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Eczema (Chronic) NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SINGLE TECHNOLOGY APPRAISAL (STA) SPECIFICATION FOR MANUFACTURER/SPONSOR SUBMISSION OF EVIDENCE Update to reflect the new Guide to the Methods of Technology Appraisals Update July 2008 Page 1 of 151 Contents 3 Executive summary 7 4 Context 10 5 Equity and equality 15 6 Clinical evidence 15 7 Cost effectiveness 81 8 Assessment of factors relevant to the NHS and other parties 119 9 References 127 10 Appendices 127 Update July 2008 Page 2 of 151 Section A 1 Description of technology under assessment 1.1 Give the brand name, approved name and, where appropriate, therapeutic class. Toctino®, oral alitretinoin (9-cis retinoic acid) 1.2 Does the technology have a UK marketing authorisation/CE marking for the indications detailed in this submission? Oral alitretinoin was granted a Marketing Authorisation for the UK on 5th September 2008 following recommendation for approval under the EMEA decentralised procedure and became commercially available on the 22nd September 2008. 1.3 What are the (anticipated) indication(s) in the UK? Oral alitretinoin (9-cis retinoic acid) is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. 1.4 To what extent is the technology currently being used in the NHS for the proposed indication? Toctino (oral alitretinoin) was launched on 8th September 2008 and became commercially available on the 22nd September 2008. 1.5 Does the technology have regulatory approval outside the UK? Oral alitretinoin has regulatory approval in Germany, France, Denmark, and Finland. 1.6 Is the technology subject to any other form of health technology assessment in the UK? A new product assessment form for alitretinoin was submitted to the Scottish Medicines Consortium (SMC) on Monday 22nd September 2008. It is anticipated that the review will follow the timescale outlined below. Deadline NDC NDC Deadline Deadline SMC Advice Advice Deadline Advice for Meeting Draft for Patient for Meeting issued issued to for posted Company Date Advice to Submission Company Date to NHS Comparator Comparator on SMC Submission Company to SMC Response Scotland Company Comments Website to to SMC for Secretariat Comment 3 Nov 2008 16 Dec 19 Dec 12 Jan 16 Jan 3 Feb 06 Feb 09 Feb 18 Feb 09 Mar 2009 1.7 For pharmaceuticals, what formulation(s) (for example, ampoule, vial, sustained-release tablet, strength(s) and pack size(s) will be available? Oral alitretinoin is available in 10mg and 30mg soft capsules. 1.8 What is the proposed course of treatment? The recommended dose range for alitretinoin is 10mg-30mg once daily, with a meal. The recommended start dose for alitretinoin is 30mg once daily. A dose reduction to 10mg once daily may be considered in patients with unacceptable adverse reactions to the higher dose. Update July 2008 Page 3 of 151 A treatment course of alitretinoin may be given for 12 to 24 weeks depending on response. In the phase III trial, the average time to response was 12.9 weeks in responders (patients achieving clear/almost clear hands) and 15.4 weeks overall. Discontinuation of therapy should be considered for patients who still have severe disease after the initial 12 weeks of treatment. In the event of relapse, patients may benefit from further treatment courses of alitretinoin. Prescriptions of alitretinoin for women of childbearing potential should be limited to 30 days of treatment per prescription. Continuation of treatment requires a new prescription and pregnancy testing; issuing a prescription and dispensing of alitretinoin should ideally occur on the same day. Dispensing of alitretinoin should occur within a maximum of 7 days of the prescription. 1.9 What is the acquisition cost of the technology (excluding VAT)? Oral alitretinoin has the same price for both 10mg and 30mg soft capsules with the NHS list price of both being £411.43 per 30 capsule pack (one capsule to be taken daily). 1.10 What is the setting for the use of the technology? Oral alitretinoin should be used only under the supervision of dermatologists or physicians experienced in the use of systemic retinoid therapy, for adult patients with severe CHE who are unresponsive to potent topical corticosteroids, as an alternative to phototherapy or systemic immunosuppressants. Although phototherapy and immunosuppressants are used commonly at present, oral alitretinoin will be the first drug treatment licensed for treatment of severe CHE which is unresponsive to topical corticosteroids. 1.11 For patients being treated with this technology, are there any other aspects that need to be taken into account? Alitretinoin should not be prescribed if the patient’s eczema can be adequately controlled by standard measures, including skin protection, avoidance of allergens and irritants, and treatment with potent topical corticosteroids. Alitretinoin is TERATOGENIC. Alitretinoin is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met: ▪ She understands the teratogenic risk ▪ She understands the need for rigorous follow-up, on a monthly basis ▪ She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the duration of treatment and 1 month after the end of treatment. At least one and preferably two complementary forms of contraception including a barrier method should be used ▪ Even if she has amenorrhoea she must follow all of the advice on effective contraception ▪ She should be capable of complying with effective contraceptive measures ▪ She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy ▪ She understands the need and accepts to undergo pregnancy testing before, during and 5 weeks after the end of treatment ▪ She has acknowledged that she has understood the hazards and necessary precautions associated with the use of alitretinoin Update July 2008 Page 4 of 151 These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy. The prescriber must ensure that: ▪ The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding ▪ The patient has acknowledged the aforementioned conditions ▪ The patient has used at least one and preferably two methods of effective contraception including a barrier method for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment ▪ Negative pregnancy test results have been obtained before, during and 5 weeks after the end of treatment. The dates and results of pregnancy tests should be documented Contraception Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. As a minimum requirement, female patients at potential risk of pregnancy must use at least one effective method of contraception. Preferably the patient should use two complementary forms of contraception including a barrier method. Contraception should be continued for at least 1 month after stopping treatment with alitretinoin, even in patients with amenorrhea. Pregnancy testing According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mIU/mL are recommended to be performed in the first 3 days of the menstrual cycle, as follows: One month prior to starting therapy - In order to exclude the possibility of pregnancy prior to starting contraception, it is recommended that an initial medically supervised pregnancy test should be performed and its date and result recorded. In patients without regular menses, the timing of this pregnancy test should reflect the sexual activity of the patient and should be undertaken approximately 3 weeks after the patient last had unprotected sexual intercourse. The prescriber should educate the patient about contraception. At the start of therapy - A medically supervised pregnancy test should also be performed during the consultation when alitretinoin is prescribed or in the 3 days prior to the visit to the prescriber, and should have been delayed until the patient had been using effective contraception for at least 1 month. This test should ensure the patient is not pregnant when she starts treatment with alitretinoin. Follow-up visits - Follow-up visits should be arranged at 28 day intervals. The need for repeated medically supervised pregnancy tests every month should be determined in consideration amongst other of the patient’s sexual activity and recent menstrual history (abnormal menses, missed periods or amenorrhea). Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber. End of treatment - Five weeks after stopping treatment, women should undergo a final pregnancy test to exclude pregnancy. Prescribing and dispensing restrictions Prescriptions of alitretinoin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of alitretinoin should
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