Qalsody (tofersen)
Qalsody (tofersen) is a prescription medicine for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) with the SOD1 (superoxide dismutase 1) genetic mutation.
In April 2023, Qalsody was granted accelerated approval by the FDA in the USA.
- Disease Indications : Amyotrophic Lateral Sclerosis (ALS)
- Manufacturer : Biogen
- Usage : Intrathecal Injection
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
Details
What is Qalsody (tofersen) for?
Qalsody (tofersen) is a medicine prescribed to treat adults with amyotrophic lateral sclerosis (ALS), who have an SOD1 gene mutation.
The medicine is available as a spinal injection (100 mg/15 mL). The first three doses are administered every 14 days, followed by a maintenance dose every 28 days.
How does Qalsody (tofersen) work?
Qalsody (tofersen) is an antisense therapy. It binds to messenger RNA associated with the SOD1 gene. In this way, Qalsody can help reduce the production of the harmful SOD1 protein.
According to clinical study results, patients treated with Qalsody experienced an average 55% reduction in a biomarker called [lasma neurofilament (NfL) at Week 28 of the study. In comparison, participants who received placebo had a 12% increase in NfL.
Where has Qalsody (tofersen) been approved?
Qalsody was granted accelerated approval by the FDA in the USA in April, 2023. This approval was based on Qalsody's clinical trial results showing a reduction in NfL levels. A Phase 3 randomized, double-blind, placebo-controlled trial is underway to confirm these clinical benefits of Qalsody. Continued approval in the USA depends on the outcome of this additional trial.
References
-
Qalsody| Official Patient site. Qalsody, Accessed 20 July 2023.
FDA Grants Accelerated Appoval to Qalsody (tofersen) for SOD1-ALS. Biogen Investor Relations, 25 April 2023.
Qalsody (tofersen) prescribing information. Accessed 20 July 2023.
FDA approves treatment of ALS associated with a mutation in the supero. FDA, 25 April 2023.
Price & Costs
Qalsody (tofersen) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| single-dose vial x 100 mg/15 mL | 32775 EUR | 54108 AUD | 48905 CAD | 59529 NZD | 54447292 NGN | 46297 SGD | 27019 GBP | 34519 USD |
*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Qalsody (tofersen) treatment costs
The cost for a monthly or yearly treatment of Qalsody (tofersen) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (capsule/injection/vial/etc).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Qalsody (tofersen) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Qalsody (tofersen) price and additional costs
- The price of Qalsody (tofersen)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Qalsody (tofersen)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Qalsody (tofersen) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Qalsody (tofersen), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Qalsody (tofersen) reimbursement
It might be possible for you to claim the cost of Qalsody (tofersen) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Qalsody: You can access Qalsody from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
Email Address
Sshealthcare1012@gmail.com
+91 7575883015
Landline
079 48916267
Disclaimer
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