Cost Savings Matrix – ENGLAND Generic name (MIMS) ethinylestradiol / progestogen Desogestrel 75 microgram Company Other manufacturers brand Other brand cost for 3 cycle pack1 Schering- Plough Ltd Cerazette® £8.68 Bayer Healthcare Microgynon® 30 £2.82 Pfizer Ltd Ovranette® £2.20 Morningside Healthcare Ltd Levest® £3.00 Ethinylestradiol 30 microgram / desogestrel 150 microgram Schering-Plough Ltd Marvelon® £6.45 Ethinylestradiol 20 microgram / desogestrel 150 microgram Schering-Plough Ltd Mercilon® £7.67 Ethinylestradiol 30 microgram / gestodene 75 microgram Bayer Healthcare Femodene® £6.73 Stragen UK Ltd Katya® £5.03 Ethinylestradiol 20 microgram / gestodene 75 microgram Bayer Healthcare Femodette® £8.85 Stragen UK Ltd Sunya® £6.62 Logynon® £3.82 Ethinylestradiol 30 microgram / levonorgestrel 150 microgram Ethinylestradiol 30 / 40 / 30 microgram / Bayer Healthcare levonorgestrel 50 / 75 / 125 microgram References 1. Chemist & Druggist December 2012 2. Data on file based on 2011 PCA data England Consilient Health brand (CH) CH brand cost for 3 cycle pack 1 % difference Annual volume of 3 cycle packs in England 2 Total potential annual savings to NHS England by changing to CH brand £4.30 50.46% 2,099,352 £9,195,161.76 £1.89 33% 3,335,858 £3,102,347.94 £1.89 14% 301,098 £93,340.38 £1.89 37% 63,404 £70,378.44 Gedarel® 30/150 £4.93 24% 282,579 £429,520.08 Gedarel® 20/150 £5.98 22% 173,443 £293,118.67 £4.85 28% 250,971 £471,825.48 £4.85 4% 1,192 £214.56 £6.37 28% 102,283 £253,661.84 £6.37 4% 1,245 £311.25 £2.87 25% 182,393 £173,273.35 Cerelle® Rigevidon® Millinette® 30/75 Millinette® 20/75 TriRegol® Total potential annual savings to NHS England by changing to all CH brands % potential annual savings to NHS England by changing to all CH brands For further information and to download the free ‘My OC’ reminder app, please visit: www.knowyourcontraceptives.co.uk £14,083,154 40% Cost Savings Matrix – ENGLAND Abbreviated Prescribing Information – for full prescribing information, including side effects, precautions and contra-indications, see Summary of Product Characteristics (SmPC) Product Name: Rigevidon Coated Tablets. Composition: 1 tablet contains 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel. Gedarel 30/150 microgram Film-coated Tablets. Composition: 1 tablet contains 30 micrograms ethinylestradiol and 150 micrograms desogestrel. Gedarel 20/150 microgram Film-Coated Tablets. Composition: 1 tablet contains 20 micrograms ethinylestradiol and 150 micrograms desogestrel. Millinette 30/75 microgram Coated Tablets. Composition: 1 tablet contains 30 micrograms ethinylestradiol and 75 micrograms gestodene. Millinette 20/75 microgram Coated Tablets. Composition: 1 tablet contains 20 micrograms ethinylestradiol and 75 micrograms gestodene. TriRegol Coated Tablets. Composition: Each pink tablet contains 30 micrograms ethinylestradiol and 50 micrograms levonorgestrel; each white tablet contains 40 micrograms ethinylestradiol and 75 micrograms levonorgestrel; each ochre tablet contains 30 micrograms ethinylestradiol and 125 micrograms levonorgestrel. Cerelle 75 microgram film-coated Tablets. Composition: One tablet contains 75 micrograms desogestrel. Please refer to the relevant Summary of Product Characteristics (SmPC) for a full list of excipients. Indication: Oral contraception. Dosage and Administration: Rigevidon, Gedarel 30/150, Gedarel 20/150, Millinette 30/75, Millinette 20/75, TriRegol: One tablet is to be taken daily for 21 consecutive days, starting on day 1 of the normal cycle. Every subsequent pack is started after a 7-day tablet free interval, during which time a withdrawal bleed usually occurs. Bleeding usually starts on the 2nd or 3rd day after the last tablet and may not end before the next pack is started. For details of usage, especially where a patient either misses a dose or has vomiting/diarrhoea, please refer to the relevant SmPC. Gedarel 30/150, Gedarel 20/150: No data are available on safety and efficacy of desogestrel in adolescents below 18 years. Cerelle: One tablet taken each day continuously, without taking any notice of possible bleeding. Each new pack to be started directly after the previous one. The first tablet should be taken on the first day of menstrual bleeding. If changing from another contraceptive method, Cerelle should be started on the day after the last active tablet of a combined oral contraceptive (COC), at any time if the woman is on a progestogen only pill (POP), on the day of removal of a vaginal ring/transdermal