Research and analysis

PAR: Reclassification of Benacort Hayfever Relief for Adults 64 micrograms nasal spray from POM to GSL

Published 17 November 2020

1. Background on deciding where medicines are available

1.1 The role of the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK, on behalf of the UK Licensing Authority. This means that MHRA decides whether medicines are available:

• on prescription only - ‘prescription only medicine’ (POM)
• bought from pharmacies - ‘pharmacy medicine’ (P)
• bought from other shops - ‘general sales list medicine’ (GSL)

1.2 What is re-classification of a medicine?

Making a change on where a medicine is available is called ‘re-classification’. This is sometimes referred to as ‘switching’. To decide on this change, the MHRA may:

• take advice from the Commission on Human Medicines and its Expert Advisory Groups
• take advice from a group (‘stakeholder group’) of health professionals and representatives of people affected by the classification change
• run a public consultation

To be reclassified from P to GSL, a medicine must be a medicine which can, with reasonable safety, be sold or supplied by or under the supervision of a pharmacist. “Reasonable safety” has been defined as: “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small, and where wider sale would be a convenience to the purchaser.”

These conditions are set out in the Human Medicines Regulations 2012, regulation 62(5).

1.3 What evidence is needed?

A company or organisation can ask the MHRA for a medicine to be available as a pharmacy medicine or a general sale medicine. To do this, they need to get together evidence to show that the medicine:

1. is likely to be used appropriately, and
2. with relatively little danger to the public

This evidence needs to focus on the risk to the public. This includes evidence on the possible abuse or misuse of the medicine. The evidence may include:

• clinical studies
• evidence showing acceptable level of side effects
• advice of experts
• views of relevant health professionals and their professional bodies
• views of relevant public associations and individuals with an interest in the medicine under consideration.

1.4 Who makes the final decision?

The final decision on whether to approve a change is made by the MHRA, on behalf of the UK Licensing Authority.

2. About Benacort Hayfever Relief for Adults 64 micrograms nasal spray

Benacort Hayfever Relief for Adults 64 micrograms, nasal spray is a medicine sprayed inside the nose for the treatment of seasonal allergic rhinitis (hayfever) in adults aged 18 years and over.

The full name of the medicine is Benacort Hayfever Relief for Adults 64 micrograms, nasal spray. In this document, we will call it ‘Benacort Hayfever Relief’.

The MHRA considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

2.1 What is in Benacort Hayfever Relief?

Each spray of the product contains 64 micrograms of budenoside.

2.2 What is Benacort Hayfever Relief used for?

Benacort Hayfever Relief belongs to a group of medicines called ‘corticosteroids’. They work by reducing inflammation. The nasal spray is used to treat the inflammation in the nose caused by allergy to pollen (hayfever). Symptoms may include sneezing and/or a runny, itchy or blocked nose.

POMs can only be supplied on prescription under the supervision of a doctor or other healthcare professional (e.g., nurse or pharmacist) qualified to prescribe. Pharmacy (P) medicines can be supplied without prescription only from pharmacies, by or under the supervision of a pharmacist. General Sales List (GSL) medicines can be sold or supplied in retail outlets other than pharmacies (such as shops and supermarkets).

Benacort Hayfever Relief (product licence [PL] 15513/0409) is a copy of the licence for Rhinocort Aqua 64 micrograms, nasal spray (PL 15513/0403) which is a POM. The licence holder for both products, McNeil Products Limited, also owns the licence for Benacort 64 micrograms Nasal Spray (PL 15513/0404), which was reclassified from POM to P in April 2009.

2.3 Who has made the proposal?

McNeil Products Ltd, applied to make Benacort Hayfever Relief available as a GSL medicine for sale through general retail outlets.

3. Proposed Terms of Reclassification

3.1 What are the details of this change?

Benacort Hayfever Relief will be made available through general retail outlets with the following terms of reclassification:

1. For use in the treatment of seasonal allergic rhinitis (hayfever)
2. A starting dose of 2 sprays into each nostril each morning, is recommended.
3. Once symptoms are under control, a maintenance dose of one spray into each nostril each morning may be used. If symptoms recur patients should revert to the starting dose. The lowest dose at which effective control of symptoms is achieved should be used.
4. This medicine should not be used in children and adolescents under 18 years of age.
5. The maximal duration of treatment is 1 month’s continuous self-care use, before seeking medical advice.
6. Patients are advised to seek professional advice if their symptoms worsen or do not improve after 7 days
7. Maximum pack size, 10ml (60 sprays)

4. How the application was assessed

Under the provisions of The Human Medicines Regulations 2012, medicines which do not meet the criteria for classification as a Prescription Only Medicine (as set out in The Human Medicines Regulations 2012, regulation 62(3)), could, under regulation 62(5), be classified as General Sales List if they can, with reasonable safety, be sold or supplied by someone other than a pharmacist. The term “with reasonable safety” has been defined as: “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser.”

4.1 Assessment of suitability for General Sales List availability

While the licence for Benacort Hayfever relief was a copy of a product that is classified as POM, there is already an identical product classified as P. Therefore, the MHRA considered that the conditions for P classification had already been met and assessed the application against the General Sales List criterion, as stated in the paragraph above.

4.2 Hazard to health

Safety profile

The safety and efficacy of budenoside nasal spray for the treatment of hayfever is well established.

The Global post-marketing data between December 2013 to April 2017 and USA Post-marketing data from 01 January 2016 to 30 April 2017 (which is mostly data on non-prescription use) did not raise any concerns which would affect the proposed reclassification to GSL.

The comparison of post-marketing safety data from when the product was available only on prescription and when it has been available as a P medicine did not raise concerns which would affect the proposed reclassification to GSL.

