Amended IPTR Process & Amended IPTR Process & Other - - PowerPoint PPT Presentation

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

Requested deadline: 1 Requested deadline: 1st

st April 2011

April 2011 Actual live date: 1 Actual live date: 1st

st October 2011

October 2011

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 SMC not recommended medication/indication or has

• r has not

not yet been assessed by the SMC yet been assessed by the SMC (including medicines not (including medicines not recommended by the SMC due to non recommended by the SMC due to non-

• submission by

submission by company) company) AND AND patient’s clinical circumstances patient’s clinical circumstances (condition and (condition and characteristics) characteristics) and potential response to treatment and potential response to treatment with with the medicine are the medicine are significantly different significantly different to the general to the general population of population of patients covered by the medicines license patients covered by the medicines license

• r the
• r the population of patients

population of patients included in clinical trials for included in clinical trials for the medicine’s licensed indication the medicine’s licensed indication appraised by the SMC appraised by the SMC AND AND patient is likely to gain significantly more benefit patient is likely to gain significantly more benefit 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) Scotland) OR OR

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

• f no money in current budget
• f 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 The IPTR process will apply to new process will apply to new 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 initiated on a non-

• SMC medicine

SMC medicine

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 CMTs with the exception of Cancer. with the exception of Cancer. 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

Under what circumstances can an Under what circumstances can an IPTR Appeal be made? IPTR Appeal be made?

It is thought that: It is thought that: NHS Lothian IPTR Panel failed to act fairly (this NHS Lothian IPTR Panel failed to act fairly (this would be where it was felt that due process had would be where it was felt that due process had not been followed) not been followed) OR OR NHS Lothian IPTR Panel reached a decision NHS Lothian IPTR Panel reached a decision which cannot be justified in light of the evidence which cannot be justified in light of the evidence

• submitted. [Note: An appeal will not be
• submitted. [Note: An appeal will not be

accepted solely because the patient or a accepted solely because the patient or a clinician does not agree with the views or clinician does not agree with the views or conclusions reached] conclusions reached] OR OR NHS Lothian IPTR Panel has acted outside of its NHS Lothian IPTR Panel has acted outside of its remit or has acted unlawfully. remit or has acted unlawfully.

Process for IPTR Appeal Application

Frequency of IPTR Panel Frequency of IPTR Panel Meetings? Meetings?

The committee will meet on an as required The committee will meet on an as required basis but no more frequently then once a basis but no more frequently then once a month month

Resubmission Resubmission vs vs Appeal? Appeal?

A resubmission through the initial process A resubmission through the initial process instead of an appeal in the following instead of an appeal in the following circumstances: circumstances: Where new evidence for the medicine Where new evidence for the medicine emerges or emerges or If the original decision was based on a If the original decision was based on a factual inaccuracy factual inaccuracy

When would you consider When would you consider co co-

• payment instead?

payment instead?

Co Co-

• payments are an option at two stages:

payments are an option at two stages:

– – When a clinician does not support an IPTR When a clinician does not support an IPTR – – When an IPTR submission is rejected on When an IPTR submission is rejected on appeal appeal

Note: NHS Lothian's Financial Operating Procedure for Note: NHS Lothian's Financial Operating Procedure for the Management of Private, Overseas and co the Management of Private, Overseas and co-

• payment patients to be followed in this circumstance.

payment patients to be followed in this circumstance.

in Lothian in Lothian A recap of formulary processes A recap of formulary processes and forms and forms

Formulary Application Forms Formulary Application Forms

FAF1 FAF1

drugs that have been approved by the SMC drugs that have been approved by the SMC

FAF2 FAF2

drugs that pre drugs that pre-

• date the SMC and medical devices

date the SMC and medical devices

FAF3 FAF3

unlicensed or off unlicensed or off-

• label drugs

label drugs

When completing When completing FAFs FAFs… …

Need to be aware existing or new SMC decisions on Need to be aware existing or new SMC decisions on medicines; or when the SMC are going to review (if not medicines; or when the SMC are going to review (if not yet accessed) yet accessed) Need to be aware of where the new medicine will fit Need to be aware of where the new medicine will fit into current prescribing (if at all) into current prescribing (if at all) Need to liaise with other clinical specialities (if Need to liaise with other clinical specialities (if applicable) applicable)

Formulary Decisions Formulary Decisions

Added to LJF as first or second choice drug Added to LJF as a prescribing note Added to Additional list (approved for use in specialist use or when formulary drugs are ineffective, not tolerated or are contraindicated) Not preferred (recommended by SMC but ‘not preferred’ in Lothian as suitable alternatives exist) Not recommended for use (SMC not recommended)

So what about process for non So what about process for non-

• formulary medicines besides

formulary medicines besides IPTRs IPTRs… …

Medicines that are not recommended for use in Medicines that are not recommended for use in Lothian (but predating SMC) Lothian (but predating SMC) Medicines not yet assessed by Formulary Medicines not yet assessed by Formulary Committee (i.e. waiting on a FAF following SMC Committee (i.e. waiting on a FAF following SMC approval) approval) Medicines ‘not preferred in Lothian’ following Medicines ‘not preferred in Lothian’ following SMC approval SMC approval Unlicensed and off label medicines not yet Unlicensed and off label medicines not yet assessed by Formulary Committee assessed by Formulary Committee Non Non-

• formulary medical devices

formulary medical devices

Note

* = In paediatric populations always check that the medicines license/SMC Decision includes the age group you wish to use

the medicine in. If it does not then follow, the unlicensed medicine/off-label indication route.

