Medicines Not Reimbursed Through National Prices and Directly Commissioned by Nhs England

MEDICINES NOT REIMBURSED THROUGH NATIONAL PRICES AND DIRECTLY COMMISSIONED BY NHS ENGLAND

VERSION 9.1 PUBLISHED NOVEMBER 2015

SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL HIV IN COMBINATION WITH OTHER ABACAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS

HIV IN COMBINATION WITH OTHER ABACAVIR WITH DOLUTEGRAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NHS ENGLAND POLICY: B06/P/b BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS AND LAMIVUDINE (TRIUMEQ®) HIV IN COMBINATION WITH OTHER ABACAVIR WITH LAMIVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS NHS ENGLAND CLINICAL ABATACEPT JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: E03/P/d PAEDIATRIC INDICATIONS (WHERE ABATACEPT NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER ADULT TA'S (TA195, TA280) NICE NICE NICE √ ADULT TA AVAILABLE) TA259 (SEE ALSO SSC1438) NHS ENGLAND/ NICE/NHS ENGLAND POLICY NICE ABIRATERONE CANCER HORMONE ANTAGONISTS 8.3.4.2 CDF POLICY - BOTH: ONLY IN SACT √ CDF CDF CDF ENZALUTAMIDE NAÏVE PATIENTS NHS ENGLAND CLINICAL ADALIMUMAB JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: E03/P/d NOT ROUTINELY COMMISSIONED (NHS ENGLAND CLINICAL ADALIMUMAB UVEITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ COMMISSIONING POLICY: D12/P/a & D12/P/a) HIGHLY SPECIALISED HIGHLY SPECIALISED ADALIMUMAB BEHCETS SYNDROME NHS ENGLAND CYTOKINE MODULATORS 10.1.3 HIGHLY SPECIALISED CRITERIA ONLY HIGHLY SPECIALISED CRITERIA √ CRITERIA ONLY CRITERIA ONLY PAEDIATRIC INDICATIONS (WHERE AS PER ADULT TA'S (TA130, TA143, ADALIMUMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NICE NICE NICE AUDIT √ ADULT TA AVAILABLE) TA146, TA187, TA199) NOT ROUTINELY COMMISSIONED - ADALIMUMAB HIDRADENITIS SUPPURATIVA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS VIRAL HEPATITIS (B&C) & NOT ROUTINELY COMMISSIONED ADEFOVIR HEPATITIS B NHS ENGLAND 5.3.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS (CG165) NOT ROUTINELY COMMISSIONED AFLIBERCEPT CANCER NHS ENGLAND CANCER EXCLUSION 8.1 AS PER CDIFR APPROVAL AS PER CDIFR APPROVAL SACT √ (TA307) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED AGALSIDASE ALFA FABRY'S DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED AGALSIDASE BETA FABRY'S DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY ALDESLEUKIN CANCER NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL SACT √ DRUGS AFFECTING THE IMMUNE ALEMTUZUMAB MULTIPLE SCLEROSIS NHS ENGLAND 8.2.3 TA312 NICE NICE NICE AUDIT √ √***** RESPONSE TRUST GUIDELINES: ISLET PRE-TRANSPLANT DRUGS AFFECTING THE IMMUNE ALEMTUZUMAB NHS ENGLAND 8.2.3 TRANSPLANTATION (ONLY IF PROVIDED TRUST GUIDELINES TRUST GUIDELINES √ IMMUNOSUPPRESSION RESPONSE AT ZERO DRUG COST) DRUGS AFFECTING THE IMMUNE TRUST GUIDELINES: (ONLY IF ALEMTUZUMAB CLL NHS ENGLAND 8.2.3 TRUST GUIDELINES TRUST GUIDELINES √ RESPONSE PROVIDED AT ZERO DRUG COST) HIGHLY SPECIALISED CRITERIA ONLY HIGHLY SPECIALISED HIGHLY SPECIALISED ALEMTUZUMAB BEHCETS SYNDROME NHS ENGLAND CYTOKINE MODULATORS 10.1.3 (ONLY IF PROVIDED AT ZERO DRUG HIGHLY SPECIALISED CRITERIA √ CRITERIA ONLY CRITERIA ONLY COST) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED ALGLUCOSIDASE ALFA POMPE DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC ALIPOGENE TIPARVOVEC LIPOPROTEIN LIPASE DEFICIENCY NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS VIRAL HEPATITIS (B&C) & ALISPORIVIR HEPATITIS C NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS ALPHA MANNOSIDASE DRUGS USED IN METABOLIC ALPHA MANNOSIDASE DEFICIENCY NHS ENGLAND 9.8.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RECOMBINANT HUMAN DISORDERS VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL AMBRISENTAN NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION AMIFAMPRIDINE PHOSPHATE LEMS NHS ENGLAND NEUROMUSCULAR DISORDERS 10.2.1 NHS ENGLAND POLICY: D04/PS/a AS PER IFR APPROVAL AS PER IFR APPROVAL N/A √ AMIKACIN LIPOSOMAL CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NUMBER OF PATIENTS TREATED AMPHOTERICIN LIPOSOMAL FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY NHS ENGLAND CLINICAL ANAKINRA JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: E03/P/d SPECIALIST AUTOINFLAMMATORY ANAKINRA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISEASE ANAKINRA PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CRYOPYRIN ASSOCIATED PERIODIC CRYOPYRIN ASSOCIATED PERIODIC HIGHLY SPECIALISED HIGHLY SPECIALISED ANAKINRA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 HIGHLY SPECIALISED DATABASE √ SYNDROME SYNDROME SERVICE SPECIFICATION CRITERIA ONLY CRITERIA ONLY NUMBER OF PATIENTS TREATED ANIDULAFUNGIN FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.4 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY ANTIHAEMOPHILIC FACTOR/VON AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ WILLEBRAND FACTOR COMPLEX SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL

APLASTIC ANAEMIA DRUGS USED IN HYPOPLASTIC, ANTILYMPHOCYTE GLOBULIN NHS ENGLAND 9.1.3 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ ORGAN TRANSPLANT HAEMOLYTIC, AND RENAL ANAEMIAS

ANTITHROMBIN III AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √

ANTITHYMOCYTE APLASTIC ANAEMIA DRUGS USED IN HYPOPLASTIC, NHS ENGLAND 8.2.2 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ IMMUNOGLOBULIN ORGAN TRANSPLANT HAEMOLYTIC, AND RENAL ANAEMIAS

