Impact assessment

Introducing the HRT PPC: equality impact assessment

Published 31 March 2023

Applies to England

Executive summary

In response to the Menopause (support and services) Private Members Bill (PMB), Minister Caulfield made a parliamentary commitment on 29 October 2021 to reduce the costs of hormone replacement therapy (HRT) prescriptions, which was widely welcomed by Parliament and in the media.

An operational solution to deliver this reduction has been announced, meaning that from 1 April 2023 a patient can purchase a prescription prepayment certificate (PPC) exclusively to obtain qualifying NHS prescription HRT medicines and treatments.

According to the House of Commons Women and Equalities Committee, which last year undertook an inquiry on menopause and the workplace, menopausal symptoms have prompted nearly 900,000 UK women to leave their jobs, with those in their late 40s and early 50s eligible for senior roles resigning at the peak of their careers. This can lead to ripple effects on company productivity and gender-related pay and pension gaps. The committee found that the repercussions of that were not merely individual. Excluding menopausal women from the workplace is detrimental to our economy, our society and our place on the world stage.

Menopause is not a protected characteristic under the Equality Act 2010, but if an employee or worker is put at a disadvantage and treated less favourably because of their menopausal symptoms, this could be discrimination if related to a protected characteristic, such as sex, age, gender reassignment and disability. Depending on the circumstances of a case, a claimant may be able to mount a claim for discrimination relating to either one of these protected characteristics, or any combination of them.

All of the protected characteristics mentioned above, including sex, apply equally to both women and men, including transgender men and women.

The HRT PPC will deliver a reduction in the prescription charge a patient could pay for their medication to treat symptoms of the menopause. It is proposed that this PPC will be available for people to purchase from April 2023, subject to implementation.

Introduction

Around 400,000 women of the 30 million in the UK enter the menopause each year. Menopause usually happens between the ages of 45 and 55 and the average age of onset is 51. Around 75 to 80% of women will experience menopause symptoms, and around a quarter of women will experience severe symptoms. Symptoms may last for a long time, with an average duration of 7 years and 1 in 3 women experience symptoms beyond the 7 years.

Medication, including HRT, can be very important to women in reducing the severity of symptoms of menopause. The introduction of the HRT PPC is part of a range of measures dedicated to improving access to appropriate care for menopause for all people experiencing it.

The Department of Health and Social Care (DHSC) is proposing to introduce the HRT PPC which will cost twice the applicable single item prescription charge (currently £9.35 per item), subject to annual uplift, and will be available to purchase on-line via the NHS Business Services Authority (NHSBSA) website, by telephone, or in person in selected pharmacies who currently sell PPCs.

The certificate, once purchased, will allow the patient to pay for their listed NHS HRT treatments up front for a period of 12 months beginning on the start date of the validity of their PPC, and not incur a prescription charge per item, or combination pack for that period. The cost of the PPC will be non-refundable and patients who currently have a 3 or 12 month PPC will be advised to wait until that expires before purchasing the HRT PPC as refunds for the general or standard PPC will not be granted on the basis that the HRT PPC has been purchased.

In England a broad range of NHS prescription charge exemptions are in place to help those with the greatest need. These measures include a variety of charge exemptions and eligibility for these is based on whether people are in receipt of certain qualifying benefits or tax credits, whether they are pregnant or have recently had a baby, their age, whether they are in qualifying full-time education, whether they are in receipt of a war pension or have a qualifying medical condition. People who are already covered by an exemption will not need to purchase the HRT PPC, as these prescription items will continue to be supplied for free under their existing exemption.

The existing prescription charge exemptions already in place mean that in 2022 approximately 60% of HRT patients are exempt from charges, the remaining 40% of patients must pay a single or double prescription charge, depending on how many medicines are prescribed, individually or within a combination pack each time they have their prescription dispensed, which could be several times a year. The option to purchase a PPC specifically to reduce the cost of HRT medication prescribed for the treatment of menopause allows patients more choice in deciding which product they feel is most appropriate for them, whether that be the HRT PPC, a standard PPC or paying the single charge.

