COST-EFFECTIVENESS OF TREATMENT FOR MODERATE-TO-SEVERE PSORIASIS
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1 COST-EFFECTIVENESS OF TREATMENT FOR MODERATE-TO-SEVERE PSORIASIS Cheryl S. Hankin PhD 1 ; Steven R. Feldman, MD, PhD 2 ; Daniel Pearce, MD 2 1 BioMedEcon, San Jose, CA, USA; 2 Wake Forest University School of Medicine, Winston-Salem, NC, USA Funded by Connetics Corporation
2 OVERVIEW Definition and Prevalence Treatment Cost-Effectiveness Study Background Objective Methods Findings Conclusion Discussion
3 DEFINITION Chronic polygenic disorder that results from predisposing & triggering factors (e.g., trauma, infection) Epidermal proliferation and differentiation Sharply demarcated, scaly erythematous plaques with silvery white scales During exacerbations, lesions often itch
4 PREVALENCE of MODERATE-TO-SEVERE PSORIASIS Affects up to 30% of patients Generally involves > 2% body surface area Disabling Location (face, hands, fingernails, feet, genitals) Symptoms (pain, tightness, bleeding, severe itching)
5 TREATMENT Oral Systemics acitretin (Soriatane - Connetics) cyclosporine (Neoral - Novartis) methotrexate (Trexall - Barr) Biologics alefacept (Amevive -Biogen) efalizumab (Raptiva - Genentech/Xoma) etanercept (Enbrel - Amgen) Phototherapy Ultraviolet B (UVB) Psoralen with Ultraviolet A (PUVA) Combined Phototherapy with acitretin
6 Systemic Treatment Options are Burgeoning methotrexate cyclosporine acitretin
7 Systemic Treatment Options are Burgeoning methotrexate cyclosporine acitretin alefacept efalizumab etanercept
8 Systemic Treatment Options are Burgeoning methotrexate cyclosporine acitretin alefacept efalizumab etanercept rosiglitazone maleate bimosiamose pimecrolimus humira ISA247 AE-941 onercept alitretinoin psoraxine infliximab MEDI-507 IR50 rosiglitazone maleate
9 Systemic Treatment Options are Burgeoning But, Head-to-Head Efficacy Comparisons are Lacking methotrexate alefacept cyclosporine efalizumab acitretin etanercept rosiglitazone maleate bimosiamose pimecrolimus humira ISA247 AE-941 onercept alitretinoin psoraxine infliximab MEDI-507 IR50 rosiglitazone maleate
10 OBJECTIVE From the perspective of U.S. managed healthcare decision makers, to compare efficacy and costs across the range of treatments for moderate-tosevere psoriasis.
11 METHODS Total Costs CE = Clinical Outcomes Johnson NE, 1996.
12 METHODS Drug or UV Total Costs CE = Clinical Outcomes Administration Screening Adverse Events Johnson NE, 1996.
13 METHODS Total Costs CE = Clinical Outcomes Drug or UV Administration Screening Adverse Events Average Wholesale Prices Medicare Reimbursement Rates Johnson NE, 1996.
14 METHODS Total Costs CE = Clinical Outcomes Drug or UV Administration Screening Adverse Events Average Wholesale Prices Medicare Reimbursement Rates Average % Improvement Johnson NE, 1996.
15 METHODS Total Costs CE = Clinical Outcomes Drug or UV Administration Screening Adverse Events Average Wholesale Prices Medicare Reimbursement Rates Average % Improvement Psoriasis Area & Severity Index (PASI) Johnson NE, 1996.
16 METHODS Total Costs CE = Clinical Outcomes Drug or UV Administration Screening Adverse Events Average Wholesale Prices Medicare Reimbursement Rates Average % Improvement Psoriasis Area & Severity Index (PASI) Systematic Literature Review by Expert Panel Consensus Johnson NE, 1996.
