National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9) (PB 88 of 2017) (Cth)
PB 88 of 2017
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmacy and Insurance Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 26 October 2017
JULIANNE QUAINE
Assistant Secretary
Pharmacy and Insurance Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 9).
(2)This Instrument may also be cited as PB 88 of 2017.
Commencement
This Instrument commences on 1 November 2017.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Part 2, Division 4, Section 24(2)
(a)insert in alphabetical order:
(db) for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.
(b)insert in alphabetical order:
(zd) for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of moderate to severe ulcerative colitis—the appropriate number of vials to provide for a single infusion of 300 mg per dose.
(c)insert in alphabetical order:
(ze) for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of severe Crohn disease— the appropriate number of vials to provide for a single infusion of 300 mg.
Part 2, Division 4, Section 25(2)
(a)insert in alphabetical order:
(gb) for infliximab, for the treatment of an adult with severe Crohn disease:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re-commencement of treatment (initial 2)—up to 2 repeat supplies;
(iii) for continuing treatment—up to 2 repeat supplies.
(b)insert in alphabetical order:
(zg) for vedolizumab, for the treatment of severe Crohn disease:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re-commencement of treatment (initial 2)—up to 2 repeat supplies;
(iii) for initial PBS-subsidised treatment (grandfather)—up to 2 repeat supplies;
(iv) for continuing treatment—up to 2 repeat supplies.
(c)insert in alphabetical order:
(zh) for vedolizumab, for the treatment of moderate to severe ulcerative colitis:
(i) for initial treatment (new patient – initial 1)—up to 2 repeat supplies;
(ii) for a change or re-commencement of treatment after a break in therapy (initial 2)—up to 2 repeat supplies;
(iii) for initial PBS-subsidised treatment (grandfather patient)—up to 2 repeat supplies;
(iv) for continuing treatment—up to 2 repeat supplies.
Schedule 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe
omit from the column headed “Section 100 only”: PB substitute: C
Schedule 1, after entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL [Brand: Sintetica Baclofen Intrathecal]
insert in the columns in the order indicated :
Intrathecal injection 40 mg in 20 mL Injection Sintetica Baclofen Intrathecal BZ EMP C7134 C7148 C7152 C7153 C7156 C7157 C7159 C7162 2 0 PB
Schedule 1, entry for Clarithromycin
omit from the column headed “Section 100 only”: D substitute: PB
Schedule 1, entry for Eltrombopag in each of the forms: Tablet 25 mg (as olamine); and Tablet 50 mg (as olamine)
omit from the column headed “Circumstances”: 6739 substitute: C6739
Schedule 1, entry for Infliximab
omit from the column headed “Circumstances” for all brands: C5078
insert in numerical order for all brands: C7145
Schedule 1, entry for Mannitol
omit from column headed “Brand”: Bronchitol substitute: bronchitol
Schedule 1, entry for Mycophenolic Acid in each of the forms; Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid; and Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
in the column headed “Circumstances”, re-arrange codes in numerical order
Schedule 1, entry for Mycophenolic Acid in each of the forms: Capsule containing mycophenolate mofetil 250 mg; and Tablet containing mycophenolate mofetil 500 mg
omit from the column headed “Section 100 only” (all instances): D substitute: C
Schedule 1, entry for Omalizumab in each of the forms: Injection 75 mg in 0.5 mL single dose pre-filled syringe; and Injection 150 mg in 1 mL single dose pre-filled syringe
in the column headed “Circumstances”, re-arrange codes in numerical order
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL
in the column headed “Circumstances”, re-arrange codes in numerical order
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Section 100 only”: C substitute: PB
Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in 50 mL
omit from the column headed “Section 100 only”: D substitute: PB
Schedule 1, entry for Sofosbuvir with velpatasvir
omit from the column headed “Section 100 only”: D
Schedule 1, entry for Sucroferric oxyhydroxide
omit from the column headed “Section 100 only”: D substitute: C
Schedule 1, entry for Tacrolimus in each of the forms: Capsule 0.5 mg; Capsule 0.5 mg (once daily prolonged release); Capsule 0.75 mg; Capsule 1 mg; Capsule 1 mg (once daily prolonged release); Capsule 2 mg; Capsule 5 mg; and Capsule 5 mg (once daily prolonged release)
omit from the column headed “Section 100 only” (all instances): D substitute: C
Schedule 1, entry for Tocilizumab in each of the forms: Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL
omit from the column headed “Section 100 only”: D substitute: PB
Schedule 1, entry for Vedolizumab
(a)omit from the column headed “Circumstances”: C5085
insert in numerical order: C7146 C7158
(b)omit from the column headed “Maximum Quantity”: 1
substitute: See Note 1
(c)omit from the column headed “Number of Repeats”: 0
substitute: See Note 2
