Eflornithine (Vaniqa®▼) for the Treatment of Facial Hirsutism in Women
VERDICT & SUMMARY Eflornithine (Vaniqa®▼) For the treatment of facial hirsutism in women
Committee’s Verdict: CATEGORY A (Q4) BNF: 13.9 Treatment with eflornithine is suitable for prescribing in primary care. However, the evidence base for efficacy and long-term safety is weak as no clinical trials have been published. It is important that the patient is properly assessed before eflornithine is prescribed, because hirsutism can result from serious medical conditions. Category A: Suitable for prescribing in primary care
Q4 rating: The evidence for the comparative efficacy and safety of Q2 Q1 eflornithine was considered to be weak as none of the studies have been higher place higher place fully published. Although eflornithine is the only topical treatment available weaker evidence stronger evidence for hirsutism, it was considered to have a relatively low place in therapy as the long-term safety of the drug has not been evaluated. It has not been compared with the only other licensed therapy, co-cyprindiol. Q4 Q3 lower place lower place The Q rating relates to the drug’s position on the effectiveness indicator grid. weaker evidence stronger evidence The strength of the evidence is determined by the quality and quantity of studies that show significant efficacy of the drug compared with placebo or alternative care in primary therapy in Place therapy. Its place in therapy in primary care takes into account safety and practical Strength of evidence for efficacy aspects of using the drug in primary care, alternative options, relevant NICE guidance, and the need for secondary care input.
MTRAC reviewed this drug because it is a new product with potential for prescribing in primary care.
Licensed indication therapy are sufficient, although mechanical methods of hair removal can result in skin irritation and Eflornithine 11.5% cream is licensed for the treatment scarring.3 of facial hirsutism in women.1 Systemic therapies include oral contraceptives, Background information spironolactone, flutamide, finasteride and cyproterone 3 The adult body is covered in two types of hair: vellus acetate. Co-cyprindiol (cyproterone acetate 2 mg and terminal hair. Vellus hair is soft, short and plus ethinyloestradiol 35 mcg) is the only systemic unpigmented; it covers most of the body before therapy licensed in the UK for hirsutism. Response to puberty. Terminal hair is coarse, pigmented and is systemic therapies may take up to 18 months. androgen-sensitive. Hirsutism refers to the presence Eflornithine is the first topical preparation to be of increased terminal hair growth in androgen- licensed in the UK. It is an irreversible inhibitor of dependent areas and the term is applied to women 2 ornithine decarboxylase, an enzyme involved in the who develop a male hair pattern. It is usually a sign production of the hair shaft by the hair follicle.1 It of an underlying endocrine disorder causing excess slows hair growth and reduces the size of the hairs so circulatory androgens, but may also be due to that they become less coarse and less visible. increased sensitivity of the hair follicles to normal androgen levels. The most common cause is the Clinical efficacy polycystic ovary syndrome. Some women have There are no fully published studies on the efficacy of “idiopathic hirsutism” with normal ovulatory function eflornithine. The results reported below have been and androgen levels. Hirsutism is often associated 4 obtained from the European Medicines Agency and with mental and emotional distress. 5,6 from poster presentations. 2 Hirsutism has a strong familial and ethnic link. It 4 A double-blind, parallel-group, dose-response study affects between five and fifteen percent of women. (duration 24 weeks plus eight weeks follow-up; n = The underlying cause of hirsutism should be 187) assessed the efficacy of 3.83%, 7.67% and determined before treatment is initiated. In many 11.5% eflornithine cream compared with vehicle. A cases counselling, reassurance and cosmetic significant reduction in hair length (but not area, methods e.g. shaving, waxing, bleaching and laser opacity or stiffness) as measured by the modified
January 2006 Page 1 of 2 Ferriman-Gallwey scoring method was seen with evidence that eflornithine caused phototoxic or 11.5% eflornithine cream when compared with vehicle photoallergic reactions. (p < 0.001) after 24 weeks’ treatment.4 At follow-up, Refer to the Summary of Product Characteristics for eight weeks after treatment cessation, the significant further details.1 difference had been lost. None of the lower strength formulations showed any difference in the hair scores Additional information compared with vehicle. • Eflornithine 11.5% cream should be applied thinly, Two double-blind, randomised, trials4,5 (duration 24 twice daily (at least eight hours apart) to affected weeks plus 8 weeks follow-up; n = 569) assessed the areas of the face and chin.1 An improvement efficacy of eflornithine 11.5% cream compared with should be seen within eight weeks of initiating vehicle. The primary outcome was clinical success, treatment. Continual therapy is necessary to (defined as “clear/almost clear” or “marked maintain the effect, as hirsutism may return to pre- improvement”) as measured by the Physician’s Global treatment levels with eight weeks of therapy Assessment. At week 24, clinical success was 24% cessation.1 to 44% in eflornithine-treated women compared with • There are no known drug interactions. 4% to 13% in those treated with vehicle (p < 0.001). In both studies there was a significant difference in the • Long-term safety of eflornithine 11.5% cream has reduction in spatial hair mass (p < 0.05), but not not been assessed. It has not been compared with length, at week 24 in eflornithine-treated patients any other therapies; in particular, there are no when compared with vehicle-treated patients. In both direct comparisons with oral co-cyprindiol, the only studies the patients’ quality of life (measured by the other licensed therapy for facial hirsutism. Subjects Self-Assessment Questionnaire) was • At current prices one year’s treatment with superior when treated with eflornithine compared with eflornithine 11.5% cream is £156 (based on 15 vehicle at week 24 (p < 0.05). g/month) compared with £48 with co-cyprindiol There were no differences between the groups in both tablets. studies for any outcomes at week 32 (eight weeks References after cessation of eflornithine therapy). 1. Shire Pharmaceuticals. Vaniqa 11.5% cream. Summary Eflornithine was assessed in two open-label studies (n 4,6 of Product Characteristics 2005. = 216, 754; duration 12 or 6 months). Clinical 2. Azziz R. The evaluation and management of hirsutism. success was 24% at week 52 in the first study and Obstet Gynecol 2003;101:995-1007. 47% at week 26 in the second. In the first study, 81% 3. London New Drugs Group. Eflornithine cream (Vaniqa). of women showed some improvement by week 20 APC/DTC Briefing 2004;1-10. and in the second, 90% of the women showed some 4. Scientific Discussion: Vaniqa Shire Pharmaceuticals. improvement at week 26. 2004. http://www.emea.eu.int/humandocs/PDFs/EPAR/vaniqa/ Adverse effects 021201en6.pdf
Launch date: July 2004 Manufacturer: Shire Pharmaceuticals Ltd EU/1/01/173/001-003 WARNING: This sheet should be read in conjunction with the Summary of Product Characteristics This guidance is based upon the published information available in English at the time the drug was considered. It remains open to review in the event of significant new evidence emerging. MTRAC can be contacted at the Dept. of Medicines Management, Keele University, Keele, Staffs ST5 5BG Tel: 01782 584131 Fax: 01782 713586 Email: [email protected] Web: www.mtrac.co.uk
RELEVANT NICE GUIDANCE WAS NOT AVAILABLE AT THE TIME OF ISSUE OF THIS VERDICT Date: January 2006 ©Midlands Therapeutics Review & Advisory Committee VS06/01