Crawley CCG LCS Dec 15 Final

Crawley CCG LCS Dec 15 Final Crawley CCG Service Proposal for the inclusion of administration and monitoring of Denosumab 60mg Injection (Prolia )in GP Practices under a Locally Commissioned Service February 2016

Executive Summary Denosumab (Prolia ), a drug for osteoporosis, is administered by six-monthly injection and requires monitoring of calcium levels. GP Practices in Brighton and Hove CCG and High Weald Lewes and Havens CCG are paid to administer and monitor Denosumab under their agreed LCS s. The possibility of patients receiving the same service from their GP practice was raised at the Crawley CCG Locality Prescribing Committee where some patients attend hospital to receive this treatment. The current position is different in Crawley CCG where 73% of Denosumab (based on epact figures (April 14-Nov15) is prescribed and administered by the Fracture Liaison Service*/Bridge Medical Centre. This document outlines the options available for administering and monitoring Denosumab in GP practices in Crawley CCG and their potential financial impact. This proposal has been agreed in principle at the Crawley CCG Executive Committee. *Note: The CCG has now received notice that this service will no longer be available from 31 st March 2016 The Primary Care Commissioning Committee is asked to review the proposal and to make a decision on appropriate payment for GP practices to provide this service. Background Information Denosumab (Prolia, Amgen) is a monoclonal antibody that reduces osteoclast activity, and so reduces bone breakdown. Denosumab has a UK marketing authorisation for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. The summary of product characteristics states that in postmenopausal women that Denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Denosumab is administered as a single subcutaneous injection into the thigh, abdomen or back of the arm. The recommended dosage is 60 mg once every 6 months In October 2010 NICE published NICE technology appraisal guidance [TA204] for Denosumab for the prevention of osteoporotic fractures in postmenopausal women. TA204 recommends Denosumab as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women at increased risk of fractures, who comply with particular combinations of bone mineral density measurement, age and independent risk factors for fracture, as indicated in the full NICE guidance (available at

www.nice.org.uk/ta204 NICE TA 204 also recommends Denosumab as a treatment option for postmenopausal women for secondary prevention of osteoporosis. For both primary and secondary prevention Denosumab is only recommended by NICE for those women who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, (all oral therapies) or have an intolerance of, or a contraindication to, those treatments. NICE TA 204 means that Denosumab must be available in our CCG as a treatment option to patients fulfilling NICE criteria Since the publication of the NICE TA the CCG has determined the place of Denosumab in the osteoporosis prevention and treatment pathway agreeing the recommendation of the PCN in the CPMAP meeting in June 2014 to make it GREEN on the CCG Formulary Traffic Light System (Suitable for non-specialist initiation) The Case for Change Since the introduction of Denosumab for osteoporosis the number of patients receiving Denosumab as a six-monthly injection has increased dramatically. In Crawley CCG a GREEN formulary designation means practices are able to initiate Denosumab in appropriate patients, without the need for referral. In practice around 70% Crawley patients have been receiving Denosumab via a commissioned Fracture Liaison Service* provided by Bridge Medical Centre/Fracture Liaison Nurse. The cost of the Denosumab for these patients has been born by Bridge Practices prescribing budget. The CCG has now received notice that this service will no longer be available from 31st March 2016 There is no vehicle by which Crawley practices can be reimbursed for the time taken to prescribe, initiate, administer and monitor denusomab patients within their surgeries although they may claim under GMS for personally administered items. As the number of patients receiving 6 monthly injections has increased (from 104 injections prescribed in 2012/13 to 215 prescribed items in 2014/15) so the impact for GP practices and/or the Fracture Liaison Service has increased. Denosumab must be administered by subcutaneous injection. In addition prior to each injection the patient must attend for a blood test to check for hypocalcaemia as clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose.

This proposal is also being put forward by Crawley CCG following a Prescribing Meeting where concern was expressed about the additional work entailed for practices, especially practice nurses, and the resulting impact on other practice services. It was requested therefore that Denosumab for osteoporosis is added to the current drug monitoring LCS. Period Name Prescriber Name BNF Name Total Items Total Act Cost Financial 2012/2013 Financial 2013/2014 Financial 2014/2015 Financial 2015/16 (Year to date April 14 to Nov 15) CRAWLEY CCG Denosumab Inj 60mg/1ml pfs 104 17,784.22 CRAWLEY CCG Denosumab Inj 60mg/1ml pfs 181 31,183.86 CRAWLEY CCG Denosumab Inj 60mg/1ml pfs 215 37,143.29 CRAWLEY CCG Denosumab Inj 60mg/1ml pfs 142 24,588.10 Figures from EPACT Options 1. Do nothing 2. Commission additional capacity from the Secondary Care or Fracture Liaison Service* 3. Include Denosumab for osteoporosis in existing LCS for Shared Care Drug Monitoring cost 22.18 per patient, claimed quarterly (Equivalent 88.71 p.a.) - Brighton and Hove CCG have included Denosumab in their Shared Care Drug Monitoring LCS 4. Include Denosumab under the Minor Surgery LCS with the following options:- a) half unit per activity ( 15.15) This option already includes administration of hormonal implants by injection e.g. Prostap, Zoladex which require no blood monitoring b) one whole unit per activity ( 30.30) HWLH CCG includes Denosumab in the same category as Prostap etc ( 11.84 per injection).

