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Publication, Part of

NICE Technology Appraisals in the NHS in England (Innovation Scorecard) to March 2019

Official statistics

Medicine Groupings Specification

Introduction

Medicine groupings were introduced to the Innovation Scorecard in January 2016 and have been developed by analysts and pharmacists at NHS Digital, ABPI, OHE, NICE, OLS and NHS England.

These groups have been designed to show the combined use of medicines where:

  • There are a number of medicines as options for treatment of a specific condition
  • One TA covers more than one medicine for the same indication
  • Two or more TAs cover the same specific condition

It is more informative to compare uptake of combined options for treatment than only showing uptake of the individual medicines in isolation.

The published medicine groupings will only include those medicines with a positive TA. All other treatment options which may be available will not be reported in the Innovation Scorecard.

 


NOACs in Primary Care

NICE recommends apixaban, dabigatran etexilate, edoxaban and rivaroxaban for the treatment and/or prevention of complications such as heart attack or stroke, caused by blood clots.

NICE Technology Appraisals (TAs)

Title

Date Link
Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults Jan 2012 TA245
Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation Mar 2012 TA249
Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation May 2012 TA256
Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism Jul 2012 TA261
Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism Jun 2013 TA287
Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism Dec 2014 TA327
Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome Mar 2015 TA335
Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism Jun 2015 TA341
Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism Aug 2015 TA354
Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation Sep 2015 TA355

Medicines included in the NOACs in Primary Care group

Drug Presentation1 Dose Frequency

Actual Daily Dose

Unit(s)2

Actual Daily Dose

Dose (mg)3

apixaban

2.5mg tablet

2.5mg

twice daily

2 tabs

5

 

5mg tablet

5mg

twice daily

2 tabs

10

dabigatran etexilate

110mg capsule

110mg

twice daily

2 caps

220

 

150mg capsule

150mg

twice daily

2 caps

300

edoxaban

15mg tablet

15mg

once daily

1 tab

15

 

30mg tablet

30mg

once daily

1 tab

30

 

60mg tablet

60mg

once daily

1 tab

60

rivaroxaban

2.5mg tablet

2.5mg

twice daily

2 tabs

5

 

15mg tablet

15mg

twice daily

2 tabs

30

 

20mg tablet

20mg

once daily

1 tab

20

 

Initiation pack

   

1.75 tab

27.5

Notes:

  1. All other presentations of these medicines are excluded from the calculations.
  2. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  3. Dose is the total number of mgs the patient takes per day.

Calculations for NOACs in Primary Care

Data published at national, regional and CCG levels.

Numerator

Total Actual Daily Doses (ADD) for the medicine presentations in primary care.

Calculated from utilisation data in primary care data - where medicines have been prescribed and dispensed in the community (FP10 prescriptions); data from ePACT (NHS Business Services Authority).

Denominator

Resident population using mid-year population estimates published by ONS.

Value

ADD per 100,000 resident population.

General comments for NOACs in Primary Care

  • The use of NOACs prescribed in secondary care to prevent thromboembolism following hip or knee surgery are excluded and are covered in the NOACs in secondary care group.
  • The majority of prescribing of these medicines for the conditions covered by the TAs occurs in primary care; however, the data presented may be an under-estimate of use as it does not include data on prescribing in secondary care for these indications.
  • Other medicines, including warfarin, are available as alternative options for treatment but do not have a NICE TA and are therefore ineligible for inclusion in the publication.

 


NOACs in Secondary Care

NICE recommends apixaban, dabigatran etexilate and rivaroxaban for the prevention of venous thromboembolism after elective total hip or total knee replacement surgery in adults.

NICE Technology Appraisals (TAs)

Title

Date Link
Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults Sep 2008 TA157
Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults Apr 2009 TA170
Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults Jan 2012 TA245

Medicines included in the NOACs in Secondary Care group

Drug Presentation1 Dose Frequency

Actual Daily Dose

Unit(s)2

Actual Daily Dose

Dose (mg)3

apixaban

2.5mg tablet

2.5mg

twice daily

2 tabs

5

dabigatran etexilate

75mg capsule

75mg

twice daily

2 tabs

150

 

110mg capsule

110mg

twice daily

2 caps

220

rivaroxaban

10mg tablet

10mg

once daily

1 tab

10

Notes:

  1. All other presentations of these medicines are excluded from the calculations.
  2. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  3. Dose is the total number of mgs the patient takes per day.

