InfantileSpasms.Com

A message that I posted on a Yahoo group that discusses the Questcor stock:

 

Hi all,

My name is Mike Bartenhagen and I am not a owner of any shares of Questcor stock and I am not a doctor but I am the father of a son that was diagnosed with Infantile Spasms in 2002. You can confirm that with a look at Broc's website at www.infantilespasms.com. I wasn't actually looking for this site but came across it in a search for Questcor. My assumption is that many, if not all of you, are stock holders in Questcor, which makes you the owners of Questcor, so my intention in posting here is to let the owners of the company know what many in the Infantile Spasms community think of your August 27th price increase from roughly $1000.00 per vial to $23,265.00 dollars per vial because, after all, we are your customers. First of all I want to say that I am very pro pharmaceutical company. Unlike a lot of people I don't get mad when I see drug companies are making large profits, I hope the companies always continue to be profitable otherwise there would be no incentive to manufacture any medication whether that be Acthar or Viagra. With that said I don't think Questcor should get a free pass in regards to an enormous price increase in what appears to be an effort to make up for poor business decisions in the past. I think in the next few days and weeks Questcor will become very aware of the fact that they under estimated how well connected those in the Infantile Spasms community are with each other, all over the US and the world. In fact I believe that they are already aware of this as I have had the opportunity to speak with the Executive Vice President of Questcor and also received several emails from him.

The message from him made its way here:

http://blogs.timesunion.com/austinbenconnor/

It was only posted to our IS forum with his approval.

Some things you may want to be aware of.

1. Vigabatrin (Sabril) should soon be approved in the U.S., this is the 1st line treatment for IS in most other countries, ACTH is generally consider first line treatment here. Vigabatrin is available here with a script sent to a Canadian pharmacy, easy and legal under Compassionate Use. Many kids including my son have used it. Many studies show it to be as effective as ACTH in the treatment of IS, there is some risk of vision loss with Vigabatrin but ACTH is not without risk, it is a nasty (but necessary) medication. This price increase may make the decision of ACTH or Vigabatrin a different decision than it used to be when Acthar was reasonable priced. It has been several years since Broc was on Vigabatrin but if I remember correctly cost without insurance was about $100.00 a month.

2. Most information you read in regards to IS says that immediate treatment is very important. With the new distribution model doctors may opt for a treatment that is readily available, Acthar may not be this treatment, it is my understanding hospitals will not be able to keep this in inventory, nor will they want to with an overhead cost of $23,265.00.

3. Ganaxolone (Marinus Pharma) is in the trial phase for FDA approval as treatment for Infantile Spasms, it should be approved in a few years, competition is coming.

4. Synacthen (Novartis) is a synthetic ACTH that is used in other countries. I had never heard of this until today, after the price increase was announced many started looking for options. This product is synthetic and Acthar is natural, what that difference between a natural and a synthetic means as far as results are I don't know but Synacthen is the form used in the UK. This study seems to suggest that there is no difference:

From the abstract of a 2001 retrospective study by Drs. Demos, Gerber and
Farrell (Canada):

"Title: Comparison of Efficacy and Adverse Effects of Natural and Synthetic
Adrenocorticotrophin in Treatment of Epileptic Spasms.

RATIONALE:
Natural and synthetic formulations of adrenocorticotrophic hormone (ACTH)possess
different chemical characteristics. Natural ACTH is no longer marketed in Canada
and patients at our centre now receive synthetic ACTH. We compared the efficacy
and adverse effects in children with epileptic spasms.

METHODS:
This retrospective study compared 17 children with spasms, who received
synthetic ACTH, with a historical control group of the previous 16 children, who
had received natural ACTH. The hospital charts were reviewed.

