Elements of Successful PBS Applications. Barbara Radulski RN. Copyright

Transcription

1 Elements of Successful PBS Applications Barbara Radulski RN

2 PBS Requirements April THE RULES

3 PBS Requirements 18 years and over Psoriasis x 6 months Failed to achieve an adequate response to 3 systemic treatments following a minimum of 6 weeks of treatment

4 PBS Requirements Failure to achieve an adequate response PASI > 15 (x 3)

5 Systemic Therapies Response to Treatment PASI s must be documented preferably whilst still on systemic therapy or within 1 month of treatment cessation

6 Systemic Therapies Response to Treatment Response to systemic treatment prescribed > April must be demonstrated via FULL PASI score Most recent PASI assessment must be no more than 1 month old at the time of application

7 PBS Requirements Systemic Therapies MTX 10 mg / week Cyclosporin 2 mg / kg / day Acitretin 0.4 mg / kg / day Phototherapy 3 X weekly x 6 Weeks + PASI >15

8 PBS Requirements Unwritten rule: systemic treatments must have been trialed within last 10 years

9 Treatment Trials Documentation

10 13 Jan 12

11 02 March 12 Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

12 13 Jan Mar 12

13 13 January March March 12

14 27 Apr 12 Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

15 13 January March March Apr 12

16 13 January March March Apr (90kg) 27 Apr12

17 29 June12 Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

18 13 January March March Apr Apr12 29 June 12

19 Induction Dose Prescription

20 Patient and Prescriber Acknowledgement Signatures Eligibility criteria for ongoing treatment Timelines for demonstrating response to PBS Consequences of three treatment failures

21 02 March 12 (UVB) Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

22 27 Apr 12 (MTX) Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

23 29 June12 (Cyclo A) Head Upper Limbs Trunk Lower Limbs Erythema Thickness Scaling Sub Total 1 S Severity Weighting Factor X 0.1 X 0.2 X 0.3 X 0.4 Sub Total 2 0=None 1=Mild 2= Moderate 3= Severe 4= Very Severe Degree of Involvement 0=None 1=1-9% 4=50-69% 2=10-29% 5=70-89% 3=30-49% 6=90-100% Sub Total 2 x Degree of Involvement

24 Contraindications Intolerance and Toxicity Criteria

25 Contraindications to Treatment Obesity Metabolic syndrome Cardiovascular disease Psoriatic arthritis Inflammatory bowel disease NAFLD Anxiety/depression Nicotine/ ETOH Malignancies

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27 75% respondents at least 2 concomitant medical conditions 8% no comorbidities 46% combined joint related conditions 1. Baker CS, et al, Australasian Journal of Dermatology (2013) 54 (Suppl. 1), 1-6

28 Contraindications-Communicating with Medicare According to TGA approved Product Information / MIMS (absolute contraindications) Reason why patient has NEVER tried a required treatment Reason why a required treatment that may have been used in the past is currently contraindicated

29 MTX Contraindications Serious infection Peptic ulcer Ulcerative colitis Pregnancy Lactation Known hypersensitivity to MTX Immunodeficiency

30 MTX Contraindications (continued) Severe hepatic disorders Alcoholism including alcoholic liver disease Concomitant retinoids Severe renal impairment Bone marrow depression Blood dyscrasia

31 ? MTX Obese ETOH abuse Liver disease Dyslipidaemia Hypertension Rural

32 MTX Contraindications Severe Hepatic Disorders Alcoholism including alcoholic liver disease Concomitant retinoids Severe renal impairment Bone marrow depression Blood dyscrasia

33 MTX Contraindications Contraindicated: Severe hepatic disorder

34 Cyclosporin Contraindications Uncontrolled hypertension Uncontrolled infection Primary or secondary immunodeficiency Known hypersensitivity to cyclosporin Renal impairment Nephrotic syndrome with baseline renal impairment. Serum creatinine > 200 micromol/l

35 ? Cyclosporin Obese ETOH abuse Liver disease Dyslipidaemia Hypertension Rural

36 Contraindications Contraindicated: Uncontrolled hypertension

37 Acitretin Contraindications Lactation Use with concurrent alcohol Blood donation (during and for 1 year after treatment) Concurrent tetracyclines, MTX, Vitamin A or other retinoids Pregnancy

38 Acitretin Contraindications Females of childbearing potential Chronic abnormally elevated blood lipids Severe hepatic impairment Retinoid hypersensitivity Severe renal impairment

39 ? Acitretin Obese ETOH abuse Liver disease Dyslipidaemia Hypertension Rural

40 Contraindications Contraindicated: Chronic abnormally elevated blood lipids

41 Phototherapy Contraindications Severe hepatic, renal or cardiovascular disease Photosensitive diseases such as lupus, erythrmatosus, or porphyria

42 Phototherapy Contraindications Geographically unable to access History of skin cancer, particularly malignant melanoma Immunosuppression

43 ? UVB Obese ETOH abuse Liver disease Dyslipidaemia Hypertension Rural

44 Contraindications Contraindicated: Lives in XXX-no access to UVB

45 Contraindications Contraindicated: Lives in XXX-no access to UVB

46 PBS Requirements-Intolerances and Toxicities toxicity-description-tables-adult.pdf

47 PBS Requirements-Intolerances and Toxicities Intolerances or toxicities to systemic therapies must be submitted as per PBS Toxicology Criteria Reasons why patient needed to permanently cease required systemic treatment