The proposed policy will allow any patient requiring listed HRT prescription items dispensed in the community to reduce their HRT prescription charge expenditure annually to the cost of 2 applicable prescription charges by purchasing the HRT PPC. The HRT PPC will be valid for 12 months and will cover all of the HRT items they require during its validity, provided the items are within scope for free supply under the HRT PPC scheme (see the ‘HRT products’ section, below).

The items that will be covered by the HRT PPC will be identified as those with a licensed indication which includes “for treatment of the menopause”. A full list of items will be published in Part XVI of the Drug Tariff, and be included in guidance for patients, prescribers, GPs and other healthcare practitioners. This list will be updated as new products are granted licences for HRT for the menopause, or any other changes, for example, a change of product name.

The following regulations will be amended to implement the HRT PPC:

• The NHS Charges (Drugs and Appliances) Regulations 2015
• The National Health Service (General Medical Services Contracts) Regulations 2015
• The National Health Service (Personal Medical Services Agreements) Regulations 2015
• The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Eligibility

The policy will allow any person who wishes to reduce their annual HRT prescription charges to purchase the HRT PPC, which will be a benefit for patients who are not exempt and who therefore are liable to pay the applicable prescription charge for their prescriptions. Information about eligibility for help with health costs (including free NHS prescription items) and an online exemption checker tool to enable patients to check their eligibility for free prescriptions before they purchase a PPC or pay the prescription charge before their items are dispensed, is available on the NHSBSA website.

Currently, around 1.3 million patients are issued with HRT prescriptions each year. Around 300,000 patients are expected to benefit from the HRT PPC, either by saving on single charges or by switching from a 3 or 12 month PPC to a cheaper HRT PPC once their 3 or 12 month PPC has expired.

Many of these patients will then have to pay separate charges for prescriptions not related to HRT, alongside their HRT PPC cost. However, this is expected to still be cheaper on average for many patients than purchasing a standard PPC (saving £30 on average).

The cost of the HRT PPC is being set at twice the applicable single item prescription charge and could save patients money on their prescription charges, especially if they are not on a settled HRT treatment or receive their prescriptions monthly. Patients could also save money if they only use a 3 or 12 month PPC to partly or solely cover the cost of their HRT medicines.

If a patient currently holds a 3 or 12 month PPC following the introduction of the HRT PPC, they will be advised to allow this to expire before they purchase the HRT PPC as refunds will be unavailable in these circumstances.

Statutory duties

The public sector equality duty (PSED)

The Secretary of State must have regard to the need to reduce inequalities between the people in England with respect to the benefits that may be obtained by them from the health service.

The department is committed to equal treatment and equality of opportunity and the PSED, set out in Section 149 of the Equality Act 2010 set out below. The PSED (also known as the ‘general duty’) is a key lever for ensuring that public bodies take into account equality when conducting their day-to-day work in shaping policy and delivering services. Under Section 149, set out below, public bodies are required to consider the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations when making policy decisions and delivering services.

Section 149 of the PSED

1. A public authority must, in the exercise of its functions, have due regard to the need to:

• eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under this Act
• advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it
• foster good relations between persons who share a relevant protected characteristic and persons who do not share it

2. A person who is not a public authority but who exercises public functions must, in the exercise of those functions, have due regard to the matters mentioned in subsection (1), above.

3. Having due regard to the need to advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it involves having due regard, in particular, to the need to:

• (a) remove or minimise disadvantages suffered by persons who share a relevant protected characteristic that are connected to that characteristic
• (b) take steps to meet the needs of persons who share a relevant protected characteristic that are different from the needs of persons who do not share it
• (c) encourage persons who share a relevant protected characteristic to participate in public life or in any other activity in which participation by such persons is disproportionately low

4. The steps involved in meeting the needs of disabled persons that are different from the needs of persons who are not disabled include, in particular, steps to take account of disabled persons’ disabilities.

5. Having due regard to the need to foster good relations between persons who share a relevant protected characteristic and persons who do not share it involves having due regard, in particular, to the need to:

• tackle prejudice
• promote understanding

6. Compliance with the duties in this section may involve treating some persons more favourably than others; but that is not to be taken as permitting conduct that would otherwise be prohibited by or under this Act.

