The NICE guideline on Long-acting reversible contraception1,2 was published in October 2005 and was closely followed in December 2005 by a report examining the cost impact of implementing the guideline.3 It was estimated by NICE in its national cost-impact report that full implementation of the guideline would produce a net annual saving of £102 million; a PCT with a population of 40,000 women aged between 15 and 49 years could expect to save more than £300,000 annually.3
The guideline from NICE and the National Collaborating Centre for Women’s and Children’s Health defines long-acting reversible contraception (LARC) methods as those that require administration less than once per cycle or month.1,2 They are characterised by having typical and perfect failure rates that are more or less equal.1,4 Failure rates during perfect use reflect how effective these contraceptive methods can be in preventing pregnancy when used consistently and correctly. Failure rates during typical use reflect how effective methods are for the average person who does not always use methods correctly and consistently.
The key recommendations for GPs from NICE are those on effectiveness, training, and on progestogen-only injectable contraceptives.1,2 However, it also gives information on copper intrauterine devices (IUDs) and the intrauterine system (IUS), and subdermal implants. This includes:2
- the IUS and IUDs are highly effective methods of contraception with very low pregnancy rates for the former, and IUDs containing 380 mm2 of copper: fewer than 20 in 1000 over 5 years
- up to 60% of women stop using their device within 5 years; the most common reasons are unacceptable vaginal bleeding and pain
- expulsion occurs in fewer than 1 in 20 women in 5 years
- the risk of ectopic pregnancy is lower than when using no contraception.
Advice from NICE on subdermal implants includes:2
- the pregnancy rate is very low: fewer than 1 in 1000 over 3 years
- the effect on bleeding patterns is variable and remains variable over time
- women over 70 kg can use progestogen-only subdermal implants as an effective method of contraception
- there is no evidence of an effect on bone mineral density (based on one study).
When considering LARC, NICE advises that women should receive detailed information that will enable them to choose a method and use it effectively. This information should take into consideration their individual needs and should include: contraceptive efficacy, duration of use, risks and possible side-effects, non-contraceptive benefits, the procedure for initiation and removal/discontinuation, and when to seek help while using their chosen contraceptive method.
Contraceptive service providers should be aware that:1,2
- the combined contraceptive pill is less cost effective than any of the currently available LARC methods, even if used for 1 year
- IUDs, the IUS, and subdermal implants are more cost-effective than injectable contraceptives
- increased use of LARC methods will have the effect of reducing the number of unintended pregnancies.
Recommendations on training in the NICE guideline are that:1,2
- if LARC is not provided by a patient’s own practice, there should be an agreed mechanism in place to enable contraceptive providers to refer women for this contraceptive method
- healthcare professionals providing IUDs or subdermal contraceptives should receive training to develop and maintain the relevant skills to provide these methods, which includes advising women on risks and benefits of all methods that fit their needs, and being able to manage common side-effects and problems
- IUDs and the IUS should only be fitted by trained personnel with continuing experience of inserting at least one device a month.
The NICE guideline makes several recommendations on injectable LARCs. These include:1,2
- depot medroxyprogesterone acetate (DMPA) is associated with a small loss of bone mineral density (BMD), but much of this is recovered when DMPA use stops
- care should be taken in recommending DMPA to adolescents or women over 40 years of age because of the possible effect on BMD, but it may be given if other methods are unsuitable or unacceptable.
The use of injectables results in very low pregnancy rates: fewer than 4 in 1000 over 2 years. However, disadvantages are the return of fertility may be delayed by as much as 1 year on discontinuation, and use of DMPA may be associated with an increase of up to 2–3 kg in weight over 1 year.1
Excellent training for healthcare professionals responsible for advising and managing patients requiring contraception is available through the Royal College of Obstetricians and Gynaecologists’ Faculty of Sexual & Reproductive Healthcare (FSRH; www.fsrh.org). Theory courses for the Diploma of the Faculty of Sexual and Reproductive Healthcare comprise six modules and are held in all regions of the UK. Practical instruction can take place in a variety of settings and uses a competency-based approach. Once basic training is completed, additional competencies in intrauterine and subdermal-implant techniques can be undertaken.
