NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Formulary Update

Formulary News (February 2012)

Please note: All the following changes will be reflected in full on the Formulary database.  Some of the indications have been summarised for brevity but complete details can be found by following the links to the SMC advice.

Additions to Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on February 13th and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Boceprevir (Victrelis®) is included in the Total Formulary for the treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (both treatment naïve and treatment experienced). It is restricted to consultant use in accordance with local protocol.
For the relevant SMC advice click here and here

Emtricitabine/tenofovir/rilpivirine (Eviplera®), a new combination, is included in the Total Formulary for HIV-1 infection in treatment naïve adults.  It is restricted to use only by HIV specialists. 
For the relevant SMC advice click here

Exenatide Once-Weekly (Bydureon®) is included in the Total Formulary for type 2 diabetes mellitus restricted to specialist initiation for third-line use in combination with other agents.
For the relevant SMC advice click here

Linagliptin (Trajenta®) is included in the Total Formulary for the treatment of type 2 diabetes mellitus. It is restricted to specialist initiation in combination therapy with metformin when diet and exercise plus metformin alone does not provide adequate glycaemic control in patients for whom the addition of a sulphonylurea is inappropriate.  In primary care, it is expected that initiation would follow interaction between the GP/Diabetic Specialist Nurse and the consultant contact within the acute sector. The use of linagliptin as monotherapy or in combination with metformin and a sulphonylurea is not recommended by SMC and is non-Formulary.
For the relevant SMC advice click here

Nevirapine prolonged-release tablets (viramune®) is included in the Total Formulary for the treatment of HIV-1 patients in combination with other agents.  It is restricted to use by HIV specialists.
For the relevant SMC advice click here

Rilpiverine (Edurant®) is included in the Total Formulary for the combination treatment of HIV-1 infection in treatment naïve adults.  It is restricted to use only by HIV specialists.
For the relevant SMC advice click here

Rivaroxaban (Xarelto®) is included in the Total Formulary for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.  Use is restricted to patients currently receiving warfarin who have poor INR control despite evidence that they are complying, or patients with allergy or intolerable side effects from coumarin anticoagulants.  Use in other patient groups remains non-Formulary.  Further information can be found in the National Consensus Statement on the NHS HIS website (link here). For the relevant SMC advice click here

Telaprevir (incivo®) is included in the Total Formulary for use in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients (both treatment naïve and treatment experienced). It is restricted to consultant use in accordance with local protocol.
For the relevant SMC advice click here and here

New medicines, indications and formulations not included in the GGC Formulary

The following are not included in the GGC Formulary following the latest ADTC meeting. Where the reason is other than not recommended advice from SMC it is noted.  NB: these medicines may be included in the Formulary for other indications or for other formulations.  Please refer to Formulary.

Apixaban (Eliquis®) is not included in the Total Formulary for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacements because the decision is that the medicine does not represent sufficient added benefit to other comparator medicines already available in the Formulary.
For the relevant SMC advice click here

Aztreonam for nebulisation (Cayston®) for suppressive therapy of Pseudomonas aeruginosa infections in adults with cystic fibrosis For the relevant SMC advice click here

Dabigatran etexilate (Pradaxa®) is not included in the Total Formulary for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery because the decision is that the medicine does not represent sufficient added benefit to other comparator medicines already available in the Formulary.
For the relevant SMC advice click here

Dexamethasone ocular implant (Ozurdex®) for non infectious uveitis.
For the relevant SMC advice click here

Eculizumab (Soliris®) for the treatment of patients with atypical haemolytic uremic syndrome (aHUS).
For the relevant SMC advice click here

Entecavir (Baraclude®) for the treatment of chronic hepatitis B virus (HBV) infection in adults with decompensated liver disease
For the relevant SMC advice click here

Fentanyl singe dose nasal spray (Instanyl®) is not included in the Total Formulary for breakthrough pain in chronic cancer pain is not included in the Formulary because the medicine does not represent sufficient added benefit to other comparator medicines already available in the Formulary.
For the relevant SMC advice click here

Lapatinib (Tyverb®) for treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
For the relevant SMC advice click here

Panitumumab (Vectibix®) for the treatment of patients with wild-type KRAS metastatic colorectal cancer in first-line in combination with FOLFOX;  in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
For the relevant SMC advice click here

Pemetrexed (Alimta®) as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy
For the relevant SMC advice click here

Prednisone MR tablets (Lodotra®) for moderate to severe, active rheumatoid arthritis in adults
For the relevant SMC advice click here

Ranolazine (Ranexa®) for patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies.
For the relevant SMC advice click here

Saxagliptin (Onglyza®) for type 2 diabetes mellitus in combination with insulin (with or without metformin).
For the relevant SMC advice click here

Tapentadol normal-release tablets (Palexia®) for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.
For the relevant SMC advice click here

Other GGC Formulary decisions

Budesonide 64microgram nasal spray (Rhinocort Aqua®) for seasonal and perennial allergic rhinitis and vasomotor rhinitis was moved from the Total Formulary to the Preferred List in the Adult Formulary, replacing mometasone furoate nasal spray.

Carmellose Sodium (Celluvisc®) for the treatment of dry eyes was subject to an appeal to have it added to the Preferred List as a first-choice agent in atopic patients.  The appeal was rejected on the basis of insufficient evidence and the potential cost implications.  Celluvisc® remains a Total Formulary preparation restricted to use only in those patients with severe dry eyes in addition to external eye or corneal conditions who demonstrate intolerance to preservatives.

New medicines, indications and formulations not added to Formulary pending protocol

The following new medicines, indications or formulations require the development of a protocol or further consultation before Formulary status can be reconsidered.  Until reconsideration, these medicines, indications or formulations are not included in the Formulary.

Erlotinib (Tarceva®) for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations (Regional Cancer Advisory Group).

Midazolam buccal liquid (Buccolam®) for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (Paediatric Drug and Therapeutic Committee)

Rivaroxaban (Xarelto®) for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults (NHSGGC Thrombosis Group).

Tocilizumab (RoActemra®) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older (Paediatric Drug and Therapeutic Committee).

Formulary reviews

The latest meeting of ADTC also endorsed recommendations for changes to the Formulary for several therapeutic areas following full Formulary Section Reviews.

A multidisciplinary group representing both primary care and the acute sector reviewed the content of the chapter 3: Respiratory System pertaining to the management of asthma and chronic obstructive pulmonary disease (COPD) at the start of December 2011.  The vast majority of changes were the inclusion of additional prescribing notes for entries and the restructuring of how the section is displayed to ensure clarity.  The changes have subsequently been made to the Formulary on the website.

A review of the contraceptive section of the GGC Formulary took place between December 2011 and January 2012.  Representatives from the acute sector, Sexual and Reproductive Health (Sandyford) and primary care all participated.  Much of the review focused on choosing a shorter list of contraceptives as previously the Formulary had just referred to the BNF.  In addition, a first-line combined oral contraceptive was chosen (Rigevidon®).  Once again, all changes have subsequently been made to the Formulary on the website.

The final review was a reconvening of the multidisciplinary group who reviewed the first half of chapter 13: Skin back in November.  The review of the remainder of this chapter was completed in January 2012 and includes some restructuring of how Formulary information is portrayed to make it easier for prescribers to find the group of products they require.  For the first time, the Formulary also gives some guidance on manufactured specials commonly recommended by Dermatology, listing the most used preparations and strengths.  Full detail can be found in the Formulary on the website.