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Xiaflex Collagenase Injection

 


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 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 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?


 

Dr. Grabow is the only hand specialist in Nevada who is trained in all aspects of Dupuytrens treatment!  This includes Needle Aponeurotomy, Open Surgery, and Collagnenase Injection.

Other doctors may tell you they don't recommend a certain procedure or type of injection, but if they don't know how to do it, how can they give you a complete explanation of your treatment options.  There are many factors that determine what is the best treatment for your contracture.

Since Dr. Grabow offers all forms of treatmet for your Dupuytrens, you will be able to discuss all treatment options and together with Dr. Grabow determine what is the best course of treatment for your condition.  


WHAT IS BETTER NEEDLE APONEUROTOMY OR COLLAGENASE? 

Collagenase injection and Needle Aponeurotomy are the only nonsurgical treatments to help patients suffering from dupuytrens contracture. There are comparison studies of Needle Aponeurotomy and Collagenase injection, but both are effective in releasing the main cord of your contracture.

Unfortunately, many patients see a hand surgeon who is not trained nor skilled in Needle Aponeurotomy so the patient is not given this option. Sadly these patients are not getting the best care for their problem because they do not have the opportunity to talk with a specialist trained in all procedures.

For those specialists like Dr. Grabow, who are able tooffer both procedures many factors are used  to determine the right option for you.

Needle Aponeurotomy requires far more skill to peform well compared to collagenase injection. It is for this reason that many surgeons will tell you they don't offer it or don't recommend it - THEY DON'T KNOW HOW!  They only recommend the injection because it is the "only club in their bag"! 

Specialsists skilled in Needle Release typically do more Needle Release than Collagenase injection due to the simplicity of the procedure for the patient, ability to do muliply fingers at the same time, ability to address earlier disease, and contractures at all levels of the finger.   

Collagenase is often used by those same specialists when the patient has very thick disease or when they have an insurance that will not allow them to do needle release in the office but does allow collagenase injection.  This insurance issue is often a problem in California but is not an issue in Nevada.

Dr. Grabow has a detailed conversation with each patient and together you and he will decide what is the best treatment for you.


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. 

Most insurances will cover some portion of the cost of the medication. Medicare will cover 80%. If the patient has a co-insurance with Medicare it will usually pick up the difference. Financial assistance and discounts are available based on need, but in many cases there is no out of pocket cost to the patient for the medication. If you will be having a collagenase injection with Dr. Grabow, we will provide you all the details regarding your costs before scheduling the procedure. 

 


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 of the cost differences in Needle Release and Collagenase injection.

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*

 Yes*

 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

Varies based on insurance but typically covered by insurance.

 Number of needle sticks

 Average: 3 - 5

 Recommended: 3

 Number of visits required

 1

 2 or more

TOTAL COST

Cash Pay

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)

YES - fully covered (minus deductible)

 PRIVATE INSURANCE  COVERAGE

YES - covered by private insurance (minus deductible and copay). Some insurances will not cover it. 

YES - covered by private insurance (minus deductible and copay). Some insurances will not cover it.  

 * According to Auxillium website

** According to Auxillium Press Release 2/17/10

© Grabow Hand to Shoulder Center.