Community contraception clinics provide 80% of training for all professionals providing contraceptive care.5 In order that professionals may receive training in the future, PCT commissioners need to protect and invest in these clinics. Unfortunately, this has not been the case and there has been lack of investment and even disinvestment in specialist community contraception services.6
Since the publication by NICE of the guideline on Long-acting reversible contraception, the FSRH has published a revised version of its guidance on intrauterine contraception.7 A new recommendation is that certain IUDs with copper sleeves on the side arms may remain in situ for up to 10 years.7
The FSRH will shortly be producing guidance on progestogen-only implants.8 It is surprising that we are still reliant on data for the levonorgestrel implant for some of the guidance for the etonogestrel implant. There has been a study of continuation rates with the etonogestrel implant in a real-life setting rather than a clinical trial. Continuation rates were 75% at 1 year and 59% at 2 years;9 these levels of continuation are far higher than is seen with methods such as the contraceptive pill.10 In one study, almost 50% of pill users changed their method of contraception or used no contraception during an average of 8 months of follow up.10
A systematic review of 32 studies showed that the loss of BMD in DMPA users is generally less than 1 standard deviation, which is not within the osteopenic range.11 There has been much talk about DMPA and osteoporosis but no causal link has been demonstrated. It was noticeable that the guideline from NICE took a less hardline approach on the matter of reduced BMD with DMPA1,2 than the Committee on Safety of Medicines.12 It is salutary to note the adverse effect the regulatory announcement has had on the prescribing of injectable contraceptives (see Figure 1), which has changed from a ten-fold increase in prescription levels between 1991 and 2004, to a 7% fall in prescriptions for injectables between 2004 and 2006.13 This is part of a widespread ‘scare’ effect, which may have resulted in many extra unintended pregnancies, particularly among teenagers.
Another recent systematic review of studies evaluating changes in BMD after discontinuation of DMPA concluded that BMD consistently returned towards or to baseline values following discontinuation of use in women of all ages.14 Patterns of BMD recovery post-DMPA use are similar to those seen after cessation of lactation.14 Several international organisations have published position statements on this subject and not one of them recommends any restriction of initiation or continuation of DMPA to address skeletal health concerns.14 Available evidence does not justify the requirement of a limit to the duration of DMPA use, even in adolescents.14
Figure 1: Prescription cost analysis data for depot medroxyprogesterone acetate and norethisterone enanthate (England)
Prescription data for levonorgestrel and etonogestrel implants show a 62% increase,13 (see Figure 2) reflecting an increasing commitment to insertion of implants in the context of general practice. When combined with the increase of 40% in women attending community clinics and using this method over the same period,15 this illustrates a definite surge in popularity of the implant. How much of this is due to demand from the public or to promotion by health professionals it is difficult to say.
Figure 2: Prescription cost analysis data for levonorgestrel and etonogestrel implants (England)
Data on intrauterine devices are difficult to interpret. Use of the levonorgestrel-releasing intrauterine system continues to increase, but increased use for menorrhagia16 and other non-contraceptive purposes cannot be quantified.
Barriers to implementation
Since publication of the NICE guideline in 2005 there have been some barriers to implementation. These include:
- difficulties for GPs in training to fit IUDs and subdermal implants17
- few PCTs have appraisal processes in place for assessing competence of doctors in contraception17
- a reduction in the number of community contraception clinics for teaching and training healthcare professionals about effective and appropriate contraception methods5
- contraception being a low priority for PCT targets17
- wariness with regard to injectable contraception since the publication of the Committee on Safety of Medicines report.12
One-fifth of responding PCTs in the Department of Health’s 2006 baseline review of contraceptive services reported that they had policies in place that restricted access to LARC methods. These included:18
- capping budgets
- disallowing out-of-area patients
- age limits or parity limits.
A parliamentary survey of PCTs in March 2007 with a low response rate showed that almost 90% of general practices provided injectable contraceptives, approximately 66% provided IUDs, and 30% provided implants.19
General practice provides 80% of contraceptive consultations in the UK20 but the emphasis remains on more user-dependent oral methods. Item of service fees were cut and the QOF attracts only two points for contraception.21 Local Enhanced Services or National Enhanced Services may be employed but this is patchy.
