Item Number: formal Governing Body Meeting Date of meeting: 18 September /14

Transcription

1 Hastings and Rother CCG Item Number: formal Governing Body Meeting Date of meeting: 18 September /14 Title of report: Prescribing for Clinical Need Policy Recommendation: The Governing Body is recommended to approve the policy for implementation across the CCG. Summary: The CCG operates within finite budgetary constraints hence there is a need to prioritise resources and provide interventions with the greatest proven health gain for the population. Taking into account evidence for clinical effectiveness, safety, cost effectiveness and affordability, the following are considered to provide limited health benefits for the resources they use: Treatments for self-limiting conditions. Treatments where there is insufficient evidence of clinical benefit or costeffectiveness. Preparations where there is not a clinical need to treat. Treatments which fall into these categories are summarised on the Low priority prescribing list (LPRx) and should be considered not suitable for prescribing other than in exceptional circumstances where there is a clear clinical need: All patients should be able to have treatments prescribed for them if they are clinically necessary regardless of their ability to pay. Basing prescribing decisions solely on clinical need removes the influence of socioeconomic factors, such as the patient s ability to purchase treatments if they are not prescribed, and removes any inequity that may arise from applying such judgements. The policy is accompanied by tools intended to help patients understand about the policy and to support prescribers when implementing it. Patients will have the opportunity to feedback regarding the policy to a dedicated medicines management account. The comments received will be used to inform policy review at a later date. Governing Body sponsor: Dr Rob McNeilly, Governing Body GP member Author: Eileen Callaghan, Head of Medicines Management Date of report: 22/08/14 Review by other committees: None. Health impact: This policy is not expected to impact on health outcomes, as patients with a clinical need will still be prescribed the treatments that they require. Financial implications: By reducing prescribing where treatments are not indicated, this policy is likely to deliver annual savings of approximately 260,000 across Eastbourne, Hailsham and Seaford (EHS) and Hastings and Rother (HR) CCGs if fully implemented and will help practices meet their cost containment plans. Legal or compliance implications: None.

2 Link to key objective and/or principal risks: Financial balance, improving quality. Patient and public engagement: The principles of the policy were explored with patients and the public at two shaping health events and also with the critical friends group. The consensus was that NHS spending should be based on evidence and clinical effectiveness and the principles of the policy were well received. Equality Impact Assessment (EIA) completed: Yes. As the primary focus of this policy is prescribing for clinical need, it is applied equally across all protected characteristic groups and has a neutral impact.

3 Prescribing for Clinical Need Policy APPROVED BY: EFFECTIVE FROM: tbc REVIEW DATE: 2 years Eastbourne, Hailsham and Seaford Clinical Commissioning Group 1

4 Version Control Policy Category: Medicines Management Relevant to: GP Members and practice staff Version History Version Date Changes Made: No. 1 09/04/14 Initial version based on policy from other areas drafted by Acute/Interface Specialist Pharmacist. 2 16/04/14 Addition of further information based on output from Medicines Management team meeting. 3 25/05/14 Change in format and addition of explanatory text. 4 29/05/14 Review by Head of Medicines Management - addition of calculated savings. 5 06/06/14 Review by CCG Prescribing leads minor changes to format. 6 04/07/14 Minor changes to format. 7 24/07/14 Discussion with Communications Lead change of name and addition of appendices 2 and /08/14 Discussion with Eastbourne, Hailsham and Seaford prescribing Lead and Communications addition of appendix 1, refinement of appendices 2 and 3. Contents Summary... Error! Bookmark not defined. Policy Rationale... 4 Treatments for self-limiting conditions... 4 Treatments where there is insufficient evidence of clinical benefit and cost effectiveness... Error! Bookmark not defined. Preparations where there is not a clinical need to treat... 5 Appendix 1 The Low Priority Prescribing List... 6 Appendix 2 Template letter for practices... 8 Appendix 3 Information for patients... Error! Bookmark not defined.9 Eastbourne, Hailsham and Seaford Clinical Commissioning Group 2