48 MTX Toxicity - Nausea Nausea Toxicity Description NIH Toxicity Grade Oral intake significantly decreased and symptoms that do not respond to at least two of the following: Dose reduction Folic acid supplementation Switching from oral to IM route Dividing dose over 12 hours A minimum of three doses should be trialled Grade 2 or higher

49 MTX Toxicity-nausea example 10 mg 01 Feb Mar 11 Intolerance: Nausea grade 2 (despite dose dividing over 12 hours and folic acid supplementation)

50 Cyclosporin Toxicity- hypertension Toxicity Description NIH Toxicity Grade Hypertension Recurrent/persistent rise of > 20mmHg diastolic BP or rise to > 150/90 on two occasions if BP previously normal Grade 2 or higher

51 Cyclosporin Toxicity-hypertension Intolerance: Hypertension Grade 2 (BP>150/90 on two occasions, previously normal) 200 mg --/--/ /--/2000

52 Acitretin Toxicity - Transaminases Toxicity Description NIH Toxicity Grade Transaminases ALT and / or AST > 2.5 x ULN or ALT and or AST > 1.5 x ULN on 3 occasions over a 3 month period Grade 2 or higher

53 Acitretin Toxicity-transaminases Intolerance: Grade 2 transaminase elevation 30 mg 19 Oct Nov 12

54 Phototherapy Toxicity Toxicity Description NIH Toxicity Grade Severe photosensitivity reaction Erythema with Grade 3 or higher desquamation

55 Phototherapy Toxicity-photosensitivity 05 July July 2006 Grade 3 photosensitivity reaction (erythema with desquamation)

56 No Systemic treatment ever trialed? Yes Yes Complete Documentation Contraindication? No Candidate for 6 Week Trial Correct dose vs. weight? Correct duration? Within 10 years? PASI > 15 x 3? FHF criteria met? Scored whilst still on systemic treatment or within 30 days of ceasing?

57 PBS Requirements Face Hand and Foot

58 Qualifying Criteria Face, Hand, Foot After 6 weeks of each systemic treatment trial a treatment failure = Surface area in any 1 region 30% and/or Two of the three sub scores in any 1 region must be severe or very severe

59 Documentation FHF % Involvement PERCENT OF SURFACE AREA INVOLVEMENT Face Right Palm Left Palm Right Sole Left Sole 30 % Qualifying Application: Must be 30% involvement in one or more region

60 Documentation FHF AND/OR

61 Documentation FHF 0 0 = None 1 = Slight OF 2 PSORIATIC = Moderate LESIONS 3 = Severe 4 = Very Severe 0 = None 1 = Slight 2 = Moderate 3 = Severe 4 = Very Severe Sub Scores Face Right Palm Left Palm Right Sole Left Sole Erythema 1 111aa1 Thickness 3 Scaling 3 Qualifying Application: Two of the three sub-scores must be severe or very severe in one or more region

62 % Involvement Face Right Palm Left Palm Right Sole Left Sole 30 % Qualifying Application: Must be 30% involvement in one or more region Sub Scores Face Right Palm Left Palm Right Sole Left Sole Erythema 1 111aa1 Thickness 3 Scaling 3 Qualifying Application: Two of the three sub-scores must be severe or very severe in one or more region

63 Permitted concurrent PBS funded treatment: MTX phototherapy Acitretin*: Code disorders of keratinisation * non-psoriasis indication only

64 Continuation Applications

65 Patient must achieve and sustain PASI 75 improvement Baseline PASI = 25.6 PASI 75 = 25.6 x 0.25 = 6.4 Successful continuation applications must demonstrate PASI < 6.4

66 Area affected must achieve and sustain 75% reduction in any one qualifying region or Sub-scores in any one region must achieve and sustain improvement to none or slight (0 or 1)

67 Baseline % Involvement = 30% Baseline Sub Scores Face Right Palm Left Palm Right Sole Left Sole < 8 % Continuation Application: Must achieve and sustain >75% improvement in one or more region Face Right Palm Left Palm Right Sole Left Sole Erythema aa1 Thickness 3 0 Scaling 3 1 Continuation Application: ALL sub scores in any one region must achieve and sustain improvements to none or slight ( 0 or 1)

68 Response to treatment scoring must be documented after at least 12 weeks of treatment (calculated from first DISPENSING date) and no later than 1 month from the date of completion of the initial course of treatment

69 Assessment of Response to Initial Courses of Treatment Initial Course of Treatment-Weeks Adalimumab = 17 Etanercept = 16 Infliximab = 22 Ustekinumab = 28 Timelines for DOR Adalimumab: week Etanercept: week Infliximab: week Ustekinumab: week 12-32

70 Patients who are not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that agent

71 Visit Scheduling Aim for uninterrupted drug supply Continuation applications 1 month prior to patient being due to commence next prescription

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73 Allowed to trial all PBS funded biological treatments May swap treatment without penalty as long as PASI 75 response to current treatment filed with PBS

74 If DOR not filed (or not received by PBS) PBS assumes treatment failure 3 biological treatment failures = 5 years OFF PBS funded biological treatment

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