Calculations for NOACs in Secondary Care

Data published at national and regional level.

Data is shown for secondary care: supplies of medicines recorded in the hospital pharmacy departments, data from HPAI (IMS Health).

Observed

Total Actual Daily Doses (ADD) for the medicines in the NICE guidance and licenced dose regimens.

Expected

Expected days of treatment (see detailed method below).

Value

Ratio of observed ADD to calculated expected days of treatment.

Calculating expected days of treatment

Expected days of treatment is calculated based on the number of hip and knee replacement procedures recorded in the hospital episode statistics (HES) admitted patient care (APC) dataset and the recommended length of treatment with a NOAC as specified in the NICE Technology Appraisal.

Clinical coding advice was provided by the NHS Classifications Service at NHS Digital for relevant OPCS procedure codes for total hip and knee replacements.

OPCS-4 codes used to identify hip replacements

W37.1 Primary total prosthetic replacement of hip joint using cement

W37.2 Conversion to total prosthetic replacement of hip joint using cement

W37.3 Revision of total prosthetic replacement of hip joint using cement

W37.4 Revision of one component of total prosthetic replacement of hip joint using cement

W37.8 Other specified total prosthetic replacement of hip joint using cement

W37.9 Unspecified total prosthetic replacement of hip joint using cement

W38.1 Primary total prosthetic replacement of hip joint not using cement

W38.2 Conversion to total prosthetic replacement of hip joint not using cement

W38.3 Revision of total prosthetic replacement of hip joint not using cement

W38.4 Revision of one component of total prosthetic replacement of hip joint not using cement

W38.8 Other specified total prosthetic replacement of hip joint not using cement

W38.9 Unspecified total prosthetic replacement of hip joint not using cement

W39.1 Primary total prosthetic replacement of hip joint NEC

W39.2 Conversion to total prosthetic replacement of hip joint NEC

W39.3 Revision of total prosthetic replacement of hip joint NEC

W39.5 Revision of one component of total prosthetic replacement of hip joint NEC

W39.8 Other specified other total prosthetic replacement of hip joint

W39.9 Unspecified other total prosthetic replacement of hip joint

W93.1 Primary hybrid prosthetic replacement of hip joint using cemented acetabular component

W93.2 Conversion to hybrid prosthetic replacement of hip joint using cemented acetabular component

W93.3 Revision of hybrid prosthetic replacement of hip joint using cemented acetabular component

W93.8 Other specified hybrid prosthetic replacement of hip joint using cemented acetabular component

W93.9 Unspecified hybrid prosthetic replacement of hip joint using cemented acetabular component

W94.1 Primary hybrid prosthetic replacement of hip joint using cemented femoral component

W94.2 Conversion to hybrid prosthetic replacement of hip joint using cemented femoral component

W94.3 Revision of hybrid prosthetic replacement of hip joint using cemented femoral component

W94.8 Other specified hybrid prosthetic replacement of hip joint using cemented femoral component

W94.9 Unspecified hybrid prosthetic replacement of hip joint using cemented femoral component

W95.1 Primary hybrid prosthetic replacement of hip joint using cement NEC

W95.2 Conversion to hybrid prosthetic replacement of hip joint using cement NEC

W95.3 Revision of hybrid prosthetic replacement of hip joint using cement NEC

W95.8 Other specified hybrid prosthetic replacement of hip joint using cement

W95.9 Unspecified hybrid prosthetic replacement of hip joint using cement

OPCS-4 codes used to identify knee replacements

W40.1 Primary total prosthetic replacement of knee joint using cement

W40.2 Conversion to total prosthetic replacement of knee joint using cement

W40.3 Revision of total prosthetic replacement of knee joint using cement

W40.4 Revision of one component of total prosthetic replacement of knee joint using cement

W40.8 Other specified total prosthetic replacement of knee joint using cement

W40.9 Unspecified total prosthetic replacement of knee using cement

W41.1 Primary total prosthetic replacement of knee joint not using cement

W41.2 Conversion to total prosthetic replacement of knee joint not using cement

W41.3 Revision of total prosthetic replacement of knee joint not using cement

W41.4 Revision of one component of total prosthetic replacement of knee joint not using cement

W41.8 Other specified total prosthetic replacement of knee joint not using cement

