NICE Technology Appraisals About Medicines: Formulary Adherence Checklist

This spreadsheet is updated monthly and enables self-audit of a medicines formulary for adherence to current NICE Technology Appraisals. All guidelines refer to adults unless indicated. No copyright is asserted on this material if used for non-commercial purposes within the NHS.

Last updated 18-Jun-19

Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 TA517 Avelumab for Avelumab for treating metastatic Merkel cell carcinoma. 1 treating metastatic 11/04/2018 Evidence-based recommendations on avelumab (Bavencio) for treating metastatic X 10/07/2018 17/12/2018 250 Merkel cell carcinoma (secondary) Merkel cell carcinoma in adults. TA518 Tocilizumab for Tocilizumab for treating giant cell arteritis. 1 treating giant cell 18/04/2018 Evidence-based recommendations on tocilizumab (RoActemra) for treating giant cell X 17/07/2018 16/07/2018 89 arteritis arteritis in adults. Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after TA519 Pembrolizumab platinum-containing . for treating locally Evidence-based recommendations on pembrolizumab (Keytruda) for previously advanced or metastatic treated locally advanced or metastatic urothelial carcinoma in adults. 1 urothelial carcinoma 25/04/2018 X 24/07/2018 04/05/2018 9 after platinum- containing chemotherapy

TA520 - Atezolizumab Evidence-based recommendations on atezolizumab (Tecentriq) for locally advanced for treating locally or metastatic non-small-cell lung cancer after chemotherapy in adults. advanced or metastatic 1 16/05/2018 X 14/08/2018 18/06/2018 33 non-small-cell lung cancer after chemotherapy TA521 - Guselkumab Evidence-based recommendations on guselkumab (Tremfya) for treating moderate to for treating moderate to severe plaque psoriasis in adults. 1 13/06/2018 X 11/09/2018 16/07/2018 33 severe plaque psoriasis

TA522 - Evidence-based recommendations on pembrolizumab (Keytruda) for untreated Pembrolizumab for locally advanced or metastatic urothelial carcinoma in adults. untreated locally advanced or metastatic NICE is aware that European Medicines Agency’s Committee for Medicinal Products urothelial cancer when for Human Use (CHMP) has recommended restricting the use of pembrolizumab as a is unsuitable first line-treatment for patients with urothelial cancer ineligible for cisplatin-based 1 13/06/2018 X 11/09/2018 18/06/2018 5 chemotherapy. It has said that pembrolizumab should now only be used for first-line treatment of urothelial cancer in adults ineligible for cisplatin-based chemotherapy with high levels of PD-L1. The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding licensing decision applicable in all EU Member States.

TA523 - Midostaurin for Evidence-based recommendations on midostaurin (Rydapt) for untreated FLT3- 1 untreated acute myeloid 13/06/2018 mutation-positive acute myeloid leukaemia in adults. x 11/09/2018 22/08/2018 70 leukaemia TA524 - Brentuximab Evidence-based recommendations on brentuximab vedotin (Adcetris) for treating vedotin for treating CD30-positive Hodgkin lymphoma in adults. CD30-positive Hodgkin 1 lymphoma 13/06/2018 This guidance is a Cancer Drugs Fund reconsideration of brentuximab vedotin for x 11/09/2018 22/08/2018 70 treating CD30-positive Hodgkin lymphoma (TA446). This guidance replaces TA446.

TA525 - Atezolizumab Evidence-based recommendations on atezolizumab (Tecentriq) for previously treated for treating locally locally advanced or metastatic urothelial carcinoma in adults. advanced or metastatic 1 urothelial carcinoma 13/06/2018 There is separate guidance on atezolizumab for people with untreated disease who X 11/09/2018 18/06/2018 5 after platinum- cannot have cisplatin-based chemotherapy. containing chemotherapy TA526 - Evidence-based recommendations on arsenic trioxide (Trisenox) for treating acute for treating acute promyelocytic leukaemia in adults. 1 13/06/2018 x 11/09/2018 22/08/2018 70 promyelocytic leukaemia TA527 - Beta Evidence-based recommendations on beta interferons (Avonex, Betaferon, Extavia, interferons and Rebif) and glatiramer acetate (Copaxone) for treating multiple sclerosis in adults. glatiramer acetate for 1 treating multiple 27/06/2018 This guidance replaces NICE technology appraisal guidance 32 on beta interferon X 25/09/2018 19/10/2018 114 sclerosis and glatiramer acetate for the treatment of multiple sclerosis.