APREMILAST PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS ARAGAM AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) DRUGS USED IN METABOLIC ASFOTASE ALFA HYPOPHOSPHATASIA NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS VIRAL HEPATITIS (B&C) & ASUNAPREVIR WITH DACLATASVIR HEPATITIS C NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS NOT ROUTINELY COMMISSIONED (NHS ENGLAND CLINICAL ATALUREN DUCHENNE MUSCULAR DYSTROPHY NHS ENGLAND NEUROMUSCULAR DISORDERS N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ COMMISSIONING POLICY: E09/P/a) - NICE TA IN PROGRESS HIV IN COMBINATION WITH OTHER ATAZANAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS AXITINIB CANCER NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 TA333 NICE NICE SACT √ AZACITIDINE CANCER NHS ENGLAND MYELODYSPLASTIC SYNDROME 8.1.3 TA218 NICE NICE SACT √ NHS ENGLAND CLINCAL AZTREONAM LYSINE CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS 5.1.2.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √* √* COMMISSIONING POLICY: A01/P/b CORTICOSTEROIDS AND OTHER BASILIXIMAB RENAL TRANSPLANT NHS ENGLAND 8.2.2 TA85 & TA99 NICE NICE √ IMMUNOSUPPRESSANTS NHS ENGLAND CLINICAL BEDAQUILINE EXTENSIVELY DRUG RESITANT TB NHS ENGLAND ANTITUBERCULOSIS DRUGS 5.1.9 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: F04/P/a NHS ENGLAND CLINICAL BEDAQUILINE MULTI DRUG RESITANT TB NHS ENGLAND ANTITUBERCULOSIS DRUGS 5.1.9 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: F04/P/a DRUGS AFFECTING THE IMMUNE NOT ROUTINELY COMMISSIONED - NICE BELATACEPT RENAL TRANSPLANT NHS ENGLAND 8.2.2 NICE TA IN PROGRESS NICE TA IN PROGRESS NICE TA IN PROGRESS √ RESPONSE TA IN PROGRESS DRUGS AFFECTING THE IMMUNE NOT ROUTINELY COMMISSIONED - NICE BELIMUMAB SLE NHS ENGLAND 10.1.3 NICE TA IN PROGRESS NICE TA IN PROGRESS NICE TA IN PROGRESS √ RESPONSE TA IN PROGRESS BERACTANT RESPIRATORY DISTRESS SYNDROME NHS ENGLAND PULMONARY SURFACTANTS 3.5.2 TRUST GUIDELINES TRUST GUIDELINES √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED BETAINE HOMOCYSTINURIA NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY BEVACIZUMAB CANCER CDF ANTINEOPLASTIC DRUGS 8.1.5 CDF POLICY CDF CDF SACT √ AS PER NATIONAL PROTOCOL (SEE NF2 AS PER NATIONAL AS PER NATIONAL BEVACIZUMAB NEUROFIBROMATOSIS NHS ENGLAND ANTINEOPLASTIC DRUGS 8.1.5 AS PER NATIONAL PROTOCOL √ SERVICE SPEC) PROTOCOL PROTOCOL VIRAL HEPATITIS (B&C) & BOCEPREVIR HEPATITIS C NHS ENGLAND 5.3.3 TA253 NICE NICE NICE AUDIT √ √ RESPIRATORY SYNCYTIAL VIRUS NOT ROUTINELY COMMISSIONED ORGAN REJECTION POST KIDNEY BORTEZOMIB NHS ENGLAND ANTINEOPLASTIC DRUGS 8.1.5 (NHS ENGLAND CLINICAL AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TRANSPLANT COMMISSIONING POLICY: A07/P/c) NHS ENGLAND/ TA129, TA228, TA311 NICE NICE BORTEZOMIB CANCER ANTINEOPLASTIC DRUGS 8.1.5 SACT √ CDF CDF POLICY CDF CDF VASODILATOR ANTIHYPERTENSIVE NHS ENGLAND CLINICAL BOSENTAN DIGITAL ULCERS NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ COMMISSIONING POLICY: A13/P/b HYPERTENSION VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL BOSENTAN NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION TORSION DYSTONIAS AND OTHER BOTULINUM TOXIN FOCAL SPASTICITY IN CHILDREN NHS ENGLAND 4.9.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES AS PER POLICY √ INVOLUNTARY MOVEMENTS INTRAVESICAL USE IN SPINAL CORD TORSION DYSTONIAS AND OTHER NOT ROUTINELY COMMISSIONED FOR BOTULINUM TOXIN NHS ENGLAND 4.9.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ INJURY INVOLUNTARY MOVEMENTS NEW PATIENTS HEREDITARY ANGIOEDEMA - ACUTE C1 ESTERASE INHIBITORS NHS ENGLAND ALLERGIC EMERGENCIES 3.4.3 NHS ENGLAND POLICY: B09/P/b NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ TREATMENT ONLY CRYOPYRIN ASSOCIATED PERIODIC CRYOPYRIN ASSOCIATED PERIODIC HIGHLY SPECIALISED HIGHLY SPECIALISED CANAKINUMAB NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 HIGHLY SPECIALISED DATABASE √ SYNDROME SYNDROME SERVICE SPECIFICATION CRITERIA ONLY CRITERIA ONLY NOT ROUTINELY COMMISSIONED CANAKINUMAB JUVENILE ARTHRITIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ (TA302) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED CARGLUMIC ACID UREA CYCLE DISORDERS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY HIGHLY SPECIALISED HIGHLY SPECIALISED CARNITINE CARNITINE DEFICIENCY NHS ENGLAND DRUGS USED IN METABOLIC DISORDERS 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ CRITERIA ONLY CRITERIA ONLY NUMBER OF PATIENTS TREATED CASPOFUNGIN FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.4 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY CONGENITAL FACTOR XIII A-SUBUNIT CATRIDECACOG NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DEFICIENCY CERTOLIZUMAB PEGOL PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NHS ENGLAND/ TA145, TA176 NICE NICE CETUXIMAB CANCER ANTINEOPLASTIC DRUGS 8.1.5 SACT √ CDF CDF POLICY CDF CDF NUMBER OF PATIENTS TREATED CIDOFOVIR CYTOMEGALOVIRUS NHS ENGLAND CYTOMEGALOVIRUS INFECTION 5.3.2.2 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY CLADRIBINE MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √***** SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL PULMONARY LANGERHANS CLADRIBINE NHS ENGLAND IMMUNOMODULATING DRUGS 8.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HISTIOCYTOSIS HIV IN COMBINATION WITH OTHER NHS ENGLAND CLINICAL COBICISTAT NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NHS ENGLAND POLICY NHS ENGLAND POLICY HARS DATASET √ ANTI-RETROVIRAL DRUGS COMMISSIONING POLICY: F03/P/b NHS ENGLAND CLINICAL CO-CARELDOPA INTESTINAL GEL PARKINSON'S DISEASE NHS ENGLAND NEURODEGENERATIVE CONDITIONS 4.9.1 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ COMMISSIONING POLICY: D04/P/e NHS ENGLAND CLINICAL NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY COLISTIMETHATE SODIUM CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS 5.1.7 COMMISSIONING POLICY: A01/P/b √* √* NICE NICE NICE AUDIT TA276 HEREDITARY ANGIOEDEMA - ACUTE CONESTAT ALFA NHS ENGLAND ALLERGIC EMERGENCIES 3..4.3 NHS ENGLAND POLICY: B09/P/b NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ TREATMENT ONLY CRIZOTINIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ VIRAL HEPATITIS (B&C) & NOT ROUTINELY COMMISSIONED - NICE DACLATASIVIR HEPATITIS C NHS ENGLAND N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS TA IN PROGRESS CORTICOSTEROIDS AND OTHER DRUG HAS BEEN DRUG HAS BEEN DACLIZUMAB ORGAN TRANSPLANT NHS ENGLAND N/A DRUG HAS BEEN DISCONTINUED DRUG HAS BEEN DISCONTINUED √ IMMUNOSUPPRESSANTS DISCONTINUED DISCONTINUED CORTICOSTEROIDS AND OTHER DRUG HAS BEEN DRUG HAS BEEN DACLIZUMAB MULTIPLE SCLEROSIS NHS ENGLAND N/A DRUG HAS BEEN DISCONTINUED DRUG HAS BEEN DISCONTINUED √***** IMMUNOSUPPRESSANTS DISCONTINUED DISCONTINUED HIV IN COMBINATION WITH OTHER DARUNAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS DARUNAVIR AND HIV IN COMBINATION WITH OTHER NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ COBICISTAT (REZOLSTA®) ANTI-RETROVIRAL DRUGS DASATINIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ NOT ROUTINELY COMMISSIONED DECITABINE CANCER NHS ENGLAND MYELODYSPLASTIC SYNDROME N/A AS PER IFR APPROVAL AS PER IFR APPROVAL SACT √ (TA270) DRUGS USED IN HYPOPLASTIC, IRON CHELATION IN THALASSAEMIA DEFERASIROX NHS ENGLAND HAEMOLYTIC, AND RENAL ANAEMIAS - 9.1.3 POLICY IN PROGRESS TRUST GUIDELINES TRUST GUIDELINES √ AND SICKLE CELL IRON OVERLOAD DRUGS USED IN HYPOPLASTIC, IRON CHELATION IN THALASSAEMIA DEFERIPRONE*** NHS ENGLAND HAEMOLYTIC, AND RENAL ANAEMIAS - 9.1.3 POLICY IN PROGRESS TRUST GUIDELINES TRUST GUIDELINES √ AND SICKLE CELL IRON OVERLOAD DEFIBROTIDE HEPATIC VENO-OCCLUSIVE DISEASE NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NHS ENGLAND POLICY: B04/P/c NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ NHS ENGLAND CLINICAL DELAMANID EXTENSIVELY DRUG RESITANT TB NHS ENGLAND ANTITUBERCULOSIS DRUGS 5.1.9 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: F04/P/a NHS ENGLAND CLINICAL DELAMANID MULTI DRUG RESITANT TB NHS ENGLAND ANTITUBERCULOSIS DRUGS 5.1.9 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: F04/P/a DRUGS USED IN HYPOPLASTIC, IRON CHELATION IN THALASSAEMIA DESFERRIOXAMINE*** NHS ENGLAND HAEMOLYTIC, AND RENAL ANAEMIAS - 9.1.3 POLICY IN PROGRESS TRUST GUIDELINES TRUST GUIDELINES √ AND SICKLE CELL IRON OVERLOAD DEXRAZOXANE ANTHRACYCLINE EXTRAVASATION NHS ENGLAND IMMUNOMODULATING DRUGS 8.1 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ DEXRAZOXANE ANTHRACYCLINE CARDIOTOXICITY NHS ENGLAND IMMUNOMODULATING DRUGS 8.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DIBOTERMIN ALFA COMPLEX SPINAL SURGERY NHS ENGLAND BONE MORPHOGENETIC PROTEIN N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HIV IN COMBINATION WITH OTHER DIDANOSINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS DIMETHYL FUMARATE MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 TA320 NICE NICE NICE AUDIT √ √***** HIV IN COMBINATION WITH OTHER DOLUTEGRAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NHS ENGLAND POLICY: B06/P/b NHS ENGLAND POLICY NHS ENGLAND POLICY HARS DATASET √ ANTI-RETROVIRAL DRUGS NHS ENGLAND CLINICAL DORNASE ALFA CYSTIC FIBROSIS NHS ENGLAND MUCOLYTICS 3.7 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √* √* COMMISSIONING POLICY: A01/P/b DRISAPERSEN DUCHENNE MUSCULAR DYSTROPHY NHS ENGLAND NEUROMUSCULAR DISORDERS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HEREDITARY ANGIOEDEMA - ACUTE ECALLANTIDE NHS ENGLAND ALLERGIC EMERGENCIES N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TREATMENT ONLY NOT ROUTINELY COMMISSIONED ORGAN REJECTION POST KIDNEY PAROXYSMAL NOCTURNAL ECULIZUMAB NHS ENGLAND 9.1.3 (NHS ENGLAND CLINICAL AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TRANSPLANT HAEMOGLOBINURIA COMMISSIONING POLICY: A07/P/b) PAROXYSMAL NOCTURNAL NHS ENGLAND POLICY: E03/PS(HSS)/A NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY ECULIZUMAB AHUS NHS ENGLAND 9.1.3 √ HAEMOGLOBINURIA NICE HST1 NICE NICE NICE NHS NATIONAL SPECIALISED PAROXYSMAL NOCTURNAL PAROXYSMAL NOCTURNAL ECULIZUMAB NHS ENGLAND 9.1.3 COMMISSIONING TEAM SERVICE NSCT SERVICE SPEC NSCT SERVICE SPEC NSCT SERVICE SPEC √ HAEMOGLOBINURIA HAEMOGLOBINURIA SPECIFICATION HIV IN COMBINATION WITH OTHER EFAVIRENZ NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS EFRALOCTOCOG ALFA HAEMOPHILIA A NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ EFTRENONACOG ALFA HAEMOPHILIA B NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC ELIGLUSTAT GAUCHER'S DISEASE NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS NOT ROUTINELY COMMISSIONED LYSOSOMAL STORAGE DISORDER ELOSULFASE ALFA MUCOPOLYSACCHARIDOSIS IV TYPE A NHS ENGLAND N/A (NHS ENGLAND CLINICAL AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS COMMISSIONING POLICY: E06/P/b) HIV IN COMBINATION WITH OTHER NOT ROUTINELY COMMISSIONED - ELVITEGRAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS N/A BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS POLICY IN PROGRESS ELVITEGRAVIR WITH COBICISTAT, HIV IN COMBINATION WITH OTHER NHS ENGLAND CLINICAL EMTRICITABINE AND TENOFOVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NHS ENGLAND POLICY NHS ENGLAND POLICY HARS DATASET √ ANTI-RETROVIRAL DRUGS COMMISSIONING POLICY: F03/P/a (STRIBILD®) HIV IN COMBINATION WITH OTHER ELVUCITABINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ ANTI-RETROVIRAL DRUGS HIV IN COMBINATION WITH OTHER EMTRICITABINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL HIV IN COMBINATION WITH OTHER ENFUVIRTIDE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS VIRAL HEPATITIS (B&C) & ENTECAVIR HEPATITIS B NHS ENGLAND 5.3.3 TA153 & IN PROGRESS NICE NICE NICE AUDIT √ RESPIRATORY SYNCYTIAL VIRUS TA316 (SEE ALSO SSC1439) NHS ENGLAND/ NICE/NHS ENGLAND POLICY NICE ENZALUTAMIDE CANCER HORMONE ANTAGONISTS 8.3.4.2 CDFPOLICY - BOTH: ONLY IN SACT √ CDF CDF CDF ABIRATERONE NAÏVE PATIENTS VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL EPOPROSTENOL (5) NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.8.1 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION EPRATUZUMAB SLE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ EPRODISATE AMYLOIDOSIS NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ EPTOTERMIN ALFA COMPLEX SPINAL SURGERY NHS ENGLAND BONE MORPHOGENETIC PROTEIN N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TA162, TA227 & IN PROGRESS ERLOTINIB CANCER NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 NICE NICE SACT √ NHSE LETTER NHS ENGLAND CLINICAL ETANERCEPT JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 COMMISSIONING POLICY: E03/P/d NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ TA35 PAEDIATRIC INDICATIONS (WHERE AS PER ADULT TA'S (TA103, TA130, ETANERCEPT NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NICE NICE NICE AUDIT √ ADULT TA AVAILABLE) TA143, TA199) HIV IN COMBINATION WITH OTHER ETRAVIRINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS EVEROLIMUS (AFINITOR®) CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ PREVENTING ORGAN REJECTION IN NOT ROUTINELY COMMISSIONED EVEROLIMUS (CERTICAN®) NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ LIVER TRANSPLANTATION (TA348) SUBEPENDYMAL GIANT CELL NOT ROUTINELY COMMISSIONED - EVEROLIMUS (VOTUBIA®) ASTROCYTOMA (SEGA) ASSOCIATED NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS WITH TUBULAR SCLEROSIS

