Fertility Treatment Centre

Transcription

1 Fertility Treatment Centre GP Information Pack Welcome to the Fertility Treatment Centre, Croydon University Hospital. We are on Hospital Way (opposite the staff gym).

2 Referrals are via GPs and Consultants. GPs are requested to complete a gynaecology referral; please outline any fertility issues and ensure that relevant investigations, as per Fertility Treatment Centre referral proforma (included), are completed for each referral. The majority of new referrals are seen by our specialist nurses. Investigations prescribed such as HSG, cycle monitoring, seminal fluid analysis and hormone profiling will take place over the period of a few months. Upon completion of these investigations the patient and the partner will be seen again in the clinic by one of the doctors. If IVF is indicated and agreed, an application for funding is put forward. The couple must meet the criteria set out by the PCT before funding application can be made. Please see enclosed funding application forms for your information for Croydon funded patients. Once funding is approved the couple will be offered a mutually agreed appointment to meet with one of the Fertility Nurses for a detailed discussion regarding their proposed treatment. The current waiting time for IVF treatment is approximately 6 months. We are also able to offer treatment on a self-fund basis for those couples who do not meet CCG funding criteria. Contact Details. Lead Nurse: Gaye Ward Consultants: Michael Booker and Emmanuel Ofuasia Associate Specialist: Dr Subha Tel No: Fax No: Opening Hours: 0830 to 1600 Monday to Friday except Bank Holiday

3 Referral Proforma for Croydon GPs

4 530 London Road Croydon CR7 7YE Switchboard Tel: (020) Tel: (020) x4381 Fax: (020) Fertility Clinic Referral Proforma for Croydon GPs. Please complete and attach photocopies of the test results: 1. Man s name and date of birth 2. Woman s name, date of birth and address 3. FSH/LH blood to be taken between day two and five of the menstrual cycle 4. TSH and prolactin 5. Cervical smear 6. Rubella status 7. Full blood count 8. Haemoglobin and electrophoresis (all women) 9. Endocervical swabs for bacteriology and chlamydia 10. Semen Analysis

5 IVF Notification Form

6 Croydon Borough Team NHS CROYDON NOTIFICATION/PRIOR APPROVAL FORM FOR FERTILITY TREATMENT ( ) (4 pages) Please refer to the Effective Commissioning Initiative document for guidance on criteria. If the patient does not meet the South West London criteria but surgery is still required, then authorisation must be given by the Individual Funding/ Exceptional Circumstances Panel (ECP). In these circumstances please complete the appropriate IFR/EC Form. Applicant Details: Applicant (Consultant/GP) Applicant (Consultant/GP) Telephone No: Applicant (Consultant/GP) Patient Details: Initials: Applicant (Trust/GP Practice): Applicant (Consultant/GP) fax no: GP Practice name & Post Code: NHS No: CUH Hospital No (M000 xxxxx) GP Name (if referred by Consultant) M000 DOB: Date of referral from GP (if applicable): IF ALL OF THE CONDITIONS BELOW ARE NOT MET THE REMAINDER OF THE FORM MUST BE COMPLETED FOR CONSIDERATION BY THE EXCEPTIONS PANEL. 1. Have the couples experienced thirty six months of unexplained infertility or have Yes No an identified cause of infertility. 2. Will the patient be 39 or younger at the time of application. (nb treatment, if Yes No approved, should be started within six months of the application.) 3. Is the BMI of the patient between 19-30kg/m 2 and has this been maintained for Yes No the last six months prior to application? 4. Have both partners been non-smokers for at least six months prior to Yes No commencement of treatment? 5. Have the applicants self-funded previous cycles, and if so how many cycles have been funded? (nb previously funded treatments should not exceed TWO). Yes No How many? 6. Do either partner have any living children from this or previous relationships (including adopted children)? 7. Have either partner undergone previous sterilisation? Yes No 8. Do the couple comply with a welfare of the child assessment? Yes No 9. Has the applicant had any previous IVF treatment funded by the NHS? Yes No South West London Effective Commissioning Initiative Updated 1 st April 2012

