1. New application process for the listing of Medical Devices in Part IX of the NHS England and Wales Drug Tariff
Dr Joanna Lloyd, Senior Specialist Pharmacist
Miss Nikki Dodds, Pharmaceutical Specialist
NHS Prescription Services, NHSBSA

2. What we will cover The NHS England and Wales Drug Tariff
The current Part IX application process and why we identified the need for change
The new process outlined
How it will work
How it will be communicated
How it will be monitored
Questions

3. What is the Drug Tariff?
Regulation 89 of the National Health Service (Pharmaceutical Services) Regulations 2012 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 dispensed or expected to be dispensed in accordance with NHS prescriptions.
NHS Prescription Services deals with applications on behalf of the Secretary
of State.
Part IX of the Drug Tariff – this list – contains the appliances and chemical reagents, which can be prescribed by appropriate practitioners at NHS expense.

4. What does this mean in practice?
The Drug Tariff outlines
What will be paid to contractors for NHS services provided either for reimbursement (the cost of the drugs, appliances etc that a pharmacy or dispensing appliance contractor supplied against an NHS prescription form) or for remuneration (what they are paid as part of their dispensing contract with their local health trust for fees/allowances etc)
The rules that should be followed when dispensing
The value of the fees and allowances that will be paid
The drug and appliance prices that will be paid.

5. The Drug Tariff is not a product catalogue for promoting products
a clinical endorsement of the product
a prescribing tool for clinicians
a list of products that the NHS wholesales. There is no link between the Drug Tariff listing process and the NHS Supply Chain
We do not order, buy or market products listed in the Drug Tariff

6. Background to the process for applying for a Part IX listing
The Part IX application process has remained fundamentally unchanged since the Prescription Pricing Authority - now the NHS BSA – took the process over from the Department of Health in 2002.
NHS BSA deal with applications for a wide variety of products for which applicants require varying degrees of support to complete.
The increasingly diverse range of products being applied for has meant that any general advice has become more and more difficult to give, as well as becoming less useful for applicants.
NHS BSA must keep a ‘critical distance’ from the detail of the application, before formal assessment takes place.

7. Some Facts and Figures
During the financial year 2013/14 NHS BSA 334 applications:
6% ‘new’ products – Most would require a new Drug Tariff category/subcategory
13% line extensions
81% ‘me too’ products
Although only 6% are applications for ‘new’ products, proportionally these take far more time in terms of supporting the applicant to provide enough detail and in the assessment of the information.

8. Where does it all go wrong?
In 2013/14, the reasons applications could not be assessed without referring back to the applicant for further information were as follows:
Problems with certificates – 44%
No ‘declaration of conformity’ certificate – 31%
No confirmation of European Member State - 44%
No/incorrect Notified Body certificate - 25%
Problem with sample e.g. no sample, lack of sample labelling etc - 27%
Lack of information to support a premium price for “me-too”/ line extensions – 27%
Incomplete application forms – 4%, and 67% of these weren’t signed
Between April 2010 and April 2013, % of ‘me-too/line extensions’ application could be approved first time without going back to the applicant for further information. This continues to fluctuate with an unpredictable pattern and in the quarter July-October 2014 dropped to 16%.

9. The Pre-logging Process
The pre-logging process was introduced in 2010 to circumvent a growing problem whereby applicants were submitting incomplete applications in order to ‘get in the queue’.
This was causing problems for the NHS BSA as it held up the progress of complete applications and removed the incentive for applicants to make good quality, complete applications first time.
Now an administrative assessment is completed first, and any incomplete applications are acknowledged, and at the same time, any missing information is requested.
The application is not formally logged and is not ‘officially in the system’ until ALL the ‘basic’ information is received.
The ‘basic’ information does not include cost benefit analyses; an application will always be formally logged whether or not the cost-benefit evidence submitted is sufficient.

10. Why is a new process needed?
The aims of the ‘new’ application process are to
Improve work flow and efficiency –
Appropriate staff carrying out appropriate tasks: administrative staff support administrative tasks and specialist staff are free to provide technical support;
Reduces dual handling of applications by all staff – more applications should be able to go straight through to completion.
Enables the NHS BSA to provide more focused advice by making it easier to identify where the applicant is having problems and for NHSBSA staff to explain more succinctly what information is still needed;

11. Why is a new process needed?
Greater transparency to applicants - it should be more obvious
When they do not have the correct certification for their product;
When their application is not complete and has not been formally accepted into the process.
Rewards and reinforces the requirement for accurate and complete applications
Reduced wastage and cost through tailored advice regarding sample submission. We will ensure that the paperwork is correct and signed off before requesting samples.

