Advice Pool - Insurance

Cosmetic surgery, in its true sense, is an elective procedure that is performed to reshape or enhance b

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

ody parts a patient may find unflattering. Since cosmetic surgery has an intrinsic aesthetic intent, it

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

Examples of combination products may in

is usually not covered by health insurance. The argument put forth by insurance firms is that a person

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

can very well do without cosmetic surgery, and the procedure is used for mere beautification instead o

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

f being a life saving surgery. On the other hand, reconstructive surgery is generally covered by health

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

Combination pro

insurance, though the extent of coverage may vary a lot from one case to another.

In many ways, the a

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

nswer to the insurance question lies in discerning whether the plastic surgery procedure is cosmetic or

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

reconstructive. For instance, abdominoplasty (or tummy tuck), when performed on an obese patient to gu

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

ard the patient against heart problems, is eligible for health insurance. Breast reduction surgery, whe

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

n carried out with the intent of reducing weight of the breasts to curtail orthopedic pain, is typicall

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

covered by health insurance. On the other hand, breast implants or augmentations are performed with th

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

Following aspects would a

e aesthetic aspect in mind and, therefore, don’t normally qualify for an insurance.

There is a fine li

dd to the challenges in developing combination products:

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

ne dividing the two categories of plastic surgery, namely cosmetic and reconstructive surgery, as far a

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

s eligibility for insurance is concerned. For instance, eyelid surgery, when performed to attain an aes

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

thetic enhancement is considered cosmetic and ineligible for insurance. The same procedure may be cover

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

ed by insurance if the eyelids are drooping to the extent of obscuring a patient’s vision. The hard fac

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

Professional from academic institutions, pharmaceutical industries, health care indust

t remains that most of the plastic surgery procedures are performed with an aesthetical intent, in orde

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

r to enhance alluring portions of the body.

To summarise, plastic surgery that is performed to improve

.

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

function instead of aesthetics is normally eligible for an insurance cover. However, it’s best to disc

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

Companies that provide selfless information through particip

uss your case with an insurance agent, in order to determine if you are eligible for an insurance cover

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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