7. The relevant protected characteristics are

• age
• disability
• gender reassignment
• pregnancy and maternity
• race
• religion or belief
• sex
• sexual orientation

8. A reference to conduct that is prohibited by or under this Act includes a reference to:

• a breach of an equality clause or rule
• a breach of a non-discrimination rule

Officials have considered the implications for each of the 3 equality objectives in relation to the proposals for introducing a reduced cost HRT PPC. Overall, our view is that patients will benefit through reduced prescription costs, especially if they are trialling different HRT treatments, or if they are obtaining 3 or more HRT items per year.

Secretary of State’s duties under the National Health Service Act 2006

The National Health Service Act 2006 (NHSA) contains a number of overarching duties that are imposed on the Secretary of State for Health which apply to every action undertaken in relation to the NHS and public health. The following duties appear to be engaged in relation to the proposals being analysed in this Equality Assessment. These are:

• the duty to continue to promote a comprehensive health service in England (section 1)
• the duty as to improvement in quality of services (section 1A)
• the duty as to reducing inequalities (section 1C)

Duty to continue the promotion in England of a comprehensive health service (section 1)

This duty requires the Secretary of State to continue the promotion in England of a comprehensive health service designed to secure improvement:

• in the physical and mental health of the people of England
• in the prevention, diagnosis and treatment of physical and mental illness

Duty as to improvement in quality of services (section 1A)

The Secretary of State must exercise the functions of the Secretary of State in relation to the health service with a view to securing the continuous improvement in the quality of services provided to individuals for or in connection with:

• the prevention, diagnosis or treatment of illness
• the protection or improvement of public health

In relation to this duty, and the section 1 duty to continue to promote a comprehensive health service in England, our view is that this policy will enable ministers to discharge these duties as it is intended to increase access to HRT for a wider group of patients and to help patients to manage their HRT symptoms, as they will be able to benefit from reduced prescription costs by purchasing an annual HRT PPC.

Duty as to reducing inequalities (section 1C)

In exercising functions in relation to the health service, the Secretary of State must have regard to the need to reduce inequalities between the people of England with respect to the benefits that they can obtain from the health service.

It is important to emphasise that this duty is separate from the PSED duty and is about a need to reduce inequalities that may or may not be based on protected characteristics. Socio-economic impacts need therefore to be considered in terms of other socio-economic factors such as income, social deprivation and rural isolation. We have considered the various impacts of the proposals on different groups of people in this analysis. Socio-economic issues are dealt with in the section ‘Socio-economic disadvantage’ below.

The Family Test

The Family Test was designed to complement the existing work of departments to consider the 3 aims of the public sector equality duty (PSED).

Applying the Family Test when developing policy and complying with the PSED should lead to better overall outcomes for people. The test seeks to ensure that during the development of policy, particular attention is paid to its impact on supporting families and relationships:

• couple relationships (including same sex couples) including marriage, civil partnership, co-habitation and couples not living together
• relationships in lone parent families, including relations between the parent and children with a non-resident parent, and with extended family
• parent and step-parent to child relationships
• relationship with foster children and adopted children
• sibling relationships
• children’s relationships with their grandparents
• relatives or friends looking after children unable to live with their parents
• extended families, particularly where they are playing a role in raising children or caring for older or disabled family members

The 5 Family Test questions are:

• What kind of impact might the policy have on family formation?
• What kind of impact will the policy have on families going through key transitions such as becoming parents, getting married, fostering or adopting, bereavement, redundancy, new caring responsibilities or the onset of a long-term condition?
• What impacts will the policy have on all family members’ ability to play a full role in family life, including with respect to parenting and other caring responsibilities?
• How does the policy impact families before, during and after couple separation?
• How does the policy impact those families most at risk of deterioration of relationship quality and breakdown?

Analysis of equality impacts

A full cost impact assessment has been published alongside this equality analysis which explores the health and other impacts. The key equality issues are summarised below.

