Hormone Replacement Therapy Implant

Tracey Crouch Excerpts

Wednesday 28th January 2015 Commons Chamber

[Tracey Crouch (Chatham and Aylesford) (Con)]

I am very pleased to have the opportunity this evening to speak on behalf of not only my constituents but many women across the country on the issue of commissioning and funding the hormone replacement therapy implant.

While I appreciate that for the overwhelming majority of women experiencing the menopause alternative HRT treatments are perfectly effective in addressing their symptoms, for a small number this is not the case, and the impact is significant. This issue was first brought to my attention by a group of my constituents who were being treated with the implant from the well woman clinic at Lordswood community healthy living centre in my constituency. In March 2014, after Medway clinical commissioning group announced that it would no longer be providing funding for the insertion of HRT implants, they sent me a copy of a petition signed by 200 women, one of whom has since sadly passed away.

After receiving the petition, I met a number of the individuals concerned to discuss why the alternative treatments were inadequate. They described the effect on their quality of life of no longer having access to the implant, and the problems that they had experienced with other formats of the therapy not addressing their menopausal symptoms.

The purpose of today’s debate is not to advocate access to the implant for all women going through the menopause. I am aware that many women either go through the menopause without any major problems or can sufficiently negate their symptoms with the cheaper licensed alternatives such as patches and gels. However, for a selection of women, the HRT implant provides benefits not addressed by alternative forms of the therapy.

A small percentage of women are severely affected by this issue. They include women with a history of breast cancer in the family. HRT has been thought to increase the risk of breast cancer, especially when used over long periods of time. However, the implant is seen as a preferable option for those seeking HRT treatment as there is a reduced risk, because it is absorbed directly into the blood and bypasses the liver. They also include women who experience some of the more severe symptoms. Symptoms such as joint pain and depression, which cannot be eased by the other licensed formats of the therapy, can also be improved by the implant. These more severe symptoms can have a huge impact on the quality of daily life and on well-being, affecting factors such as employment and mental health, which have cost and health implications of their own, both to the economy and to the individual. The small percentage of women severely affected by this issue also includes women who suffer from early menopause. This means that they are likely to suffer symptoms over a protracted period, and they have also been seen to have much better results from the implant.

The personal experience of my constituent Sarah clearly highlights the reality and severity of the effects involved, as well as the benefits that the implant can provide. Sarah King is suffering early menopause. She is a lovely young married mum with three young boys. For most of her life she had been healthy, active and happy, but in recent years she suffered a number of accumulating health problems. These included joint pain—to the point of hospitalisation—skin problems, depression, headaches and lethargy. After a number of years of various treatments and no real improvement, she was sent for a simple blood test which revealed extremely low hormone levels, indicating that she was suffering an early menopause.

Owing to a family history of breast cancer, Sarah was first offered the opportunity to try the HRT implants. Within a short time, all her poor health issues had gone. When the HRT implant service stopped, she tried the HRT patches and then the gel, but neither gave her the same result that she had experienced with the implants. Her health deteriorated to the point that she had to quit her full-time job as a teaching assistant. She started researching on the internet and discovered that the Chelsea and Westminster hospital in London had a specialist menopause clinic and HRT implant service.

[Jim Shannon (Strangford) (DUP)]

I thank the hon. Lady for bringing this delicate issue to the House for our consideration. My understanding is that this hormone replacement therapy is available only in certain locations across the United Kingdom. Does she agree that we need consistency of availability, from Aberdeen to London and from Cardiff to Belfast, and that it should be available to everyone?

[Tracey Crouch]

I am grateful to the hon. Gentleman for his intervention. The implant is no longer uniformly available nationally. The decisions being taken locally are affecting people who might not be able to travel to London, for example. I shall come to that later in my speech.

Sarah contacted Medway CCG to ask whether it would object to her being referred to the Chelsea and Westminster hospital as an NHS patient. The CCG told her that there was no objection and that the patient’s well-being was its priority. Following that consultation, Sarah had her first appointment at the Chelsea and Westminster on Monday 12 January this year. She was accompanied by her husband, and he was able to tell the medical practitioner who interviewed Sarah what it had been like before she received HRT implants at the Lordswood clinic, what it had been like after she had the implants, and what it had been like to see her health deteriorate again when that treatment was no longer available. He said:

“I just want my happy, healthy Sarah back.”

