|
|
FREQUENTLY ASKED QUESTIONS |
I have received many emails regarding the availablilty of the collagenase injection for Dupuytrens contracture and its proposed cost. I have compiled this Frequently Asked Questions page for your information. In order to be accurate all information regarding the collagenase injeciton drug Xiaflex, has been obtained from their website.
IS IT AVAILABLE?
Yes - it is FDA approved and the company is in the process of training physicians for its administration.
IS IT SAFE?
The safety of any medication or procedure is based on two factors: 1) The inherent safety of the medication or technique 2) The knowledge and skill of the professional performing the procedure or administering the medication. The FDA has approved use of the collagenase injection for dupuytrens but they have mandated very specific training to help reduce the inherent risks in using the medication. COLLAGENASE CAN RUPTURE THE TENDONS THAT FLEX YOUR FINGERS. This is one of the major complications of the medication and is the main reason why the FDA has mandated special training to use the medication. To download the Medication Guide and the safety information regarding collagenase use for dupuytrens - click here.
Below is the Safety Information listed on the Xiaflex™ website.
IMPORTANT SAFETY INFORMATION
In the controlled and uncontrolled portions of clinical trials, flexor tendon ruptures occurred after XIAFLEX injection. Injection of XIAFLEX into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand.
Other serious local adverse reactions in clinical trials include: pulley rupture, ligament injury, complex regional pain syndrome (CRPS), and sensory abnormality of the hand.
In the controlled portions of the clinical trials, a greater proportion of XIAFLEX-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX-associated pruritus increased after more XIAFLEX injections.
Although there were no severe allergic reactions observed in the XIAFLEX studies (e.g., those associated with respiratory compromise, hypotension, or end-organ dysfunction), severe reactions including anaphylaxis could occur following XIAFLEX injections. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections.
In the XIAFLEX trials, 70% and 38% of XIAFLEX-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. The efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin) within 7 days prior to XIAFLEX administration is not known. Therefore, use with caution in patients with coagulation disorders including patients receiving concomitant anticoagulants (except for low-dose aspirin).
The most frequently reported adverse drug reactions (= 25%) in the XIAFLEX clinical trials and at an incidence greater than placebo included edema peripheral (mostly swelling of the injected hand, 73% vs. 5%), contusion (70% vs. 3%), injection site hemorrhage (38% vs. 3%), injection site reaction (35% vs. 6%), and pain in the treated extremity (35% vs. 4%). (To see this page on the Xiaflex website - click here)
DOES DR. GRABOW USE THE COLLAGENASE FOR PATIENTS?
I do not currently use collagenase injections for dupuytrens and have no plans to offer it to patients at this time. My first responsibility to patients is to Do No Harm. As a specialist in the non-operative treatment of dupuytrens it is important for me to be familiar with all facets of its treatment. However, because of the excellent safety record of needle aponeurotomy and the low cost to my patients I believe needle aponeurotomy is a better treatment option than collagenase injection. I will be participating in the training process for the administration for the drug at the end of this month, but I have no plans on stocking the medication at this time.
IS IT BETTER THAN NEEDLE APONEUROTOMY
Personally I believe it is WORSE than Needle Aponeurotomy but BETTER than open surgery.
While it has been shown to help correct dupuytrens contractures, no study comparing collagenase treatment and needle aponeurotomy has been performed and to my knowledge there are no plans on comparing needle release and collagenase injection. In order for a surgical procedure, medication, or new treatment to be considered better than the existing treatment for a condition there needs to be an objective study performed.
Needle release has been compared to surgery and patients hands down (pun intended) preferred needle release to open surgery and the risks and complications of needle release were less than for open surgery - click here.
No study comparing needle release and collagenase injection has been performed to date and would certainly hurt sales of this new drug if this study were performed. The reason I believe that is the case is due to 3 factors: 1) The cost to the patient (significantly higher with collagenase treatment) 2) The time requirement (patients need to come back the next day after collagenase injection to "break the cord" (needle release is all done the same day) 3) The risks and complications of collagenase use are greater than needle aponeurotomy. (Compare the medication risks as provided from the company vs. the risks listed for Needle release.)
AM I BIASED IN MY OPINION?
