Hi all, I started off with Besremi 2 weeks ago. My inital dose was 50mcg and from now on for the time being I am supposed to take 100 mcg every two weeks. I was wondering now if its ok to take the 3rd dose from my first pen. In the instructions it says that the pen can be used up to 30 days once opened but it also states that each pen should only be used twice.I hate the thought of wasting any of this precious and scarce stuff.
Any thoughts on this?
I would say the answer is NO to that question. The pens are not designed for that many uses.
Here in the USA, we only have 500mcg prefilled single-dose syringes available. I only take 175mcg. I have to waste 375mcg every time of a drug with a retail cost of $8,500/dose. It makes my skin crawl. While I only have to pay $100/month for $17,000 of Besremi, I still despise the waste. There really should be a better way to handle this.
Yes Hunter the cynic in me feels that big pharma are not adverse to waste when profit is key. Theres no reason spare needles couldnt be inc im the pack! I asked my hospital pharmacist to raise this with the manufacturer and she said she will as she also felt as we do. Thank you.
The cynicism is justified, but there are legitimate reasons that autojectors should not be used more times than they are designed for. Most are single use devices. Once the sterile seal is broken, there is a risk of contaminations and degradation of the medication. There is a risk of backflow of blood/fluids into the device, though I expect it is minimal risk.
The best way for the pharma companies to maximize multi-use dosing would be to issue the medication in multi-use vials that are designed to allow safe administration of multiple doses. There is a simple reason why this is not done. Revenue maximization.
To be fair, the cost of the medication is more a reflection of the research and development than the manufacturing. The cost of bringing a new drug to market ranges from $1.3-$2.6 billion. Small molecule drugs are typically less expensive. Biologics like Besremi are more expensive. Drugs for rare diseases have the cost spread out over a smaller number of people. The actual cost of manufacturing a drug is typically 10-30% of the total cost charged. Again, biologics tend to be more expensive to manufacture. The economics of drug development and production drive the cost. So do investors who expect a profit on their investment.
Unfortunately, there are no simple solutions. I am fortunate to have good insurance so I can afford Besremi. Not everyone has that good fortune. It still makes my skin crawl every time I waste so much of a very expensive medication. I wish it was possible to give my wasted Besremi to someone who cannot afford it.
Wishing ready access to the medication needed to one an all.
Hello there, I'm a newbie too to Besremi and took my 1st dose mid Nov. I went through exactly the same thoughts and my specialust team said no. Only the 2 doses. If it helps spuur you on I am doing well on it, and already reds white and plt started to reduce. Keep going its a wonderful drig in my experience. I am still on 50 but look to inc to 100 next mnth. All best on your journey back to better health and vitality xx
Thanks to the both of you. I'm so grateful for this drug. Up til now I feel hardly any side effects at all. And telling from your experience Roxanne, plts will hopefully start to go down pretty soon.
But I just can't think of a proper reason why it shouldn't be possible to use that 3rd dose within 30 days except for big pharma making up this nonsense rule to sell more of this super expensive substance. Anyway I'll wait for a reply from my specialist and if he doesnt mind, I just might go for it.
We have to continue to be vocal about the waste for future patients' sake, even though the FDA's response to my complaint ridiculously seems to think patients can get in on the packaging issue early on in approval of the drug.
I actually have to throw away 90% of the solution each month. I've contacted the FDA, etc. about this waste, and attach info from my congressperson's office, with last names deleted.
The FDA responded to the complaint about the package size for Besremi:
Thank you for your email and for your patience as we looked into this..
The Food and Drug Administration (FDA or Agency) understands that high drug prices have a direct impact on patients — too many American patients are priced out of the medicines they need. FDA is committed to facilitating increased competition in the market for drug and biological products through the approval of generic drug products and biosimilar biological products.
Currently, Besremi is approved as a 500 mcg/mL solution in a 1 mL single-dose prefilled syringe.
FDA encourages applicants to communicate with the Agency early in the drug development process about labeled container sizes. During drug development, as the dosing regimen of a drug product is determined, FDA will work with the applicant and discuss the labeled container sizes of the products that are being developed. Labeled container sizes are specific to each drug, indication, recommended dosage, and patient population. As an applicant considers new indications and patient populations for a product, FDA will reassess the labeled container sizes. FDA also may recommend development of an additional or alternative presentation in an advice letter to the applicant after approval of their original application. The decision of whether or not to develop or seek approval of such additional or alternative presentations is made by the applicant.
FDA notes that even if an applicant develops, and FDA approves, multiple container sizes containing different drug product strengths, the applicant is not required to market all of those labeled container sizes. In addition, pharmacies are not required to purchase all of the approved and marketed labeled container sizes.