TA528 - for Evidence-based recommendations on niraparib (Zejula) for treating relapsed, maintenance treatment platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary of relapsed, platinum- peritoneal cancer that has responded to the most recent course of platinum-based 1 04/07/2018 x 02/10/2018 16/07/2018 12 sensitive ovarian, chemotherapy in adults. fallopian tube and peritoneal cancer TA529 - Crizotinib for Evidence-based recommendations on crizotinib (Xalkori) for treating ROS1-positive treating ROS1-positive advanced non-small-cell lung cancer in adults. 1 04/07/2018 x 02/10/2018 16/07/2018 12 advanced non-small- cell lung cancer TA530 - Nivolumab for Evidence-based recommendations on nivolumab (Opdivo) for treating locally treating locally advanced unresectable or metastatic urothelial carcinoma in adults who have had advanced unresectable platinum-containing chemotherapy. or metastatic urothelial . 1.1 Nivolumab is not cancer after platinum- recommended, within its marketing authorisation, for treating locally advanced containing unresectable or metastatic urothelial carcinoma in adults who have had platinum- 1 chemotherapy 04/07/2018 containing therapy. x 02/10/2018 16/07/2018 12

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 TA531 - 18/07/2018 Evidence-based recommendations on pembrolizumab (Keytruda) for untreated PD- Pembrolizumab for L1-positive metastatic non-small-cell lung cancer in adults. untreated PD-L1- 1 X 16/10/2018 09/08/2018 22 positive metastatic This guidance replaces NICE technology appraisal guidance 447. non-small-cell lung cancer TA532 - Cenegermin 18/07/2018 Evidence-based recommendations on cenegermin (Oxervate) for treating for treating neurotrophic keratitis in adults. 1 X 16/10/2018 10/08/2018 23 neurotrophic keratitis Cenegermin is not recommended, within its marketing authorisation, for treating moderate or severe neurotrophic keratitis in adults. TA533 - Ocrelizumab 25/07/2018 Evidence-based recommendations on ocrelizumab (Ocrevus) for treating for treating relapsing–remitting multiple sclerosis in adults. 1 relapsing–remitting X 23/10/2018 16/07/2018 0 multiple sclerosis

TA534 - Dupilumab 01/08/2018 Evidence-based recommendations on dupilumab (Dupixent) for treating moderate to for treating moderate severe atopic dermatitis in adults. 1 X 30/10/2018 22/08/2018 21 to severe atopic dermatitis TA492 - Atezolizumab 02/07/2018 Evidence-based recommendations on atezolizumab (Tecentriq) for untreated PD-L1- for untreated PD-L1- positive locally advanced or metastatic urothelial carcinoma in adults. positive locally advanced or ! July 2018: The European Medicines Agency restricted the use of atezolizumab for metastatic urothelial untreated urothelial carcinoma. It should now only be used in adults with high levels 1 cancer when cisplatin of PD-L1. For more information, see the summary of product characteristics for X 10/10/2018 09/08/2018 38 atezolizumab. is unsuitable There is separate guidance on atezolizumab for people who have had cisplatin- based chemotherapy.

TA522 - 24/07/2018 Evidence-based recommendations on pembrolizumab (Keytruda) for untreated PD- Pembrolizumab for L1-positive locally advanced or metastatic urothelial carcinoma in adults. untreated PD-L1- positive locally ! July 2018: The European Medicines Agency restricted the use of pembrolizumab 1 advanced or metastatic for untreated urothelial carcinoma. It should now only be used in adults with high X 22/10/2018 09/08/2018 16 urothelial cancer when levels of PD-L1. For more information, see the summary of product characteristics for cisplatin is unsuitable pembrolizumab.