W41.9 Unspecified total prosthetic replacement of knee joint not using cement

W42.1 Primary total prosthetic replacement of knee joint NEC

W42.2 Conversion to total prosthetic replacement of knee joint NEC

W42.3 Revision of total prosthetic replacement of knee joint NEC

W42.5 Revision of one component of total prosthetic replacement of knee joint NEC

W42.8 Other specified other total prosthetic replacement of knee joint

W42.9 Unspecified other total prosthetic replacement of knee joint

O18.1 Primary hybrid prosthetic replacement of knee joint using cement

O18.2 Conversion to hybrid prosthetic replacement of knee joint using cement

O18.3 Revision of hybrid prosthetic replacement of knee joint using cement

O18.8 Other specified hybrid prosthetic replacement of knee joint using cement

O18.9 Unspecified hybrid prosthetic replacement of knee joint using cement

Identifying elective procedures in HES

Admission method (ADMIMETH)

11 = Waiting list

12 = Booked

13 = Planned

Selecting relevant providers and grouping outputs to national and regional level

Procedures were only included in the outputs if they were undertaken in an NHS hospital in England. Procedures undertaken by private providers, or NHS providers outside England, were not included even if they have been commissioned and funded by the NHS in England. This should most closely match the numerator data of supplies of medicines recorded in the hospital pharmacy departments.

Relevant NHS Trust codes were sourced from the Organisation Data Service (ODS) at the NHS Digital and identified in HES using the PROCODET provider code field.

Procedures were summed to region by mapping Area Team of Treatment (AT_TREATMENT) and to the new NHS England regions using the mapping information published by ODS.

Expected length of treatment

Expected length of treatment with NOACs is defined in the NICE guidance and presented in the table below:

Length of treatment (days):

apixaban

dabigatran etexilate

rivaroxaban

Average

Minimum

Maximum

Hip replacement

32 to 38 (mid point 35)

28 to 35 (mid point 32)

35 34 28 38
Knee replacement

10 to 14 (mid point 12)

10 14 12 10 14

The expected range of days of treatment is calculated by multiplying the number of procedures recorded in HES by the average, minimum and maximum length of treatment recommended by NICE.

General comments for NOACs in Secondary Care

  • It is assumed that patients will receive the full course of NOACs within the secondary care setting.
  • The majority of NOAC prescriptions in secondary care will be post-surgery; however, some of the NOAC formulations can be prescribed for other purposes in secondary care. For example apixaban 5mg and dabigatran etexilate 220mg can also be prescribed for the treatment or prevention of complications due to blood clots as well as post-surgery. The data for this group may therefore over-estimate use following hip and knee replacement surgery.

 


Acute Coronary Syndromes

NICE recommends ticagrelor combined with low-dose aspirin for up to a year as a possible treatment for some people with acute coronary syndromes.

Ticagrelor, in combination with aspirin, is recommended within its marketing authorisation as an option for preventing atherothrombotic events in adults who had a myocardial infarction and who are at high risk of a further event.

Prasugrel 10 mg is recommended as a possible treatment for adults with acute coronary syndrome who are having percutaneous coronary intervention.

Rivaroxaban (also known as Xarelto) with aspirin alone, or with aspirin plus clopidogrel, is recommended. It is a possible treatment for adults who have had a certain type of heart problem (acute coronary syndrome with raised cardiac biomarkers). The aim is to prevent further problems, such as heart attack or stroke, caused by blood clots.

NICE Technology Appraisals (TAs)

Title

Date Link
Ticagrelor for the treatment of acute coronary syndromes Oct 2011 TA236
Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes Jul 2014 TA317
Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome Mar 2015 TA335
Ticagrelor for preventing atherothrombotic events after myocardial infarction Dec 2016 TA420

Medicines included in the Acute Coronary Syndromes group

Drug Presentation1 Dose Frequency

Actual Daily Dose

Unit(s)2

Actual Daily Dose

Dose (mg)3

prasugrel4

5mg tablet

5mg

once daily

1 tab

5

 

10mg tablet

10mg

once daily

1 tab

10

rivaroxaban5

2.5mg tablet

2.5mg

twice daily

2 tabs

5

ticagrelor6

90mg tablet

90mg

twice daily

2 tabs

180

Notes:

  1. All other presentations of these medicines are excluded from the calculations.
  2. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  3. Dose is the total number of mgs the patient takes per day.
  4. Also known as brand Efient.
  5. Also known as brand Xarelto.
  6. Also known as brand Brilique.

