i NOTIFICATION Iron infusions in the community 11 September 2017 What we re doing Eligible people will now be able to receive ferric carboxymaltose iron infusions in some general practitioners clinics or other community based settings. We re pleased to inform you about our decision to list ferric carboxymaltose (Ferinject) 50 mg per ml, 10 ml vial in Section B (Community) of the Pharmaceutical Schedule. Patients will need to meet the Special Authority criteria to be eligible to receive the funded medicine. Any changes to the original proposal? This was the subject of a consultation letter dated 2 June 2017, and having carefully considered consultation feedback, we have made the following changes: the decision will take effect from 1 October 2017; and amendments to the proposed access criteria to: o remove the requirement to trial oral iron for some clinical circumstances; and o remove the ferritin limit for applications made by specialists (or on the recommendation of a specialist). Who we think will be most interested This decision will be of interest to community and hospital clinicians, internal medicine physicians, anaesthetists, surgeons, and general practitioners. hospital and community pharmacists, DHBs, suppliers and wholesalers. patients who currently travel to hospital to have an iron infusion in an outpatient setting. A1052455 PHARMAC NOTIFICATION 1
What will the effect of this decision be? This decision is expected to improve patient health outcomes by providing funded access to ferric carboxymaltose (Ferinject) in primary care. DHBs may gain value from reduced hospital pharmaceutical expenditure, reduced use of blood products related to surgery and reduced demand on hospital outpatient infusion clinics. For patients From 1 October 2017 patients that meet the Special Authority criteria will be eligible for funded ferric carboxymaltose. Ferric carboxymaltose will be dispensed by a community pharmacy on presentation of a prescription. In some cases patients might need to collect it from the pharmacy prior to the administration date and take it with them to the appointment, in others the health service will arrange this. Service availability and costs may also differ between regions, so patients should discuss these matters with their doctor. For community pharmacies From 1 October 2017, pharmacies will be able to dispense ferric carboxymaltose, fully funded, to patients with a valid Special Authority approval. Pharmacies may wish to ask their local general practices if they are providing iron infusions. For hospital pharmacies From 1 October 2017, ferric carboxymaltose will be funded, when dispensed to patients with a valid Special Authority approval. Reimbursement claims can be made (electronically or manually) by pharmacies with a community pharmacy contract claimant number. The Ferinject brand was listed in Section H of the Pharmaceutical Schedule, for inpatient and outpatient use, from 1 August 2014. There are no changes to the Section H restrictions. For prescribers From 1 October 2017, ferric carboxymaltose will be funded, subject to Special Authority criteria. A Special Authority can be applied for electronically or manually and the approval number should be printed on the prescription. Prescribers and practices will need to liaise with their DHB regarding delivery of community based infusion services in the DHB region and any accreditation that might be required for a practice to provide DHB funded infusion services. Patients should be advised if there are likely any service charges applicable. PHARMAC notes that the Special Authority criteria are not a clinical guideline for the use of ferric carboxymaltose and the management of iron deficiency anaemia. Prescribers are encouraged to reference their local DHB health pathways (or equivalent guideline) for the management of iron deficiency anaemia. PHARMAC intends to provide support materials for general practice on the management of chronic anaemia and the use of ferric carboxymaltose. For DHBs From 1 October 2017, DHBs will fund the pharmaceutical cost of ferric carboxymaltose for community patients via the Combined Pharmaceutical Budget (managed by A1052455 PHARMAC NOTIFICATION 2
