RECOMMENDATIONS OF THE
PHARMACEUTICAL BENEFIT ADVISORY COMMITTEE
19 June 2018
Summary
The Pharmaceutical Benefit Advisory Committee (PBAC) met on 19 June 2018 to consider applications for changes to the Prescribed List.
The PBAC was unanimous in its recommendations for the addition of six new medicinal products to the Prescribed List and the removal of one product, together with other changes to entries in the List as follows:
1 Items to be added to the Prescribed List
- Evolocumab 140mg/1ml solution for injection for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia in accordance with NICE TA394
- Escitalopram tablets 5mg, 10mg, 20mg (generic only) for the treatment of depression and anxiety disorders
- Tadalafil tablets 2.5mg, 5mg, 10mg, 20mg (generic only) for the treatment of erectile dysfunction
- Trelegy Ellipta 92mcg/55mcg/22mcg dry powder inhaler (containing fluticasone + umeclidinium + vilanterol) for the treatment of chronic obstructive pulmonary disease
- Calcipotriol 50mcg/betamethasone 500mcg per gram cutaneous foam (Enstillar) for the treatment of psoriasis
- Vitamin E gel capsules 400IU for the treatment and prevention of vitamin deficiency
2 Items to be listed as generic only
- Nystatin with chlorhexidine (with and without hydrocortisone) cream and ointment
3 Other amendments to the Prescribed List
- Rosuvastatin 40mg strength tablet to be added in addition to all other strengths included in the List
- Gliclazide 40mg strength tablet to be added in addition to the one other strength included in the List
- Pregabalin oral solution 20mg/mL to be added in addition to the oral capsules included in the List
- Trimovate cream to be removed from the List as no licensed product is now available
- Triptorelin injection, which is already included in the List for the treatment of prostate cancer, to also be available for prescribing under shared care agreement for the management of gender dysphoria
In addition, the PBAC recommended discontinuation of the Jersey Dental List in favour of reimbursement for dental prescriptions in accordance with the Dental Practitioners’ Formulary for England and Wales.
Financial impact
The overall financial impact of the above changes is estimated as an overall £50,000 increase in expenditure each year. Due to the commercial in confidence price in place for one of these products, further detail is provided in a separate report.
Mrs Alison Creed
Chair, PBAC
2 July 2018
Recommendations
- Items to be added to the Prescribed List
There was unanimous support from the Committee for the addition of the following products to the Prescribed List
- Evolocumab 140mg/1ml solution for injection for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia in accordance with NICE TA394.
The Committee noted that this medicine, one of a new type of medicines for reducing cholesterol, is recommended by NICE for use in specific patients in accordance with defined criteria. It is added to optimise other treatments to reduce cholesterol in patients who have failed to achieve significant reductions in cholesterol and who are at risk of a cardiovascular event. The Committee received assurance from the applicant that patients would be assessed and, where appropriate, initiated on treatment in hospital before the patient’s GP would be invited to take on longer term prescribing.
- Escitalopram tablets 5mg, 10mg, 20mg (generic only) for the treatment of depression and anxiety disorders
The Committee noted recently published evidence which supported escitalopram as an effective and well tolerated anti-depressant. It is less expensive than some other treatments for depression and anxiety disorders that are included in the List, particularly the related drug, citalopram, which is commonly used.
- Tadalafil tablets 2.5mg, 5mg, 10mg, 20mg (generic only) for the treatment of erectile dysfunction
The Committee noted that the patent for tadalafil (Cialis) has expired and generic tadalafil is now available at reduced cost. Tadalafil is the same type of medicine as sildenafil, which has been included in the List for a number of years. Tadalafil has a longer action and some advantages over sildenafil that makes it an appropriate addition to the List.
- Trelegy Ellipta 92mcg/55mcg/22mcg dry powder inhaler (containing fluticasone + umeclidinium + vilanterol) for the treatment of chronic obstructive pulmonary disease
The Committee noted that the Trelegy inhaler contains three medicines that are already available on the Prescribed List but in separate inhaler devices. Using the Trelegy device instead of the separate components is expected to be as effective, but less expensive. The use of the Trelegy device also allows patients with COPD to be escalated through the treatment pathway with a consistent device.
- Calcipotriol 50mcg/betamethasone 500mcg per gram cutaneous foam (Enstillar) for the treatment of psoriasis
The Committee noted that other products containing calcipotriol and betamethasone for the treatment of psoriasis are currently included in the List. This product, Enstillar, is a foam for application on the skin and, following use in the hospital, has been found to be preferred to the ointment by patients. Enstillar is no more expensive than other products on the List that contain calcipotriol and betamethasone.
- Vitamin E gel capsules 400IU for the treatment and prevention of vitamin deficiency
The Committee noted that there are two formulations containing vitamin E currently included in the List but availability of these products is variable and they are expensive. Vitamin E gel capsules are available and substantially less expensive than the currently listed products.
2 Other changes to the Prescribed List
- Nystatin with chlorhexidine (with and without hydrocortisone) cream and ointment.
This product is to be reimbursed by generic name as the branded products (Nystaform/Nystaform HC) are no longer available.
3 Other amendments to the Prescribed List
- Rosuvastatin 40mg strength tablet to be added in addition to all other strengths included in the List to allow patients to take the 40mg dose without having to take two 20mg tablets, which is more expensive.
- Gliclazide 40mg strength tablet to be added in addition to the one other strength (80mg) included in the List so that patients on the lower dose don’t need to break tablets in half.
- Pregabalin oral solution 20mg/mL to be added in addition to the oral capsules included in the List
Pregabalin in a widely prescribed medicine, already included in the List, for epilepsy and neuropathic pain. It is currently only reimbursed as an oral capsule. Addition of the oral solution will allow patients with swallowing difficulties to take it more easily.
- Trimovate cream to be removed from the List as no licensed product is now available
- Triptorelin injection, which is already included in the List for the treatment of prostate cancer, to also be available for prescribing under shared care agreement for the management of gender dysphoria.
The Committee noted that patients with gender dysphoria are managed by the hospital endocrinology service in collaboration with highly specialised services in England. As part of the management pathway, patients may require hormone therapy. Triptorelin is one of the hormones used and is prescribed long-term. The Committee agreed that it is appropriate for GPs to prescribe triptorelin as ongoing therapy in patients who have been assessed and initiated by the specialist service, in accordance with shared care agreement. Triptorelin is already included in the List, for the treatment of prostate cancer. Use for the unlicensed indication of gender dysphoria would increase the number of patients receiving the medicine by about 10 per year.
- Other considerations
- Discontinuation of the Jersey Dental List
Following consultation with local dentists, the Committee recommended discontinuation of the Jersey Dental List in favour of adoption of the Dental Practitioners’ Formulary (DPF) that is used in England and Wales to determine which medicines may be prescribed by dentists. Five responses were received in the consultation, all of which broadly supported the change. Two of the responses highlighted two specific medicines that would no longer be available to dentists to prescribe under the terms of the DPF. However, the Committee noted that alternative to both these medicines would be available under the DPF and so recommended in favour of discontinuing the Jersey Dental List. Adopting the DPF is not expected to increase prescribing expenditure.