TA535 - Lenvatinib and 08/08/2018 Evidence-based recommendations on lenvatinib (Lenvima) and sorafenib (Nexavar) sorafenib for treating for progressive, locally advanced or metastatic differentiated thyroid cancer in adults 1 differentiated thyroid who have had radioactive iodine. X 06/11/2018 09/08/2018 1 cancer after radioactive iodine TA536 - Alectinib for 08/08/2018 Evidence-based recommendations on alectinib (Alecensa) for untreated anaplastic untreated ALK-positive lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer in adults. 1 X 06/11/2018 09/08/2018 1 advanced non-small- cell lung cancer TA537 - Ixekizumab for 08/08/2018 Evidence-based recommendations on ixekizumab (Taltz) for treating active psoriatic treating active psoriatic arthritis in adults. 1 arthritis after X 06/11/2018 20/11/2018 104 inadequate response to DMARDs TA538 - Dinutuximab 22/08/2018 Evidence-based recommendations on dinutuximab beta (Qarziba) for high-risk 1 beta for treating neuroblastoma in people aged 12 months and over. X 20/11/2018 17/09/2018 26 neuroblastoma TA539 - Lutetium 29/08/2018 Evidence-based recommendations on lutetium (177Lu) oxodotreotide (Lutathera) for (177Lu) oxodotreotide treating unresectable or metastatic neuroendocrine tumours in adults. for treating 1 unresectable or X 27/11/2018 17/09/2018 19 metastatic neuroendocrine tumours TA540 - 03/09/2018 Pembrolizumab is not recommended for treating relapsed or refractory classical Pembrolizumab for Hodgkin lymphoma in adults who have had autologous stem cell transplant and treating relapsed or brentuximab vedotin. Pembrolizumab is recommended for use within the Cancer refractory classical Drugs Fund as an option for treating relapsed or refractory classical Hodgkin 1 Hodgkin lymphoma lymphoma in adults who have had brentuximab vedotin and cannot have autologous X 02/12/2018 21/01/2019 140 stem cell transplant, only if: pembrolizumab is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and the conditions in the managed access agreement for pembrolizumab are followed. TA541 - Inotuzumab 19/09/2018 Evidence-based recommendations on inotuzumab ozogamicin (Besponsa) for ozogamicin for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia relapsed or refractory B- in adults. 1 X 18/12/2018 08/11/2018 50 cell acute lymphoblastic leukaemia

TA542 - Cabozantinib 03/10/2018 Evidence-based recommendations on cabozantinib (Cabometyx) for untreated for untreated advanced advanced renal cell carcinoma in adults. 1 X 01/01/2019 08/11/2018 36 renal cell carcinoma

TA543 - Tofacitinib for 03/10/2018 Evidence-based recommendations on tofacitinib (Xeljanz) for treating active psoriatic treating active psoriatic arthritis in adults after inadequate response to DMARDs. 1 arthritis after X 01/01/2019 21/01/2019 110 inadequate response to DMARDs TA221 - Romiplostim 26/10/2018 Published 27th April 2011, last updated 26th Oct 2018 for the treatment of Evidence-based recommendations on romiplostim (Nplate) for treating chronic chronic immune immune (idiopathic) thrombocytopenic purpura in adults. 1 (idiopathic) x 24/01/2019 15/11/2018 20 thrombocytopenic October 2018: We updated the recommendations because the marketing purpura authorisation for romiplostim now includes people who have not had a splenectomy. Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 TA293 - Eltrombopag 26/10/2018 Published 24th July 2013, last updated 26th Oct 2018 for treating chronic Evidence-based recommendations on eltrombopag (Revolade) for treating chronic immune (idiopathic) immune (idiopathic) thrombocytopenic purpura in adults. thrombocytopenic purpura This guidance updates and replaces NICE technology appraisal guidance on 1 eltrombopag for the treatment of chronic immune (idiopathic) thrombocytopenic x 24/01/2019 15/11/2018 20 purpura (TA205).

October 2018: We updated the recommendations because the marketing authorisation for eltrombopag now includes people who have not had a splenectomy.

TA544 - Dabrafenib 17/10/2018 Evidence-based recommendations on dabrafenib (Tafinlar) with trametinib (Mekinist) with trametinib for for resected stage III, BRAF V600 mutation-positive melanoma in adults. adjuvant treatment of 1 x 15/01/2019 15/11/2018 29 resected BRAF V600 mutation-positive melanoma TA545 - 14/11/2018 Evidence-based recommendations on gemtuzumab oxogamicin (Mylotarg) for Gemtuzumab untreated acute myeloid leukaemia in people aged 15 years and over. 1 ozogamicin for X 12/02/2019 21/01/2019 68 untreated acute myeloid leukaemia TA546 - Padeliporfin 21/11/2018 Evidence-based recommendations on padeliporfin (Tookad) for untreated, unilateral, for untreated low-risk prostate cancer in adults. Padeliporfin is 1 X 19/02/2019 17/12/2018 26 localised prostate not recommended, within its marketing authorisation, for untreated, unilateral, low- cancer risk prostate cancer in adults. TA547 - Tofacitinib 28/11/2018 Evidence-based recommendations on tofacitinib (Xeljanz) for previously treated for moderately to moderately to severely active ulcerative colitis in adults. 1 X 26/02/2019 18/02/2019 82 severely active ulcerative colitis TA548 - 05/12/2018 NICE is unable to make a recommendation about the use in the NHS of decitabine for untreated acute for untreated acute myeloid leukaemia because no evidence submission was 1 myeloid leukaemia received from Janssen. We will review this decision if the company decides to make X 05/03/2019 21/01/2019 47 (terminated appraisal) a submission.

