Description

Review:

Buprenorphine once weekly transdermal patches (Butec/ BuTrans/Panitaz/Reletrans/Sevodyne).

Buprenorphine twice weekly transdermal patches (Bupeaze/ Hapoctasin/Transtec).

Rapid Drug Assessment:

Human Papillomavirus 9-valent vaccine (Gardasil 9).

Shared Care Update:

Shared Care Guideline – Methotrexate in Dermatology and Respiratory (August 2016).

MHRA Drug Safety Update (September 2016):

Levonorgestrel-containing emergency hormonal contraception: Advice on interactions with hepatic enzyme inducers and contraceptive efficacy.

NHS England - Alert issued following accidental death of a patient linked to E45 cream.

Risk of confusion between 0.5mg and 5mg strengths of warfarin.

NICE Technology Appraisal:

NICE Technology Appraisal 259: Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen (July 2016).

NICE Technology Appraisal 398: Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del mutation (July 2016).

NICE Technology Appraisal 399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts (July 2016).

NICE Technology Appraisal 400: Nivolumab in combination with ipilimumab for treating advanced melanoma (July 2016).

NICE Technology Appraisal 391: Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel (August 2016).

NICE Technology Appraisal 401: Bosutinib for previously treated chronic myeloid leukaemia (August 2016).

NICE Technology Appraisal 402: Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin (August 2016).

NICE Technology Appraisal 403: Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer (August 2016).

NICE Technology Appraisal 405: Trifluridine–tipiracil for previously treated metastatic colorectal cancer (August 2016).

NICE Technology Appraisal 406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (September 2016).

NICE Technology Appraisal 407: Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors (September 2016).

NICE Technology Appraisal 408: Pegaspargase for treating acute lymphoblastic leukaemia (September 2016).

NICE Technology Appraisal 409 Aflibercept for treating visual impairment caused by macular oedema after branch retinal vein occlusion (September 2016).

Description

Review:

Escalating cost of Nefopam 30mg tablets.

Rapid Drug Assessment:

Budesonide 200microgram/formoterol 6microgram per actuation metered dose inhaler (Symbicort pMDI).

Loteprednol etabonate 0.5% eye drops (Lotemax).

Budesonide 9mg multimatrix tablets (Cortiment).

Rapid Cost Comparison:

Tiotropium bromide monohydrate 2.5microgram per actuation (Spiriva Respimat) price reduction.

Fosfomycin 3g granules (Monuril).

NICE Technology Appraisal:

NICE Technology Appraisal 404: Degarelix for treating advanced hormone-dependent prostate cancer (August 2016).

Description

Review of Gonadotropin Releasing Hormone Agonists for Prostate Cancer.

Gonadotropin releasing hormone (GnRH) agonists such as goserelin, leuprorelin and triptorelin given as long acting sub-cutaneous or intra-muscular injections have a well-established, NICE endorsed role as hormonal therapy in the treatment of prostate cancer.

Triptorelin intramuscular injection (Decapeptyl) has the full range of marketing authorisations for prostate cancer, has a finer needle than goserelin (Zoladex), is lower cost than Zoladex and leuprorelin (Prostap) and has a six monthly IM preparation for increased patient convenience. Prescribers are urged to review all of their patients currently receiving a gonadotropin releasing hormone agonist for prostate cancer to ensure that, wherever possible, treatment is standardised around first line triptorelin (Decapeptyl). Where a second line option is required, leuprorelin (Prostap) is preferred. Both products are designated AMBER without shared care and are approved for first and second line use respectively where a GnRH agonist is indicated for prostate cancer.

Goserelin (Zoladex) is the only GnRH agonist licensed for the treatment of breast cancer and is included on the Lincolnshire Joint Formulary solely for this indication; designation: AMBER without shared care.

Following review within United Lincolnshire Hospitals, urologists and other specialists initiating GnRH agonist therapy have agreed to specify triptorelin or leuprorelin as the preferred first line GnRH agonists of choice. Goserelin (Zoladex) will only be specified by name within the context of breast cancer treatment. A copy of the revised ULH Out-Patient Letter specifying the two preferred options is included as an Appendix to this Bulletin.

