Iforg Limited webBlog

by Kazeem Olalekan MRPharmS

Pfizer has decided to withdraw its novel inhaled insulin, Exubera..not because of safety problems…not beacuse of negative response from patients but because ‘too few patients are taking EXUBERA’ (1)

How could this be? Diabetic patients have been crying for a less painful way of administering insulin for years..Here is a product that requires no injection but prescibers are not using it.

Low take up should have been anticipated

If you examine the datasheet for this product closely you will find that there are specific reasons why the low take up of this product is not surprising. I have identified these below:

The prescriber will always play safe

Diabetes mellitus occurs because of a lack of insulin or resistance to its action. The decision to put someone on insulin is generally the last resort for type 2 patients and the mainstay for type 1 patients. The effect of inappropriate control of blood sugar can result in serious consequences for the patient - retinopathy, neuropathy and nephropathy to mention a few.

Let us forget about the evidence for one moment (these are undoubtably important). Exubera is inhaled - yes. Another class of drug which are administered by inhalation are drugs for relieving asthma and other respiratory conditions. The evidence here for the appropriate use of inhaled medication is not good. It has been suggested that one of the reasons for poor asthma control is the inappropriate use of the devices. The prescriber has this at the back of his mind.

Diabetes is a strong risk factor for cardiovascular disease. A significant proportion of patients presenting with Diabetes (especially type 2 ) probably have other risk factors such as smoking, hypertension and obesity. Well you can’t use Exubera if ‘You smoke, start smoking, or if you quit smoking less than 6 months ago; You have an unstable or poorly controlled lung disease (such as unstable or poorly controlled asthma, chronic obstructive pulmonary disease, or emphysema)’ (1)

That rules out a lot of candidates then.

When you put all of these in the pot…the patient is either excluded or the prescribers will stick to tried and tested interventions.

Getting the pricing right

If Pfizer accepts that this is not going to be a drug for everyone, it must price the product appropriately. Less volume, more expensive drug. With tight squeeze on NHS drug budgets, it will be difficult, if not impossible, to allow an expensive inhaled insulin to be freely prescribeable. PCT will watch the pattern of prescibing this drug like a hawk (well…understandably!). In actual fact, I feel Exubera is reasonably priced considering the time and costs of developing this delivery system (table 1):

Undoubtedly, this drug will not be for everyone. It will only be suitable for a niche patient group. Hence Pfizer pricing model should have reflected this. I don’t have the facts but I suspect, Pfizer was less conservative with its estimations of target patients (why else will there be a need to withdraw the product now?). Should the price have been set higher, with the proviso to reduce price or even refund some cash to the NHS if take up of drug prove to be higher?

General Practitioners want new ways of treating conditions which will bring benefits to the patients and I suspect they will actively look for patients who will benefit from the use of a particular new drug.

My Concern

You lure patients into the promise of a novel intervention and then have to withdraw it because not enough people has taken it up! What happens to the patients already stabilised on this therapy? I am sure we all agree that this is a useful drug…why not give it a chance.

My challenge to pharmaceutical companies is this…when pricing a new drug, be realistic about the potential take-up of the product and price the products appropriately. This threat of withdrawal or intention to withdraw is no good to anyone.

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This entry was posted on Monday, October 22nd, 2007 at 9:58 pm and is filed under Viewpoint. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.