rebate principles and process · recommendation to the derbyshire prescribing dpg will review...

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September 2019 Rebate Principles and Process Background Primary care rebate schemes (PCRS) are contractual arrangements offered by pharmaceutical companies, or third-party companies, which offer financial rebates on prescribing expenditure. Under the terms of such a scheme, the NHS is charged the Drug Tariff price for primary care prescriptions dispensed, the manufacturer then provides a rebate to the primary care organisation based on an agreed discount price. Such schemes are being offered to Clinical Commissioning Groups by the pharmaceutical industry in relation to named products. Rebate agreements usually take the form of legal agreements between the manufacturer and CCG. It is important that NHS Derby and Derbyshire CCG has a process to support evaluation and sign off of rebate schemes to ensure that schemes are only signed off where they provide good value for money to the public purse and the scheme’s terms are in line with organisation vision, values, policies and procedures and to ensure that the CCG is transparent in its process for considering these schemes. This rebate process provides a framework for managing rebates in a legal and ethical way. The principles outlined in this document allow for the objective evaluation of schemes submitted to the CCG and a clear process for approving and scrutinising agreements. Principles for Assessing Rebate Schemes NHS Derby and Derbyshire CCG will adopt the following principles when deciding whether to participate in a PCRS or not. Product Related Any medicine considered under a PCRS must be licensed in the UK. Where there is more than one licensed indication for a medicine, a scheme should not be linked to a particular indication for use.* Any device or nutritional supplement considered under a PCRS should be included within the relevant chapter of the Drug Tariff. Products should not have a negative decision by NICE, or be included in the Joint Area Prescribing Committee Red or Black traffic light list. Rebate schemes promoting unlicensed or off label uses will not be entered into. All recommendations for use of a medicine within a PCRS must be consistent with the Marketing Authorisation of the medicine in question. PCRS are not appropriate for medicines in Category M and some medicines in Category A of the Drug Tariff. This is due to the potential wider impact on community pharmacy reimbursement. Rebate Scheme Related Ideally the PCRS should not be linked directly to requirements to increase market share or volume of prescribing. A volume based scheme should only be agreed if clinically appropriate. However, the administrative burden of monitoring such a scheme should be carefully considered. The primary care rebate scheme will not preclude the CCG from considering any other schemes subsequently offered by manufacturers of competitor drugs, should they wish to do so.

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September 2019

Rebate Principles and Process

Background Primary care rebate schemes (PCRS) are contractual arrangements offered by pharmaceutical companies, or third-party companies, which offer financial rebates on prescribing expenditure. Under the terms of such a scheme, the NHS is charged the Drug Tariff price for primary care prescriptions dispensed, the manufacturer then provides a rebate to the primary care organisation based on an agreed discount price. Such schemes are being offered to Clinical Commissioning Groups by the pharmaceutical industry in relation to named products. Rebate agreements usually take the form of legal agreements between the manufacturer and CCG. It is important that NHS Derby and Derbyshire CCG has a process to support evaluation and sign off of rebate schemes to ensure that schemes are only signed off where they provide good value for money to the public purse and the scheme’s terms are in line with organisation vision, values, policies and procedures and to ensure that the CCG is transparent in its process for considering these schemes. This rebate process provides a framework for managing rebates in a legal and ethical way. The principles outlined in this document allow for the objective evaluation of schemes submitted to the CCG and a clear process for approving and scrutinising agreements. Principles for Assessing Rebate Schemes NHS Derby and Derbyshire CCG will adopt the following principles when deciding whether to participate in a PCRS or not. Product Related Any medicine considered under a PCRS must be licensed in the UK. Where there is more than one licensed indication for a medicine, a scheme should not be linked to a particular indication for use.* Any device or nutritional supplement considered under a PCRS should be included within the relevant chapter of the Drug Tariff. Products should not have a negative decision by NICE, or be included in the Joint Area Prescribing Committee Red or Black traffic light list. Rebate schemes promoting unlicensed or off label uses will not be entered into. All recommendations for use of a medicine within a PCRS must be consistent with the Marketing Authorisation of the medicine in question. PCRS are not appropriate for medicines in Category M and some medicines in Category A of the Drug Tariff. This is due to the potential wider impact on community pharmacy reimbursement. Rebate Scheme Related Ideally the PCRS should not be linked directly to requirements to increase market share or volume of prescribing. A volume based scheme should only be agreed if clinically appropriate. However, the administrative burden of monitoring such a scheme should be carefully considered. The primary care rebate scheme will not preclude the CCG from considering any other schemes subsequently offered by manufacturers of competitor drugs, should they wish to do so.

