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Declaration and Determination Drugs

    and medicinal preparations

    (PB 113 of 2008)

    as amended

    made under subsections 85(2), 85(2AA) and 85(2A) of the

    National Health Act 1953

    This compilation was prepared on 1 May 2009

    taking into account amendments up to PB 31 of 2009

    Prepared by the Office of Legislative Drafting and Publishing,

    Attorney-General’s Department, Canberra

    Declaration and determination Drugs and medicinal preparations (PB 113 of 2008)

    Commencement [see Note 1]

    1. This instrument commences on 1 December 2008.

    Repeal

    2. Instrument number PB 74 of 2008 is repealed.

    Definitions

    3. In this instrument:

    ―Act‖ means the National Health Act 1953;

    ―electronic communication‖ has the meaning given by subsection 5(1) of the Electronic

    Transactions Act 1999;

    ―extemporaneously-prepared pharmaceutical benefit‖ means a pharmaceutical benefit

    other than a ready-prepared pharmaceutical benefit;

    ―GP Management Plan‖ means a comprehensive written plan for the treatment of a

    patient, prepared by a medical practitioner, that includes a description of the patient’s

    health care needs, management goals, actions to be taken by the patient and treatment

    and services the patient is likely to need;

    ―Medicare Australia CEO‖ means the Chief Executive Officer of Medicare Australia;

    ―PBS‖ means Pharmaceutical Benefits Scheme;

    ―palliative care patient‖, in relation to a circumstance specified in Schedule 1A, means

    a patient with an active, progressive, far-advanced disease, and for whom the prognosis

    is limited and the focus of care is the quality of life;

    ―ready-prepared pharmaceutical benefit‖ means a pharmaceutical item in respect of

    which there is in force a determination under subsection 85(6) of the Act;

    ―Regulations‖ means the National Health (Pharmaceutical Benefits) Regulations 1960;

    ―Team Care Arrangements‖ means a document prepared by a medical practitioner,

    following consultation with collaborating providers, that includes a description of the

    treatment and service goals for the patient, the treatment and services that all

    collaborating providers will provide and the actions to be taken by the patient.

    Drugs and medicinal preparations to which Part VII applies

    4. Part VII of the Act applies in relation to each of the drugs and medicinal preparations

    the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances

    (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the

    name of that drug or medicinal preparation apply when the drug or medicinal

    preparation is prescribed by a medical practitioner.

Instrument Number PB 113 of 2008

    2

4A. Part VII of the Act applies in relation to each of the drugs and medicinal preparations

    the name of which is specified in column 1 of Schedule 2 and the circumstances (if any)

    specified in column 2 of Schedule 2 opposite the name of that drug or medicinal

    preparation apply when the drug or medicinal preparation is prescribed by a

    participating dental practitioner.

    4B. Part VII of the Act applies in relation to each of the drugs and medicinal preparations

    the name of which is specified in column 1 of Schedule 2A and the circumstances (if

    any) specified in column 2 of Schedule 2A opposite the name of that drug or medicinal

    preparation apply when the drug or medicinal preparation is prescribed by an

    authorised optometrist.

    5. A medicinal preparation composed of a compound that includes a drug or medicinal

    preparation the name of which is specified in column 1 of Schedule 3, other than a

    compound the name of which is specified in column 2 of that Schedule opposite the

    name of that drug or medicinal preparation, is not a medicinal preparation to which Part

    VII of the Act applies, unless the name of that drug or medicinal preparation is also

    specified in Schedule 4, in which case the provisions of paragraphs 7 and 8 apply. 6. Part VII of the Act does not apply in relation to a drug or medicinal preparation

    composed of a compound that includes a ready-prepared pharmaceutical benefit, other

    than Sodium Chloride injection or a pharmaceutical benefit, the name of which is

    specified in column 1 of Schedule 3.

    7. Part VII of the Act applies in relation to medicinal preparations composed of one or

    more of the drugs or medicinal preparations the names of which are specified in

    Schedule 4.

