Portsmouth CCG Rebate Policy

Pharmaceutical companies are offering schemes whereby Clinical Commissioning Groups (CCGs) can receive rebates on dispensed prescription products.  These may be referred to as “Rebate Schemes”, “Local Pricing Agreements” or “Local Discount Schemes”.

Primary care rebates schemes are contractual arrangements offered by pharmaceutical companies or third party companies which offer financial rebates on GP prescribing expenditure for particular branded medicines or prescribable products.

Individual CCGs will need to reach a decision regarding whether it will enter into these rebates or local discount schemes. This policy summarises the main points for consideration and outlines a process for assessing and managing these schemes.

This policy applies to Portsmouth Clinical Commissioning group including all employees, members of the CCG, co-opted members, members of the governing body and committees.

In the interests of transparency it is the duty of all staff to ensure that all declarations of interest are made in accordance with the CCG policy.

Price reductions on branded products are not available when items are prescribed on FP10; the Prescription Pricing Division of the NHSBSA will reimburse dispensing contractors at the manufacturer’s list price.  Hospital Trusts can often negotiate purchasing discounts particularly if a group of Trusts are buying collectively.  In addition, lower prices agreed as a condition of a NICE TA recommendation (Patient Access Scheme or PAS discount) are generally only available to purchasing NHS Trusts. As the discounted price is a condition of the NICE recommendation for provision of the medicine within the NHS, if the NHS does not obtain the discounted price it is not complying with the NICE TA guidance.

The rebate schemes may cover medicinal and non-medicinal products, appliances and assistive technology. The potential value of the rebate scheme and indirect costs associated with administering the scheme should be considered.

Legal advice sought by the London Procurement Partnership (LPP) in 2012 concluded that primary care rebate schemes are not unlawful and are within the powers of CCGs to agree to, provided they meet certain requirements. This advice has been used to inform this policy.

2.1 Product related

Rebate schemes should only be considered if the medicine in question is appropriate for Portsmouth CCG patients, and already accepted onto the Portsmouth and South Eastern Hampshire area Local Health Economy Formulary. Acceptance of a rebate scheme should not constrain the existing local decision making processes or formulary development and should not influence treatment decisions for individual patients.  In summary, any financial benefit accrued from these schemes should be viewed as incidental and not as a driver for local population or individual decision-making.

Rebate schemes should only be entered into for UK licensed medicines and be based on use of the medicine in accordance with the SPC. Where there is more than one licensed indication for a medicine, the scheme should cover all indications.  Rebate schemes promoting unlicensed or off-label use will not be entered into.

Primary care rebate schemes should be agreed at a statutory organisational level, they should not be agreed at GP practice level.

Schemes encouraging exclusive use of a particular drug should be avoided and Portsmouth Clinical Commissioning group should not enter into any schemes that preclude them from considering any other schemes subsequently offered by manufacturers of competitor drugs, should they wish to do so. The CCG should not enter into schemes that require them to provide information to a manufacturer about competitor products market share.

Rebate schemes are not appropriate for medicines in Category M and some medicines in Category C of the Drug Tariff, because of the potential wider impact on community pharmacy reimbursement.

Resilience of supply of relevant products is important. The availability of the product should match the likely uptake should the scheme be adopted widely within Portsmouth.  This is not a contractual element but reassurance will be sought that any significant increase or spike in demand can be managed by the company,

2.2 Rebate scheme related

The administrative burden to the NHS of setting up and running the scheme must be factored into the assessment of the likely financial benefit of the scheme, managing the scheme should be minimal once the scheme has been agreed.  Consideration should be given to audit requirements, financial governance, data collection, any other hidden costs and practical issues such as the term of agreement.

All rebate schemes should be considered on their own merits using the same criteria (see appendix 1).

The proposed scheme should not be directly linked to requirements to increase market share or volume of prescribing.  In practice, only schemes that offer a simple discount based on ePACT prescribing data are likely to be approved.  There should be no requirement to collect or submit to the manufacturer any data other than volume of use as derived from ePACT data.