patch/implant/IUS or when the next injectable is due. For details of usage, especially where a patient either misses a dose or has vomiting/diarrhoea, please refer to the SmPC. Contraindications: Rigevidon, Gedarel 30/150, Gedarel 20/150, Millinette 30/75, Millinette 20/75, TriRegol: Combined oral contraceptives (COCs) should not be used if present or previous venous or arterial thrombosis, (e.g. pulmonary embolism, myocardial infarction (MI) or cerebrovascular disorder/accident), present or previous prodromal symptoms of thrombosis, (e.g. transient cerebral ischaemia/ attack or angina pectoris), considerable or multiple risk factors for venous or arterial thrombosis or a predisposition to either condition (please refer to the relevant SmPC), cardiovascular disorders, (e.g. cardiac diseases, valvulopathy, arrhythmic disturbances), ocular disorder of vascular origin, severe hypertension, diabetes complicated with angiopathy, migraine with focal neurological symptoms, pancreatitis with severe hypertriglyceridaemia, severe or recent hepatic disorders, liver tumours, undiagnosed vaginal bleeding, sex-steroid influenced malignancies, (e.g. breast or endometrial), or a hypersensitivity to the components of the tablet. Cerelle: Hypersensitivity to desogestrel or any of the excipients of Cerelle; active venous thromboembolic disorder; presence or history of severe hepatic disease (whilst liver function tests are abnormal); known or suspected sex-steroid sensitive malignancies; undiagnosed vaginal bleeding. Warnings and Precautions: Rigevidon, Gedarel 30/150, Gedarel 20/150, Millinette 30/75, Millinette 20/75, TriRegol: Prior to starting or resuming use a complete history should be taken, a physical examination performed and pregnancy ruled out. The woman should be instructed to carefully read the user leaflet and adhere to the advice. The benefits of COC use must be weighed against possible risks in each individual case and discussed with the woman with respect to the following conditions: Circulatory disorders: Venous or arterial thromboembolism including MI or transient ischaemic attack/stroke. Please refer to the relevant SmPC for associated risk factors and symptomology associated with the above conditions. Tumours: A possible increased risk of cervical cancer has been reported with all long-term COC use. Breast cancer has been reported in COC users, though no direct causation has been shown. Hepatic tumours have also been reported. Other Conditions: Clinically relevant increases in blood pressure (rare) and pancreatitis in the presence of or with a family history of hypertriglyceridaemia have also been reported as have an influence on peripheral insulin resistance and glucose tolerance, Crohn’s disease and ulcerative colitis. The following conditions may arise or worsen during use of COCs although evidence of a relationship is inconclusive: Jaundice and/or pruritus associated with cholestasis, development of gallstones, porphyria, system lupus erythematosis, haemolytic uraemic syndrome, Sydenham’s chorea, herpes gestationis, hearing loss due to otosclerosis. COCs should be stopped and an alternative contraceptive method used in women with: an increase in the frequency or severity of migraine, impaired liver function (until tests return to normal), severe depression (until the cause is identified), or persistent clinical hypertension. Please refer to the relevant SmPC for further details. Bleeding: With all COCs, irregular bleeding may occur, especially during the first months of use. The evaluation of any irregular bleeding should be considered after approximately three cycles. If bleeding irregularities occur after previously regular cycles, adequate diagnostic measures should be taken to exclude malignancy or pregnancy. Please refer to the relevant SmPC for further information regarding cycle control. Cerelle: The benefits of progestogen use should be weighed against the possible risks for each individual woman. The risk of breast cancer is slightly increased with COC use, but for POPs the evidence is less conclusive. A benefit/risk assessment should be made in women with liver cancer since progestogens may affect this. Women should be referred to a specialist if acute or chronic disturbances of liver function occur. Cerelle should be discontinued in the event of a thrombosis and women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence. Discontinuation of Cerelle should also be considered if there is long-term immobilization. Diabetic patients