Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women

Size: px
Start display at page:

Download "Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women"

Transcription

1 Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women Resource impact The guidance Denosumab for the prevention of osteoporotic fractures in postmenopausal women (NICE technology appraisal guidance 204) is unlikely to have a significant impact on the use of NHS resources. However, because of variation in practice across the country, organisations may incur costs or savings depending on their circumstances. Therefore, organisations are encouraged to assess costs locally. Introduction The Secretary of State and the Welsh Assembly Minister for Health and Social Services have issued directions to the NHS on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends use of a drug or treatment, or other technology, the NHS must usually provide funding and resources for it within 3 months of the guidance being published. If the Department of Health issues a variation to the 3-month funding direction, details will be available on the NICE website. When there is no NICE technology appraisal guidance on a drug, treatment or other technology, decisions on funding should be made locally. Background of this technology appraisal NICE technology appraisal guidance 160 recommends strontium ranelate as an option for the treatment of the primary prevention of osteoporotic fragility fractures in postmenopausal women who are unable to comply with the special instructions for the administration of alendronate and etidronate or risedronate or who are intolerant of or contraindicated to those treatments and meet the criteria of T-score, age and number of independent clinical risk factors (see below). NICE technology appraisal guidance 161 recommends strontium ranelate or raloxifene as alternative treatment options for the secondary prevention of postmenopausal women 1 of 5

2 osteoporotic fragility fractures in postmenopausal women who are unable to comply with the special instructions for the administration of alendronate and etidronate or risedronate or who are intolerant of or contraindicated to those treatments and meet the T-score, age and number of independent clinical risk factors (see below). Clinical risk factors For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis. Primary prevention of osteoporotic fragility fractures Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures: who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate; or have an intolerance of, or a contraindication to, those treatments and who have a combination of T-score 1, age and number of independent clinical risk factors for fracture (see above) as indicated in the following table. 1 T-score measures bone mineral density using central (hip and/or spine) dual-energy X-ray (DXA) scanning, and is expressed as the number of standard deviations (SD) below peak bone mineral density. postmenopausal women 2 of 5

3 T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or etidronate are unsuitable Age (years) Number of independent clinical risk factors for fracture a or older a Treatment with denosumab is not recommended. Secondary prevention of osteoporotic fragility fractures Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments. The technology 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 at increased risk of fractures. The summary of product characteristics states in the indication that denosumab significantly reduces the risk of vertebral, nonvertebral and hip fractures. Cost impact Denosumab is an alternative treatment option for the prevention of both primary and secondary osteoporotic fragility fractures in certain postmenopausal women. The initial prescribing will be started in secondary care via a hospital outpatient appointment. It will subsequently be delivered almost exclusively in primary care. However, it is acknowledged that GPs may be cautious about administering a new therapy, particularly a monoclonal antibody, in a primary care setting following initiation in secondary care. If denosumab is not administered in primary care after the initial dose, commissioners will have recurring costs due to additional outpatient postmenopausal women 3 of 5

4 appointments. Commissioners are advised to check local practice for administration of the drug when considering the cost impact of implementation. Expert opinion suggests that the change in prescribing may affect up to 25% of the eligible population. However, the manufacturers of Denosumab suggest that the change in prescribing may be as high as 50%. It is, therefore, important that commissioners are aware of their local circumstances and monitor trends locally. If uptake of denosumab is below 70% then the net cost of implementation of the guidance is estimated to be less than 1 million for the whole of England. The costs of each of the treatment options currently recommended by NICE are shown in the table below. Costs may vary in different settings because of negotiated procurement discounts. Drug Annual cost per patient Denosumab (Prolia)* Strontium ranelate (Protelos) Raloxifene (Evista) *The first year costs of Denosumab will be 622, which includes 256 for administration of the first dose in secondary care in an outpatient setting. The administration cost for the first dose of denosumab is the cost for a first outpatient attendance for Rheumatology (specialty 410) per 2010/11 Outpatient Attendance National Tariff (WF01B). If practice differs locally, costs will vary. The manufacturers' submission identified a cohort of patients who are currently not receiving any treatment for the prevention of either primary or secondary osteoporotic fractures. The manufacturer of denosumab estimated that this cohort is between 11,000 and 18,000 patients. Expert opinion suggests that it is unlikely that this cohort of patients will not be receiving any treatment at all. This group of patients was not included in estimating the national cost but commissioners are advised to check practice locally when implementing the guidance. postmenopausal women 4 of 5