Agreements must meet the requirements of the Data Protection Act and patient confidentially must never be compromised.

A formal written contract is required, signed by both parties to ensure that the terms of the scheme are clear and to maximise legal protection. Agreements should include a right to terminate on notice (i.e. without having to have any reason for doing so) with a sensible notice period e.g. three or six months.

The need for an exit criteria and exit strategy should be considered before a scheme is agreed. It is essential to allow flexibility to respond to emergence of significant new clinical evidence, or significant changes in market conditions.  A shorter notice period should be agreed in these circumstances.

a) The CCG should make public the existence of any schemes that they have agreed to.

b) Information relating to rebate schemes is disclosable under Freedom of Information (FOI). This should be discussed with the manufacturer before any agreement is entered into.  Ideally, redacted non-commercial contracts should be provided as commercially sensitive information is contained in the contract.  This will help the Medicines Management Team differentiate between commercial and non-commercial details and allow the team to reactively respond to such FOI requests.  If a redacted non-commercial contract is not available Portsmouth Clinical Commissioning group will request an FOI contact from within the company.

c) Schemes which link a rebate to prescribing of more than one drug should be carefully considered to avoid the risk that savings made on one are indirectly offset by costs incurred on another.

2.3 Information and Transparency

a) Portsmouth Clinical Commissioning group will make public, via its website the existence of any rebate schemes signed up to.

b) Portsmouth Clinical Commissioning group will not enter in to any rebate schemes which preclude them from considering other schemes offered by others.

c) Details of the rebates signed up to by Portsmouth Clinical Commissioning Group scheme and discounts offered should be allowed to be shared within the NHS, if applicable.

Assessment

It is proposed that Medicines Management will assess all proposed rebate schemes that have already been assessed by the PrescQIPP Pharmaceutical Industry Scheme Governance Review Board using the checklist in appendix 1.

Process

Portsmouth Clinical Commissioning Group’s decision making process has the following steps:

1. Only consider schemes which have gone through the PrescQIPP Pharmaceutical Industry Scheme Governance Review Board with a grey (scheme considered; no significant reservations) or amber (scheme considered; not fully appropriate) rating.
2. Use the checklist (appendix 1) to support local decision making, fully documenting the assessment of the rebate scheme.
3. All initial rebate schemes will be evaluated by the Medicines Management team (agree or decline). The Chief Finance Officer and the Director of Medicines Management will jointly approve each rebate scheme for use within Portsmouth Clinical Commissioning group.

Details of how to claim reimbursement will be included in the contract for individual schemes.  Portsmouth Clinical Commissioning group will generally be required to make a claim within 28 days of the end of each quarter or alternative period agreed.  Claims will be made according to the specific instructions in the agreement.

Portsmouth Clinical Commissioning group acknowledges that receipt of a rebate is a taxable event on which the CCG must declare output tax to HM Revenue & Customs.

A copy of the contract will be kept of all rebates or local discount schemes entered into by the Portsmouth Clinical Commissioning group together with the completed checklist and relevant paperwork.  Claims made and income from each scheme will be tracked by the Portsmouth Clinical Commissioning group Finance team.

PrescQIPP Pharmaceutical Industry Scheme Governance Review Board – operating model.
https://www.prescqipp.info/primary-care-rebates/finish/76-primary-care-rebate-governance/467-primary-care-rebate-board-operating-model

PrescQIPP Pharmaceutical Industry Scheme Governance Review Board.
https://www.prescqipp.info/primary-care-rebates/finish/76-primary-care-rebate-governance/2449-guidance-on-pisgrb-contractual-assessment

Primary Care Rebate Scheme (PCRS) Decision Form for those rebates that have been through the PrescQIPP Pharmaceutical Industry Scheme Governance Board *Confidential*

Approval

Portsmouth CCG Medicines Management Team Rebate Policy version 2

Approved by CAG: November 2020. Review Date: November 2022.