NICE SINGLE TECHNOLOGY APPRAISAL Flashcards
WHAT ARE TECHNOLOGY APPRAISALS? (TA)
RECOMMENDATIONS ON THE USE OF NEW AND EXISTING MEDICINES AND TREATMENTS WITHIN THE NHS
- CAN CONCERN MEDICINES, MEDICAL DEVICES, DIAGNOSTIC TECHNIQUES, SURGICALPROCEDURES, HEALTH PROMOTION ACTIVITIES
- NICE BASES ITS RECOMMENDATIONS ON A REVIWE OF THE CLINICAL AND ECONOMIC EVIDENCE!!!!!
3 FORMS TECHNOLOGY APPRAISALS INITIALLY TAKE?
SINGLE TECHNOLOGY APPRAISALS (STA)
- COVER A SINGLE TECHNOLOGY FOR A SINGLE INDICATION (40-49 WEEKS)
FAST TRACK APPRAISALS (FTA)
- COVER A SINGLE TECHNOLOGY FOR A SINGLE INDICATION BUT WITH A SHORTER PROCESS TIME TO SPEED UP ACESS TO THE MOST COST-EFFECTIVE NEW TREATMETNS (32 WEEKS)
MULTIPLE TECHNOLOGY APPRAISALS (MTA)
- NORMALLY COVER MORE THAN TECHNOLOGY, OR ONE TECHNOLOGY FOR MORE THAN ONE INDICATION (47-60 WEEKS)
CLASSIFICATION OF NICE RECOMMENDATIONS AT THE END OF TECHNOLOGY APPRAISALS?
- OUTCOME OF EACH TECHNOLOGY APPRAISAL MAY CONTAIN MORE THAN ONE RECOMMENDATION
5 CATEGORIES OF RECOMMENDATIONS:
- RECOMMENDED (APPROVAL FOR USE FOR THE WHOLE POPULATION)
- OPTIMISED (SPECIFIC USE FOR A SUBSET OF THE POPULATION OR APPROVAL OF A SPECIFIC PART OF INDICATED USE)
- ONLY IN RESEARCH (CAN BE USED IN CLINICAL TRIALS TO FURTHER EXPLORE THE VALUE)
- NOT RECOMMENDED (CLINICAL AND COST EFFECTIVENESS DOESN’T FIT THE TRESHOLD)
- RECOMMENDED FOR USE IN THE CANCER DRUGS FUND
QUALIFYING FOR CANCER DRUG FUND (CDF)?
- TO QUALIFY FOR ENTRY INTO CDF THE DRUG MUST SHOW PLAUSIBLE POTENTIAL TO SATISFY THE CRITERIA FOR ROUTINE COMMISSIONING DESPITE REMAINING CLINICALLY UNCERTAIN
THE COMMITTEE MUST DECIDE IF THE FOLLOWING CRITERIA ARE MET:
- LIKELY COST EFFECTIVE AT THE CURRENT PRICE, TAKING INTO ACCOUNT END OF LIFE CRITERIA
- FURTHER DATA COLLECTION WILL REDUCE CLINICAL UNCERTAINTY
- ANY UNGOING STUDIES WILL PROVIDE USEFUL DATA
- CDF DATA COLLECTION IS FEASIBLE
BENEFIT: DRUG IS MADE/REMAINS AVAILABLE TO PATIENTS WHILST FURTHER EVIDENCE IS BEING COLLECTE, PROVIDING EARLIER ACCESS TO NEW TREATMENT OPTIONS
- PROOF OF CERTAINTY ON CLINICL AND COST EFFECTIVENESS USUALLY MUST BE PROVIDED WITHIN 24 MONTHS OF INITIAL APPROVAL FOR CDF
CANCER DRUG FUND?
The Cancer Drugs Fund (CDF) is a source of funding for cancer drugs in England.
NHS England and the National Institute for Health and Care Excellence (NICE) work in partnership with pharmaceutical companies to address uncertainty about the effectiveness of new cancer treatments. This usually involves the collection of additional data, during a managed access period when patients are able to access the treatment. The additional data helps NICE to decide whether a new treatment should be routinely funded.
CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)
- MALIGNANT DISORDER OF WHITE BLOOD CELLS (LYMPHOCYTES)
- CAUSES ANAEMIA, SWOLLEN LYMPH NODES, SPLEEN ENLARGEMENT, UNEXPLAINED WEIGHT LOSS AND INCREASED SUSCEPTIBILITY TO INFECTION
- 2,982 NEW DIAGNOSES OF CLL IN ENGLAND EACH YEAR
- RISK INCREASES WITH AGE, CONDITION MORE COMMON IN MEN
- 5-10% CONSIDERD TO BE HIGH RISK
WHAT DOES THE BRITISH COMMITTEE FOR STANDARDS IN HAEMATOLOGY DEFINES AS PEOPLE AT HIGH RISK OF CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)?
- 17p DELETION or TP53 MUTATION
- THEIR DISEASE RELAPSES/IS REFRACTORY TO CHEMOTHERAPY
REFRACTORY TUMOURS
Cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment or it may become resistant during treatment.
VENETOCLAX?
- SELECTIVE SMALL MOLECULE INHIBITOR OF B-CELL LYMPHOMA 2 (ANTIPOPTOTIC PROTEIN EXPRESSED IN 95% OF PEOPLE WITH CHRONIC LYMPHOCYTIC LEUKAEMIA)
- TAKEN ORALLY, ONCE A DAY
- TAKEN UNTIL DISEASE PROGRESSION OR TOXICITY
- PRICE: A BIT UNDER 5000 POUNDS
MARKETING AUTHORIZATION IN ENGLAND FOR: (WITHIN THE CANCER DRUGS FUND)
- ADULTS WITH 17p OR TP53 MUTATION WHO ARE UNSUITABLE FOR OR WHO HAVE FAILED B-CELL RECEPTOR PATHWAY INHIBITOR
- ADULTS WITHOUT 17p OR TP53 MUTATION WHO HAVE FAILED BOTH CHEMO-IMMUNOTHERAPY AND A B-CELL RECEPTOR PATHWAY INHIBITOR
‘One form of anticancer therapeutic, termed ‘BH3-mimetic drugs’, has been developed to directly activate the apoptosis machinery in malignant cells. These drugs bind to and inhibit specific prosurvival BCL-2 family proteins, thereby mimicking their interaction with the BH3 domains of proapoptotic BCL-2 family proteins. The BCL-2-specific inhibitor venetoclax is approved by the US Food and Drug Administration and many regulatory authorities worldwide for the treatment of chronic lymphocytic leukaemia and
acute myeloid leukaemia.
WHAT HAPPENS AFTER A DRUG IS AUTHORISED FOR USE IN CANCER DRUGS FUND (CDF)?
- A MANAGED ACCESS AGREEMENT WILL NEED TO BE FORMED BETWEEN THE PHARMACEUTICAL COMPANY AND NHS ENGLAND FOR RESOLVING SIGNIFICANT REMAINING CLINICAL UNCERTAINTY
WHAT DOES THE MANAGED ACCESS AGREEMENT AFTER A DRUG HAS BEEN APPROVED FOR CDF COMPRISE?
2 COMPONENTS:
- DATA COLLECTION ARRANGEMENT (JOINT AGREEMENT WITH A DEADLINE TO ADDRESS SPECIFICALLY DEFINED AREAS OF CLINICAL UNCERTAINTY)
- CDF COMMERCIAL ARRANGEMENT
VENETOCLAX HAS BEEN APPROVED FOR CANCER DRUGS FUND. UNDER THE DATA COLLECTION ARRANGEMENT, WHICH ADDITIONAL AREAS OF CLINICAL UNCERTAINTY NEED TO BE ADDRESED FOR IT TO BE REGULARLY APPROVED ON THE NHS?
- GENERALISABILITY OF VENETOCLAX DATA TO NHS POPULATION (PARTICIPANTS IN VENETOCLAX TRIALS HAD LESS ADVANCED DISEASE THAN WHAT WOULD BE EXPECTED WHEN PATIENTS PRESENT TO THE NHS)
- RELATIVE EFFICACY OF VENETOCLAX COMPARED WITH BEST SUPPORTIVE CARE