TA549 - Denosumab 05/12/2018 NICE is unable to make a recommendation about the use in the NHS of denosumab for preventing skeletal- for preventing skeletal-related events in multiple myeloma because no evidence related events in submission was received from Amgen. We will review this decision if the company 1 multiple myeloma decides to make a submission. X 05/03/2019 21/01/2019 47 (terminated appraisal)

TA550 - Vandetanib 12/12/2018 Evidence-based recommendations on vandetanib (Caprelsa) for treating medullary for treating medullary thyroid cancer in adults. 1 thyroid cancer X 12/03/2019 21/01/2019 40 The scope for this technology appraisal included cabozantinib (Cometriq). NICE’s recommendations on cabozantinib are published separately. TA551 - Lenvatinib for Evidence-based recommendations on lenvatinib (Lenvima) for untreated untreated advanced advanced hepatocellular carcinoma in adults. 1 19/12/2018 X 19/03/2019 11/01/2019 23 hepatocellular carcinoma TA552 - Liposomal Evidence-based recommendations on liposomal – cytarabine–daunorubici (Vyxeos) for untreated acute myeloid leukaemia in adults. 1 n for untreated acute 19/12/2018 X 19/03/2019 21/01/2019 33 myeloid leukaemia

TA553 - Evidence-based recommendations on pembrolizumab (Keytruda) for adjuvant Pembrolizumab for treatment of stage III melanoma with lymph node involvement in adults. adjuvant treatment of 1 19/12/2018 X 19/03/2019 22/01/2019 34 resected melanoma with high risk of recurrence TA554 - Evidence-based recommendations on tisagenlecleucel therapy (Kymriah) for Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people treating relapsed or aged up to 25 years. 1 refractory B-cell acute 21/12/2018 X 21/03/2019 18/02/2019 59 lymphoblastic leukaemia in people aged up to 25 years TA555 - Regorafenib 09/01/2019 Evidence-based recommendations on regorafenib (Stivarga) for treating advanced for previously treated hepatocellular carcinoma in adults who have had sorafenib. 1 advanced X 09/04/2019 11/02/2019 33 hepatocellular This guidance replaces NICE technology appraisal guidance on regorafenib for carcinoma previously treated advanced hepatocellular carcinoma (TA514). TA556 - Darvadstrocel 09/01/2019 Evidence-based recommendations on darvadstrocel (Alofisel) for previously treated for treating complex complex perianal fistulas in adults with non-active or mildly active luminal Crohn’s 1 perianal fistulas in disease. X 09/04/2019 11/02/2019 33 Crohn’s disease

TA557 - 10/01/2019 Evidence-based recommendations on pembrolizumab (Keytruda) with Pembrolizumab with and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell pemetrexed and lung cancer in adults whose tumours have no epidermal growth factor receptor platinum chemotherapy (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations. 1 X 10/04/2019 11/02/2019 32 for untreated, metastatic, non- squamous non-small- cell lung cancer TA558 - Nivolumab for 23/01/2019 Evidence-based recommendations on nivolumab (Opdivo) for the adjuvant treatment adjuvant treatment of of completely resected melanoma in adults with lymph node involvement or completely resected metastatic disease. 1 melanoma with lymph X 23/04/2019 12/02/2019 20 node involvement or metastatic disease Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 TA559 - Axicabtagene 23/01/2019 Evidence-based recommendations on axicabtagene ciloleucel therapy (Yescarta) for ciloleucel for treating treating diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma in diffuse large B-cell adults after 2 or more systemic therapies. lymphoma and primary 1 mediastinal large B-cell X 23/04/2019 11/04/2019 78 lymphoma after 2 or more systemic therapies

TA560 - Bevacizumab 20/02/2019 NICE is unable to make a recommendation about the use in the NHS of with , bevacizumab with carboplatin, and for treating the first gemcitabine and recurrence of platinum-sensitive advanced ovarian cancer because no evidence paclitaxel for treating submission was received from Roche. The company has confirmed that it does not the first recurrence of intend to make a submission because the technology is unlikely to be used at this 1 X 21/05/2019 28/02/2019 8 platinum-sensitive point in the treatment pathway and is unlikely to be a cost-effective use of NHS advanced ovarian resources. cancer (terminated appraisal)