5 Non-recurrent costs Additional non-recurrent costs may also be incurred for the training of GPs in the administration of denosumab in a primary care setting. The requirement for this training will need to be determined at a local level. Savings and benefits Some patients who are eligible to receive denosumab as set out in the recommendations, may have already tried several drugs. Denosumab is an additional treatment option for patients, with the aim of preventing osteoporotic fragility fractures and the associated costs of care. There will, therefore, be savings from a reduced number of initial hospital treatments, and from a reduction in costs of follow-up rehabilitation appointments and social care. Compliance with NICE guidance is one of the criteria of good risk reduction strategies, and in combination with meeting other criteria could lead to a discount on contributions to the NHS Litigation Authority schemes, including Clinical Negligence Scheme for Trusts (CNST). Implications for commissioners This technology falls into the programme budgeting category 215X Problems of the musculoskeletal system. Conclusion Because denosumab is one of several treatment options recommended by NICE for the prevention of osteoporotic fragility fractures and additional patients receiving denosumab may incur both costs and savings (from a reduction in secondary care activity), we do not anticipate that its use within the NHS will result in a significant impact on NHS resources. The recommendations in NICE technology appraisals 160 and 161 relating to strontium ranelate are currently being reviewed. We are considering the production of a more comprehensive costing model which will incorporate this guidance and all other current NICE guidance once this review is complete. postmenopausal women 5 of 5

Quality and Outcomes Framework Programme NICE cost impact statement July Indicator area: Osteoporosis - fragility fracture

Quality and Outcomes Framework Programme NICE cost impact statement July Indicator area: Osteoporosis - fragility fracture Quality and Outcomes Framework Programme NICE cost impact statement July 2011 Indicator area: Osteoporosis - fragility fracture Indicators NM29: The practice can produce a register of patients: 1. Aged

More information

Denosumab for the prevention of osteoporotic fractures in postmenopausal women

Denosumab for the prevention of osteoporotic fractures in postmenopausal women Denosumab for the prevention of osteoporotic fractures in Issued: October 2010 guidance.nice.org.uk/ta204 NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to

More information

Denosumab for the prevention of osteoporotic fractures in postmenopausal women

Denosumab for the prevention of osteoporotic fractures in postmenopausal women Issue date: October 2010 Denosumab for the prevention of osteoporotic fractures in postmenopausal women This guidance was developed using the single technology appraisal process NICE technology appraisal

More information

Horizon Scanning Centre March Denosumab for glucocorticoidinduced SUMMARY NIHR HSC ID: 6329

Horizon Scanning Centre March Denosumab for glucocorticoidinduced SUMMARY NIHR HSC ID: 6329 Horizon Scanning Centre March 2014 Denosumab for glucocorticoidinduced osteoporosis SUMMARY NIHR HSC ID: 6329 This briefing is based on information available at the time of research and a limited literature

More information

Understanding NICE guidance. NICE technology appraisal guidance advises on when and how drugs and other treatments should be used in the NHS.

Understanding NICE guidance. NICE technology appraisal guidance advises on when and how drugs and other treatments should be used in the NHS. Understanding NICE guidance Information for people who use NHS services Alendronate, etidronate, risedronate, strontium ranelate and raloxifene for preventing bone fractures in postmenopausal women with

More information

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464 Bisphosphonates for treating osteoporosis Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

Osteoporosis: fragility fracture risk. Costing report. Implementing NICE guidance

Osteoporosis: fragility fracture risk. Costing report. Implementing NICE guidance Osteoporosis: fragility fracture risk Costing report Implementing NICE guidance August 2012 NICE clinical guideline 146 1 of 15 This costing report accompanies the clinical guideline: Osteoporosis: assessing

More information

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464 Bisphosphonates for treating osteoporosis Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta464 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

S H A R E D C A R E G U I D E L I N E Drug: Denosumab 60mg injection Indication: treatment of osteoporosis in postmenopausal women

S H A R E D C A R E G U I D E L I N E Drug: Denosumab 60mg injection Indication: treatment of osteoporosis in postmenopausal women S H A R E D C A R E G U I D E L I N E Drug: Denosumab 60mg injection Indication: treatment of osteoporosis in postmenopausal women Introduction Indication: Denosumab (Prolia ) is recommended in NICE TA204

More information

Issue date: October Review date: July 2010

Issue date: October Review date: July 2010 Issue date: October 2008 Review date: July 2010 Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal

More information

Submission to the National Institute for Clinical Excellence on

Submission to the National Institute for Clinical Excellence on Submission to the National Institute for Clinical Excellence on Strontium ranelate for the prevention of osteoporotic fractures in postmenopausal women with osteoporosis by The Society for Endocrinology

More information

Horizon Scanning Technology Briefing. Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal. National Horizon Scanning Centre

Horizon Scanning Technology Briefing. Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal. National Horizon Scanning Centre Horizon Scanning Technology Briefing National Horizon Scanning Centre Zoledronic Acid (Aclasta) once yearly treatment for postmenopausal osteoporosis December 2006 This technology summary is based on information

