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Patient Access Schemes The NHS View (Risk Share). By Kevan Wind Medicines Procurement Pharmacist London and East of England. First a little digression!!!. By Kevan Wind. A Personal View Change the Name from Pharmaceutical Price Regulation Scheme (PPRS) To.

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Patient Access Schemes

The NHS View

(Risk Share)

By Kevan Wind

Medicines Procurement Pharmacist

London and East of England.


First a little digression!!!

By Kevan Wind

A Personal View

Change the Name from Pharmaceutical Price

Regulation Scheme (PPRS)


Pharmaceutical Profit Regulation Scheme



  • Because that is what it really is.
  • Operates as a control on profit but allows prices to be set high.

Remember I am a Simple Man

You can make profit from few sales of a high cost product


Lots of sales from a low cost product


The NHS has a problem

Too many patients to treat and not enough money.

Expensive Medicines

Sales of medicines tend to rise if the price goes down. (Elastic demand)

Especially if price has been a constraint.






ondansetron oral usage units
Ondansetron Oral Usage – UNITS

Source: IMS Health, HPAI, Dec 07

omeprazole oral usage units
Omeprazole Oral Usage – UNITS

Source: IMS Health, HPAI, Dec 07


The German Generics Market - What happens after Patent Expiry Omeprazole-Performance (Volume) after Generic Launch

Source: IMS Health

oxaliplatin usage total mg s
Oxaliplatin Usage – TOTAL MG’S

Source: IMS Health, HPAI, Dec 07

clozapine usage units
Clozapine Usage – UNITS

Source: IMS Health, HPAI, Dec 07


So My Thesis is That TRUE partnership =

A relationship where the price of the medicine is set at one

that the NHS can afford

On the basis that we treat an agreed number of patients.

You get your profit….. We treat our patients.


Some Potential Issues

    • Reference Pricing.
    • Demand might be inelastic
    • Money used on other health priorities
    • Difficult to explain to boards and shareholders?
    • Also Norman Evans effect (Fluoxetine)
  • BUT
  • It would be a fundamentally moral arrangement that would give us what we need.
  • We can link price to volumes in a framework contract.
  • And don’t forget the patients………… or many of your mission statements.

Patient Access Schemes(Risk Share)

This should be their fundamental purpose……………….

To reduce the effective price so that more patients can be treated.

Are fundamentally inferior to a straightforward price reduction

Are costly and complicated to administer


PJ 29th March 2008 reported (Cancer Network Pharmacists Forum)

  • Three scenarios for risk sharing schemes
  • Where a company wants to get a foothold in the market before NICE appraisal.
  • Where a company wishes to reduce the cost per QALY after a negative NICE appraisal.
  • Where a company wishes to reduce the cost per QALY and allow the product to hit the NICE threshold.
In my view this misrepresents true Patient Access Schemes

Schemes should NOT bypass or undermine

normal NHS approval mechanisms.


Some schemes are masquerading as Patient Access

  • Is potential for abuse and some schemes may be marketing opportunities not true Patient Access Schemes.
  • DoH have a set of criteria
  • Need to come up with a clear definition
            • Long term
            • Agreed definition (DoH / NHS/ ABPI)
            • Conforms with best practice.

Not a New Idea

Antiemetic effectiveness contract 10 years ago.

(Relied on measuring volume of vomit so not very popular)

MS Risk Share Scheme (for Beta interferon ) 2003

Allowed 10,000 patients to be treated.


Straw Poll of Pharma reveals

  • Limited number of schemes being envisaged
  • Caution about the unpredictability of financial risk
  • Caution about the rigidity of the arrangements
  • Mostly a UK solution (by-product of NICE approval process)(Italy has some schemes Sutent, Tarceva, Nexavar)
  • May be a response of slow (or appropriate) uptake of new medicines by NHS(commercial survey result shows NICE Networks and PCT influence uptake).
  • (thanks to those involved)

NHS Position

DoH Authorising some schemes

Comply with NICE guidance

Meet DoH criteria

DoH specialist in this area.

