Naproxcinod for the Second Line Treatment of Osteoarthritis

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Proposed Single Technology Appraisal (STA)

Naproxcinod for the second line treatment of osteoarthritis

Provisional matrix of consultees and commentators

Consultees Commentators (no right to submit or appeal)

Manufacturers/sponsors General • NicOx (naproxcinod) • Board of Community Health Councils in Wales Patient/carer groups • British National Formulary • Action on Pain • Care Quality Commission • Afiya Trust • Commissioning Support Appraisals • Arthritic Association Service • Arthritis & Musculoskeletal Alliance • Department of Health, Social Services (ARMA) and Public Safety for Northern Ireland • Arthritis Care • Medicines and Healthcare products • Black Health Agency Regulatory Agency • Carers UK • National Association of Primary Care • Chinese National Healthy Living • NHS Alliance Centre • NHS Commercial Medicines Unit • Counsel and Care • NHS Confederation • Equalities National Council • NHS Quality Improvement Scotland • Leonard Cheshire Disability • Public Health Wales NHS Trust • Muslim Council of Great Britain • Scottish Medicines Consortium • Muslim Health Network • National Osteoporosis Society Possible comparator manufacturer(s) • Pain Concern • A .Menarini Pharma UK SRL • Pain Relief Foundation (ketoprofen) • RADAR - Royal Association for • Abbot Laboratories (ibuprofen, Disability and Rehabilitation flurbiprofen) • Skill: National Bureau for Students • Actavis UK (ibuprofen, ketoprofen, with Disabilities piroxicam, naproxen, fenbufen, • South Asian Health Foundation aceclofenac,indometacin, mefenamic • Specialised Healthcare Alliance acid, meloxicam, nabumetone, • STEPS Charity Worldwide flurbiprofen, diclofenac, tartrate, co- codamol, co-dydramol) Professional groups • Allergan (flurbiprofen) • Association of Surgeons of Great • Almirall (aceclofenac, etodolac, Britain and Ireland diclofenac sodium) • Bone Research Society • Arrow Generics (ibuprofen, piroxicam, • British Association for Services to naproxen, indometacin, mefenamic the Elderly acid, meloxicam, diclofenac, co- • British Association for Surgery of the codamol, co-dydramol) National Institute for Health and Clinical Excellence Provisional matrix for the proposed technology appraisal of naproxcinod for the second line treatment of osteoarthritis Issue date: July 2010 Consultees Commentators (no right to submit or appeal)

Knee • Bayer (naproxen, co-codamol) • British Geriatrics Society • Boehringer Ingelheim (meloxicam) • British Health Professionals in • Boots Company (ketoprofen, Rheumatology indometacin, co-dydramol, ibuprofen) • British Hip Society • Bristol Laboratories (ibuprofen, co- • British Institute of Musculoskeletal codamol) Medicine • Bristol Myers Squibb Pharmaceuticals • British Institute of Radiology (triamcinolone acetonide) • British Orthopaedic Association • Chanelle Medical (meloxicam) • British Pain Society • Chatfield Laboratories (ibuprofen) • British Society for Rheumatology • Chemidex Pharma (mefenamic acid) • British Society of Rehabilitation • Chiesi (ketoprofen, diclofenac sodium, Medicine piroxicam) • British Society of Skeletal Radiology • Daiichi Sankyo UK (diclofenac • Chartered Society of sodium) Physiotherapists • Dermal Laboratories (ibuprofen) • College of Occupational Therapists • Dexcel Pharma (ibuprofen, diclofenac • Primary Care Rheumatology Society sodium) • Royal College of Anaesthetists • Discovery Pharmaceuticals • Royal College of General (diclofenac sodium) Practitioners • Dr Reddy’s Laboratories (UK) • Royal College of Nursing (piroxicam, indometacin) • Royal College of Pathologists • Essential Generics (tenoxicam) • Royal College of Physicians • Galen (diclofenac sodium, co- • Royal College of Radiologists dydramol) • Royal College of Surgeons • Genus Pharmaceuticals (ibuprofen, • Royal Pharmaceutical Society fenbufen, meloxicam, flurbiprofen) • Royal Society of Medicine • GlaxoSmithKline Consumer • Society and the College of Healthcare (ibuprofen, co-codamol) Radiographers • Goldshield Pharmaceuticals • Society for Endocrinology (ibruprofen, ketoprofen, fenbufen, • United Kingdom Clinical Pharmacy diclofenac sodium, tartrate, co- Association codamol) • Javelin Pharmaceuticals(diclofenac) Others • Kent pharmaceuticals (ibuprofen, • Department of Health ketoprofen, piroxicam, naproxen, • NHS Cornwall and the Isle of Scilly fenbufen, indometacin, mefenamic • NHS Redcar and Cleveland acid, meloxicam, sulindec, tenoxicam, flurbiprofen, diclofenac, co-codamol, • Welsh Assembly Government co-dydramol) • Martindale Pharmaceuticals (co- codamol) • McNeil Products (ibuprofen, co- codamol) • Meda Pharmaceuticals (etodolac,