More information

Technology appraisal guidance Published: 27 October 2008 nice.org.uk/guidance/ta160

Technology appraisal guidance Published: 27 October 2008 nice.org.uk/guidance/ta160 Raloxifene for the primary prevention ention of osteoporotic fragility fractures in postmenopausal women Technology appraisal guidance Published: 27 October 2008 nice.org.uk/guidance/ta160 NICE 2018. All

More information

Putting NICE guidance into practice

Putting NICE guidance into practice Putting NICE guidance into practice Resource impact report: Olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after

More information

DENOSUMAB SHARED CARE GUIDLINES

DENOSUMAB SHARED CARE GUIDLINES DENOSUMAB LICENSING Denosumab (PROLIA ) is licensed for the treatment of osteoporosis in postmenopausal women at increased risk of fractures and for bone loss associated with hormone ablation in men with

More information

Putting NICE guidance into practice. Resource impact report: Hearing loss in adults: assessment and management (NG98)

Putting NICE guidance into practice. Resource impact report: Hearing loss in adults: assessment and management (NG98) Putting NICE guidance into practice Resource impact report: Hearing loss in adults: assessment and management (NG98) Published: June 2018 Summary This report focuses on the recommendation from NICE s guideline

More information

Thank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS.

Thank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS. Appendix I - Thank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS. Healthcare professionals can provide a unique perspective

More information

Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the costeffectiveness

Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the costeffectiveness Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the costeffectiveness of risedronate and strontium ranelate in those people who would be treated with generic

More information

Clinical Specialist Statement Template

Clinical Specialist Statement Template Clinical Specialist Statement Template Thank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS. Healthcare professionals can

More information

Osteoporosis Clinical Guideline. Rheumatology January 2017

Osteoporosis Clinical Guideline. Rheumatology January 2017 Osteoporosis Clinical Guideline Rheumatology January 2017 Introduction Osteoporosis is a condition of low bone mass leading to an increased risk of low trauma fractures. The prevalence of osteoporosis

More information

Advanced medicine conference. Monday 20 Tuesday 21 June 2016

Advanced medicine conference. Monday 20 Tuesday 21 June 2016 Advanced medicine conference Monday 20 Tuesday 21 June 2016 Osteoporosis: recent advances in risk assessment and management Juliet Compston Emeritus Professor of Bone Medicine Cambridge Biomedical Campus

More information

FINANCE COMMITTEE DEMOGRAPHIC CHANGE AND AGEING POPULATION INQUIRY SUBMISSION FROM NATIONAL OSTEOPOROSIS SOCIETY

FINANCE COMMITTEE DEMOGRAPHIC CHANGE AND AGEING POPULATION INQUIRY SUBMISSION FROM NATIONAL OSTEOPOROSIS SOCIETY FINANCE COMMITTEE DEMOGRAPHIC CHANGE AND AGEING POPULATION INQUIRY SUBMISSION FROM NATIONAL OSTEOPOROSIS SOCIETY What is your view of the effects of the demographic change and an ageing population on the

More information

nogg Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK

nogg Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK nogg NATIONAL OSTEOPOROSIS GUIDELINE GROUP Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK Produced by J Compston, A Cooper,

More information

Dumfries and Galloway. Treatment Protocol for Osteoporosis

Dumfries and Galloway. Treatment Protocol for Osteoporosis Dumfries and Galloway Treatment Protocol for Osteoporosis DIAGNOSIS OF OSTEOPOROSIS 2 Diagnostic Criteria 2 REFERRAL CRITERIA FOR DEXA 3 TREATMENT 4 Non-Drug Therapy : for all 4 Non-Drug Therapy : in the

More information

The recent publication of guidance from the National

The recent publication of guidance from the National 216 Clinical Pharmacist May 2009 Vol 1 Several guidelines exist for the identification and treatment of osteoporosis. Patients diagnosed with the condition should be prescribed bisphosphonates, if suitable,

More information

Pathway from Fracture or Risk Factor to Treatment

Pathway from Fracture or Risk Factor to Treatment Appendix 6A - Guidance on Diagnosis and Management of Osteoporosis Pathway from Fracture or Risk Factor to Treatment Fragility Fracture = fracture sustained from a low energy fall from standing height

More information

Prevention of Osteoporotic Hip Fracture

Prevention of Osteoporotic Hip Fracture Prevention of Osteoporotic Hip Fracture Dr Law Sheung Wai 8th July 2007 Associate Consultant Spine team / Orthopedic Rehabilitation Department of Orthopedics and Traumatology NTE Cluster 1 Objectives Problems

More information

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see:

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see: : assessing the risk of fragility fracture bring together everything NICE says on a topic in an interactive flowchart. are interactive and designed to be used online. They are updated regularly as new