17 METHODS Total Costs CE = Clinical Outcomes Drug or UV Administration Screening Adverse Events Average Wholesale Prices Medicare Reimbursement Rates WHAT IS THE COST OF 1% PASI IMPROVEMENT? WHAT IS THE COST OF CLINICALLY MEANINGFUL IMPROVEMENT? (50%, 75%) Johnson NE, Average % Improvement Psoriasis Area & Severity Index (PASI) Systematic Literature Review by Expert Panel Consensus
18 Cost-effectiveness Model Perspective Viewpoint: Health Systems Country of Analysis: United States Target Population: Adults with moderate-to-severe psoriasis Setting of Care: Outpatient Time Frame: 1 year
19 RESULTS OF SYSTEMATIC LITERATURE REVIEW OF PASI EFFICACY MEDLINE 1966-August 2004 Psoriasis AND [Treatment] Published, Peer-Reviewed English Language Total Articles Identified 3,886 Less Excluded Due To: Efficacy Characteristics 1,351 Sample Selection 225 Treatment Characteristics 398 Study Design 1,896 Total Excluded 3,870 Total Efficacy Studies Included 16
20 Treatment Dose PASI% Broadband UVB 3 exp/wk 47%, 80.1%, 83.7% Narrowband UVB 3 exp/wk 73.0% PUVA 3 exp/wk 92.9% 3 exp/wk 61.1% acitretin 48.2 mg/day 60.4% cyclosporine 1.5 mg/kg/day 33.4% 3 mg/kg/day 52.0% methotrexate 7.5 mg/wk 58.4% 15 mg/wk 71.6% alefacept 15 mg/wk 2-12wk courses 45.0% efalizumab 1 mg/kg/wk 51%, 52.0% etanercept 50 mg 2xs weekly 64.2% infliximab 5 mg/kg wks 0, 2, % UVB + acitretin 5-7 exp/wk + 25 mg/d 80.7 % PUVA + acitretin 3 exp/wk + 20mg 97.3%
21 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin January 2004 Screen AE Average Wholesale Price (AWP) TOTAL COSTS PASI% PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , , Medicare Reimbursement Rates BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
22 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI% PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 Self-Administered PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 IV Injection (@ 2004 Medicare Rate) etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 IV Infusion (@ 2004 Medicare Rate) infliximab 5 mg/kg 24,898 1, , ,946
23 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE Product TOTAL 2004 Medicare COSTS PASI% Rate PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 Consensus 2004 Medicare Rate cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
24 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI% PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 Risk-adjusted Costs PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
25 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI% PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
26 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 Expert Panel Systematic Literature Review PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
27 Total Costs / PASI ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI PASI 1% PASI 75 methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946
28 PASI 1% * 75 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI PASI 1% methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946 PASI 75%
29 ANNUALIZED COSTS (USD) ANNUAL COSTS TO ACHIEVE Treatment Tx Admin Screen AE TOTAL COSTS PASI PASI 1% methotrexate 7.5 mg 595-1,188-1, ,290 methotrexate 15 mg 1,190-1,188-2, ,491 cyclosporine 1.5mg/kg 2,789-1, , ,600 PUVA 3xs/wk 3, , ,111 PUVA 3xs/wk 3, , ,731 BBUVB+acitretin 25mg 3, , ,149 BB UVB 3xs/wk 4, , ,617 cyclosporine 3 mg/kg 5,019-1, , ,025 PUVA+acitretin 20mg 6, , ,735 acitretin 50 mg 12, , ,217 efalizumab 1 mg/kg 17, , ,960 etanercept 50 mg 21, , ,717 alefacept 15 mg IM 23, ,412-27, ,163 infliximab 5 mg/kg 24,898 1, , ,946 PASI 75%