♠ = FAF1,FAF2 and FAF3 and directions on when to complete are available at

http://www.ljf.scot.nhs.uk/FormularyCommittee/FormularyApplicationForms/Pages/default.aspx

Ŧ = A non-formulary request form will be required to be completed for any patient medicine prescribed for until formulary

approval given.

§ = Non-formulary request form (previously known as Non-approved form) will be required to be completed for each individual

patient until formulary approval given. The form is available on the NHS Lothian intranet at

http://intranet.lothian.scot.nhs.uk/NHSLothian/Healthcare/A-Z/MedicinesManagement/DrugsTherapeutics/Documents/Pharmacy%20Forms/Non- approved%20Medicine%20Request%20Form.pdf

¥ = Applicable to new patients being initiated on a medicine not for existing patients receiving a medicine for a SMC not

recommended indication.

‡ = ULM form is available on the NHS Lothian intranet at

http://intranet.lothian.scot.nhs.uk/NHSLothian/Healthcare/A- Z/MedicinesManagement/DrugsTherapeutics/Documents/Pharmacy%20Forms/ULM%20Form.pdf

NHS Lothian Flowchart for Medicines Management Applications and Forms

Version 1 Produced by NHS Lothian Medicines Information Service September 2011

Note: Non-approved to change to Non-formulary as directed by ADTC

Non-formulary Follow IPTR Process

Consultants Responsibilities Consultants Responsibilities

Key person who can initiate and prescribe non Key person who can initiate and prescribe non-

• approved medicines.

approved medicines. Discuss with the clinical pharmacist to ensure no Discuss with the clinical pharmacist to ensure no alternate approved medicines are suitable. alternate approved medicines are suitable. Consultant must discuss with the Clinical Consultant must discuss with the Clinical Director any resource implications prior to Director any resource implications prior to implementing the treatment planned in order to implementing the treatment planned in order to identify a budget. identify a budget. This should be expedited as soon as possible to This should be expedited as soon as possible to avoid a detriment to patient care. avoid a detriment to patient care.

Pharmacists Responsibilities Pharmacists Responsibilities

Provide professional advice regarding the non Provide professional advice regarding the non-

• formulary medicine and identify any alternate

formulary medicine and identify any alternate approved medicines. approved medicines. The signed request form should be received The signed request form should be received before the supply of the medicine (e before the supply of the medicine (e-

• signature

signature acceptable). acceptable). Arrange the supply of the non Arrange the supply of the non-

• formulary

formulary medicine through the pharmacy department medicine through the pharmacy department (distribution/dispensary). (distribution/dispensary). Communicate that there may be a delay in Communicate that there may be a delay in procuring the medicine, due to pharmacy not procuring the medicine, due to pharmacy not routinely stocking non routinely stocking non-

• approved medicines.

approved medicines. Send completed form to appropriate person. Send completed form to appropriate person.

Clinical Directors Responsibilities Clinical Directors Responsibilities

If the cost of the treatment is significant (in If the cost of the treatment is significant (in relation to the approved medicine) the relation to the approved medicine) the CD’s approval must be given CD’s approval must be given If the expenditure can not be managed If the expenditure can not be managed within the allocated budget, consultation within the allocated budget, consultation with the relevant Director of Operations with the relevant Director of Operations required. required.

What if there is disagreement? What if there is disagreement?

If disagreement between the consultant If disagreement between the consultant and the pharmacist, the discussion may be and the pharmacist, the discussion may be referred to the relevant Clinical Director, referred to the relevant Clinical Director, Associate Director of Pharmacy or Chair of Associate Director of Pharmacy or Chair of Drugs and Therapeutics for arbitration Drugs and Therapeutics for arbitration If in the professional judgement of If in the professional judgement of Consultant or Pharmacist there is an Consultant or Pharmacist there is an emergency situation then the medicine emergency situation then the medicine should be obtained without delay should be obtained without delay

Monitoring Monitoring

Completed non Completed non-

• formulary forms, IPTR forms and

formulary forms, IPTR forms and ULM forms will be reviewed locally ULM forms will be reviewed locally DURG will collate the information quarterly and DURG will collate the information quarterly and report it to the relevant D&T committee and the report it to the relevant D&T committee and the

• MRG. The report will include details on any
• MRG. The report will include details on any

prescribing patterns. prescribing patterns. D&T are required to review the requests, identify D&T are required to review the requests, identify trends and take appropriate action. trends and take appropriate action.

– – e.g. suggesting a change to the LJF or asking for a e.g. suggesting a change to the LJF or asking for a Formulary Application to be made. Formulary Application to be made.