PHARMAC responds on TNF inhibitors for inflammatory arthritis [4]

New Zealand Medical Journal

Volumn 118, Issue 1227, 2005, Pages

  Metcalfe, Scott ^a   Moodie, Peter ^a   Grocott, Rachel ^a   Wilkinson, Tommy ^a  

^a PHARMAC ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; METHOTREXATE; PLACEBO; PREDNISONE; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; TUMOR NECROSIS FACTOR ALPHA RECEPTOR;

ANKYLOSING SPONDYLITIS; ARTHROPATHY; AUSTRALIA; CLINICAL TRIAL; CONSULTATION; COST BENEFIT ANALYSIS; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; DRUG COST; DRUG EFFICACY; DRUG INDUSTRY; ECONOMIC EVALUATION; HEALTH CARE NEED; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; LETTER; MEDICAL DECISION MAKING; MEDICAL DOCUMENTATION; NEW ZEALAND; POPULATION RESEARCH; PRESCRIPTION; PSORIATIC ARTHRITIS; QUALITY ADJUSTED LIFE YEAR; QUESTIONNAIRE; RHEUMATOID ARTHRITIS; SIDE EFFECT; TREATMENT OUTCOME;

EID: 29944436203     PISSN: 11758716     EISSN: 11758716     Source Type: Journal    
DOI: None     Document Type: Letter

References (25)

