Oxford University Hospitals NHS Trust, Oxfordshire Primary Care Trust, Oxfordshire Clinical Commissioning Group and Oxford Health NHS Trust

Transcription

1 Oxford University Hospitals NHS Trust, Oxfordshire Primary Care Trust, Oxfordshire Clinical Commissioning Group and Oxford Health NHS Trust Shared Care Protocol and Information for GPs TERIPARATIDE, rhpth (1-34) (FORSTEO ) This shared care guideline provides the necessary information and guidance for the shared care of adult patients requiring teriparatide rhpth (1-34) (FORSTEO ) therapy Summary NICE technology appraisal guidance 161 Alendronate, etidronate, risedronate, strontium and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008 and amended in January 2010 and January Background Teriparatide is a recombinant form of naturally occurring parathyroid hormone. It stimulates new bone formation i.e. is anabolic and also increases resistance to fracture. Indications Teriparatide is licensed for treatment of osteoporosis; in postmenopausal women and in men at increased risk of fracture, associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture Teriparatide is recommended by NICE in TA 161 as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are either: 1. unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment despite instructions for administration having been followed correctly) or 2. who have a contraindication to or are intolerant of strontium (defined as persistent nausea or diarrhoea either of which warrants discontinuation of treatment) or 3. who have had an unsatisfactory response to treatment with alendronate, risedronate or etidronate (defined as occurring when a woman has another fragility fracture despite adhering to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline. NICE defines a fragility fracture as one sustained as the result of a force equivalent to the force of a fall from a height equal to, or less than, that of an ordinary chair.) AND either: years or older and have a T score of -4.0SD or below or years or older and have a T score of -3.5SD or below plus more than two fractures or 3. who are aged years and have a T score of -4SD or below plus more than two fractures 1

2 Criteria for consideration of teriparatide therapy (All criteria must be met) The attached Teriparatide Baseline Patient Pro-Forma should be completed and copies forwarded to both the Oxfordshire PCT Medicines Management Team and the Patient s GP. i. Post menopausal female ii. Age 55 years or over iii. A) An unsatisfactory response to bisphosphonate therapy, defined as another fragility fracture despite adhering fully to treatment for one year and when there is also evidence of a decline in BMD below the pretreatment baseline. Or B) Intolerant to oral bisphosphonate therapy, defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment and which occurs even though instructions for administration have been correctly followed. Or C) Contraindication or intolerant to strontium, defined as persistent nausea and diarrhoea either of which warrants discontinuation of treatment Or D) Contraindication to or intolerance of denosumab that warrants discontinuation of treatment AND iv. Very high fracture risk, defined as secondary prevention of osteoporotic fragility fractures with: 65 years or older and with a T score of -4.0SD or below or 65 years or older and with a T score of -3.5SD or below plus more than two fractures or years and with a T score of -4SD or below plus more than two fractures For patients over 75 years who have not previously had the BMD measured and who have one or more independent clinical risks for fractures (parental history of hip fracture, alcohol intake of 4 or more units per day, rheumatoid arthritis) or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible, providing they also fulfill criterion iii. v. Patient (patient and carer where needed) consent and able to cope with up to 18 months treatment by daily subcutaneous injection. Prescribing Information / Dose The recommended dose of teriparatide is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. The maximum total duration of treatment with teriparatide under the product license should be 24 months The 24-month course of teriparatide (Forsteo ) should not be repeated over a patient's lifetime. In accordance with NICE Oxfordshire patients should not be treated for more than 18 months unless this has been approved by the Medicines Management Team Patients should receive locally recommended supplemental calcium and vitamin D supplements unless clinician is confident that dietary intake is sufficient Other osteoporosis treatments e.g. alendronate, risedronate and strontium ranelate should not be used concomitantly with teriparatide and should be discontinued. Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies. Advice should be sought from the Osteoporosis Centre if this is considered. 2