More information

Denosumab for the treatment of osteoporosis in postmenopausal women at increased risk of fractures

Denosumab for the treatment of osteoporosis in postmenopausal women at increased risk of fractures APper apc15-0avgfh7 Shared Care Guideline Denosumab for the treatment of osteoporosis in postmenopausal women at increased risk of fractures For the latest information on interactions and adverse effects,

More information

Guideline for the investigation and management of osteoporosis. for hospitals and General Practice

Guideline for the investigation and management of osteoporosis. for hospitals and General Practice Guideline for the investigation and management of osteoporosis for hospitals and General Practice Background Low bone density is an important risk factor for fracture. The aim of assessing bone density

More information

Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181)

Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181) Putting NICE guidance into practice Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181) Published: July 2014 This costing report accompanies Lipid modification:

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Health and social care directorate Quality standards and indicators Briefing paper

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Health and social care directorate Quality standards and indicators Briefing paper NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Health and social care directorate Quality standards and indicators Briefing paper Quality standard topic: Osteoporosis Output: Prioritised quality improvement

More information

Overview. Bone Biology Osteoporosis Osteomalacia Paget s Disease Cases. People Centred Positive Compassion Excellence

Overview. Bone Biology Osteoporosis Osteomalacia Paget s Disease Cases. People Centred Positive Compassion Excellence Overview Osteoporosis and Metabolic Bone Disease Dr Chandini Rao Consultant Rheumatologist Bone Biology Osteoporosis Osteomalacia Paget s Disease Cases Bone Biology Osteoporosis Increased bone remodelling

More information

1. UK List Price of Zoledronic acid (Zoledronate) 5 mg (Aclasta )

1. UK List Price of Zoledronic acid (Zoledronate) 5 mg (Aclasta ) Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR Dr C M Longson Director, Centre for Health Technology Evaluation National Institute for Health and Clinical Excellence

More information

Page 1

Page 1 Osteoporosis Osteoporosis is a condition characterised by weakened bones that fracture easily. After menopause many women are at risk of developing osteoporosis. Peak bone mass is usually reached during

More information

Audit on follow-up of patients with primary Osteoporosis

Audit on follow-up of patients with primary Osteoporosis Abstract Aim: To document the frequency of Dual-energy X- ray absorptiometry (DEXA) scanning and Rheumatology clinic follow-up visits of patients with primary osteoporosis, and compare these with recommended

More information

Vol. 19, Bulletin No. 108 August-September 2012 Also in the Bulletin: Denosumab 120mg for Bone Metastases

Vol. 19, Bulletin No. 108 August-September 2012 Also in the Bulletin: Denosumab 120mg for Bone Metastases ה מ ר א פ הביטאון לענייני תרופות ISRAEL DRUG BULLETIN 19 years of unbiased and independent drug information P H A R x M A Vol. 19, Bulletin No. 108 August-September 2012 Also in the Bulletin: Denosumab

More information

Bisphosphonate treatment break

Bisphosphonate treatment break Bulletin 110 December 2015 Bisphosphonate treatment break Bisphosphonates have been widely used in the treatment of osteoporosis with robust data demonstrating efficacy in fracture risk reduction over

More information

DRAFT FOR PUBLIC CONSULTATION. Integrated Impact Assessment Report for Clinical Commissioning Policies

DRAFT FOR PUBLIC CONSULTATION. Integrated Impact Assessment Report for Clinical Commissioning Policies Integrated Impact Assessment Report for Clinical Commissioning Policies Policy Reference Number Policy Title A03X06 Teriparatide for the treatment of osteogenesis imperfecta (Adults) Accountable Commissioner

More information

Osteoporosis: assessing the risk of fragility fracture

Osteoporosis: assessing the risk of fragility fracture Osteoporosis: assessing the risk of fragility fracture Issued: August 2012 NICE clinical guideline 146 guidance.nice.org.uk/cg146 NICE has accredited the process used by the Centre for Clinical Practice

More information

1

1 www.osteoporosis.ca 1 2 Overview of the Presentation Osteoporosis: An Overview Bone Basics Diagnosis of Osteoporosis Drug Therapies Risk Reduction Living with Osteoporosis 3 What is Osteoporosis? Osteoporosis:

More information

Denosumab (Prolia 60 mg) Effective Shared Care Agreement For the treatment of Osteoporosis. Date: Date:

Denosumab (Prolia 60 mg) Effective Shared Care Agreement For the treatment of Osteoporosis. Date: Date: Denosumab (Prolia 60 mg) Effective Shared Care Agreement For the treatment of Osteoporosis Section 1: Shared care arrangements and responsibilities Section 1.1 Agreement for transfer of prescribing to

