APPENDIX D – FLOW CHART PROCESS FOR THE MANAGEMENT OF DRUG TREATMENTS by tyndale

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									 High Cost Drugs - EAST OF ENGLAND PCTs and Specialist Commissioning                                                       Appendix 1
PROCESS FOR THE MANAGED ENTRY OF DRUG TREATMENTS INCLUDING FUNDING MECHANISM FOR DRUGS


                                                     Does treatment have a UK
                           Y                         licence for this indication?                                N


     Has a business case been submitted
    to the PCT for consideration of clinical
       effectiveness by Area Prescribing                                                                Is treatment likely to
       Committee (APC) or equivalent?
                                                                             N
                                                                                                            be licensed?



                            Y
                                                                                                   Y                       N

                        Has the APC supported use for the
                      indication applied for in business case?
                                                                                                       Is there sufficient published
                                                                                                        RCT evidence to merit
                                                                                                        evaluation by APC?
                  Y                                            N
                                                                                                       For rare, life-threatening
                                                                                                        conditions that are unlikely to go
                                                                                                        through RCTs, is there
                                              Consider if appropriate to refer
             Is the                          to PCT system for
                                                                                                        adequate lower level evidence
          treatment                          managing Exceptional                                       or audit information?
         listed as a                         Treatment (ET) cases.
         PbR Tariff                            ET Panel to consider case if
         exclusion?                           exceptional. Refer to criteria                                Y
                                              in Exceptional Cases policy                                                      N


                                                                                            Y          Urgent single
       Y              N                                  Approved by
                                                                                                         request
                                                          ET Panel?

           Is treatment
         included in non-                                                N                                  N
        mandatory tariffs                                Y
            if used for
        services outside
        PbR e.g. chemo?                                                                                Submit
                                                                                                       Business
                                                                                                       Case to PCT
                                           Does treatment
                                           meet criteria for
                                           Pass -Through
                                             Payment?
           Y           N                  (see Appendix 3)
                                                                                  Responsibility lies with provider to fund if
             Is funding already
                                                                                 treatment considered clinically necessary.
           contained in non-PbR
           part of SLA/contract?            Y       N
                                                                             Trust can submit a business case if they wish the
                                                                             treatment to be commissioned. Business cases will
           N           Y                                                     normally be considered within 3 to 4 months of receipt.



  PCT will only fund if they have commissioned the service and treatment
  from that provider. N.B. Decisions on funding new drugs may take longer
    than 3 months if APC had not previously been asked to review the drug
  Ref 15 Feb 09
 High Cost Drugs - EAST OF ENGLAND PCTs and Specialist Commissioning                                            Appendix 1
PROCESS FOR THE MANAGED ENTRY OF DRUG TREATMENTS INCLUDING FUNDING MECHANISM FOR DRUGS

 Appendix 3 gives criteria for Pass Through Payments as well as an application form

 Questions to ask in considering requests for funding outside PbR mandatory or indicative tariffs

 1. What exactly is funding required for?      Drug AND Indication for use
  Is it a new drug (or device) or a new        both these criteria must be specified when individual drugs or
    use for an existing drug (device)?            technologies are included in a Pass Through Payments
  Was this change in treatment                   arrangement, SLA, or activity schedule etc.
    identified through the providers’
    horizon scanning work?

 2. Does it work and how might it change       Review of evidence through normal local channels for drug or
    treatment pathways?                        technology recommendation e.g.
  Is it evidence based?                        DTC and area prescribing group
  Is it effective and cost-effective?          Equipment management group
  How does it compare with alternative
    treatment options?                         Will use of this new drug or technology lead to or enable pathway or
  Place in therapy?                           clinical service redesign that improves overall VFM, improves access or
                                               choice?
  Process to manage introduction and
    monitor impact on care pathway?

 3. Is it on Annex of PbR-excluded drugs       Is it excluded when both drug and indication are taken into account?
    (or devices)?                              PbR Exclusions List. DH guidance indicates that
  Does the mandatory tariff apply or is        drugs added to a BNF section where all existing drugs in the BNF
    an indicative tariff being used to               section/sub-section are on PbR exclusions list: all new drugs in that
    charge for this treatment?                       BNF section will be excluded but note that not all uses for the new
  Is there a locally agreed price for the           drug will be funded by the PCT – an APC application and business
    activity? If so, is that price drug-             case will normally be required for each use of the drug
    inclusive?                                  where only named drugs and/or indications are listed in PbR
  Is there a block contract in place for            exclusions appendices: new drugs within that BNF section, or new
    drug costs outside tariffs?                      uses for drugs within that BNF section, will not be excluded from
  Are the costs of administering the                tariffs in the year of introduction
    drug or using the device on the PbR         pass through payment (PTP) may be applied for only if the criteria
    excluded list?                                   agreed by EoE PCTs for PTP are met
                                               Exceptional treatment/case arrangements and extended access
                                               programmes (or similar) should NOT be used in an attempt to
                                               circumvent restrictions on funding of new service developments
                                               delivered in effect by introducing new drugs or new uses for drugs

 4. If yes (outside tariff) then               Local commissioning group to set priorities for funding and identify local
  Do PCTs and/or PBC groups wish to           budgets and anticipated patient numbers, thresholds for treatment,
      commission it in the current year?       monitoring and auditing arrangements that would be required if the
  If commissioned, how much is to be          treatment were commissioned
      commissioned and through what
      contractual arrangements?                If the proposal is for the drug to be initiated in hospital then continued in
      e.g. patient numbers, budget,            primary care e.g. after stabilisation, then PCT/PBC prescribing groups
      route of supply, cost of drug,           must be consulted on priority setting for primary care prescribing
      associated activity costs for supply     budgets, (where appropriate) shared care arrangements and supporting
      and/or administration                    training, and relative VFM and priority setting re this potential treatment
                                               option

    New is defined for this purpose as newly licensed or drug used for a new indication unless the drug was not
     uncommonly used (prior to licensing) within the NHS
    Definition of ‘use’ relates to the NHS overall and not to a particular hospital (tariffs are based on national averages)
    Where unlicensed use is not uncommon for a particular condition or patient group then these are included in the
     mandatory and non-mandatory tariffs.
 For further information contact your PCT’s area prescribing committee or PCT’s chief pharmacist’s office
 Ref 15Feb09
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