The medical practitioner that Sarah saw said she was an ideal candidate for the HRT implant and did not hesitate in giving it to her during that first visit. Within a week Sarah says she is already feeling much better, and she has now set up a website dedicated to supporting women suffering severe menopausal symptoms. I am sure that Sarah is just one woman of many who have found themselves in this predicament, but not all have had such positive outcomes.

I would like to take this opportunity to thank the constituents of mine, especially Val Weeden, who have tirelessly researched and campaigned on this issue. They have actively searched for solutions and continuously shared their information with me. They have constantly supported each other through what has clearly been a very tough situation for many. It is extremely unlikely that this issue is unique to my constituency; I am sure that many women across the country and beyond who suffer from severe symptoms no longer have access to this potentially life-enhancing treatment because of localised commissioning structures. They may not all come across information for Chelsea and Westminster’s specialised service, and women in the far north or far south of the country who do may struggle to travel to London, at a potentially extortionate cost. Although I appreciate that this is not a cost to be incurred by the health care system, it is one that I would like the Minister to consider today.

After some research into this issue, I identified that on 5 July 2011 MSD, the only licensed provider of the Estradiol implant here in the UK, issued a letter to GPs stating that it was to cease manufacture of the product. It stated:

“the company’s global decision to discontinue the manufacturing of Estradiol was made after consideration of commercial factors and the fact that therapeutic alternatives are available in most countries. The decision is not related to a product quality or safety issue”.

For most women, this issue of cost has no impact on their treatment and well-being, but the 200 women in my constituency, and, I imagine, many others beyond for whom the alternative forms of HRT are not suitable, have been left with a void in their health care. The UK now has no licensed provider for a treatment that enables sufferers to live a normal, high-quality, day-to-day existence.

I recognise that the lack of a licensed provider is not necessarily a problem, as GPs are able to prescribe unlicensed medicines if they feel there is a special need and an unlicensed provider of the product exists in the UK. However, in my constituency this process has not adequately represented the women for whom this treatment is so important, because when our CCG made the announcement in March 2014 that it would no longer be providing funding, the justification was that 200 women was far too great a number to be treated with an unlicensed medicine when licensed alternatives were available.

Although I disagree with the idea that an increased demand for treatment somehow de-legitimises its suitability, I am aware of the potential concerns about licensing. However, just because a product is unlicensed, it does not necessarily mean that it is unsafe, as has been highlighted in MSD’s notice of cessation. In fact, in this case the unlicensed treatments being provided have been widely used across the country and the world. The only reason they are currently unlicensed is that the license holder deemed its provision economically unviable.

That brings me to my conclusion. My constituents found the Chelsea and Westminster clinic through independent research on the internet. That is not a good enough procedure to ensure that women have access to the vital services they need in our health care system. I, for one, recognise the positive changes that this Government have made to our health care system—namely the emphasis on the importance of well-being. I also believe that, for the most part, our doctors are best placed to commission our local services, but this case is an example of where the economics of devolved commissioning are perhaps having a negative impact on specialist services.

The Chelsea and Westminster clinic is proof that there is clearly a recognised medical need for the HRT implant to be made available, as a uniquely successful treatment, to a significant minority of women. I therefore ask the Minister to commit to take steps to ensure that our shared vision of our health care system is a reality for all who use it, including these women. I urge the Minister to take steps to make sure that this specialised service is available to all women who may need it, in an appropriate location, and that appropriate referrals take place. To follow any actions that he may take on this issue, will he make a commitment to publish new guidance or write to GPs to inform them about best practice for their patients in this position.

Looking forward, we also need to understand early menopause better and how it may be affecting women from an earlier age. I urge the Minister to engage with national organisations such as the Daisy Network, which was set up for this age group to see how best we can do that. We also need more research into severe menopausal symptoms and treatment for them. Will the Minister commit to look at this whole area of concern?

Finally, I thank Val, Sarah and the rest of my constituents who have campaigned tirelessly on this issue. Their support has enabled me to raise this issue in the House not just for them but for many, many women across the nation in similar circumstances.

[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.