Description

Update:

The use of intranasal corticosteroids in perennial and seasonal allergic rhinitis.

Updated guidance on calcium and vitamin D supplementation.

Rapid Drug Assessment:

Co-danthrusate 50mg/60mg capsules (danthron/ docusate).

Voriconazole 1% eye drops for corneal ulcers and fungal keratitis (unlicensed).

NICE Technology Appraisal:

NICE Technology Appraisal 387: Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (July 2016).

NICE Technology Appraisal 392: Adalimumab for treating moderate to severe hidradenitis suppurativa (June 2016).

NICE Technology Appraisal 395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer (June 2016).

NICE Technology Appraisal 396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (June 2016).

NICE Technology Appraisal 397: Belimumab for treating active autoantibody-positive systemic lupus erythematosus (June 2016).

NICE Technology Appraisal 390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes (May 2016).

MHRA Drug Safety Update (July 2016):

Warfarin – reports of calciphylaxis.

Citalopram – suspected drug interaction with cocaine.

Description

New Drug Assessment:

Brivaracetam tablets/oral solution (Briviact).

Rapid Cost Comparison:

Diltiazem 60mg modified release tablets (Retalzem).

Review:

Doxycycline 40mg modified release capsules (Efracea).

Longer acting diltiazem formulations.

Rapid Cost Comparison:

Naproxen effervescent tablets (Stirlescent).

MHRA Drug Safety Update (June 2016):

Canagliflozin (Invokana, Vokanamet): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients.

Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung.

Topical miconazole, including oral gel: potential serious interactions with warfarin.

Description

Overview:

Alogliptin (Vipidia) is non-inferior to other DPP-4 inhibitors and significantly lower in cost than competitors. It is now the preferred first line DPP-4 inhibitor on the Lincolnshire Joint Formulary and should be prescribed preferentially in new patients requiring a DPP-4 inhibitor. Even in patients with renal impairment, alogliptin can usually be prescribed, subject to recommended dosage adjustments, although it should be avoided in severe renal impairment. Designation: GREEN first line.

Existing patients on alternative DPP-4 inhibitors should be reviewed and considered for a therapeutic switch to alogliptin.

Sitagliptin (Januvia) is no longer recommended as the first line DPP-4 inhibitor of choice, although it can be considered as a second line alternative to alogliptin. Designation: GREEN second line.

Linagliptin (Trajenta) requires no dosage adjustment in renal and hepatic impairment and can be considered as a second line alternative to alogliptin in those with severe renal impairment or hepatic impairment. Designation: GREEN second line (see page).

In view of declining use, saxagliptin (Onglyza) has been removed from the Lincolnshire Joint Formulary. Designation: RED-RED.

Vildagliptin (Galvus) is not approved for use through the Formulary and remains RED-RED.

Description

New Drug Assessments:

Ivermectin 19mg/g cream (Soolantra).

Mesalazine gastro-resistant granules (Salofalk).

Rapid Drug Assessments:

Fosfomycin 3g granules for oral solution.

Insulin Lispro 200 units/ml (Humalog Kwik Pen).

Review:

Apremilast (Ortezla) for the treatment of psoriasis and active psoriatic arthritis.

Gluten-Free prescribing guidance reminder.

Rapid Cost Comparison:

Oxybutynin 2.5mg in 5ml and 5mg in 5ml oral solutions sugar-free (Thame Laboratories Ltd).

New Trial Assessment:

Empagliflozin/EMPA-Reg Outcome.

NICE Technology Appraisal:

NICE Technology Appraisal 391 Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel (May 2016).

NICE TA 388 Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction (April 2016).

Other:

Lincolnshire Guidance for Patients with Heart Failure with Reduced Ejection Fraction.

Description

New Formulation Assessments:

New pregabalin preparations (Alzain/ Zentiva).

