York and Scarborough Medicines Commissioning Committee

Request to commission a new medicine / new indication for a medicine / formulary submission / change or amend existing formulary position

  1. Guidance on completing the form
  • The application should be developed jointly with the lead pharmacist in your speciality/area and should reflect consensus in your clinical area / across the clinical directorate.
  • Your submission should be comprehensive and state if any of the information submitted has been supplied by a pharmaceutical company.
  • The submission must be countersigned by the relevant Clinical Director
  • Submissions in electronic form should be sent (please send via one of the Trust Pharmacists)
  1. Medicines Commissioning Committee (YSMCC) Procedure
  • The York and Scarborough MCC is scheduled for the third Wednesday of every month from 10-12noon.
  • You will be notified of when your application will be considered and of the outcome in due course
  1. The decision making process

3.1YSMCC will base their decisions on the following key areas:

  • Clinical effectiveness
  • Cost effectiveness / resource impact
  • Strength of evidence
  • Patient safety
  • Place in therapy relative to available treatments
  • National guidance and priorities
  • Local health priorities
  • Equity of access
  • Stakeholder views

3.2Decision Summary

This will be recorded by the YSMCC. Each organisation is then responsible for cascading the decision to its clinicians and other relevant parties.

  1. Application Form

4.1 Clinical / drug details

Drug name (generic and brand) / Generic name
Brand name
Manufacturer
Manufacturer signed up to All Trials Petition?
Formulation
Dose / strength / frequency of administration
Clinical indication – give brief detail
Route of administration
Duration of treatment: one off / fixed period / long term / other
Me too / brand new class / new formulation
What are the other current treatment options?
Black triangle status
Patent expiry if known
When to start / stop drug
Potential benefits / advantages
Side effect profile
Significant drug interactions
Estimated use / population impact:
Year 1
Year 2 and beyond – give details
Safety / Pharmacovigilance

4.2Evidence base & medicine status – e.g. red / amber / green / black

Interface issues: proposed RAG status. Is shared care required? If so please consider draft SCG.
NICE status
NY & Humber TAG status
Other local commissioning positions where known e.g. Leeds, Sheffield, Hull, East Riding, Tees
Other national policy status: Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group
National or regional clinical reviews: e.g. MTRAC, UKMI, RDTC, Cochrane
Any other evidence
Summary of clinical trial evidence (only where no national reviews / guidance available). Please add additional sheet as necessary. State whether compared with placebo or standard therapy.
Additional benefits

4.3Place in therapy

Describe impact on currently available drugs and their place in therapy compared to the new drug in question e.g. is the proposal to use this new drug ahead of a drug that is already commissioned / on the formulary
Give details of the new pathway / new formulary extract

4.4Financial impact

Comparative drug costs

Product / Monthly secondary care cost(state if discount or regional contract price applies) / Monthly primary care cost

Cost implications (product)

Budget holder / Patients / year (a) / Product cost / year (b) / Total cost per year (a x b) / Comparative product cost / year / Comments / other
Primary care
Secondary care

Other costs and considerations: -

Drug in tariff or excluded?
Known rebate schemes offered by pharmaceutical company (NB these would be considered only in strict accordance with each CCG’s policy)?
Please give any details regarding DH or NICE approved patient access schemes – PAS.
State any opportunities for collaborative savings
State if use of this drug as per the submission forms part of a clinical trial

4.5Change / communication process

Please detail what pathways / policies / protocols this product need to be incorporated into?
Clinical communications – detail to whom and by whom and when
How and when will this new therapy be audited / monitored in primary / secondary care and by whom?
Are any other processes / systems approval required? E.g. antimicrobial subgroup etc.
Patient communications – detail requirements
Patient information leaflet – give details re if required and if so who will develop this and issue to patients

4.6References

Please give details here of any references used / referred to in the submission:

4.7 Details and declaration of interest of requesting clinician / author

Name of requesting clinician
Name of supporting pharmacist
Name of clinical directorate/s
Name of organisation
Application written by
Was any information written by or provided with pharmaceutical company support? If so please state which company:
Links to references
Date of application
Declaration of interest*: / Individual
Departmental
Organisational (if known by applicant)

Examples of conflict of interest include*:

  • Any individual, departmental or organisationalfinancial benefit from the manufacturer of the drug applied for - including – payments of any kind; research funding, staff funding
  • You or your staff receive funding for attendance or delivery of research / education / scientific meetings from this company

4.8YSMCC Decision Process Record

Date application received
Date decision made
Decision made

Dates for submission for inclusion in monthly meeting:

Complete submissions with all relevant attachments or links will be considered if submitted nine days in advance of the meeting i.e. by the Monday of the week prior to the meeting. Clinical papers should be attached in full. All completed submissions to be made to:

Vale of York and Scarborough Ryedale Medicines Commissioning Committee

New Product Request Form – v2 March 2014