HIGHLY SPECIALISED DRUGS PROGRAM AND HERCEPTIN PROGRAM. Western Australia Administrative Guidelines

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1 HIGHLY SPECIALISED DRUGS PROGRAM AND HERCEPTIN PROGRAM Western Australia Administrative Guidelines Pharmaceutical Services Branch Health Protection Group

2 Table of Contents BACKGROUND...1 Overview...1 AHMAC s Highly Specialised Drugs Program Working Party...2 Selection Criteria for Drugs included in Highly Specialised Drugs Program...2 Submission to the Working Party...2 PRINCIPLES OF THE AGREEMENT...3 Patient Eligibility...3 Prescriber Eligibility...4 Dispensing Requirements...4 Applicable Medicines...4 Patient Co-payments...4 Joint Safety Net...5 Patient Number Definition...5 Monitoring Information...5 National Drug Price...5 CLAIMING...6 Claim Form Information...6 Certification...6 Submission of Claim Form...6 COMPLEX AUTHORITY REQUIRED HIGHLY SPECIALISED DRUGS (CAR HSDs) AND PBS TRASTUZUMAB (HERCEPTIN )...7 Prescribing...7 Dispensing...7 Additional Claiming Information...8 AUDIT...8

3 BACKGROUND The Highly Specialised Drug Program was established through an initiative of the Australian Health Ministers Advisory Council (AHMAC) in The Program is also known as Section 100 drugs as the funding arrangements are authorised through Section 100 of the Commonwealth s National Health Act Overview Highly Specialised Drugs are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public or private hospitals having access to appropriate specialist facilities. To prescribe these drugs as pharmaceutical benefit items, medical practitioners are required to be affiliated with these specialist hospital units. A general practitioner or nonspecialist hospital doctor may only prescribe Highly Specialised Drugs to provide maintenance therapy under the guidance of the treating specialist. From 1 July 2009, Medicare Australia will administer the HSD program and Pharmaceutical Benefits Scheme (PBS) trastuzumab (Herceptin ), with payments being made to States and Territory Health Departments. For more information please visit > For health professionals > PBS > Highly Specialised Drugs program WA HSD and Herceptin Programs Administrative Guidelines 1

4 AHMAC s Highly Specialised Drugs Program Working Party The purpose of AHMAC s Highly Specialised Drugs Working Party is: Identification of such drugs. Collection of price and usage data from hospitals within the State. Requesting the Pharmaceutical Benefits Advisory Committee (PBAC) to consider such drugs for listing under S100 of the National Health Act to enable the drug to be incorporated into the Highly Specialised Drugs Program. Provision of supporting data for such requests. Selection Criteria for Drugs included in Highly Specialised Drugs Program The criteria used to select drugs referred for consideration by the PBAC for inclusion in the Programs are: 1) Subject of Marketing Approval for Specific Indications by the Therapeutic Good Administration (TGA) From the Commonwealth s perspective the only avenue for funding any drug under the agreed arrangements is through the Pharmaceutical Benefits Scheme (PBS) via Section 100 of the National Health Act, involving endorsement by PBAC; and meeting TGA specified marketing conditions. 2) Ongoing Specialised Medical Supervision Required Ongoing specialist treatment should not preclude treatment in a community setting and should be interpreted to include specialist initiated treatment where ongoing treatment may be under the supervision of a community general practitioner but involve periodic reference to the specialist facility. 3) Treatment of Chronic Medical Conditions Not Acute Episodes of In-patient Treatment The intent is to assist the maintenance of patients in the community setting. If the planned treatment ceases within 8 weeks after an acute inpatient episode, it will not be considered as treatment of a chronic condition. 4) Drug Highly Specialised This criterion is defined as relating to high cost drugs in respect of which a treatment regimen is associated with ongoing specialist supervision which normally occurs in an institutional setting. 5) High Unit Cost and an Identifiable Patient Target Group In this context high unit cost is interpreted as a cost beyond the normal financial capacity of individuals and imposing significant financial burden on specialised institutions. Submission to the Working Party Hospitals seeking an additional drug to be incorporated in the Program should write a submission which addresses the following: Highly Specialised Drugs Program s five selection criteria, clinical advantages over existing treatments, cost effectiveness in comparison to these treatments, and projected level of use. The submission should be forwarded to Murray Patterson, Chief Pharmacist, Pharmaceutical Services, Western Australia Department of Health (DOH), PO Box 8172 Stirling Street, Perth W.A. 6849, by facsimile on (08) , or to WA HSD and Herceptin Programs Administrative Guidelines 2