    8. Part VII of the Act applies in relation to medicinal preparations composed of one or

    more of the drugs or medicinal preparations the names of which are specified in

    Schedule 4 with the addition of one or more of the substances the names of which are

    specified in Schedule 5.

    9. The substances the names of which are specified in Schedule 5 are additives for the

    purposes of paragraph 85(2)(b) of the Act.

    10. Part VII of the Act applies in relation to each of the drugs and medicinal preparations

    the name of which is specified in Schedule 6.

    11. The drugs and medicinal preparations the names of which are specified in Schedule 6

    are additional pharmaceutical benefits made available under arrangements provided for

    by section 100 of the Act.

    Circumstances

    12. Where circumstances are specified in column 3 of Schedule 1 or column 2 of Schedule

    1A, 2, 2A or 4 for a listed drug specified in column 1 of any of those Schedules, a

    pharmaceutical benefit that has the listed drug (in the form if any mentioned in column

    3 or 2 respectively) is a relevant pharmaceutical benefit for the purposes of section 88A

    of the Act.

Instrument Number PB 113 of 2008

    3

    13. Where circumstances are specified in column 2 of Schedule 4 for a drug or medicinal

    preparation specified in column 1 of that Schedule, an extemporaneously prepared

    pharmaceutical benefit that contains the drug or medicinal preparation as an ingredient

    is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

    14. Subject to paragraph 16, the following circumstances are determined in relation to each

    relevant pharmaceutical benefit for the purposes of section 85(2A)(b) of the Act:

    (a) where a class of persons is specified in column 3 of Schedule 1 or column 2 of

    Schedule 1A, 2, 2A or 4 that the pharmaceutical benefit is to be supplied for

    the treatment of a person included in that class of persons;

    (b) where a disease or condition is specified in column 3 of Schedule 1 or column 2

    of Schedule 1A, 2, 2A or 4

    (i) if subsubparagraph (ii) does not apply that the pharmaceutical benefit is

    to be supplied for the treatment of that disease or condition in relation to

    any person; or

    (ii) if the disease or condition is specified in relation to a specified class of

    persons that the pharmaceutical benefit is to be supplied for the

    treatment of that disease or condition in a person included in that class of

    persons;

    (c) where a purpose is specified in column 3 of Schedule 1 or column 2 of Schedule

    1A, 2, 2A or 4 that the pharmaceutical benefit is to be supplied for that

    purpose;

    (d) where it is specified in column 3 of Schedule 1 or column 2 of Schedule 1A (in

    respect of medical practitioners), or in column 2 of Schedule 2A (in respect of

    authorised optometrists), that compliance with authority procedures set out in

    subparagraph 14(d) is required that a medical practitioner or authorised

    optometrist has submitted to the Medicare Australia CEO a prescription for the

    supply of the pharmaceutical benefit:

    (i) by delivering or posting to the Medicare Australia CEO the prescription

    prepared and signed by the medical practitioner or authorised optometrist:

    (A) in a form approved by the Secretary and completed by the medical

    practitioner or authorised optometrist in ink in his or her own

    handwriting; or

    (B) in a form, prepared by means of a computer, that is in accordance

    with the form approved by the Secretary under subsubsubparagraph

    (A); or

    (C) in a form, prepared by means of a computer, approved in writing for

    the purpose by the Secretary and in the format approved in writing by

    the Secretary; or

    (D) by a method approved in writing by the Secretary; or

    (ii) by submitting the prescription by giving the Medicare Australia CEO, by

    telephone, details of the prescription which has been prepared and signed

    by the medical practitioner or authorised optometrist in accordance with

    subsubparagraph (i); or

    Instrument Number PB 113 of 2008

    4

    (iii) where the medical practitioner or authorised optometrist has attempted to

    obtain an authorisation by submitting details of the prescription to the

    Medicare Australia CEO in accordance with subsubparagraph (ii) but has

    been unable to do so because of a failure or other form of unavailability in

    the telephone system established by the Medicare Australia CEO for the

    provision of such authorisations, by submitting the prescription in

    accordance with the instructions stipulated in an emergency telephone

    message provided to the medical practitioner or authorised optometrist by

    the Medicare Australia CEO; or

    (iv) by submitting the prescription by giving the Medicare Australia CEO, by

    means of an electronic communication of a kind approved in writing by the

    Medicare Australia CEO, details of the prescription which has been

    prepared and signed by the medical practitioner in accordance with

    subsubparagraph (i).

