|
Drug
Tariff Part IX Guidance to Manufacturers and Suppliers
of Medical Devices
AN INTRODUCTION
TO PART IX OF THE DRUG TARIFF
The
guidance document - AN INTRODUCTION TO PART IX OF THE
DRUG TARIFF has been compiled by the Department of Health
in conjunction with the Part IX Drug Tariff Industry
Forum to assist companies submitting a product for inclusion
in Part IX.
To
view some of the documents in this section you need
to have a PDF viewer. Click here
to download Adobe Acrobat Reader and read our help page.
Description of Part IX of The Drug Tariff
1. Regulation 56 of the National Health Service
(Pharmaceutical Services) Regulations 2005 provides
that the Secretary of State shall compile and publish
a statement, referred to as the Drug Tariff, which shall
include, among other things, the list of appliances
and chemical reagents approved by the Secretary of State
for the supply to persons under Section 41 of the NHS
Act 1977. The NHS Business Services Authority (NHSBSA)
deals with applications on behalf of the Secretary of
State. This list - Part IX of the Drug Tariff - is of
the appliances and chemical reagents which general practitioners
are able to prescribe at NHS expense.
2.
Part IX has four sections:
- Dressings,
bandages and certain other appliances;
- Incontinence
appliances;
- Stoma
appliances;
- Chemical
reagents.
3.
The Drug Tariff is published monthly and is available
from Stationery Office Bookshops and the Stationery
Office Publications Centre.
4.
Manufacturers wishing to supply appliances and chemical
reagents for the GP prescribing market must seek approval
from the Department of Health for inclusion of a product
in Part IX. The Regulations mentioned above provide
that the Drug Tariff shall state the prices at which
the dispenser's reimbursement for appliances is to be
calculated.
5.
This guidance document has been compiled by the Department
of Health in conjunction with the Part IX Drug Tariff
Industry Forum to assist companies submitting a product
for inclusion in Part IX.
Geographical
basis
6. The Department of Health's responsibilities in
relation to Part IX of the Drug Tariff now extend only
to England. However, for the present, the National Assembly
for Wales is operating a common policy with the Department
of Health and the Drug Tariff is published as covering
both England and Wales, any differences that do arise
being noted in the text. The arrangements as regards Scotland
and Northern Ireland are unchanged in that separate Drug
Tariffs continue to be maintained in both countries. The
formal position is that separate applications to Wales,
Scotland and Northern Ireland are not necessary in that
a listing consideration in those countries will always
follow any decision in England. However, the Department
of Health will not be in a position at any stage to predict
what the decision in Wales, Scotland or Northern Ireland
might be.
Nurse Prescribing and Supplementary Prescribing
7.A listing in Part IX enables products to be prescribed
on the NHS by GPs, Nurse Independent Prescribers and
Pharmacist Independent Prescribers. Qualified Supplementary
Prescribers can prescribe listed Part IX products under
agreed Clinical Management Plans (nurses, pharmacists,
physiotherapists, chiropodists/podiatrists, radiographers
and optometrists can train as Supplementary Prescribers).
Medical Devices
8.
Medical devices are regulated in the UK under Regulations
implementing three EC Directives: Directive 90/385/EEC,
for active implantable medical devices; Directive 93/42/EEC
for medical devices generally; and Directive 98/79/EC
for in vitro diagnostic medical devices (IVDs). These
Directives provide the regulatory framework to ensure
that medical devices throughout the European Union are
safe and of adequate quality and performance to fulfil
the manufacturers' intended purpose. Acting on behalf
of the Secretary of State, the Medicines and Healthcare
products Regulatory Agency (MHRA) discharges the responsibility
of the UK Competent Authority for the purposes of both
Directives.
9.
Regulations implementing the IVDs Directive came into
force on 7 June 2000 and include a transitional period
until 7 December 2003, after which date manufacturers
must comply with the legislation. IVDs which conform
with existing national legislation and are already in
the distribution chain at the end of the transitional
period can continue to be supplied to the end user for
a further two years (ie until 7 December 2005).
Criteria for inclusion of products in Part IX
10. There are three criteria for the inclusion of
products in Part IX:
- The
products are safe and of good quality;
- They
are appropriate for GP and, if relevant, nurse prescribing;
- They
are cost effective.
