New Medicine Applications Brought to The
NEW MEDICINE APPLICATIONS BROUGHT TO THE
BORDERS FORMULARY COMMITTEE (BFC)
AND AREA DRUG & THERAPEUTICS COMMITTEE (ADTC)
2012/13
New Medicine Product/Device Endorsement Categories
A
/ recommended for general use - hospital and general practiceB / recommended for specialist use only
C / recommended for shared care between hospital and general practice
D / not recommended (reason given)
E / no decision - need more details
F / recommended for consultant initiation and subsequent general use – hospital and general practice
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 18TH APRIL 2012
NMA / Indication / BFC Decision
Paliperidone palmitate / Prolonged release suspension for injection. / CAT ‘F’
Nortriptyline / Neuropathic pain. / CAT ‘A’
Pregabalin / For restricted use in patients who have not achieved pain relief or tolerated 1st & 2nd line treatments for peripheral neuropathic pain. / CAT ‘A’
Lidocaine / Localised neuropathic pain. / Approved but to go to ADTC of 9/5/12
Romiplostim / For use in adults with chronic immune thrombocytopenic purpura splenectomised patients who are refractory to other treatments. / CAT ‘B’
Etanercept / Systemic juvenile idiopathic arthritis. / CAT ‘B’
Nutricia preOp / For use in the ERAS (enhanced recovery after surgery) programme. / CAT ‘B’
Dexamphetamine complex / ADHD / CAT ‘B’
Ustekinumab / For use in patients who have failed to respond to or who have a contraindication to or intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment. / CAT ‘B’
Orlistat / Weight loss in adults who are overweight (BMI>28kg/m²). / Approved for patients with BMI >35
PleureX / NHS Borders palliative care team with to use this drug. Proposed indication – Malignant recurrent ascites. 6 patients to be treated with this per annum. / Discussion with procurement.
Colecalciferol / To be used as an adjunct to specific therapy for osteoporosis in patients with Vitamin D deficiency at risk of Vitamin D insufficiency. / CAT ‘A’
Capsaicin / Treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. / CAT ‘B’
Clobetasol Propionate Shampoo / Topical treatment of moderate scalp psoriasis in adults. / CAT ‘A’
Fluorouracil 0.5%
Salicylic Acid 10%
Cutaneous Sol / Topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade 1/11) in Immunocompetent adult patients. / CAT ‘A’
NEW MEDICINE APPLICATIONS BROUGHT TO ADTC MEETING OF 9TH MAY 2012
NMA / Indication / ADTC
Decision
Budesonide – Eosinophilic oesophagitis / Dose to be identified. / CAT ‘B’
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 13TH JUNE 2012
NMA / Indication / BFC Decision
Duloxetine / For the treatment of diabetic peripheral neuropathic pain in adults and patients who are not diabetic. / CAT ‘A’
Urea 5%
Ceramide 0.1% / For the treatment of dry skin conditions. / Check if on EMISS. If guidance in formulary to bring to the ADTC meeting of 11.07.12
White soft paraffin 13.2%, light liquid paraffin 10.5% / Emollient for inflamed, damaged dry or chapped skin including eczema, psoriasis and other skin inflammatory conditions. / As above.
Urea 10%
Lauromacrogols 3% / For treatment of dry, scaling and itching skin. / As above
Cream - Glycerol 10%, light liquid paraffin 10%, white soft paraffin 5%
Intensive ointment – light liquid paraffin 50.5%, white soft paraffin 20%
Lotion – white / For treatment of dry skin conditions including eczema, psoriasis, ichthyosis, pruritis. / As above
Enzyme alginogel with glucose oxidase and lactoperoxidase / For treatment of chronic wounds such as leg ulcers, diabetic ulcers, infected wounds, post surgical wound dressing etc. / To go to wound group and bring to the next ADTC meeting.
Natilizumab / Treatment of multiple sclerosis. / CAT ‘B’
Carboxymaltose / Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. / CAT ‘B’
Finasteride / Treatment of male pattern baldness. / Consultant to prescribe for a trial period of 6 months and afterwards to liaise with GP.
Telaprevir / Treatment of genotype 1 chronic Hepatitis C in adult patients. / For noting only.