The policy change overall will be a positive benefit for those impacted, and the most vulnerable patients currently do not have to pay for their prescriptions if they qualify for free prescriptions on one of the various grounds of exemption. A patient requiring HRT may also be exempt under another exemption (see Annex A).

It is important to identify any potential negative impact in relation to patient’s accessing their prescriptions, which may affect some groups of individuals disproportionately. People at the very bottom of the income distribution should be protected from paying prescription charges due to receiving income related benefits that qualify for a prescription charge exemption or via the NHS Low Income Scheme (NHS LIS). However, there will be people who are just above qualifying for income-related benefits and for Help with Health Costs under the NHS LIS. These people must pay for their prescriptions, but they could potentially benefit from being able to reduce their HRT prescription charges. Comprehensive promotion of, and communication about, the HRT PPC will be essential to ensure that all eligible patients are aware of the introduction of the HRT PPC, and are able to benefit from it, particularly those who are at the lower end of the income distribution scale but who do not qualify for another exemption.

Disability

People with long-term conditions or a disability requiring medicines not covered by an existing exemption and who currently pay for their prescriptions are unlikely to benefit from the HRT PPC as they will also have other regular prescriptions likely to total more than £89.40 per year. A 3 or 12 month PPC will remain available as a cost-effective solution for those who require other medicines as well as HRT. We have considered that prioritising treatments for menopause in this way may potentially have a detrimental impact on fostering good relations between people who have a protected characteristic and those who do not. We recognise this risk and have taken into account the potential impact on good relations. Nevertheless, we think it is important to make this change given the overall positive benefit of the proposal for those impacted. We think the case in relation to other medical conditions and other groups should be considered on their own merits.

Sex

Women will experience the menopause at some stage in their life, so this policy will be an overall benefit for those women who currently pay for their prescriptions to reduce their annual HRT charges. This policy change may encourage more women to seek support from their GP or other healthcare practitioner for their menopausal symptoms. Sex is a protected characteristic under the PSED. The HRT PPC will be an overall benefit for women experiencing menopause symptoms, but we are not taking similar steps in relation to men experiencing problems with the male menopause (‘andropause’) as hormone treatment for this condition is out of scope for the HRT PPC. We have carefully considered this differential treatment and consider that any indirect discrimination in relation to men being prescribed treatments for male menopause can be justified. This is on the basis that the introduction of the HRT PPC is proportionate to the legitimate aim being achieved of ensuring that a greater number of people can access HRT medicines for menopausal symptoms at a reduced cost where they are not otherwise eligible for exemption from prescription charges.

Anyone can purchase the HRT PPC on their own or on another person’s behalf. The policy intention is that the HRT PPC is intended to apply to treatments for menopausal symptoms, more likely to be prescribed for women, but anyone who is prescribed qualifying HRT medicines for any reason, not just menopause symptoms, could benefit from the HRT PPC. People with conditions that require hormone treatments not licensed as being for menopause are therefore unlikely to have any incentive to apply for the HRT PPC or to benefit from its introduction. The department will ensure that information and guidance about what HRT medicines can be supplied under the HRT PPC scheme is widely available to the public and to healthcare professionals. This will ensure that people buying the HRT PPC are clear as to whether or not it will benefit them, and that healthcare professionals can clearly advise their patients about this. It is important that those patients receiving HRT treatment for menopause-related conditions are aware that they are eligible for this PPC; and that those receiving hormone treatments not listed for menopause, or other non-hormone treatments for menopause symptoms, receive sufficient information about other options available to them that could help them to manage costs.

Gender reassignment

Anyone can purchase the HRT PPC either on their own or on someone else’s behalf, including people who have undergone gender reassignment, or who are currently transitioning, to cover the costs of some hormone therapies they may be prescribed. This is likely to apply to any trans women who are taking feminising hormones, as these are likely to be on the list of medicines mentioned above that are licensed for treatment of the menopause. Prescriptions do not contain information about why a treatment has been prescribed so the arrangements will benefit anyone who is prescribed an item that is within scope of the HRT PPC. However, masculinising hormones (such as testosterone) will not be available for reduced charges under the HRT PPC scheme as they are not licensed in the UK for the treatment of menopause. The government has taken the decision to restrict eligibility for the HRT PPC to licensed medicines for the treatment of menopause as part of the Womens’ Health Strategy. More about the definition of products in scope for the HRT PPC can be found in the ‘HRT products’ section, below. As such, trans men who are seeking masculinising treatments will not be able to benefit from the scheme. This means the scheme will benefit trans women to a greater extent than trans men.

