Sweden's TLV confirms reimbursement for Qutenza patch for treatment of peripheral neuropathic pain

Astellas Pharma Europe LimitedMar 1 2011

- Decision to Reimburse Qutenza(TM) (capsaicin 8% w/w dermal patch) by Sweden's Dental and Pharmaceutical Benefits Agency (Tand-och Lakemedelsformansverket) Gives new Option to Patients Living With Difficult-to-Treat Condition

Patients in Sweden living with peripheral neuropathic pain are set to gain access to a new treatment option which can provide pain relief for up to three months following a single 30- or 60-minute application. The new treatment patch uses capsaicin - the substance found in chilli peppers which gives them their 'heat' - to change the function of pain sensing nerves in the area of skin affected. The Dental and Pharmaceutical Benefits Agency (TLV) has confirmed that the capsaicin 8% w/w dermal patch will be reimbursed for patients who have not tolerated, or who have not achieved adequate pain relief from, amitriptyline or gabapentin.

Neuropathic pain is caused by damage to nerves and it is estimated that approximately 1.5% of the Swedish population may require treatment for the condition. It is a complex and difficult-to-treat disorder that can last indefinitely and have a detrimental effect on a patient's quality of life.

"In many patients peripheral neuropathic pain substantially affects quality of life aspects. With currently used evidence based pharmacological treatments, frequently with bothersome side effects, we are able to relieve pain in a useful way in 30-40% of patients only. Hence there is a huge need for new effective treatments that are minimally side effect prone and that do not interact with other medicines. With Qutenza we can treat selected patients with peripheral neuropathic pain in the area where pain is experienced," says Per Hansson, professor and senior consultant at the Pain Center, Karolinska University Hospital in Stockholm. "It is now pertinent to accumulate and communicate treatment related experience on which types of pain are most susceptible to this type of treatment."

The efficacy and safety of the capsaicin 8% w/w dermal patch have been investigated in a comprehensive clinical trial programme involving 1,327 patients who received at least one application. The treatment has been shown to significantly reduce neuropathic pain. Pain relief is rapid in onset (between one and two weeks to take full effect) and long-lasting following a single application. Reductions in pain were achieved with high concentration capsaicin treatment when used alone or in combination with other treatments for pain. In clinical trials, 44% of patients with post-herpetic neuralgia, a type of peripheral neuropathic pain, treated with the patch reported greater than or equal to 30% decrease in pain compared with 33% of controls. In the same study, twelve weeks post-treatment, 55% of patients treated with capsaicin 8% w/w still reported improvement in pain relief compared to 43% of controls. The reported side effects with the high concentration capsaicin patch are temporary, self-limiting and mild to moderate in intensity.

Use of conventional therapies for peripheral neuropathic pain can be restricted by factors such as side effects, drug-drug interactions, slow onset of action, the need for potentially complex titration and multiple daily dosing. Since the capsaicin 8% w/w dermal patch acts only on the affected area, with a minimal amount of capsaicin being absorbed into the body, application of the patch is not associated with systemic drug-drug interactions or side effects such as sedation and dizziness that may be experienced with other treatments currently prescribed for neuropathic pain.

The capsaicin 8% w/w dermal patch has to be applied by a healthcare professional. It is already available in a number of European countries and will become more widely available across Europe in the coming months.