EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
Final shared care agreement for gonadorelin analogues time log
Version Date Author Notes Timescale Draft 1 22/12/1 S Murnion For circulation to consultants in Comments to be 0 the Acute Trusts by the Chief returned to Pharmacists sheila.murnion@suffol kpct.nhs.uk by 23/01/11 Shared Care Agreements to be Complete by 7/2/11 by amended to incorporate the S Murnion consultants feedback
Draft 2 S Murnion Shared Care Agreement to be Document returned by presented at the Acute Trusts 7/9/2011 for inclusion D&Ts in Sept D&T agenda Draft shared care agreement to be presented at the NHS Suffolk D&T S Murnion Paper to be prepared for CPG to present the shared care agreement S Murnion Shared Care document to be sent to LMC for consideration Draft 3 L Taylor Shared Care agreed at IHT MMC on October 2012 L Taylor Shared Care agreed by Suffolk D+T January 2013 L Taylor Shared Care sent to LMC for comment February 2013 L Taylor Shared Care document approved at Clinical Priorities Group May 2013
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
Gonadorelin analogues (buserelin, goserelin, histrelin, leuprorelin& triptorelin)
ESCA: For treatment of prostate cancer
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of gonadorelin analogues for prostate cancer can be shared between the specialist and general practitioner (GP). GPs are invited to participate. If GPs are not confident to undertake these roles, then they are under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug and the GP does not feel confident to do so they should inform the consultant of this as soon as practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with prostate cancer are under regular specialist follow-up, which provides an opportunity to discuss drug therapy.
The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use.
RESPONSIBILITIES and ROLES
Specialist responsibilities Confirm diagnosis and assess patient’s appropriateness for treatment with gonadorelin analogues Discuss benefits and side effects of treatment with the patient. Ask the GP whether he or she is willing to participate in shared care and discuss the agreement with the patient Initiate treatment for flare up if required and request GP to prescribe a gonadorelin analogue. Regularly review the patient’s condition and communicate promptly with the GP when treatment is changed. Monitor response to treatment Advise the GP interval of administration - whether it be monthly, three monthly or six monthly, when to stop treatment, or consult with the specialist Continue regular review of patient as agreed with GP Ensure clear back-up arrangements exist for GPs, including direct telephone numbers for advice and support Report adverse events to the MHRA and GP. www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/index.htm
Primary Care prescribers responsibilities If unwilling to agree to shared care the consultant should be informed as soon as practicable so as not to delay treatment Prescribe the specified gonadorelin analogue at the dose recommended and for the time specified. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment Monitor PSA at regular intervals as specified by secondary care as agreed. Refer to secondary care if the patient has symptoms to suggest local, regional or metastatic progression or if there has been a rise in the PSA. The absolute level and or rate of rise (doubling time) as specified by secondary will indicate when to refer back to secondary care.’ Prescribe anti-androgen where requested by specialist Monitor U&Es and FBC every 6 months. Contact the hospital specialist if potassium or serum creatinine (unless known to have chronic renal failure) are significantly raised and unrelated to diuretic/antihypertensive treatment. Refer back to specialist in the event of deteriorating clinical condition or intolerance occurs. Report adverse events to specialist and MHRA www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/index.htm Stop treatment on advice of specialist
Patient's role Report any adverse effects to the specialist or GP. Share any concerns in relation to treatment Report to the specialist or GP if he does not have a clear understanding of their treatment.
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
BACK-UP ADVICE AND SUPPORT
Ipswich Hospital Contact details Telephone No. Fax: Specialist doctor Urologists Mr. Robert Brierly 01473 703689 Mr. Gautam Banerjee 01473 703689 Mr Peter Donaldson 01473 703689 Mr George Yardy 01473 703799 Oncologists Dr. Scrase 01473 704908 Dr. R. Venkitaraman 01473 704908 Specialist nurse (for general advice around side effects) 01473 712233 Uro-oncology 01473 712233 Charlotte Etheridge (Macmillan 01473 702773 Urology CNS) Radiotherapy Amanda Ford (Macmillan 01473 704361 Radiotherapy Specialist) Hospital Pharmacy dept 01473 703600 01473 703607
Medicines Information 01473 704431 01473 704433
SUPPORTING INFORMATION Therapeutic review
Dosage and Administration
Prostate cancer: Patients suitable for hormonal manipulation may receive a depot injection every 28 days, or the longer acting depot every 12 weeks as specified by the specialist. For stable patients having long term therapy the 3 monthly or 6 monthly injection is usually recommended. The monthly/28 day gonadorelin analogue preparation is usually recommended for use prior to and with radiotherapy as the 12 weekly/3 monthly preparation may result in patients receiving androgen suppression for months beyond the intended period thereby resulting in unnecessary side-effects. Where the agent is to be continued longer-term as adjuvant therapy it is quite reasonable for the patient to be converted to the longer depot injection but this should be clearly specified. Note that in some cases secondary care will recommend conversion to high dose (150mg) adjuvant oral bicalutamide in view of the superior side-effect profile.