Calculations for Acute Coronary Syndromes

Data published at national, regional and CCG levels.

Numerator

Total Actual Daily Doses (ADD) for the medicine presentations in primary and secondary care.

Calculated from utilisation data in primary and secondary care data:

  • Primary care - where medicines have been prescribed and dispensed in the community (FP10 prescriptions); data from ePACT (NHS Business Services Authority)
  • FP10HP - where medicines have been prescribed in hospital and dispensed in the community; data from Hospital ePACT (NHS Business Services Authority)
  • Secondary care - supplies of medicines recorded in the hospital pharmacy departments; data from HPAI (IMS Health)
Denominator

Resident population using mid-year population estimates published by ONS.

Value

ADD per 100,000 resident population.

General comments for Acute Coronary Syndromes

  • Grouping does not include medicines, included in TAs, recommended by NICE to be co-administered with medicines included in the grouping e.g. clopidogrel, low dose aspirin.

 


Multiple Sclerosis

Natalizumab is recommended as a possible treatment for people with rapidly evolving severe relapsing-remitting multiple sclerosis.

NICE recommends fingolimod as a possible treatment for some adults with highly active relapsing–remitting multiple sclerosis.

Alemtuzumab is recommended as a possible treatment for people with active relapsing–remitting multiple sclerosis.

Teriflunomide is recommended as a possible treatment for adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis.

Dimethyl fumarate is recommended as a possible treatment for people with active relapsing-remitting multiple sclerosis that isn't highly active or rapidly evolving severe relapsing-remitting multiple sclerosis.

Daclizumab is recommended as an option for treating multiple sclerosis in adults, only if:

  • the person has active relapsing–remitting multiple sclerosis previously treated with disease-modifying therapy, or rapidly evolving severe relapsing–remitting multiple sclerosis (that is, at least 2 relapses in the previous year and at least 1 gadolinium-enhancing lesion at baseline MRI) and
  • alemtuzumab is contraindicated or otherwise unsuitable and
  • the company provides the drug with the discount agreed in the patient access scheme.

Cladribine tablets are recommended as an option for treating highly active multiple sclerosis in adults, only if the person has:

  • rapidly evolving severe relapsing–remitting multiple sclerosis, that is, at least 2 relapses in the previous year and at least 1 T1 gadolinium-enhancing lesion at baseline MRI or
  • relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity.
NICE Technology Appraisals (TAs)

Title

Date Link
Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis Aug 2007 TA127
Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis Apr 2012 TA254
Teriflunomide for treating relapsing–remitting multiple sclerosis Jan 2014, Jun 2014 TA303
Alemtuzumab for treating relapsing‑remitting multiple sclerosis May 2014 TA312
Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis Aug 2014 TA320
Daclizumab for treating relapsing–remitting multiple sclerosis Apr 2017 TA441
Cladribine tablets for treating relapsing–remitting multiple sclerosis Dec 2017 TA493

Medicines included in the Multiple Sclerosis group

Drug Presentation1 Dose Frequency

Actual Daily Dose

Unit(s)2

Actual Daily Dose

Dose (mg)3

alemtuzumab4

12mg vial

12mg

4 times per year

0.01 vial

0.13

daclizumab5

150mg/1mg pre-filled injection

150mg

Once monthly

 

5

dimethyl fumarate6

120mg tablet

120mg

twice daily

2 tabs

240

 

240mg tablet

240mg

twice daily

2 tabs

480

fingolimod7

0.5mg capsule

0.5mg

once daily

1 cap

0.5

natalizumab8

300mg vial

300mg

every 4 weeks

0.04 vial

10.71

teriflunamide9

14mg tablet

14mg

once daily

1 tab

14

cladribine10

10mg tablet

1.75mg/kg

Per year for 2 years

0.04 tab

0.38

Notes:

  1. All other presentations of these medicines are excluded from the calculations.
  2. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  3. Dose is the total number of mgs the patient takes per day.
  4. Also known as brand Lemtrada.
  5. Also known as brand Zinbryta.
  6. Also known as brand Tecfidera.
  7. Also known as brand Gilenya.
  8. Also known as brand Tysabri.
  9. Also known as brand Aubagio.
  10. Also known as Mavenclad.