Presenter slides have been produced to accompany the guideline, which include aspects of implementation; these are useful for local meetings on LARC methods. In September 2006, an accompanying local cost template was produced. This provides data so that calculations can be made to illustrate cost savings of implementation in English PCTs.22
In summary, LARC methods now have a higher profile but, in order to attain the shift predicted in the cost-impact document, the proportion of women aged 16–49 years using the IUS needs to double and the proportion using implants to quadruple!23
There still appear to be commissioners who are nervous about the up-front costs of the IUS and subdermal implant, despite the emphatically favourable economic analyses. This seems to be a reflection of persistent inability to take into account medium-term and long-term perspectives when planning health services. It fails to take into account costs that are incurred in obstetric and gynaecology services in connection with miscarriages, abortions, ectopic pregnancies, and antenatal, intrapartum and postpartum care.
There is no evidence that any of the progestogen-only hormonal LARC methods (implant, injectable, and IUS) are associated with an increased risk of stroke, myocardial infarction, or venous thromboembolism. They are therefore suitable for women for whom the combined pill is contraindicated (e.g. in women who have migraine with aura) because it contains oestrogen.
- NICE cost templates predict that greater use of LARC methods would result in savings to PBC budgets
- Savings would appear against secondary care as well as prescribing budgets
- The IUS, IUDs and implants do need specialist training to fit and take more surgery time
- Practices could easily agree local enhanced services schemes with PCTs for the fitting and removal of these devices to encourage more use
- Cost for LARC methods (device only):a
- Injectable DMPA = £6.01 (£24.04 yearly)
- IUS = £83.16 (£16.63 yearly)
- Implant = £81 (£27 yearly)
- National Collaborating Centre for Women’s and Children’s Health. Long-acting reversible contraception. London: Royal College of Obstetricians and Gynaecologists, 2005.
- National Institute for Health and Care Excellence. Long-acting reversible contraception. Clinical Guideline 30. London: NICE, 2005.
- National Institute for Health and Care Excellence. National cost-impact report: implementing the NICE clinical guideline on long-acting reversible contraception. London: NICE, 2005.
- Trussell J. Contraceptive failure in the United States. Contraception 2004; 70 (2): 89–96.
- Kishen M, Belfield T. Contraception in crisis. J Fam Plann Reprod Health Care 2006; 32 (4): 211–212.
- Gould J. Independent Advisory Group on Sexual Health and HIV. Annual Report 2005/2006. London: DH; 2006.
- Faculty of Sexual & Reproductive Healthcare Clinical Effectiveness Unit. Intrauterine contraception. London: FSRH, 2007.
- Faculty of Sexual & Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only implants. London: FSRH; 2008. (In press.)
- Lakha F, Glasier A. Continuation rates of Implanon in the UK: data from an observational study in a clinical setting. Contraception 2006; 74 (4): 287–289.
- Oakley D, Sereika S, Bogue E. Oral contraceptive pill use after an initial visit to a family planning clinic. Family Planning Perspectives 1991; 23: 150–154.
- Curtis K, Martins S. Progestogen-only contraception and bone mineral density: a systematic review. Contraception 2006; 73 (5): 470–487.
- Committee on Safety of Medicines. Updated prescribing advice on the effect of Depo-Provera contraception on bones. 18-11-2004. London: DH, 2004.
- Kaunitz A, Arias R, McClung M. Bone density recovery after depot medroxyprogesterone acetate injectable contraception use. Contraception 2008; 77 (2): 67–76.
- The Information Centre. NHS contraceptive services England 2006–07. London: The Information Centre; 2007.
- National Collaborating Centre for Women’s and Children’s Health. Heavy menstrual bleeding. London: Royal College of Obstetricians and Gynaecologists, 2007.
- Walling M. Long-acting contraception. Update 2006; March: 92–94.
- Department of Health, Sexual Health and HIV Team. Findings of the baseline review of contraceptive services in England. London: DH, 2007.
- All-Party Parliamentary Pro-Choice and Sexual Health Group. A report into the delivery of sexual health services in general practice. London: fpa, FSRH and BASHH, 2007.
- Medical Foundation for AIDS & Sexual Health. Recommended standards for sexual health services. London: MedFASH, 2005.
- British Medical Association. Revisions to the GMS contract 2006–2007: Delivering investment in general practice. London: BMA, 2006.
- Lader D. Contraception and sexual health 2006/07. Newport: Office for National Statistics, 2007.G