Amended IPTR Process & Amended IPTR Process & Other Formulary Processes… Other Formulary Processes… an update and awareness an update and awareness session session Melinda Cuthbert Melinda Cuthbert September 2011 September 2011
CEL 17 (2010) & CEL 17 (2010) & Good Practice Guidance Good Practice Guidance Focuses on consistency of approach in relation Focuses on consistency of approach in relation to the introduction and availability of newly to the introduction and availability of newly licensed medicines across NHS Scotland. licensed medicines across NHS Scotland. This is to ensure that all patients across NHS This is to ensure that all patients across NHS Scotland, regardless of health board, have equal Scotland, regardless of health board, have equal access or opportunity for to be considered for access or opportunity for to be considered for treatment with a medicine even if not treatment with a medicine even if not recommended by the SMC recommended by the SMC All health boards must align their local policies All health boards must align their local policies with the framework set out by the Scottish with the framework set out by the Scottish Government Government
Required NHS Lothian to Required NHS Lothian to amend existing Exceptional amend existing Exceptional Cases Panel Cases Panel st April 2011 Requested deadline: 1 st April 2011 Requested deadline: 1 st October 2011 Actual live date: 1 st October 2011 Actual live date: 1
Single System Policy Single System Policy This policy is applicable to patients being This policy is applicable to patients being treated within primary care and secondary treated within primary care and secondary care across NHS Lothian to ensure care across NHS Lothian to ensure equitable decisions equitable decisions There are no clinicians (including non- - There are no clinicians (including non medical prescribers) exempt from this medical prescribers) exempt from this policy policy
Criteria to be met to launch an Criteria to be met to launch an IPTR Request (1) IPTR Request (1) SMC not recommended medication/indication or has or has not not SMC not recommended medication/indication yet been assessed by the SMC (including medicines not (including medicines not yet been assessed by the SMC recommended by the SMC due to non- -submission by submission by recommended by the SMC due to non company) company) AND patient’s clinical circumstances patient’s clinical circumstances (condition and (condition and AND characteristics) and potential response to treatment and potential response to treatment with with characteristics) the medicine are significantly different significantly different to the general to the general the medicine are population of patients covered by the medicines license population of patients covered by the medicines license or the population of patients population of patients included in clinical trials for included in clinical trials for or the the medicine’s licensed indication appraised by the SMC appraised by the SMC the medicine’s licensed indication AND patient is likely to gain significantly more benefit patient is likely to gain significantly more benefit AND from the treatment than might normally be expected from from the treatment than might normally be expected from patients for whom NHS policy is not to use the medicine patients for whom NHS policy is not to use the medicine OR OR
Criteria to be met to launch an Criteria to be met to launch an IPTR Request (2) IPTR Request (2) An unlicensed medicine wishes to be used An unlicensed medicine wishes to be used when a licensed version exists for this when a licensed version exists for this indication within the UK AND indication within the UK AND Considered to be the most appropriate Considered to be the most appropriate treatment for a particular patient AND treatment for a particular patient AND Patient is likely to gain significantly more Patient is likely to gain significantly more benefit/less side effects from the treatment benefit/less side effects from the treatment than might from the licensed preparation than might from the licensed preparation OR OR
Criteria to be met to launch an Criteria to be met to launch an IPTR Request (3) IPTR Request (3) To request orphan medicines (including To request orphan medicines (including those approved under risk sharing those approved under risk sharing agreement with National Services agreement with National Services Scotland) OR OR Scotland)
Criteria to be met to launch an Criteria to be met to launch an IPTR Request (4) IPTR Request (4) A surgical procedure is indicated in the absence of A surgical procedure is indicated in the absence of sufficient evidence to determine whether or not it is sufficient evidence to determine whether or not it is effective; is considered the most appropriate treatment effective; is considered the most appropriate treatment for a particular patient AND for a particular patient AND Patient’s clinical circumstances and potential response Patient’s clinical circumstances and potential response to surgery are significantly different to the general to surgery are significantly different to the general population of patients for whom NHS Policy is not to population of patients for whom NHS Policy is not to recommend the surgery AND recommend the surgery AND Patient is likely to gain significantly more benefit from the Patient is likely to gain significantly more benefit from the surgery than might normally be expected from patients surgery than might normally be expected from patients for whom NHS policy is not to carry out the surgical for whom NHS policy is not to carry out the surgical procedure. procedure.
An IPTR Application cannot be An IPTR Application cannot be denied by a CMT on the basis denied by a CMT on the basis of no money in current budget of no money in current budget to fund to fund All applications that meet the IPTR All applications that meet the IPTR criteria must be submitted to the IPTR criteria must be submitted to the IPTR Panel/OMMC for a decision Panel/OMMC for a decision
What about existing patients on SMC Not What about existing patients on SMC Not Recommended Medicines? Recommended Medicines? The IPTR process will apply to new process will apply to new The IPTR patients ONLY patients ONLY Submissions to IPTR will not be required Submissions to IPTR will not be required for patients who have already been for patients who have already been initiated on a non- -SMC medicine SMC medicine initiated on a non
Process for IPTR Application
Roles & responsibilities? Roles & responsibilities? Patients/Relatives/Carers Patients/Relatives/Carers Clinicians Clinicians Clinical Director Clinical Director Associate Divisional Medical Director Associate Divisional Medical Director Director of Operations Director of Operations Clinical Pharmacists Clinical Pharmacists Medicines Information Medicines Information Pharmacy departments and community Pharmacy departments and community pharmacies pharmacies IPTR Administrator IPTR Administrator
IPTR Panel IPTR Panel Will meet once monthly on second Will meet once monthly on second Tuesday of the month Tuesday of the month Applications must be received two weeks Applications must be received two weeks prior by IPTR Administrator prior by IPTR Administrator Exception: Urgent cases => refer to NHS Lothian Exception: Urgent cases => refer to NHS Lothian Medical Director Medical Director
IPTR Panel will… IPTR Panel will… Receive and consider IPTR applications from all Receive and consider IPTR applications from all CMTs with the exception of Cancer. with the exception of Cancer. CMTs The Oncology Medicines Management The Oncology Medicines Management Committee will have devolved responsibility from Committee will have devolved responsibility from the IPTR Panel to review and approve IPTR the IPTR Panel to review and approve IPTR applications from their speciality. All IPTR applications from their speciality. All IPTR decisions from the OMMC will be reviewed decisions from the OMMC will be reviewed retrospectively for ratification by the Medical retrospectively for ratification by the Medical Director/IPTR Panel. Director/IPTR Panel.
Remember Remember The IPTR Panel do not have money that is The IPTR Panel do not have money that is used to fund any medicines/surgeries used to fund any medicines/surgeries approved! approved! Funding must come from existing CMT Funding must come from existing CMT budget budget If do not adequate funds then must be If do not adequate funds then must be identified as financial pressure identified as financial pressure
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