1. Background and context

A free of charge (FOC) medicines scheme is defined as an arrangement where a UK licensed, or unlicensed medicine is provided free of charge by a pharmaceutical company to an individual patient (or their family member or carer on their behalf as appropriate) or an identified cohort of patients. Medicines in FOC schemes are generally, high cost, tariff excluded medicines commissioned by NHS Integrated Care Boards (ICBs) or NHS England Specialised Commissioning. 

This definition also includes very discounted medicines offered at a price so low that they are almost free of charge for example, £1 per pack or schemes offering money back.

There are different types of schemes for:

• free of charge medicines
  • before a commissioning agreement is in place for example, before publication of a positive National Institute for Health and Care Excellence (NICE) Technology Appraisal (TA) recommendation, or before publication of an NHS England commissioning policy.
  • following a positive NICE TA appraisal determination (FAD).
• significantly discounted medicines – where a Patient Access Scheme (PAS) or commercial arrangement may already be in place, for example after publication of a positive NICE TA guidance or FAD and the scheme is offering medicines at a much lower cost than the current PAS/commercial agreement.

Signing up to FOC schemes can:

• lead to unwarranted variation.
• undermine NICE guidance and contribute to inequitable access to these medicines across England.
• introduce risks associated with national commercial medicines negotiations and financial risks to local systems.

2. Aim of the policy guidance

In line with NHS England’s operating framework and its advisory role this policy provides guidance to integrated care systems (ICSs) on free of charge (FOC) medicines schemes including providing advice on potential financial, administrative, and clinical risks.

These recommendations are for Systems to consider in the following context:

• the implementation or approval of FOC schemes within local providers.
• appropriate governance and management of FOC schemes.
• requests to fund medicines once any scheme ends.

This policy guidance aims to:

• support the NHS to drive value from the medicines.
• ensure consistent and equitable access to medicines across England.

There are established frameworks in place in England to enable access to medicines without charge. These are the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) and the European Medicines Agency (EMA) access for compassionate use in certain scenarios. These are out of the scope of the FOC policy recommendations.

For medicines currently commissioned by NHS England Specialised Commissioning, ICSs should discuss all FOC schemes with their regional specialised commissioning team in the first instance, before a decision is made on whether to implement the FOC scheme.

These policy recommendations that cover FOC schemes are offered by pharmaceutical companies both before and after NICE TA recommendations are published. This policy guidance will look at FOC schemes before and after NICE TA publication separately as they have different considerations.

ICSs should follow the recommendations here to determine whether to implement any FOC scheme including assessing suitability and any risks in the short, medium, and long term.

3. Policy recommendations

3.1 Recommendations for all FOC schemes

These policy recommendations apply to all FOC schemes regardless of whether a NICE TA or NICE highly specialised technology (HST) has been published or not:

1. Early discussion of potential FOC schemes (with an identified clinical need) should be undertaken with the relevant ICS stakeholders to allow robust suitability assessment of potential impact on currently commissioned pathways (locally or nationally commissioned through NHS England).

See Appendix 1 for further detail on suitability assessment.  

2. We recommend that ICSs should not sign up to a FOC scheme if:

• there is no unmet clinical need.
• it is solely offering a licensed medicine free of charge or at a lower cost for the purpose of market access in advance of a commissioning agreement.
• the pharmaceutical company has chosen not to make a submission on a topic that NICE has identified as requiring guidance. This includes medicine indications that the company has chosen not to submit to NICE, which has meant that NICE are unable to issue guidance. Such arrangements are therefore not generally supported because the clinical and cost effectiveness of the treatment is unknown.
• a positive NICE FAD /Final Draft Guidance, a PAS, EAMS or other commercial arrangement is already in place, including any schemes offering medicines at a significantly discounted rate or at a lower cost than the current PAS price for indications as defined within the NICE guidance, FAD (i.e. post NICE TA).
• if a PAS or commercial agreement is already in place and the scheme could potentially lead to an increase in inequity in access to medicines and will affect treatment pathways for that indication.
• the medicine or condition is currently commissioned by NHS England specialised commissioning. As above any medicines commissioned by NHS England will need to be discussed with regional specialised commissioning leads prior to any FOC being implemented.