September 2019

Suppliers should not make guideline or formulary positioning conditional to any rebate offer. The administrative burden to the NHS of setting up and running the scheme must be factored into assessment of likely financial benefit of the scheme. Consideration should be given to audit requirements, financial governance, data collection, any other hidden costs and practical issues such as the term of agreement. PCRS agreements should include a right to terminate on notice (without having to have any reason for doing so) with a sensible notice period e.g., three or six months. There will be no requirement to collect or submit to the manufacturer any data other than volume of use as derived from ePACT data. Primary care rebate schemes will not be entered into that requires provision of patient specific data. Primary care rebate schemes will be subject to Freedom of Information (FOI) requests. The CCG will publish a list of the schemes it participates in on the CCG website. The full terms of the scheme may not be published depending on the nature of the rebate scheme contract.

September 2019

Approval and Rebate Management Process

PrescQIPP is a CIC NHS Programme to support

quality, optimised medicines management

within the NHS. Their Pharmaceutical industry

scheme governance review board assesses any

rebate schemes for clinical, financial and

contractual issues to support CCGs in

addressing the risk of perverse incentives from

such schemes.

PrescQIPP

It is expected that the majority of rebates will be

considered following the Prescqipp assessment.

Rebates outside of the Prescqipp process will be

considered on an individual basis.

Rebate Offer

Senior Medicines

Management Team

(SMMT)

The SMMT will assess schemes against the

Derbyshire rebate principles, making a

recommendation to the Derbyshire Prescribing

Group.

DPG will review rebate recommendations from

the SMMT, providing oversight and assurance.

Derbyshire Prescribing

Group

(DPG)

Chief Finance Officer

(CFO)

The CFO has designated responsibility for the CCG.

The CFO will ensure that due process has been

followed and will sign off all contracts.

Medicines Management

Team

(MMT)

The MMT will activate and monitor contracts with

the company supported by the CCG finance team.

Approved rebate schemes will be published on the

Derbyshire Medicines Management website. MMT

will liaise with SMMT, DPG, CFO regarding contract

expiries, renewals and terminations.

September 2019

Current rebate agreements within Derbyshire Date updated September 2019 Inclusion of any medicine or appliance on to this list does not in any way endorse prescribing of the product. See traffic lights for local status of the drug.

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby &

Derbyshire CCG

Abtard Oxycodone Hydrochloride

Prolonged Release

ETHYPHARM UK LTD Tel: 01483 662805 e-mail: [email protected]

Ju

ly 2

017

Ju

ly 2

017

Ju

ly 2

017

Ju

ly 2

017

*CS

AirFluSal Forspiro Salmeterol/ Fluticasone

Combination Inhaler

SANDOZ LTD TEL: 01276 698020 e-mail: [email protected] M

arc

h 2

017

Ma

rch

2017

Ma

rch

2017

Ma

rch

2017

*CS

AirFluSal MDI Salmeterol/ Fluticasone Propionate

SANDOZ LTD TEL: 01276 698020 e-mail: [email protected] O

cto

be

r 2

018

Octo

be

r 2

018

Octo

be

r 2

018

Octo

be

r 2

018 *CS

Apidra Insulin Gluisine SANOFI TEL: 01483 505515 e-mail: [email protected] O

cto

be

r 2

017

Octo

be

r 2

017

Octo

be

r 2

017

Octo

be

r 2

017 April 2019 *CS

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Aproderm Barrier Cream

Dimethicone and Trimethysiloxysilicate

4%

FONTUS HEALTH LTD TEL: 0121 6614615 e-mail: [email protected]