Rapid Cost Comparison:

Tramadol 37.5mg/paracetamol 325mg tablets and effervescent tablets (Tramacet/Tramacet Effervescent).

Tramadol cost comparison.

MHRA Drug Safety Update (April 2016):

SGLT2 inhibitors - updated advice on the risk of diabetic ketoacidosis.

Apomorphine with domperidone – minimising risk of cardiac side effects

Live attenuated vaccines – avoid use in those who are clinically immunosuppressed

Meprobamate – License to be cancelled

Paraffin-based emollients on dressings or clothing – fire risk.

Other:

European Medicines Agency, Review of canagliflozin (15th April 2016).

Description

Review:

Insulin degludec and liraglutide 100 units/3.6mg per ml 3ml pre-filled pen (Xultophy).

Propantheline bromide 15mg tablets (Pro Banthine).

New Formulation Assessment:

Prednisolone 5mg in 5ml and 10mg in 1ml oral solution (Prednisolone Dompe).

Updated Cost Comparison:

Quetiapine sustained release tablets

NICE Technology Appraisal:

NICE Technology Appraisal 387: Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (April 2016).

NICE Technology Appraisal 389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016).

Description

Rapid Cost Comparison:

New ZeroDerma Range of Emollients.

Cetraban ointment and Cetraben lotion.

Etanercept 50mg SB4 – biosimilar (Benepali).

Mexiletine 100mg and 200mg capsules (Mexitil).

Tedizolid 200mg tablets and 200mg powder for solution for infusion (Sivextro).

Rapid Product Assessment:

Fresubin Thickened Stage 1 and 2.

NICE Technology Appraisal:

NICE Technology Appraisal 385: Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia (February 2016).

NICE Technology Appraisal 386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis (March 2016).

NICE TA23: Guidance on the use of temozolomide for the treatment for the treatment of recurrent malignant glioma (brain cancer) (April 2001).

Description

Rapid Drug Assessment:

Salmeterol 50microgram/fluticasone propionate 500microgram per actuation dry powder inhaler (AirFluSal Forspiro).

Beclometasone dipropionate 200microgram/formoterol 6microgram per actuation (Fostair 200/6) metered dose inhaler and NEXThaler.

Other:

Supply difficulties with amiodarone and flecainide.

Shared Care Guidelines - Somatropin for growth deficiencies in adults; Cinacalcet in the management of secondary hyperparathyroidism in adult.

MHRA Drug Safety Update (February 2016):

Valproate and risk of abnormal pregnancy outcomes; Spironolactone and renin-angiotensin system drugs and risk of potentially fatal hyperkalaemia in heart failure.

MHRA Drug Safety Update (March 2016):

Trametinib (Mekinist): Risk of gastrointestinal perforation and colitis.

NICE Technology Appraisal:

NICE Technology Appraisal 367: Vortioxetine for treating major depressive episodes (November 2015).

NICE TA375 Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (January 2016).

NICE TA376 Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (January 2016).

NICE TA377 Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (January 2016).

NICE TA378 Ramucirumab for treating advanced gastric cancer or gastro–oesophageal junction adenocarcinoma previously treated with chemotherapy (January 2016).

NICE TA379 Nintedanib for treating idiopathic pulmonary fibrosis (January 2016).

NICE TA380 Panobinostat for treating multiple myeloma after at least two previous treatments (January 2016).

NICE TA381 Olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum based chemotherapy (January 2016).

NICE TA382 Eltrombopag for treating severe aplastic anaemia refractory to immunosuppressive therapy (terminated appraisal) (January 2016).

NICE TA383 TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (February 2016).

NICE TA384 Nivolumab for treating advanced (unresectable or metastatic) melanoma (February 2016).

Description

Review:

Avanafil 50mg, 100mg and 200mg tablets (Spedra).

New Device Assessments:

Acapella Vibratory PEP Therapy System and Lung Flute Secretion Mobilization Device.

Other:

Wound Management Cost Comparison - Clinifast Elasticated Tubular Bandage vs Comfifast vs Tubifast.