Trans men who have not medically transitioned and who are prescribed HRT for menopausal symptoms could benefit from the introduction of the HRT PPC. We have carefully considered this differential impact and consider that any indirect discrimination in relation to trans men can be justified on the basis that it is proportionate to the legitimate aim being achieved of ensuring that a greater number of people can access HRT medicines for treatment of menopausal symptoms at a reduced cost where they are not otherwise eligible for exemption from prescription charges.

Sexual orientation

The reduction to HRT prescription costs will be available to, and will be an overall benefit for, all patients who are potentially impacted by the implementation of the HRT PPC scheme, regardless of their sexual orientation.

Race

Addressing racial inequalities is about identifying any ethnic group that experiences inequalities. Race and ethnicity includes people from any ethnic group including BME communities, non-English speakers, Gypsy Roma and Traveller people and others who experience inequalities so includes addressing the needs of black or minority ethnic communities but is not limited to addressing their needs, it is equally important to recognise the needs of white groups that experience inequalities. The Equality Act 2010 also prohibits discrimination on the basis of nationality and ethnic or national origins, issues related to national origin and nationality.

The proposed reduction to HRT prescription charges will be available to all people regardless of their race or ethnicity.

Age

The menopause is more common in women aged 40 and above. However, some women can enter early menopause naturally, and women may also enter early menopause, for example following surgery or other medical treatments, such as treatments for some types of cancers. People can also be prescribed qualifying HRT medicines for reasons other than menopause and may require these at any age. The reduction to HRT prescription charges can apply to and can potentially be an overall benefit for people of all age groups, although those aged 60 and over will be exempt from all prescription charges on the grounds of their age, and so would not need to purchase the HRT PPC.

Religion or belief

People with religions or beliefs, or no religion will not be affected any differently to other patient groups as the reduction to HRT prescription costs will be available to all. The HRT PPC will therefore be of overall benefit to all those eligible to apply (by virtue of being prescribed listed HRT medicines), regardless of religion, or religious beliefs.

Pregnancy and maternity

People who are pregnant or people who have given birth are entitled to exemption from prescription charges under current provision, until the child’s first birthday, so they would not be required to pay for their prescriptions during that time.

Marriage and civil partnership

People who are married or in a civil partnership will not be affected any differently to other patient groups by the implementation of the HRT PPC scheme, as the reduction for HRT prescription charges would apply to and will be an overall benefit for all people who are eligible regardless of their marital status.

Families

Family and people living in the same household could be impacted positively by the reduction of HRT prescription costs, as this would save them money if they previously paid for more than 2 HRT items in a year.

As stated previously, the introduction of the HRT PPC scheme will sit alongside the other grounds of exemptions from prescription charges that will remain unchanged. This will potentially be an overall benefit for people in the family relationships mentioned above who do not currently qualify for free prescriptions under current provision. Patients will have the option of choosing to get the HRT PPC to reduce their annual HRT prescription costs. We will however encourage patients to use the NHS Business Services Authority (NHSBSA) exemption checker before committing to purchase the HRT PPC to ensure that they will benefit from the scheme. We consider that enabling wider access to HRT medicines will potentially be an overall benefit for those impacted in the scenarios mentioned above in that it may enable more people to better manage their menopause symptoms, or symptoms of any other conditions requiring treatment with listed HRT medicines, to save money on their HRT medicines and to remain economically active during this period of their life.

Socio-economic disadvantage

To reduce the chance of misunderstanding about the changes and avoid confusion about the PPCs available, we will promote information about the HRT prescription charge reduction to ensure patients make an informed choice as to whether purchasing the HRT PPC will be cost effective for them. We will also work with stakeholder organisations on the promotion of 3 and 12 month PPCs as a cost-effective option for paying for wider prescriptions other than HRT medicines.