3 Administration Teriparatide is supplied as pre-filled disposable pens, each containing 28 doses. The patient (or their carer) must be trained to use the proper injection technique. A new insulin pen injection needle should be used with the pen for every injection. Storage should be at 2-8 C at all times with the pen returned to the refrigerator immediately after use. Training of patient (patient carer) to self administer Training is provided by the specialist home delivery service Adverse effects The Summary of Product Characteristics states; of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event. The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness. Very common ( 1/10) Limb pain Common ( 1/100 to <1/10), palpitations, anaemia, dizziness, headache, sciatica, syncope, vertigo, dyspnoea, nausea, vomiting, hiatus hernia, GORD, increased sweating, muscle cramps, hypercholesterolaemia, hypotension, Fatigue, Chest pain, Asthenia, Mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site, depression In patients suffering from transient orthostatic hypotension or dizziness, these patients should refrain from driving or use of machines until symptoms have subsided. Uncommon ( 1/1,000 to <1/100) Tachycardia, emphysema, haemorrhoids, urinary incontinence, polyuria, micturation urgency, nephrolithiasis, myalgia, arthralgia, back cramp/pain, hypercalcaemia greater than 2.76 mmol/l, hyperuricaemia, injection site erythema and reaction, weight increase and cardiac murmur. Rare ( 1/10,000 to <1/1,000) Renal failure/impairment, hypercalcaemia greater than 3.25 mmol/l, possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral) All adverse effects should be reported to the GP and the consultant for advice. Contra-indications/Cautions: Should not be used in patients with severe renal impairment (egfr < 29 ml/min/1.73m²) Use with caution in patients with moderate renal impairment (egfr ml/min/1.73m²) Hypersensitivity to teriparatide or any of its excipients Pre-existing hypercalcaemia Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget s disease of the bone) Unexplained elevations of alkaline phosphatase Prior radiation therapy to the skeleton Pregnancy and lactation Studies in rabbits have shown reproductive toxicity (please refer to SPC). The potential risk to humans is unknown. Given the indication, teriparatide should not be used during pregnancy or by breast feeding women. Drug interactions Because teriparatide transiently increases serum calcium, it should be used with caution in patients taking digoxin. 3

4 Pre-Treatment Monitoring by Specialist BMD: Pre treatment DXA / Baseline T Score: Needed in order to determine whether patient meets NICE criteria (unless over 75 years as detailed above) Serum Calcium Level: Pre treatment monitoring required Renal Function:: Pre treatment monitoring required (Should not be used in patients with severe renal impairment and in caution in patients with moderate renal impairment) Alkaline phosphatase (Alk Phos): Pre treatment monitoring required (Should not be used in patients with unexplained elevations of alkaline phosphatase) NICE suggests formal assessment of calcium and vitamin D status is not necessary.nice assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and or vitamin D supplementation should be considered In normocalcaemic patients, slight transient elevations of serum calcium have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Routine calcium monitoring during therapy is not required. If any blood samples are taken from a patient, this should be at least 16 hours after the most recent injection. Patient information leaflet Patients should be supplied with an information leaflet from the manufacturer and- the hospital team. NICE also provides an information leaflet about TA 161. Shared Care Responsibilities Shared care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient and accepted by them. Patients should be under regular follow-up which provides an opportunity to discuss drug therapy. a) Aspects of care for which the Hospital Consultant is responsible: At initiation Confirm the patients BMD perform lateral spinal x-rays or MRI scan and check bone biochemistry and PTH. This will also be recorded on the pro-forma (see below) Measurement of BMD using central (hip and or spine) DXA scanning should be used to estimate fracture risk. Exclude contra-indications listed on shared care protocol: This will also be recorded on the pro-forma Ensure the patient understands the nature and complications of drug therapy and their role in reporting adverse effects promptly. Ensure discontinuation of other treatments, especially bisphosphonates Complete patient pro-forma in order to confirm that the patient meets the NICE criteria and that all necessary monitoring and stabilisation has been completed. Send to Oxfordshire Medicines Management Team for prior approval in accordance with the contract and send copy to GP. Register the patient with the specialist home deliver service, sending a copy of the registration from to the Oxfordshire Medicines Management Team and prescribe three months supply of teriparatide on monthly FP10 hospital prescriptions plus calcium and vitamin D, according to status, on a separate FP10 hospital prescription. Contacting GP for shared care In the absence of adverse reactions arrange shared care with the patients GP & PCT at three month review by writing to the GP requesting shared care and outline shared care protocol criteria. Advise GP of the need to continue to prescribe appropriate supplementation unless patient s dietary intake is deemed sufficient. Ensure clinical supervision of the patient is done by follow-up as appropriate: Review the patient between 3 and 18 months, only if required due to their situation changing, adverse drug reactions or compliance issues highlighted by the patient or GP. Provide clear instruction to GP on when therapy needs to be referred back to specialist. Advise the GP when to stop treatment and give advice on any further treatment of osteoporosis. 4