    14A. For the purposes of subsubparagraph 14(d)(i), a prescription that has been prepared and

    signed by the medical practitioner or authorised optometrist in accordance with that

    subparagraph is taken to have been submitted by him or her if it is submitted by one of

    his or her employees.

    15. Subject to paragraph 15B, the authorisation of a prescription submitted under

    subparagraph 14(d) may be made:

    (a) if the prescription was submitted in accordance with subsubparagraph 14(d)(i)

    by the Medicare Australia CEO signing his or her authorisation of the

    prescription on it and:

    (i) if the Medicare Australia CEO requires the medical practitioner or

    authorised optometrist to alter the prescription by returning it to the

    medical practitioner or authorised optometrist for alteration before the

    medical practitioner or authorised optometrist gives it to the person in

    respect of whom it was prepared; or

    (ii) in any other case:

    (A) by returning it to the medical practitioner or authorised optometrist;

    or

    (B) by sending it to the person in respect of whom it was prepared; or (b) if the prescription was submitted in accordance with subsubparagraph 14(d)(ii)

    orally, at the time the Medicare Australia CEO is given details of the prescription;

    or

    (c) if the prescription was submitted in accordance with subsubparagraph 14(d)(iv)

     by the Medicare Australia CEO sending his or her authorisation, by electronic

    communication, to the medical practitioner.

    15A. If the Medicare Australia CEO authorises a prescription in accordance with

    subparagraph 15(b) or (c):

    (a) the Medicare Australia CEO must tell the medical practitioner, orally or by

    electronic communication, the number that has been allotted to the authorised

    prescription; or in the case of an authorised optometrist, must tell the optometrist

    orally the number that has been allotted to the authorised prescription; and

    Instrument Number PB 113 of 2008

    5

(b) the medical practitioner or authorised optometrist must:

    (i) mark that number on the prescription; and

    (ii) retain a copy of the prescription for 1 year from the date on which the

    prescription was authorised.

    15B. Notwithstanding paragraph 15, if the prescription was submitted in accordance with

    subsubparagraph 14(d)(iii), authorisation shall be deemed to have been granted upon

    completion by the medical practitioner or authorised optometrist of the prescription in

    accordance with the instructions stipulated in the emergency telephone message

    provided to the medical practitioner or authorised optometrist by the Medicare

    Australia CEO.

    15C. If a medical practitioner has written on a prescription, that has been prepared and

    signed in accordance with subsubparagraph 14(d)(i), the streamlined authority code

    mentioned in Schedule 1 for a pharmaceutical benefit and circumstances:

    (a) subparagraph 14(d) is taken to have been complied with; and

    (b) the Medicare Australia CEO is taken to have authorised the prescription.

    15D. Paragraph 15C applies to a prescription only if there is a streamlined authority code for

    the pharmaceutical benefit and circumstances in Schedule 1.

    16. Where the circumstances "For use in accordance with paragraph 16" are specified in

    column 3 of Schedule 1, the circumstances specified for the purpose of subparagraph

    14(c) are:

    (a) that the pharmaceutical benefit is to be supplied for the treatment, in conjunction

    with dietary therapy, of a patient identified as being in one of the following very

    high risk categories:

    (i) coronary heart disease which has become symptomatic;

    (ii) cerebrovascular disease which has become symptomatic;

    (iii) peripheral vascular disease which has become symptomatic;

