TRUST BOARD - WEDNESDAY 28 JANUARY 2009 POLICIES FOR THE COMMISSIONING OF APPROPRIATE, EFFECTIVE AND PRIORITY HEALTH CARE: PROPOSED AMENDMENTS

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1 TRUST BOARD - WEDNESDAY 28 JANUARY 2009 AGENDA ITEM NO. 18 POLICIES FOR THE COMMISSIONING OF APPROPRIATE, EFFECTIVE AND PRIORITY HEALTH CARE: PROPOSED AMENDMENTS 1. INTRODUCTION 1.1 The PCT adopted the above suite of policies in November The policies are available on the PCT website and the suite comprises of 24 policies, including a general policy. The policies confirm that the PCT may consider issues of appropriateness, effectiveness and priority when commissioning services. 2. CONTEXT 2.1 The Commissioning Group has recently reviewed a number of the policies and this paper proposes amendments, additions and deletions to these policies and details the rationale for this. 3. POLICY 5: POLICY FOR THE COMMISSIONING OF COSMETIC PROCEDURES 3.1 The Policy for the Commissioning of Cosmetic Procedures was amended by the Board in January Based on the experience of applying the policy in practice, it is proposed that a number of minor amendments are made to the policy for specific procedures. 3.2 Female Breast Reduction (Reduction Mammoplasty) An abstract of the current policy is shown below: Breast Reduction Surgery is an effective intervention that should be available on the NHS if the following circumstances are met: The patient is suffering from neck ache, backache and/or intertrigo The wearing of a professionally fitted brassiere has not relieved the symptoms The patient has a body mass index (BMI) of less than 30 kg/m2 Patients should have an initial assessment prior to an appointment with a consultant plastic surgeon to ensure that these criteria are met. At, or following, this assessment, there should be access to a trained bra fitter and where it is available, laser scanning of the thorax should be considered. Breast reduction places considerable demand on NHS resources (volume of cases and length of surgery) and yet has been shown to be a highly effective health intervention. There is published evidence showing that most women seeking breast reduction are not wearing a bra of the correct size and that a well fitted bra can sometimes alleviate the symptoms that are troubling the patient. Recent evidence has shown that not all commercial bra fitters meet the required standards and so commissioners will need to satisfy themselves that a suitable service is available.

2 The upper limit of normal BMI is 25 Kg/m2. Patients seeking breast reduction have physical restrictions on their ability to exercise and additional weight in their excess breast tissue (sometimes 3-4 Kg). Major complications for surgery in general and specifically related to breast reduction surgery have been shown to be greater if the BMI exceeds 30. Despite a higher complication rate, obese patients generally benefit from breast reduction. Local policies will need to consider both these factors in setting a BMI threshold for inclusion. It is proposed that an addition to the wording is adopted so that the first bullet point reads as follows: The patient is suffering from persisting, disabling neck/upper back pain despite standard treatment with analgesics/anti-inflammatory medication and a recognised course of physiotherapy/manipulative therapy and/or intertrigo. 3.3 Male Breast Reduction for Gynaecomastia An abstract of the current policy is shown below: Surgery to correct gynaecomastia is allowable if the patient is: Post pubertal and of normal BMI (<= 25 Kg/m2) There should be a pathway established to ensure that appropriate screening for endocrinological and drug related causes and/or psychological distress occurs prior to consultation with a plastic surgeon. Liposuction may form part of the treatment plan for this condition. Commonly gynaecomastia is seen during puberty and may correct once the postpubertal fat distribution is complete if the patient has a normal BMI. It may be unilateral or bilateral. Rarely it may be caused by an underlying endocrine abnormality or a drug related cause including the abuse of anabolic steroids. It is important that male breast cancer is not mistaken for gynaecomastia and, if there is any doubt, an urgent consultation with an appropriate specialist should be obtained. It is proposed that an addition to the wording is adopted so that the first sentence reads as follows: Surgery to correct significant gynaecomastia is allowable if the patient is 3.4 Tummy tuck (apronectomy or abdominoplasty) An abstract of the current policy for apronectomy or abdominoplasty is shown below: Abdominoplasty and apronectomy may be offered to the following groups of patients who should have achieved a stable BMI between 18 and 27 Kg/m2 and be suffering from severe functional problems: Those with scarring following trauma or previous abdominal surgery Those who are undergoing treatment for morbid obesity and have excessive abdominal skin folds 2