5 PRINCIPLES OF THE AGREEMENT Patient Eligibility 1) A patient must attend a HSD approved public hospital and be (for both the offline and online solution): a day admitted patient a non-admitted patient a patient on discharge. 2) The patient must be under appropriate specialist medical care. They must also be an eligible person under the Health Insurance Act 1973 (the Act, as amended from time to time). If the criteria under the Act should change, then the eligible person requirements will adjust accordingly. An eligible person means being: an Australian resident a person covered by a Reciprocal Health Care Agreement an eligible overseas representative. 3) An Australian resident is a person who resides permanently in Australia and is: an Australian citizen a person who holds a permanent visa a New Zealand citizen an applicant for a permanent residence in certain circumstances (see Interim card below). 4) An eligible person is entitled to have one of the following Medicare cards: Medicare card (green) issued to Australian permanent residents Medicare card (blue) stamped INTERIM CARD, issued in certain circumstances to persons who have applied for permanent resident status. These cards have an expiry date beyond which eligibility is invalid for PBS subsidy (including HSDs) Medicare card (green) stamped RECIPROCAL HEALTH CARE, issued to visitors from the UK, Malta, Italy, Sweden, Finland, Norway and the Netherlands. o Visitors from New Zealand and the Republic of Ireland are not issued with cards: their eligibility for the PBS is on presentation of their passports. o Visitors from Belgium will be eligible for reciprocal health care, on presentation of their passports or a Medicare card (green) stamped RECIPROCAL HEALTH CARE, from 1 September o Supply of drugs to eligible persons from the above countries is limited to the original prescription only. Repeat prescriptions for these patients are not permitted. 5) An eligible person who has enrolled in Medicare, but is waiting for, and has not yet received their card, may utilise their Medicare card receipt (with their Medicare number printed on it) as evidence of eligibility. Eligible overseas representative means: the head of a diplomatic mission or consular post, established in Australia, of those countries with which Australia has a Reciprocal Health Care Agreement, except for New Zealand and Norway staff of those diplomatic missions or consular posts family members of heads or staff of those diplomatic missions or consular posts. Eligible overseas persons will have a Medicare card (green). WA HSD and Herceptin Programs Administrative Guidelines 3

6 Prescriber Eligibility 1) A person eligible to prescribe HSDs will be either: a staff hospital specialist a visiting or consulting hospital specialist an accredited prescriber of HIV/AIDS medication as outlined in section 2 of this Guideline an accredited prescriber of Hepatitis C maintenance medication as outlined in section 3 of this Guideline a hospital doctor or GP as outlined in section 6 of this Guideline. 2) Hospital based doctors and GP may prescribe HIV/AIDS HSDs where they are accredited prescribers of HIV/AIDS medication (refer to section 4 of this Guideline). 3) GPs and community based non-specialist doctors may prescribe Hepatitis C HSDs for maintenance where they are accredited prescribers of Hepatitis C medication (refer to section 5 of this Guideline). 4) A GP or non-specialist hospital doctor can be accredited to prescribe HIV/AIDS medication following relevant State or Territory approval. 5) A GP or community based non specialist doctor can be accredited to prescribe Hepatitis C maintenance medication following relevant State or Territory approval. 6) Hospital based doctors and community based non-specialist doctors may prescribe HSDs in the following situations: To provide maintenance therapy: in situations where it is impractical to obtain a prescription from the treating specialist and with that specialist s agreement, and where the State/Territory and Commonwealth agree on a specific arrangement. Dispensing Requirements HSDs and PBS trastuzumab (Herceptin ) must be dispensed in approved public hospitals to be eligible for payment under this program. Where a HSD public hospital utilises an outreach service to prison or similar, or a community pharmacy supplies HSDs as an agent of the hospital, the claim must be lodged by the HSD public hospital overseeing the dispensing. Applicable Medicines Only those drugs determined to be HSDs, and trastuzumab (Herceptin ) funded through the PBS for early stage breast cancer are included in these arrangements. Trastuzumab (Herceptin ) for late stage breast cancer is funded outside the PBS and is not included in these arrangements. For further information visit the Schedule of Pharmaceutical Benefits Patient Co-payments All eligible patients will incur a co-payment fee in respect of each supply of medication so as to complement charges levied on medications received through the PBS or the Repatriation Pharmaceutical Benefits Scheme (RPBS). Medicare Australia will deduct co-payments from claims. HSD approved public hospitals will be required to establish all patient eligibility for concessional benefits. WA HSD and Herceptin Programs Administrative Guidelines 4

7 Joint Safety Net All items dispensed under this initiative will be eligible to accrue to an eligible person s PBS Safety Net threshold. Under the PBS Safety Net, patients whose annual out-of-pocket costs for prescription medicines exceed a specified threshold receive additional PBS benefits. The PBS Safety Net threshold may be reached using prescriptions filled at both community pharmacies and out-patient pharmacies at public hospitals. For more information please visit > For health professionals > PBS > PBS for pharmacists > PBS Safety Net Patient Number Definition The total number of community based patients who receive a drug funded through the HSD program in each month. The count is performed per person per drug and it should be undertaken following the end of the month. If a patient receives more than one highly specialised drugs, they must be counted in each drug category. If a patient receives one or more doses of a highly specialised drug in a month, they would still only be counted as one patient. Monitoring Information Hospitals may be requested to provide other information as required by the Highly Specialised Drugs Working Party to enable it to fulfil its drug monitoring role. National Drug Price Standard national drug prices will be established through direct negotiations with suppliers through the Pharmaceutical Benefits Pricing Authority. The price is referred to as the agreed price. Where generically equivalent brands of a drug are included in these arrangements, then the subsidy will equal the price of the lowest priced brand. WA HSD and Herceptin Programs Administrative Guidelines 5