PHARMAC). PHARMAC has provided supplementary information to DHBs to support this change. Detail of this decision Ferric carboxymaltose (Ferinject) will be listed in Section B of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST): Chemical Presentation Brand Pack size Ferric carboxymaltose Inj 50 mg per ml, 10 ml vial Price and subsidy Ferinject 1 $150.00 A confidential rebate will apply to Ferinject, reducing its net price to the Funder (DHBs). Ferric carboxymaltose (Ferinject) will be listed in Section B, subject to the following Special Authority eligibility criteria: Initial application (serum ferritin less than or equal to 20 mcg/l) from any medical practitioner. Approval valid for 3 months for applications meeting the following criteria: 1. Patient has been diagnosed with iron-deficiency anaemia with a serum ferritin level of less than or equal to 20 mcg/l; and 2. Any of the following: 2.1.Patient has been compliant with oral iron treatment and treatment has proven ineffective; or 2.2.Treatment with oral iron has resulted in dose-limiting intolerance; or 2.3.Rapid correction of anaemia is required. Renewal (serum ferritin less than or equal to 20 mcg/l) from any medical practitioner. Approval valid for 3 months for applications meeting the following criteria: 1. Patient continues to have iron-deficiency anaemia with a serum ferritin level of less than or equal to 20 mcg/l; and 2. A re-trial with oral iron is clinically inappropriate. Initial application (iron deficiency anaemia) only from an internal medicine physician, obstetrician, gynaecologist, anaesthetist or a medical practitioner on the recommendation of an internal medicine physician, obstetrician, gynaecologist or anaesthetist. Approval valid for 3 months for applications meeting the following criteria: 1. Patient has been diagnosed with iron-deficiency anaemia; and 2. Any of the following: 2.1. Patient has been compliant with oral iron treatment and treatment has proven ineffective; or 2.2.Treatment with oral iron has resulted in dose-limiting intolerance; or 2.3.Patient has symptomatic heart failure, chronic kidney disease stage 3 or more or active inflammatory bowel disease and a trial of oral iron is unlikely to be effective; or 2.4.Rapid correction of anaemia is required. Renewal (iron deficiency anaemia) only from an internal medicine physician, obstetrician, gynaecologist, anaesthetist or a medical practitioner on the recommendation of an internal medicine physician, obstetrician, gynaecologist or anaesthetist. Approval valid for 3 months for applications meeting the following criteria: 1. Patient continues to have iron-deficiency anaemia; and 2. A re-trial with oral iron is clinically inappropriate. A1052455 PHARMAC NOTIFICATION 3
For the avoidance of doubt, iron polymaltose will remain listed in both Section B and Section H of the Pharmaceutical Schedule, and iron sucrose will remain listed in Section H. Therefore, clinicians can continue to choose which iron preparation to prescribe, depending on the clinical situation. Our response to what you told us We re really grateful for the time people took to respond to this consultation. All consultation responses received by 21 June 2017 were considered in their entirety when making a decision. The table below summarises the main themes raised in feedback, any changes we have made after listening to you, and other comments on the feedback. If you have any questions, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50. Theme The Special Authority criteria is very permissive. PHARMAC Comment We are aware that the criteria cover a large patient group and this has been taken into account in our budget impact assessment and forecasting. Evidence was provided to support that a trial of oral iron should not be required first in patients who do not absorb oral iron effectively namely patients with: chronic kidney disease active IBD symptomatic heart failure Patients in general practice that have upcoming surgery should be able to be initiated by a GP and GPs should be entitled to apply for patients with a ferritin >20mcg/L. Haemoglobin thresholds should be included. The requirement for anaemia should be removed for heart failure patients (those with a ferritin under 300 mcg/l are treated) The cause of iron deficiency should be stated on the special authority form. The proposed Special Authority criteria have been amended following consideration of this feedback. Pre-surgical patients will be eligible under criterion 2.3 for rapid correction of anaemia which does not include a timeframe as this should be determined by the treating clinician. Pre-surgical patients with a ferritin greater than 20 mcg/l would be under the care of a specialist and the treating specialist could provide the GP a treatment plan (a recommendation) as to when an iron infusion would be appropriate. PHARMAC sought clinical advice on Special Authority criteria and both PTAC and the Haematology Subcommittee considered haemoglobin levels for inclusion, however the recommendation provided was for criteria that was not inhibitive to different patient groups. PHARMAC considers that removing the requirement for diagnosis with iron-deficiency anaemia would be a much larger group of patients than we have assessed. We intend to seek advice on this feedback from the relevant PTAC Subcommittee. PHARMAC notes that the Special Authority is not intended as a clinical guideline. PHARMAC agrees that the cause for iron deficiency anaemia should be investigated by the treating clinician as part of best practice and recorded in the patient s notes; but we do not consider it should be a criterion for accessing funding. A1052455 PHARMAC NOTIFICATION 4