11.
In relatively rare cases, NHSBSA may seek independent advice
bearing on these issues. The responsibility for the eventual
decision will, however, remain with the NHSBSA.
Safety and Quality
12. Under the EU Directives all products which fall
within their scope and are placed on the market within
the EU are required to carry the CE marking. Exceptions
to this are custom-made devices, devices for clinical
investigation (ie, devices which are themselves to be
the subject of investigation in a clinical setting) and
systems and procedure packs which do not bear the CE marking.
The Department will normally consider all products which
carry a CE marking to be safe and of an acceptable quality.
Any suspected infringements of the Directives are, however,
likely to be reported to the MHRA who may take enforcement
action.
13. The majority of the appliances listed in Part IX are
covered by the two Directives. However, certain products,
for example, deodorants, fall outside the scope of the
Directives and of the MHRA. The Department will continue
to look into the safety and quality aspects of these.
Appropriateness for GP (and Nurse) Prescribing
14. This criterion is similar to but slightly narrower
than the earlier "appropriateness for use in the
community". It reflects the fact that appliances
may be supplied for community use by means other than
GP (or nurse) prescribing and that some appliances may
be appropriate for use in the community but not for prescribing.
An example would be a product which it would be more appropriate
to make available on loan to a patient rather than prescribing
it, when it becomes his property.
15.
This criterion would not be satisfied if the product
in question could only be used in a hospital setting;
it would be satisfied if the use of the product in a
community setting and its prescribing by GPs was appropriate.
It will generally be taken to extend to all similar
products. Consideration of this criterion is therefore
likely to be necessary only when similar products have
not been listed in Part IX before.
16.
Products considered appropriate for GP prescribing will
usually be for self administration by the patient, perhaps
with the help of a carer. Some products may, however,
need to be administered by a doctor or other health professional.
However, such products should not require enhanced training
of the doctor or health professional specifically in their
use.
Cost Effectiveness
17. Issues of cost effectiveness boil down to whether
it will be sensible for the NHS to buy the product in
question. The two main considerations are:
- Whether
the product should be reimbursed at all.
- Cost.
There are two aspects:
- The cost of using the product in a given treatment
regime compared with the cost of the most effective
alternative treatment regime (or no treatment regime
if there is none currently available).
- The price of the product compared with the price
of similar products. (Whether or not a product is
"similar" to other products may itself be
a matter for discussion between NHSBSA and the applicant
- certainty may not be possible on either side in
advance of such discussions.) .)
18.
The following paragraphs discuss these points in greater
detail.
Whether the NHS should reimburse at all
19. This issue may arise if similar products have
not been listed before. The EU Directives govern the placing
of products covered by them on the open market. It is
not the case that products which satisfy the requirements
of the EU Directives will necessarily be reimbursed by
the NHS if, for example, the product is for a purpose
which does not form part of NHS services or if provision
of the product via prescribing would be unaffordable.
Cost compared with alternative treatments
20. This issue may also arise if similar products
have not been listed before. The NHSBSAs consideration will
centre on the question of whether other products/treatment
regimes are available which deal with the condition in
question cheaper and/or more effectively.
Cost
compared with similar products
21. This question may arise if similar products have been
listed before. See the "Pricing" paragraph below.
Negotiation
22.
There may a degree of negotiation in the agreeing of
a price between the applicant and the NHSBSA. This will
tend to be a more necessary feature if information enabling
acceptable comparisons to be made is unavailable.
Evidence
required
23.
This will depend on the circumstances of each application.
Bearing in mind that the object of the exercise is to
demonstrate that it is sensible for the product to be
prescribable by GPs (or nurses) on the NHS, the need for
evidence is likely to be greater if similar products have
not been listed before. But applicants may also be asked
to support their case with evidence if they are asking
for a higher price than apparently similar products which
have been listed before. Where questions arise over the
appropriateness of listing, NHSBSA will explain their concerns
and be prepared to clarify to the applicant what evidence
might meet those concerns.
24.
If questions arise over the cost effectiveness issues
the NHSBSA will explain to the applicant exactly what its
concerns are and will be prepared to clarify to the
applicant what evidence would be likely to address the
concerns.