7 Croydon Borough Team ONLY TO BE COMPLETED IF THE APPLICATION IS FOR FERTILITY TREATMENT OTHER THAN IVF Intervention Requested: (NB: Intervention refers to requested treatment, investigation, etc) Diagnosis (for which intervention is requested): Name of the intervention (for which funding is requested): Clinical reasons why the patient has been unable to conceive if known. If the patient has not experienced 36 months of infertility please give details of how long the patient has been trying to conceive. Summary of previous intervention(s) this patient has received for the condition (drugs etc): * Reasons for stopping may include: Course completed No or poor response Adverse effects/poorly tolerated Dates (Month/ Year) Intervention (e.g.surgery) and by whom Reason for stopping* / Response achieved Anticipated date of procedure (processing a request usually takes up to 2 weeks from the date received by the PCT. If the case is more urgent than this, please state why): Signature:... Print Name:... Date:.... Please return this form to Marion Abbott by fax ( ) or by post (Croydon PCT, 13th Floor Leon House, 233 High Street, Croydon, CR0 9XT)or by directed to cro-pct.referrals@nhs.net South West London Effective Commissioning Initiative Updated 1 st April 2012

8 Croydon Borough Team 1. Duration of subfertility 2. Age of woman at start of treatment cycle 3. Body mass index of woman 4. Smoking status of couple IVF CRITERIA Criteria Couples will be eligible for referral for treatment if they have experienced 36 months of unexplained infertility or have an identified cause of infertility The patient should be 39 or younger at the time of application. (nb treatment, if approved, should be started within six months of the application) kg/m 2, weight to be maintained for the last 6 months prior to application. Both partners should have been nonsmokers for at least six months prior to commencement of treatment. 5. Previous cycles Couples will be eligible for one NHS funded cycle and a maximum of two un-stimulated frozen cycles. The storage cost for frozen embryos for up to three years or a live birth (whichever is sooner) would be paid for by the PCT s. Where couples have self-funded previous cycles, these must not exceed TWO. 6. Childlessness Neither partner must have any living children from this or previous relationships (including adopted children) 7. Sterilisation Treatments will not be available if either partner has undergone previous sterilisation. 8. HFEA Code of Practice Women in same sex couples/ and women not in a partnership Couples must comply to a Welfare of the Child assessment Sub fertility treatment will be funded for women in same sex couples or women not in a partnership if those seeking treatment are demonstrably sub fertile. In the case of women in same sex couples in which only one partner is sub fertile, clinicians should discuss the possibility of the other partner receiving treatment before Rationale 84% of women will conceive within one year of regular unprotected sexual intercourse, this increases to 92% after 2 years and 93% after 3 years The likelihood of a live birth following assisted conception declines with age. Chances of live birth per IVF cycle are: >20% for women aged % for women aged % for women aged 39 years 6% for women aged 40 years and over Higher body mass index reduces the probability of success associated with assisted conception techniques Smoking can adversely affect the success rates of assisted reproductive techniques. The probability of a live birth following the IVF is consistent for the first three cycles but effectiveness of subsequent cycles is uncertain. As funding for assisted conception is limited, priority will be given to couples with the greatest need. Sterilisation is offered as an irreversible method of contraception and individuals on the NHS are made aware of this at the time of the procedure. Human Fertilisation and Embryology (HFE) Act 1990 (as amended) states: Section 13 (5): A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth. Section 2 (1) treatment services means medical, surgical or obstetric services provided... for the purpose of assisting women to carry children. This section was copied from the South Central criteria to ensure equality of access to the service. South West London Effective Commissioning Initiative Updated 1 st April 2012

