Advice Pool - Insurance

Most people will be familiar with insurance in some form or another. We all have taken out home insurance, car insuranc

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

e or credit insurance among others. Insurance contracts are long and complex documents with a lot of small print. Somet

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

mes even a lawyer would get lost in the complexities involved in them. However, there are a few features that all insur

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

nce contracts must have in common.

All insurance contracts will cover a chance event that may or may not occur. T

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

is is the risk you are insuring against. The event may be a fire in your home, a car accident, medical costs or virtual

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

y any other event. The sole exception to this is life insurance, which covers your death. This is an event that is boun

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

to occur, however, it is the timing of death that is uncertain here.

There must be some quantifiable economic lo

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ss. Insurers will take on risks, but they must be able to quantify and predict the loss involved. The insurance company

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

must be able to know roughly what kind of loss will be involved should the event occur. The loss must be quantifiable i

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

monetary terms. For example, you may be able to insure yourself for medical expenses or a new car, but not for the sad

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ess you experience as a result of an accident.

The loss must be definite. Again, insurers must know what kind of

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

inancial risks they are taking one; otherwise they will not be able to set the price of the premium.

The loss mus

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

be significant. The financial cost of the insured risk must justify the administrative costs of the insurance contract

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Suppose you want to insure a racehorse. Someone will come from the insurance company, assess the value of the horse, w

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

rite up a contract stating what’s covered and what conditions you must meet, calculate the premium and issue the contra

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

t. This will be worth all the effort for a valuable racehorse. However if you wanted to insure your goldfish, it would

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e difficult to justify the effort involved in setting up the contract.

The loss must not be catastrophic. What is

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

catastrophic will depend on the size of the insurer and the assets they have available. But the insurance will not be w

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rth anything if the loss is more than the insurer could afford. For example, insuring against an earthquake will often

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e impossible as the losses, should the event occur, would be impossible for the insurance company to ever pay out.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice Pool - Insurance: The Common Insurance Points

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