1. Grainger R, Harrison A. TNF inhibitors for inflammatory arthritis in New Zealand. N Z Med J. 2005;118(1224). URL: http://www.nzma.org.nz/journal/118-1224/1706/
2. Schedule of Pharmaceutical Benefits from 1 December 2005, Immunosuppressive agents. Australian Government Department of Health and Ageing. URL: http://www1.health.gov.au/pbs/scripts/ dispther.cfm?lvl3id=26916&sched=GA&lvl3name= Immunosuppresive%20agents&lvl2name=Immunosuppresive%20agents& lvl1name=Antineoplastic%20and%20immunomodulating%20agents
3. PHARMAC. Operating policies and procedures of the Pharmaceutical Management Agency ("PHARMAC"), 2nd edition. January 2001. URL: http://www.pharmac.govt.nz/pdf/opps.pdf (Section 2.2 Decision Criteria)
4. PHARMAC. Infliximab (Remicade) and etanercept (Enbrel) for rheumatoid arthritis. Final Hospital Pharmaceutical Assessment summary discussion document no. 12, Wellington, February 2005. Unpublished information for DHB use only.
5. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999;354:1932-9.
6. This subgroup of those 87 patients in the ATTRACT trial who had severe treatment-resistant disease was restricted to patients with all of the following features: rheumatoid factor positive; had failed three or more alternative DMARDs including methotrexate; had ESR ≥28 mm/hr or CRP ≥20 mg/L (ATTRACT inclusion criteria); and had ≥15 swollen or tender joints.
7. For this subgroup, 40% of patients switched treatment after 14 weeks because they failed to meet the criteria for continuing treatment (being a 50% reduction in the number of swollen and tender joints).
8. Data sheet: Remicade® powder for injection datasheet (infliximab 100mg, Schering-Plough). Medsafe, 2004. URL: http://www.medsafe.govt.nz/DatasheetPage.htm
9. Adalimumab. Prescrire Int. 2004;13:171-5.
10. The TEMPO trial of etanercept found that the ACR responses of patients administered etanercept and methotrexate were significantly better compared with etanercept alone and methotrexate alone. At 52 weeks, 69% of patients in the combination group achieved ACR50, compared with 43% in the methotrexate group (p=0.0091) and 48% in the etanercept group (p=0.0151). More than a third (35%) of patients receiving combination treatment had disease remission after one year, compared with 16% of patients administered etanercept only and 13% administered methotrexate only. However, a number of patients still had active inflammation. (Klareskog L, van der Heijde D, de Jager JP, et al; TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet. 2004;363:675-81.)
11. Maini et al 1998 found that patients receiving 1 mg/kg of infliximab without methotrexate became unresponsive to repeat infusions of infliximab. However those who were coadministered methotrexate appeared to benefit from a synergy between the drugs, which was observed as a prolonged duration of response. (Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41:1552-63.)
12. Redelmeier DA, Lorig K. Assessing the clinical importance of symptomatic improvements. An illustration in rheumatology. Arch Intern Med. 1993;153:1337-42.
13. Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000;43:1478-87.
14. The HAQ measures both function and pain, by assessing patients' ability to dress, arise, eat, walk, maintain personal hygiene, reach, and grip (degrees of difficulty) and pain (visual analogue scale) (Blumenauer B, Cranney A, Clinch J, Tugwell P. Quality of life in patients with rheumatoid arthritis: which drugs might make a difference? Pharmacoeconomics. 2003;21:927-40.).
15. Scott DL, Strand V. The effects of disease-modifying anti-rheumatic drugs on the Health Assessment Questionnaire score. Lessons from the leflunomide clinical trials database. Rheumatology (Oxford). 2002;41:899-909.
16. American College of Rheumatology (ACR) 20/50/70 system (Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-35.), frequently used in treatment intervention trials.
17. Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000;43:1478-87.
18. Drossaers-Bakker KW, Kroon HM, Zwinderman AH, et al. Radiographic damage of large joints in long-term rheumatoid arthritis and its relation to function. Rheumatology (Oxford). 2000;39:998-1003.
19. Maillefert JF, Combe B, Goupille P, et al. The 5-yr HAQ-disability is related to the first year's changes in the narrowing, rather than erosion score in patients with recent-onset rheumatoid arthritis. Rheumatology (Oxford). 2004;43:79-84.
20. Clarke AE, St-Pierre Y, Joseph L, et al. Radiographic damage in rheumatoid arthritis correlates with functional disability but not direct medical costs. J Rheumatol. 2001;28:2416-24.
21. Sokka T, Kankainen A, Hannonen P. Scores for functional disability in patients with rheumatoid arthritis are correlated at higher levels with pain scores than with radiographic scores. Arthritis Rheum. 2000;43:386-9.
22. Scott DL, Pugner K, Kaarela K, et al. The links between joint damage and disability in rheumatoid arthritis. Rheumatology (Oxford). 2000;39:122-32.
23. Metcalfe S, Dougherty S, Brougham M, Moodie P. PHARMAC measures savings elsewhere to the health sector. N Z Med J. 2003;116(1170). URL: http://www.nzma.org.nz/journal/116-1170/362/ PHARMAC. A prescription for pharmacoeconomic analysis (version 1.1). September 2004. URL: http://www.pharmac.govt.nz/pdf/pfpa.pdf The perspective taken by PHARMAC when conducting cost effectiveness analyses is that of the health sector. This relates to PHARMAC's primary objective of achieving the best health outcomes possible from pharmaceutical treatment within the funding available (New Zealand Public Health and Disability Act 2000 [NZPHDA], Section 47 Objectives of Pharmac). This implies that any patient benefits and/or costs that accrue beyond being either healthy or unhealthy are outside the scope of PHARMAC analysis (where "health" is defined by default in the NZPHDA as amenable to health services interventions). This means that extra economic production stemming from an individual being healthier is outside the scope of PHARMAC's analyses. Including indirect costs, such as loss of earnings, may prejudice decisions against issues affecting the young, elderly, and less economically productive groups. This conflicts with the public priorities as stated by the Government under the New Zealand Health Strategy (http://www.moh.govt.nz/nzhs.html). In addition, indirect costs such as patient travelling times and productivity losses are not easily measured. There is usually little available data on these issues or how to cost them across patient sub-groups. Consequently, incorporating these into analyses would mean using significant and untestable assumptions. Given the large uncertainties involved, PHARMAC has felt it best to avoid incorporating these estimates into its base case analyses.
24. HPAD analyses are undertaken for DHB hospitals as part of the Hospital Pharmaceutical Assessment Process (HPAP). HPAP was established in 2002 as part of the National Hospital Pharmaceutical Strategy, to reduce duplication of work and increase discussion on the costs and benefits of new pharmaceuticals by distributing hospital pharmaceutical assessments nationally. These assessments are distributed to DHBs as confidential documents, which is at the request of and agreement with the pharmaceutical industry. Further information on the purpose of HPAP and PHARMAC's role in the distribution of discussion documents can be found on the PHARMAC website - http://www.pharmac.govt.nz/hospital_strategy.asp
25. PHARMAC receives about 30 applications for funding each year. In general, of those applications that PTAC does assign priority to, about 40% have been given high or moderate priority, 30% low priority or fund only if cost-neutral, and for 30% PTAC has recommended they be declined (applications considered by PTAC during 2004 and 2005 to date). Priority ratings are used both to inform PHARMAC on the use of analyst resources in conducting technology assessments and for PHARMAC to prioritise spending.