Intermittent Hormones
Intermittent hormone therapy is increasingly advocated in the management of prostate cancer where long term hormones are indicated. In this situation, patients will typically be on monthly depot injects for EIGHT months and then monitored off therapy until such time as the PSA and/or testosterone reaches a predetermined level (as agreed with secondary care) when the depot inject should be re-instituted. It is vital that the potential flare response is averted with anti-androgens at the outset of EACH eight month cycle. The PSA should be monitored at TWO monthly periods whilst the patient is OFF hormonal therapy.
No dosage adjustment is necessary for patients with renal or hepatic impairment, or in the elderly.
Contraindications
Known hypersensitivity to the active substance, to other LHRH analogues, or to any of the excipients of this product. Gonadorelin analogues are not indicated for use in children, as safety and efficacy have not been established in this group of patients.
Cautions
The use of gonadorelin analogues in men at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully, and the patients monitored closely during the first month
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer of therapy. Consideration should be given to the initial use of an anti-androgen at the start of LHRH analogue therapy since this has been reported to prevent the possible sequelae of the initial rise in serum testosterone. Bicalutamide 50mg once daily is the preferred anti-androgen to be utilized for a minimum of THREE days prior to the first depot implant and preferably TWO weeks prior and certainly for TWO weeks after the first depot injection only unless secondary care have advised continuation of the anti-androgen to achieve sustained total androgen blockade. Cyproterone acetate 100mgTDS may also be used but is absolutely contra-indicated in a patient with a history of liver disease.
If spinal cord compression or renal impairment due to ureteric obstruction are present or develop, specific standard treatment of these complications should be instituted.
Side Effects
General Rare incidences of hypersensitivity reactions, which may include some manifestations of anaphylaxis, have been reported. If this occurs treatment should be stopped. Arthralgia has been reported. Non-specific paraesthesias have been reported. Skin rashes have been reported which are generally mild, often regressing without discontinuation of therapy. Changes in blood pressure, manifest as hypotension or hypertension, have been occasionally observed in patients administered Goserelin. The changes are usually transient, resolving either during continued therapy or after cessation of therapy with Goserelin. Rarely, such changes have been sufficient to require medical intervention including withdrawal of treatment from Goserelin. As with other agents in this class, very rare cases of pituitary apoplexy have been reported following initial administration. Occasional local reactions include mild bruising at the subcutaneous injection site.
Pharmacological effects in men include hot flushes and sweating and a decrease in libido, seldom requiring withdrawal of therapy. Breast swelling and tenderness have been noted infrequently. Initially, prostate cancer patients may experience a temporary increase in bone pain, which can be managed symptomatically. Isolated cases of ureteric obstruction and spinal cord compression have been recorded. The use of LHRH agonists in men may cause a loss of bone mineral density.
All suspected reactions (including those considered not to be serious and even where the causal link is uncertain) should be reported to the MHRA www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/index.htm
Monitoring undertaken by the specialist in prostate cancer:
Clinical response to therapy, e.g. bone pain and performance status. Baseline FBC & U&Es, including LFTs & prostate-specific antigen (PSA) Radiology and radioisotopes (MRI scans of abdomen and pelvis and bone scans may be performed)*
* these tests will be performed at diagnosis if appropriate and subsequently if indicated by specialists
Drug Interactions None known.