More information

SCHEDULE 2 THE SERVICES. A. Service Specifications

SCHEDULE 2 THE SERVICES. A. Service Specifications SCHEDULE 2 THE SERVICES A. Service Specifications Service Specification No. 04/MSKT/0013 Service PAN DORSET FRACTURE LIAISON SERVICE Commissioner Lead CCP for Musculoskeletal & Trauma Provider Lead Deputy

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE GUIDANCE EXECUTIVE (GE) Consideration of consultation responses on review proposal

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE GUIDANCE EXECUTIVE (GE) Consideration of consultation responses on review proposal NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE GUIDANCE EXECUTIVE (GE) Consideration of consultation responses on review Review of TA160, TA161 and TA204; Technologies for the primary and secondary

More information

Osteoporosis - New Guidelines. Michelle Glass B.Sc. (Pharm) June 15, 2011

Osteoporosis - New Guidelines. Michelle Glass B.Sc. (Pharm) June 15, 2011 Osteoporosis - New Guidelines Michelle Glass B.Sc. (Pharm) June 15, 2011 Outline What is Osteoporosis? Who is at risk? What treatments are available? Role of the Pharmacy technician Definition of Osteoporosis

More information

Prescribing of Denosumab (Prolia ) in Wales: Review. Full document

Prescribing of Denosumab (Prolia ) in Wales: Review. Full document Prescribing of Denosumab (Prolia ) in Wales: Review Full document October 2013 This report has been prepared by a multiprofessional collaborative group, with support from the All Wales Prescribing Advisory

More information

PROCTER & GAMBLE and SANOFI-AVENTIS v ROCHE and GLAXOSMITHKLINE

PROCTER & GAMBLE and SANOFI-AVENTIS v ROCHE and GLAXOSMITHKLINE CASES AUTH/1803/2/06 and AUTH/1804/2/06 PROCTER & GAMBLE and SANOFI-AVENTIS v ROCHE and GLAXOSMITHKLINE Bonviva Once Monthly slide kits Procter & Gamble and Sanofi-Aventis complained jointly about two

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single technology appraisal (STA)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single technology appraisal (STA) NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Single technology appraisal (STA) Denosumab for the Prevention of Osteoporotic Fractures in Postmenopausal Women Manufacturer Response to Clarification

More information

denosumab (Prolia ) Policy # Original Effective Date: 07/21/2011 Current Effective Date: 04/19/2017

denosumab (Prolia ) Policy # Original Effective Date: 07/21/2011 Current Effective Date: 04/19/2017 Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Based on review of available data, the Company may consider the use of denosumab (Prolia) for the

Based on review of available data, the Company may consider the use of denosumab (Prolia) for the Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Summary. Background. Diagnosis

Summary. Background. Diagnosis March 2009 Management of post-menopausal osteoporosis This bulletin focuses on the pharmacological management of patients with post-menopausal osteoporosis both those with clinically evident disease (e.g.

More information

Management of postmenopausal osteoporosis

Management of postmenopausal osteoporosis Management of postmenopausal osteoporosis Yeap SS, Hew FL, Chan SP, on behalf of the Malaysian Osteoporosis Society Committee Working Group for the Clinical Guidance on the Management of Osteoporosis,

More information

Putting NICE guidance into practice. Resource impact report: Obeticholic acid for treating primary biliary cholangitis (TA443)

Putting NICE guidance into practice. Resource impact report: Obeticholic acid for treating primary biliary cholangitis (TA443) Putting NICE guidance into practice Resource impact report: Obeticholic acid for treating primary biliary cholangitis (TA443) Published: April 2017 Summary Obeticholic acid is recommended as an option

More information

Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide

Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide Dr Matt Stevenson Sarah Davis July 2006 1 Page Executive

More information

May Professor Matt Stevenson School of Health and Related Research, University of Sheffield

May Professor Matt Stevenson School of Health and Related Research, University of Sheffield ASSESSING THE FEASIBILITY OF TRANSFORMING THE RECOMMENDATIONS IN TA160, TA161 AND TA204 INTO ABSOLUTE 10-YEAR RISK OF FRACTURE A REPORT PRODUCED BY THE DECISION SUPPORT UNIT IN THE CONTEXT OF THE REVIEW

More information

Osteoporosis update. Dr. Claire Vandevelde Consultant Rheumatologist, LTHT

Osteoporosis update. Dr. Claire Vandevelde Consultant Rheumatologist, LTHT Osteoporosis update Dr. Claire Vandevelde Consultant Rheumatologist, LTHT Outline Background BMD Tools for assessing fracture risk Case study Denosumab Treatment breaks BMD BMD predicts fracture risk but

More information

Report to the Minister of State for Care Services: Breaking Through: Building Better Falls and Fracture Services in England

Report to the Minister of State for Care Services: Breaking Through: Building Better Falls and Fracture Services in England Report to the Minister of State for Care Services: Breaking Through: Building Better Falls and Fracture Services in England February 2012 Foreword Mr Paul Burstow MP Minister of State for Care Services