8 CLAIMING Claim Form Information A claim form must include the following data: PBS item name PBS code form pack size total cost total number of patients All HSDs and PBS trastuzumab (Herceptin ) are to be claimed on the spreadsheet that relates to the month in which they are dispensed. For example, if a drug is dispensed in July 2009, then it must to be claimed in the July 2009 spreadsheet. Information about the identification of the patient is not required. Failure to provide complete information will delay payment for that item. Where a quantity of a drug claimed is not equal to the quantity contained in the manufacturer's pack, claim payments will be for the cost of drugs multiplied by the percentage that the quantity supplied bears to the quantity contained in the manufacturer's pack. HSD and PBS trastuzumab (Herceptin ) items dispensed under this initiative will have no mark-ups applied. All drugs under this arrangement will be reimbursed for the drug cost less patient co-payment and no other fees, such as dangerous drug or broken pack fees will apply. Certification By submitting the claim form, the authorised person will be deemed to agree and certify that the eligible HSDs and PBS trastuzumab (Herceptin ) medications were supplied for a particular month and that the items have not been included in any separate claim made directly by the approved HSD public hospital or by any agent of the hospital to Medicare Australia. Submission of Claim Form Claim form for a particular month will be sent to all participating public hospitals by the end of each month. Hospitals should submit the claim forms within two weeks period to to guarantee inclusion in the following monthly payment run. WA HSD and Herceptin Programs Administrative Guidelines 6

9 COMPLEX AUTHORITY REQUIRED HIGHLY SPECIALISED DRUGS (CAR HSDs) AND PBS TRASTUZUMAB (HERCEPTIN ) As of 1 July 2009, the CAR HSDs are: Abatacept Bosentan Epoprostenol Etanercept Iloprost Infliximab Rituxumab Sildenafil Citrate Sitaxentan Prescribing All CAR HSDs and PBS trastuzumab (Herceptin ) require prior approval from Medicare Australia before dispensing. CAR HSDs and PBS trastuzumab (Herceptin ) which are not approved or have not been approved prior to dispensing cannot be claimed. No retrospective approval will be permitted. Information and application on authority approvals for these drugs can be gained by ringing Medicare Australia on * or by visiting our website > For health professionals > PBS > Specialised drugs When applying to Medicare Australia for authority approval, public hospital prescribers must use a Medicare Australia Authority Prescription form or a form approved by Medicare Australia. If a signatory to the Pharmaceutical Reforms, then a Public Participating Prescription can be used in place of these forms. Public hospital prescribers must submit the appropriate CAR HSDs and PBS trastuzumab (Herceptin ) authority application form and supporting information together with a Medicare Australia Authority Prescription form as follows: The prescriber indicates on the Medicare Australia Authority Prescription form whether the approved script is to be returned to the prescriber or the patient. The prescriber sends the completed and signed PBS authority application supporting information, Medicare Australia Authority Prescription and patient declaration forms to Medicare Australia by mail. When approved, Medicare Australia stamps the form with a HSD approval stamp and returns the prescription to the prescriber or patient by mail (as indicated on the form). If the program has allowances for applications to be made by telephone, the prescriber will enter the phone approval number, as provided by the Medicare Australia operator, on the Medicare Australia authority prescription. The format for phone approval numbers is: Z XXXXXX 4 digits + 2 alphas (for example, Z1234XM). This may be preceded by the letters HSD. Dispensing The Medicare Australia authority prescription with approval number or approval stamp, for a CAR HSD item and PBS trastuzumab (Herceptin ), can be dispensed either by the public hospital pharmacy, public participating hospital or community pharmacy. Dispensing repeats from public hospital pharmacy Repeats on CAR HSDs and PBS trastuzumab (Herceptin ) can be dispensed up to the maximum number which has been approved by Medicare Australia and shown on the Medicare Australia authority approval. Repeats are to be identified on hospital pharmacy records by the Medicare Australia authority prescription number. Patient co-payment arrangements will be the same as for other HSDs. WA HSD and Herceptin Programs Administrative Guidelines 7

10 Additional Claiming Information Claiming for approved CAR HSDs and PBS trastuzumab (Herceptin ) dispensed by public hospital pharmacies must include the following additional information: Medicare Original Item Hospital Australia Supply Supply Packs Drugs Month State Code Provider Prescription or Date Dispensed Number Authority Repeat Number No. Abatacept Bosentan Epoprostenol Etanercept Iloprost Infliximab Rituxumab Sildenafil Sitaxentan Trastuzumab AUDIT DOH will apply usual audit processes as for Highly Specialised Drugs and Herceptin Programs. Medicare Australia will conduct post-supply sample audits of prescribing and dispensing in public hospitals, to confirm that approval requirements were met and that approved patients did receive the approved quantities. WA HSD and Herceptin Programs Administrative Guidelines 8

11 WA HSD and Herceptin Programs Administrative Guidelines 9

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