A proposed change to a product’s strength under an applicant’s biologics license application (BLA) requires an applicant to request approval of the change in a supplement to the approved BLA. This would be done through submission of a prior approval supplement (PAS). A PAS must be approved by the FDA prior to distribution of the product manufactured using the change (21 CFR 601.12(b)(3)).
Should your constituent have further questions specific to FDA, they can contact the FDA CDER Division of Drug Information directly at: druginfo@fda.hhs.gov; or 855-543-3784.
Hi Vanessa, I’m having trouble understanding this. Is the applicant the pharmaceutical company? If so, it sounds like the FDA is saying: “You are not involved, Citizen. This is a matter between the corporate/pharmaceutical entities and us.” I’d say a government agency should have a better response when these catastrophically priced drugs are involved. Perhaps, like so many in the medical and health fields, they feel the issue of affordability is outside their ken. They obviously were not even interested in the practical packaging issue. Too bad for those of us who could get help if only the drug were reasonably priced.
Vanessa wrote:
The “applicant” in this case is the pharmaceutical company. The FDA is basically asking you to complaint to the distributor so the distributor decides to change the packaging options.
If the FDA gets enough complaints, they may intervene and make a special request—or if supply chains get disrupted, that sort of thing.
We hope that this information is helpful.
Please let me know if you have questions or need additional information.
-Vanessa
Woulsnt the drug company just sell a “half dose” of 250 mcg, but could charge almost the exact same amount? I’m not sure the price would be that different.
Sure, nobody is controlling corporations, it seems. But at least that medicine could be used by someone else.
The answer from the FDA is legally correct. I have spoken directly to the Medical Director at PharmaEssentia about this issue. The FDA has to approve each dosing/device that is made available. The manufacturer would be required to submit additional applications for the exact same medication in a different dosing level. That is how the FDA approval process works. Likewise, if PharmaEssentia makes the autoinjectors available in the USA, that is another application for approval. Even if PharmaEssentia made a 250mcg and 500mcg prefilled syringe available, the cost difference to the patient would be minimal if any at all. Note also that PharmEssnetia believes in maximum dosing for all patients. many of us, however, prefer the low and slow approach.
Perhaps at some point they will get approval for a multi-use autoinjector in the USA. One can only hope since there is little financial incentive for them to do so. I would be concerned that with autoinjectors we may lose our flexibility in dosing in 25mcg increments as some of us choose to do.
For any who wish to get active on this topic, suggest contacting PharmaEssentia directly. us.pharmaessentia.com/contact/ . They are sensitive to their public image so continued feedback is a good thing for all of us.
"We have to continue to be vocal about the waste for future patients' sake" - so true and good that you brought it up with the FDA. I understand now that the waste issue is even bigger in the US. A single use 500mcg syringe sounds ridiculous.
In Europe Besremi comes in 250 mcg/mL pens which are approved for double use within 30 days. One pen costs around 1.700 $. We also have Pegasys approved for treatment of PV and ET but that's completely out of stock at the moment.
PharmaE seems to have applied for the autoinjector in the US also. But the FDA issued a "CRL" which is a drug app rejection:
"The regulatory agency cited that COVID-19–related travel restrictions resulted in delayed pre-approval inspection of the company’s manufacturing facility in Taiwan. Moreover, the agency asked for more data regarding the administration format of the drug. However, no concerns were raised regarding the clinical profile of the agent"
onclive.com/view/fda-issues...
Bes was approved in Euro almost three years before the US approval so it seems likely Pharma originally applied in the US with the Euro style 2-use pen.
I looked into it back then, even trying to figure the Chinese meaning of the equiv to "administration format" and my take was FDA felt the Euro auto injector instructions and/or device were too complicated for US pts. So Pharma quickly came up with the crude solution we see in the US, a pre-filled syringe where the user splurts out all the juice while watching the level till just the dose is left, then inject. It was approved about 9 months after that "CRL". I think double use was not inherently a problem except measuring the dose while busy injecting is not a broadly practical administration format.
On two vs three uses, the cut off does seem arbitrary, if a 3rd use within 30 days is too risky, why is the 2nd use not so? All the same hypothetical risk factors are in play after dose 1. But the applicant (the drug Co) does need to select some clear criteria.
Interestingly insulin pens for SC (subcutaneous like IFN) injection typically have no limit to uses per cartridge, only that a new needle be used. So, unless the Bes pen is somehow different, similar should be possible. This doesn't mean one should not obey the Bes instructions.
On arbitrariness of some important medical things, I read long ago that the doses for the Covid vaxes were a best guess absent more clinical data early on. So we ended up with two very different mRNA doses for the two equivalent mRNA versions.
Besremi decision time
Does Besremi cause high blood sugar?
BESREMi Ropeginterferon alfa-2b is available in Austria and Germany