Calculations for Multiple Sclerosis

Data published at national, regional and CCG levels.

Numerator

Total Actual Daily Doses (ADD) for the medicine presentations in primary and secondary care.

Calculated from utilisation data in primary and secondary care data:

  • Primary care - where medicines have been prescribed and dispensed in the community (FP10 prescriptions); data from ePACT (NHS Business Services Authority)
  • FP10HP - where medicines have been prescribed in hospital and dispensed in the community; data from Hospital ePACT (NHS Business Services Authority)
  • Secondary care - supplies of medicines recorded in the hospital pharmacy departments; data from HPAI (IMS Health)
Denominator

Resident population using mid-year population estimates published by ONS.

Value

ADD per 100,000 resident population.

General comments for Multiple Sclerosis

  • Treatment with alemtuzumab consists of initial dose of 12mg for 5 consecutive days followed a further 12mg for 3 days 12 months later. Therefore ADD based on average of 4 doses per year as unable to establish whether use is initial or follow-up treatment. Correlates with WHO DDD of 0.13mg.
  • Treatment with cladribine consists of cumulative dose of 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Treatment of 4 or 5 days per treatment week. Therefore ADD based on average body weight of 70-80 kg[1] patient taking 70mg per week for 2 weeks in a year.

Diabetes

Dapagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in adults, only in combination with metformin and a sulfonylurea.

Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:

  • a sulfonylurea is contraindicated or not tolerated or
  • the person is at significant risk of hypoglycaemia or its consequences.

Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

Canagliflozin, dapagliflozin and empagliflozin as monotherapies are recommended as options for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if:

  • a dipeptidyl peptidase‑4 (DPP‑4) inhibitor would otherwise be prescribed and
  • a sulfonylurea or pioglitazone is not appropriate.

Adults whose treatment with canagliflozin, dapagliflozin or empagliflozin as monotherapy is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Use as ‘add-on’ treatment is recommended in NICE guidance Type 2 diabetes in adults.

NICE Technology Appraisals (TAs)

Title

Date Link
Dapagliflozin in triple therapy for treating type 2 diabetes Nov 2016 TA418
Dapagliflozin in combination therapy for treating type 2 diabetes Jun 2013, Nov 2016 TA288
Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes May 2016 TA390
Type 2 diabetes in adults: management Dec 2015, May 2017 NG28

Medicines included in the Diabetes group

Drug Presentation1

Actual Daily Dose

Unit(s)2

canagliflozin2

100mg tablet

1 tab

 

300mg tablet

1 tab

canagliflozin/metformin3

50mg/850mg tablet

2 tabs

 

50mg/1000mg tablet

2 tabs

canagliflozin/metformin

150mg/850mg tablet

2 tabs

 

150mg/1000mg tablet

2 tabs

dapagliflozin4

5mg tablet

1 tab

 

10mg tablet

1 tab

dapagliflozin/metformin5

5mg/850mg tablet

2 tabs

 

5mg/1000mg tablet

2 tabs

dapagliflozin/saxagliptan6

10mg/5mg tablet

1 tab

empagliflozin7

10mg tablet

1 tab

 

25mg tablet

1 tab

empagliflozin/metformin8

5mg/850mg tablet

2 tabs

 

5mg/1000mg tablet

2 tabs

 

12.5mg/850mg tablet

2 tabs

 

12.5mg/1000mg tablet

2 tabs

Notes:

  1. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  2. Also known as brand Invokana.
  3. Also known as brand Vokanamet.
  4. Also known as brand Forxiga.
  5. Also known as brand Xigduo.
  6. Also known as brand Qtern.
  7. Also known as brand Jardiance.
  8. Also known as brand Synjardy.

Calculations for Diabetes

Data published at national, regional and CCG levels.

Numerator

Total Actual Daily Doses (ADD) for the medicine presentations in primary and secondary care.

Calculated from utilisation data in primary and secondary care data:

  • Primary care - where medicines have been prescribed and dispensed in the community (FP10 prescriptions); data from ePACT (NHS Business Services Authority)
  • FP10HP - where medicines have been prescribed in hospital and dispensed in the community; data from Hospital ePACT (NHS Business Services Authority)
  • Secondary care - supplies of medicines recorded in the hospital pharmacy departments; data from HPAI (IMS Health)
Denominator

Number of patients on the Quality and Outcomes Framework (QOF) diabetes register.