Adverse events

The post-marketing data from Sweden on adverse events following non-prescription use of budenoside nasal spray between 1999 and 2017 did not raise any concerns which would impact the proposed reclassification to GSL.

The post-marketing data covering the period from 1 May 2017 to 30 April 2018 and the period from 1 May 2018 to 30 April 2019 showed that the number of adverse events reported was low in relation to the amount of product used and the majority of adverse events reported were non-serious, easily managed and known to be associated with the product.

The adverse events reported with budenoside nasal spray were consistent between clinical trials and the post-marketing period (both during prescription and non-prescription use) and the proposed product information addresses the majority of the key safety concerns adequately for GSL classification.

The pattern of adverse events during the period concerned did not raise any concerns which would affect the proposed reclassification to GSL.

Overall, the safety profile of Benacort Hayfever Relief is considered acceptable for GSL availability.

4.3 Drug interactions

The summary of product characteristics includes the interaction of Benacort Hayfever Relief with several medicines. If a patient is on any of the medicines that interact with Benacort Hayfever Relief, patients are alerted to the interaction on the label and patient information leaflet (PIL).

The most significant drug interaction is with HIV medicines which should not be taken with Benacort Hayfever. To minimise the risk of people mistakenly taking HIV medicines with Benacort Hayfever, the Licence Holder was asked to include a warning on the outer carton; ‘do not use if you are taking medicine for HIV’. With this additional warning on the outer carton, overall, it is considered that the drug interaction profile is acceptable for GSL availability of the product.

4.4 Risk of Misuse

The MHRA considers that there is no reason to believe that there is a higher risk of misuse for Benacort Hayfever Relief compared to other corticosteroid nasal sprays that are already classified as GSL. There is no evidence of abuse of these products since they were reclassified to GSL.

Self-diagnosis

GSL medicines for the treatment of hayfever have been available for decades. Therefore, a patient’s ability to self-diagnose hayfever has already been established.

Risk of misdiagnosis or delayed diagnosis of a more serious condition

Instructions about who should not use the product, and warnings and precautions for when using it are on the label and PIL. The maximum duration of continuous use before seeking medical advice has been limited to one month, which has been emphasised clearly on the product information. Patients are advised to seek professional advice if symptoms are not controlled or persist for longer than 7 days. These limitations on use are considered safe enough for users to self-treat their condition without masking any underlying serious conditions or delaying the amount of time it takes for them to seek further advice from a healthcare professional. They are also consistent with the limitations on use for other GSL corticosteroid nasal sprays.

Pack size

The 60-actuation (spray) pack size provides a maximum of 30 days treatment (at the minimum daily dose), which is not greater than the maximum length of treatment of other GSL corticosteroid nasal sprays and aligns with the maximum recommended length of continuous treatment (at minimum dose) before seeking medical advice.

4.5 Special precautions in handling

Although there is insufficient evidence to confirm it, there is a possible risk of damage to the nasal septum (the middle of the inside of the nose) associated with use of the product. To minimise this possible risk, the following warning has been included in the PIL:

‘To avoid the risk of injury, direct the nozzle to the side of the nose, and away from the middle of the nose (the ‘nasal septum’)’.

This provides reassurance that the product will be used and handled safely without the supervision of a pharmacist.

4.6 Wider sale would be a convenience

The treatment of hayfever is a well-established GSL indication within the UK environment. Consumers are used to buying hayfever treatments including nasal sprays on self-selection in a general retail outlet. The MHRA accepts that the wider availability of Benacort Hayfever Relief would be beneficial to patients as it would allow access to another corticosteroid nasal spray in the GSL setting.

5. Further details on the application

5.1 Risk Management Plan

The application contained a risk management plan (RMP). RMPs contain information on a medicine’s safety profile and one or more of the following:

• How any risks identified in the safety profile will be prevented or minimised in patients
• Plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine
• Risk factors for side effects
• Measuring the effectiveness of measures taken to prevent or minimise risks

Additional risk minimisation measures have been added to the RMP to reflect the GSL classification including:

• The product not being used by patients who are also taking HIV medicines
• Advice for patients that they should use the lowest dose at which effective control of symptoms is achieved
• Advice that the medicine should not be used continuously for longer than I month without seeking medical advice
• The product not being used by children and adolescents under 18 years or age
• Advice that professional advice should be sought if symptoms worsen or do not improve after 7 days

The RMP for this product considered the main risks associated with the product and proposed additional warnings on the labelling and PIL about the symptoms which a patient should seek further advice from a doctor or pharmacist. The MHRA considers that apart from this, no further risk minimisation measures are need for this application.

6. Reasons for not seeking advice from the Commission on Human Medicines

No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons:

• The treatment of hayfever is very common with two other intranasal corticosteroids available to treat this condition in the GSL setting. Non-sedating antihistamine tablets and liquids are also available. Patients can self-diagnose hayfever when purchasing these products so it would be considered reasonable that patients who wish to purchase Benacort Hayfever Relief can correctly diagnose themselves with hayfever
• The proposed indication, route of administration, duration of treatment and maximum pack size are in line with the two GSL intranasal corticosteroids currently available.
• Since the reclassification of other corticosteroid nasal sprays, no additional safety concerns have been raised as a result of their availability as GSL products.

7. Conclusion

The MHRA has taken the decision to approve GSL legal status for Benacort Hayfever Relief with the following terms of reclassification:

1. For use in the nose in the form of a nasal spray
2. For the treatment of seasonal allergic rhinitis (hayfever).
3. Maximum strength: 64 micrograms per actuation (spray)
4. Maximum dose: 132 micrograms per nostril (264 micrograms)
5. Maximum daily dose: 132 micrograms per nostril (264 micrograms)
6. Maximum duration of treatment: 1 month
7. Maximum pack size: 10 mls (60 actuations)