30 Annualized Total Costs (USD) ( Rx/Tx + Admin + Screen + AE) methotrexate 15 mg PUVA BB UVB+acitretin Annualized Total Costs cyclosporine 1.5 mg/kg BB UVB PUVA + acitretin acitretin 50 mg efalizumab 1mg/kg etanercept 50 mg infliximab 5 mg/kg alefacept 15 mg IM 0 5,000 10,000 15,000 20,000 25,000 30,000 USD
31 MTX 15 mg PUVA 3xs/wk BB UVB+acitretin CyA 1.5mg/kg BB UVB 3xs/w k PUVA+acitretin acitretin 50 mg Annualized Total Costs efalizumab 1 mg/kg etanercept 50 mg infliximab 5 mg/kg alefacept 15 mg IM 0 5,000 10,000 15,000 20,000 25,000 30,000
32 Reported Average PASI % Improvement from Baseline (% Efficacy) CyA 1.5mg/kg alefacept 15 mg IM efalizumab 1 mg/kg acitretin 50 mg etanercept 50 mg PASI % MTX 15 mg BB UVB 3xs/w k BB UVB+acitretin infliximab 5 mg/kg PUVA 3xs/w k PUVA+acitretin 0% 20% 40% 60% 80% 100% PASI % IMPROVEMENT FROM BASELINE
33 MTX 15 mg PUVA 3xs/wk BB UVB+acitretin CyA 1.5mg/kg BB UVB 3xs/w k PUVA+acitretin acitretin 50 mg Annualized Total Costs efalizumab 1 mg/kg etanercept 50 mg infliximab 5 mg/kg alefacept 15 mg IM 0 5,000 10,000 15,000 20,000 25,000 30,000 CyA 1.5mg/kg alefacept 15 mg IM efalizumab 1 mg/kg acitretin 50 mg etanercept 50 mg MTX 15 mg BB UVB 3xs/w k BB UVB+acitretin infliximab 5 mg/kg PASI % PUVA 3xs/w k PUVA+acitretin
34 Annualized Costs to Achieve 1% PASI Improvement (USD) MTX 15 mg PUVA 3xs/w k BBUVB+acitretin PUVA+acitretin CyA 1.5mg/kg acitretin 50 mg infliximab 5 mg/kg etanercept 50 mg efalizumab 1 mg/kg Annualized Costs to Achieve 1% PASI Improvement alefacept 15 mg IM USD
35 MTX 15 mg PUVA 3xs/wk BB UVB+acitretin CyA 1.5mg/kg BB UVB 3xs/w k PUVA+acitretin acitretin 50 mg Annualized Total Costs efalizumab 1 mg/kg etanercept 50 mg infliximab 5 mg/kg alefacept 15 mg IM 0 5,000 10,000 15,000 20,000 25,000 30,000 CyA 1.5mg/kg alefacept 15 mg IM efalizumab 1 mg/kg acitretin 50 mg etanercept 50 mg MTX 15 mg BB UVB 3xs/w k BB UVB+acitretin infliximab 5 mg/kg PASI % PUVA 3xs/w k PUVA+acitretin MTX 15 mg PUVA 3xs/wk BBUVB+acitretin Annualized Costs to Achieve 1% PASI Improvement PUVA+acitretin CyA 1.5mg/kg acitretin 50 mg infliximab 5 mg/kg etanercept 50 mg efalizumab 1 mg/kg alefacept 15 mg IM
36 Annualized Costs to Achieve 75% PASI Improvement (USD) MTX 15 mg PUVA 3xs/w k BBUVB+acitretin Annualized Costs to Achieve 75% PASI Improvement CyA 1.5mg/kg acitretin 50 mg infliximab 5 mg/kg etanercept 50 mg efalizumab 1 mg/kg alefacept 15 mg IM 0 10,000 20,000 30,000 40,000 50,000 USD
37 MTX 15 mg PUVA 3xs/wk BB UVB+acitretin CyA 1.5mg/kg BB UVB 3xs/w k PUVA+acitretin acitretin 50 mg Annualized Total Costs efalizumab 1 mg/kg etanercept 50 mg infliximab 5 mg/kg alefacept 15 mg IM 0 5,000 10,000 15,000 20,000 25,000 30,000 CyA 1.5mg/kg alefacept 15 mg IM efalizumab 1 mg/kg acitretin 50 mg etanercept 50 mg MTX 15 mg BB UVB 3xs/w k BB UVB+acitretin infliximab 5 mg/kg PASI % PUVA 3xs/w k PUVA+acitretin MTX 15 mg PUVA 3xs/wk BBUVB+acitretin Annualized Costs to Achieve % PASI Improvement MTX 15 mg PUVA 3xs/w k BBUVB+acitretin Annualized Costs to Achieve 75% PASI Improvement PUVA+acitretin CyA 1.5mg/kg acitretin 50 mg infliximab 5 mg/kg etanercept 50 mg efalizumab 1 mg/kg alefacept 15 mg IM CyA 1.5mg/kg acitretin 50 mg infliximab 5 mg/kg etanercept 50 mg efalizumab 1 mg/kg alefacept 15 mg IM ,000 20,000 30,000 40,000 50,000
38 Conclusions The most costly treatments are not necessarily the most efficacious. Biologics do not appear to be as costeffective as oral systemics, phototherapies, or combined phototherapy with acitretin. Our results do not justify positioning biologics as first-line therapy for moderateto-severe psoriasis.