More information

Barts Health NHS Trust and local GPs Shared Care Guidelines. DENOSUMAB (Prolia) Post menopausal osteoporosis

Barts Health NHS Trust and local GPs Shared Care Guidelines. DENOSUMAB (Prolia) Post menopausal osteoporosis Barts Health NHS Trust and local GPs Shared Care Guidelines Indication: DENOSUMAB (Prolia) Post menopausal osteoporosis DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AS AND FILED IN NOTES Patient Name

More information

EU Osteoporosis Report SWEDEN

EU Osteoporosis Report SWEDEN EU Osteoporosis Report 2007-2008 SWEDEN Completed by: Kristina Åkesson, Bone & Joint Decade Eva Waern, Andreas Kindmark, Caroline Åkerhielm Swedish Rheumatism Association OVERVIEW 2001-2005 2007 Ref: Osteoporosis

More information

An Update on Osteoporosis Treatments

An Update on Osteoporosis Treatments An Update on Osteoporosis Treatments Dr Mike Stone University Hospital Llandough Treatments for osteoporosis Calcium and vitamin D HRT Raloxifene Etidronate Alendronate Risedronate Ibandronate (oral and

More information

Pharmacy Management Drug Policy

Pharmacy Management Drug Policy SUBJECT: - Forteo (teriparatide), Prolia (denosumab), Tymlos (abaloparatide) POLICY NUMBER: Pharmacy-35 EFFECTIVE DATE: 9/07 LAST REVIEW DATE: 9/29/2017 If the member s subscriber contract excludes coverage

More information

Administration of Denosumab (PROLIA ) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures

Administration of Denosumab (PROLIA ) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures Administration of Denosumab (PROLIA ) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures 2017 18 1. Purpose of Agreement This agreement outlines the expectations

More information

EU Osteoporosis Report MALTA

EU Osteoporosis Report MALTA EU Osteoporosis Report 2007-2008 MALTA Overview completed by: Dr Raymond Galea MD, FRCOG, Acc O&G.(Leu) Progress report completed by: Dr Raymond Galea in conjunction with the Strategy and Sustainability

More information

Dumfries and Galloway. Treatment Protocol for Osteoporosis

Dumfries and Galloway. Treatment Protocol for Osteoporosis Dumfries and Galloway Treatment Protocol for Osteoporosis DIAGNOSIS OF OSTEOPOROSIS 2 Diagnostic Criteria 2 Multiple low trauma vertebral fractures in the absence of myeloma or metastatic disease. 2 T-score

More information

Assessment and Treatment of Osteoporosis Professor T.Masud

Assessment and Treatment of Osteoporosis Professor T.Masud Assessment and Treatment of Osteoporosis Professor T.Masud Nottingham University Hospitals NHS Trust University of Nottingham University of Derby University of Southern Denmark What is Osteoporosis? Osteoporosis

More information

John J. Wolf, DO Family Medicine

John J. Wolf, DO Family Medicine John J. Wolf, DO Family Medicine Objectives: 1. Review incidence & Risk of Osteoporosis 2.Review indications for testing 3.Review current pharmacologic & Non pharmacologic Tx options 4.Understand & Utilize

More information

BONIVA (ibandronate sodium)

BONIVA (ibandronate sodium) BONIVA (ibandronate sodium) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices

More information

FRiSCy Oxford Fracture Prevention Service

FRiSCy Oxford Fracture Prevention Service FRiSCy Oxford Fracture Prevention Service MK Javaid Lecturer in Metabolic Bone Disease, University of Oxford Hon Consultant Rheumatologist, Nuffield Orthopaedic Centre Lead Clinician for FRiSCy Declaration

More information

Falls and non-hip fragility fractures: The past decade and the way ahead..

Falls and non-hip fragility fractures: The past decade and the way ahead.. Falls and non-hip fragility fractures: The past decade and the way ahead.. David Oliver Regional NHFD Meeting, London September 2011 I: Epidemiology of falls and fractures in England Falls Epidemiology

More information

NICE SCOOP OF THE DAY FRAX with NOGG. Eugene McCloskey Professor of Adult Bone Diseases University of Sheffield

NICE SCOOP OF THE DAY FRAX with NOGG. Eugene McCloskey Professor of Adult Bone Diseases University of Sheffield NICE SCOOP OF THE DAY FRAX with NOGG Eugene McCloskey Professor of Adult Bone Diseases University of Sheffield Disclosures Consultant/Advisor/Speaker for: o ActiveSignal, Amgen, AstraZeneca, Consilient