5 Provide written communication directly to GP regarding changes in disease management, drug dose, missed clinic appointments. Be available to give advice and support to GP and patient. At 18 months To follow up patient and assess response to treatment at 18 months by completing a repeat BMD Complete follow up teriparatide patient proforma if desired and send to Oxfordshire Medicines Management Team as an exceptional funding request. Send copy to GP b) Aspects of care for which the GP is responsible: After 3 months of specialist prescribing to prescribe (teriparatide) according to a written protocol. Prescribe calcium and vitamin D supplements if required unless contraindicated. Monitor for adverse effects as detailed above Report any adverse events of teriparatide to the consultant and seek advice if necessary. Stop treatment after 18 months (unless exceptional funding has been agreed) or earlier if advised to do so by the consultant. Advise the Hospital Consultant of any clinical changes where appropriate. c) Aspects of care for which the specialist home delivery service are responsible for: The manufacturers of teriparatide (Forsteo ) operate a specialist home delivery and support service for patients who are prescribed teriparatide injection, provided by Healthcare at Home, in collaboration with Eli Lilly Company Limited: Forsteo Homecare (FHC). On receipt of the patient registration by the specialist home delivery service from the consultant, the specialist home delivery service should confirm funding from the Oxfordshire Medicines Management Team for each individual patient considered to meet the criteria for treatment. The PCT will guarantee funding for all patients that meet the NICE criteria, for up to 18 months treatment. This service provides support for the patient in two main areas: o Delivery of the drug and all items (injection needles etc) to support the use of injections o Training in storage and administration of the drug To contact patient and arrange a convenient time for specialist home deliver service nurse training and teriparatide delivery To provide delivery of the drug and any items to support the use of injections (pen needles and waste disposal facilities monthly for months 1-3 and every 3 months thereafter, ensuring an unbroken cold chain to the patient s home To provide a collection service for clinical and pharmaceutical waste. The specialist home deliver service nurse will train the patient in their own home to administer the drug subcutaneously and provide support until the patient is competent. To monitor compliance for the first 3 months and check for any adverse events. To flag up any issues with hospital clinician. The patient will be able to call the specialist homecare nurse 24 hours a day, or the Forsteo telephone helpline on (Mon-Fri 8am to 6pm) in case of problems or queries. The essential requirements for this service are: 1. All patients will require initial registration with the specialist home care company (Forsteo Homecare (FHC) The consultant will complete the necessary documentation which includes the name and address and telephone number of the patient s GP. A copy of the registration form will be forwarded to the GP and PCT together with a copy of this shared care guideline, after 3 months once the patient has been stabilised. 2. Three hospital FP10 (NC) prescriptions each for one month s supply of teriparatide are sent by post with the registration form to FHC. 5

6 3. The Pharmacist at Healthcare at Home will ensure legal validation and will clinically check the information provided. Once satisfied that the prescription is suitable for dispensing then the process of delivering the drug commences. 4. FHC will contact the patient directly at home and agree a time and date for delivery. A qualified nurse will call at the patient s home within 24 working hours of delivery to commence the training of the patient in the storage and administration of the drug, which will be accompanied by a training package that the patient will have for their use. 5. During the first three months, patients will be requested to send back their pens at the end of the 28 days of use in pre-paid envelopes to FHC. The remaining volume will be measured that will indicate the degree of compliance. This will be communicated back to the clinicians both GP and consultant in the form of a report. 6. Further prescriptions will be prompted by FHC who will contact the GP in good time for a repeat prescription. Pre-paid envelopes are provided by FHC. GP practices are requested to put systems in place to monitor this in order to prevent the potential for over prescribing / supply. Prescriptions will be dispensed and delivered monthly for the first 3 months then every 3 months thereafter d) Aspects of care for which the Patient / (Patients Carer if they are administering) is responsible: To ensure they have a full understanding of the treatment To report any adverse events to the GP and / or consultant To store, prepare and administer the medication properly and safely Attend for regular appointments as requested Contact Details Dr M Kassim Javaid Kerri Rance Nurse Specialist Osteoporosis Healthcare at Home Limited Customer Service Lilly Customer Care Oxford University Hospitals Trust Medicines Information Department This is intended as an outline guide for further information please refer to the Summary of Product Characteristics or above contacts. 6