QOF data is published by NHS Digital at https://qof.digital.nhs.uk/.

Value

ADD per 100,000 patients on the Quality and Outcomes Framework (QOF) diabetes register.

QOF data is published by NHS Digital at https://qof.digital.nhs.uk/.

General comments for Diabetes

  • Low volume of prescribing in secondary care.

 


Hepatitis C

Sofosbuvir–velpatasvir–voxilaprevir is recommended as an option for treating chronic hepatitis C in adults, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit.

Glecaprevir–pibrentasvir is recommended, within its marketing authorisation, as an option for treating chronic hepatitis C in adults, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit.

Sofosbuvir–velpatasvir is recommended as an option for treating chronic hepatitis C in adults, only if the company provides the drug with the discount agreed in the simple discount agreement.

Elbasvir–grazoprevir is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit.

Daclatasvir (Daklinza) is recommended as a possible treatment for adults with some types (called genotypes) of chronic hepatitis C, depending on their level of fibrosis. It is taken with sofosbuvir or peginterferon alfa, and sometimes with a drug called ribavirin.

Ledipasvir-sofosbuvir (Harvoni) is recommended as a possible treatment for adults with some types (called genotypes) of chronic hepatitis C.

Ombitasvir–paritaprevir–ritonavir with or without dasabuvir is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1, only if the company provides ombitasvir–paritaprevir–ritonavir and dasabuvir at the same price or lower than that agreed with the Commercial Medicines Unit.

Simeprevir (also known as Olysio) with peginterferon alfa and ribavirin is recommended as a possible treatment for adults with genotype 1 or 4 chronic hepatitis C.

Sofosbuvir (also known as Sovaldi) is recommended as a possible treatment for adults with some types (called genotypes) of chronic hepatitis C. It is taken with other drugs (peginterferon alfa and ribavirin, or ribavirin alone).

Please note the following 2 medicines are no longer in the HepC grouping as of the January 2018 publication, due to discontinuing use that has been replaced by newer medicines.

NICE recommends boceprevir with peginterferon alfa and ribavirin as a possible treatment for genotype 1 chronic hepatitis C in adults with the earlier stages of liver disease (known as compensated liver disease).

NICE recommends telaprevir with peginterferon alfa and ribavirin as a possible treatment for genotype 1 chronic hepatitis C in adults with the earlier stages of liver disease (known as compensated liver disease).

NICE Technology Appraisals (TAs)

Title

Date Link
Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C Feb 2018 TA507
Glecaprevir–pibrentasvir for treating chronic hepatitis C Jan 2018 TA499
Sofosbuvir–velpatasvir for treating chronic hepatitis C Jan 2017 TA430
Elbasvir–grazoprevir for treating chronic hepatitis C Oct 2016 TA413
Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C Nov 2015 TA365
Daclatasvir for treating chronic hepatitis C Nov 2015 TA364
Ledipasvir–sofosbuvir for treating chronic hepatitis C Nov 2015 TA363
Simeprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C Feb 2015 TA331
Sofosbuvir for treating chronic hepatitis C Feb 2015 TA330
Boceprevir for the treatment of genotype 1 chronic hepatitis C Apr 2012 TA253
Telaprevir for the treatment of genotype 1 chronic hepatitis C Apr 2012 TA252

Medicines included in the Hepatitis C group

Drug Presentation1 Dose Frequency

Actual Daily Dose

Unit(s)2

Actual Daily Dose

Dose (mg)3

sofosbuvir–velpatasvir4

400mg/100mg tablet

1 tablet

once daily

1 tab

 

elbasvir–grazoprevir5

50mg/100mg tablet

1 tablet

once daily

1 tab

 

ombitasvir–paritaprevir–ritonavir6

12.5mg/75mg/50mg tablet

2 tablets

once daily

2 tabs

 

daclatasvir

30mg tablet

30mg

once daily

1 tab

30mg

 

60mg tablet

60mg

once daily

1 tab

60mg

 