25.
Depending on the nature of the NHSBSAs concerns, such
evidence may need to include clinical data to demonstrate
that the product delivers any clinical benefits claimed
or that physical characteristics claimed are of clinical
significance.
26.
Companies may want to be clear, by discussion or through
correspondence, exactly what the NHSBSA wants and why before
embarking on any costly, special, work which it would
not want for its own purposes.
Listing
decisions
27. Two types of listing decision are available:
- Acceptance
- the GP may prescribe on the NHS for any patient
or condition for whom he considers the appliance appropriate.
-
Rejection - the appliance may not be prescribed by
GPs on the NHS. Prior to a formal rejection decision,
NHSBSA will issue a "minded to reject" letter
outlining why the application does not meet the selection
criteria. The applicant will respond in writing, within
a period of 28 days, either providing the additional
supporting evidence required or setting out proposals
to collect the additional evidence in support of the
application. The NHSBSA will make a final decision within
28 days of the applicant submitting the additional
evidence.
Applications for review
28. An applicant may submit a request for a review
of a rejection decision by NHSBSA. Applications for review
are limited to:
i)
NHSBSA not having acted fairly and in accordance with this
guidance document;
ii) NHSBSAs decision is perverse in the light of the evidence
submitted.
The
application for review must be made in writing no longer
than 15 days following notification by NHSBSA of the rejection.
The Review Panel will consist of at least one Non-Executive
Director of the NHS Business Services Authority (NHSBSA) who will chair the panel, an officer
or nominee of an appropriate trade association and a
third [neutral, with neither NHSBSA nor trade association
interests] member to be agreed between the two parties.
Secretariat function will be undertaken by NHSBSA.
Review
panel members will have had no prior involvement with
the application under review. The place and time of
meetings will be agreed with panel members. The Review
Panel will consider only the written documentation and
evidence obtained by NHSBSA in connection with the application.
The applicant will not be present and there will be
no oral presentations. The Panel's final decision,specifying
the reasons, will be notified in writing within 14 days
of the hearing. The review mechanism is not intended
to affect other legal rights of challenge.
Pricing
29. The Department has reached agreement with industry representatives
on a number of issues in connection with Part IX. Two
are of direct relevance to the costs/pricing question.
Attached are:
- At Annex A:
a statement by the Department on settling the entry
price of products.
- At Annex B:
an agreement reached between the Department, NHSBSA and
the Drug Tariff Forum on price rises. In reaching this
agreement the Drug Tariff Forum represented all relevant
manufacturers.
The
Application Procedure
30. Manufacturers or suppliers should complete an
application form, DT1,
for each product they seek to include in Part IX. A copy
of the form, together with one sample of the product,
should be sent to the Pharmaceutical Services Manager,
NHS Business Services Authority, Prescription Pricing
Division, Bridge House, 152 Pilgrim Street, Newcastle-upon-Tyne,
NE1 6SN. Spare application forms may be obtained from
the NHS Business Services Authority, Prescription Pricing
Division. .
31.
Product samples should be identical to the final product,
though not necessarily from a production run if this
is impractical. The text of the proposed labelling should
be final though it may be presented in mock up form
if the finally produced version is not available.
32.
The NHS Business Services Authority will acknowledge
each application within 7 working days of receipt.
Procedure
to remove products from Part IX
33. This procedure applies to products listed in Part
IX - Appliances. Those products which have not been prescribed
during the previous twelve calendar months - using data
from the NHSBSA database - will be eligible for removal
from Part IX. The criteria and procedure to be applied
are set out in Annex
C.
Contact
details
For
further details please contact:
Pharmaceutical Services Manager,
NHS Business Services Authority,
Prescription Pricing Division,
Bridge House,
152 Pilgrim Street,
Newcastle-upon-Tyne,
NE1 6SN.
Telephone: 0191 203 5276
email: Helen.Kendall@ppa.nhs.uk
ANNEX
A
STATEMENT
BY THE DEPARTMENT OF HEALTH ON THE ENTRY PRICING OF
PRODUCTS
1.