Denosumab / For off label use. / Approved but applicant to bring back if requires using on more than 3 patients.
NEW MEDICINE APPLICATIONS BROUGHT TO ADTC MEETING OF 11TH JULY 2012
NMA / Indication / ADTC Decision
Exanatide Solution for injection, prefilled pen. / Adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults with type 2 diabetes who have not achieved adequate glycaemic control with these agents. / CAT ‘F’
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 8TH AUGUST 2012
NMA / Indication / BFC
Decision
Octenisan / For use in MRSA eradication / CAT ‘F’.
Chlorthalidone 50mg
Indapamide 2.5mg
Indapamide 1.5mg MG / For use in Hypertension. / Draft copy to be sent to those who should have attended the group and bring back to the next meeting.
NEW MEDICINE APPLICATIONS BROUGHT TO ADTC MEETING OF 12TH SEPTEMBER 2012
NMA / Indication / ADTC
Decision
Ranolazine 375mg, 500mg, 750mg / For use in non alcoholic fatty liver disease in non diabetics & pre-cirrhotics. / CAT ‘F’
Vitamin E / For use in non alcoholic fatty liver disease in non diabetics & pre-cirrhotics. / CAT ‘F’
Micafungin 50mg, 100mg vials / For the use in treatment of chronic pulmonary aspergillosis in one patient. / CAT ‘F ‘
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 17TH OCTOBER 2012
NMA / Indication / BFC
Decision
Fingolimod / For restricted use as a single disease modifying therapy in highly active RRMS in adult patients with high disease activity despite treatment with a beta-interferon with an unchanged or increased relapse rate or ongoing severe relapses, as compared to previous year. / CAT ‘B’
Denosumab / For use in osteoporosis (chronic renal impairment) – variable. / CAT ‘B’
NO NEW MEDICINE APPLICATIONS BROUGHT TO ADTC MEETING OF 14TH NOVEMBER 2012
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 12TH DECEMBER 2012
NMA / Indication / BFC
Decision
Ranibizumab / For use in the treatment of visual impairment due to diabetic macular oedema (DMO) in adults. / CAT ‘B’.
aclidinium / Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). / CAT ‘A’.
Fluticasone proprionate and formoterol fumarate metered dose inhaler, / Regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA)] is appropriate:for patients not adequately controlled on ICS and ‘as required’ inhaled short-acting β2 agonist orfor patients already adequately controlled on both an ICS and a LABA. / Deferred for more info until February 2013 meeting.
NO NEW MEDICINE APPLICATIONS WERE BROUGHT TO THE ADTC MEETING OF 9TH JANUARY 2013
NEW MEDICINE APPLICATIONS BROUGHT TO BFC MEETING OF 13TH FEBRUARY 2013
NMA / Indication / BFC
Decision
Desogestrel (Cerelle®) / Progestogen Only Oral Contraception / CAT ‘A’
Denosumab (Prolia®) / Osteoporotic fractures, needs bone protecting medication. / CAT ‘B’
Naltrexone / Treatment of CFS/ME / Not approved further supporting evidence requested.
Pravastatin / Use in hypercholesterolaemia or hyperlipidaemia; prevention of cardiovascular events. / CAT ‘A’
Mistletoe Therapy / Used in the treatment of malignant conditions alongside appropriate conventional management. / Not approved. Not on correct paperwork. GP to be asked to resubmit on correct form.
NEW MEDICINE APPLICATIONS BROUGHT TO ADTC MEETING OF 13TH MARCH 2013
NMA / Indication / ADTC
Decision
Ingenol Mebutate (Picato) / For cutaneous treatment of non-hyperkeratotic, non hypertrophic actinic keratosis in adults. / CAT ‘A’
Dapagliflozin 5mg & 10mg film coated tabs (Forxiga) / For use in adults aged 18 yrs & older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin. / CAT ‘F’
Colecalciferol (Desunin) / For prevention and treatment of Vit D deficiency in adults and adolescents. / CAT ‘F’
Rivaroxaban / For the treatment of pulmonary embolism (PE) and prevention of recurrent deep vein thrombosis (DVT) and PE in adults. / CAT ‘A’
Immunoglobulin / Required for chronic steroid therapy. / CAT ‘B’