“Exception rather than the rule”


Paper from BOPA

Paper from NPSG for discussion with ABPI

Unusually is essential agreement!


The schemes should allow greater access to medicines and may speed uptake, something which the NHS has been accused of failing to manage in the past. They are by definition value based and give transparency to outcomes. They are however potentially administratively burdensome especially if they multiply and have the potential to overburden the clinical staff who should be involved in patient care not financial reconciliation.

Summarised in editorial in Hospital Pharmacist Vol 15 No 4 p114

NPSG Paper


DoH only looking at NICE approved treatments.

PCT / Trust medicines management procedures must still be followed.

Scheme should be assessed in same way as new medicines (London New Drugs Approach).


Advantages of Schemes (to NHS)

Patient Access schemes make medicines available to the UK in the global arena of linked market prices but with localised cost effectiveness targets (e.g. cost per QALY).

Healthcare should be improved with the right patient being treated at the right time.

Speed of uptake of new medicines could be improved.

The system is by definition a value based one.

Outcomes of treatment will be in the public domain.

Sales of medicines will be increased and profitability of manufacturers could be improved.

There will be increased opportunities for partnerships between industry and the NHS within these schemes.


Problems with Schemes

Schemes have potential to be administratively burdensome with a danger that the extra workload will fall on clinical staff. The burden is cumulative with increasing numbers of schemes.

Financial flows in the new NHS are complex and there is a need for reconciliation of responses and financial flows between providers and commissioners.

Schemes may require the transfer of individual patient data with the resultant need for confidentiality.

Auditing of the schemes may be complex as all sides (industry commissioners and providers) need to be assured of fairness.

There is a need to agree mechanisms for measuring clinical criteria (who will measure what).

Specific objective measures of clinical response are not available for all treatments.

As clinical experience grows and responses improve the return to the NHS could fall.

Clinicians may treat more freely with “free” medicine.

There is the potential for abuse of the schemes by all parties.


Recommended features of ideal schemes

BOPA and NPSG Positions essentially in agreement.



Jointly Developed Schemes 1. Calls for discussion with commissioners(industry, commissioners and providers) 15. Calls for single local mechanism for approval of schemes locally.

One Preferred Model 4. Flexibility in how scheme operates. 11. Should be a consistent approach to approval

Simplicity of Arrangements 12. Schemes are offered across the whole NHS

13. If scheme ceases prices should remain constant.

14. If scheme ceases NHS should have contingency arrangements.

Clear Financial Flows 2. Trusts must have robust financial processes for dealing with reconciliation of pt outcomes with pay back

schemes to commissioners.

4. Actual price paid recorded on pharmacy systems

Prices do not vary 5. Prices should be reflected in HRG payments.

9. Discounted prices should be available to NICE

16. NHS have contingency for dealing with cessation of scheme.

Infrastructure Costs Agreed 8. Information collected by appropriate staff. May need

Data Manager may be needed. extra establishment.

States need for patient confidentiality 7. No patient identifiable information used.

10. DoH needs to establish a position on interim schemes.

Have agreement with ABPI Supply Chain Group and NPSG to work on a joint approach to define “Best Practice”

So Patient Access Schemes could be described as being rather Like these ladies

Whilst they have many desirable features, the costs of becoming involved with too many of them is likely to be high.

(High Maintenance)

So perhaps one should limit one’s experience to just a few!



Cautious welcome from the NHS

Schemes must be jointly agreed & not bypass normal approval mechanisms

Schemes must be easy to administer

Costs for NHS must be taken into account within the scheme.

Payment delayed until agreement about continuing scheme?

But if my poll is to be believed we are not going to be inundated with them

So if they are set up and managed appropriately this could be a win win.

NPSG / ABPI “Task and Finish Group” being set up to come up with

a Best Practice Approach.