90mg tablet

90mg

once daily

1 tab

90mg

ledipasvir–sofosbuvir7

90mg/400mg tablet

1 tablet

once daily

1 tab

 

simeprevir8

150mg capsule

1 capsule

once daily

1 cap

150mg

sofosbuvir9

400mg tablet

1 tablet

once daily

1 tab

400mg

boceprevir

200mg capsule

4 capsules

three times daily

12 caps

2400mg

telaprevir

375mg tablet

2 tablets

three times daily

6 tabs

2250mg

glecaprevir–pibrentasvir10

100mg/40mg tablet

3 tablets

once daily

3 tabs

 

sofosbuvir–velpatasvir–voxilaprevir11

400mg/100mg/100mg tablet

1 tablet

once daily

1 tab

 

Notes:

  1. All other presentations of these medicines are excluded.
  2. Units are the number of patches; number of millilitres of an oral solution; the number of tablets or the number of capsules taken per day.
  3. Dose is the total number of mgs the patient takes per day.
  4. Also known as brand Epclusa.
  5. Also known as brand Zapatier.
  6. Also known as brand Viekirax.
  7. Also known as brand Harvoni.
  8. Also known as brand Olysio.
  9. Also known as brand Sovaldi.
  10. Also known as brand Maviret. 
  11. Also known as brand Vosevi.

Calculations for Hepatitis C

Data published at national and regional levels.

Numerator

Total Actual Daily Doses (ADD) for the medicine presentations in primary and secondary care.

Calculated from utilisation data in primary and secondary care data:

  • Primary care - where medicines have been prescribed and dispensed in the community (FP10 prescriptions); data from ePACT (NHS Business Services Authority)
  • FP10HP - where medicines have been prescribed in hospital and dispensed in the community; data from Hospital ePACT (NHS Business Services Authority)
  • Secondary care - supplies of medicines recorded in the hospital pharmacy departments; data from HPAI (IMS Health)
Denominator

Resident population using mid-year population estimates published by ONS.

Value

ADD per 100,000 resident population.

General comments for Hepatitis C

  • Boceprevir has been discontinued (Dec 2015) and is no longer in the HepC grouping as of the January 2018 publication, due to discontinuing use that has been replaced by newer medicines.
  • Telaprevir has been discontinued (Oct 2015) and is no longer in the HepC grouping as of the January 2018 publication, due to discontinuing use that has been replaced by newer medicines.
  • TAs for ‘adjunct’ treatments are not included in this grouped medicine i.e. peginterferon alfa, ribavirin, dasabuvir.
  • Sofosbuvir is also used as an ‘adjunct’ treatment with daclatasvir.
  • More complex modelling could account for potential for some/all of prescribing of sofosbuvir as an ‘adjunct’ only with daclatasvir.

 


ADD values

Actual Daily Dose (ADD) is a new prescribing measure developed for and introduced to the Innovation Scorecard in January 2016. They have been developed where current prescribing measures, such as DDDs, are not available or representative of prescribing practices in England.

  • Unlike DDDs that use a value for a drug (chemical substance), ADDs use a unique value for each presentation based on the actual dose likely to be taken.
  • ADDs assign a unique value for each presentation of a drug based on units (tablets, capsules, patches etc.) and the recommended frequency of daily use (e.g. one a day, three times a day).
  • The general assumption being that each dose is equal to a unit of each preparation.
  • The advantage of ADDs is that a measure can be created that matches the prescribing patterns when a DDD has not been calculated; was created for a different indication (e.g. a DDD for NOACs is based on utilisation in secondary care, but different doses of medicines are used in primary care that are not covered by the DDD); the dose is variable depending on age or a dose and hence presentation is specific to an indication.
  • Therefore, different presentations of the same chemical are likely to have different ADD values whereas a single DDD value for a chemical substance is usually applied to all presentations of the substance.

Calculating ADD values

Step 1: Calculate the number of ADDs for each presentation of each drug

 

If the total number of units prescribed is known:

\(\mathrm{Total\ ADDs\ for\ presentation\ X\ of\ drug\ A\ =\ }\frac{\mathrm{Total\ number\ of\ units\ prescribed\ presentation\ X}}{\mathrm{ADD\ dose\ (units)}}\)

 

If the total number of mgs prescribed is known:

\(\mathrm{Total\ ADDs\ for\ presentation\ X\ of\ drug\ A\ =\ }\frac{\mathrm{Total\ number\ of\ units\ prescribed\ presentation\ X}}{\mathrm{ADD\ dose\ (units)}}\)

 

Step 2: Sum the number of ADDs for each presentation to give the ADDs for each drug

 