Sep

tem

be

r 2017

Sep

tem

be

r 2017

Sep

tem

be

r 2017

Sep

tem

be

r 2017 April 2019 Flat rate discount

Aquamax Cream n/a INTRAPHARM LABORATORIES Ltd TEL: 01628 771800 e-mail: [email protected]

Ma

rch

2017

Ma

rch

2017

Ma

rch

2017

Ma

rch

2017

April 2019 Flat rate discount

Aymes Oral Nutritional

Supplements

n/a AYMES TEL: 07921 403818 e-mail: [email protected]

Jan

ua

ry 2

019

Jan

ua

ry 2

019

Jan

ua

ry 2

019

Jan

ua

ry 2

019

April 2019 *CS

Biquelle XL Quetiapine ASPIRE PHARMA LIMITED TEL: 01730 231148 e-mail: [email protected]

Ap

ril 2018

Ap

ril 2018

Ap

ril 2018

Ap

ril 2018

April 2019 Flat rate discount

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Carbocisteine sachets

n/a INTRAPHARM LABORATORIES LIMITED TEL: 01628 771800 e-mail: [email protected]

Fe

bru

ary

2016

Fe

bru

ary

2016

Fe

bru

ary

2016

Fe

bru

ary

2016

April 2019 Flat rate discount

Clenil Modulite CFC-free Beclometasone

Dipropionate inhaler

CHIESI LTD TEL: 01553 615540

Email: [email protected]

July 2019 *CS

Clexane - injection Enoxaparin SANOFI Email: [email protected]

April 2019 *CS

ConvaTec Wound Care Portfolio

n/a CONVATEC LTD TEL: 01244 284882 e-mail: [email protected]

Octo

be

r 2

018

Octo

be

r 2018

Octo

be

r 2

018

Octo

be

r 2

018

April 2019 *CS

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Fencino Fentanyl matrix patches

ETHYPHARM formerly D B ASHBOURNE LTD TEL: 01483 662805 e-mail: [email protected]

Ju

ly 2

014

Ju

ly 2

014

Octo

be

r 2

014

No

vem

be

r 2014

Flat rate discount

Fobumix Easyhaler Budesonide with Formorterol

ORION PHARMA UK Ltd TEL: 07775 816401 e-mail: [email protected]

Au

gu

st

2018

Au

gu

st

2018

Au

gu

st

2018

Au

gu

st

2018

April 2019 *CS

Glucophage SR Metformin SR MERCK SERONO LIMITED TEL: 020 88187373 e-mail: [email protected]

Octo

be

r 2

017

Octo

be

r 2

017

Octo

be

r 2

017

Octo

be

r 2

017

April 2019

Flat rate discount

Insuman products NPH Insulin SANOFI TEL: 01483 505515 e-mail: [email protected]

Jan

ua

ry 2

015

Jan

ua

ry 2

015

Jan

ua

ry 2

015

Jan

ua

ry 2

015 April 2019 *CS

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Januvia Sitagliptin MERCK SHARP & DOHME LIMITED TEL: 01992 467272 EMAIL: [email protected]

Ap

ril 2

018

Ap

ril 2018

Ap

ril 2018

Ap

ril 2018

April 2019 *CS

Lantus Insulin Glargine SANOFI TEL: 01483 505515 e-mail: [email protected]

April 2019 *CS

Lixiana Edoxaban DAIICHI SANKYO UK LTD. TEL: 01753 893600 e-mail: [email protected]