In the case of products similar to products already
listed, NHSBSA will generally aim to ensure that the price
of the new product is broadly in line with those already
listed. If applicant companies want, at the time of
application, to suggest factors supporting the price
they are seeking they are free to do so.
2.
NHSBSA will take applicants' suggestions into account in
reaching their views. There is no obligation on companies
to volunteer suggestions if they do not wish to, though
it may save time if it means NHSBSA does not have to ask.
Whether they do or not NHSBSA will reach provisional decisions
on entry pricing and will tell the applicant company,
with an explanation of their reasoning. It will then
be open to the company to make any points, or further
points, it wishes. Listing will not go ahead until NHSBSA
and the company are agreed, among other things, on the
entry price.
3.
It is open to companies to say, with reasons, which
product or products it would be appropriate to compare
their new product with. If the entry price sought by
the applicant is different from similar products it
is open to companies to say why. The following may be
relevant:
Any
anticipated difference in cash costs to the NHS arising
from use of the new product (because, for example,
of different product durability or different quantities
required);
Any
anticipated differences in patient benefits arising
from use of the new product (e.g., comfort, ease of
patient application, speed of recovery);
Any
other anticipated impacts within the NHS (eg savings
of staff time, greater ease of disposal). Note that
it would be difficult for us to reflect such factors
in the entry price unless any savings are actually
realisable.
4.
It is recognised that considerable investment in research
and development costs might be incurred in developing
new products or treatment regimes. In some instances
applicants might be seeking higher prices to reflect
the investment they have incurred. However, the Department
and NHSBSA have a duty to ensure that the NHS gets value
for money. Therefore, applicants requesting a listing
for new products or treatment regimes for which there
are no listed comparators should provide satisfactory
evidence of improved outcomes/savings/patient benefits
commensurate with the requested price. NHSBSA, having accepted
that a product is suitable for listing, will negotiate
a price on the evidence submitted by the applicant.
ANNEX B
PART
IX OF THE DRUG TARIFF: AGREEMENT ON PRICE RISES
[The
agreement was set out in a letter from the Department
of Health to the Drug Tariff Forum dated 10 March 2003,
the text of which was as follows.]
1.
I am writing to record the agreement ratified at the
meeting on 19 February 2003, on the formula for price
rises of products listed in Part IX of the Drug Tariff.
The agreement will apply to price rises coming into
effect from 1 April 2003 for a period of three years.
2.
The agreement is between the Department of Health (DH),
the NHS Business Services Authority (NHSBSA), which administers
the arrangements on behalf of the Secretary of State,
and the Part IX Drug Tariff Forum deemed for this purpose
to represent companies marketing products listed in
Part IX of the Drug Tariff.
3.
The agreement is not intended to be legally binding
on either DH, NHSBSA, ABHI or the companies marketing listed
products. Neither is the agreement intended to create
legal rights or obligations in respect of any person.
ABHI will use its best endeavours to ensure that the
companies adhere to the agreement.
4.
NHSBSA will ensure that any companies which apply for a
Part IX listing, are informed that price rises will
be determined in accordance with this agreement.
5.
This agreement applies to price rises for which NHSBSA
agreement may be sought periodically in respect of listed
products. The agreement applies to both branded and
generic products.
6.
Companies may seek price rises for a particular product
once a year or any longer period which they may determine.
If price rises are sought at intervals longer than one
year, the amount will not be greater than if they were
sought at annual intervals. However, this will not prevent
NHSBSA from considering financially neutral applications
from companies wishing, for example, to change the dates
of their pricing year.
7.
The maximum price rise will calculated as being the
forecast of the gross domestic product (GDP) deflator
minus 0.75 percent. For applications made in accordance
with this agreement the maximum so calculated will apply
to individual products and NHSBSA will grant the maximum
amount unless the company applies for less. However,
higher rises for some products will not be granted even
if offset by lower increases for other products.
8.
The forecast of the GDP deflator to be applicable will
be the Treasury forecast for the following financial
year current on the date the written application for
a price rise is received by NHSBSA. Information relating
to the latest forecast on the GDP for the following
financial year can be found on the Treasury
Website.
Applications
for price rises should be sent by companies so as to
be received by NHSBSA at least three months before the
price rise is intended to take effect.
9.