RENAL ANGIOMYOLIPOMA NOT ROUTINELY COMMISSIONED - EVEROLIMUS (VOTUBIA®) ASSOCIATED WITH TUBULAR NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS SCLEROSIS FACTOR IX AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR VII AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR VIIA AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR VIII AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR VIII FC FUSION PROTEIN AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS N/A BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR VIII INHIBITOR BYPASSING AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FACTOR FACTOR XIII AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ NOT ROUTINELY COMMISSIONED: NHS FAMPRIDINE MULTIPLE SCLEROSIS NHS ENGLAND NEUROMUSCULAR DISORDERS 10.2.1 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √***** ENGLAND POLICY: D04/PS/d FIBRINOGEN AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ FIBROBLAST GROWTH FACTOR 1 SOMATOSTATIN ANALOGUE NHS ENGLAND SOMATOSTATIN ANALOGUES N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GENE THERAPY HIGHLY SPECIALISED HIGHLY SPECIALISED FILGRASTIM BARTH SYNDROME NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 HIGHLY SPECIALISED CRITERIA ONLY √ CRITERIA ONLY CRITERIA ONLY NUMBER OF PATIENTS TREATED PROPORTION GIVEN FOR SPC FILGRASTIM NEUTROPENIA NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 SPC TRUST GUIDELINES TRUST GUIDELINES INDICATIONS WITHIN POLICY √ PRODUCT WITH LOWEST ACQUISITION COST TO BE USED VIRAL HEPATITIS (B&C) & FILIBUVIR HEPATITIS C NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS TA254 FINGOLIMOD MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 NHS ENGLAND POLICY NHS ENGLAND POLICY NICE AUDIT √ √***** NHS ENGLAND POLICY: D04/P/b CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS FLEBOGAMMA AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS FLEBOGAMMADIF AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) FORIGERIMOD ACETATE SLE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HIV IN COMBINATION WITH OTHER FOSAMPRENAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS NUMBER OF PATIENTS TREATED FOSCARNET CYTOMEGALOVIRUS NHS ENGLAND CYTOMEGALOVIRUS INFECTION 5.3.2.2 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED GALSULFASE MUCOPOLYSACCHARIDOSIS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS GAMMAGARD AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS GAMMANORM AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS GAMMAPLEX AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS GAMUNEX AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) NUMBER OF PATIENTS TREATED GANCICLOVIR CYTOMEGALOVIRUS NHS ENGLAND CYTOMEGALOVIRUS INFECTION 5.3.2.2 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY DRUGS AFFECTING THE IMMUNE GANETESPIB CANCER NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL SACT √ RESPONSE GEFITINIB CANCER NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 TA192 NICE NICE SACT √ GEVOKIZUMAB UVEITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GLATIRAMER MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 TA32 & NHS ENGLAND POLICY: D04/P/b NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER NHSE POLICY √ √***** GLYCOPEGYLATED FACTOR IX HAEMOPHILIA A NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GOLIMUMAB PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER ADULTS TA'S (TA220, TA233) NICE NICE NICE AUDIT √ GRANULOCYTE-MACROPHAGE ANTIBODY-POSITIVE PULMONARY COLONY-STIMULATING FACTOR NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ ALVEOLAR PROTEINOSIS (LEUKINE® - IMPORT) CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS HIZENTRA AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED HUMAN ARGINATE HEPATIC PORPHYRIA NHS ENGLAND 9.8.2 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY HUMAN HETEROLOGOUS LIVER DRUGS USED IN METABOLIC UREA CYCLE DISORDERS NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CELLS DISORDERS INTRAVENOUS/SUBCUTANEOUS HYQVIA AS PER NATIONAL DMP NHS ENGLAND 14.5.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HUMAN NORMAL IMMUNOGLOBULINS HEREDITARY ANGIOEDEMA - ACUTE ICATIBANT NHS ENGLAND ALLERGIC EMERGENCIES 3.4.3 NHS ENGLAND POLICY: B09/P/b NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ TREATMENT ONLY IDEBENONE DUCHENNE MUSCULAR DYSTROPHY NHS ENGLAND NEUROMUSCULAR DISORDERS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED IDURSULFASE MUCOPOLYSACCHARIDOSIS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL ILOPROST (5) NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION NHS ENGLAND/ TA70, TA86, TA251, TA326 NICE IMATINIB CANCER PROTEIN KINASE INHIBITORS 8.1.5 NICE OR CDF SACT √ CDF CDF POLICY CDF IMATINIB GRAFT VERSUS HOST DISEASE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED IMIGLUCERASE GAUCHER'S DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY HIV IN COMBINATION WITH OTHER INDINAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS NHS ENGLAND CLINICAL INFLIXIMAB JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: E03/P/d NOT ROUTINELY COMMISSIONED (NHS ENGLAND CLINICAL INFLIXIMAB UVEITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ COMMISSIONING POLICY: D12/P/a & D12/P/a) PAEDIATRIC INDICATIONS (WHERE AS PER ADULT TA'S (TA130, TA134, INFLIXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NICE NICE NICE AUDIT √ ADULT TA AVAILABLE) TA140, TA143, TA163, TA199) CONNECTIVE TISSUE DISEASE - NOT ROUTINELY COMMISSIONED - INFLIXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ INTERSTITAL LUNG DISEASE POLICY IN PROGRESS INFLIXIMAB CROHN'S DISEASE IN CHILDREN NHS ENGLAND CYTOKINE MODULATORS 10.1.3 TA187 NICE NICE NICE AUDIT √ INFLIXIMAB GRAFT VERSUS HOST DISEASE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ INFLIXIMAB RENAL NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ INFLIXIMAB SARCOIDOSIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NOT ROUTINELY COMMISSIONED - INFLIXIMAB HIDRADENITIS SUPPURATIVA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS HIGHLY SPECIALISED HIGHLY SPECIALISED INFLIXIMAB BEHCETS SYNDROME NHS ENGLAND CYTOKINE MODULATORS 10.1.3 HIGHLY SPECIALISED CRITERIA ONLY HIGHLY SPECIALISED CRITERIA √ CRITERIA ONLY CRITERIA ONLY INTERFERON ALFA HEPATITIS B AND C NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 TA75 NICE NICE NICE AUDIT √ TA32 INTERFERON BETA MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER NHSE POLICY √ √***** NHS ENGLAND POLICY: D04/P/b CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS INTRATECT AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) ISAVUCONAZOLE FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS NOT ROUTINELY COMMISISONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NHS ENGLAND CLINICAL IVACAFTOR CYSTIC FIBROSIS NHS ENGLAND MUCOLYTICS 3.7 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: A01/P/c IXAZAMIB AMYLOIDOSIS NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS KIOVIG AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) VIRAL HEPATITIS (B&C) & LAMIVUDINE HEPATITIS B NHS ENGLAND 5.3.3 CG165 NICE NICE NICE AUDIT √ RESPIRATORY SYNCYTIAL VIRUS HIV IN COMBINATION WITH OTHER LAMIVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS PRODUCT WITH LOWEST LANREOTIDE CANCER NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ PROCUREMENT COST TO BE USED SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL HIGHLY SPECIALISED HIGHLY SPECIALISED LANREOTIDE CONGENITAL HYPERINSULINISM NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 HIGHLY SPECIALISED CRITERIA ONLY √ CRITERIA ONLY CRITERIA ONLY PRODUCT WITH LOWEST LANREOTIDE**** ACROMEGALY NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ √ PROCUREMENT COST TO BE USED LAPATINIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 NOT ROUTINELY COMMISSIONED CDIFR CDIFR SACT √ LAQUINIMOD MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √***** DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED LARONIDASE MUCOPOLYSACCHARIDOSIS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY NHS ENGLAND/ TA171, TA322 NICE NICE LENALIDOMIDE CANCER IMMUNOMODULATING DRUGS 8.2.4 SACT √ CDF CDF POLICY CDF CDF NUMBER OF PATIENTS TREATED PROPORTION GIVEN FOR SPC LENOGRASTIM NEUTROPENIA NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 SPC TRUST GUIDELINES TRUST GUIDELINES INDICATIONS WITHIN POLICY √ PRODUCT WITH LOWEST ACQUISITION COST TO BE USED HIGHLY SPECIALISED HIGHLY SPECIALISED LENOGRASTIM BARTH SYNDROME NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 HIGHLY SPECIALISED CRITERIA ONLY √ CRITERIA ONLY CRITERIA ONLY LEVOFLOXACIN (INHALED) CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NOT ROUTINELY COMMISSIONED - LIPEGFILGRASTIM NEUTROPENIA NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS HYPONATRAEMIA AND OTHER POSTERIOR PITUITARY HORMONES LIXIVAPTAN NHS ENGLAND 6.5.2 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ ENDOCRINE USES AND ANTAGONISTS HOMOZYGOUS FAMILIAL LOMITAPIDE NHS ENGLAND LIPID-REGULATING DRUGS 2.12 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HYPERCHOLESTEROLEMIA HIV IN COMBINATION WITH OTHER LOPINAVIR WITH RITONAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS LUMACAFTOR AND IVACAFTOR CYSTIC FIBROSIS NHS ENGLAND MUCOLYTICS 3.7 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GROWTH HORMONE & GROWTH MACIMORELIN GROWTH FAILURE NHS ENGLAND 6.7.4 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HORMONE RECEPTOR ANTAGONIST VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL MACITENTAN NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION NHS ENGLAND CLINICAL NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY MANNITOL CYSTIC FIBROSIS NHS ENGLAND MUCOLYTICS 3.7 COMMISSIONING POLICY: A01/P/b √ NICE NICE NICE AUDIT TA266 HIV IN COMBINATION WITH OTHER MARAVIROC NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS MASITINIB PANCREATIC CANCER/GIST NHS ENGLAND PROTEIN KINASE INHIBITORS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GROWTH HORMONE & GROWTH MECASERMIN GROWTH FAILURE NHS ENGLAND 6.7.4 NHS ENGLAND POLICY: EO3/P/a NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HORMONE RECEPTOR ANTAGONIST MEPOLIZUMAB ASTHMA NHS ENGLAND ALLERGEN IMMUNOTHERAPY 3.4.2 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED MERCAPTAMINE (CYSTEAMINE) NEPHROPATHIC CYSTINOSIS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY NUMBER OF PATIENTS TREATED MICAFUNGIN FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.4 SPC TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY MIFEPRISTONE CUSHING'S DISEASE NHS ENGLAND OTHER ENDOCRINE DRUGS 6.7 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED MIGALASTAT FABRY'S DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED MIGLUSTAT GAUCHER'S DISEASE/ NIEMANN-PICK NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY VIRAL HEPATITIS (B&C) & MOTAVIZUMAB RSV PROPHYLAXIS NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS TA127 NATALIZUMAB MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 NHS ENGLAND POLICY NHS ENGLAND POLICY NICE AUDIT √ √***** NHS ENGLAND POLICY: D04/P/b HIV IN COMBINATION WITH OTHER NELFINAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS HIV IN COMBINATION WITH OTHER NEVIRAPINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS NILOTINIB CANCER NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 TA241, TA251 NICE NICE SACT √ NINTEDANIB OVARIAN CANCER NHS ENGLAND IMMUNOMODULATING DRUGS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NOT ROUTINELY COMMISSIONED - NICE NINTEDANIB (OFEV®) IDIOPATHIC PULMONARY FIBROSIS NHS ENGLAND IMMUNOMODULATING DRUGS N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TA IN PROGRESS NINTEDANIB (VARGATEF®) NON-SMALL-CELL LUNG CANCER NHS ENGLAND IMMUNOMODULATING DRUGS N/A TA347 NICE NICE SACT √ VIRAL HEPATITIS (B&C) & NITAZOXANIDE HEPATITIS C NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED NITISINONE ALKAPTONURIA NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED NITISINONE TYROSINAEMIA NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NITRIC OXIDE NHS ENGLAND DRUGS/PULMANORY ARTERIAL N/A AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ HYPERTENSION HYPERTENSION CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS NORMAL IMMUNOGLOBULIN AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) DRUGS AFFECTING THE IMMUNE OCRELIZUMAB MULTIPLE SCLEROSIS NHS ENGLAND 8.2.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPONSE SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS OCTAGAM AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) OCTOCOG ALFA HAEMOPHILIA A NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ GROWTH HORMONE & GROWTH OCTREOLIN ACROMEGALY NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HORMONE RECEPTOR ANTAGONIST