RESULTS:
The mean maximum dose of ACTH was 69 IU (40 - 120) in the 16 children receiving
natural ACTH and 45 IU (30 - 60) in those receiving synthetic ACTH. Epileptic
spasms were controlled in 9 of 16 on natural ACTH and 11 of 17 on synthetic
ACTH. In the patients admitted for ward observation (13 on natural and 14 on
synthetic ACTH), the most common adverse effects (natural v synthetic)were
irritability (12 v 13), hypertension (11 v 5) and electrolyte disturbance (8 v
4). ACTH was discontinued because of adverse effects alone in 7 patients
receiving synthetic ACTH (possible sepsis 2, hypertension 2, gastrointestinal
bleed 2, irritability 1) and in 1 on natural ACTH (hypertension/cardiomyopathy).
ACTH was discontinued because of a combination of adverse effects and lack of
efficacy in 2 (natural) and 3 (synthetic).

CONCLUSIONS:
Natural and synthetic ACTH appeared to be equally effective in controlling
epileptic spasms. Although hypertension and electrolyte disturbance tended to
occur more often during initiation of treatment in those receiving natural ACTH,
ACTH was discontinued more often for adverse effects in those receiving
synthetic ACTH.

Here is a post from a forum suggesting that the treatment cost with synthetic is about $1000.00 compared to $150,000.00 for Acthar;

"I spoke to a local pharmacy and they said it comes in something called
an ampule. The cost is $36.46.

My daughters clinical nurse said that in Canada, Synacthen is what we
use to treat IS (after Vigabatrin). They stopped using the gel YEARSis
usually takes 42 units/viles to complete treatment. She said that she
believed that at the end of the cost was around $1000.00

5. In my opinion, again as a father that has had a son on ACTH not a medical person, Questcor is low in their estimate as to how much a course of ACTH will cost. Input from our forum is that a lot of people are using 6 to 7 vials, maybe more. That puts the cost closer to $150,000, maybe more. A second course is not uncommon. Questcor's position is that insurance will most likely cover the cost. A child that goes through 2 courses could have $300,000.00 or more billed to insurance, if your lifetime maximum is $1,000,000, as some insurance plans are, the price of Acthar may be prohibitive.

6. Many times ACTH is started during a hospital stay. This was the case with Broc, we spent two days in the hospital learning to give the injections ourselves. This meant the Acthar was billed as part of our hospital stay. I spoke with a pharmacist at a large hospital and she said because of this massive increase in price hospitals may reevaluate their use of Acthar as they will be concerned about a $25,000 to $50,000 dollar write off if the claim is denied by insurance and the patient can't pay. A different protocol may be established for Infantile Spasms patients that doesn't include Acthar.

7. I am surprised that Questcor is spending so much time and effort on FDA approval, as they say "if it ain't broke don't fix it."

Questcor's position seems to be that they are the only manufacture of Acthar and if they go broke it won't be available, the fear factor, that would probably not be a good thing but there are other options and based on past action by the FDA, I doubt they would allow Acthar to fail, with or without Questcor. My concern is that they assumed that they would get a free pass based on this position, maybe it does cost $23,265.00 to produce and make a reasonable profit on a vial of Acthar, I don't know, but I don't think they have done a good job of explaining this increase. What is Questcor's production cost per unit, as a publicly traded company is this information available? What I do know is that this has not gone unnoticed as I think Questcor expected it would. This product has been around for nearly 50 years, you would have to assume that during most of that time someone was making a profit. Questcor has been making the drug for 7 years (?), did they just recently discover that they miscalculated by $22,000.00 the cost to produce Acthar and make a profit? This is what is concerning to people. I work in sales, there are many ways to make a product profitable or more profitable, a price increase is usually the easiest way but can also be the method with the most risk, at 23,265.00 is this still a cost effective treatment based on the availability of other options? If the price would have double I think most people would have grumbled a bit and gone on but this increase is to big to ignore. I hope Questcor is able to become a viable company and is able to manufacture Acthar at a profit for years to come but they have made a terrible miscalculation if they assumed that there were no other options for Infantile Spasms patients and parents would allow this price increase without question. They have also made a terrible miscalculation if they assumed they were going to make up for poor judgment in the past at the expense of our kids.

Mike

 

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