Prescribed List (Jersey): Changes from 1st November 2019

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A decision made on 25 October 2019

Decision Reference: MD-S-2019-0085
Decision Summary Title :	DS Prescribed list as of 1 Nov 2019		Date of Decision Summary:	23 October 2019
Decision Summary Author:	Policy Principal		Decision Summary: Public or Exempt?	Public
Type of Report: Oral or Written?	Written		Person Giving Oral Report:	NA
Written Report Title :	WR report PBAC 19 September 2019		Date of Written Report:	22 October 2019
Written Report Author:	Prescribing Advisor		Written Report : Public or Exempt?	Public
Subject: Changes to be made to the Prescribed List (Jersey) as of 1 November 2019
Decision(s): Further to Article 15, paragraphs (11) and (12), of the Health Insurance (Jersey) Law 1967, and having consulted with the Pharmaceutical Benefit Advisory Committee, the Minister decided to make amendments to the Prescribed List with effect from 1 November 2019 as set out in the accompanying report and supporting document.
Reason(s) for Decision: The Pharmaceutical Benefit Advisory Committee met on 19 September 2019 and has provided the Minister with recommendations regarding amendments to the Prescribed List. Items to be added to the Prescribed List Semaglutide 1.34mg/mL solution for injection pre-filled devices Azelastine hydrochloride 125 micrograms/fluticasone propionate 50 micrograms nasal spray (Dymista brand) Hydrocortisone 500mcg/1mg/2mg/5mg granules in capsules for opening (Alkindi) for children Tiotropium 2.5microgram inhalation solution cartridge; tiotropium 2.5microgram/olodaterol 2.5mcg inhalation solution cartridge Following the meeting, the PBAC was asked to urgently consider changes to the Prescribed List in response to the Supply Disruption Alert for ranitidine (a treatment for stomach ulcers and acid reflux) issued on 16th October. Using its agreed procedure, the Committee recommends addition of the following product to provide an alternative to ranitidine while it is out of stock: Nizatidine 150mg capsules The recommendations reflect current evidence and expert advice, and ensure that patients in Jersey have access to an appropriate range of modern, safe and effective treatments from their GPs and community prescribers at a proportionate cost to the Fund. Other changes to the Prescribed List Further minor amendments and deletions will be made to the Prescribed List following a line by line review of the List and its reformatting to comply with dm+d nomenclature as requested by NHS Business Services Authority.
Resource Implications: The overall financial impact of the above changes is expected to be a small increase in total annual expenditure. One of the additions to the List has a commercial in confidence price, therefore the exact figure has not been published.
Action required: Health Zone Manager at Customer and Local Services to issue a public notice listing amendments and notify all approved medical practitioners and approved contractors.
Signature:		Position: Minister
Date Signed:		Date of Decision (If different from Date Signed):

Prescribed List (Jersey): Changes from 1st November 2019

RECOMMENDATIONS OF THE

PHARMACEUTICAL BENEFIT ADVISORY COMMITTEE

22 October 2019

Summary

The Pharmaceutical Benefit Advisory Committee (PBAC) met on 19 September to consider applications for changes to the Prescribed List.

The PBAC was unanimous in its recommendations for the following changes to the Prescribed List to be implemented from 1 November 2019.

Items to be added to the Prescribed List
1. Semaglutide 1.34mg/mL solution for injection pre-filled devices
2. Azelastine hydrochloride 125 micrograms/fluticasone propionate 50 micrograms nasal spray (Dymista brand)
3. Hydrocortisone 500mcg/1mg/2mg/5mg granules in capsules for opening (Alkindi) for children
4. Tiotropium 2.5microgram inhalation solution cartridge; tiotropium 2.5microgram/olodaterol 2.5mcg inhalation solution cartridge (change required following notice from manufacturer that a reusable inhaler device will be available)

In addition, the PBAC was asked to urgently consider changes to the Prescribed List in response to the Supply Disruption Alert for ranitidine issued on 16th October. The Committee recommends addition of the following product to provide an alternative to ranitidine while it is out of stock:

1.5 Nizatidine 150mg capsules

Other changes to the Prescribed List
1. A summary list of all amendments and deletions (for discontinued products only) was agreed by the Committee. These were made following a line by line the review of the List and reformatting to comply with dm+d nomenclature, as requested by NHS Business Services Authority.

Other considerations
1. An application for the addition of imiquimod 5% cream, for the treatment of a number of skin conditions, was supported conditionally as a means to reduce hospital waiting times and speed up access to treatment. This support was conditional on views from the hospital dermatologist, to be requested following the meeting. Those views have now been received and do not support making imiquimod cream available in primary care. Therefore, the application will be returned to the Committee for their further consideration.

