Find a urologist in your area who is familiar with XIAFLEX (collagenase clostridium histolyticum)
Is XIAFLEX covered in Canada?
for the treatment of adult men with Peyronie’s disease who have a palpable plaque at the commencement of therapy and a curvature deformity of at least 30 degrees. The important IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials, the Phase 3 double-blinded placebo-controlled studies that investigated XIAFLEX for the treatment of Peyronie’s disease, were the basis for Health Canada’s review and approval.
How much is XIAFLEX in Canada?
This type of analysis has already been done in depth by Baltzer and Binhammer (8). They conducted a cost-utility study of the various Dupuytren’s disease treatment options available in Canada. This research was first presented at the Canadian Society Meeting in Toronto (Ontario) in 2012, a year before the Xiaflex price was determined. They compare standard surgery, percutaneous aponeurotomy, and Xiaflex on the basis of cost both direct and indirect, from the perspective of the patient and the health-care system and include QALY efficacy threshold costs in their analysis.
The most cost-effective treatment was needle aponeurotomy, which was followed by collagenase injection and fasciectomy. The article makes the assumption that all surgeons have had needle aponeurotomy training, which may not be the case. Even when working under the assumption that American pricing would be used in Canada and while likely overestimating the number of doses required for the treatment of a single cord contracture, those who use the traditional surgical approach demonstrate a clear treatment advantage for injection over traditional surgery. Even more intriguing, they calculated that Xiaflex became cost effective at CAD$1,250 per dose, virtually exactly the amount the firm used when it was brought to market, using QALY to assess cost effectiveness. This is likely not a coincidence and the fact that the makers and writers arrived at the same market pricing suggests that these calculations are consistent, and work.
When cost and quality are integrated into treatment algorithms, the article provides a wonderful example of a detailed cost study that allows us to begin asking questions about how we treat this condition. Should we use this information to justify covering the cost of Xiaflex in practices where the only alternative to injection is surgery, or should we use it to argue funding needle aponeurotomy training to reduce disease management costs for the system?
Why is XIAFLEX no longer available in Canada?
Greetings, Medical Professional: We’re writing to let you know that Paladin will stop selling XIAFLEX (clostridium histolyticum collagenase) in Canada as of June 30, 2020. The decision to discontinue is not based on concerns about safety or efficacy.
Is XIAFLEX covered under insurance?
All major US health insurance policies cover Xiaflex. Precertification is required and takes about 1-2 weeks. Health insurance typically cover all associated expenditures, including doctor visits.
Why is XIAFLEX no longer available?
Actelion Pharmaceuticals Ltd, on the other hand, has yet to act on PBAC’s suggestion. As a result, the Pharmaceutical Benefits Scheme (PBS) does not cover Xiaflex for the treatment of Dupuytren’s contracture (Email correspondence with PBAC on 15 September 2016).
Is there a generic for XIAFLEX?
For individuals with Dupuytren’s contracture when a cord can be felt, Xiaflex (collagenase Clostridium histolyticum) is a nonsurgical enzyme therapy developed from Clostridium histolyticum bacteria. Collagenase Clostridium histolyticum is the generic name for Xiaflex.
What Are Side Effects of Xiaflex?
Tell your doctor if you have any serious Xiaflex side effects, such as feeling dizzy or fainting (even while lying down); bruising or bleeding in the treated hand; severe pain, itching, redness, warmth, swelling, or other irritation in the treated hand; numbness or tingling in the treated hand; fever, chills, body aches, flu symptoms, swollen glands; swollen glands in your elbow or underarm; or sudden pain, snapping
Dosage for Xiaflex
Xiaflex is a single-use collagenase developed from Clostridium histolyticum that comes in glass vials containing 0.9 mg of the enzyme. Xiaflex should be given by a healthcare provider who is familiar with hand injection procedures and Dupuytren’s contracture treatment; the drug is injected into the contracture cord. Depending on which joint is afflicted, the amounts vary.
Xiaflex During Pregnancy and Breastfeeding
If you are pregnant or plan to get pregnant while taking Xiaflex, tell your doctor. A fetus is unlikely to be harmed by Xiaflex. It’s unclear whether Xiaflex goes into breast milk or whether it could affect a nursing baby. Before you start nursing, talk to your doctor.
Additional Information
Our Xiaflex Negative Effects Drug Center gives you a complete picture of all available drug information on the medication’s potential side effects.
This is not an exhaustive list of potential side effects; others may occur. For medical advice on side effects, contact your doctor. You can contact the FDA at 1-800-FDA-1088 to report side effects.
How do I get XIAFLEX?
The XIAFLEX Copay Assistance Program can reimburse up to $1200 in out-of-pocket expenses for each XIAFLEX injection (collagenase clostridium histolyticum). The cost of XIAFLEX is determined by your health benefits or insurance coverage. Call 1-800-743-2382 to see if you qualify.
Is Peyronie’s disease treatment covered by insurance?
In most circumstances, Medicare and other insurance plans fund the operation. In the physician’s office, billing specialists can assist you in confirming your coverage.
What are the side effects of XIAFLEX?
Swelling, bruising, bleeding, redness, and itching at or near the injection site are all possible side effects. When this medicine is injected into the hand, it might cause swollen, painful lymph nodes in the elbow and underarm. Tell your doctor right away if any of these side effects continue or worsen.
Remember that your doctor prescribed this medication because he or she believes the benefit to you outweighs the risk of side effects. The majority of people who take this medicine do not have any substantial adverse effects.
If you’re being treated for Dupuytren’s contracture, notify your doctor right away if you experience any serious side effects, such as fever, chills, or increased redness/swelling in the treated hand, signs of nerve injury (such as numbness/tingling/pain/strange feeling in the treated hand), or tears in the skin around the injection site (lacerations).
A rare side effect of this drug/procedure is serious (possibly permanent) injury to the tendons/ligaments of the hand. Repairing the injury may necessitate surgery. If you experience difficulties moving your fingers or hand after your doctor has said it is OK to do so, call your doctor straight away.
Some persons who were prescribed this medicine for Peyronie’s disease had lower back pain shortly after receiving an injection. If you experience abrupt lower back discomfort or pain that spreads to your legs, feet, arms, or chest, call your doctor straight once. Back pain can cause spasms and make it difficult to walk. These symptoms generally pass in 15 minutes, but they can linger longer.
This medicine seldom causes a severe allergic reaction. However, if you detect any symptoms of a major allergic response, such as a rash, itching/swelling (particularly of the face/tongue/throat), extreme dizziness, or problems breathing, seek medical treatment right once.
This isn’t an exhaustive list of potential adverse effects. Contact your doctor or pharmacist if you have any other side effects not listed above.
For medical advice on side effects, contact your doctor. You can contact the FDA by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch to report side effects.
Call your doctor for medical advice about side effects if you live in Canada. You can contact Health Canada at 1-866-234-2345 to report side effects.
Does XIAFLEX work for Peyronie’s?
The FDA has approved XIAFLEX (collagenase clostridium histolyticum) as the only nonsurgical therapy option for suitable adult men with Peyronie’s disease (FDA).
A series of injections are administered by qualified urologists in their offices. XIAFLEX has been shown to help minimize erectile curvature when used in conjunction with mild stretching and straightening of the penis.