\(\mathrm{Total\ ADDs\ for\ presentation\ X\ of\ drug\ A\ =\ }\frac{\mathrm{Total\ number\ of\ units\ prescribed\ presentation\ X}}{\mathrm{ADD\ dose\ (units)}}\)

 

Step 3: Repeat steps 1 and 2 for each drug within the group of medicines

 

Step 4: Sum the number of ADDs for each drug to give the number of ADDs for the group of medicines

 

\(\mathrm{Total\ ADDs\ for\ presentation\ X\ of\ drug\ A\ =\ }\frac{\mathrm{Total\ number\ of\ units\ prescribed\ presentation\ X}}{\mathrm{ADD\ dose\ (units)}}\)

 

Worked example of calculating an ADD for a group of medicines

This example will demonstrate the steps required to calculate the total number of ADDs for two drugs: Drug A and Drug B.

The ADD information for the presentations of Drug A and Drug B is provided below:

Drug Presentation Dose Frequency

Actual Daily Dose

Unit(s)

Actual Daily Dose

Dose (mg)

A

5mg tablet

5mg

twice daily

2

10

 

10mg tablet

10mg

once daily

1

10

 

5mg/5ml oral solution

7.5ml

once daily

7.5

7.5

B

20mg capsule

20mg

twice daily

2

40

 

10mg patch

10mg

once daily

1

10

 

The quantities of the Drug A and Drug B that have been prescribed is available below:

Drug Presentation

Total number of units prescribed

Total number of mgs prescribed

A

5mg tablet

100

500

 

10mg tablet

100

1,000

 

5mg/5ml oral solution

-

750

B

20mg capsule

50

1,000

 

10mg patch

50

500

 

The total number of ADDs for Drug A and Drug B combined is calculated as follows.

Step 1: Calculate the number of ADDs for each presentation of Drug A

 

\(\mathrm{Total\ ADDs\ for\ 5mg\ tablets\ =\ }\frac{\mathrm{100\ tablets}}{\mathrm{2\ (ADD\ dose\ units)}}=50\)

 

\(\mathrm{Total\ ADDs\ for\ 10mg\ tablets\ =\ }\frac{\mathrm{100\ tablets}}{\mathrm{1\ (ADD\ dose\ units)}}=100\)

 

\(\mathrm{Total\ ADDs\ for\ 5mg/5ml\ oral\ solution\ =\ }\frac{\mathrm{750mgs}}{\mathrm{7.5\ (ADD\ dose\ mg)}}=100\)

 

Step 2: Sum the number of ADDs for each presentation to give the ADDs for Drug A

 

\(\mathrm{Total\ ADDs\ for\ Drug\ A\ =\ 50\ +\ 100\ +\ 100}=250\)

 

Step 3a: Repeat step 1 for Drug B

 

\(\mathrm{Total\ ADDs\ for\ 20mg\ capsule\ =\ }\frac{\mathrm{1,000mg}}{\mathrm{40\ \ (ADD\ dose\ mg)}}=25\)

 

\(\mathrm{Total\ ADDs\ for\ 10mg\ patch\ =\ }\frac{\mathrm{50\ patches}}{\mathrm{1\ (ADD\ dose\ units)}}=50\)

 

Step 3b: Repeat step 2 for Drug B

 

\(\mathrm{Total\ ADDs\ for\ Drug\ B\ =\ 25\ +\ 50\ }=75\)

 

Step 4: Sum the number of ADDs for Drug A and Drug B to give the number of ADDs for the group of medicines

 

\(\mathrm{Total\ ADDs\ for\ the\ group\ of\ medicines\ =\ 250\ +\ 75\ }=325\ \mathrm{ADDs}\)

 

325 ADDs is the equivalent of 325 days of treatment with Drugs A and B.

 


Glossary

Acronym Definition

ADD

Actual Daily Dose

DDD

Defined Daily Dose

HES

Hospital Episode Statistics

NOAC

Novel Oral Anti-coagulant

ONS

Office for National Statistics

TA

Technology Appraisal

QOF

Quality Outcomes Framework

WHO

World Health Organisation

CCG

Clinical Commissioning Group

ePACT

Electronic Prescribing Analysis and Cost

HPAI

Hospital Pharmacy Audit Index

NICE

National Institute for Health and Care Excellence 

 

 



Last edited: 5 July 2021 6:00 pm