PRODUCT WITH LOWEST OCTREOTIDE CANCER NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ PROCUREMENT COST TO BE USED HIGHLY SPECIALISED HIGHLY SPECIALISED OCTREOTIDE CONGENITAL HYPERINSULINISM NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 HIGHLY SPECIALISED CRITERIA ONLY √ CRITERIA ONLY CRITERIA ONLY PRODUCT WITH LOWEST OCTREOTIDE**** ACROMEGALY NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ PROCUREMENT COST TO BE USED NHS ENGLAND/ TA344 NICE NICE OFATUMUMAB CANCER IMMUNOMODULATING DRUGS 8.2.3 SACT √ CDF CDF POLICY CDF CDF OFATUMUMAB PEMPHIGUS VULGARIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ OLESOXIME SPINAL MUSCULAR ATROPHY NHS ENGLAND NEUROMUSCULAR DISORDERS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ OMALIZUMAB ASTHMA NHS ENGLAND ALLERGEN IMMUNOTHERAPY 3.4.2 TA278 NICE NICE NICE AUDIT √ √ NHS ENGLAND CLINICAL OMBITASVIR/PARITAPREVIR/RITON NHS ENGLAND VIRAL HEPATITIS (B&C) & HEPATITIS C N/A COMMISSIONING POLICY: B07/P/a - NHS ENGLAND POLICY NHS ENGLAND POLICY SVR12 √ √ AVIR + DASABUVIR + RIBAVIRIN CENTRAL TEAM RESPIRATORY SYNCYTIAL VIRUS NICE TA IN PROGRESS PACRITINIB MYELOFIBROSIS NHS ENGLAND PROTEIN KINASE INHIBITORS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ VIRAL HEPATITIS (B&C) & JCVI GUIDELINES PALIVIZUMAB RSV PROPHYLAXIS NHS ENGLAND 5.3.5 AS PER SPECIFICATION AS PER SPECIFICATION √ √ RESPIRATORY SYNCYTIAL VIRUS PHE SPECIFICATION SPECIALIST ENDOCRINOLOGY PARATHYROID HORMONE NHS ENGLAND PARATHYROID HORMONE 6.6.1 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ CONDITIONS

