| Status | Suspended |
| Process | STA pre-2018 |
| Referral date | 01 November 2011 |
| Topic area |
|
| Description |
Scoped as part of Batch 20 |
Provisional Schedule
| Closing date for invited submissions / evidence submission: | 22 June 2012 |
| 1st appraisal committee meeting: | TBC |
Project Team
| Communications manager: | Laura Gibson |
| Executive Lead: | TBC |
| Project manager: | Rebecca Pye |
| Technical Lead: | TBC |
Consultees
| Manufacturers/sponsors | Celgene (romidepsin) |
| Others | Department of Health |
| Leicestershire PCT cluster | |
| South East London PCT cluster | |
| Welsh Government | |
| Patient/carer groups | Lymphoma Association |
| Rarer Cancers Foundation | |
| Professional groups | British Society for Haematology |
| Cancer Research UK | |
| Royal College of Nursing | |
| Royal College of Pathologists | |
| Royal College of Physicians |
Commentators
| Associated Guideline Groups | National Collaborating Centre for Cancer |
| Associated Public Health Groups | None |
| Comparator manufacturers | Actavis UK (epirubicin, fludarabine, gemcitabine, prednisolone) Confidentiality agreement not signed, not participating |
| Alliance Pharmaceuticals (prednisolone) Confidentiality agreement not signed, not participating | |
| Amdipharm (prednisolone) Confidentiality agreement not signed, not participating | |
| Auden McKenzie (Pharma Division) (dexamethasone)Confidentiality agreement not signed, not participating | |
| Baxter (cyclophosphamide, ifosfamide) Confidentiality agreement not signed, not participating | |
| Bristol-Myers Squibb (carboplatin, cisplatin, etoposide)Confidentiality agreement not signed, not participating | |
| Eli Lilly and Company (gemcitabine) Confidentiality agreement not signed, not participating | |
| Essential Generics (dexamethasone) Confidentiality agreement not signed, not participating | |
| Genzyme Therapeutics (fludarabine) Confidentiality agreement not signed, not participating | |
| Goldshield Critical Care (cisplatin) Confidentiality agreement not signed, not participating | |
| Hameln Pharmaceuticals (epirubicin) Confidentiality agreement not signed, not participating | |
| Hospira UK (carboplatin, cisplatin, cytarabine, epirubicin, etoposide, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating | |
| Medac UK (epirubicin, etoposide, gemcitabine, lomustine) Confidentiality agreement not signed, not participating | |
| Merck Sharp & Dohme (dexamethasone) Confidentiality agreement not signed, not participating | |
| Mylan (epirubicin, gemcitabine) Confidentiality agreement not signed, not participating | |
| Pfizer (cisplatin, cyclophosphamide, cytarabine, epirubicin, methylprednisolone) Confidentiality agreement not signed, not participating | |
| Rosemont Pharmaceuticals (dexamethasone) Confidentiality agreement not signed, not participating | |
| Sandoz (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating | |
| Sigma Pharmaceuticals (methylprednisolone) Confidentiality agreement not signed, not participating | |
| Sun Pharmaceuticals UK (carboplatin, gemcitabine) Confidentiality agreement not signed, not participating | |
| Teva UK (carboplatin, cisplatin, epirubicin, etoposide, Confidentiality agreement not signed, not participating | |
| Wockhardt UK (carboplatin, cisplatin, epirubicin, fludarabine, gemcitabine) Confidentiality agreement not signed, not participating | |
| Evidence Review Group | NHS Centre for Reviews and Dissemination and Centre for Health Economics - York |
| National Institute for Health Research Health Technology Assessment Programme | |
| General | Commissioning Support Appraisals Service |
| Department of Health,Social Services and Public Safety for Northern Ireland | |
| Health Improvement Scotland | |
| Relevant research groups | None |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 23 November 2012 |
Following an update on the regulatory status of this technology which has received a negative CHMP opinion, this appraisal remains suspended whilst we consider the next steps. |
| 10 July 2012 |
The manufacturer of romidepsin has informed NICE that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal. |
| 22 February 2012 |
Following on from advice received from the manufacturer, this appraisal has now been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during late April 2012 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late June 2012. |
For further information on how we develop guidance, please see our page about NICE technology appraisal guidance