Option 1 Do Nothing Practices could refer all patients requiring Denosumab injections back to the Secondary Care or Fracture Liaison Service* for blood tests and administration of injections resulting in increased work for this service giving routine injections. Risk of less future practice engagement in taking up shared care and/or treating complex patients in primary care Option 2 Commission additional capacity for FLS* The Fracture Liaison Service* or Secondary Care would require additional resources and clinic time to provide this routine service. Patients would need to travel further from home to receive the service. *Note The CCG has now received notice that the Fracture Liaison Service will no longer be available from 31 st March 2016 Option 3 Add Denosumab to the Drug Monitoring LCS Denosumab has been designated GREEN on the CCG Formulary by the CCG. All drugs on the current Drug Monitoring LCS are currently designated at least AMBER and are initiated in secondary care with prescribing and monitoring being undertaken by the GP under an agreed shared care agreement. If Denosumab were included under this LCS this would be an exception since the GREEN designation means patient care can be managed wholly in primary care. Estimated Annual Cost for Crawley CCG if Denosumab is added to the drug monitoring LCS = 9,492 based on 107 patients at 88.71 patients p.a. *(213/2 six monthly injections extrapolated from April-14-Nov-15 epact figures) Option 4 Include Denosumab under the Minor Surgery LCS The current Minor Surgery LCS already includes hormonal implants by injection e.g. Zoladex, Prostap paid at half unit per quarter These require no specific blood monitoring. These drugs are designated BLUE or GREEN on the Formulary and are usually initiated by a specialist. a) Half Unit per activity Estimated Cost in Crawley CCG if Denosumab is added to the Minor Surgery LCS = 3,242 p.a. based on 107* patients at 30.30 ( 15.15 per administration x 2). b) Whole Unit per activity

Estimated Cost in Crawley CCG if Denosumab is added to the Minor Surgery LCS as a whole unit = 6,484 p.a. based on 107* patients at 60.60 ( 30.30 per administration x 2). *(213/2 six monthly injections extrapolated from April-14-Nov-15 epact figures) Definition from current Minor Surgery LCS: Half Unit could be performed by a practice nurse e.g Hormonal implants by injection, Suture removal, Ear syringing, vault smears Whole Unit could be performed by practice nurse more usually doctor e.g. Repair of laceration by glue, steroid injection of keloid, removal of nasal packaging, drainage of subungual haematoma Benefits of Change The proposed addition of Denosumab to an LCS will:- Reduce the number of referrals to the Fracture Liaison Service* or Secondary Care for initiation and continued administration of Denosumab freeing capacity for this service for assessment and diagnosis. Enable more patients to be treated closer to home at their own GP surgeries. Provide funding for additional practice nurse time to ensure Denosumab is correctly administered and monitored in GP Practices. Additional experience could mean that patients fulfilling NICE TA 204 criteria could also be commenced on Denosumab without referral to Secondary Care or the Fracture Liaison Service. Risks of having an LCS: If uptake of the LCS is not consistent across the CCG there could be a risk of inequity in treatment and care of patients with osteoporosis. This risk could be mitigated by offering practices the opportunity to provide the service on behalf of another practice or a group of practices Risks of not having an LCS: Practices could refer all patients requiring Denosumab injections back to Secondary care or the Fracture Liaison Service* for blood tests and administration of injections resulting in increased work for this service giving routine injections. Risk of less future practice engagement in taking up shared care and/or treating complex patients in primary care

Summary of Proposal Summary Proposal Drug Indication Dosage and monitoring To determine how Denosumab (Prolia ), a six-monthly injection for patients with osteoporosis fulfilling TA204 will be given in primary care in Crawley CCG Addition of Denosumab (Prolia ) to either Shared Care Drug Monitoring LCS or Minor Surgery LCS or to continue existing arrangement where approx.70% of patients are treated and monitored by the Fracture Liaison Service* or Secondary Care. Denosumab (Prolia ) 60mg pre-filled syringe for subcutaneous injection (NB There is another Denosumab (Xgeva ) licensed for bone metastases from breast cancer. This proposal does not include this product) Primary and secondary prevention of osteoporosis in women intolerant or unable to comply with oral bisphosphonates fulfilling NICE TA204 Six monthly sub-cutaneous injection Blood test for hypocalcaemia before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose. Formulary status Green Reason for request Advantages of addition to LCS Monitoring of LCS CCG member practices have requested inclusion in the current LCS scheme because of increased use of this drug in primary care requiring administration by injection and blood test monitoring Patients may be treated at their own surgeries closer to home. Removal of administration of routine injections will mean Fracture Liaison Service* or Secondary Care will have additional capacity. As individual schemes

Potential Costs Drug Monitoring LCS 22.18 per patient per quarter (Equivalent 88.71 p.a.) Estimated annual cost 9,492 based on an estimated 107 patients Minor Surgery LCS Half-Unit 15.15 per administration (Equivalent to 30.30 p.a.) Estimated annual cost 3,242 based on an estimated 107 patients Whole Unit 30.30 per administration (Equivalent to 60.60 p.a.) Estimated annual cost 6,484 based on an estimated 107 patients Fracture Liaison Service* No costs specific to administration of Denosumab in existing service identified. *Note: The CCG has now received notice that this service will no longer be available from 31 st March 2016