5 Summary The Governing Bodies of Eastbourne, Hailsham and Seaford (EHS) and Hastings and Rother (HR) CCGs advise that treatments on the Low Priority Prescribing List (LPRx List) should be considered a low priority. Criteria for inclusion on the LPRx List: Treatments used to treat minor ailments which are in nature self-limiting; treatments where there is insufficient evidence of clinical benefit or cost effectiveness; and preparations where there is not a clinical need to treat. Clinicians should prescribe medicines which are known to be clinically effective and provide a health benefit to patients at a cost which is acceptable to the local health economy. Prescribers are asked to consider whether the treatment effect is clinically significant and likely to improve the health status of individual patients. Aids to assist prescribers in implementing this policy are included in the appendices. Patients will have the opportunity to provide feedback regarding the policy to a dedicated medicines management account. The comments received will be used to inform the next review of the policy. Low Priority Prescribing List Treatment Exception Cough Mixtures. Terminally ill patients. Nasal decongestants for hayfever or colds. Emollients and bath/shower products not listed in the East Sussex Health Economy Formulary. Wart treatments. Sexual Health and Genito-Urinary Medicine (GUM). Products for oral hygiene and mouth ulcers. Immunocompromised and terminally ill. Vitamins and Multivitamin preparations. Proven cases of deficiency. Health supplements. Probiotics. VSL#3 for pouchitis (ACBS criteria). Topical antifungals (athletes foot and fungal nails). Antiperspirants. Cold sore treatments. Sunscreens. Rubifacients. Ear wax removers. Gluten free products. Chinese medicines. Homeopathic remedies. Products on the CCGs agreed list for prescribing. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 3

6 Policy Rationale EHS and HR CCGs operate within finite budgetary constraints hence there is a need to prioritise resources and provide interventions with the greatest proven health gain for the population. To this effect, EHS and HR CCGs prioritise resource allocation based on evidence of the clinical effectiveness and safety of treatments, their cost effectiveness and affordability, and on which interventions provide the best health outcomes. In the case of treatments which can be prescribed on NHS prescriptions, the CCGs consider the following treatments to provide limited health benefit for the NHS resources they use hence they should be considered a low priority and not suitable for prescribing unless patients fall into an exception category (see list above) or there are patient specific exceptional circumstances. 1 Treatments for self-limiting conditions Many minor ailments are not of a serious nature and will resolve within a short time-frame without the need for treatment. Products aimed at treating the symptoms of these ailments may not offer value for money and should not be prescribed. Category Examples 2 Cough and cold remedies. Codeine linctus, pholcodine linctus, Simple linctus, pseudoephedrine tablets and liquid, xylometazoline nasal spray, ephedrine nasal drops, menthol and eucalyptus inhalation. Cold sore treatments. Aciclovir cream, Zovirax cold sore cream, Vectavir cold sore cream. Lozenges, gels, throat sprays, Bonjela, Calgel, Corsodyl products, Iglu gel, mouthwashes and gargles. Merocets lozenges, Oraldene products, Rinstead pastilles, Hydrocortisone pellets, Difflam products. Restricting prescribing of treatments for self-limiting conditions could save approximately 30,000 per year across EHS and HR CCGs. Treatments where there is insufficient evidence of clinical benefit or cost-effectiveness Many of the products listed below are not licensed drugs under the Medicines Act. This means that they have not undergone the stringent testing laid down by the regulatory authorities to confirm their safety, quality and efficacy. There is no summary of product characteristics (SPC) for prescribers to consult and hence no indemnity for prescribers should the treatment cause harm. Many of these products are classed as food substitutes and are not covered by ACBS regulations nor do they appear in the current British National Formulary (BNF) or the Drug Tariff. They are often not manufactured to the same high pharmaceutical standards used for licensed medicines hence there is no guarantee of consistency in formulation and potency. These treatments will not have undergone rigorous clinical trials to demonstrate that they are 1 Defined as the patient having clinical circumstances outside the range you would normally see within the patient population with this condition and at the same stage of disease progression. 2 This list is not exhaustive. Any product falling into this category of treatments should be considered as a low priority for prescribing. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 4

