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Does NHS Pay For Xiapex In UK?

I was invited to attend a scoping workshop held at NICE offices in Central London on 29th July 2015. I attended as British Dupuytren's Society Opens in new window symbol Trustee representative, i.e. representing Peyronie's patients’ point of view.

Doctor injecting banana

The purpose of the meeting was to provide NICE with input from interested parties but NICE has been asked to perform technical appraisal on Xiapex and Potaba, two drugs that have been used to treat men with Peyronie's disease.

This is my first formal insight into the world of public funding of drugs. It was very interesting and informative. These are my rough notes from the day.

Will Xiapex Be Available On NHS To PD Patients In The UK?

NICE (National Institute for Health And Care Excellent) has been asked to perform technical appraisal of two drugs used to treat Peyronie’s disease (PD). These are Xiapex (a.k.a. Xiaflex) and Potassium P-Aminobenzoate (Potaba).

The Xiapex is marketed in Europe by Sobi (Swedish Orphan Biovitrum), a Swedish biotechnology company, under license from Auxilium. The Potassium is manufactured and sold by German company named Glenwood GmbH.

NICE conducted a workshop with the interested parties to this study, i.e. the two marketing companies, representatives on behalf of urologists, patient group, and technical analysts. The purpose of the workshop was to identify and clarify any issues, benefits, and processes in place, i.e. in order to perform analysis of the benefits of these drugs to patients and NHS as part of recommended Peyronie's treatment.

Why Does This Matter?

Xiapex and Potaba are both drugs that are currently available to patients in the UK. However, since they have not been approved as part of the Peyronie's treatment process, the UK NHS does not automatically pay for the use of the drugs for Peyronie’s patients. It is therefore important from patients point of view that NICE evaluates the use of these drugs, and if their conclusion is beneficial, NICE will make a recommendation to Ministers to make these drugs available free of charge to patients through NHS.

Currently these drugs are only available to patients who pay for themselves. Therefore, mainly private hospitals and practices offer Xiapex treatments, but the cost of each treatment cycle (1 injection) is around £1,500. Each patient will normally require 8 injections, so the treatment cost is substantial.

The Approval Process

As said before, NICE has been asked to conduct technical analysis of the benefits to NHS and patients for approving NHS funding for the use of the drug. NICE only acts as evaluating body to the process, they don’t approve or object to the use. They do the technical analysis and then make recommendations to Ministers who then decide whether the drug is paid for by NHS or not.

What Does This Mean In Practice?

NICE can recommend the use of a drug in the treatment of a disease, like PD, but it is down to the Ministers to approve the funding. If funding is approved, then the drug will become free of charge to patients through NHS. However, if NICE does not recommend the use of a drug, then it means it will never be funded by any NHS Trust.

It can therefore be better for marketing companies that their drug is not evaluated by NICE because it can then be used and paid by NHS in some cases (depending on the relevant NHS Primary Care Trust).

The Workshop

As said before I was invited to attend the workshop representing the Peyronie's patients’ point of view. Then there were 3 representatives present from each of the marketing companies, 2 urology surgeons, one that is already providing Xiapex treatments to his private hospital patients and 2 representatives from technical analysis company.

It was very useful for the project leader from NICE to be able to hear all interested parties views.

During the workshop it was explained the intended use of these two drugs. Potaba is only administered orally during the acute phase while the Xiapex is administered during the stable phase. They are never administered together.

What was interesting was the revelation from the Urologist that there is no standard treatment for Peyronie’s disease. Something that all patients find out quickly enough, but was somewhat news to the team from NICE.

The doctors said that the only approved NICE treatment, Shockwave Therapy (ESWT) is never used. It was never proved to be effective.

It is therefore difficult to evaluate the benefits from using Xiapex and Potassium against a particular treatment practice. This makes the economical analysis bit more difficult, but in practice though, Xiapex can in some cases mean that a patient does not have to undergo surgery. From pure economical point of view, surgery is cheaper option. But from emotional point of view (patients), surgery is worse!

What became obvious is the lack of clinical data available from the marketing companies for the clinical benefits of using Xiapex. This is because it has only been used for a short while on members of the public. The surgeon said that through his practice auditing process, data from his treatments will be available in due course.

Also, they said the clinical data collected during the FDA clinical studies are not applicable as such as the administration process has changed. The surgeon who performs these treatments said he delivers 1 injection each month followed by some modeling exercises. Up to 8 injections are normally administered. The clinical trials were based on 2 injection a week, every six weeks for 4 rounds (8 injections in total).

Sobi said patients with more than 30-degree curvature in the stable phase would be considered as candidates. They said it would probably result in 25% less patients requiring surgery. When asked if that meant Xiapex should be administered to reduce plaque in order to simplify surgery, they could not answer. The average curvature correction from the FDA clinical trials showed on average under 20-degree improvement. That means that a patient with 60-90 degree curvature would more than likely require surgery as well in order to reduce the curvature to less than the 10-15 degrees that is considered normal (straight penis).

Again, lack of clinical data and suggestions of benefits are somewhat hindering the evaluation process.

Since the two drugs are not used together, it is not necessary, or recommended, to evaluate both of them as one during the NICE technology appraisal. Potassium has been available since 1959 and is much less expensive drug. On the other hand, Xiapex is newly patented and quite expensive. It therefore makes sense to evaluate them separately, and make recommendations as such.

Will NICE Approve Xiapex And Potaba As PD Treatments?

The NICE project manager for the evaluation project expects conclusion on their work by November 2015. However, during the closing statements at the workshop, the Sobi representative said that they do not want NICE to complete the technical analysis of Xiapex! The main reason was cost, both to NICE and to their company who have limited resources.

This was very interesting development right to the end of the workshop. But maybe not. There are basically 3 scenarios here. If NICE does NOT recommend the use of Xiapex for PD treatments then no NHS will ever pay for a treatment. If NICE recommends the use of Xiapex, then it is very likely that Ministers will provide funding to NHS for treatments, and NHS must pay for it every time. If NICE does not evaluate the use, then the drug can be paid in special circumstances through NHS, i.e. the door is left ajar! This I learned is the world of public funding of drugs.

At this stage I think it is unlikely that NHS will offer Xiapex free of charge to UK Peyronie's patients, but you never know. At least it is now available to patients in the UK who are ready and willing to pay for it themselves or can convince their NHS Primary Care Trust that they require treatment.

NICE expects to have their recommendations ready by November 2015 if the complete the technical analysis.

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