More information

The Glasgow UK Experiment: What a Working System Can Deliver

The Glasgow UK Experiment: What a Working System Can Deliver ASBMR Symposium Systems Approaches to Secondary Fracture Prevention: Doing Something that Actually Works The Glasgow UK Experiment: What a Working System Can Deliver Alastair R. McLellan MD, FRCP Western

More information

Fracture Liaison Service and nhfd Local provision in London

Fracture Liaison Service and nhfd Local provision in London Fracture Liaison Service and nhfd Local provision in London Dr Louise Dolan Consultant Rheumatologist Queen Elizabeth Hospital, Woolwich South London NHS Trust Fracture liaison Service Systematic assessment

More information

Putting NICE guidance into practice. Resource impact report: ifuse for treating chronic sacroiliac joint pain (MTG39)

Putting NICE guidance into practice. Resource impact report: ifuse for treating chronic sacroiliac joint pain (MTG39) Putting NICE guidance into practice Resource impact report: ifuse for treating chronic sacroiliac joint pain (MTG39) Published: October 2018 Summary NICE has recommended ifuse for treating chronic sacroiliac

More information

An audit of osteoporotic patients in an Australian general practice

An audit of osteoporotic patients in an Australian general practice professional Darren Parker An audit of osteoporotic patients in an Australian general practice Background Osteoporosis is a major contributor to morbidity and mortality in Australia, and is predicted to

More information

Osteoporosis Agents Drug Class Prior Authorization Protocol

Osteoporosis Agents Drug Class Prior Authorization Protocol Osteoporosis Agents Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of

More information

Osteoporosis Update. Greg Summers Consultant Rheumatologist

Osteoporosis Update. Greg Summers Consultant Rheumatologist Osteoporosis Update Greg Summers Consultant Rheumatologist DEFINITION OSTEOPOROSIS is LOW BONE MASS (& micro-architectural deterioration) causing AN INCREASED RISK OF FRACTURE 23 years 82 years 23 y/o

More information

Resource impact report: Sofosbuvir velpatasvir for treating chronic hepatitis C TA430

Resource impact report: Sofosbuvir velpatasvir for treating chronic hepatitis C TA430 Putting NICE guidance into practice Resource impact report: Sofosbuvir velpatasvir for treating chronic hepatitis C TA430 Published: January 2017 Summary Sofosbuvir velpatasvir is recommended as an option

More information

Costing Report: atrial fibrillation Implementing the NICE guideline on atrial fibrillation (CG180)

Costing Report: atrial fibrillation Implementing the NICE guideline on atrial fibrillation (CG180) Putting NICE guidance into practice Costing Report: atrial fibrillation Implementing the NICE guideline on atrial fibrillation (CG180) Published: June 2014 This costing report accompanies the clinical

More information

Aneurin Bevan Health Board Medicines & Therapeutics Committee. enewsletter

Aneurin Bevan Health Board Medicines & Therapeutics Committee. enewsletter Aneurin Bevan Health Board Medicines & Therapeutics Committee August 2013 enewsletter Dear Gwent Prescriber At its last two meetings (23 rd May and 11 th July) ABHB s Medicines & Therapeutics Committee

More information

This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only.

This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only. This Coverage Policy applies to Individual Health Insurance Marketplace benefit plans only. INJECTABLE OSTEOPOSIS AGENTS SUBJECT Pharmacologic Agents: Bisphosphonates: Boniva IV (ibandronate) Reclast (zoledronic

More information

TYMLOS (abaloparatide)

TYMLOS (abaloparatide) TYMLOS (abaloparatide) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs

More information

Osteoporosis and Lupus. Andrew Ruthberg, MD University Rheumatologists

Osteoporosis and Lupus. Andrew Ruthberg, MD University Rheumatologists Osteoporosis and Lupus Andrew Ruthberg, MD University Rheumatologists 1 Forget the medical terminology (osteoporosis, osteopenia, low bone mass, DEXA, DXA, T score etc) The bottom line is that you don

More information

Greater Manchester Interface Prescribing Group Shared Care Template

Greater Manchester Interface Prescribing Group Shared Care Template Greater Manchester Interface Prescribing Group Shared Care Template Shared Care Guideline the use of Denosumab for the prevention of osteoporotic fractures in postmenopausal women. Author(s)/Originator(s):

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 December 2010 DIDRONEL 200 mg, tablets B/60 (CIP code: 345 098-5) DIDRONEL 400 mg, tablets B/14 (CIP code: 333

More information

Osteoporosis. Open Access. John A. Kanis. Diseases, University of Sheffield, UK

Osteoporosis. Open Access. John A. Kanis. Diseases, University of Sheffield, UK Journal of Medical Sciences (2010); 3(3): 00-00 Review Article Osteoporosis Open Access John A. Kanis WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK incorporated into