3.2 Recommendations for FOC schemes for medicines following a positive NICE TA recommendation.

1. After NICE TA publication, ICSs should not sign up to a FOC scheme if it may result in patients receiving medicines that are not as efficacious as other treatments i.e. those treatments that are recommended earlier in the NICE treatment pathway.

2. Where NICE recommends the treatment and the patient meets the eligibility criteria (including NHS England criteria), the FOC scheme should specify that the free supply stops at the funding date and the commissioner is expected to fund ongoing treatment thereafter.

3.3 Recommendations for FOC schemes for medicines that have not yet received a positive NICE TA or following a negative NICE TA recommendation.

1. Where NICE does not recommend the treatment including non-submissions by companies, ongoing supply arrangements should be considered at the outset of the FOC scheme and exit provisions included in the written agreement where there is an ongoing patient benefit.

2. Where NICE approved eligibility criteria are not met, the pharmaceutical company is responsible to continue to supply treatment FOC until the clinician and the patient decide that the treatment should be stopped.

3.4 Exclusions to the recommendations

These recommendations:

• do not preclude access to treatments which are considered exceptional and suitable for consideration through the commissioners IFR process.
• do not primarily focus on FOC schemes that allow access to treatments for rare conditions which would ordinarily be covered by a compassionate use scheme or a clinical trial.
• exclude those medicines approved by regulatory agencies as outlined below, where more defined frameworks are specified. This document will only provide signposting to these schemes. These are compassionate use supplies, free of charge medicines as part of a NICE patient access scheme or the MHRA early access to medicines scheme.

3.5 Risks with FOC schemes

FOC schemes may appear to offer the potential for a short-term saving in the cost of the medicine, however, other factors and hidden costs need to be considered:

• supporting costs for staff, equipment, concomitant medicines (particularly if funded).
• ongoing ordering, supply, and monitoring of the medicine. Failure of supply route could be an operational risk and therefore trust(s) may want to discuss stock commitments within the FOC agreement to meet their needs.
• ongoing management of the scheme.
• data anonymisation and transfer risks and the associated administrative workload.
• waste management.
• cost of medicines after the end of the FOC scheme.
• provider tariff activity costs that have not been commissioned for example admissions, outpatient appointments, follow up ratios, monitoring, treating adverse effects.
• potential for harm and medical negligence claim should an adverse incident occur, plus the resulting reputational risk.
• There is a risk of undermining the NICE guidance as the funding mandate still applies to medicines approved by NICE, therefore any FOC scheme should not preclude patients from accessing a NICE approved treatment.
• Where FOC drug could be given in combination with currently funded medicine(s), there is a risk that this could lead to increases in the costs of the currently funded medicine(s) due to an increase in duration of treatment; this is more common in chemotherapy regimens.

Any additional costs outside of the FOC scheme should be discussed and agreed within the ICS before a decision to progress the scheme is made, particularly if new activity is involved. ICSs should confirm that the FOC scheme does not undermine the impact of local or national commissioning arrangements, including approved pathways and guidelines. It is important to keep a record of approved ICS FOC schemes and decisions to ensure a trail of accountability.

Before the formation of ICSs, where the commissioner did not agree to the FOC scheme, the entire financial risk remained with the trust, however with the formation of ICSs, and the joint funding pot, the risk now lies with the ICS.

Where multiple schemes are in place, the above factors should be considered along with the cumulative burden of managing multiple schemes.

3.6 Responsibilities and accountabilities

The introduction of FOC schemes carries with it various risks as outlined above. Key responsibilities and accountabilities are therefore defined below to minimise and mitigate some of these risks.