3 Previously obese patients who have achieved significant weight loss and have maintained their weight loss for at least two years Where it is required as part of abdominal hernia correction or other abdominal wall surgery Severe Functional problems include: Recurrent intertrigo beneath the skin fold Experiencing severe difficulties with daily living i.e. Ambulatory restrictions Where previous post trauma or surgical scarring (Usually midline vertical, or multiple) leads to very poor appearance and results in disabling psychological distress or risk of infection Problems associated with poorly fitting stoma bags. Excessive abdominal skin folds may occur following weight loss in the previously obese patient and can cause significant functional difficulty. There are many obese patients who do not meet the definition of morbid obesity (see glossary) but whose weight loss is significant enough to create these difficulties. These types of procedures, which may be combined with limited liposuction, can be used to correct scarring and other abnormalities of the anterior abdominal wall and skin. It is important that patients undergoing such procedures have achieved and maintained a stable weight so that the risks of recurrent obesity are reduced. The availability of teams specialising in the surgical treatment of the morbidly obese ( bariatric surgery) is limited, although this may rise with the implementation of NICE guidance in this area. Many patients therefore achieve their weight loss outside such teams and should not be disadvantaged in accessing body contouring The policy which was previously in place allowed for abdominoplasty after pregnancy provided it had been 3 years since the applicant had had their last child. In light of the fact that the current policy provides for procedures to be approved for people who have become overweight through overeating/under-exercising, it could be argued that this should be allowed to be performed on women who are significantly disfigured as a result of pregnancy provided that there are also severe functional problems. With regards obese patients, the current policy includes a time requirement for previously obese patients but not for those undergoing treatment for morbid obesity. It is proposed that these requirements be aligned. 1 Add 5 th bullet point to first paragraph as follows: for the removal of redundant skin, when the problem is seriously disfiguring, and has resulted from previous childbirth. Such cases are unlikely to be authorised until at least three years have elapsed since the birth of the last child. 2 Amend 2 nd bullet point of the first paragraph and add... skin folds and have maintained their weight loss for at least two years. 3.5 Other skin excision for contour e.g. Buttock lift, Thigh lift, Arm lift (brachioplasty) 3

4 Other skin excision for contour e.g. Buttock lift, Thigh lift, Arm lift (brachioplasty)! "#$% Liposuction & '! &() The wording under liposuction is not felt to be sufficiently explicit about what will and will not be commissioned. Panel members have suggested that more definitive guidance would be helpful when considering applications. Delete liposuction section and replace with: Liposuction is not routinely available on the NHS and will only be commissioned in exceptional circumstances. : Liposuction will not be commissioned simply to improve appearance by correcting the distribution of fat. Liposuction may be useful for contouring areas of localised fat atrophy or pathological hypertrophy (e.g. Multiple lipomatosis, lipodystrophies). &( 4. POLICY 17: POLICY FOR THE COMMISSIONING OF SERVICES THAT ARE THE SUBJECT OF GUIDANCE FROM THE NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE The name of this organisation has changed to the National Institute of Health and Clinical Excellence. Amend the wording of this Policy (and any references to NICE in any of the other policies) to reflect the revised name of this organisation as the National Institute of Health and Clinical Excellence. 5. POLICY NUMBER 16: POLICY FOR THE COMMISSIONING OF SERVICES FOR PEOPLE WITH AGE RELATED MACULAR DEGENERATION The National Institute of Health and Clinical Excellence (NICE) has issued national guidance on the commissioning of these services. The suite of policies includes Policy 17; Policy for the Commissioning of Services that are the subject of Guidance from the National Institute for Clinical Excellence. Delete Policy 16. 4

5 6. NEW POLICY: INTERIM COMMISSIONING POLICY ON ORPHAN AND ULTRA ORPHAN DRUGS The North West Specialised Commissioning Group (NWSCG) has recommended that PCTs adopt an interim commissioning policy for orphan and ultra orphan drugs, pending the development of North West specific policies. The policy describes the principles which will be used in considering the commissioning of new treatments for rare or very rare conditions (sometimes referred to as orphan and ultra orphan diseases) in situations where there is no national guidance. Currently, the Department of Health selection criteria for the referral of topics to NICE specifically exclude ultra orphan diseases. Thus, PCTs will not be able to rely on NICE to issue guidance for the NHS in the case of these developments. A PCT must develop its own mechanism for making robust, equitable and defensible commissioning decisions in this area of health care. There are no clear or apparent reasons why the rarity of a disease or condition alone should be sufficient grounds to waive the usual mechanisms for scrutiny and assessment of new interventions. Indeed, to remove consideration of factors such as clinical and cost effectiveness from the assessment of this category of drugs would be to ascribe greater worth to the health of those who suffer from rare diseases than to the health of those with more common conditions. The interim policy is attached at Appendix 1. This also details the rationale for the policy and the review date which has been agreed through NWSCG. 7. RECOMMENDATION The Board is asked to approve the amendments to the following Policies: (i) Policy 5: Commissioning of Cosmetic Procedures o Female Breast Reduction (Reduction Mammoplasty) o Male Breast Reduction for Gynaecomastia o Tummy Tuck (apronectomy or abdominoplasty) o Other skin excision for contour eg Buttock lift, Thigh lift, Arm lift (brachioplasty) and Policy 17: Policy for the Commissioning of Services that are the subject of Guidance from the National Institute for Clinical Excellence (ii) The deletion of the following Policy: Policy 16: Policy for the Commissioning of Services for People with Age Related Macular Degeneration 5

