me...

<<There are four main potential IFN-α2a pegylation sites, at lysine positions 31, 121, 131, and 134.>>

Few of us are expert enough to really understand it but I accept that these differences are important, where controlling the PEG site matters.