12. New Process outline – Completion of DT1 Form(A)
No new information being requested.
Completion of DT1 form(A) - common to all applications (see examples)
As a general rule use more than one DT1 form(A) if the products being applied for are in different sub-categories/categories
Name and address of applicant
Proposed Drug Tariff category or suggested new Drug Tariff category
List of comparable products
Indication/use
Pack sizes e.g. 6 devices (not the physical dimensions of the pack)
Price and order codes
Estimated patient population and anticipated yearly sales volume
‘Readily available’
Original signature of a responsible person in the company in ink (no digital signatures accepted)

13. New Process outline – Completion of DT1 Form(B)
There are 6 options for DT1 Form(B)
The choice of the correct form will depend on the Class of the Medical Device
The form summarises the specific certification that is required for that particular Class of Device and takes the applicant through the process of checking the certificates.

14. What does ‘readily available mean’?
By ‘Readily available’ we mean that
The product(s) is available through the normal wholesale network and is stocked as a ‘standard line’ and not a ‘special’ obtain
You can choose to supply the product ‘on equivalent terms’ i.e. directly from yourself but the list price must include delivery, postage and packing.
It is important that the pharmacist or dispensing appliance contractor does not incur any extra charges when buying the product. For products listed in Parts IXA and IXR, these will not be reimbursed and the contractor will be left out of pocket if the charges are passed on.
The price applied for MUST include out of pocket expenses that may be incurred by the contractor.
Please do your research before you make an application!

15. What next?
DT1 Forms (A) and (B) should be signed and sent via to the usual address of Do not copy to individuals.
No samples or supporting evidence are required at this point.
An administrative assessment will be carried out by the NHS BSA to ensure that all the information and certificates are correct.
All this information must be correct before we request the samples.
Sending samples before being requested to do so will not expedite the process.

16. And then?
The NHS BSA will advise as to how many samples and labels are required.
Samples, evidence (if bulky) and labels need to be posted as usual, together with the final DT1(A) and (B) signed in ink (not a digital signature).
The whole application is then formally logged and joins the queue to be assessed in the usual way.
Forms can be sent by post and will be treated in exactly the same way as above.

17. Communication of the process
Implementation date was 1st December . Cut-off date after which no old application forms will be accepted is 31st January 2015.
A statement to notify applicants of the new process has been placed
On the NHS BSA’s website
On all the NHS BSA’s correspondence to applicants
It has also been made available to Trade Organisations to upload and inform members.
Step-by-step instructions have been placed on the NHS BSA’s website.

18. Transition period
The NHS BSA will accept the old forms for the period between the implementation (1st December) and cut-off date (31st January 2015), but applicants will be warned that after the cut-off date all applications on the old forms will be not be logged and will be returned for resubmission on the new forms.
Samples sent in with the old forms will be retained but applicants may be requested to send further samples once the paperwork has been assessed.

19. How will we monitor the success of this change?
Key Performance Indicators are already collected for the quarterly and annual Part IX statistics. Most these will still be relevant to the new process and a direct comparison will be possible.
Some may not be relevant anymore [e.g. whether the (correct) sample was provided or not]
We may be able to devise new ones (e.g. whether the correct DT1B form was selected)
Collection of this data will help us to decide whether the process is helping workflow and whether it is necessary to make any further adjustments to help applicants further.

20. Where will I get help?
There are instructions on the NHS BSA website information, together with the forms. There will also be a copy of this presentation uploaded onto the site.
Staff at the NHS BSA can help with very specific queries which should be ed to
Contact the secretariat of the Part IX Drug Tariff Forum at

21. Any Questions?

22. Confirmation of registration with the Competent Authority
This is an acknowledgement from the Competent Authority (the MHRA in the UK) that the manufacturer has declared to the Authority that they are operating under the appropriate Medical Devices Directive by fully complying with the essential requirements.
Not all Competent Authorities issue a written confirmation of registration. In this instance we will accept a letter on company headed paper confirming where the product is registered, contact details of the Competent Authority, and include relevant code numbers that refer to the manufacturer or products registered with the Authority. It should also be signed by a senior person within the company.

23. Declaration of Conformity
This is a declaration made by the manfacturer of a medical device to confirm that the product meets the requirement of the relevant directive (the Medical Device Directive 93/42/EEC or the In Vitro Diagnostic Directive 98/79/EC).
The declaration is usually made on company heaed paper and signed by a senior person within the company.
It should make reference to the product name or group of products to which it belongs and also make reference to which directive the product complies to.
The Declaration of conformity must cover all products being applied for on the DT1 form