should be carefully observed during the first months of use due to a potential effect on insulin resistance and glucose tolerance. If sustained hypertension develops, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, consider discontinuing Cerelle. Ectopic pregnancy should be included in the differential diagnosis if a woman gets amenorrhoea or abdominal pain. Chloasma may occasionally occur, and women with a tendency to this should avoid exposure to the sun or UV radiation whilst taking Cerelle. The following conditions have been reported during sex steroid use: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema. Women with certain rare hereditary problems of carbohydrate metabolism should not take Cerelle since this contains lactose. Pregnancy and lactation: Rigevidon, Gedarel 30/150, Gedarel 20/150, Millinette 30/75, Millinette 20/75, TriRegol: The COCs are not indicated during pregnancy; treatment should be withdrawn immediately if pregnancy occurs. The use of COCs is not recommended during breast feeding. Cerelle: Cerelle is not indicated during pregnancy and treatment should be stopped if pregnancy occurs. Cerelle may be used during lactation; the development and growth of a nursing infant, whose mother uses Cerelle should, however, be carefully observed. Effects on ability to drive and use machinery: There is no influence on the ability to drive and use machines. Undesirable effects: Rigevidon, Gedarel 30/150, Gedarel 20/150, Millinette 30/75, Millinette 20/75, TriRegol: The following adverse reactions have been reported in women using COCs: Very common (>1/10): irregular bleeding, nausea, weight increase, breast tenderness and headache. These usually occur at the beginning of treatment and are transient. Other common (>1/100, <1/10): fluid retention, changes to libido, mood changes including depression, irritability, dizziness, nervousness, corneal disorder, ocular irritation in contact lens wearers, visual disturbance, migraine, hypertension, abdominal pain, vomiting, cholelithiasis, acne, chloasma, rash, urticaria, amenorrhoea, hypomenorrhoea, dysmenorrhoea, metrorrhagia, changes in cervical ectropion and secretion, breast pain, enlargement or secretion and weight decrease. Venous and arterial thromboembolic disorders, cervical cancer, liver tumours and erythema nodosum have also been reported with COC use. Cerelle: The most commonly reported is bleeding irregularity but after a couple of months of treatment, bleedings tend to become less frequent. The following adverse reactions have been reported: Common (>1/100, <1/10): mood altered, libido decreased, depressed mood, headache, nausea, acne, breast pain, menstruation irregular, amenorrhoea, weight increased. Uncommon (>1/1,000, <1/100): Vaginal infection, contact lens intolerance, vomiting, alopecia, dysmenorrhoea, ovarian cyst, fatigue, Rare (>1/10,000, <1/1,000): rash, urticaria, erythema nodosum. Breast discharge may occur during use of Cerelle. Rarely ectopic pregnancies have been reported. Please refer to the relevant SmPC on each product in relation to other side effects. Overdose: There have been no reports of serious adverse effects from overdose. NHS Price: Rigevidon 3 x 21 tablets £1.89; Gedarel 30/150 3 x 21 tablets £4.93; Gedarel 20/150 3 x 21 tablets £5.98; Millinette 30/75 3 x 21 tablets £4.85; Millinette 20/75 3 x 21 tablets £6.37; TriRegol 3 x 21 tablets £2.87; Cerelle 3 x 28 tablets £4.30. Legal category: All POM. Authorisation numbers: Rigevidon 17550/0032; Gedarel 30/150 PL 04854/0061; Gedarel 20/150 PL 04854/0060; Millinette 30/75 PL 17550/0043; Millinette 20/75 PL 17550/0042; TriRegol PL 17550/0031; Cerelle PL 20154/0029. Marketing Authorisation Holder: Rigevidon: Gedeon Richter France, 1 – 3 rue Caumartin, 75009 Paris, France. Millinette 30/75, Millinette 20/75, TriRegol: Medimpex France SA, 1 – 3 rue Caumartin, 75009 Paris, France. Gedarel 30/150, Gedarel 20/150, Cerelle: Gedeon Richter Plc. 1103 Budapest, Gyömrői út, 19-21, Hungary. Further information is available on request from Consilient Health (UK) Ltd, 500 Chiswick High Road, London W4 5RG, UK on 020 8956 2310. CH-OCs-1109-11/2012 Date of preparation of prescribing information: December 2012 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Consilient Health (UK) Ltd, 500 Chiswick High Road, London W4 5RG, UK on 020 8956 2310. CH-OCs-623b-08/2012 Date of Preparation: December 2012 For further information and to download the free ‘My OC’ reminder app, please visit: www.knowyourcontraceptives.co.uk