ONLY WHEN DURATION OF PN IS > 14 DAYS OR INITIATED PRIOR TO INTESTINAL FAILURE; INADEQUATE/ PARENTERAL NUTRITION NHS ENGLAND PARENTERAL NUTRITION 9.3 ADMISSION. ADULTS; SEE ALSO CG32. TRUST GUIDELINES TRUST GUIDELINES √ UNSAFE ENTERAL FEEDING SEE ALSO 'MANUAL FOR PRESCRIBED SPECIALISED SERVICES' PASIREOTIDE CUSHING'S DISEASE NHS ENGLAND SOMATOSTATIN ANALOGUES 8.3.4.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NHS ENGLAND/ TA215 NICE NICE PAZOPANIB CANCER PROTEIN KINASE INHIBITORS 8.1.5 SACT √ CDF CDF POLICY CDF CDF VIRAL HEPATITIS (B&C) & TA75, TA96, TA106, TA200, TA 300 PEG INTERFERON ALFA HEPATITIS B AND C NHS ENGLAND 8.2.4 NICE NICE NICE AUDIT √ RESPIRATORY SYNCYTIAL VIRUS CG165 NOT ROUTINELY COMMISSIONED - PEGFILGRASTIM NEUTROPENIA NHS ENGLAND DRUGS USED IN NEUTROPENIA 9.1.6 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS PEGINTERFERON BETA-1A MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √***** PEGINTERFERON LAMBDA-1A HEPATITIS C NHS ENGLAND IMMUNOMODULATING DRUGS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HYPOTHALMIC & ANTERIOR PITUITARY NOT ROUTINELY COMMISSIONED - PEGVISOMANT ACROMEGALY NHS ENGLAND 6.5.1 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HORMONES & ANTI-OESTROGENS POLICY IN PROGRESS MELANOMA (UNRESECTABLE, PEMBROLIZUMAB NHS ENGLAND CANCER EXCLUSION N/A TA 357 NICE NICE SACT √ METASTATIC) TREATMENT NAÏVE MELANOMA NOT ROUTINELY COMMISSIONED - NICE PEMBROLIZUMAB NHS ENGLAND CANCER EXCLUSION N/A AS PER IFR APPROVAL AS PER IFR APPROVAL SACT √ (UNRESECTABLE, METASTATIC) TA IN PROGRESS PIRFENIDONE IDIOPATHIC PULMONARY FIBROSIS NHS ENGLAND PULMONARY FIBROSIS 3.11 TA282 (SPECIALIST CENTRE ONLY) NICE NICE NICE AUDIT √ √ NUMBER OF PATIENTS TREATED DRUGS AFFECTING THE IMMUNE NUMBER OF PATIENTS PLERIXAFOR STEM CELL MOBILISATION NHS ENGLAND 9.1.7 NHS ENGLAND POLICY: B04/P/2 NHS ENGLAND POLICY NHS ENGLAND POLICY √ √ RESPONSE SUCCESSFULLY TRANSPLANTED STAGE DRUG UTILISED POMALIDOMIDE CANCER CDF IMMUNOMODULATING DRUGS 8.2.4 CDF POLICY CDF CDF SACT √ POMALIDOMIDE MYELOFIBROSIS NHS ENGLAND PROTEIN KINASE INHIBITORS 8.2.4 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ PRODUCT WITH LOWEST PORACTANT ALFA RESPIRATORY DISTRESS SYNDROME NHS ENGLAND PULMONARY SURFACTANTS 3.5.2 TRUST GUIDELINES TRUST GUIDELINES √ PROCUREMENT COST TO BE USED PORCINE FACTOR AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS N/A BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ NUMBER OF PATIENTS TREATED POSACONAZOLE FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.1 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS PRIVIGEN AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) PROTEIN C AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ PROTHROMBIN COMPLEX AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS 2.11 BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ HIV IN COMBINATION WITH OTHER RALTEGRAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS GOUT AND CYTOTOXIC-INDUCED RASBURICASE HYPERURICAEMIA NHS ENGLAND 10.1.4 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ HYPERURICAEMIA RESLIZUMAB ASTHMA NHS ENGLAND ALLERGEN IMMUNOTHERAPY 3.4.2 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NICE AUDIT VIRAL HEPATITIS (B&C) & RIBAVIRIN HEPATITIS C NHS ENGLAND 5.3.5 TA75, TA106, TA200 NICE NICE PRODUCT WITH LOWEST √ RESPIRATORY SYNCYTIAL VIRUS PROCUREMENT COST TO BE USED RIGOSERTIB MDS/PANCREATIC CANCER NHS ENGLAND MYELODYSPLASTIC SYNDROME N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CRYOPYRIN-ASSOCIATED PERIODIC RILONACEPT NHS ENGLAND IMMUNOMODULATING DRUGS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ SYNDROMES SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL HIV IN COMBINATION WITH OTHER RILPIVIRINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL RIOCIGUAT NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION HIV IN COMBINATION WITH OTHER RITONAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS STEROID SENSITIVE NEPHROTIC NHS ENGLAND CLINICAL RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ SYNDROME COMMISSIONING POLICY: E03/P/b STEROID RESISTANT NEPHROTIC NHS ENGLAND CLINICAL RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ SYNDROME COMMISSIONING POLICY: E03/P/c PRIMARY SJOGREN'S SYNDROME NOT ROUTINELY COMMISSIONED - RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ (PSS) POLICY IN PROGRESS CHRONIC INFLAMMATORY NOT ROUTINELY COMMISSIONED - RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DEMYELINATING POLYNEUROPATHY POLICY IN PROGRESS NHS ENGLAND CLINICAL RITUXIMAB JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: E03/P/d NHS ENGLAND CLINICAL RITUXIMAB ACQUIRED HAEMOPHILIA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ COMMISSIONING POLICY: F02/P/a TA308 NICE/ NHS ENGLAND NICE/ NHS ENGLAND RITUXIMAB ANCA-POSITIVE VASCULITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NICE/ NHS ENGLAND POLICY √ NHS ENGLAND POLICY: A13/P/a POLICY POLICY CONNECTIVE TISSUE DISEASE - NOT ROUTINELY COMMISSIONED - RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ INTERSTITIAL LUNG DISEASE POLICY IN PROGRESS RITUXIMAB GRAFT VERSUS HOST DISEASE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RITUXIMAB SLE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NHS ENGLAND POLICY: A13/PS/a NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ RITUXIMAB MYOSITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RITUXIMAB NEPHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RITUXIMAB NEUROMYELITIS OPTICA NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER SPECIFICATION AS PER SPECIFICATION AS PER SPECIFICATION AS PER SPECIFICATION √ ABO-INCOMPATIBLE KIDNEY RITUXIMAB NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER SPECIFICATION AS PER SPECIFICATION AS PER SPECIFICATION AS PER SPECIFICATION √ TRANSPLANTS RITUXIMAB PEMPHIGUS VULGARIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ TA65, TA137, TA174, TA193, TA65, TA137, TA174, TA193, TA65, TA137, TA174, TA193, TA226, TA243 RITUXIMAB IV CANCER NHS ENGLAND CYTOKINE MODULATORS 8.2 TA226, TA243 TA226, TA243 SACT √ NHS ENGLAND CDF LETTER NHS ENGLAND CDF LETTER NHS ENGLAND CDF LETTER