While some of my colleagues who have an all cash practice for needle aponeurotomy may be biased in their opinion of this drug, I am not. I accept most insurances and most of my patients have needle release covered by their insurance so the potential "loss of income" due to collagenase injection is just not there. I perform needle aponeurotomy because it is the right thing to do. In my opinion and supported by studies - it is a better procedure for dupuytrens than surgery. After my review of the complications and costs involved to the patient for Collagenase injection - I do not believe it is as safe a procedure for my patients nor do I believe they should pay such a high price compared to the cost of needle release.
HOW DO YOU DECIDE? If you are trying to decided what to have done (needle release or collagenase injection and you have unlimited funds you should do 2 things: 1) Talk to a hand specialist who performs needle aponeurotomy and discuss both procedures 2) Talk to a patient who has had needle release performed. (Most of my patients have volunteered to answer patients questions - so if you want to talk to someone let me know.)
HOW MUCH DOES IT COST?
This is a difficult question to answer directly because there are several factors. 1) The cost of the medication to the physician ($3,250.00 per vial) 2) The cost of the injection procedure by the physician - (cost varies) 3) How many vials are used (average 1.1 vials per pt = $3.575) 4) Will Medicare and Insurance Companies cover the cost. After speaking with the Xiaflex representatives at our AAOS meeting, they said that they are trying to get Medicare to cover the cost of the medication. Physicians have not received any indication from Medicare or any insurance company that they are paying for the medication. Private insurance companies and managed care plans will be even slower than Medicare to adopt any new medication so you would have to check with yours personally. Ii is unlikely for anyinsurance company to cover any new drug when it first hits the market. This has nothing to do with the medication but is just how they (insurance companies) do business. If they determine it is in their best interest to pay for some or all of the drug then they will. It is a matter of cost vs. benefit to the insurance company. Unfortunately the patient is not part of this equation. This is the basic approach for all new drugs, this drug is no exception.
The costs listed above are based on the Auxillium Press Release on 2/17/10 - click here to view press release
The following is an excerpt from that press release:
XIAFLEX Pricing Strategy Announced
Following the Company's discussions with physicians, patients and managed care organizations around the value that XIAFLEX offers as a new non-surgical treatment option for Dupuytren's contracture, the list price per vial of XIAFLEX to distributors will be $3,250.00. Additionally, the Company believes that, on average, Dupuytren's contracture patients treated with XIAFLEX will have 1.5 cords treated and that an average of 1.1 vials of XIAFLEX will be used to treat each cord.
The cost to distributors is NOT the cost to physicians using the drug. Physicians will have to pay more for the drug to buy it from the distributors. This is no different than if a store buys soda from a beverage distributor. Everyone marks up the cost. So while the exact amount you will have to pay will vary based on the factors listed above - it will be expensive.
COST COMPARISON TO NEEDLE APONEUROTOMY
Many patients call to ask the price difference in treatment. They know the costs of surgery are significantly higher but they are not aware the cost of the collagenase injection is at least 5 times more than the cost of needle aponeurotomy. There are many factors to consider so I listed them in a table.
Since I am one of the few Needle Aponeurotomy Specialists in the country who takes insurance - most of my patients pay very little out-of-pocket.
| |
NEEDLE APONEUROTOMY
|
COLLAGENASE INJECTION
|
Covered by Insurance
- includes consult and procedure / injection / drugs
|
Yes*
|
No* |
Cash price for consult
|
$200 |
Likely the same
|
Cash price for procedure
|
1 finger = $700
2 fingers = $1100
Additional fingers = $300
|
Cost of injection procedure is variable based on physician
|
Medication costs
|
Included in cost of procedure
|
$3,250 minimum per vial**
Each cord likely 1.1 vials = $3575
|
Number of needle sticks
|
Average: 3 - 5
|
Recommended: 3
|
Number of visits required
|
1 |
2 or more
|
|
TOTAL COST:
1 finger treated
|
NEEDLE APONEUROTOMY
$900
(includes consult, procedure, medications)
|
COLLAGENASE INJECTION
At least $3250
(for medication / per finger)
PLUS additional cost of procedure and consult
|
MEDICARE COVERAGE
|
YES - fully covered (minus deductible)
|
Not currently covered
|
* According to Auxillium website
** According to Auxillium Press Release 2/17/10
Last updated 3.15.10