Hormone Replacement Therapy Implant

Dan Poulter Excerpts

Wednesday 28th January 2015 Commons Chamber

[The Parliamentary Under-Secretary of State for Health (Dr Daniel Poulter)]

I congratulate my hon. Friend the Member for Chatham and Aylesford (Tracey Crouch) on securing this debate on the funding of hormone replacement therapy implants. She gives me the opportunity to discuss the issues she has raised on behalf of her constituent, Sarah, and others more generally.

Hormone replacement therapy is effective for treating women who are entering the menopause and experiencing hot flushes and night sweats as well as sleep and mood disturbances. There are a number of different types of hormone replacement therapies available, including an oral tablet taken daily, or a transdermal patch applied once or twice weekly.

We should acknowledge that there are risks for those who are prescribed hormone replacement therapy, and the guidance of the National Institute for Health and Care Excellence suggests that, among other risks, there is a small increased risk of breast cancer, stroke and gallbladder disease.

Turning to the issues raised today concerning hormone replacement therapy implants, I have been advised by the Health and Social Care Information Centre that the number of items prescribed and dispensed for hormone replacement therapy implants has been declining since 1996, from around 36,700 prescription items per year to around 5,300 in 2010, the year prior to the licence being withdrawn. HRT implant prescriptions are now down to negligible levels.

HRT implants are no longer routinely offered as a treatment for menopausal symptoms, as my hon. Friend said, and that has been the case since 2011 when the manufacturer of the licensed product, the pharmaceutical company MSD, stopped making the implants. The decision to cease manufacture was based on two main factors. First, therapeutic alternatives are available in the UK, including tablets taken by mouth, patches and gels. Secondly, cost-effective manufacturing processes are unsustainable because few countries use the implant formulation.

GPs and prescribers were advised in 2011 that treatment should be continued until a discussion could take place between the patient and their prescriber. I understand that most GPs and prescribers reviewed their patients at that time and agreed suitable alternative treatments to switch to. The Medicines and Healthcare Products Regulatory Agency advises me that the only HRT implant preparations now available are not licensed for use in England, as my hon. Friend pointed out.

There has been a change in the prescribing culture surrounding HRT implants. In the past, they were popular as they gave a steady amount of oestrogen over a period of time and women did not experience fluctuating hormone levels. However, the insertion of HRT implants requires a small surgical procedure, and that can only be done by certain clinicians. Some women increased their tolerance to HRT as a result of having an implant, and returned for higher and higher doses at reducing intervals.

Newer hormone replacement therapy patches now provide steady amounts of oestrogen hormone without the disadvantages of the implant, and this phenomenon of HRT tolerance occurs less frequently.

[Tracey Crouch]

I understand what the Minister is saying, but does he recognise that some women have allergic reactions to the patches? Certainly, my constituents who came to see me found that neither the patches nor the gel offered a suitable alternative to the implant, not least because the patches often fall off or there is some kind of reaction to them.

[Dr Poulter]

Indeed. My hon. Friend makes a fair point, and I shall make some reassuring comments in that regard in a moment. It is possible to have a reaction to a device or implant, and one would hope that if people have an allergy or reaction to any product, that would be taken into account before it is used. If it causes discomfort, irritation or any adverse reaction, its use should be discontinued and alternative therapies considered.

Clinical commissioning groups are responsible at local level for commissioning the majority of NHS services, and decisions about those services should be made, we would all agree, as close to patients as possible by those who are best placed to work with the patients and the public to understand their needs. Local NHS commissioners now have the freedom and autonomy to take responsibility for meeting the needs of patients in their area, and other health care professionals can work with the CCG, including in secondary care, to help to integrate and join up services more effectively. While clinical commissioning groups are led by primary care professionals, they are also guided by the expertise of other local clinicians.

I understand that my hon. Friend’s local CCG—Medway CCG—released new guidance on HRT implants in 2014. The guidance states that from April 2014, patients will no longer be able routinely to receive hormone replacement therapy implants from their GP. Medway CCG has advised me that the guidance was developed for HRT treatment following clinical input and review through a clear governance process. Because HRT implants are no longer licensed and more suitable alternatives are generally available, the CCG decided that it would no longer pay GPs for inserting such implants from 1 April 2014. The CCG’s policy is in accordance with General Medical Council guidance on prescribing unlicensed medicines, and my hon. Friend will appreciate that medical professionals and doctors have to have regard to those requirements under the licence that they hold, and because they are regulated by the GMC. The CCG has assured me that it does not prevent doctors from inserting an HRT implant if they think it is clinically necessary for an individual patient, having assessed their needs and tried alternatives, and providing that they have sufficient evidence to demonstrate the treatment’s safety and effectiveness.

In exceptional circumstances, where a licensed medicine is considered unsuitable or ineffective for an individual, I would expect those patients to be referred for expert opinion. I am pleased that that is exactly what happened in Sarah’s case, and that Chelsea and Westminster hospital provided her with excellent care and support. We would expect a similar process to be in place in other CCGs. If someone needs more expert support and care, perhaps because they are suffering from the menopause and their GP finds their symptoms and presentation complicated, there should always be a facility for referral to specialist care and support. What happened in Sarah’s case—thankfully, it has resulted in a positive outcome for her—is available at other centres of excellence. Expert care and advice is there, and available for patients.

Medway CCG has written to GPs locally to issue information that they can share with all patients who are still using HRT implants, and to ask them to discuss alternative forms of HRT with them at their next routine appointment.

The CCG advises me that patients should be referred to a gynaecologist for expert opinion if the GP and their patient consider that there is no suitable alternative to the HRT implant. I hope that that is reassuring to my hon. Friend. At a local level the CCG has taken the issue seriously and has written to local GPs and reminded them of the importance of reviewing the current treatment plan for women who have the implant, but if they need more specialist support and advice, to make sure that a referral is made to a specialist centre of care. That process should be available to patients throughout the country. Where specialist support is required, CCGs should routinely refer those patients on. That is part and parcel of good medical practice.

Most of the time, HRT therapy and the expertise of GPs in supporting patients through menopause is enough for the majority of patients, as my hon. Friend outlined, but sometimes there is a need for more specialist support. Centres of excellence such as the Chelsea and Westminster can provide that and consider alternative treatments and therapies where they may be appropriate.

I hope my hon. Friend finds that reassuring. I thank her once again for bringing the issue to the attention of the House. I hope I have been able to provide some reassurance to her on the issues she raised regarding support for women in Medway who need HRT therapy and potentially implants, and more generally on the process that is in place to ensure that women who need specialist care and support can receive it, and that all CCGs and all doctors would always be mindful to take the right action for the patients they look after.

Question put and agreed to.