    (iv) diabetes mellitus with microalbuminuria (defined as urinary albumin

    excretion rate of greater than 20 micrograms per minute, or urinary albumin

    to creatinine ratio of greater than 2.5 for males or greater than 3.5 for

    females);

    (v) diabetes mellitus in Aboriginal or Torres Strait Islander patients;

    (vi) diabetes mellitus in patients aged 60 years or more;

    (vii) family history of coronary heart disease which has become symptomatic

    before the age of 55 years in two or more first degree relatives;

    (viii) family history of coronary heart disease which has become symptomatic

    before the age of 45 years in one or more first degree relatives; or

    (b) if subparagraph 16(a) does not apply that the pharmaceutical benefit is to be

    supplied for the treatment, in conjunction with dietary therapy, of a patient who,

    after at least 6 weeks of dietary therapy, qualifies for the supply of the benefit in

    accordance with the following table:

    Instrument Number PB 113 of 2008

    6

    Category of patient Fasting lipid level Patients with diabetes mellitus not otherwise total cholesterol greater than 5.5 mmol per L

    included

    Aboriginal or Torres Strait Islander patients; total cholesterol greater than 6.5 mmol per

    L; Patients with hypertension

    or

    total cholesterol greater than 5.5 mmol per L

    and high density lipoprotein cholesterol

    less than 1 mmol per L Patients with high density total cholesterol greater than 6.5 mmol per L

    lipoprotein cholesterol less than 1 mmol

    per L

    Patients with familial hypercholesterolaemia If aged 18 years or less at treatment

    identified by: initiation:

     (1) DNA mutation; or low density lipoprotein cholesterol greater

    than 4 mmol per L (2) tendon xanthomas in the patient or their

    first or second degree relative

     If aged more than 18 years at treatment

    initiation: Patients with:

    low density lipoprotein cholesterol greater (1) family history of coronary heart disease

    than 5 mmol per L; which has become symptomatic before the

    age of 60 years in one or more first degree or

    relatives; or total cholesterol greater than 6.5 mmol per

     (2) family history of coronary heart disease L;

    which has become symptomatic before the or

    age of 50 years in one or more second total cholesterol greater than 5.5 mmol per L degree relatives and high density lipoprotein cholesterol

    less than 1 mmol per L Patients not eligible under the above: total cholesterol greater than 7.5 mmol per

    L; (1) men over 34 but less than 76 years of

    age; or or

     (2) post-menopausal women less than 76 triglyceride greater than 4 mmol per L years of age

    Patients not otherwise included total cholesterol greater than 9 mmol per L;

    or

    triglyceride greater than 8 mmol per L

    Instrument Number PB 113 of 2008

    7

    SCHEDULE 1 READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A MEDICAL PRACTITIONERColumn 2 Column 3 Column 1 Streamlined Circumstances (if any) specified for the purposes of section Listed Drug authority code 85(2A)(b) of the Act Abciximab In compliance with authority procedures set out in subparagraph 14 (d):

     1716 Patients undergoing percutaneous coronary balloon angioplasty

     1717 Patients undergoing percutaneous coronary atherectomy

     1718 Patients undergoing percutaneous coronary stent placement Acamprosate In compliance with authority procedures set out in subparagraph 14 (d):

     2665 For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence

    Acarbose

    Acetazolamide

    Acetylcysteine Bronchiectasis

     Cystic fibrosis

    Aciclovir In respect of the tablet 200 mg:

    In compliance with authority procedures set out in subparagraph 14 (d):

     Moderate to severe initial genital herpes

     Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

     In respect of the tablet 800 mg:

    In compliance with authority procedures set out in subparagraph 14 (d):

     Treatment of patients with herpes zoster within 72 hours of the onset of the rash

     Herpes zoster ophthalmicus

     Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)

     In respect of the eye ointment 30 mg per g, 4.5 g:

    Herpes simplex keratitis

    Acitretin In compliance with authority procedures set out in subparagraph 14 (d):