9 Croydon Borough Team proceeding to interventions involving the sub fertile partner. NHS funding will not be available for access to insemination facilities for fertile women who are part of a same sex partnership or those not in a partnership. In circumstances in which women in a same sex partnership or individuals are eligible for sub fertility treatment, the other criteria for eligibility for sub fertility treatments will also apply. Women in same sex couples and women not in a partnership should have access to professional experts in reproductive medicine to obtain advice on the options available to enable them to proceed along this route if they so wish. References (1) National Institute for Health & Clinical Excellence (NICE) CG11Fertility: assessment and treatment for people with fertility problems, Feb 2004 South West London Effective Commissioning Initiative Updated 1 st April 2012

10 If the patient does not meet the South West London criteria but treatment is still required, then authorisation must be given by the Individual Funding /Exceptional Circumstances Panel. Definition of Exceptionality NHS South West London IFR Policy defines exceptionality as some unusual clinical factor about the patient that suggests that they are: Significantly different to the general population of patients with the condition in question Likely to gain significantly more benefit from the intervention than might be normally expected for the average patient with the condition. Additionally: The fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for an exception. If a patient s clinical condition matches the accepted indications for a treatment that is not funded, their circumstances are not, by definition, exceptional. It is for the requesting clinician (or patient) to make the case for exceptional status. Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

11 Individual Funding Request (IFR) Application Form

12 Case Ref No. (IFR Staff Use Only):.. INDIVIDUAL FUNDING REQUEST (IFR) APPLICATION FORM Please tick or select the corresponding CCG that the patient is registered to: Croydon CCG Kingston CCG Merton CCG Sutton CCG Richmond CCG Wandsworth CCG Bexley CCG Greenwich CCG Lambeth CCG Lewisham CCG Southwark CCG All fields must be completed (or n/a stated where field is not applicable). Incomplete mandatory fields will result in the form being returned and may cause delays to consideration for funding. Anonymity Please ensure that in order to protect patient s identity, apart from Section A, the patient is not referred to by name or initials within the application form. SECTION A: CONTACT INFORMATION 1. NHS Approved Provider Name 2. Address 3. Applicant Details Name: The applicant should have clinical responsibility for this intervention Designation: for this patient for this specific clinical indication. Tel: Please ensure the declaration is signed and dated (Section H) nhs.net address - No other accepted 4. Patient Details Initials: NHS Number: Hospital ID number: DoB: Registered Consultant: Registered GP name: GP practice code: Date of referral: Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

13 Case Ref No. (IFR Staff Use Only):.. SECTION B: INTERVENTION REQUESTED (NB: Intervention refers to requested treatment, investigation, etc) 5. Patient Diagnosis or condition (for which intervention is requested) 6. Do you consider this condition to be rare? If so please state UK prevalence and quote the source/reference 7. Other relevant diagnosis or co-morbidities 8. Details of intervention (for which funding is requested). If the intervention forms part of a drug regimen, please document the full regimen (e.g. Drug X as part of regimen Y (consisting of drug V, drug W, drug X and drug Z). UK prevalence: Name of intervention: Ref: Type of Intervention: Drug Procedure Device Other Planned duration of intervention: (please do not use abbreviations) Dose and frequency of drug: Route of administration of drug: 9. Anticipated start date Clinical Urgency The decision to treat in the event of immediate or lifethreatening circumstances must be made in accordance with NHS Approved Provider (Trust) governance mechanisms. 10. Is requested intervention part of a clinical trial? Your request will be acknowledged within 5 working days of receipt. A funding decision usually takes the CSU up to 4 weeks from the date of receipt of a full & accurately completed application with copies of supporting clinical papers and completion of section I.. Is the case more urgent than this? Yes No If YES please state why If Yes, then STOP HERE. This funding route is not appropriate. Please speak to your Trust Chief Pharmacist for drug trials. There is no need to complete the rest of this proforma. SECTION C: COMPARISON WITH STANDARD COMMISSIONED INTERVENTION 11. (a) What would be the standard intervention / management at this stage? (b) What would be the expected outcome from the standard intervention? (c) What are the patient specific reasons that make the standard intervention inappropriate for this patient? Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