AS PER CIRCULAR IE ONLY RITUXIMAB SUBCUTANEOUS CANCER NHS ENGLAND CYTOKINE MODULATORS 8.2 COMMISSIONED FOR FOLLICULAR AS PER CIRCULAR AS PER CIRCULAR SACT √ FORMULATION LYMPHOMA MAINTENANCE TREATMENT RUXOLITINIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS SANDOGLOBULIN AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) NOT ROUTINELY COMMISSIONED DRUGS USED IN METABOLIC SAPROPTERIN CHILDREN WITH PHENYLKETONURIA NHS ENGLAND 9.4.1 (NHS ENGLAND CLINICAL AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS COMMISSIONING POLICY: E06/P/a) DRUGS USED IN METABOLIC SAPROPTERIN MATERNAL PHENYLKETONURIA NHS ENGLAND 9.4.1 NHS ENGLAND POLICY: E12/P/a NHS ENGLAND POLICY NHS ENGLAND POLICY HIGHLY SPECIALISED DATABASE √ DISORDERS HIV IN COMBINATION WITH OTHER SAQUINAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS DRUGS USED IN METABOLIC SEBELIPASE ALFA LYSOSOMAL ACID LIPASE DEFICIENCY NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DISORDERS SECUKINUMAB PAEDIATRIC INDICATIONS NHS ENGLAND CYTOKINE MODULATORS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL SELEXIPAG NHS ENGLAND DRUGS/PULMANORY ARTERIAL N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HYPERTENSION HYPERTENSION VASODILATOR ANTIHYPERTENSIVE AS PER POLICY PULMONARY ARTERIAL NHS ENGLAND CLINICAL SILDENAFIL NHS ENGLAND DRUGS/PULMANORY ARTERIAL 2.5.1 NHS ENGLAND POLICY NHS ENGLAND POLICY PRODUCT WITH LOWEST √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION PROCUREMENT COST TO BE USED SILTUXIMAB CASTLEMAN'S DISEASE NHS ENGLAND** CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NHS ENGLAND CLINICAL SIMEPREVIR/PEGINTERFERON + NHS ENGLAND VIRAL HEPATITIS (B&C) & NHS ENGLAND POLICY NHS ENGLAND POLICY HEPATITIS C 5.3.3 COMMISSIONING POLICY: B07/P/a SVR12 √ √ RIBAVIRIN CENTRAL TEAM RESPIRATORY SYNCYTIAL VIRUS NICE NICE TA331 SODIUM OXYBATE NARCOLEPSY - PEADIATRIC SERVICES ONLYNHS ENGLAND HYPNOTICS & ANXIOLYTICS 4.1.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED SODIUM PHENYLBUTYRATE UREA CYCLE DISORDERS NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY SOFOSBUVIR/DACLATASVIR + NHS ENGLAND VIRAL HEPATITIS (B&C) & NHS ENGLAND CLINICAL HEPATITIS C 5.3.3 NHS ENGLAND POLICY NHS ENGLAND POLICY SVR12 √ √ RIBAVIRIN CENTRAL TEAM RESPIRATORY SYNCYTIAL VIRUS COMMISSIONING POLICY: B07/P/a SOFOSBUVIR/LEDIPASVIR +/- NHS ENGLAND VIRAL HEPATITIS (B&C) & NHS ENGLAND CLINICAL HEPATITIS C 5.3.3 NHS ENGLAND POLICY NHS ENGLAND POLICY SVR12 √ √ RIBAVIRIN CENTRAL TEAM RESPIRATORY SYNCYTIAL VIRUS COMMISSIONING POLICY: B07/P/a NHS ENGLAND CLINICAL SOFOSBUVIR/PEGINTERFERON+ NHS ENGLAND VIRAL HEPATITIS (B&C) & NHS ENGLAND POLICY NHS ENGLAND POLICY HEPATITIS C 5.3.3 COMMISSIONING POLICY: B07/P/a SVR12 √ √ RIBAVIRIN CENTRAL TEAM RESPIRATORY SYNCYTIAL VIRUS NICE NICE TA330 SORAFENIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ HIV IN COMBINATION WITH OTHER STAVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS SUBCUVIA AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS SUBGAM AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) NHS ENGLAND/ TA169, TA179 NICE NICE SUNITINIB CANCER PROTEIN KINASE INHIBITORS 8.1.5 SACT √ CDF CDF POLICY CDF CDF TABALUMAB SLE NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NHS ENGLAND CLINICAL TADALAFIL NHS ENGLAND DRUGS/PULMANORY ARTERIAL 7.4.5 NHS ENGLAND POLICY NHS ENGLAND POLICY AS PER POLICY √ HYPERTENSION COMMISSIONING POLICY: A11/P/c HYPERTENSION DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED TALIGLUCERASE ALFA GAUCHER'S DISEASE NHS ENGLAND N/A NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY VIRAL HEPATITIS (B&C) & TARIBAVIRIN HEPATITIS C NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS TEDUGLUTIDE SHORT BOWEL SYNDROME NHS ENGLAND CYTOKINE MODULATORS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ VIRAL HEPATITIS (B&C) & TELAPREVIR HEPATITIS C NHS ENGLAND 5.3.3 TA252 NICE NICE NICE AUDIT √ √ RESPIRATORY SYNCYTIAL VIRUS VIRAL HEPATITIS (B&C) & NOT ROUTINELY COMMISSIONED TELBIVUDINE HEPATITIS B NHS ENGLAND 5.3.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RESPIRATORY SYNCYTIAL VIRUS (TA154) TEMSIROLIMUS CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ HIV IN COMBINATION WITH OTHER ANTI-RETROVIRAL DRUGS BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) TENOFOVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 TA173 & IN PROGRESS HARS DATASET √ HEPATITIS B +/- OTHER ANTI- NICE NICE RETROVIRAL DRUGS HIV IN COMBINATION WITH OTHER TENOFOVIR WITH EMTRICITABINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS TENOFOVIR WITH EMTRICITABINE HIV IN COMBINATION WITH OTHER NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ AND EFAVIRENZ ANTI-RETROVIRAL DRUGS TENOFOVIR WITH EMTRICITABINE HIV IN COMBINATION WITH OTHER NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ AND RILPIVIRINE ANTI-RETROVIRAL DRUGS TA303 TERIFLUNOMIDE MULTIPLE SCLEROSIS NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 NICE NICE NICE AUDIT √ √***** NHS ENGLAND POLICY: D04/P/b DRUGS AFFECTING BONE TERIPARATIDE MALE AND JUVENILE OSTEOPOROSIS NHS ENGLAND 6.6.1 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ METABOLISM DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED TETRAHYDROBIOPTERIN PHENYLKETONURIA NHS ENGLAND 9.4.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY THALIDOMIDE CANCER NHS ENGLAND IMMUNOMODULATING DRUGS 8.2.4 TA228 NICE NICE SACT √ THROMBIN PSEUDOANEURYSM NHS ENGLAND BLOOD-RELATED PRODUCTS N/A IPG060 IPG060 √ HIV IN COMBINATION WITH OTHER TIPRANAVIR NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS NHS ENGLAND CLINICAL NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY TOBRAMYCIN CYSTIC FIBROSIS NHS ENGLAND ANTIBACTERIAL DRUGS 5.1.4 COMMISSIONING POLICY: A01/P/b √* √* NICE NICE NICE AUDIT TA276 NHS ENGLAND CLINICAL TOCILIZUMAB JUVENILE ARTHRITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 COMMISSIONING POLICY: E03/P/d NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ TA238 TOCILIZUMAB LARGE VESSEL VASCULITIS NHS ENGLAND CYTOKINE MODULATORS 10.1.3 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POSTERIOR PITUITARY HORMONES TOLVAPTAN HYPONATRAEMIA IN LUNG CANCER NHS ENGLAND 6.5.2 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ AND ANTAGONISTS TRENONACOG ALPHA HAEMOPHILIA B NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NOT ROUTINELY COMMISSIONED FOR VASODILATOR ANTIHYPERTENSIVE PULMONARY ARTERIAL NEW PATIENTS - NHS ENGLAND TREPROSTINIL SODIUM NHS ENGLAND DRUGS/PULMANORY ARTERIAL N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ HYPERTENSION CLINICAL COMMISSIONING POLICY: HYPERTENSION A11/P/c TUROCTOCOG ALFA AS PER BCSH GUIDELINES NHS ENGLAND BLOOD-RELATED PRODUCTS N/A BCSH GUIDELINES BCSH GUIDELINES BCSH GUIDELINES √ DRUGS AFFECTING IMMUNE USTEKINUMAB PAEDIATRIC INDICATIONS NHS ENGLAND 13.5.3 AS PER ADULT TA180 NICE NICE NICE √ RESPONSE NUMBER OF PATIENTS TREATED VALGANCICLOVIR CYTOMEGALOVIRUS NHS ENGLAND CYTOMEGALOVIRUS INFECTION 5.3.2.2 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY SACT VANDETANIB THYROID CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF √ CDF NATIONAL AUDIT NOT ROUTINELY COMMISSIONED - TA IN VEDOLIZUMAB CROHN'S DISEASE IN CHILDREN NHS ENGLAND CYTOKINE MODULATORS 10.1.3 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ PROGRESS DRUGS USED IN METABOLIC HIGHLY SPECIALISED HIGHLY SPECIALISED VELAGLUCERASE ALFA GAUCHER'S DISEASE NHS ENGLAND 9.8.1 NHS ENGLAND SERVICE SPECIFICATION HIGHLY SPECIALISED DATABASE √ DISORDERS CRITERIA ONLY CRITERIA ONLY VEMURAFENIB MELANOMA NHS ENGLAND PROTEIN KINASE INHIBITORS 8.1.5 TA269 NICE NICE NICE AUDIT √ CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS VIGAM AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) CLINICAL GUIDELINES FOR INTRAVENOUS/SUBCUTANEOUS VIVAGLOBIN AS PER NATIONAL DMP NHS ENGLAND 14.5.1 IMMUNOGLOBULIN USE, SECOND NATIONAL GUIDELINES NATIONAL GUIDELINES QUALITY DASHBOARD √ HUMAN NORMAL IMMUNOGLOBULINS EDITION UPDATE (JULY 2011) VON WILLEBRAND FACTOR, VON WILLEBRAND DEFICIENCY NHS ENGLAND BLOOD-RELATED PRODUCTS N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RECOMBINANT NUMBER OF PATIENTS TREATED VORICONAZOLE FUNGAL INFECTION NHS ENGLAND ANTIFUNGALS 5.2.1 AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES PROPORTION GIVEN FOR SPC √ INDICATIONS WITHIN POLICY CHRONIC PULMONARY HIGHLY SPECIALISED HIGHLY SPECIALISED VORICONAZOLE NHS ENGLAND ANTIFUNGALS 5.2.1 HIGHLY SPECIALISED CRITERIA ONLY √ ASPERGILLOSIS CRITERIA ONLY CRITERIA ONLY NOT ROUTINELY COMMISSIONED - ZICONOTIDE INTRATHECAL ANALGESIA NHS ENGLAND NON-OPIOID ANALGESICS 4.7.1 AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ POLICY IN PROGRESS SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL HIV IN COMBINATION WITH OTHER ZIDOVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS HIV IN COMBINATION WITH OTHER ZIDOVUDINE WITH LAMIVUDINE NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ ANTI-RETROVIRAL DRUGS ZIDOVUDINE WITH LAMIVUDINE HIV IN COMBINATION WITH OTHER NHS ENGLAND AIDS/HIV ANTIRETROVIRALS 5.3.1 AGREED TRUST GUIDELINES BHIVA GUIDELINES (9) BHIVA GUIDELINES (9) HARS DATASET √ AND ABACAVIR ANTI-RETROVIRAL DRUGS OTHER DRUGS NOT LISTED UNDER PBR EXCLUSIONS 3,4 DIAMINOPYRIDINE LAMBERT EATON MYASTHENIC SYNDROMENHS ENGLAND AGREED TRUST GUIDELINES TRUST GUIDELINES TRUST GUIDELINES √ AFATINIB CANCER NHS ENGLAND CANCER EXCLUSION 8.1 TA310 NICE NICE SACT √ AFLIBERCEPT CANCER NHS ENGLAND CANCER EXCLUSION 8.1 NOT ROUTINELY COMMISSIONED AS PER CDIFR APPROVAL AS PER CDIFR APPROVAL SACT √ TREATMENT OF BREAST CANCER ALBUMIN BOUND PACLITAXEL PATIENTS WITH DOCUMENTED NHS ENGLAND CANCER EXCLUSION 8.1 TRUST GUIDDELINES TRUST GUIDDELINES TRUST GUIDDELINES SACT √ TAXANE HYPERSENSITIVITY TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL AZATHIOPRINE NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED NHS ENGLAND/ TA216 NICE NICE BENDAMUSTINE CANCER CANCER EXCLUSION 8.1.1 SACT √ CDF CDF POLICY CDF CDF BOSUTINIB CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ BRENTUXIMAB CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ CABAZITAXEL CANCER CDF CANCER EXCLUSION 8.1 NOT ROUTINELY COMMISSIONED AS PER CDIFR APPROVAL AS PER CDIFR APPROVAL SACT √ CABOZANTINIB CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ NHS ENGLAND/ TRUST GUIDELINES/ NICE/ TRUST GUIDELINES/ NICE/ CHEMOTHERAPY CANCER - (NOT SPECIFICALLY LISTED) CANCER EXCLUSION 8.1 & 8.2 TRUST GUIDELINES/ NICE/ CDF POLICY SACT √ CDF CDF POLICY CDF POLICY TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL PRODUCT WITH LOWEST CICLOSPORIN NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED PROCUREMENT COST TO BE USED HYPERPARATHYROIDISM - DIALYSIS DRUGS FOR MINERAL BONE CINACALCET NHS ENGLAND 9.5.1.2 TA117 NICE NICE √ PATIENTS ONLY DISORDERS CLOFARABINE CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ DRUGS FOR MINERAL BONE COLESTILAN ADULT RENAL DIALYSIS ONLY NHS ENGLAND 9.5.2.2 TRUST GUIDELINES TRUST GUIDELINES √ DISORDERS DABRAFENIB CANCER NHS ENGLAND CANCER EXCLUSION 8.1.5 TA321 NICE NICE SACT √ RENAL DIALYSIS ONLY, INCLUDING VIA PRODUCT WITH LOWEST DARBEPOETIN DIALYSIS-INDUCED ANAEMIA NHS ENGLAND ERYTHROPOETINS 9.1.3 OUTPATIENTS, AND ONLY AS PER NICE TRUST GUIDELINES TRUST GUIDELINES √ PROCUREMENT COST TO BE USED CG114 RENAL DIALYSIS ONLY, INCLUDING VIA NICE NICE PRODUCT WITH LOWEST EPOETIN (ALL VARIANTS) DIALYSIS-INDUCED ANAEMIA NHS ENGLAND ERYTHROPOETINS 9.1.3 OUTPATIENTS, AND ONLY AS PER NICE TRUST GUIDELINES (RENAL TRUST GUIDELINES (RENAL PROCUREMENT COST TO BE USED √ CG114 USE ONLY) USE ONLY) (NICE CG114) ERIBULIN CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ METHOTREXATE INDUCED RENAL GLUCARPIDASE NHS ENGLAND N/A NHS ENGLAND POLICY: B15/P/a NHS ENGLAND POLICY NHS ENGLAND POLICY NHS ENGLAND POLICY √ DYSFUNCTION IBRUTINIB CANCER CDF PROTEIN KINASE INHIBITORS 8.1.5 CDF POLICY CDF CDF SACT √ CDF POLICY NHS ENGLAND/ IDELALISIB CANCER PROTEIN KINASE INHIBITORS 8.1.5 EAS CDF / NICE CDF/ NICE SACT √ CDF NICE TA 359 (from 27th Jan 2016) IPILIMUMAB CANCER NHS ENGLAND CANCER EXCLUSION 8.1.5 TA268, TA319 NICE NICE SACT √ DRUGS FOR MINERAL BONE LANTHANUM ADULT RENAL DIALYSIS ONLY NHS ENGLAND 9.5.2.2 TRUST GUIDELINES TRUST GUIDELINES √ DISORDERS MESENCHYMAL STEM CELLS (E.G. ACUTE GVHD AND OTHER NHS ENGLAND N/A NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ PROCHYMAL®) INDICATIONS (BCSH) TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL PRODUCT WITH LOWEST MYCOPHENOLATE MOFETIL NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED PROCUREMENT COST TO BE USED

TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL PRODUCT WITH LOWEST MYCOPHENOLIC ACID NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED PROCUREMENT COST TO BE USED NELARABINE CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ OBINUTUZUMAB CANCER NHS ENGLAND CANCER EXCLUSION 8.2.3 TA343 NICE NICE SACT √ PANITUMUMAB CANCER CDF CANCER EXCLUSION 8.1 CDF POLICY CDF CDF SACT √ NOT ROUTINELY COMMISSIONED - PANOBINOSTAT CANCER NHS ENGLAND CANCER EXCLUSION N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NICE TA IN PROGRESS PEGYLATED LIPOSOMAL NHS ENGLAND/ TA91 NICE NICE CANCER CANCER EXCLUSION 8.1.2 SACT √ DOXORUBICIN CDF CDF POLICY CDF CDF NHS ENGLAND/ TA135, TA181, TA190 NICE NICE PEMETREXED CANCER CANCER EXCLUSION 8.1.3 SACT √ CDF CDF POLICY CDF CDF PEPTIDE RECEPTOR CANCER CDF NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ RADIONUCLEOTIDE THERAPY PERTUZUMAB CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ PIXANTRONE CANCER NHS ENGLAND CANCER EXCLUSION 8.1.5 TA306 NICE NICE SACT √ POMALIDOMIDE CANCER CDF CANCER EXCLUSION 8.1.5 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ PONATINIB CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ ENDOCRINOLOGY; NON-MALIGNANT PROTEIN KINASE INHIBITORS NHS ENGLAND 8.1.5 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CONDITIONS RADIUM-223 DICHLORIDE CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ NOT ROUTINELY COMMISSIONED - RAMUCIRUMAB CANCER NHS ENGLAND CANCER EXCLUSION N/A AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ NICE TA IN PROGRESS REGORAFENIB CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ DRUGS FOR MINERAL BONE SEVELAMER ADULT RENAL DIALYSIS ONLY NHS ENGLAND 9.5.5.2 TRUST GUIDELINES TRUST GUIDELINES √ DISORDERS SUITABLE FOR SUITABLE FOR SHARED CARE SHARED CARE BETWEEN PRIOR WITH PRIMARY SPECIALIST SPECIALIST BNF APPROVAL CARE (IF DRUG NAME INDICATION COMMISSIONER PBR CATEGORY TA/POLICY STARTING CRITERIA STOPPING CRITERIA MONITORING/AUDIT REQUIREMENTS CENTRE AND CATEGORY PROFORMA SUPPORTED BY ONLY SECONDARY REQUIRED LOCAL CARE VIA PRESCRIBING NETWORK COMMITTEE) MODEL