3.6.1 ICS responsibilities

• Standard medicines governance processes must be followed to prevent the introduction of inequity with patients of equal clinical need being treated differently.
• All supplies of FOC medicines must be processed through the provider pharmacy departments to ensure appropriate governance standards are in place.
• A written agreement between the company supplying the FOC medicine and the trust must be signed. Any data collection requirements must be formally agreed by the trust prior to commencement. Patient identifiable data should not be shared under any circumstances.
• Note that if providers do sign up to FOC schemes any future financial risk remains with ICSs.
• It should be noted that the medicine cost could already be included in a block contract arrangement.
• When a FOC scheme is agreed, there should be consideration of equity across the local health economy. ICSs should manage the introduction of an FOC scheme and carry out an impact assessment in the approval of FOC schemes in order to plan for future developments.
• ICSs should not sign up to FOC schemes that cap the number of patient numbers who are eligible for access as this leads to inequity.

3.6.2 Pharmaceutical Company responsibilities

• For post NICE TA publication FOC Schemes, pharmaceutical companies should review the current PAS or commercial arrangement with NHSE and NICE. New offers to local organisations in respect of FOC schemes or equivalent for post-NICE medicines should not be made.
• If a FOC scheme is approved, companies should prepare a draft written agreement which sets out an overview and specific operational details of the proposed scheme for initial discussions with the trust clinical staff, chief pharmacist and other relevant NHS colleagues.

The written agreement must clearly set out:

1. Clinical criteria/cohort and unmet clinical need.
2. Patient information
3. Any data collection requirements (non-identifiable only)
4. Labelling, packaging, storage requirements and pack inserts of the necessary clarity and legibility to enable to the product to be safely administered in the NHS.
5. The length and scope of the agreement, particularly in regard to continuity of supply until NICE or commissioning approval
6. Exit arrangements if treatment does not receive NICE approval or approval is delayed beyond length of the FOC scheme.
7. If patients do not meet the treatment criteria set by NICE, NHS England or the relevant commissioner, the position regarding continuation on the FOC medicine and the management of the financial risk is to be specified in the agreement.

• In principle, all FOC supplies must continue until the medicine is commissioned and funding is in place. Any exceptions to this principle must be detailed in the formal written agreement outlined above.
• Companies should not introduce FOC schemes that cap the number of patient numbers who are eligible for access as this leads to inequity.

3.6.3 NHS England responsibilities

• Where requested, NHS England, working with NICE, will review PAS, commercial agreements or Commercial Medicines Unit frameworks, where applicable, to ensure that the agreements remain the best value for the NHS and patients.
• Promoting better national agreements to drive improved value for money and reduce the administration burden of the medicine across the NHS in the long term.
• Regional specialised commissioning leads need to engage with ICSs on any FOC schemes for medicines or conditions that fall within specialised commissioning.
• Specialised commissioning teams will liaise with the relevant teams nationally to make them aware of any new FOC schemes that may undermine the national agreements.

3.3.4 Patient Information

• As with all treatments, discussions with the patient (or their parent and or carer) must take place prior to commencing the treatment. The patient must be made aware and understand that treatment with the FOC medicine will be stopped if the medicine is no longer provided free of charge by the pharmaceutical company, even if the patient perceives they have had benefit from treatment.
• Any patients undergoing treatment with a medicine in a FOC scheme must be fully informed of the characteristics of the medicine and how the scheme will operate., including details of what will happen if the treatment is stopped due to the end of FOC scheme.
• Patients should also be informed this does not affect their right to access NICE approved treatments.
• When the FOC scheme involves some element of patient data collection, the scheme must have a non-disclosure agreement or the explicit consent from patients to share relevant, non-identifiable information. This protects patient data that would not be available if the patient had not entered a FOC scheme. Sharing of patient identifiable information is not acceptable.