7 effective and safe. It is inappropriate to direct NHS resources towards products that do not have proven efficacy or safety in preference to licensed medicines. Category Examples 2 Vitamins and Multivitamin preparations. Sanatogen products, Centrum products, Haliborange products, Lambert s products. Health supplements. Products containing glucosamine, chondroitin, fish oils, co-enzyme Q10, St. John s Wort, Eye-Q products, Icaps, Ocuvite products, Preservision products. Probiotics. VSL#3. Rubifacients. Balmosa, Deep Heat products, Radian B products. Ear wax removers. Cerumol, Exterol, Otex, Waxsol. Chinese herbal medicines. Homeopathic remedies. Restricting prescribing of treatments where there is insufficient evidence of clinical benefit or cost-effectiveness could save approximately 14,000 per year across EHS and HR CCGs. Preparations where there is not a clinical need to treat Within the following categories there are treatments generally accepted to be clinically effective which are also cost effective when used in some patients, but not when used more widely. Also, some categories will contain treatments that are clinically effective but are not considered to be a good use of NHS resources. If prescribing is deemed to be clinically necessary, only those products listed in the East Sussex Health Economy Formulary should be prescribed. Prescribers will be required to consider whether the benefits of prescribing a treatment for an individual patient justify the expense to the NHS. Such judgements should be based purely on clinical factors and should not be influenced by socio-economic aspects such as the patient s ability to purchase the treatment should they wish to do so if it is not prescribed. Category Examples 2 Emollients and bath/shower products not listed in the East Sussex Health Economy E45 products, Allergenics products, Bio-Oil, Elena s products, Flexitol. Formulary. Wart treatments. Bazuka products, Cuplex gel, Salactac gel. Topical antifungals for fungal nail infections. Amorolfine nail lacquer, Curanail, Loceryl. Antiperspirants. Driclor, Odaban, Anhydrol forte. Sunscreens. Barrier creams to prevent nappy rash not listed in the East Sussex Health Economy Formulary. Gluten-free products. Other. Delph products, Sunsense products. Bepanthen, Sudocrem, Conotrane. Rolls, pasta, crackers, biscuits, cake. Cow and Gate Comfort first formula, Milupa Aptamil, fortified puddings, Duraphat products. Restricting prescribing of treatments where there is not a clinical need to treat could save approximately 220,000 per year across EHS and HR CCGs. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 5

8 Appendix 1 Low Priority Prescribing List Treatments for self- limiting conditions Category Examples 3 Exceptions Cough and cold remedies. Cold sore treatments. Lozenges, gels, throat sprays, mouthwashes and gargles. Codeine linctus, pholcodine linctus, Simple linctus, pseudoephedrine tablets and liquid, xylometazoline nasal spray, ephedrine nasal drops, menthol and eucalyptus inhalation. Aciclovir cream, Zovirax cold sore cream, Vectavir cold sore cream. Bonjela, Calgel, Corsodyl products, Iglu gel, Merocets lozenges, Oraldene products, Rinstead pastilles, Hydrocortisone pellets, Difflam products. Cough mixtures for terminally ill. Immunocompromised and terminally ill. Immunocompromised and terminally ill. Treatments where there is insufficient evidence of clinical benefit or cost-effectiveness Category Examples 3 Exceptions Vitamins and Multivitamin preparations. Sanatogen products, Centrum products, Haliborange products, Lambert s products. Health supplements. Products containing glucosamine, chondroitin, fish oils, co-enzyme Q10, St. John s Wort, Eye-Q, Icaps, Ocuvite, Preservision products. Probiotics. VSL#3. VSL#3 for pouchitis (ACBS criteria). Rubifacients. Balmosa, Deep Heat products, Radian B products. Ear wax removers. Cerumol, Exterol, Otex, Waxsol. Olive oil to soften wax prior to microsuction. Chinese herbal medicines. Homeopathic remedies. 3 This list is not exhaustive. Any product falling into this category of treatments should be considered as a low priority for prescribing. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 6

9 Preparations where there is not a clinical need to treat Category Examples 3 Exceptions Emollients and bath/shower products. E45 products, Allergenics products, Bio-Oil, Elena s products, Flexitol. Products listed in the East Sussex Health Economy Formulary. Wart treatments. Bazuka products, Cuplex gel, Sexual Health and GUM. Salactac gel. Topical antifungals for fungal nail infections. Amorolfine nail lacquer, Curanail, Loceryl. Antiperspirants. Driclor, Odaban, Anhydrol forte. Sunscreens. Barrier creams to prevent nappy rash. Delph products, Sunsense products. Bepanthen, Sudocrem, Conotrane. Products listed in the East Sussex Health Economy Formulary. Gluten-free products. Rolls, pasta, crackers, biscuits, cake. Long-life bread: Ener-G, Glutafin, Juvela sliced & unsliced. Fresh bread: Juvela, Glutafin, Genius sliced & unsliced. Flour products: Orgran SR flour, bread mix Innovative solutions: blended, rice, potato, tapioca, teff flours, Xanthan. Other. Cow and Gate Comfort first formula, Milupa Aptamil, fortified puddings, Duraphat products. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 7