The calculation of price rises shall be to one tenth
of one penny (the unrounded sum). The price rise will
be granted to the nearest penny (the rounded sum), sums
of 0.5 of a penny being rounded up. The next periodic
calculation shall be from the unrounded sum. No price
rise will be granted where the calculation of the unrounded
sum does not produce a new rounded sum. NHSBSA will
notify companies of both the unrounded and rounded sums.
10.
NHSBSA will consider applications for additional price
rises for a category or categories of products where
cost pressures are being incurred in exceptional circumstances;
for example, raw material shortages where suitable alternatives
are not available or the imposition of statutory duties
with a recognised cost impact. Such applications, with
supporting evidence, should be submitted to NHSBSA by
the Part IX Drug Tariff Forum on behalf of companies
in the affected sector. NHSBSA will determine the period,
not less than three months, for which successful applications
will be applied.
11.
The parties to this agreement will attempt to resolve
any disputes in good faith. Any changes or additions
to the agreement will only take effect if expressed
in writing.
ANNEX C
MECHANISM
FOR REMOVING ITEMS FROM DRUG TARIFF
PART IX
Introduction
The
Drug Tariff Part IX - Appliances has developed in time
to be a large section of approximately 320 pages containing
those medical devices and chemical reagents that can
be prescribed by G.P. and nurse prescribers on prescription
form FP10 at NHS expense. The current Drug Tariff process
for medical devices does not have an agreed procedure
for removing products from the Drug Tariff. The Drug
Tariff could therefore contain products that have become
inappropriate, or not clinically effective for prescribing
on an FP10 prescription form. This paper sets out the
proposed criteria for removing medical devices from
the Drug Tariff Part IX.
Criteria
Discontinued
Drug Tariff Part IX Medical Devices
On notification or confirmation in writing that a Drug
Tariff Part IX Medical Device has been discontinued,
these appliances will be automatically removed from
the Drug Tariff Part IX with three months notice of
deletion.
The
notice of deletion will also be included in the preface
one month prior to removal from the Drug Tariff.
Drug Tariff Part IX Medical Device, which have not
been prescribed in the previous twelve calendar months
For all products listed in the Drug Tariff Part IX -
Appliances. Those products, which have not been prescribed
in the previous twelve calendar months - using data
from the NHSBSA Drug Database will be eligible for removal
from Part IX. Care will be taken to ensure that products
are not removed unnecessarily e.g. there is no intention
to remove single products from a range, and also where
there is a likelihood that the product will be prescribed
in the future.
Medical
Devices listed by Brand Name
The NHSBSA will inform the manufacturer or supplier
of the medical device, by letter that the medical device
has not been prescribed on prescription form FP10 in
the previous twelve calendar months.
If a manufacturer contacts the NHSBSA within 28 days
with valid reasons why their product should not be removed
the listing will remain.
Following
a period of twenty-eight days the medical device will
be marked in the next edition of the Drug Tariff with
three months notice of deletion. The notice of deletion
will also be included in the preface one month prior
to removal from the Drug Tariff.
Medical
Devices included under a generic category
Some medical devices can be prescribed if they meet
the technical specification for a generic category and
these products are not listed by their brand name. E.g.
Absorbent Cotton BP 1988 and Gauze Swab Type 13 Light
BP 1988, Sterile.
The
NHSBSA will inform the Department of Health and the
Association of British Healthcare Industries by letter
that no medical devices have been prescribed under the
generic category on prescription form FP10 in the previous
twelve calendar months.
Following
a period of twenty-eight days the generic category will
be marked in the next edition of the Drug Tariff with
three months notice of deletion. The notice of deletion
will also be included in the preface one month prior
to removal from the Drug Tariff.
Appeal
procedure
There
will be no formal appeal procedure. Manufacturers and
suppliers will use the application procedure to reapply
for a product to be listed in the Drug Tariff Part IX
if this is appropriate.
Start
Date
The mechanism will be implemented from 1st April 2003.
APPLICATION
FOR APPROVAL OF PRODUCTS UNDER PART IX OF THE DRUG TARIFF
FOR GP AND NURSE PRESCRIBING - Form DT1
Please
select the appropriate link to download the application
form DT1.
|