     1366 Severe intractable psoriasis

     1363 Severe forms of disorders of keratinisation

    Adalimumab In respect of the injection 40 mg in 0.8 mL pre-filled syringe, 6 and injection 40 mg in 0.8 mL pre-filled pen, 6:

     Crohn disease

     In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

     Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:

     (a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and

     (b) has not received any prior PBS-subsidised treatment with adalimumab or infliximab for Crohn disease, or, where the patient has previously received PBS-subsidised treatment with adalimumab or infliximab for this condition, has received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised treatment with adalimumab or infliximab for this condition was approved; and

     (c) has signed a patient 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; and

     (d) has failed to achieve an adequate response to prior systemic therapy including:

     (i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; and

     (ii) immunosuppressive therapy including:

Instrument Number PB 113 of 2008

    8

    SCHEDULE 1 READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A continued MEDICAL PRACTITIONERColumn 2 Column 3 Column 1 Streamlined Circumstances (if any) specified for the purposes of section 85(2A)(b) Listed Drug authority code of the Act azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or

     6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or

     methotrexate at a dose of at least 15 mg weekly for 3 or more months; and

     where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

     where the following conditions apply:

     if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

     if intolerance to treatment with the regimens mentioned at (d) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

     failure to achieve an adequate response is indicated by a severity of disease activity which results in a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as assessed, and is demonstrated in the patient at the time of the authority application;

     all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

     the most recent CDAI assessment is no more than 1 month old at the time of application;

     the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

     (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition; and

     (ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy); and

     (iii) the signed patient acknowledgement;

     a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment;

     the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment

     In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

     Continuation of initial treatment in a treatment cycle, by a gastroenterologist or a consultant physician, of a patient with severe refractory Crohn disease who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

     Crohn disease

     In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

     Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient who:

     (a) has a documented history of severe refractory Crohn disease; and

     (b) in this treatment cycle, has received prior PBS-subsidised treatment with infliximab or adalimumab for this condition; and

     (c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and

    Instrument Number PB 113 of 2008

    9

    SCHEDULE 1 READY-PREPARED PHARMACEUTICAL BENEFITS WHEN PRESCRIBED BY A continued MEDICAL PRACTITIONERColumn 2 Column 3 Column 1 Streamlined Circumstances (if any) specified for the purposes of section 85(2A)(b) Listed Drug authority code of the Act where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab or infliximab for Crohn disease in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab or infliximab, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised courses of treatment with adalimumab or infliximab up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

     where the following conditions apply:

     the application for authorisation includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

     (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition; and

     (ii) details of prior adalimumab and infliximab treatment including details of date and duration of treatment; and

     to demonstrate a response to treatment the application is accompanied by the results of the patient's most recent course of adalimumab or infliximab therapy where:

     (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

     (b) (i) if the course of therapy is a 16-week initial course (in the case of adalimumab), the assessment of response is made following a minimum of 12 weeks of treatment; or

     (ii) if the course of therapy is a 3 dose initial course (in the case of infliximab), the assessment of response is made up to 12 weeks after the first dose (6 weeks following the third dose);

     if the response assessment to the previous course of adalimumab or infliximab treatment is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

     a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment;

     the first supply authorised under this restriction is limited to a quantity sufficient for the initial 4 weeks of treatment

     In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

     Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a gastroenterologist or a consultant physician, of a patient who has a documented history of severe refractory Crohn disease, and who, qualifying under the criteria specified above, has previously been issued with 2 or more authority prescriptions for initial treatment or recommencement of treatment with adalimumab which together provide less than 16 weeks of therapy, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

     Crohn disease

     In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

     Initial treatment commencing a treatment cycle, by a gastroenterologist or a consultant physician in internal (or general) medicine specialising in gastroenterology, of a patient with severe refractory Crohn disease who satisfies the following criteria:

     (a) has confirmed Crohn disease defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and

     (b) has diagnostic imaging or surgical evidence of short gut syndrome or has an ileostomy or colostomy; and

     (c) has evidence of intestinal inflammation; and

    Instrument Number PB 113 of 2008

    10

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