14 Case Ref No. (IFR Staff Use Only):.. SECTION D: CURRENT STATUS OF PATIENT 12. (a) for all conditions Please summarise the current status of the patient in terms of quality of life, symptoms etc including any recognised condition-specific QoL / status scores. (b) In case of intervention for cancer: What is the patient s current clinical severity? Please use standard scoring systems e.g. WHO, DAS28, 6MW, cardiac index or those applicable to the patients clinical diagnosis. Please include interpretation of the score Please indicate whether the intervention is for: -adjuvant / neoadjuvant -1 st line relapse (or metastatic) -2 nd line relapse -Other (please specify) What is the WHO performance status? Or other recognised status/score How advanced is the cancer? (stage) Describe any metastases: SECTION E: PREVIOUS TREATMENT/INTERVENTIONS 13. Summary of previous intervention(s) this patient has received for the condition. * Reasons for stopping may include: Course completed No or poor response Disease progression Adverse effects/poorly tolerated (please detail nature of adverse effect/intolerance) Start Date: Stop Date: Name of Intervention (for drugs include name, dose and frequency of use) Reason for stopping* / Response achieved or indicate if still continuing 14. Has a previous application been submitted on behalf of this patient? SECTION F: EVIDENCE FOR EFFECTIVENESS OF INTERVENTION REQUESTED 15. Is the requested intervention licensed for the requested indication in the UK? 16. Governance Has the Approved NHS Provider approved the requested intervention for use through its recognised clinical governance arrangements? Drugs- Has the trust Drugs and Therapeutics Committee (DTC) or equivalent approved the requested intervention for use? If No, then STOP HERE. The application requires DTC approval Evidence MUST be supplied e.g. DTC minutes, a letter from the DTC Chairman, if Chairman s action has been taken Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

15 Case Ref No. (IFR Staff Use Only): Evidence It is the applicant s responsibility to provide robust*, relevant and valid evidence to support the use of the intervention in this patient. Medical devices & interventionshas the device/ intervention been approved in accordance with Approved NHS Provider clinical governance arrangements If No, then STOP HERE. The application requires approval Evidence MUST be supplied e.g. meeting minutes where approval was given All relevant evidence should be provided. Give details of national or local guidelines/ recommendations (e.g. NICE, Scottish Medicines Consortium, London (Cancer) New Drugs Group etc) and/or full published papers (rather than abstracts) supporting the use of the requested intervention for this condition, unless the application relates to the use of an intervention in a rare disease. Please include any available data on the use of this treatment by your unit including audits Copies of key references MUST be provided *Hierarchy of Evidence (Taken from NPC Supporting rational local decision-making about medicines (and treatments) Feb 2009) 1. Well-conducted meta-analysis of several, similar, large, well-designed RCTs 2. Large well-designed RCT 3. Meta-analysis of smaller RCTs 4. Case-control and cohort studies 5. Case reports and case series 6. Consensus from expert panels 7. Individual opinion 18. Outcomes (a) What would you consider to be a successful outcome for this intervention in this patient? include details of the parameters you intend to measure (b) How and how frequently will you monitor this? (c) What is the minimum timeframe/course of treatment at which a clinical response can be assessed? (d) What stopping criteria will be used to decide when the intervention is no longer effective? (e) Detail the current status of the patient according to these measures. 19. What are the anticipated adverse effects and potential risks of the intervention for this patient? 20. How do the benefits outweigh the risks? 21. Please confirm that the patient, (or in the case of a minor or vulnerable adult the parent / legal guardian/ carer) has been appraised of the benefits/risks and has consented to the proposed treatment Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