Ma

y 2

018

Ma

y 2

018

Ma

y 2

018

Ma

y 2

018

*CS

Luventa XL Galantamine FONTUS HEALTH LTD TEL: 0121 6614615 e-mail: [email protected]

Ap

ril 2015

Ap

ril 2015

Ap

ril 2015

Ap

ril 2015

Flat rate discount

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Mezolar Matrix Fentanyl Patch SANDOZ LTD TEL: 01276 698020 e-mail: [email protected]

Ap

ril 2016

Ap

ril 2016

Ap

ril 2016

Ma

y 2

016

*CS

Mintreleq XL Quetiapine ARISTO PHARMA LIMITED TEL: 0330 0245565 e-mail: [email protected]

Ju

ly 2

017

Ju

ly 2

017

Ju

ly 2

017

Ju

ly 2

017

April 2019 Flat rate discount

Monomax XL n/a CHIESI LTD TEL: 0161 4885555 e-mail: [email protected]

Ma

rch

2018

Ma

rch

2018

Ma

rch

2018

Ma

rch

2018

*CS

Prostap SR DCS

Prostap 3 DCS

Leuprorelin DCS 3.75mg

Leuprorelin DCS 11.25mg

TAKEDA UK Ltd TEL:01628 537900 e-mail: [email protected]

Ap

ril 2012

Ap

ril

2012

Ap

ril

2012

Ap

ril

2012

*CS

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Reletrans Buprenorphine Patches

SANDOZ LTD TEL: 01276 698020 e-mail: [email protected]

Ma

rch

2017

Ma

rch

2017

Ma

rch

2017

Ma

rch

2017

April 2019 *CS

Relevtec Buprenorphine Tranosdermal

Patches

SANDOZ LTD TEL: 01276 698020 e-mail: [email protected]

Ju

ne

2018

Ju

ne

2018

Ju

ne

2018

Ju

ne

2018

*CS

Sereflo Fluticasone / Salmeterol

CIPLA (EU) Ltd Managed by Insypher Ltd e-mail: [email protected]

Au

gu

st

2018

Au

gu

st

2018

Au

gu

st

2018

Au

gu

st

2018

April 2019 *CS

Seretide Accuhaler & Evohaler

Fluticasone / Salmeterol

GLAXOSMITHKLINE UK LTD TEL: 020 89909000 e-mail: [email protected]

Sep

tem

be

r 2015

Sep

tem

be

r 2015

Sep

tem

be

r 2015

Sep

tem

be

r 2015 April 2019 *CS

September 2019

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k C

CG

Derby & Derbyshire

CCG

Sevodyne Buprenorphine Patches

ASPIRE PHARMA LIMITED TEL: 01730 231148 e-mail: [email protected]

Ap

ril 2017

Ap

ril 2017

Ap

ril 2017

Ap

ril 2017

April 2019 Flat rate discount

Stocare Stoma Accessories

n/a RHODES PHARMA LTD TEL: 01772 647440

Au

gu

st

2017

Au

gu

st

2017

Au

gu

st

2017

Au

gu

st

2017 Mixed model of flat

rate discount

Xaggitin® XL Methylphenidate Prolonged Release

Tablets

ETHYPHARM UK LTD TEL: 01483 662805 e-mail: [email protected]

Ma

y 2

018

Ma

y 2

018

Ma

y 2

018

Ma

y 2

018

*CS

Xarelto Rivaroxaban BAYER PLC [email protected]

April 2019 *CS

September 2019

*CS – The pharmaceutical company consider this information to be commercially sensitive

Brand Name Generic drug name Pharmaceutical

company

Date original rebate contract effective from

Type of discount

SD

CC

G

Ere

wash

CC

G

ND

CC

G

Hard

wic

k

CC

G

Derby & Derbyshire

CCG

Zaluron XL Quetiapine FONTUS HEALTH LTD TEL: 0121 6614615 e-mail: [email protected]

Ap

ril 2015

Ap

ril 2015

Ap

ril 2015

Ap

ril 2015

Flat rate discount