NTS recommendation Brimonidine gel for acne …

1 NOT TO BE USED FOR COMMERCIAL OR MARKETING PURPOSES 17th June 2014 Brimonidine (Mirvaso ) gel for the treatment of acne rosacea erythema. The New Therapies Subgroup (NTS) discussed the above drug at a meeting on the 17th June 2014. The recommendation of this subgroup is as follows:* The New Therapies Subgroup of the GMMMG considered the use of Brimonidine (Mirvaso ) gel for the treatment of facial erythema associated with acne rosacea. The group recommends that Brimonidine be limited for use in patients with severe erythema, if all other formulary treatment options have failed and immediately prior to referring for laser. The group recommends that if started then treatment should be reviewed in two weeks by the initiating clinician or high quality photos should be taken prior to starting treatment so an objective assessment of efficacy can be made.

2 If no benefit is seen then treatment should be discontinued. According to set criteria Brimonidine gel was deemed to be a medium priority for funding. Review date: June 2016 * Unless superseded by NICE guidance or substantial and significant new evidence becomes available. Newly marketed drugs and vaccines are intensively monitored for a minimum of two years, in order to confirm the risk / benefit profile of the product. Healthcare professionals are encouraged to report all suspected adverse drug reactions regardless of the severity of the reaction. NOT TO BE USED FOR COMMERCIAL OR MARKETING PURPOSES Further information / commissioning implications for CCGs Spend on topical metronidazole preparations for rosacea is currently very low in CCGs.

3 recommendation The recommendation is that this drug is a medium priority for funding and use is recommended prior to consideration for referral for laser treatment. Treatment of rosacea may be considered to be for aesthetic purposes but drugs are already prescribed as above and most CCGs commission the use of laser therapy for this indication. The cost is per tube [30g] and the manufacturer has stated that average user might need 6 tubes a year [about 50 per quarter for comparison with figures above]. The NICE Evidence Summary New Medicine [ESNM 43, published July 2014] states that specialists recommend that lifestyle recommendations, such as using high-factor sunscreen and avoiding trigger factors, have been optimised before Brimonidine is considered, and that these are continued throughout treatment with Brimonidine .

4 It also states that it does not need to be used daily and some people may only use the preparation on days when they are particularly self-conscious about their appearance. Future commissioning implications ESNM 43 states there is no European guideline available for products indicated for the treatment of rosacea, and efficacy end points are not clearly established. Formulary and Interface considerations As a new product, Brimonidine gel is not in the Greater Manchester Formulary, nor on the Do Not Prescribe nor Grey lists. It currently has no RAG status although it would appear to be suitable for prescribing in Primary Care as no Specialist monitoring is required and the recommendation is to use before referral. The Formulary currently includes metronidazole cream / gel (Rozex ) 30g, 40g for rosacea.

5 This will be a new preparation for consideration at the next review of the Skin Chapter. Summary of impact It is very difficult to predict uptake and usage of this product. It could save some costs through prevention of referral and use of laser although these may be unlikely to be routinely funded and may have generated Individual Funding Request applications. Providing monitoring of the effectiveness of any prescribing is carried out as per the NTS recommendation , overall financial impact is likely to be relatively very small.