Rural communities

HRT PPCs will be available to all patients regardless of where they live. Many patients based in rural communities have GP services provided by dispensing doctors, who provide primary healthcare to around 10.5 million rural patients. Nearly 3.6 million of these patients live remotely from a community pharmacy; at the patient’s request dispensing doctors are allowed to dispense the medicines they prescribe for these patients. In England, online pharmacies are eligible to dispense prescriptions issued via the Electronic Prescription Service (EPS), an NHS service that digitally transfers prescription orders between GPs and pharmacies.

Dispensing doctors are currently unable to use the EPS to order medicines from their practice dispensary due to a gap in the EPS specification. However, patients served by dispensing doctors will be able to take advantage of reduced HRT prescription costs through the purchase of the HRT PPC and utilise this against their HRT items dispensed by their GP.

HRT products

The list of HRT prescription items that will be within scope for supply under the HRT PPC scheme has been provided by the NHSBSA and will be used to identify HRT related prescriptions with a licensed clinical indication to treat symptoms of the menopause. The definition of the scope for items to be included on the list of HRT prescription items has been developed DHSC and other stakeholders and is as follows:

• HRT hormones
• HRT replaces the hormones that a woman’s body no longer produces because of the menopause. The 2 main hormones used in HRT are:
  • oestrogen
  • progestogen

HRT involves either taking both of these hormones (combined HRT) or just taking oestrogen (oestrogen-only HRT). Oestrogen-only HRT is usually only recommended if you have had your womb removed during a hysterectomy.

To be included on the list the product must be HRT as defined above and licensed to treat the symptoms of menopause.

See the NHSBSA website for the definition and the current list of medicines.

This list will be kept under review and amended as and when new products come on the market that are within the definition.

In relation to testosterone, though this is HRT, it is not an HRT that is licensed for the treatment of menopausal symptoms in the UK and therefore these medicines are excluded from the list of medicines that may be supplied for reduced charges under the HRT PPC scheme.

Similarly, medicines that are licensed for treatment of the menopause but do not contain oestrogen or progestogen are excluded from the list of medicines that are within the scope of the HRT PPC scheme.

Summary assessment

The equality impact assessment (EQIA) summarises the equality and health inequalities findings from the policy to develop and implement the HRT PPC.

Everyone has a minimum of 5 characteristics given protection under the Equality Act 2010, and we are conscious that the HRT PPC policy needs to take full account of the needs of groups with different protected characteristics. For example, the person’s choice to purchase the HRT PPC depends on them having received appropriate information to allow them to make an informed decision about whether this PPC is the best value for money option based on their prescription requirements, while ensuring no protected characteristic group is disadvantaged.

Engagement and involvement

There is no statutory requirement to consult on changes to the National Health Service (Charges for Drugs and Appliances) Regulations 2015, but as part of the policy development of the HRT PPC scheme, the DHSC consulted with key stakeholders, listed but not limited to the following organisations:

• Pharmaceutical Services Negotiation Committee (PSNC) - engaged because it is the representative body for community pharmacists
• British Medical Association (BMA) and the General Practitioners Committee (GPC) - engaged because they are the representative body for all GPs in England
• NHS England (NHSE) - engaged because of its expertise in digital solutions and community pharmacies
• NHSE Clinical Reference Group - engaged because of its expertise in menopause treatments
• NHS Business Services Authority (NHSBSA) - leading on the development and implementation of the HRT PPC, liaison with software suppliers and advice and guidance on HRT product list
• HRT suppliers - engaged to manage HRT supply issues

Annex A: current exemptions

See who can get free NHS prescriptions on the NHS website. This page includes information on getting free prescriptions if:

• you’re pregnant or have had a baby in the past 12 months - maternity exemption certificate (MatEx)
• you have certain medical conditions - medical exemption certificate (MedEx)
• you have a low income

See if you are eligible for free NHS prescriptions using the NHSBSA eligibility checker.