Cost effective emollients with no or low paraffin content.

Shared Care Guidelines update.

MHRA Drug Safety Update (January 2016) - Levonorgestrel-releasing intrauterine systems – prescribe by brand name.

Patient Safety Alert - Risk of severe harm or death when desmopressin in omitted or delayed in patients with diabetes insipidus (February 2016).

Azithromycin incident.

Galantamine (Reminyl) can cause serious skin reactions.

Appendix: Clinical Pathway for Use of Oscillating Positive Expiratory Pressure Devices.

Description

Rapid Drug Assessment:

Ethinyloestradiol 0.02mg/drospirenone 3mg tablets (Daylette and Eloine).

Review:

Fentanyl Immediate Release Preparations.

NICE Technology Appraisal:

NICE Technology Appraisal 368: Apremilast for threating moderate to severe plaque psoriasis (November 2015).

NICE Technology Appraisal 369: Ciclosporin for treating dry eye disease that has not improved despite treatment with artificial tears (December 2015).

NICE Technology Appraisal 370: Bortezomib for previously untreated mantle cell lymphoma (December 2015).

NICE Technology Appraisal 371: Trastuzumab emtansine for treating HER2-positive, unresectable, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane (December 2015).

NICE Technology Appraisal 372: Apremilast for treating active psoriatic arthritis (December 2015).

NICE Technology Appraisal 373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (December 2015).

NICE Technology Appraisal 374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (December 2015)

Description

Rapid Drug Assessment:

Alendronic acid 70mg effervescent tablets (Binosto).

Colecalciferol 1000iu and 25000iu tablets (Stexerol-D3).

Other:

New Drug Assessment - Thick & Easy Clear.

Information - Diamorphine shortage.

Tapentadol and Nottinghamshire Pain Guidance.

Updated Shared Care Guideline - Midodrine 2.5mg and 5mg tablets for the treatment of severe orthostatic hypertension due to autonomic dysfunction and unlicensed use for the treatment of severe orthostatic hypotension or syncope in the absence of autonomic dysfunction.

MHRA Drug Safety Update (December 2015):

Thalidomide – reduced starting dose in patients older than age 75 years;

Mycophenolate – new pregnancy advice for men and women;

Bisphosphonates – very rare reports of osteonecrosis of the external auditory canal.

Description

Rapid Drug Assessment:

Oxycodone sustained release formulations (Abtard and Oxeltra)

New Product Assessment:

Insulin glargine 300iu/ml (Toujeo) (amended version).

Trent Medicines Information QIPP Detail Aid:

Salbutamol – Does it really need to be nebulised? (November 2015).

Shared Care Guidelines:

Growth hormone in the management of growth failure in children and young people and the management of attention deficit hyperactivity disorder

Other:

Clarity around the new editions of the British National Formulary.

NICE Technology Appraisal:

NICE Technology Appraisal 358 Tolvaptan for treating autosomal dominant polycystic kidney disease (October 2015).

NICE Technology Appraisal 359, Idelalisib for treating chronic lymphocytic leukaemia (October 2015).

NICE Technology Appraisal 360, Paclitaxel as albumin-bound nanoparticles in combination with gemcitabine for previously untreated metastatic pancreatic cancer (October 2015).

NICE Technology Appraisal 361, Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal) (October 2015).

NICE Technology Appraisal 362, Paclitaxel as albumin-bound nanoparticles with carboplatin for untreated non-small-cell lung cancer (terminated appraisal) (October 2015)

NICE Technology Apprasial 363 Ledipasvir–sofosbuvir for treating chronic hepatitis C (November 2015).

NICE Technology Appraisal 364 Daclatasvir for treating chronic hepatitis C (November 2015).

NICE Technology Appraisal 365 Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C (November 2015).

NICE Technology Appraisal 366 Pembrolizumab for advanced melanoma not previously treated with ipilimumab (November 2015).

Description

Guidance on the use of warfarin and newer oral anticoagulants for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism (revised second edition).