39 Discussion Cheryl S. Hankin, Ph.D. President and Chief Scientific Officer BioMedEcon Group San Jose, California
40 Backup
41 STUDY EXCLUSION CRITERIA PASI % improvement from baseline not reported or unavailable for calculation. Number of Ss receiving active treatment <10. Treatment duration <6 or > 14 wks. Diagnosis other than moderate to severe psoriasis or PASI < 8. Sample does not consist predominantly of plaque psoriasis (vs other variants). Mean dose unspecified. For monotherapies, concomitant systemic or phototherapy psoriasis. medication/treatment was received in addition to targeted treatment. Maintenance following stabilization (rather than de novo) treatment. Dose exceeds current recommendation. Duration of study or time at endpoint evaluation unspecified. Study is duplication and previously reviewed by us. Poor Study Quality (did not apply Intent To Treat). Disposition of dropouts unclear. Dropouts excluded from analysis. Biased sample selection (e.g., Ss excluded from participation if poor response to treatment previously). Study Design Retrospective review. Case Study. Randomized assignment to groups?
42 SEARCH PROCEDURE CONDCT SEARCH Medline: /2004 for (Psoriasis AND Tx) Limit English N=xxx Handsearch (Using References Obtained from Medline Articles) N=xxx REVIEW TITLES & ABSTRACTS Review Articles Rx Non Tx Case nonplaque News Possible (N=xx) Letter Methods Practice Patterns Child Adverse Events EXAMINE ARTICLES Review Articles Non Psoriasis (=x) Retrospective Study CANDIDATE ARTICLES Adverse Events News Rx Duplicate WRITTEN EVALUATION of ARTICLES Dose? Retrospective Study Dose > No PASI Dropouts? Dropouts Not Included in Analysis INCLUDED AS PASI EFFICACY Small N Endpt? Duplicate Concomitant Rx/ Tx UNCERTAIN: REQUIRES FURTHER REVIEW BY PACE Biased Sample
43 Systemic Psoriasis Drugs Under Development Drug Name Company Description Status Avandia (rosiglitazone maleate) GlaxoSmithKline oral antidiabetic agent phase III for psoriasis Bimosiamose Encysive endothelin A receptor antagonist phase II Elidel (pimecrolimus) Novartis oral anti-inflammatory phase II Humira Abbott monoclonal antibody phase II for psoriasis ISA247 Isotechnika systemic immunosuppressant phase II complete Neovastat (AE-941) Aeterna angiogenesis inhibitor phase II complete Onercept Serono anti-tnf protein phase III Panretin (alitretinoin) Ligand oral vitamin A derivative phase II Psoraxine Astralis injectable immuno-therapeutic agent phase I/II Remicade (infliximab) Centocor anti-tnf phase III for psoriatic Siplizumab (MEDI- 507) Zorcell (IR502) Medimmune Immune Response monoclonal antibody against T-cell receptor (CD2) causes immune system to shut down activated T cells phase II phase II Source: National Psoriasis Foundation updated June 23, 2004
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