National Institute for Health and Clinical Excellence Provisional matrix for the proposed technology appraisal of naproxcinod for the second line treatment of osteoarthritis Issue date: July 2010 Consultees Commentators (no right to submit or appeal)

nabumetone) • Merck Sharp and Dohme (indometacin, sulindec) • Mylan (ketoprofen, piroxicam, dexibuprofen, naproxen, fenbufen, aceclofenac, indometacin, mefenamic acid, meloxicam, nabumetone, sulindec, diclofenac, co-codamol, co- dydramol) • Napp Pharmaceuticals (ibuprofen, indometacin, tartrate, co-codamol) • Niche Generics (meloxicam) • Novartis Pharmaceuticals( diclofenac diethylammonium, diclofenac sodium, epolamine, ibuprofen, diclofenac potassium), • Nuvo Research(diclofenac sodium) • Orbis Consumer Products (ibuprofen) • Organon Laboratories (dexamethasone) • Orphan Europe (UK) (ibuprofen) • Pfizer (piroxicam, ibuprofen, naproxen, indometacin, celecoxib, diclofenac sodium), methylprednisolone acetate) • Ranbaxy (UK) (ibuprofen, etodolac, diclofenac, co-codamol, co-dydramol), • Reckitt Benkiser Healthcare (UK) (ibuprofen, flurbiprofen) • Roche Products (naproxen, naproxen sodium, tenoxicam) • Rosemont Pharmaceuticals (co- codamol, co-dydramol) • Sandoz Ltd (ibuprofen, ketoprofen, piroxicam, naproxen, aceclofenac, indometacin, meloxicam, nabumetone, tenoxicam, flurbiprofen, diclofenac sodium, co-codamol) • Sanofi-Aventis (ketoprofen, tiaprofenic acid, co-codamol) • Sovereign Medical (diclofenac sodium, hydrocortisone acetate, prednisolone acetate, co-codamol, ibuprofen) • SSL International (ibuprofen, tartrate, co-codamol) National Institute for Health and Clinical Excellence Provisional matrix for the proposed technology appraisal of naproxcinod for the second line treatment of osteoarthritis Issue date: July 2010 Consultees Commentators (no right to submit or appeal)

• Teva UK (ibuprofen, ketoprofen, piroxicam, naproxen, mefenamic acid, meloxicam, nabumetone, diclofenac, co-codamol, co-dydramol), • Therabel Pharma UK (diclofenac sodium) • Typharm (fenoprofen) • UCB Pharma (betamethasone, co- codamol) • Waymade Healthcare (ibuprofen, ketoprofen, piroxicam, naproxen, aceclofenac, nabumetone, tenoxicam, diclofenac, co-codamol) • Winthrop Pharmaceuticals (ibuprofen, mefenamic acid, meloxicam, co- codamol, co-dydramol) • Wockhardt UK (ibuprofen, naproxen, co-dydramol) • Wyeth Healthcare (ibuprofen) • Zanza Laboratories (co-codamol)

Relevant research groups • Arthritis Research Campaign • Chronic Pain Policy Coalition • MRC Clinical Trials Unit • National Institute for Health Research • Policy Research Institute on Ageing and Ethnicity • Research Institute for the Care of Older People

Evidence Review Group • Evidence Review Group tbc • National Institute for Health Research Health Technology Assessment Programme

Associated Guideline Groups • National Clinical Guideline Centre

Associated Public Health Groups • tbc

National Institute for Health and Clinical Excellence Provisional matrix for the proposed technology appraisal of naproxcinod for the second line treatment of osteoarthritis Issue date: July 2010

NICE is committed to promoting equality and eliminating unlawful discrimination. Please let us know if we have missed any important organisations from the lists contained within the matrix and which organisations we should include who have a particular focus on relevant equality issues.

PTO FOR DEFINITIONS OF CONSULTEES AND COMMENTATORS

Consultees Organisations that accept an invitation to participate in the appraisal; the manufacturer(s) or sponsor(s) of the technology; national professional organisations; national patient organisations; the Department of Health and the Welsh Assembly Government and relevant NHS organisations in England.

The manufacturer/sponsor of the technology is invited to make an evidence submission, respond to consultations and has the right to appeal against the Final Appraisal Determination (FAD).

All non-manufacturer/sponsor consultees are invited to submit a statement1, respond to consultations, nominate clinical specialists or patient experts and have the right to appeal against the Final Appraisal Determination (FAD).

Commentators Organisations that engage in the appraisal process but that are not asked to prepare an evidence submission or statement, are able to respond to consultations and they receive the FAD for information only, without right of appeal. These organisations are: manufacturers of comparator technologies; NHS Quality Improvement Scotland; the relevant National Collaborating Centre (a group commissioned by the Institute to develop clinical guidelines); other related research groups where appropriate (for example, the Medical Research Council [MRC], National Cancer Research Institute); other groups (for example, the NHS Confederation, NHS Information Authority and NHS Purchasing and Supplies Agency, and the British National Formulary.

All non-manufacturers/sponsors commentators are invited to nominate clinical specialists or patient experts.

Evidence Review Group (ERG)

An independent academic group commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA Programme) to assist the Appraisal Committee in reviewing the manufacturer/sponsor evidence submission to the Institute.

1 Non manufacturer consultees are invited to submit statements relevant to the group they are representing.

National Institute for Health and Clinical Excellence Provisional matrix for the proposed technology appraisal of naproxcinod for the second line treatment of osteoarthritis Issue date: July 2010