Rational Prescribing

Question 1

What are the strategies to achieving efficiency in health care; ‘maximum’ total benefit from a finite number of resources?

Answer 1

a) From moving resources from one program to another
b) Allocative efficiency; how to best make use of the resources you already have
c) Technical efficiency; most efficient way to execute it after choosing decision

Question 2

How does efficiency in healthcare apply to medicines and pharmacy?

Answer 2

a) Efficiency of individual drug therapies
- Drug vs. drug
- Drug vs. surgery
- Drug vs. nothing

b) Economic implications of a pharmacy service e.g. visiting nursing homes, providing domiciliary visits, New Medicines Service (NMS), GP practice pharmacist service.

Question 3

Why is there a need to use Economic Evaluations in Formulary Decision Making? What is required for this process?

Answer 3

Decisions to add new drugs to list or delete old ones:

• Who bears drug cost
• Consider economic impact beyond acquisition costs: toxicity, monitoring, impact on length of stay (LOS) and admissions, cost shifting, primary care
• Cost effectiveness of medicines ‘4th hurdle’
• Cost effectiveness information required by some countries at licensing (e.g. Australia)
• UK; Central policy guideline uses economic evaluation post-licensing

Question 4

What information is required to license a drug in the UK?

Answer 4

MHRA:

• Safety and efficacy data
• Placebo controlled studies usual model
• Head-to-head studies NOT required
• Patient groups w/o co-morbidity
• Economic analysis NOT compulsory
• Patient preferences NOT compulsory

Question 5

What are the potential routes a drug takes after application for a marketing license?

Answer 5

• Application for marketing license
• MHRA licensing authority
• Available to prescribe in the UK

Then either:
> BNF approved, NHS Rx OR Blacklisted, private Rx

Then (NHS Rx):
> NICE
> PCTs, local formularies (CCG makes drug available in 3 weeks)

> Loss of patent

> Deregulation (generic/biosimilar)

Question 6

What considerations do NICE make when making economic decisions about a new medicine?

Answer 6

Evidence at appraisal committee:

• Epidemiological; how many patients?
• Clinical evaluations (RCT, meta-analyses)
• Economic evaluations
• Expert clinician and patient views
• Manufacturers’ submissions
• Availibility of alternative treatment

Question 7

How does NICE use cost effectiveness?

Answer 7

• Cost per QALY, NHS and PSS perspective
• Threshold (or not); £20,000 - £30,000 per QALY
• Does not assess budget impact (YET)

Question 8

What exceptions are there to how NICE normally assess cost effectiveness?

Answer 8

“End of Life” (2009)
- No other treatment w/comparable benefits, <7000 patients, <2 years to live, >3 months extra survival, good quality evidence

Cancer Drugs Fund