10 Appendix 2 Template letter for Practices Dear xxxxxx, I am writing to you as I understand you are unhappy that you will no longer be able to receive prescriptions on the NHS for [insert name of treatment here]. Medicines are an integral part of the health care that many patients rely on to manage their health conditions and over 8 million prescriptions are written by local clinicians every year. At the same time as these medicines, there are thousands of alternative or complementary treatments available on the market that some patients might find help manage their conditions. Local clinicians, together with patient and carers have worked together to agree that only those treatments that are clinically effective and provide a clear health benefit to patients should be prescribed on NHS prescriptions. This is because NHS resources are limited and we need to make sure that we use them wisely. If a treatment meets a patient s clinical need, GPs are able to prescribe it on the NHS. However, if a treatment does not meet a clinical need, if there is not sufficient evidence of clinical benefits or if it is a treatment for conditions that would naturally resolve themselves if untreated, GPs are advised not to prescribe them on NHS prescriptions. Having evaluated your individual circumstances, your GP has concluded that in the case of [insert name of treatment here], this treatment does not meet a clinical need/ there is insufficient evidence of the clinical benefit of this treatment/your condition would naturally resolve itself without treatment (delete as appropriate). As a result, they are unable to prescribe it for you at this time. If your clinical circumstances or condition changes, your GP will be happy to consider whether a NHS prescription is appropriate in the future. Eastbourne, Hailsham and Seaford Clinical Commissioning Group 8

11 Appendix 3 Prescribing for clinical need policy Information for patients Your doctor has provided you with this information sheet following a conversation you have had regarding prescriptions and their decision to decline your request for a specific treatment. About prescribing in East Sussex Medicines are an integral part of the health care that many patients rely on to manage their health conditions and over eight million prescriptions are written by local clinicians every year. Local clinicians including GPs and hospital doctors as well as many others work to the East Sussex Health Economy Formulary. This tool provides guidance of over 2000 medicines that meet local and national guidance and are encouraged to be prescribed locally. What is the prescribing for clinical need policy? At the same time as these medicines, there are thousands of alternative or complementary treatments available on the market that some patients might find help manage their conditions. In order to provide clear guidance for GPs about which of this extensive range of treatments should be prescribed on NHS prescriptions, local clinical commissioning groups have worked together with GPs, consultants, pharmacists and patients and carers to agree that only those treatments that are clinically effective and provide a clear health benefit to patients should be prescribed on NHS prescriptions. The resulting prescribing for clinical need policy has been adopted by all local GP practices in the area. This policy enables GPs to evaluate whether a treatment meets a patient s clinical need and therefore whether they should prescribe it. What treatments are included in the prescribing for clinical need policy? Many treatments and medicines have a clear evidence base that demonstrates that they are clinically effective and therefore will meet a patient s clinical needs. This includes most medicines prescribed by GPs to treat common conditions such as diabetes, asthma and high blood pressure. What treatments are not included in the prescribing for clinical need policy? Whilst some patients may find other treatments useful, some do not meet clinical needs such as antiperspirants, sunscreens, emollients, wart treatments and some gluten free products and are therefore not included. Other treatments including vitamins, ear wax removers, Chinese herbal medicines or homeopathic remedies do not have sufficient evidence of clinical benefits and are also not included.

12 Finally, treatments for conditions that would naturally resolve themselves if untreated such as cold and cough remedies, cold sore treatments, lozenges mouthwashes and throat sprays are also not included. What happens if a treatment you would like is not included in this policy? If a treatment you would like: Does not meet a clinical need or, does not have sufficient evidence of clinical benefit or, if the condition would naturally resolve itself if untreated. Local GP practices will not prescribe it on an NHS prescription. If you have an exceptional clinical circumstance or if your circumstances or condition changes, your GP will be happy to consider if an NHS prescription may be appropriate in the future. For more information The prescribing for clinical need policy has been agreed by all GP practices in the area. You can view the policy online: If your condition changes please speak to your GP in the first instance. If you would like to share feedback about the prescribing for clinical need policy please leave your comments at: EHSCCG@medicinesqueries@nhs.net