3.2. An application for melatonin 2mg modified-release tablets, for the treatment of insomnia in adults aged over 55 years of age, was the subject of some debate. The Committee acknowledged that the management of insomnia was problematic and that there was misuse of existing treatment options. However, the Committee did not feel that there was compelling support for the addition of another option and, therefore, did not recommend its addition to the List. The Committee indicated that they would review this decision if further information became available.

Financial impact

The overall financial impact of the above changes is expected to be a small increase in total annual expenditure. However, since one of the additions to the List has a commercial in confidence price, the exact figure cannot be published.

Mrs Alison Creed

Chair, PBAC

22 October 2019

Recommendations

Items to be added to the Prescribed List

1.1 Semaglutide 1.34mg/mL solution for injection pre-filled devices

Semaglutide is licensed for the treatment of type II diabetes mellitus as monotherapy or in combination with other antidiabetic medicines. There are 2 other medicines in the same therapeutic class as semaglutide already included in the List. However, there is evidence that semaglutide may be preferable to these medicines in selected patients. Semaglutide is administered as a weekly injection at a cost similar to other options in its class. Its addition to the List would, therefore, be cost neutral but offer additional choice for patients.

1.2 Azelastine hydrochloride 125 micrograms/fluticasone propionate 50 micrograms nasal spray (Dymista brand)

The addition of the combination nasal spray, Dymista, for the treatment of seasonal allergic rhinitis, has been previously considered but rejected because of the high cost of the product compared with its constituents.
The price of Dymista has since fallen and it now represents a cost saving for patients who require treatment with both azelastine and fluticasone.

1.3 Hydrocortisone 500mcg/1mg/2mg/5mg granules in capsules for opening (Alkindi) for children

This formulation of hydrocortisone was requested by hospital specialists for use in the very small number of children with adrenal insufficiency who need long-term treatment with hydrocortisone but for whom there is no appropriate paediatric formulation.
The Alkindi formulation of hydrocortisone is more expensive than standard tablets; at the basic NHS list price, Alkindi is around 3 times more expensive but a confidential discount is available to reduce this gap.

1.4 Tiotropium 2.5microgram inhalation solution cartridge; tiotropium 2.5microgram/olodaterol 2.5mcg inhalation solution cartridge (change required following notice from manufacturer that a reusable Respimat inhaler device will be available)

The manufacturer has given notice that its Respimat inhaler device is to be reusable. The Committee, therefore, recommended that replacement cartridges should be included in the Prescribed List for use with the device.

1.5 Nizatidine 150mg capsules (generic only)

On 15th October, a Supply Disruption Alert was issued by the Department of Health and Social Care in England advising that no further supplied of ranitidine, a treatment for stomach ulcers and acid reflux, would be available until further notice. Around 1,700 people in Jersey are prescribed ranitidine.
The Supply Disruption Alert advised that patients taking ranitdine should be reviewed and, if ongoing treatment is needed, an alternative such as omeprazole or lansoprazole is prescribed. These alternatives are already included in the Prescribed List and have a similar cost to ranitidine. However, PBAC members advised that an alternative from the same therapeutic group as ranitidine should also be considered for patients and recommended that nizatidine is added to the List.
Nizatidine is around 8-times more expensive that ranitidine.

Estimated cost impact of PBAC recommendations
Recommended product	Estimated cost impact
1.1 Semaglutide 1.34mg/mL solution for injection pre-filled devices	No cost impact. Semaglutide is a similar price to other medicines in the same therapeutic group
1.2 Azelastine hydrochloride 125 micrograms/fluticasone propionate 50 micrograms nasal spray (Dymista brand)	Cost saving of up to £40,000 is anticipated based on existing use of the constituent products.
1.3 Hydrocortisone 500mcg/1mg/2mg/5mg granules in capsules for opening (Alkindi) for children	Confidential price. Addition of hydrocortisone will increase overall expenditure.
1.4 Tiotropium 2.5microgram inhalation solution cartridge; tiotropium 2.5microgram/olodaterol 2.5mcg inhalation solution cartridge (change required following notice from manufacturer that a reusable Respimat inhaler device will be available)	No cost impact anticipated. Cartridges are priced the same as the existing device.
1.5 Nizatidine 150mg capsules	To be added to the List as one of a number of alternatives to ranitidine while it is out of stock. Nizatidine is around 8-times more expensive than ranitidine. If 25% of patients currently taking ranitidine switch to nizatidine, the cost impact will be an increase of around £35,000pa.