More information

Putting NICE guidance into practice. Resource impact report: Asthma: diagnosis, monitoring and chronic asthma management (NG80)

Putting NICE guidance into practice. Resource impact report: Asthma: diagnosis, monitoring and chronic asthma management (NG80) Putting NICE guidance into practice Resource impact report: Asthma: diagnosis, monitoring and chronic asthma management (NG80) Published: November 2017 Summary This report focuses on the recommendations

More information

Hormonal therapies for the adjuvant treatment of early oestrogenreceptor-positive

Hormonal therapies for the adjuvant treatment of early oestrogenreceptor-positive Hormonal therapies for the adjuvant treatment of early oestrogenreceptor-positive breast cancer Issued: November 2006 guidance.nice.org.uk/ta112 NICE 2006 Contents 1 Guidance... 3 2 Clinical need and practice...

More information

Osteoporosis. Treatment of a Silently Developing Disease

Osteoporosis. Treatment of a Silently Developing Disease Osteoporosis Treatment of a Silently Developing Disease Marc K. Drezner, MD Senior Associate Dean Emeritus Professor of Medicine Emeritus University of Wisconsin-Madison Auditorium The Forest at Duke October

More information

You have been referred to the osteoporosis clinic because you have sustained a fracture of the *hip / vertebra / wrist.

You have been referred to the osteoporosis clinic because you have sustained a fracture of the *hip / vertebra / wrist. EXAMPLE 1a FRACTURE PATIENT INVITE LETTER «ClinicPhone» «PatientAddress1» «PatientAddress2» «PatientAddress3» «PatientAddress4» «PatientPostcode» Dear «PatientTitle» «PatientSurname» You have been referred

More information

Summary of the risk management plan by product

Summary of the risk management plan by product Summary of the risk management plan by product 1 Elements for summary tables in the EPAR 1.1 Summary table of Safety concerns Summary of safety concerns Important identified risks Important potential risks

More information

Putting NICE guidance into practice

Putting NICE guidance into practice Putting NICE guidance into practice Costing statement: Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes (review of technology appraisal guidance 182) Implementing

More information

Osteoporosis challenges

Osteoporosis challenges Osteoporosis challenges Osteoporosis challenges Who should have a fracture risk assessment? Who to treat? Drugs, holidays and unusual adverse effects Fracture liaison service? The size of the problem 1

More information

Technology appraisal guidance Published: 27 March 2019 nice.org.uk/guidance/ta572

Technology appraisal guidance Published: 27 March 2019 nice.org.uk/guidance/ta572 Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes Technology appraisal guidance Published: 27 March 2019 nice.org.uk/guidance/ta572 NICE 2019. All rights reserved. Subject to

More information

Title: From zero to comprehensive Fracture Liaison service (FLS) within existing resources

Title: From zero to comprehensive Fracture Liaison service (FLS) within existing resources Best of Health Staff Awards 2010/11 Best of Health Awards 2013 Dr Abhaya Gupta Consultant Physician Hywel Dda Health Board Title: From zero to comprehensive Fracture Liaison service (FLS) within existing

More information

Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480

Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480 Tofacitinib for moderate to severeere rheumatoid arthritis Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480 NICE 2018. All rights reserved. Subject to Notice of rights

More information

Fragile Bones and how to recognise them. Rod Hughes Consultant physician and rheumatologist St Peter s hospital Chertsey

Fragile Bones and how to recognise them. Rod Hughes Consultant physician and rheumatologist St Peter s hospital Chertsey Fragile Bones and how to recognise them Rod Hughes Consultant physician and rheumatologist St Peter s hospital Chertsey Osteoporosis Osteoporosis is a skeletal disorder characterised by compromised bone

More information

SCORECARD Questionnaire September 2012

SCORECARD Questionnaire September 2012 Introduction SCORECARD Questionnaire September 2012 The Osteoporosis Advisory Panel is an independent project chaired by our president Professor John Kanis, supported by a multi-stakeholder group of experts

More information

Initial Pathway for DEXA Referral and Treatment for Fracture Risk Reduction in Postmenopausal Women and Men Age 50 or Above

Initial Pathway for DEXA Referral and Treatment for Fracture Risk Reduction in Postmenopausal Women and Men Age 50 or Above Initial Pathway for DEXA Referral and Treatment for Fracture Risk Reduction in Postmenopausal Women and Men Age 50 or Above 2 or > vertebral fractures Low trauma fracture In past 5 years Risk Factors (table1)

More information

Tamer Mettyas 1* and Clare Carpenter 2

Tamer Mettyas 1* and Clare Carpenter 2 Mettyas and Carpenter Journal of Orthopaedic Surgery and Research 2013, 8:44 RESEARCH ARTICLE Open Access Secondary prevention of osteoporosis in non-neck of femur fragility : is it value for money? A

More information