16 Case Ref No. (IFR Staff Use Only):.. SECTION G: STATEMENT OF EXCEPTIONALITY OR RARITY 22. On which basis are you making this request? Exceptional clinical circumstances 23. If exceptionality, please describe why the patient s clinical circumstances are exceptional Give specific information to indicate how this patient is significantly different from the cohort of other patients with the same clinical condition 24. If rarity, please describe why this patient s condition or clinical presentation is so unusual that there is no relevant commissioning arrangement in place 25. How many patients with the same condition or presentation as this patient do you expect to see in the next 12 months? Rarity of condition or presentation SECTION H: APPLICANT S DECLARATION 26. Declaration I declare that this application is complete and accurate and that all necessary supporting information and evidence has been provided on this form (& attachments). 27. Patient Consent I confirm that this Individual Funding Request (IFR) has been discussed in full with the patient (or in the case of a minor or vulnerable adult with the parent / legal guardian/ carer). They are aware that through the submission of this form they are consenting for CCG & CSU staff involved in the preparation, consideration and funding of their case to access confidential clinical information about them including their NHS no. to enable full consideration of this request and payment of invoices. 28. Correspondence and Contact The IFR team will copy the patient into correspondence concerning progress and outcome of their application. If you do not want the patient to be contacted or to receive correspondence please indicate this. Responsible Clinician Name: Signature or confirmation: Patient Signature: Please copy the patient into correspondence. Date: DD/MM/YY SECTION I: COSTS and REVIEW If the application is for a drug, the completed form must be sent to the Trust Chief Pharmacist, for completion of Part A. If the application is for a medical device or other intervention, the completed form must be sent to the Trust Service Manager (or equivalent) for completion of Part B. Part C needs to be completed for both drug and non drug applications by the service manager. PART A DRUG INTERVENTIONS ( to be completed by approved NHS provider Chief Pharmacist) 29. Total Acquisition cost (inc VAT) for duration of treatment being applied for (or annual cost if treatment for longer than year), 30. State the value of any offset costs 31. Please benchmark these costs against London Procurement Prices 32. Application reviewed by Chief Pharmacist or nominated authorised deputy Name: Signature or confirmation: PART B - NON-DRUG INTERVENTIONS ( to be completed by approved NHS provider service manager ) 33. Total Acquisition cost (inc VAT) for duration of treatment being applied for (or annual cost if treatment for longer than one year), 34. State the value of any offset costs Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014

17 Case Ref No. (IFR Staff Use Only): Please benchmark these costs against London Procurement Prices PART C- ALL INTERVENTIONS ( to be completed by approved NHS provider service manager ) 36. Application reviewed by Service Manager or nominated authorised deputy Name: Signature or confirmation: Forward application to the IFR team (via Trust Service Agreements Department or equivalent, if applicable). For SW London CCGs: Croydon, Kingston, Merton, Sutton, Richmond and Wandsworth Forms should be submitted to slcsu.ifrswlondon@nhs.net Tel. enquiries: For SE London CCGs: Lewisham, Bexley, Greenwich, Southwark and Lambeth Forms should be submitted to: slcsu.selifr@nhs.net Tel. enquiries Equality Monitoring Data Equality Monitoring This section is for data monitoring purposes only and will be removed from the application prior to consideration by the IFR Panel. Gender Male Female Not stated Ethnicity White British Irish Any other White background (please specify). Asian or Asian British Indian Pakistani Bangladeshi Any other Asian background (please specify) Other ethnic groups Chinese Language Arabic Bengali Cantonese English Farsi French Gaelic Gujarati Hakka Hindi Korean Mandarin Patois / Creole Not stated Mixed White and Black Caribbean White and Black African White and Asian Any other mixed background (please specify). Black or Black British Caribbean African Any other Black background (please specify) Not stated Polish Portuguese Punjabi Somali Spanish Tamil Turkish Urdu Vietnamese Welsh British Sign Language Any other language (please specify). Amended and approved: Sept 2013 rev 14.1 Review: Sept 2014