6 (ii) The adoption of the following Policy: New Policy: Interim Commissioning Policy on Orphan and Ultra Orphan Drugs Kevin McGee Director of Commissioning & Performance Jim Gardner Medical Director 22 January

7 Appendix 1 Policy statement 3.1 In the absence of other specific national guidance, NW PCTs / the PCT will make decisions on the commissioning of any new orphan or ultra orphan drug in the same way and using the same principles and processes as are used to decide on any other new technology or intervention. 3.2 The PCT will require orphan and ultra orphan drugs to satisfy assessments such as demonstrable safety and clinical and cost effectiveness, just as these are required of treatments or interventions for more common conditions. This is in line with an ethical commissioning framework that supports consistent decision making across different areas of health care. In this way the residents of the PCT can be sure of fair and reasonable decisions being made on their behalf. 3.3 In assessing orphan and ultra orphan drugs, the PCT acknowledges the European Union legislation relating to the development of treatments of rare conditions and the implications this has for the nature of the research studies that are published. However, these constraints do not mean that the PCT will commission drugs with little proof of clinical effectiveness nor with cost effectiveness estimates that are significantly different to the commonly accepted thresholds that are considered to be an appropriate use of NHS resources Often orphan and ultra orphan drugs are not assessed by NICE or other national bodies. In these circumstances PCTs must make their own decisions on whether to commission an intervention or treatment. It is important that all residents of the PCT are treated fairly when the PCT has to make difficult decisions about funding new treatments. Fair and reasonable decisions can only be ensured when interventions and treatments are all assessed using the same principles and methods Whilst the NWPCTs / PCT recognises that there are real difficulties in producing high quality research trials on orphan and ultra orphan drugs because of the low numbers of patients with rare conditions, this cannot mean that these drugs are commissioned regardless of considerations of their safety, clinical and cost effectiveness. If these drugs were to be funded without satisfactory assessment in these areas, it would mean that the PCT would in effect, be ascribing a greater value to the health of people with rare conditions than those with common conditions. This is because the PCT would be committing their resources to treatments whose outcomes were much less certain and whose costs were significantly higher than would be accepted for common conditions. Generally, in assessing the clinical effectiveness of a new treatment PCTs would expect to see evidence of a significant benefit to patients over and above the standard treatment for the condition and that these benefits were sustained over a reasonable period of time. In the interests of fairness, similar outcomes would be expected of orphan and ultra orphan drugs. In the same way, the cost effectiveness of new treatments for common conditions are assessed against the thresholds used by NICE, namely 20,000 per QUALY compared to the standard treatment or in certain circumstances 30,000 per QUALY. Whilst the PCT acknowledges the need of the manufacturers to recover the development costs of new treatments, in the interests of 7

8 Policy statement 3.4 As is the case with other treatments and interventions that are not routinely offered, in the case of orphan or ultra orphan drugs that the PCT decides are a low priority for funding, the PCT will give careful consideration to any application for the use of such a drug arising from the exceptional circumstances of an individual patient. equity, the PCT cannot support the commissioning of an intervention in which the cost effectiveness is considerably beyond the accepted thresholds for more common conditions. Just as in the case of other interventions that are not routinely offered by the NHS, very rarely it is possible that a patient s particular set of circumstances mean that for them a treatment with an orphan or ultra orphan drug that is not routinely available is likely to be more clinically and cost effective than for the other patients with their condition. In these circumstances the PCT will consider the case carefully in line with its established procedures. 3.5 In the case of an orphan or ultra orphan drug that is not considered appropriate for routine use, the PCT will review its policy in the light of new evidence that may change the previous conclusions. Equally, should evidence emerge that a drug no longer meets its anticipated level of benefit, the PCT will again review its previous decision. The nature of rare conditions means that it is particularly difficult to obtain information on the effect of treatments on large numbers of patients over a long period of time. This means that PCTs have to make decisions on the best available evidence. The PCT will review the decisions it makes on orphan and ultra orphan drugs in the light of new evidence. 8

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