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
Costs
Gonadorelin analogue Strength Cost per Frequency of Cost per vial* administration 4 weeks* Goserelin (Zoladex®) 3.6mg £65 4 weekly £65
Leuprorelin (Prostap® SR DCS) 3.75mg £75.24 monthly £69
Triptorelin (Decapeptyl® SR) 3mg £69 4 weekly £69
Triptorelin (Gonapeptyl Depot®) 3.75mg £81.69 4 weekly £82
Goserelin (Zoladex® LA) 10.8mg £235 12 weekly £78
Leuprorelin (Prostap® 3 DCS) 11.25mg £225.72 3 monthly £69
Triptorelin (Decapeptyl® SR) 11.25mg £207 3 monthly £64
Triptorelin (Decapeptyl® SR) 22.5mg £414 6 monthly £64
Histrelin (Vantas®) 50mg £990 Annually £76
*Prices from BNF 64, September 2012
References SPC http://www.medicines.org.uk/EMC/searchresults.aspx?term=goserelin&searchtype=QuickSearch http://www.medicines.org.uk/EMC/searchresults.aspx?term=histrelin&searchtype=QuickSearch http://www.medicines.org.uk/EMC/searchresults.aspx?term=leuprorelin&searchtype=QuickSearch http://www.medicines.org.uk/EMC/searchresults.aspx?term=triptorelin&searchtype=QuickSearch
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
Zoladex Decapeptyl Prostap Zoladex LA Decapeptyl Prostap Decapeptyl SR 3.6mg SR SR DCS 10.8mg SR 3 DCS 22.5mg 3mg 3.75mg 11.25mg 11.25mg
Frequency of Monthly Monthly Monthly 3 Monthly 3 Monthly 3 Monthly 6 Monthly administration Metastatic prostate cancer Locally advanced prostate cancer Adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer As neo-adjuvant treatment prior to x x x x x radiotherapy in patients with high-risk localised or locally advanced prostate cancer Adjuvant treatment to radical prostatectomy x x x in patients with locally advanced prostate cancer at high risk of disease progression
Produced by – Sheila Murnion, Pharmacist and updated in 2012/13 by Lois Taylor, Pharmacist, Ipswich and East Suffolk CCG
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption. EFFECTIVE SHARED CARE AGREEMENT for gonadorelin analogues for the treatment of prostate cancer
Agreed wording for consultants at IHT to use in their letter to the GP requesting participation in the shared care agreement.
We hope that you will consider prescribing and administering the Gonadorelin (LHRH) analogue on the basis of participation within the shared care agreement. If you have any concerns with this arrangement, then please would you contact us as soon as possible (Mr Banerjee/Mr Brierly/Mr Donaldson/Mr Kapasi telephone 01473 703799 or fax 01473 ...... ).
The Clinical Commissioning Group’s preference for patients on hormonal therapy alone is Decapeptyl, this is based on cost-effectiveness. We are happy to support this on the basis that there is no evidence of difference in efficacy between the LHRH analogues. Patients who are receiving hormonal therapy prior to radiotherapy are not included.
Bicalutamide and 12 weekly Gonadorelin (LHRH) analogue therapy:
We have dispensed a 28 day course of Bicalutamide 150mg od from clinic today. Please could this patient receive a Gonadorelin (LHRH) analogue within the next 7-14 days: Intramuscular injection Decapeptyl 11.25mg (CCG preferred choice) Subcutaneous implant Zoladex 10.8mg Subcutaneous injection Prostap 11.25 mg We have asked the patient to contact your team to arrange this with you or the Practice Nurse. The patient is aware that the full course of Bicalutamide must be completed (at least 7 days before the LHRH and 14 days after the LHRH is administered to avoid tumour flare).
Subsequent injections will then be due every twelve weeks and we will review the patient in clinic in 3-4 months with a repeat PSA. There is an option to offer patients a 6-monthly Decapeptyl injection (22.5mg dose) at the 3 monthly review when PSA is stabilised.
Bicalutamide and monthly Gonadorelin (LHRH) analogue therapy:
We have dispensed a 28 day course of Bicalutamide 150mg od from clinic today. Please could this patient receive a Gonadorelin (LHRH) analogue within the next 7-14 days: Intramuscular injection Decapeptyl 3mg Subcutaneous implant Zoladex 3.6mg Subcutaneous injection Prostap 3.75 mg We have asked the patient to contact your team to arrange this with you or the Practice Nurse. The patient is aware that the full course of Bicalutamide must be completed (at least 7 days before the LHRH and 14 days after the LHRH is administered to avoid tumour flare).
Subsequent injections will then be due every four weeks (Zoladex) or one month (Decapeptyl and Prostap) and we will review the patient in clinic in 3-4 months with a repeat PSA.
This ESCA should be read in conjunction with the Summary of Products Characteristics (SPC)
Original template developed by MTRAC in January 2004 for local adaptation and adoption.