Schedule 1, entry for Zoledronic acid in each of the forms: Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL; and Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL
omit from the column headed “Section 100 only” for all brands: D substitute: PB
Schedule 3, entry for Baclofen
insert in numerical order after existing text:
C7134 Where the patient is receiving treatment at/from a public hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.Compliance with Authority Required procedures - Streamlined Authority Code 7134 C7148 Where the patient is receiving treatment at/from a public hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.Compliance with Authority Required procedures - Streamlined Authority Code 7148 C7152 Where the patient is receiving treatment at/from a public hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.Compliance with Authority Required procedures - Streamlined Authority Code 7152 C7153 Where the patient is receiving treatment at/from a public hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.Compliance with Authority Required procedures - Streamlined Authority Code 7153 C7156 Where the patient is receiving treatment at/from a private hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis.Compliance with Authority Required procedures C7157 Where the patient is receiving treatment at/from a private hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury.Compliance with Authority Required procedures C7159 Where the patient is receiving treatment at/from a private hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin.Compliance with Authority Required procedures C7162 Where the patient is receiving treatment at/from a private hospital
Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease.Compliance with Authority Required procedures
Schedule 3, entry for Infliximab
(a)omit:
C5078 Where the patient is receiving treatment at/from a private or public hospital
Severe Crohn disease
Change or Re commencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease, AND
Patient must have received prior PBS subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle, AND
Patient must not have failed PBS subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction.
Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) 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.
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.Compliance with modified Authority Required procedures
(b)insert in numerical order after existing text:
C7145 Where the patient is receiving treatment at/from a private or public hospital
Severe Crohn disease
Change or Re-commencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction.
Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) 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.
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.Compliance with Written Authority Required procedures
Schedule 3, entry for Vedolizumab
(a)omit:
C5085 P5085 Where the patient is receiving treatment at/from a private or public hospital
Severe Crohn disease
Change or Recommencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease, AND
Patient must have received prior PBS subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle, AND
Patient must not have failed PBS subsidised therapy with this drug for this condition more than once in the current treatment cycle, AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) 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.
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.Compliance with modified Authority Required procedures
(b)omit from the column headed “Purposes Code” for Circumstances Code C5099: P5099
(c)omit from the column headed “Purposes Code” for Circumstances Code C5104:P5104
(d)omit from the column headed “Purposes Code” for Circumstances Code C5121:P5121
(e)omit from the column headed “Purposes Code” for Circumstances Code C5127:P5127
(f)insert in numerical order after existing text:
C7146 Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Initial PBS-subsidised treatment (Grandfather patient)
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 August 2015; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be 18 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and baseline Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the date of commencement of this drug; and
(iii) the signed patient acknowledgement.
The current Mayo clinic or partial Mayo clinic assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug. Where a baseline assessment is not available the prescriber must contact the Department of Human Services to discuss.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.Compliance with Authority Required procedures C7158 Where the patient is receiving treatment at/from a private or public hospital
Severe Crohn disease
Change or Re-commencement of treatment (initial 2)
Patient must have a documented history of severe Crohn disease; AND
Patient must have received prior PBS-subsidised treatment with a biological disease modifying drug for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
The assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) 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.
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.Compliance with Written Authority Required procedures
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