Just Answers - Insurance

Health insurance plan is one of the most pleasing benefits you could offer your employees. Fo

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

llowing are the several basic options for setting up a plan:

A traditional indemnity plan or

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

Examples of combination products may in

fee for service: Employees select their own medical care provider; the health insurance comp

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

any either pays the provider directly or reimburses employees eligible for the covered amount

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

s.

Managed care: The two most common types of managed care are the Health Maintenance Organi

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

Combination pro

zation (HMO) and another one is Preferred Provider Organization. An HMO is basically a prepai

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

d health-care plan in which employees need to use doctors employed by or may be under contrac

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

t to the HMO and hospitals, which are approved by the HMO. Under a Preferred Provider Organiz

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

ation, the health insurance plan negotiates discounts with their particular physicians and sp

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

ecific hospitals. Employees normally choose doctors from the available approved list, and the

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

n usually pay a sum of amount per office visit (normally $10 to $25); the insurance company n

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

Following aspects would a

eeds to pay the rest.

Self-insurance: When you need to understand all or an important portio

dd to the challenges in developing combination products:

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

n of an existing risk, you are basically self-insuring yourself. Usually paperwork is handled

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

by an outside company, you just need to pay the claims, and sometimes employees assist payin

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

g the premiums. The benefits also include higher control of the health plan design, an effect

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

ive customized reporting procedures and great cash flow advantages.

Medical savings accounts

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

Professional from academic institutions, pharmaceutical industries, health care indust

: Congress of late concluded with a four year test of medical savings accounts , especially

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

on savings accounts coupled with high deductible insurance policies. Accounts are now funded

.

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

with employee’s pretax dollars; disbursements are absolutely tax free if used for specific ap

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

Companies that provide selfless information through particip

proved medical expenses. Unused funds are accumulated indefinitely and earn tax-free interest

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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