Appendix 1: Suitability assessment of FOC schemes

• There is currently no standardisation in the types of FOC schemes being offered by pharmaceutical companies. The terms can vary as can the complexity and workload involved in assessing, managing, and administering the schemes. It would be neither appropriate nor feasible for this pricing approach to be adopted for every new medicine.
• Providers and commissioners will therefore need to assess each scheme for suitability prior to signing up to any scheme.
• It is therefore recommended that providers develop a local SOP outlining how FOC scheme requests will be dealt with internally. When approached by a pharmaceutical company with a proposal of FOC scheme, it would be expected that the clinical teams liaise with their lead or specialist pharmacist as soon as possible, in order that the trust’s chief pharmacist (or pharmacist with delegated authority) is informed of a proposed FOC scheme before it being offered to patients.
• When considering a FOC scheme it must have a patient-centred approach, be safe, evidence-based and improve patient outcomes and should not be considered solely on the condition of a lower cost. Any application must therefore be reviewed against these key principles.
• A senior responsible officer must be identified, and the roles and responsibilities of others clearly defined. e.g. The chair of the medicines management committee (MMC) and chief pharmacist.
• Examples of key roles are included in Appendix 2 alongside an example template form in Appendix 3.

Appendix 2: Roles and responsibilities

Note: These roles and responsibilities should be adapted to local organisational structures

Appendix 3: Free of charge (FOC) Supply – Request for approval template

Standard template for approval of free of charge medicines schemes.

Completion of this form does not ensure future commissioning arrangements.

Appendix 4: Benefits and risks with FOC schemes

Benefits

• Any approval of free of charge schemes must be for direct patient benefit in order to address an unmet clinical need. The key considerations, principles, application process and roles/responsibilities outlined in this document are to be applied.
• FOC medicines schemes may also be suitable for individual patients who experienced benefit during a clinical trial. In this context such arrangements should be clear at the commencement of the trial. The pharmaceutical company should have an exit strategy which could include expanded access, so many of the key considerations and risks detailed in this guidance are relevant.

Risks

• An increasing number of FOC schemes offered by companies, are designed to supply medicines FOC or at very low cost to an identified cohort of patients in advance of a decision from NICE or a local commissioner.
• There are several issues with these FOC or low-cost schemes:
• they can undermine the evidence-based recommendations made by NICE or local commissioning organisations.
• they are often used in advance of commissioning approval.
• they may alter existing local pathways by using the medicine at a different stage in the care pathway.
• there is no standardisation which can lead to variation in access to treatments.
• they vary in complexity and workload involved in assessing, managing, and administering schemes.
• they can circumnavigate head-to-head trial processes to gather ‘real life data’.
• they can require submission of data back to the company, creating an administrative burden and data protection risk for the NHS.
• risk of creating inequality in access and medicines use, particularly when a national tender framework or PAS is already in place.
• use of a scheme locally following a positive NICE recommendation (or FAD) undermines national negotiations in obtaining the best value for medicines across England (for example, by offering to supply medicines FOC or at a lower cost than the costs specified in the NICE TA to some geographical areas only).
• for unlicensed medicines the safety and efficacy of the medicine made available via FOC schemes may not yet have been fully considered by the regulators.
• some provide treatment for a licensed indication that falls outside of NICE recommendations e.g. as a 1st line treatment when NICE only recommends after other treatment options have been tried or for dose escalation which may not have been assessed as being cost effective by NICE.
• The motivation of companies offering FOC schemes could be perceived as a marketing strategy to build early clinician experience of a medicine and to improve product sales over the longer term. To avoid FOC schemes being perceived in this way, companies must be able to clearly specify the unmet health needs addressed by introducing a FOC scheme, together with its duration and details of the relevant patient cohort.
• In this circumstance an unmet health need could be defined as ‘a condition for which there exists no satisfactory method of diagnosis, prevention, or treatment or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.’

Publication reference:  PRN00297