Belinda's Cosentyx journy

[Bq19]

Here is a copy of the prescribing restrictions from the pbs for psa. How does this fit with you? I will be contacting the PBS for clarification:

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Severe active psoriatic arthritis

Treatment Phase: Initial 3 - grandfather treatment

Clinical criteria:

   Patient must have a documented history of severe active psoriatic arthritis,

AND

   Patient must have received non-PBS treatment with this drug for this condition prior to 1 October 2016,

AND

   Patient must be receiving treatment with this drug for this condition at the time of application,

AND

   Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months,

AND

   Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR

   Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months,

AND

   Patient must have demonstrated an adequate response to treatment with this drug,

AND

   Patient must not receive more than 24 weeks of treatment under this restriction.

Population criteria:

   Patient must be aged 18 years or older.

Treatment criteria:

   Must be treated by a rheumatologist; OR

   Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

An adequate response to treatment is defined as:

an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and

either of the following:

(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or

(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:

(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or

(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.

The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.

Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to response, or to have failed to sustain a response to treatment with this drug.

Patients may qualify for PBS-subsidised treatment under this restriction once only. Further applications for treatment with this drug will be assessed under the continuing treatment restriction.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and

(3) a signed patient acknowledgement; and

(4) the date of commencement of this drug; and

(5) results of the baseline patient assessment prior to commencing treatment with this drug.
Note

Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at NO LINKS ALLOWED

Applications for authority to prescribe should be forwarded to:

Department of Human Services

Complex Drugs

Reply Paid 9826

HOBART TAS 7001 >
hey bill, these are the guidelines for being prescribed to someone with psoriatic arthritis, not paoriasis

[jiml]

Well spotted Belinda

[Bq19]

Hi all, I've been quiet for a while as I have absolutely nothing to report. I am all clear!!!! In relation to cosentyx in Australia, it is still readily available. Because it is government funded by the PBS and is expensive there are many hoops to jump through. This is both a good and a bad thing. I am so greatful that I was able to get it a try cost of $30 per month compare s to the original cost. I Ann so glad we have a healthcare system that can provide us with this. People with concessions (government payments or low income) get it for $6. I understand hat it can't Be given to everyone without due consideration due to this. In saying that, Also need to point out a good biologics dermatologists dermataologist has around some of the criteria means around some of the criteria. More in relation to the 3 in 5 years and trialling therapies. I for one am greatful for the free healthcare in Australiaaus and the Subsidised medications. Would love to write more on this but on my phone is painful. In Aus we have free healthcare for all. My dermatologist is even free

[jiml]

Nothing to report is the best news you could give us.Belinda  It's great to hear the treatment is still working ...to have any news about your treatment shows it's still working .

It's good to know a bit more about the healthcare you receive  and what it costs ...thanks for updating .

[Fred]

Good to hear it's still going well for you Belinda.

[Bill]

Good for you, Belinda. I am glad you are happy with the system, although how you can see the good in being left for six months without a working treatment, let alone for five years if three biologic treatments fail you, is beyond my comprehension. Here are the PBS criteria for qualifying with severe plaque psoriasis. I mistakenly thought that you had arthritis as well. I am grateful for being alerted to my error as it has made me aware of the current opportunity to make submissions to the PBS regarding the availability of biologic treatments for psoriasis and psoriatic arthropathy. I will finish mine shortly.

Cheers,

Bill

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Severe chronic plaque psoriasis

Treatment Phase: Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)

Clinical criteria:

   Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis,

AND

   Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR

   Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle,

AND

   Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks,

AND

   Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot),

AND

   The treatment must be as systemic monotherapy (other than methotrexate),

AND

   Patient must not receive more than 16 weeks of treatment under this restriction.

Population criteria:

   Patient must be aged 18 years or older.

Treatment criteria:

   Must be treated by a dermatologist.

For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.

Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.

Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.

The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:

(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:

(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or

(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.

© The most recent PASI assessment must be no more than 1 month old at the time of application.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and

(iii) the signed patient and prescriber acknowledgements.
Note

Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, cyclosporin or acitretin can be found on the Department of Human Services website.

Note

A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.

In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department of Human Services on 1800 700 270 to discuss. >