TA561 - 27/02/2019 Evidence-based recommendations on venetoclax (Venclyxto) with rituximab for with rituximab for previously treated chronic lymphocytic leukaemia in adults. 1 previously treated X 28/05/2019 18/03/2019 19 chronic lymphocytic leukaemia TA562 - Encorafenib 27/02/2019 Evidence-based recommendations on encorafenib (Braftovi) with binimetinib with binimetinib for (Mektovi) for treating unresectable or metastatic BRAF V600 mutation-positive unresectable or melanoma in adults. 1 X 28/05/2019 11/03/2019 12 metastatic BRAF V600 mutation-positive melanoma TA563 - 27/02/2019 Evidence-based recommendations on abemaciclib (Verzenios) for treating locally with an aromatase advanced or metastatic, hormone receptor-positive, human epidermal growth factor inhibitor for previously receptor 2 (HER2)-negative breast cancer in adults who have not had endocrine- untreated, hormone based therapy before. 1 receptor-positive, HER2- X 28/05/2019 28/02/2019 1 negative, locally advanced or metastatic breast cancer

TA564 - Dabrafenib 27/02/2019 NICE is unable to make a recommendation about the use in the NHS of dabrafenib with trametinib for with trametinib for treating advanced metastatic BRAF V600E mutation-positive non- treating advanced small-cell lung cancer because no evidence submission was received from Novartis. metastatic BRAF We will review this decision if the company decides to make a submission. 1 X 28/05/2019 28/02/2019 1 V600E mutation- positive non-small-cell lung cancer (terminated appraisal) TA565 - Ralizumab for Evidence-based recommendations on benralizumab (Fasenra) for treating severe 1 treating severe 06/03/2019 eosinophilic asthma in adults. X 04/06/2019 11/04/2019 36 eosinophilic asthma TA566 - Cochlear Evidence-based recommendations on cochlear implants for children and adults with implants for children severe to profound deafness. and adults with severe to profound deafness This guidance has been updated after a review of the criteria for defining severe to 1 07/03/2019 X 05/06/2019 15/04/2019 39 profound deafness and for assessing adequate benefit from acoustic hearing aids set out in recommendation 1.5. See section 4.4 of the guidance for further details. No other sections of the guidance have been updated, so these are the same as in the original guidance. TA567 - Evidence-based recommendations on tisagenlecleucel therapy (Kymriah) for treating Tisagenlecleucel for relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more treating relapsed or systemic therapies. refractory diffuse large 1 13/03/2019 X 11/06/2019 12/04/2019 B-cell lymphoma after 2 or more systemic therapies

TA568 - Abatacept for NICE is unable to make a recommendation about the use in the NHS of abatacept treating psoriatic (Orencia) for treating psoriatic arthritis after DMARDs in adults because no evidence arthritis after DMARDs submission was received from Bristol–Myers Squibb. We will review this decision if 1 13/03/2019 X 11/06/2019 11/04/2019 29 (terminated appraisal) the company decides to make a submission.

TA569 - Pertuzumab for Evidence-based recommendations on pertuzumab (Perjeta) for adjuvant treatment of adjuvant treatment of HER2‑positive early stage breast cancer in adults. 1 20/03/2019 X 18/06/2019 12/04/2019 23 HER2-positive early stage breast cancer TA570 - NICE is unable to make a recommendation about the use in the NHS of Pembrolizumab for pembrolizumab (Keytruda) for treating recurrent or metastatic squamous cell treating recurrent or carcinoma of the head and neck after platinum-based chemotherapy because no metastatic squamous evidence submission was received from Merck Sharp & Dohme. 1 cell carcinoma of the 20/03/2019 X 18/06/2019 15/04/2019 26 head and neck after platinum-based chemotherapy (terminated appraisal) TA571 - Brigatinib for Evidence-based recommendations on brigatinib (Alunbrig) for treating anaplastic treating ALK-positive lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer in adults who 1 advanced non-small- 20/03/2019 have already had crizotinib. X 18/06/2019 12/04/2019 23 cell lung cancer after crizotinib TA572 - Ertugliflozin as Evidence-based recommendations on ertugliflozin (Steglatro) as monotherapy or with monotherapy or with metformin for treating type 2 diabetes in adults. 1 metformin for treating 27/03/2019 X 25/06/2019 17/06/2019 82 type 2 diabetes

17 43 Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 Average 60 % "Yes" % "N/A" implement time (days) Adherence statistics for 2018-19 28% 72% 41