SIROLIMUS (RAPAMUNE) LYMPHANGIOLEIOMYOMATOSIS (LAM) NHS ENGLAND 8.2.2 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √

TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL PRODUCT WITH LOWEST SIROLIMUS (RAPAMUNE) NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED PROCUREMENT COST TO BE USED

TRANSPLANT IMMUNOSUPPRESSION NEW PATIENTS ONLY UNTIL FORMAL PRODUCT WITH LOWEST TACROLIMUS NHS ENGLAND 8.2.2 TRUST GUIDELINES TRUST GUIDELINES √* √* ONLY REPATRIATION AGREED PROCUREMENT COST TO BE USED ENDOCRINOLOGY; NON-MALIGNANT TEMOZOLOMIDE NHS ENGLAND CANCER EXCLUSION 8.1.5 NOT ROUTINELY COMMISSIONED AS PER IFR APPROVAL AS PER IFR APPROVAL AS PER IFR APPROVAL √ CONDITIONS TRABECTADIN CANCER NHS ENGLAND ANTINEOPLASTIC DRUGS 8.1.5 TA185 NICE NICE SACT TRASTUZUMAB EMTANSINE CANCER CDF CANCER EXCLUSION 8.1.5 CDF POLICY CDF CDF SACT √ VISMODEGIB CANCER CDF CANCER EXCLUSION N/A CDF POLICY CDF CDF SACT √

* DRUG IS BEING REPATRIATED FROM PRIMARY TO SECONDARY CARE THEREFORE SUPPLY ROUTE MAY VARY AT PRESENT ** FROM APRIL 2016 - UNTIL THEN CCG COMMISSIONED *** ROUTINELY COMMISSIONED IN COMBINATION WHEN DUAL THERAPY REQUIRED **** ONLY WHEN PRESCRIBED IN A SPECIALIST CENTRE ***** ONLY WHERE IT IS A RECOGNISED MS CENTRE WITH SPECIALIST NURSE SUPPORT NEW DRUGS ADDED TO 2015/2016 'EXCLUSIONS' LIST

ADDITIONAL NOTES: 1. WHERE THE FUNDED INDICATION IS FOR PAEDIATRIC USE THE CCG WILL BECOME THE RESPONSIBLE COMMISSIONER WHEN THE PATIENT IS TRANSFERRED TO THE ADULT SERVICE 2. CCGS ARE THE RESPONSIBLE COMMISSIONER FOR RITUXIMAB IN NON CANCEROUS HAEMOTOLOGICAL CONDITIONS (EG ITP) AND NON SPECIALIST AUTO-INFLAMMATORY CONDITIONS (EG RA) 3. ELTROMBOPAG AND ROMIPLOSTIM ARE THE RESPONSIBILTY OF CCGS REGARDLESS OF THE CAUSE OF THE THROMBOCYTOPENIA 4. IT IS A MANDATED REQUIREMENT THAT ALL USE OF CHEMOTHERAPY IS RECORDED IN THE SACT DATABASE INCLUDING THOSE TREATMENTS FUNDED THROUGH THE CDF 5. USE IN VASCULAR DISEASE IS COMMISSIONED BY NHS ENGLAND WITHIN SPECIALIST CENTRES - ALL OTHER INDICATIONS ARE CCG COMMISSIONED 6. NHS ENGLAND IS THE RESPONSIBLE COMMISSIONER WHEN SOMATROPIN ANALOGUES (GROWTH HORMONE) ARE PRESCRIBED IN SPECIALIST CENTRES FOR INDICATIONS FALLING OUTSIDE NICE GUIDANCE 7. A DERROGATION LIST CAN BE FOUND UNDER EACH PROGRAMME OF CARE - PLEASE REFER TO THIS LINK - HTTPS://WWW.ENGLAND.NHS.UK/COMMISSIONING/SPEC-SERVICES/NPC-CRG/ 8. TRUSTS USING THE ENHANCED TARIFF OPTION (ETO) SHOULD BE AWARE OF PAYMENT ARRANGEMENTS RELATING TO EXCLUDED DRUGS