Theme Consumables were not included in the proposal and these are also not available on a PSO. There is no clear mechanism for getting the medicine to general practice (uncollected, collected but failed to go to GP, unclear medicolegal accountability for follow ups when non-collection or no-show). Not all GP practices will have the capability and capacity to deliver an infusion service. Some patients may have to find a provider other than their usual GP. Some DHBs are underway with their planning for community infusion services, others are not and considered that the proposed 1 August 2017 list date was not enough time to plan for such a transition. Some DHBs noted that they have not allocated budget for this service to be provided in the community and noted that reducing hospital based infusions may appear as a saving but this does not produce monetary saving for the hospital. If a patient charge was applicable to either the medicine ($5 pharmacy co-payment) or the service/administration (which could be more than $100) this could lead to inequities based on a patient s ability to pay. One DHB considered there was a National policy, with respect to services shifting from secondary to primary care, that they must remain free to the patient. PHARMAC Comment PHARMAC considers that the cost of consumables would be part of the infusion service costs. PHARMAC note that utilising pharmacy for the distribution of ferric carboxymaltose was the only current option available to progress funding in the community setting via a claiming and reimbursement model. PHARMAC acknowledges that it is unlikely that all general practices will provide infusion services, we note that an increasing number of general practices are providing infusions for patients. DHBs that have systems in place now will have no barrier to accessing funded pharmaceutical in the community. Those that are not able to offer funded community based infusions are not required to be ready on 1 October 2017. These DHBs can continue to provide patients with ferric carboxymaltose in a hospital outpatient setting, or as alternatively arranged, as they are currently doing. DHB Hospitals will be able to claim reimbursement for the cost of the pharmaceutical for hospital outpatients who have Special Authority approvals via the Combined Pharmaceutical Budget, reducing DHB Hospitals pharmaceutical expenditure. Additionally, where services shift from hospital to the community setting, hospital pharmaceutical expenditure would also reduce although the cost to the funder would remain. PHARMAC acknowledges that freeing up infusion capacity is not realised as monetary savings for DHB Hospitals. Noted. This issue was also raised during the 2014 consultation on the hospital listing and PHARMAC committed to engaging with stakeholders to discuss this further. Since 2014 PHARMAC has explored whether a community based funding and reimbursement model for pharmaceuticals delivered in primary care could be developed. As yet this has not been resolved. PHARMAC is now in a budget position to progress a community listing and intends to continue engaging with relevant health sector stakeholders about development of a community based claiming and reimbursement model for pharmaceuticals. There are no changes to the Section H restrictions for hospitals. Therefore, eligible patients could continue to access funded ferric carboxymaltose treatment via DHB hospitals in outpatient clinics if community infusions services are cost prohibitive. Noting that inexpensive oral and intramuscular forms of iron will still be available for clinicians to provide. This decision would not change any current expectations or Crown funding agreements in place regarding DHB service provision charges. PHARMAC anticipates that DHBs would have regard to any such expectations when developing options for local service provision. A1052455 PHARMAC NOTIFICATION 5
Theme This proposal does not address what training in or accreditation is required. PHARMAC Comment PHARMAC will be engaging with primary care to develop educational materials to support the introduction of ferric carboxymaltose via agreements with Goodfellow and BPAC. A1052455 PHARMAC NOTIFICATION 6